New Drug Information

nusinersen

Spinraza

China status: Approved

Nusinersen sodium injection is a Biogen-marketed intrathecal antisense oligonucleotide for 5q spinal muscular atrophy. China approved the 12 mg/5 mL injection on 2019-02-22. The U.S. and EU have since authorized additional 50 mg/5 mL loading and 28 mg/5 mL maintenance strengths for the same SMA indication; this is a dose-regimen change, not a separate disease indication, and does not establish availability of those strengths in China.

Mechanism: A survival motor neuron 2 (SMN2)-directed antisense oligonucleotide that alters SMN2 pre-mRNA splicing to increase production of full-length survival motor neuron protein.

Developer: Ionis Pharmaceuticals developed nusinersen using its antisense technology; Biogen holds licensed global rights to develop, manufacture and commercialize Spinraza.

• 5q spinal muscular atrophy (SMA) · Approved indications

Overseas status: Spinraza is authorized in the United States for SMA in pediatric and adult patients and in the European Union for 5q SMA. U.S. FDA records show original approval on 2016-12-23 and approval of an additional high-dose regimen on 2026-03-27. The EU marketing authorization was issued on 2017-05-30; the European Commission authorized the 50/28 mg regimen on 2026-01-12. These overseas dose-regimen authorizations do not establish that the 28 mg/5 mL or 50 mg/5 mL strengths are approved or available in China.

China approval date: 2019-02-22

Source · Source

Updated 2026-10-24 · Details

osimertinib

TAGRISSO

China status: Approved

Osimertinib is AstraZeneca's oral EGFR inhibitor, marketed as TAGRISSO . It has been approved in China since 2017 and is an established imported originator medicine, not a pipeline-only or China-only product. In China, the established TAGRISSO programme covers selected EGFR-mutated non-small-cell lung cancer settings from resected early disease to locally advanced or metastatic disease; a separately approved savolitinib-plus-osimertinib regimen is also described by AstraZeneca for post-EGFR-TKI, MET-amplified disease.

Mechanism: A third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor that preferentially binds certain mutant EGFR forms, including T790M, L858R, and exon 19 deletions.

Developer: AstraZeneca

• Locally advanced or metastatic EGFR T790M mutation-positive NSCLC after progression on or after EGFR-TKI therapy · Approved indications
• First-line monotherapy for locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitutions · Approved indications
• Adjuvant treatment after complete resection of stage IB-IIIA EGFR-mutated NSCLC · Approved indications
• First-line treatment with pemetrexed and platinum-based chemotherapy for locally advanced or metastatic EGFR-mutated NSCLC · Approved indications
• Locally advanced, unresectable stage III EGFR-mutated NSCLC without progression during or after platinum-based chemoradiation · Approved indications

Overseas status: Approved in the United States and European Union. FDA records initial US approval on 2015-11-13; EMA records EU conditional marketing authorisation on 2016-02-02, converted to full authorisation on 2017-04-24.

China approval date: 2017-03-22

Updated 2026-10-24 · Details

lenvatinib (lenvatinib mesylate)

LENVIMA

China status: Approved

Lenvatinib mesylate is an oral multi-receptor tyrosine kinase inhibitor discovered and developed by Eisai. It is already approved in mainland China: the first approval was for previously untreated unresectable hepatocellular carcinoma on 2018-09-04. Official sources also document a China approval for radioiodine-refractory differentiated thyroid cancer in 2020-11 and a China-approved LENVIMA plus pembrolizumab plus TACE regimen for unresectable, non-metastatic hepatocellular carcinoma announced in 2025-07. United States and European Union approvals are established but the approved labels and combinations are region-specific.

Mechanism: Oral multi-receptor tyrosine kinase inhibitor targeting VEGFR1-3, FGFR1-4, PDGFRα, KIT and RET, thereby affecting tumour angiogenesis and growth signalling.

Developer: Eisai Co., Ltd. (discovered and developed in-house); Eisai and Merck & Co., Inc. entered a worldwide co-development and co-commercialization collaboration in March 2018.

• Previously untreated unresectable hepatocellular carcinoma (China, monotherapy) · Approved indications
• Progressive, locally advanced or metastatic radioiodine-refractory differentiated thyroid cancer (China, monotherapy) · Approved indications
• Unresectable, non-metastatic hepatocellular carcinoma (China; with pembrolizumab and transarterial chemoembolization) · Approved indications
• Advanced renal cell carcinoma (United States; specified labelled combination regimens) · Approved indications
• Advanced endometrial carcinoma (United States; with pembrolizumab for pMMR or not MSI-H disease under labelled conditions) · Approved indications

Overseas status: Approved in the United States and European Union. The current U.S. LENVIMA label covers radioiodine-refractory differentiated thyroid cancer, specified advanced renal-cell-carcinoma combinations, first-line unresectable hepatocellular carcinoma, and specified advanced endometrial carcinoma with pembrolizumab. The EU Lenvima authorisation covers differentiated thyroid carcinoma, hepatocellular carcinoma and endometrial carcinoma; renal-cell-carcinoma branding/authorisation differs in Europe (Kisplyx in many markets).

China approval date: 2018-09-04

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Updated 2026-10-24 · Details

secukinumab

Cosentyx

China status: Approved

Secukinumab is Novartis's IL-17A antagonist marketed as Cosentyx . It was approved in China in March 2019 for adult moderate-to-severe plaque psoriasis and has since received additional Chinese approvals. As of 2026-10-24, it is an approved imported medicine in China, not a pipeline product.

Mechanism: Fully human monoclonal IgG1/kappa antibody that selectively neutralizes interleukin-17A (IL-17A), blocking IL-17A-mediated inflammatory signaling.

Developer: Novartis

• Moderate-to-severe plaque psoriasis · Approved indications
• Active ankylosing spondylitis · Approved indications
• Active psoriatic arthritis · Approved indications
• Moderate-to-severe hidradenitis suppurativa · Approved indications
• Active non-radiographic axial spondyloarthritis with objective signs of inflammation · Approved indications

Overseas status: Approved and marketed internationally as Cosentyx, including in the United States and the European Union. FDA labeling states initial U.S. approval in 2015; EMA records EU marketing authorisation issued on 2015-01-14.

China approval date: 2019-03

Source · Source

Updated 2026-10-24 · Details

adalimumab

HUMIRA

China status: Approved

Adalimumab is the established anti-TNF-alpha originator marketed as HUMIRA , not a pipeline-only medicine. It was first authorised for import into China in 2010. A 2025 company announcement on an NMPA-approved biosimilar states that its eight approved indications are the same as the originator's China-approved indications. China marketing authorisation does not by itself establish local supply, reimbursement eligibility, or suitability for an individual patient. US and EU labels have their own jurisdiction-specific indication wording.

Mechanism: A fully human anti-tumour necrosis factor alpha (TNF-alpha) monoclonal antibody that binds TNF-alpha and blocks TNF-mediated inflammatory signalling.

Developer: Cambridge Antibody Technology; AbbVie Inc. (current originator owner and marketer)

• Rheumatoid arthritis · Approved indications
• Ankylosing spondylitis · Approved indications
• Psoriasis · Approved indications
• Crohn's disease · Approved indications
• Uveitis · Approved indications
• Polyarticular juvenile idiopathic arthritis · Approved indications
• Paediatric plaque psoriasis · Approved indications
• Paediatric Crohn's disease · Approved indications

Overseas status: Authorised in the United States: FDA licensed adalimumab under the HUMIRA proprietary name on 31 December 2002. Humira is also authorised throughout the European Union; EMA records marketing authorisation issued on 8 September 2003. Indication wording is jurisdiction-specific.

China approval date: 2010

Updated 2026-10-25 · Details

pembrolizumab

KEYTRUDA

China status: Approved

Pembrolizumab is Merck/MSD's PD-1-blocking antibody, marketed as KEYTRUDA . It is approved in China, with an initial 2018 approval for previously treated unresectable or metastatic melanoma; the current Chinese label has subsequently expanded. It is also authorized in the United States and European Union.

Mechanism: A humanized IgG4 kappa monoclonal antibody that binds PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of antitumor immune responses.

Developer: Merck & Co., Inc. (MSD outside the United States and Canada; Merck Sharp & Dohme entities)

• Unresectable or metastatic melanoma · Approved indications
• Perioperative treatment of resectable stage II, IIIA or IIIB non-small cell lung cancer, with platinum-containing chemotherapy before surgery followed by adjuvant monotherapy · Approved indications
• Locally advanced or metastatic urothelial cancer in adults, in combination with enfortumab vedotin · Approved indications
• Unresectable non-metastatic hepatocellular carcinoma, in combination with lenvatinib and transarterial chemoembolisation · Approved indications

Overseas status: Approved in the United States (initial FDA approval in 2014) and the European Union (marketing authorisation issued 2015-07-17).

