Haichang Biotech’s HC016 Receives FDA Orphan Drug Designation for Osteosarcoma
Haichang Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...
Cancer
Merck and Abbisko’s Pimicotinib NDA Accepted by FDA for TGCT, Building on China Approval
Merck KGaA (ETR: MRK) and Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that the U.S. FDA...
Summit Therapeutics Submits Ivonescimab BLA to FDA for EGFR‑Mutated NSCLC Post Third‑Gen TKI
Summit Therapeutics (NASDAQ: SMMT), the US partner of Akeso Inc. (HKG: 9926), announced the submission of...
Boehringer Ingelheim & Jazz Launch Phase I HER2 Breast Cancer Combo with Zongertinib & Zanidatamab
Boehringer Ingelheim and Jazz Pharmaceuticals plc (NASDAQ: JAZZ) announced a strategic clinical collaboration to evaluate a...
CARsgen Therapeutics Enters Phase I Collaboration with Dispatch Bio for CT053 CAR‑T in Solid Tumors
CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced a clinical collaboration with Dispatch Bio to evaluate DISP‑11,...
Noetik Enters $50M AI Collaboration with GSK, Licensing OCTO‑VC Virtual Cell Models for NSCLC and CRC
Noetik, an AI‑native biotech pioneering self‑supervised machine learning in cancer therapeutics, announced a five‑year strategic...
Alphamab Oncology Submits Envafolimab for First‑Line Biliary Tract Cancer (BTC) as World’s First Subcutaneous PD‑L1
Alphamab Oncology (HKG: 9966) announced that China’s National Medical Products Administration (NMPA) has accepted its marketing...
Simcere Pharma to Spin Off Zaiming Unit for Hong Kong IPO
Simcere Pharmaceutical Group Limited (HKG: 2096) announced plans to spin off its subsidiary Simcere Zaiming...
Hengrui’s Quadruple Prostate Cancer Combo Wins NMPA IND for Phase 2 Study
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that the National Medical Products...
Dongcheng Pharma’s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA)...
Pierre Fabre Partners with Iktos on AI-Driven Oncology Drug Discovery
Pierre Fabre Laboratories announced a comprehensive drug discovery collaboration with French AI specialist Iktos to...
RemeGen’s RC48 Wins Fourth Breakthrough Therapy Designation for Gastric Cancer Combo
RemeGen Ltd (SHA: 688331, HKG: 9995) announced that its core product, Disitamab Vedotin (RC48/Aidixi), has...
Hansoh Pharmaceutical’s Ameile Wins Fifth NMPA Indication for EGFR‑Mutated NSCLC
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that its core product, Ameile (almonertinib), has...
InduPro Partners with Lilly on $950M Oncology Deal Using Proximity-Guided Platform
InduPro announced a global strategic collaboration, licensing agreement, and equity investment with Eli Lilly (NYSE:...
Pfizer Partners with Cartography on $850 Million Tumor Antigen Discovery Deal
Pfizer Inc. (NYSE: PFE) and Cartography Biosciences, Inc. announced a strategic collaboration to discover tumor-selective...
Bayer’s Cevatertinib Wins Breakthrough Therapy Designation for HER2‑Mutant NSCLC
Bayer AG (VIE: BAYN) announced that cevatertinib (BAY 2927088) has been granted Breakthrough Therapy Designation (BTD)...
Amgen Acquires Dark Blue Therapeutics for $840 Million to Expand AML Portfolio
Amgen Inc. (NASDAQ: AMGN) announced the acquisition of Dark Blue Therapeutics Ltd., a privately held...
BeOne’s Sonrotoclax Wins Conditional NMPA Approval for BCL-2 Inhibitor in CLL/SLL and MCL
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that its self‑developed Class 1 innovative drug...
Hengrui’s HRS9531 and AR‑PROTAC Win NMPA IND Approval for Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that four drug candidates—HRS9531 (GLP‑1R/GIPR...
Yifan Pharmaceutical Licenses ACT001 for SCLC Brain Metastases Across 12 Asian Markets
Yifan Pharmaceutical Co., Ltd. (SHE: 002019) announced exclusive commercial cooperation and cornerstone investment agreements with...