GenFleet Therapeutics
GenFleet Therapeutics raised HK$1.82B in its HKEX IPO, surging 106% on debut. With GFH925 approved for NSCLC and GFH375 showing strong early ORR in KRAS G12D NSCLC, the company is advancing its pipeline, partnerships, and competitive position in global oncology.
K药皮下注射剂
默沙东K药皮下注射剂（MK-3475A，Keytruda Qlex）获FDA批准，可实现成人肿瘤患者1~2分钟快速给药。
Keytruda Subcutaneous Injection
Merck’s Keytruda subcutaneous injection (MK-3475A, Keytruda Qlex) approved by FDA, offering 1–2 minute dosing for adult patients with most solid tumors.
NewCo模式
中国创新药企正加速采用NewCo模式出海，将资产海外孵化，融合授权、股权和风险投资支持。Mabwell→Kalexo、恒瑞→Hercules等交易显示，该模式提升全球开发效率，助力中国创新药国际化。
NewCo Model
Chinese biotechs are increasingly spinning assets into offshore NewCos, blending licensing, equity, and VC/PE backing. Deals like Mabwell→Kalexo and Hengrui→Braveheart accelerate global development, unlock capital, and position China as a key exporter of early- and mid-stage biotech assets.
Vepdegestrant
Vepdegestrant是全球首个提交FDA的新药上市申请（NDA）的PROTAC药物，代表蛋白降解治疗在肿瘤学领域的重要里程碑。VERITAC-2 III期临床显示，ESR1突变患者中疗效显著，中位PFS达到5.0个月，而总人群未达主要终点。受此影响，辉瑞与Arvinas决定寻求第三方合作伙伴负责商业化。
Vepdegestrant
Arvinas and Pfizer’s Vepdegestrant is the first PROTAC to reach FDA review, a milestone for the modality. But Pfizer’s retreat after mixed Phase 3 data—showing benefit only in ESR1-mutant patients—raises doubts over its commercial impact and leaves PROTAC oncology’s future hanging on this outcome.
Raludotatug Deruxtecan
默沙东与第一三共联合开发的CDH6靶向ADC Raludotatug Deruxtecan（R-DXd）获FDA突破性疗法认定。早期临床显示ORR 46%，DCR 98%，彰显潜力。
Raludotatug Deruxtecan
The FDA has granted Breakthrough Therapy Designation to Raludotatug Deruxtecan (R-DXd), a CDH6-targeting ADC, for patients with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers. Early-phase trials show ORR 46% and DCR 98%.
Kalexo Bio
Kalexo Bio 由迈威生物与 Aditum 成立，推进 2MW7141 双靶点 siRNA 药物，用于血脂调控及心血管高危患者。交易包括 1200 万美元现金、优先股及最高 10 亿美元里程碑付款，体现 NewCo 出海趋势。
Kalexo Bio
Mabwell Bioscience and Aditum Bio launch Kalexo Bio, a NewCo spinout to develop 2MW7141, a dual-target siRNA therapy for dyslipidemia and high-risk cardiovascular disease. Deal includes $12M upfront, preferred shares, and up to $1B in milestones.
PTK7 ADC
Genmab宣布终止PTK7靶向ADC PRO1107开发，辉瑞及艾伯维的Cofetuzumab Pelidotin早期项目也已中止。科伦博泰SKB518成为全球首个进入II期的PTK7 ADC，同时DAY301、LY4175408等新一代ADC正在推进临床，PTK7 ADC领域迎来新局面。