China approval date: 2018-07-26

Source

Updated 2026-10-24 · Details

dupilumab

Dupixent®

China status: Approved

Dupilumab is an IL-4Rα-targeting biologic jointly developed by Sanofi and Regeneron. It has been approved by China’s NMPA since June 2020 and is not a near-launch pipeline product. The current publicly available China label covers atopic dermatitis, prurigo nodularis, asthma and eosinophilic-phenotype COPD; eligibility, dosing and reimbursement scope are indication-specific.

Mechanism: Human IgG4 monoclonal antibody that binds the IL-4 receptor alpha subunit (IL-4Rα), inhibiting IL-4 signaling through the type I receptor and IL-4/IL-13 signaling through the type II receptor.

Developer: Sanofi and Regeneron Pharmaceuticals, Inc.; jointly developed under their global collaboration. Sanofi (Beijing) Pharmaceutical Co., Ltd. is identified as the China applicant in the NHSA material.

• Moderate-to-severe atopic dermatitis in adults and children aged 6 months and older when topical prescription therapies are inadequate or not advisable · Approved indications
• Moderate-to-severe prurigo nodularis in adults suitable for systemic treatment · Approved indications
• Maintenance treatment of asthma in adolescents and adults aged 12 years and older meeting the China label criteria for type 2 inflammation or oral-corticosteroid-dependent asthma · Approved indications
• Maintenance treatment of adults with uncontrolled COPD characterized by raised blood eosinophils despite specified inhaled background therapy · Approved indications

Overseas status: Approved in the United States and in multiple other jurisdictions. The FDA prescribing information identifies DUPIXENT as an IL-4Rα antagonist and, as revised in 2026, lists nine disease indications; labels and authorized populations vary by jurisdiction.

China approval date: 2020-06-17

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Updated 2026-10-24 · Details

semaglutide

Wegovy®

China status: Approved

Wegovy is Novo Nordisk's semaglutide formulation for long-term weight management. In China, the NMPA-approved Wegovy® label covers adult long-term weight management and, since December 2025, reduction of major adverse cardiovascular event risk in specified adults with established cardiovascular disease. It is distinct from the semaglutide diabetes product Ozempic/Ozempic®. In the United States, Wegovy labeling also includes long-term weight management, cardiovascular-risk reduction, and accelerated approval for noncirrhotic MASH with F2-F3 fibrosis.

Mechanism: A long-acting glucagon-like peptide-1 (GLP-1) receptor agonist that regulates appetite, increasing fullness while reducing food intake, hunger and cravings.

Developer: Novo Nordisk A/S

• Long-term weight management in adults (China) · Approved indications
• Reduction of major adverse cardiovascular event risk in adults with established cardiovascular disease and BMI ≥27 kg/m² (China) · Approved indications
• Long-term weight reduction and maintenance in adults and eligible patients aged 12 years and older (US) · Approved indications
• Treatment of noncirrhotic MASH with moderate to advanced fibrosis (F2-F3) in adults (US; accelerated approval) · Approved indications
• Long-term weight management in lower-BMI adults with overweight or obesity (China; not approved) · Investigational indications

Overseas status: Authorised in the European Union (marketing authorisation issued 2022-01-06) and approved in the United States (original approval 2021-06-04). Current US labeling includes chronic weight management, major adverse cardiovascular event risk reduction in specified adults, and accelerated approval for noncirrhotic MASH with F2-F3 fibrosis.

China approval date: 2024-06

Updated 2026-10-24 · Details

tirzepatide

Mounjaro (China, EU and other markets); Zepbound (United States)

China status: Approved

Tirzepatide is Eli Lilly's dual GIP/GLP-1 receptor agonist. In China it is marketed as Mounjaro , not Zepbound; the current Chinese label includes type 2 diabetes, long-term weight management, and moderate-to-severe obstructive sleep apnea in adults with obesity. In the United States, Mounjaro and Zepbound are distinct brand-label pathways for the same active ingredient.

Mechanism: Once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist.

Developer: Eli Lilly and Company

• Glycaemic control in type 2 diabetes mellitus (Mounjaro; population and wording vary by regional label) · Approved indications
• Long-term weight management in eligible adults (Mounjaro in China; Zepbound in the United States; eligibility is label- and region-specific) · Approved indications
• Moderate-to-severe obstructive sleep apnea in adults with obesity (Mounjaro in China; Zepbound in the United States) · Approved indications
• Reduction of major adverse cardiovascular event risk in adults with type 2 diabetes at high cardiovascular risk (United States Mounjaro label) · Approved indications

Overseas status: United States: Mounjaro is FDA-approved for type 2 diabetes and for reduction of major adverse cardiovascular event risk in adults with type 2 diabetes at high risk; Zepbound is FDA-approved for chronic weight management and for moderate-to-severe obstructive sleep apnea in adults with obesity. European Union: Mounjaro is authorised for type 2 diabetes and weight management. Brand and indication are region-specific: Zepbound must not be used as the name of the Chinese product.

China approval date: 2024-05-15

Source · Source

Updated 2026-10-24 · Details

semaglutide

Ozempic®

China status: Approved

Ozempic is Novo Nordisk's once-weekly subcutaneous semaglutide formulation for type 2 diabetes. In mainland China, the diabetes presentation is branded Novo Tai , not an obesity-brand presentation. It has Chinese approvals for glycaemic control, cardiovascular-risk reduction in the specified type 2 diabetes population, and chronic-kidney-disease risk reduction; product access and individual treatment eligibility are separate questions.

Mechanism: Glucagon-like peptide-1 (GLP-1) receptor agonist. It enhances glucose-dependent insulin secretion and suppresses glucagon; it also decreases appetite and food intake.

Developer: Novo Nordisk A/S (China product applicant/manufacturer: Novo Nordisk (China) Pharmaceuticals Co., Ltd.)

• Glycaemic control in adults with type 2 diabetes mellitus · Approved indications
• Reduction of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease · Approved indications
• Reduction of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease · Approved indications

Overseas status: Ozempic is authorised in the United States and European Union for adults with type 2 diabetes. The current US injection label covers glycaemic control, reduction of major adverse cardiovascular events in adults with established cardiovascular disease, and reduction of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with chronic kidney disease. The EU authorisation was issued on 2018-02-08.

China approval date: 2021-04

Updated 2026-10-24 · Details

Ivonescimab

AK112 · Brand name not announced

China status: Approved

Ivonescimab injection is a PD-1/VEGF-A bispecific antibody developed by Akeso. It received its original NMPA approval on 2024-05-21 and, as of 2026-10-24, its current Chinese label contains three NSCLC indications. It is not approved in the United States or Europe; FDA accepted Summit's BLA for one EGFR-mutated NSCLC setting, with a PDUFA goal action date of 2026-11-14, which is a regulatory-review date and not an expected launch date.

Mechanism: A humanized IgG1 bispecific antibody that binds VEGF-A and PD-1 and competitively blocks their ligand interactions.

Developer: Akeso Biopharma Co., Ltd. developed ivonescimab; the Chinese applicant is Akeso Cino Medical Co., Ltd. Summit Therapeutics is the licensee in North America, South America, Europe, the Middle East, Africa, and Japan.

• With pemetrexed and carboplatin for EGFR-mutated locally advanced or metastatic non-squamous NSCLC that has progressed after EGFR-TKI treatment · Approved indications
• Monotherapy, first-line treatment of PD-L1 TPS ≥1%, EGFR-mutation-negative and ALK-negative locally advanced or metastatic NSCLC · Approved indications
• With paclitaxel and carboplatin for first-line treatment of unresectable locally advanced or metastatic squamous NSCLC · Approved indications
• Global Phase III investigational use with pemetrexed and carboplatin in EGFR-mutated locally advanced or metastatic non-squamous NSCLC after third-generation EGFR-TKI treatment · Investigational indications
• Global Phase III investigational use with mFOLFOX6 for first-line metastatic colorectal cancer · Investigational indications

Overseas status: Approved in China, not globally unapproved. As of 2026-10-24, ivonescimab has no marketing authorization in Summit's license territories, including the United States and Europe, according to Summit. The FDA accepted a BLA on 2026-01-29 for ivonescimab plus chemotherapy in EGFR-mutated locally advanced or metastatic non-squamous NSCLC after TKI therapy; the stated PDUFA goal action date is 2026-11-14. This is an ongoing regulatory review, not a US approval or a launch estimate.

