drugset
Drugs / JSKN016
last change Aug 2026 re-read 8 days ago

JSKN016

also known as JSKN016 injection
Developed for
non-small cell lung carcinoma · breast cancer · cancer · Her2-receptor negative breast cancer · triple-negative breast carcinoma
Investigated by
Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Shanghai Pulmonary Hospital, Shanghai, China

Trials 8

today NCT07533123 · Ph 3 NCT07493980 · Ph 2 NCT07475559 · Ph 1 NCT07336771 · Ph 1/2 NCT06942234 · Ph 1/2 NCT06868732 · Ph 1 NCT06775483 · Ph 2 NCT06592417 · Ph 1
20252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT07475559 Mar 2026 → Jul 2028 expected — Jiangsu Alphamab Biopharmaceuticals Co., Ltd Not yet recruiting No outcome recorded
Phase 1 NCT06868732 Apr 2025 → Jun 2028 expected non-small cell lung carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Recruiting No outcome recorded
Phase 1 NCT06592417 Apr 2024 → May 2026 overdue cancer Jiangsu Alphamab Biopharmaceuticals Co., Ltd Recruiting No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT07336771 Jan 2026 → Dec 2027 expected breast cancer Jiangsu Alphamab Biopharmaceuticals Co., Ltd Not yet recruiting No outcome recorded
Phase 1/2 NCT06942234 Jun 2025 → Jun 2027 expected Her2-receptor negative breast cancer Jiangsu Alphamab Biopharmaceuticals Co., Ltd Recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT07493980 Mar 2026 → Jan 2027 expected non-small cell lung carcinoma Shanghai Pulmonary Hospital, Shanghai, China Not yet recruiting No outcome recorded
Phase 2 NCT06775483 Jan 2025 → Jun 2027 expected non-small cell lung carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Not yet recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT07533123 Mar 2026 → Mar 2029 expected triple-negative breast carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2026-06-02 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results 2026 ASCO │ 康宁杰瑞TROP2/HER3双抗ADC JSKN016治疗HER2阴性乳腺癌临床研究数据公布 alphamabonc.com ↗
在可评估疗效的31例患者中，研究者评估的客观缓解率（ORR）为64.5%，中位无进展生存期（mPFS）为7.6个月；独立评审委员会（IRC）评估的ORR为61.3%；mPFS为7.9个月。
2026-04-23 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results 2026 ASCO预告 │ 康宁杰瑞将公布TROP2/HER3双抗ADC JSKN016治疗HER2阴性乳腺癌临床研究数据 alphamabonc.com ↗
研究结果表明，JSKN016在后线乳腺癌患者中展现了令人鼓舞的疗效和同类最佳的安全性，这为其在一线和围手术期联合化疗、免疫及靶向治疗奠定了坚实基础。
2025-12-22 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Regulatory 康宁杰瑞双抗ADC药物JSKN016联合益方生物D-0502治疗乳腺癌获批临床 alphamabonc.com ↗
2025年12月22日，中国苏州，康宁杰瑞生物制药（股票代码：9966.HK）宣布，公司自主研发的TROP2/HER3双特异性抗体偶联药物（ADC）JSKN016联合益方生物口服选择性雌激素受体降解剂（SERD）D-0502的临床试验申请（研究编号：JSKN016-204），已获得国家药品监督管理局（NMPA）药品审评中心（CDE）批准，用于治疗局部晚期或转移性HR阳性、HER2阴性（HR+/HER2-）乳腺癌。

All press releases naming this drug 4 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as JSKN016 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06868732 ↗
7

NCT07336771 ↗

NCT07533123 ↗

NCT06592417 ↗

NCT06775483 ↗

NCT07493980 ↗

NCT06942234 ↗

NCT07475559 ↗
Known as JSKN016 injection “Drug: JSKN016 injection” NCT06592417 ↗
Route Intravenous “8 mg/kgmg/kg, IV ,Q3W” NCT06592417 ↗