FDA Announces Flexible CMC Pathway for Cell and Gene Therapies to Accelerate Development
The FDA’s Center for Biologics Evaluation and Research (CBER) announced a flexible, lifecycle‑based approach to...
Drug
Huadong Medicine’s DR10624 Wins Breakthrough Designation for Severe Hypertriglyceridemia
Huadong Medicine Co., Ltd (SHE: 000963) announced that DR10624, a long‑acting triple‑target agonist developed by...
Boan Biosimilar Prolia Wins Bolivia Approval, Targets Global Markets
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that BA6101, its biosimilar version of Amgen’s...
Genrix Bio’s GR1803 NDA Accepted for BCMA-Targeted Multiple Myeloma Therapy
Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443) announced that the conditional New Drug Application (NDA)...
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...
Merck Initiates Phase 3 Trial for Calderasib + KEYTRUDA QLEX in KRAS G12C NSCLC
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK) announced the initiation of KANDLELIT‑007, a Phase 3 clinical...
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...
Imunopharm’s IM19 CAR‑T Wins NMPA IND for Second‑Line NHL Therapy
Beijing Imunopharm Technology Co., Ltd. announced that its independently developed CD19‑targeted CAR‑T cell therapy, IM19,...
Shanghai MicuRx’s Contezolid Patent Extended Through 2033, Securing Market Exclusivity
Shanghai MicuRx Pharmaceutical Co., Ltd (SHA: 688373) announced that the patent for its core product,...
Lilly’s Taltz-Zepbound Combo Meets Primary Endpoint in Psoriatic Arthritis
Eli Lilly (NYSE: LLY) announced positive topline results from the TOGETHER‑PsA open‑label Phase 3b trial evaluating...
Sciclon Licenses Augtyro Promotion Rights from Zai Lab for China Market
Sciclon Pharmaceuticals (HKG: 6600) forged a collaboration with Zai Lab (NASDAQ: ZLAB, HKG: 9688), securing exclusive promotional rights...
Hengrui’s Retlirafusp α Wins NMPA Approval for First-Line Gastric Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that its self-developed Category 1 drug,...
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...
Sanofi’s Redemplo Wins NMPA Approval as First siRNA for Familial Chylomicronemia
Sanofi (NASDAQ: SNY) announced that Redemplo (plozasiran sodium injection), the world’s first small interfering RNA...
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)...
HutchMed’s Sovleplenib Meets Phase 3 Primary Endpoint in wAIHA, Targets NDA Filing
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that the Phase 3 registration part of the...
Sichuan Biokin’s BL-B01D1 ADC Wins Priority Review for ESCC in China
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that iza-bren (izalontamab brengitecan, BL-B01D1), its first‑in‑class...
Zai Lab’s Repotrectinib Wins NMPA sNDA for NTRK Fusion-Positive Solid Tumors
Zai Lab Ltd. (NASDAQ: ZLAB, HKG: 9688) announced that the supplemental New Drug Application (sNDA)...
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...
XtalPi’s RTX-117 Wins NMPA IND for CMT Therapy
ReviR Therapeutics, an incubated company of XtalPi (HKG: 2228), announced that RTX-117 has received Investigational...