China approval date: 2024-05-21

Updated 2026-10-24 · Details

cadonilimab

Kaitanni

China status: Approved

Cadonilimab (AK104; Kaitanni) is Akeso's PD-1/CTLA-4 bispecific antibody. It received NMPA conditional approval in China on 2022-06-29 for previously platinum-treated relapsed or metastatic cervical cancer, and subsequently received China approvals for first-line persistent/recurrent/metastatic cervical cancer and first-line locally advanced unresectable or metastatic gastric or gastroesophageal-junction adenocarcinoma in combination regimens. No US or EU marketing approval was identified in the official sources reviewed as of 2026-10-24; Akeso is pursuing global studies in PD-1-treatment-resistant hepatocellular carcinoma and first-line HER2-negative gastric/GEJ adenocarcinoma.

Mechanism: A tetravalent, bispecific recombinant humanized antibody that binds and blocks the PD-1 and CTLA-4 immune-checkpoint pathways.

Developer: Akeso, Inc. ; internally developed and manufactured by Akeso

• Relapsed or metastatic cervical cancer that progressed on or after platinum-based chemotherapy · Approved indications
• First-line persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy with or without bevacizumab · Approved indications
• First-line locally advanced unresectable or metastatic gastric or gastroesophageal-junction adenocarcinoma, in combination with fluoropyrimidine and platinum-based chemotherapy · Approved indications
• PD-1-treatment-resistant advanced hepatocellular carcinoma, in combination with lenvatinib (COMPASSION-36/AK104-225 global Phase II registrational study) · Investigational indications
• First-line HER2-negative, previously untreated unresectable or metastatic gastric or gastroesophageal-junction adenocarcinoma (AK104-311 multi-regional Phase III study) · Investigational indications

Overseas status: No US or EU marketing approval was identified in the official sources reviewed as of 2026-10-24. FDA's GSRS lists cadonilimab as an ingredient substance and explicitly notes that UNII availability does not imply regulatory review or approval. Akeso reports a global Phase II registrational study in PD-1-treatment-resistant hepatocellular carcinoma, and ClinicalTrials.gov lists an ongoing multi-regional Phase III first-line HER2-negative gastric/GEJ study with sites in the US, China, Germany and Poland.

China approval date: 2022-06-29

Updated 2026-10-24 · Details

iparomlimab and tuvonralimab

QL1706 · Brand name not announced

China status: Approved

China NMPA conditionally approved Qibei'an for patients with recurrent or metastatic cervical cancer whose disease failed prior platinum-containing chemotherapy ( The China first-marketing date recorded in the NHSA dossier is 2024-09-26; NMPA's approval announcement was published on 2024-09-30. A supplemental China marketing application for first-line persistent, recurrent or metastatic cervical cancer was reported accepted by CDE in 2026, which is not an approval ( In the reviewed official sources, no overseas brand name or FDA/EMA marketing authorization was confirmed; Qilu reports U.S. clinical-trial authorization in 2019. Clinical-study registration is not evidence of treatment availability and does not establish an individual's eligibility.

Mechanism: A bifunctional combination-antibody product comprising the anti-PD-1 IgG4 antibody iparomlimab and the anti-CTLA-4 IgG1 antibody tuvonralimab. It blocks PD-1/PD-L1 and CTLA-4/B7-1/B7-2 immune-checkpoint signalling.

Developer: Qilu Pharmaceutical Co., Ltd.

• Recurrent or metastatic cervical cancer after failure of prior platinum-containing chemotherapy · Approved indications
• First-line treatment of persistent, recurrent or metastatic cervical cancer · Investigational indications
• First-line treatment of advanced hepatocellular carcinoma · Investigational indications

Overseas status: No overseas brand name or FDA/EMA marketing authorization was confirmed in the reviewed official public sources as of 2026-10-24. Qilu reports that U.S. clinical-trial authorization was obtained in 2019; this is development activity, not a marketing approval.

China approval date: 2024-09-26

Updated 2026-10-24 · Details

envafolimab

Enweida®

China status: Approved

Envafolimab (KN035; Enweida®) is a subcutaneous PD-L1 single-domain antibody-Fc fusion protein. It received NMPA conditional marketing approval in China in November 2021 for previously treated unresectable or metastatic MSI-H/dMMR advanced solid tumors. The later 300 mg every-two-weeks approval was a dosing-regimen change, not a new indication. First-line biliary tract cancer is under NMPA NDA review, and TMB-H and resectable stage III NSCLC remain investigational. No FDA or EMA marketing approval, and no same-product public US or European price, was identified in the reviewed authoritative sources as of 2026-10-24.

Mechanism: Recombinant humanized anti-PD-L1 single-domain antibody fused to the Fc region of human IgG1; it blocks the PD-L1/PD-1 interaction and is administered by subcutaneous injection.

Developer: Alphamab Oncology (inventor); co-developed in oncology with 3D Medicines; Simcere has exclusive mainland-China commercial promotion rights.

• Previously treated unresectable or metastatic MSI-H or dMMR advanced solid tumors in adults, including specified post-chemotherapy colorectal cancer and other tumors without a satisfactory alternative treatment option. · Approved indications
• First-line treatment of unresectable or metastatic biliary tract cancer in combination with gemcitabine and oxaliplatin (GEMOX). · Investigational indications
• Neoadjuvant/adjuvant treatment of resectable stage IIIA-IIIB (N2) non-small cell lung cancer with platinum-based doublet chemotherapy. · Investigational indications
• Unresectable or metastatic high tumor mutational burden (TMB-H) solid tumors after failure of standard treatment and without a satisfactory alternative treatment; NMPA breakthrough-therapy designation, not an approval. · Investigational indications

Overseas status: No US or European marketing authorization was identified in the reviewed official sources as of 2026-10-24. A US Phase 1 study in advanced/metastatic solid tumors was completed. FDA records show orphan-drug designation for soft-tissue sarcoma, explicitly marked as not FDA approved for that orphan indication; designation is not marketing approval. The ENVA-SARC Phase 2 record has unknown current status (last known active, not recruiting), so it is not presented as an available treatment or recruiting opportunity.

China approval date: 2021-11-24

Updated 2026-10-24 · Details

izalontamab brengitecan

Yizekang®

China status: Approved

Izalontamab brengitecan (iza-bren; BL-B01D1) is an EGFR×HER3 bispecific ADC. In China, injectable Yizekang received conditional NMPA approval for adults with recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor treatment; a second China approval followed for adults with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 inhibitor plus platinum chemotherapy. These are marketing-authorized labels, not statements that an individual patient can obtain treatment. Outside China, the product remains in clinical development; FDA Breakthrough Therapy Designation for a defined EGFR-mutated NSCLC population is not marketing approval.

Mechanism: EGFR×HER3 bispecific antibody-drug conjugate with a topoisomerase I inhibitor payload. The antibody blocks EGFR and HER3 signaling; after target-mediated internalization, the payload is released to cause cytotoxic stress.

Developer: Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), through its SystImmune affiliate; outside Mainland China, SystImmune and Bristol Myers Squibb jointly develop the product under a collaboration and exclusive license agreement.

• Adults with recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor treatment · Approved indications
• Adults with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 inhibitor plus platinum-based chemotherapy · Approved indications
• Locally advanced or metastatic non-small cell lung cancer (Phase 2 study in China; US FDA Breakthrough Therapy Designation covers EGFR exon 19 deletion or exon 21 L858R-mutated disease after EGFR TKI and platinum chemotherapy) · Investigational indications
• Unresectable locally advanced or metastatic triple-negative breast cancer after taxane failure (China Phase 3 study) · Investigational indications
• Unresectable locally advanced, recurrent, or metastatic HR-positive/HER2-negative breast cancer after failure of at least one prior line of chemotherapy (China Phase 3 study) · Investigational indications

Overseas status: No US or European marketing authorization was identified in the reviewed official sources as of 2026-10-24. In the US, FDA granted Breakthrough Therapy Designation on 2025-08-18 for locally advanced or metastatic EGFR exon 19 deletion or exon 21 L858R-mutated NSCLC after progression on or after an EGFR TKI and platinum chemotherapy; this designation expedites development and review and is not approval. SystImmune and Bristol Myers Squibb jointly develop iza-bren in the US, while Bristol Myers Squibb holds responsibility outside the US and Mainland China.

China approval date: 2026-06-17

Updated 2026-10-24 · Details

disitamab vedotin

Aidixi

China status: Approved

Disitamab vedotin is a HER2-directed antibody-drug conjugate developed by RemeGen and marketed in China as Aidixi. It received its first NMPA conditional approval on 2021-06-09 and had five approved indications in China by 2026-04-10. Outside China, Pfizer lists PF-08046051 as investigational; a global Phase 3 first-line HER2-expressing locally advanced or metastatic urothelial carcinoma study is active, not recruiting.

