辉瑞拟以73亿美元收购Metsera，布局潜在月度给药的新一代减肥疗法

辉瑞 ($PFE) 接近收购 Metsera ($MTRS) 73 亿美元，获得其核心资产 MET-097i，这是一款新一代 GLP-1 受体激动剂，超长效、可潜在月度给药，12 周体重下降可达 11.3%，耐受性良好。

Pfizer Eyes $7.3B Metsera Buy for Next-Gen Obesity Therapy with Monthly Dosing

Pfizer is nearing a $7.3B acquisition of Metsera, gaining MET-097i, a next-gen GLP-1 therapy with ultra-long acting, potentially monthly dosing, strong Phase 2a efficacy, and promising tolerability.

盘点2025 年 FDA 获批新药：中国创新药企缔造多项历史突破！

全面盘点 2025 年 FDA 批准新药（1–9 月，持续更新），共28款新药，涵盖抗肿瘤、罕病及神经系统等关键领域。聚焦中国创新药企(迪哲医药,康方生物 和 葆元医药)亮眼表现与全球新药研发趋势，包括适应症、作用机制及临床意义。

全球首款罕见病巴思综合征疗法：Elamipretide获FDA加速批准

Elamipretide（Forzinity）成为全球首个获FDA批准的巴思综合征疗法，为患者带来全新希望。本文回顾其意外发现、公司的研发历程、临床数据及监管挑战。

From Discovery to FDA Approval: Forzinity Becomes First Therapy for Barth Syndrome

Forzinity (elamipretide) makes history as the first FDA-approved therapy for Barth syndrome. Learn about Hazel Szeto’s discovery, Stealth Biotherapeutics’ development journey, and the clinical evidence supporting approval.

劲方医药成功上市港交所：KRAS靶向创新引领中国药企

劲方医药在港交所成功上市，首日收盘上涨106%。公司核心资产GFH925(氟泽雷塞)去年获批NSCLC，成为中国首款、全球第三款该类靶点药物。GFH375显示KRAS G12D早期高ORR. 本文回顾公司KRAS靶向管线与行业竞争，洞察未来发展机遇。

GenFleet Therapeutics’ Blockbuster IPO Highlights China’s KRAS Innovation and G12D Ambitions

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.

1~2分钟完成给药! 默沙东K药皮下注射剂获FDA批准

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 Receives FDA Approval: 1–2 Minute Dosing for Most Solid Tumors

Merck’s Keytruda subcutaneous injection (MK-3475A, Keytruda Qlex) approved by FDA, offering 1–2 minute dosing for adult patients with most solid tumors.

中国创新药企出海新趋势：NewCo模式加速全球市场竞争力（2024–2025)

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。

The Rise of the “NewCo” Model in Chinese Biotech: Global Expansion via Spinouts (2024–2025)

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.

全球首个申报上市的PROTAC药物Vepdegestrant：机遇背后的临床与商业挑战

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。