Mechanism: HER2-directed antibody-drug conjugate comprising the humanized anti-HER2 antibody disitamab, a protease-cleavable mc-vc linker, and the microtubule-disrupting payload monomethyl auristatin E (MMAE).

Developer: RemeGen Co., Ltd. (Rongchang Pharmaceuticals, Yantai) is the originator and China developer. Pfizer/Seagen holds licensed development and commercialization rights outside RemeGen's Asia territory, excluding Japan and Singapore.

• HER2-overexpressing locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, after at least two prior systemic chemotherapy regimens · Approved indications
• HER2-overexpressing locally advanced or metastatic urothelial carcinoma after at least one prior systemic chemotherapy regimen · Approved indications
• HER2-positive advanced breast cancer with liver metastases after prior trastuzumab or biosimilar and taxane chemotherapy · Approved indications
• Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer with liver metastases in adults after at least one prior systemic therapy for metastatic disease, or recurrence during or within 12 months after adjuvant chemotherapy · Approved indications
• In combination with toripalimab for HER2-expressing (IHC 1+/2+/3+) locally advanced or metastatic urothelial carcinoma · Approved indications

Overseas status: No US or European marketing approval was identified in the official regulator and sponsor resources reviewed through 2026-10-24. Pfizer identifies PF-08046051 as an investigational asset, including Phase 3 development in first-line HER2-expressing metastatic urothelial cancer; this does not establish treatment availability outside China.

China approval date: 2021-06-09

Updated 2026-10-24 · Details

becotatug vedotin

MEIYOUHENG®

China status: Approved

MEIYOUHENG (MRG003) is Lepu Biopharma's EGFR-targeted ADC conditionally approved in China for a narrowly defined, previously treated adult recurrent/metastatic nasopharyngeal carcinoma population. Its Chinese full approval depends on confirmatory evidence. The other listed cancer settings are investigational studies, not approved uses.

Mechanism: An EGFR-targeted antibody-drug conjugate composed of a humanized IgG1 anti-EGFR antibody linked through a cleavable valine-citrulline linker to monomethyl auristatin E (MMAE). Following EGFR binding, internalization and lysosomal cleavage release MMAE, which inhibits microtubule formation and can cause mitotic arrest and apoptosis.

Developer: Lepu Biopharma Co., Ltd.

• Adult recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy · Approved indications
• Second- or third-line recurrent or metastatic squamous cell carcinoma of the head and neck after PD-1/PD-L1 inhibitor and platinum therapy failure · Investigational indications
• Perioperative treatment of locally advanced resectable head and neck squamous cell carcinoma in combination with pucotenlimab · Investigational indications
• EGFR-positive advanced or metastatic solid tumors in combination with pucotenlimab · Investigational indications

Overseas status: Outside China, the verified official development evidence includes a U.S. FDA Fast Track designation for recurrent/metastatic nasopharyngeal carcinoma, publicly announced by the developer on 2023-12-04. No U.S. FDA or EU EMA marketing approval, overseas commercial brand launch, or same-product U.S./European price was identified in the reviewed official public sources as of 2026-10-24.

China approval date: 2025-10-28

Updated 2026-10-24 · Details

senaparib

Sepalna®

China status: Approved

Senaparib (IMP4297) is a PARP1/2 inhibitor. China approved senaparib capsules on 2025-01-14 for first-line maintenance after a complete or partial response to platinum-based chemotherapy in adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The Chinese brand is Paishuning. In the European Union, the proposed 20 mg hard-capsule brand Sepalna had a positive CHMP opinion on 2026-09-17, but the European Commission marketing-authorisation decision was still pending as of 2026-10-24. In the United States, an FDA orphan-drug designation for a fixed-dose senaparib-temozolomide combination in small-cell lung cancer is explicitly not an FDA approval.

Mechanism: Small-molecule PARP1/2 inhibitor that blocks repair of damaged DNA in cancer cells.

Developer: IMPACT Therapeutics, Inc. (originator; senaparib was co-developed in mainland China through the IMPACT–Junshi Biosciences joint venture)

• First-line maintenance treatment of advanced epithelial ovarian cancer after complete or partial response to platinum-based chemotherapy · Approved indications
• First-line maintenance treatment of advanced fallopian tube cancer after complete or partial response to platinum-based chemotherapy · Approved indications
• First-line maintenance treatment of advanced primary peritoneal cancer after complete or partial response to platinum-based chemotherapy · Approved indications
• Extensive-stage small-cell lung cancer (senaparib plus temozolomide; investigational and not an approved Paishuning monotherapy indication) · Investigational indications

Overseas status: No FDA marketing approval identified. FDA granted orphan-drug designation on 2022-08-03 to a fixed-dose senaparib-temozolomide combination for small-cell lung cancer; the FDA record states ‘Not FDA Approved for Orphan Indication’. In the EU, Sepalna (senaparib) had a positive CHMP opinion on 2026-09-17 for first-line maintenance treatment; European Commission authorisation remained pending as of 2026-10-24.

China approval date: 2025-01-14

Updated 2026-10-24 · Details

satricabtagene autoleucel

CT041 · Brand name not announced

China status: Approved

Satricabtagene autoleucel (CT041; satri-cel) is a CARsgen-developed autologous humanized CLDN18.2-targeting CAR T-cell therapy. China's NMPA approved the Chinese product, Kaimimei , on 2026-06-22 for CLDN18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma after failure of at least two prior lines of therapy. Investigational pancreatic-cancer and North American studies are research pathways, not additional approved indications or general-treatment availability.

Mechanism: Autologous humanized CAR T-cell therapy targeting Claudin18.2 (CLDN18.2).

Developer: CARsgen Therapeutics Holdings Limited; China marketing-authorization applicant: Kexing Life Science Technology (Shanghai) Co., Ltd.

• CLDN18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma after failure of at least two prior lines of therapy · Approved indications
• Adjuvant treatment after adjuvant chemotherapy for CLDN18.2-positive pancreatic cancer · Investigational indications
• Advanced gastric, pancreatic, or other specified digestive system cancers in the North American CT041 study · Investigational indications

Overseas status: No US marketing approval was identified in FDA's approved cellular and gene therapy product list current on 2026-09-17. CARsgen reports FDA RMAT and orphan-drug designations and EMA PRIME and orphan-medicinal-product designations; these are development designations, not marketing approvals. A US/Canada Phase 1b/2 CT041 study was active, not recruiting in its latest public registry update (2025-01-08).

China approval date: 2026-06-22

Updated 2026-10-24 · Details

mazdutide

IBI362 · Brand name not announced

China status: Approved

Mazdutide Injection is marketed in China as Xin'ermei . NMPA first approved the product on 2025-06-24 for long-term weight control in eligible adults with overweight or obesity, and approved glycemic control in adults with type 2 diabetes on 2025-09-16. The current Chinese label is a 2 mL:24 mg presentation with 4 mg or 6 mg once-weekly maintenance dosing. A 9 mg supplementary application for adults with moderate-to-severe obesity was accepted for NMPA review and was still described by Innovent as pending approval in June 2026. No FDA or EMA marketing authorization or non-China trade brand was located in the official public approval resources reviewed on 2026-10-24; the FDA GINAS substance record is not a marketing authorization. FDA approval database: ; EMA medicine finder scope: .

Mechanism: A once-weekly oxyntomodulin analogue and dual glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) agonist.

Developer: Innovent Biologics (Suzhou) Co., Ltd.; exclusive licensee from Eli Lilly and Company for development and commercialization in China.

• Long-term weight control in eligible adults with overweight or obesity · Approved indications
• Glycemic control in adults with type 2 diabetes · Approved indications
• Long-term weight management in adults with moderate-to-severe obesity (9 mg) · Investigational indications
• Overweight or obesity with metabolic dysfunction-associated fatty liver disease (MAFLD) · Investigational indications

Overseas status: No US FDA or EU EMA marketing authorization for mazdutide/IBI362 was located in the respective official public approval resources reviewed on 2026-10-24, and no non-China trade brand was announced. FDA's GINAS record validates the substance name and codes but does not constitute a marketing authorization. Consequently, no US or European product price is entered. FDA Drugs@FDA: ; FDA GINAS: ; EMA: .

China approval date: 2025-06-24

Updated 2026-10-24 · Details

ecnoglutide

XW003 · Brand name not announced

China status: Approved

Ecnoglutide (XW003) is a Sciwind-developed, long-acting cAMP-biased GLP-1 receptor agonist. China approved the injection for glycaemic control in adults with type 2 diabetes on 2026-01-30, followed by chronic weight management in adults with overweight or obesity on 2026-03-06. Publicly reviewed sources did not confirm an overseas commercial brand, FDA approval, EMA centralised authorisation, or a same-product US/European public price as of 2026-10-24.

Mechanism: Long-acting, cAMP-biased glucagon-like peptide-1 receptor agonist (GLP-1RA) administered once weekly by subcutaneous injection; it preferentially activates cAMP signalling while minimizing beta-arrestin recruitment.

Developer: Hangzhou Sciwind Biosciences Co., Ltd.

• Glycaemic control in adults with type 2 diabetes mellitus · Approved indications
• Chronic weight management in adults with overweight or obesity, as an adjunct to reduced-calorie diet and increased physical activity · Approved indications

Overseas status: No overseas commercial brand or non-China marketing authorisation was confirmed from the reviewed public sources as of 2026-10-24. A completed XW003 Phase 2 obesity study was registered in Australia; this research activity is not evidence of commercial availability.

China approval date: 2026-01-30

Updated 2026-10-24 · Details

Dorzagliatin

HuaTangNing® (mainland China); MYHOMSIS® (Hong Kong SAR, China)

China status: Approved

Dorzagliatin is an oral glucokinase activator developed by Hua Medicine. In mainland China, HuaTangNing is approved to improve glycaemic control in adults with type 2 diabetes as monotherapy with diet and exercise, or with metformin when metformin alone does not provide adequate control. Hong Kong SAR, China separately authorized dorzagliatin for adult type 2 diabetes under the MYHOMSIS® / HuaTangNing® (mainland China); MYHOMSIS® (Hong Kong SAR, China)® brand. Regulatory approval does not establish suitability or access for an individual patient.

Mechanism: An oral allosteric glucokinase (GK) activator that acts on GK in pancreatic islets, intestinal endocrine cells and the liver.

Developer: Hua Medicine

• Improvement of glycaemic control in adults with type 2 diabetes as monotherapy with diet and exercise · Approved indications
• Improvement of glycaemic control in adults with type 2 diabetes as add-on therapy to metformin, with diet and exercise, when metformin alone provides inadequate control · Approved indications

Overseas status: Hua Medicine reports that Hong Kong SAR, China authorized dorzagliatin for marketing for adult type 2 diabetes in February 2026 under MYHOMSIS® / HuaTangNing® (mainland China); MYHOMSIS® (Hong Kong SAR, China)®. No US or European marketing authorization, or public US/European price for dorzagliatin itself, was identified in the primary materials reviewed as of 2026-10-25.

China approval date: 2022-09-30

Updated 2026-10-25 · Details

Telitacicept

Tai’ai®

China status: Approved

Telitacicept is a BLyS/APRIL-targeting fusion protein developed by RemeGen and marketed in China as Tai’ai®. NMPA conditionally approved it in March 2021, with conventional treatment, for adults with active, autoantibody-positive systemic lupus erythematosus who remain highly active despite conventional treatment; the approval was converted to full approval in November 2023. By June 2026, company disclosures state that it also held China marketing approvals for rheumatoid arthritis, anti-AChR-antibody-positive generalized myasthenia gravis in adults, Sjögren’s disease, and primary IgA nephropathy. Approval does not determine individual suitability, access, or treatment outcome.

Mechanism: A TACI-Fc fusion protein that binds and inhibits the B-cell survival factors BLyS and APRIL, thereby modulating B-cell- and plasma-cell-mediated autoimmune responses.

Developer: RemeGen Co., Ltd.

• Active, autoantibody-positive systemic lupus erythematosus in adults with high disease activity despite conventional treatment, in combination with conventional treatment · Approved indications
• Rheumatoid arthritis · Approved indications
• Anti-acetylcholine receptor antibody-positive generalized myasthenia gravis in adults, in combination with conventional therapeutic drugs · Approved indications
• Sjögren’s disease · Approved indications
• Reduction of proteinuria in adults with primary immunoglobulin A nephropathy who are at risk of disease progression · Approved indications

Overseas status: No US or European marketing authorization is asserted in the primary materials reviewed as of 2026-10-25. RemeGen stated in May 2025 that it was advancing a global multicentre Phase 3 study in generalized myasthenia gravis to support overseas BLA submissions; this development statement is not a marketing approval or a launch date.

China approval date: 2021-03

Updated 2026-10-25 · Details

Stapokibart

Kangyueda

China status: Approved

Stapokibart (CM310) is an IL-4Rα monoclonal antibody developed by Keymed Biosciences. In China, it is marketed as Kangyueda and has approvals for adult moderate-to-severe atopic dermatitis, chronic rhinosinusitis with nasal polyps, and seasonal allergic rhinitis. China Phase 3 studies supporting the atopic dermatitis and seasonal allergic rhinitis programs were published or registered; use remains subject to the approved Chinese labeling and clinical assessment.

Mechanism: Humanized IgG4 monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα); it blocks IL-4 and IL-13 signaling through this receptor.

Developer: Keymed Biosciences Co., Ltd.

• Moderate-to-severe atopic dermatitis in adults whose disease is inadequately controlled with topical therapies or who are not suitable for topical therapy · Approved indications
• Chronic rhinosinusitis with nasal polyps · Approved indications
• Moderate-to-severe seasonal allergic rhinitis in adults with symptoms inadequately controlled after intranasal corticosteroid and antihistamine treatment · Approved indications

Overseas status: The reviewed primary materials document approvals in China. No US or European regulatory approval, comparable local price, or evidence-based overseas launch window was identified for this record as of 2026-10-25.

China approval date: 2024-09-12

Updated 2026-10-25 · Details

golidocitinib

DZD4205 · Brand name not announced

China status: Approved

Golidocitinib is an oral selective JAK1 inhibitor conditionally approved in China as monotherapy for adults with relapsed or refractory peripheral T-cell lymphoma after at least one prior systemic therapy. The multinational Phase I/II JACKPOT8 study is completed. In the United States, the drug has FDA orphan-drug and Fast Track designations for T-cell lymphoma/r/r PTCL, but these designations are not marketing approval; the FDA orphan-drug record states that it is not FDA approved for that orphan indication.

Mechanism: An oral, selective Janus kinase 1 (JAK1) inhibitor that blocks JAK/STAT signaling and inhibits STAT3 phosphorylation in tumor cells.

Developer: Dizal (Jiangsu) Pharmaceutical Co., Ltd. (Dizal Pharmaceuticals)

• Relapsed or refractory peripheral T-cell lymphoma in adults after at least one prior systemic therapy, as monotherapy · Approved indications

Overseas status: United States: FDA orphan-drug designation for treatment of T-cell lymphoma (designated 2020-09-10) and company-reported Fast Track designation for relapsed or refractory peripheral T-cell lymphoma (2022-02-18). FDA's orphan-drug record states, 'Not FDA Approved for Orphan Indication.' JACKPOT8, a multinational Phase I/II study, was completed on 2024-02-22. No US or European marketing approval, separate overseas trade name, or golidocitinib-specific public US/European price was confirmed in the reviewed primary sources.

China approval date: 2024-06-19

Updated 2026-10-25 · Details

Lisaftoclax

APG-2575 · Brand name not announced

China status: Approved

Lisaftoclax is an oral selective BCL-2 inhibitor conditionally approved in China for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously received at least one systemic therapy including a BTK inhibitor. Other clinical uses remain investigational.

Mechanism: An orally administered, small-molecule selective BCL-2 inhibitor. It blocks the anti-apoptotic BCL-2 protein to restore apoptosis signaling in cancer cells.

Developer: Ascentage Pharma Group Inc.

• Adult chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with at least one systemic therapy including a Bruton tyrosine kinase inhibitor · Approved indications

Overseas status: Investigational outside China. Ascentage stated on 2025-07-10 that lisaftoclax had not been approved by the US FDA. The developer reported FDA-cleared global registrational Phase III programs and FDA/EMA clearance to conduct GLORA-4; these trial clearances are not marketing authorization.

China approval date: 2025-07-10

Updated 2026-10-25 · Details

dalnacogene ponparvovec

BBM-H901 · Brand name not announced

China status: Approved

Dalnacogene ponparvovec injection (BBM-H901; Chinese brand Xinjiuning) is an rAAV factor IX gene therapy developed and manufactured by Belief BioMed. NMPA approved it in mainland China on 2025-04-08 for adult patients with moderate to severe haemophilia B. The only currently substantiated labelled indication for this brand-specific product is that adult haemophilia B indication; trial-entry thresholds are not presented as an additional approved indication.

Mechanism: A single-dose intravenous recombinant AAV gene therapy. Its engineered liver-tropic AAV843 capsid delivers a liver-specific cassette encoding the high-activity human factor IX Padua variant; hepatocytes then express and secrete factor IX into the bloodstream.

Developer: Belief BioMed (BBM), through its wholly owned subsidiary Shanghai Belief-Delivery Biomed Co., Ltd., developed and manufactures the product. Takeda China is responsible for commercialization in mainland China, Hong Kong, China, and Macao, China.

• Treatment of adult patients with moderate to severe haemophilia B (congenital coagulation factor IX deficiency) · Approved indications

Overseas status: Outside mainland China, BBM publicly announced approval by the Pharmaceutical Administration Bureau of Macao Special Administrative Region on 2026-03-19 for adult patients with moderate to severe haemophilia B. The official company notices document US FDA orphan-drug designation in 2022 and rare-pediatric-disease designation in 2024, plus EMA ATMP classification in 2024; these designations/classification are not US or EU marketing approvals. No US or EU marketing approval or product-specific public US/European price was substantiated in the official sources reviewed as of 2026-10-24.

China approval date: 2025-04-08

Updated 2026-10-24 · Details

Obinutuzumab beta injection

Bejescin

China status: Approved

Bejescin (MIL62; obinutuzumab beta injection) is a Beijing Mabworks anti-CD20 monoclonal antibody approved in China. Its first approval, dated 2026-02-10, was for neuromyelitis optica spectrum disorder; the developer reports a second Chinese approval for primary membranous nephropathy dated 2026-06-09. Systemic lupus erythematosus and follicular lymphoma remain in clinical development. No US or European marketing approval, directly comparable price, or evidence-based overseas launch window was identified in the reviewed primary sources as of 2026-10-25.

Mechanism: A glycoengineered type II anti-CD20 humanized monoclonal antibody designed to deplete CD20-positive B cells, including through enhanced antibody-dependent cellular cytotoxicity.

Developer: Beijing Mabworks Biotech Co., Ltd.

• Neuromyelitis optica spectrum disorder (NMOSD) · Approved indications
• Primary membranous nephropathy (pMN) · Approved indications
• Systemic lupus erythematosus (SLE) · Investigational indications
• Follicular lymphoma (FL) · Investigational indications

Overseas status: No marketing approval outside China was identified in the reviewed primary sources as of 2026-10-25. The developer reports Chinese, US, and European patent grants, which are not marketing approvals.

China approval date: 2026-02-10

Updated 2026-10-25 · Details

teprotumumab N01

SYCUME® (China); TEPEZZA® (United States)

China status: Approved

IBI311 is Innovent's recombinant anti-IGF-1R antibody, marketed in China as SYCUME . The NMPA approved it on 2025-03-14 for thyroid eye disease. The corresponding teprotumumab brand in the United States is TEPEZZA, which FDA first approved in 2020; brand, sponsor and presentation must be distinguished by market.

Mechanism: Recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody that blocks IGF-1R signaling, reducing downstream inflammatory signaling and orbital fibroblast-mediated tissue changes in thyroid eye disease.

Developer: Innovent Biologics developed IBI311/SYCUME for China; Horizon Therapeutics was the FDA BLA sponsor for TEPEZZA, which is now marketed by Amgen in the United States.

• Thyroid eye disease · Approved indications
• Inactive thyroid eye disease · Investigational indications
• First-line treatment of thyroid eye disease in a head-to-head study versus steroid therapy · Investigational indications

Overseas status: In the United States, TEPEZZA (teprotumumab-trbw) received FDA approval on 2020-01-21 for thyroid eye disease. The current FDA label indicates TEPEZZA for thyroid eye disease regardless of disease activity or duration. This record does not assert a Europe-wide approval because no EMA approval record was verified in this research pass.

China approval date: 2025-03-14

Updated 2026-10-24 · Details

risvutatug rezetecan

HS-20093 · Brand name not announced

China status: Investigational

Risvutatug rezetecan is an investigational B7-H3-directed antibody-drug conjugate discovered by Hansoh Pharma. In China, its biologics license application for adults with small-cell lung cancer after prior platinum-based chemotherapy failure was accepted by the NMPA on 2026-09-02 (CXSS2600134); acceptance is not marketing approval. The product therefore remains unavailable as an approved medicine in China as of 2026-10-24. GSK is developing it outside Greater China, where it remains investigational.

Mechanism: B7-H3-directed antibody-drug conjugate comprising a fully human anti-B7-H3 monoclonal antibody linked through a cleavable tetrapeptide linker to topoisomerase I inhibitor payloads.

Developer: Hansoh Pharma (discoverer and developer in Greater China); GSK (exclusive licensee outside mainland China, Hong Kong, Macau and Taiwan).

• Small-cell lung cancer in adults after failure of prior platinum-based chemotherapy · Investigational indications
• Osteosarcoma progressed or relapsed after at least two prior systemic treatment lines · Investigational indications
• Non-small-cell lung cancer · Investigational indications
• Esophageal squamous cell carcinoma · Investigational indications
• Prostate cancer · Investigational indications

Overseas status: Investigational outside Greater China; no US, EU or Japanese marketing approval identified as of 2026-10-24. GSK's global phase III EMBOLD SCLC-301 trial is recruiting. Regulatory designations are not approvals: FDA Breakthrough Therapy Designation covers relapsed/refractory extensive-stage SCLC after platinum-based chemotherapy and late-line relapsed/refractory osteosarcoma; EMA PRIME covers relapsed extensive-stage SCLC.

China approval date: Date not disclosed

Updated 2026-10-24 · Details

sonesitatug vedotin

CMG-901 · Brand name not announced

China status: Investigational

Sonesitatug vedotin (CMG901; AZD0901) is an investigational CLDN18.2-directed MMAE antibody-drug conjugate. In the global Phase III CLARITY-Gastric01 trial in second- and later-line CLDN18.2-positive advanced gastric, gastroesophageal-junction, or oesophageal adenocarcinoma, AstraZeneca reported a statistically significant overall-survival result; the dual primary progression-free-survival endpoint did not reach statistical significance. It is not a marketed medicine in China as of 2026-10-25.

Mechanism: CLDN18.2-targeting antibody-drug conjugate composed of an anti-CLDN18.2 monoclonal antibody, a protease-degradable linker, and a monomethyl auristatin E (MMAE) cytotoxic payload.

Developer: AstraZeneca (global licensee); KYM Biosciences Inc. (originator, a Keymed Biosciences and Lepu Biopharma joint venture)

• Second- and later-line treatment of CLDN18.2-positive locally advanced or metastatic gastric cancer, gastroesophageal-junction cancer, or oesophageal adenocarcinoma · Investigational indications
• First-line combination treatment of CLDN18.2-positive, HER2-negative advanced or metastatic gastric, gastroesophageal-junction, or oesophageal adenocarcinoma · Investigational indications
• CLDN18.2-positive pancreatic cancer · Investigational indications
• CLDN18.2-positive biliary tract cancer · Investigational indications

Overseas status: Investigational outside China as of 2026-10-25. The FDA and European Commission have granted orphan-drug designations for gastric/GEJ cancer, and China CDE has granted Breakthrough Therapy Designation for a specified advanced gastric-cancer setting; these development designations are not marketing authorisations.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

arcotatug tavatecan

IBI343 · Brand name not announced

China status: Investigational

Arcotatug tavatecan (IBI343; TAK-921 outside Greater China) is an investigational CLDN18.2-targeted antibody-drug conjugate from Innovent. In China, the NMPA accepted an NDA with Priority Review on 2026-06-04 for previously treated, locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal-junction adenocarcinoma after at least two prior systemic therapies; this is review, not marketing approval. On 2026-10-23, Takeda stated that the medicine had not been approved by the FDA or any other regulatory authority. No commercial brand name, product-specific US/European price, or evidence-based launch window was identified as of 2026-10-25.

Mechanism: A CLDN18.2-targeted, Fc-silenced antibody-drug conjugate that uses a cleavable linker to deliver the topoisomerase I inhibitor exatecan to CLDN18.2-expressing tumour cells.

Developer: Innovent Biologics (Suzhou) Co., Ltd.; Takeda holds rights to develop, manufacture and commercialize the product outside Greater China.

• Previously treated, CLDN18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma after at least two prior systemic therapies · Investigational indications
• CLDN18.2-positive locally advanced unresectable or metastatic pancreatic cancer after at least two prior systemic therapies · Investigational indications
• First-line gastric or gastroesophageal junction adenocarcinoma · Investigational indications
• First-line pancreatic ductal adenocarcinoma · Investigational indications

Overseas status: Not approved outside China as of 2026-10-25. Takeda holds rights outside Greater China. The FDA granted Fast Track designation for CLDN18.2-positive locally advanced or metastatic pancreatic cancer after two prior systemic therapies; Fast Track is not marketing approval. Takeda reported Phase 3 gastric/GEJ results on 2026-10-23 and said the data would support a planned filing in Japan, without announcing a filing date.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

tecotabart vedotin

LM 302 · Brand name not announced

China status: Investigational

Tecotabart vedotin (LM-302) is an investigational CLDN18.2-targeted ADC. It was not approved for marketing in China as of 2026-10-25. Its most advanced disclosed China program is the randomized LM302-03-101 Phase III study in CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal-junction adenocarcinoma after at least two prior systemic treatment lines. A separate first-line Phase III combination study with tislelizumab is listed as recruiting on China’s drug-trial registry. China CDE breakthrough-therapy designations and the reported US FDA IND and orphan-drug designations are development or regulatory facilitation measures, not marketing approvals.

Mechanism: CLDN18.2-directed antibody-drug conjugate with a cleavable linker to the microtubule-disrupting payload monomethyl auristatin E (MMAE). After binding and internalization, released MMAE binds tubulin and inhibits microtubule polymerization.

Developer: LaNova Medicines Ltd. (originator and sponsor of the China program; a wholly owned subsidiary of Sino Biopharmaceutical Limited as stated in its 2025 announcement)

• CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after progression on or after at least two lines of systemic therapy · Investigational indications
• Previously untreated CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, in combination with tislelizumab · Investigational indications
• CLDN18.2-positive advanced solid tumors · Investigational indications

Overseas status: Investigational outside China. LaNova licensed US and rest-of-world rights excluding Greater China and South Korea to Turning Point Therapeutics in 2022 under the development code TPX-4589. The developer reported US FDA IND approval and orphan-drug designation for pancreatic, biliary-tract, and gastric/gastroesophageal-junction cancers; these are not US marketing approvals.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

bofanglutide

GZR18 · Brand name not announced

China status: Investigational

Bofanglutide is Gan & Lee Pharmaceuticals' investigational biweekly GLP-1 receptor agonist. In China, its marketing authorization application for long-term weight management in people with obesity or overweight was accepted by the National Medical Products Administration on 2026-09-02; acceptance is not marketing approval. Development also includes phase 3 programs in obesity or overweight, type 2 diabetes mellitus, and obesity with moderate-to-severe obstructive sleep apnea. A U.S. phase 2 study has evaluated obesity or overweight, but no U.S. or EU marketing authorization is reported in the cited primary sources as of 2026-10-25.

Mechanism: A long-acting, structurally modified human glucagon-like peptide-1 receptor agonist (GLP-1RA) designed for subcutaneous dosing once every two weeks.

Developer: Gan & Lee Pharmaceuticals

• Long-term weight management in adults with obesity or overweight · Investigational indications
• Type 2 diabetes mellitus · Investigational indications
• Moderate-to-severe obstructive sleep apnea in adults with obesity · Investigational indications

Overseas status: Investigational outside China. A U.S. phase 2 study in adults with obesity or overweight evaluated every-two-week GZR18 versus tirzepatide and placebo; no FDA or EMA marketing authorization is reported in the cited primary sources as of 2026-10-25.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

ribupatide

HRS9531 · Brand name not announced

China status: Investigational

Ribupatide is Hengrui Pharma's investigational GLP-1/GIP dual receptor agonist, developed as a once-weekly subcutaneous injection and a once-daily oral tablet. In China, NMPA has accepted marketing authorization applications for the injection for adult long-term weight management and for glycaemic control in adults with type 2 diabetes; acceptance is under review and is not approval. Outside Greater China it is called KAI-9531 and is being evaluated by Kailera in the global KaiNETIC Phase 3 program for obesity or overweight.

Mechanism: A dual agonist peptide at the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.

Developer: Hengrui Pharma (Jiangsu Hengrui Pharmaceuticals Co., Ltd.)

• Long-term weight management in adults with overweight or obesity · Investigational indications
• Glycaemic control in adults with type 2 diabetes · Investigational indications
• Obesity with polyendocrine-metabolic ovarian syndrome (PMOS) · Investigational indications

Overseas status: Investigational. Outside Greater China, ribupatide is called KAI-9531; its once-weekly injection is in Kailera's global KaiNETIC Phase 3 program for obesity or overweight.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

safiglipron

HRS-7535 · Brand name not announced

China status: Investigational

Safiglipron (HRS-7535; KAI-7535 outside Greater China) is Hengrui's oral small-molecule GLP-1 receptor agonist. It had not received marketing approval in China as of 2026-10-25. Hengrui reported that China's NMPA had accepted marketing applications for adult type 2 diabetes glycemic control and adult long-term weight management; acceptance begins regulatory review and is not approval. The Chinese Phase 3 OUTSTAND diabetes and HARBOR-1 overweight/obesity programmes had completed key studies. Outside Greater China, Kailera is evaluating KAI-7535 in a global Phase 2 obesity trial in the United States and Australia.

Mechanism: A once-daily oral non-peptide small-molecule glucagon-like peptide-1 receptor agonist (GLP-1RA).

Developer: Jiangsu Hengrui Pharmaceuticals Co., Ltd.; Kailera Therapeutics, Inc. (outside Greater China)

• Glycemic control in adults with type 2 diabetes · Investigational indications
• Long-term weight management in adults · Investigational indications

Overseas status: Kailera holds exclusive development, manufacturing and commercialization rights outside Greater China and is conducting a global Phase 2 obesity trial of KAI-7535 in the United States and Australia. The trial started in April 2026 and the company expects data in 2027. No US or EU marketing approval, commercial brand name, or same-product US/European price was identified in the reviewed primary sources as of 2026-10-25.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

bulumtatug fuvedotin

9MW2821 · Brand name not announced

China status: Investigational

Bulumtatug fuvedotin (BFv; 9MW2821) is Mabwell's investigational Nectin-4-targeting antibody-drug conjugate. It is not recorded here as marketed in China: the verified China programme includes ongoing pivotal Phase III studies in locally advanced or metastatic urothelial carcinoma and recurrent or metastatic cervical cancer, as well as a Phase III study in locally advanced or metastatic triple-negative breast cancer. A U.S. Phase Ib study in previously ADC-treated recurrent or metastatic triple-negative breast cancer was recruiting as of 2026-10-23. FDA Fast Track and orphan-drug designations, and CDE breakthrough-therapy designation, are development designations rather than marketing approvals.

Mechanism: A site-specific Nectin-4-targeting antibody-drug conjugate that uses a cleavable linker to deliver the microtubule-disrupting payload monomethyl auristatin E (MMAE) to Nectin-4-expressing cells.

Developer: Mabwell (Shanghai) Bioscience Co., Ltd.

• Locally advanced or metastatic urothelial carcinoma previously treated with platinum-containing chemotherapy and a PD-(L)1 inhibitor · Investigational indications
• First-line unresectable locally advanced or metastatic urothelial carcinoma in combination with toripalimab · Investigational indications
• Recurrent or metastatic cervical cancer progressing on or after platinum-based chemotherapy · Investigational indications
• Locally advanced or metastatic triple-negative breast cancer previously treated with a taxane and a topoisomerase-inhibitor-payload ADC · Investigational indications

Overseas status: No FDA or EMA marketing approval, commercial brand, or same-product US/European price was identified in the reviewed primary sources as of 2026-10-25. In the United States, a recruiting Phase Ib study is evaluating BFv in previously ADC-treated recurrent or metastatic triple-negative breast cancer. Mabwell reports FDA Fast Track designations for esophageal squamous cell carcinoma, recurrent or metastatic cervical cancer after platinum therapy, and Nectin-4-positive locally advanced or metastatic triple-negative breast cancer, plus FDA orphan-drug designation for esophageal cancer; these designations are not marketing approvals.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

IBI363

TAK-928 · Brand name not announced

China status: Investigational

IBI363 (Takeda R&D code TAK-928) is an investigational PD-1/IL-2α-biased bispecific fusion protein; it has no verified marketing authorization or formal commercial brand name in China, the United States, or Europe as of 2026-10-25. In China, it has received three NMPA Breakthrough Therapy Designations, which facilitate development and review but are not marketing approvals. Its clinical program includes China pivotal/Phase 3 studies in melanoma and colorectal cancer and the global Phase 3 MarsLight-11 study in immunotherapy-resistant non-small cell lung cancer.

Mechanism: A PD-1/IL-2α-biased bispecific fusion protein. Its anti-PD-1 arm blocks PD-1/PD-L1 signaling and directs the engineered IL-2 moiety to PD-1-positive cells in the tumor environment. The IL-2 moiety retains affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, an approach intended to preferentially activate selected T-cell populations while limiting peripheral IL-2 activity.

Developer: Innovent Biologics, Inc.; co-developed globally with Takeda Pharmaceutical Company Limited since October 2025.

• Unresectable locally advanced or metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy · Investigational indications
• Previously untreated acral or mucosal melanoma · Investigational indications
• Advanced microsatellite-stable or proficient mismatch repair colorectal cancer after failure of at least two prior lines of standard therapy, in combination with bevacizumab · Investigational indications

Overseas status: Investigational outside China. FDA cleared the IND for the global Phase 3 MarsLight-11 trial in immunotherapy-resistant squamous NSCLC on 2025-08-24; the company reports FDA Fast Track Designation for this indication and for melanoma. These development designations and the IND clearance are not US marketing approval. The global Phase 3 trial was recruiting as of the reviewed registry record, and no US or European marketing authorization, commercial brand name, or same-product public price was identified in the reviewed primary sources as of 2026-10-25.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

SSGJ-707

PF-08634404 · Brand name not announced

China status: Investigational

SSGJ-707 (PF-08634404; PF'4404) is an investigational PD-1/VEGF bispecific antibody developed by 3SBio and licensed to Pfizer. It has no published proprietary trade name or published nonproprietary name in the reviewed primary sources. China granted Breakthrough Therapy Designation on 2025-04-17 for first-line treatment of PD-L1-positive locally advanced or metastatic non-small cell lung cancer; this designation is not marketing approval. As of 2026-10-25, Pfizer's Phase 3 global programs include first-line locally advanced/metastatic NSCLC with chemotherapy and first-line metastatic colorectal cancer with chemotherapy. Clinical trials and regulatory designations do not establish routine treatment availability.

Mechanism: An investigational fully human IgG4 tetravalent bispecific antibody that targets programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF).

Developer: 3SBio developed SSGJ-707 on its CLF2 platform. Under 2025 agreements, Pfizer received exclusive development, manufacturing, and commercialization rights globally, including mainland China.

• First-line monotherapy for PD-L1-positive locally advanced or metastatic non-small cell lung cancer · Investigational indications
• With chemotherapy for first-line locally advanced or metastatic non-small cell lung cancer · Investigational indications
• With chemotherapy for first-line metastatic colorectal cancer · Investigational indications
• Monotherapy or combination with enfortumab vedotin for locally advanced or metastatic urothelial cancer · Investigational indications

Overseas status: Pfizer identifies PF-08634404 as an investigational compound whose safety and efficacy have not been established. As of 2026-10-25, the reviewed primary sources show global Phase 3 and earlier-stage studies, rather than a confirmed US or European marketing authorization.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

pumitamig

BNT327 · Brand name not announced

China status: Investigational

Pumitamig (BNT327; formerly PM8002) is an investigational PD-L1×VEGF-A bispecific antibody. It is not approved for marketing in China, the United States, or Europe as of 2026-10-25. China is a study location in the global ROSETTA Lung-01 and ROSETTA Lung-02 programmes, and earlier Phase 2 studies were conducted in China. Ongoing global Phase 3 trials are evaluating pumitamig plus chemotherapy in previously untreated extensive-stage small-cell lung cancer, first-line non-small-cell lung cancer, and PD-L1-negative locally recurrent inoperable or metastatic triple-negative breast cancer.

Mechanism: Investigational bispecific antibody that combines PD-L1 checkpoint inhibition with VEGF-A neutralization.

Developer: BioNTech SE and Bristol Myers Squibb (joint global development and commercialization); originally developed by Biotheus

• Previously untreated extensive-stage small-cell lung cancer, in combination with chemotherapy · Investigational indications
• First-line non-small-cell lung cancer, in combination with chemotherapy · Investigational indications
• Previously untreated PD-L1-negative locally recurrent inoperable or metastatic triple-negative breast cancer, in combination with chemotherapy · Investigational indications

Overseas status: Investigational; no FDA, EMA, or other marketing approval identified as of 2026-10-25. FDA granted orphan-drug designation for small-cell lung cancer in 2025; this designation is not a marketing approval.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

mocertatug rezetecan

HS-20089 · Brand name not announced

China status: Investigational

Mocertatug rezetecan (HS-20089; GSK5733584; Mo-Rez) is an investigational B7-H4-targeted antibody-drug conjugate discovered by Hansoh Pharma. It is not approved for marketing in China as of 2026-10-25: the NMPA granted Breakthrough Therapy Designation in May 2025 for platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, and the product remains in clinical development. GSK holds rights outside mainland China, Hong Kong, Macau and Taiwan; its global programme remains investigational, with five pivotal phase III studies under way in gynaecological cancers as of the cutoff. No marketed brand name, US/EU price, or evidence-based launch window was identified.

Mechanism: B7-H4-targeted antibody-drug conjugate comprising a fully human anti-B7-H4 monoclonal antibody covalently linked to a topoisomerase I inhibitor payload, with a drug-to-antibody ratio of 6.

Developer: Hansoh Pharma (discoverer and developer in mainland China, Hong Kong, Macau and Taiwan); GSK (exclusive licensee outside mainland China, Hong Kong, Macau and Taiwan).

• Platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer · Investigational indications
• Platinum-sensitive ovarian cancer · Investigational indications
• Advanced or recurrent endometrial cancer · Investigational indications

Overseas status: Investigational outside mainland China, Hong Kong, Macau and Taiwan. GSK's global BEHOLD programme includes phase I/II studies and, as of 2026-10-23, five pivotal phase III studies in ovarian and endometrial cancers. No US or EU marketing approval was identified in the reviewed primary sources as of 2026-10-25.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

tifcemalimab

JS004 · Brand name not announced

China status: Investigational

Tifcemalimab is an investigational anti-BTLA antibody developed by Junshi Biosciences. It is listed in the developer's Phase III pipeline, not among its marketed products. Its lead program is a recruiting, multi-regional Phase III consolidation study with toripalimab for limited-stage small cell lung cancer after chemoradiotherapy. A Phase I study in relapsed or refractory lymphoma was published in 2025. These studies do not constitute an approved indication.

Mechanism: A recombinant humanized IgG4 monoclonal antibody against B- and T-lymphocyte attenuator (BTLA). It is designed to block the HVEM-BTLA interaction and thereby counter BTLA-mediated inhibitory signaling.

Developer: Shanghai Junshi Bioscience Co., Ltd.

• Consolidation treatment after chemoradiotherapy in limited-stage small cell lung cancer without disease progression · Investigational indications
• Relapsed or refractory lymphoma · Investigational indications

Overseas status: Investigational internationally. The developer reports U.S. and Chinese IND authorizations and a Japanese PMDA clinical-trial authorization; the lead multi-regional Phase III LS-SCLC study was recruiting at the latest registry update before the cutoff. No marketing approval for tifcemalimab was identified in the reviewed primary sources.

China approval date: Date not disclosed

Updated 2026-10-25 · Details

Ivonescimab

AK112 · Brand name not announced

China status: Approved

Ivonescimab is a PD-1/VEGF-A bispecific antibody approved in China, where the current label contains three non-small cell lung cancer indications. Separately, it has no marketing authorization in Summit's license territories, including the United States and Europe, as of 2026-10-25. The U.S. FDA accepted a BLA for ivonescimab plus chemotherapy in one post-TKI EGFR-mutated non-squamous NSCLC setting; the stated PDUFA goal date is 2026-11-14. FDA review is not an approval or a launch estimate.

Mechanism: A humanized IgG1 bispecific antibody that binds VEGF-A and PD-1 and competitively blocks their ligand interactions.

Developer: Akeso Biopharma Co., Ltd. is the originator of ivonescimab. Summit Therapeutics Inc. is the licensee in North America, South America, Europe, the Middle East, Africa, and Japan.

• With pemetrexed and carboplatin for EGFR-mutated locally advanced or metastatic non-squamous NSCLC that has progressed after EGFR tyrosine kinase inhibitor treatment · Approved indications
• Monotherapy for first-line treatment of PD-L1 TPS at least 1%, EGFR-mutation-negative and ALK-mutation-negative locally advanced or metastatic NSCLC · Approved indications
• With paclitaxel and carboplatin for first-line treatment of unresectable locally advanced or metastatic squamous NSCLC · Approved indications
• Under U.S. BLA review with platinum-doublet chemotherapy for EGFR-mutated locally advanced or metastatic non-squamous NSCLC after third-generation EGFR-TKI therapy · Investigational indications

Overseas status: China approval and overseas status are distinct. As of 2026-10-25, ivonescimab has no marketing authorization in Summit's license territories, including the United States and Europe. The FDA accepted Summit's BLA on 2026-01-29 for ivonescimab plus platinum-doublet chemotherapy in EGFR-mutated locally advanced or metastatic non-squamous NSCLC after third-generation EGFR-TKI therapy. Summit's latest pre-cutoff statement gives a PDUFA goal date of 2026-11-14; the application remains an ongoing regulatory review, not an overseas approval.

China approval date: 2024-05-21

Updated 2026-10-25 · Details