Everest lerodalcibep PCSK9 FDA Approval Targets China Launch
Everest Medicines Limited (HKG: 1952) announced that the U.S. FDA has approved the Biologics License...
Cryofocus GERD System Secures NMPA Approval in China
Cryofocus Medtech (Shanghai) Co., Ltd. (HKG: 6922) announced that its Anti-Gastroesophageal Reflux System has been...
Sanofi Adel Alzheimer’s Deal Targets Phase 1 ADEL-Y01 Antibody
Sanofi (NASDAQ: SNY) announced a license agreement with South Korean biotech Adel to gain exclusive...
Byterna Therapeutics Raises Angel Plus Round for cmRNA CAR‑T Pipeline
Byterna Therapeutics completed its angel plus round financing, exclusively invested by Efung Capital. Proceeds will...
GSK’s Exdensur Wins FDA Approval as First Twice‑Yearly Asthma Biologic
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) approved...
Beijing Friendship Hospital Launches Cell and Gene Therapy Center for Liver Diseases
The Cell and Gene Therapy Innovation and Transformation Center was officially established at Beijing Friendship...
Kelun-Biotech Settles with Medilink in Multi-Million Dollar ADC Revenue Sharing Deal
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced a settlement agreement with Medilink Therapeutics resolving...
Hansoh Licenses EGFR Drug Aumolertinib to Glenmark for $1B+ in Milestones
Jiangsu Hansoh Pharmaceutical Co. Ltd. (HKG: 3692) entered into an exclusive license, collaboration, and distribution...
Fangzhou and Huilun Partner on AI-Driven Chronic Disease Management Platform
Guangzhou-based smart healthcare service platform Fangzhou Inc. (HKG: 6086) and Shanghai Huilun Pharmaceutical Co., Ltd....
Adagene’s Muzastotug Wins FDA Fast Track for CTLA-4 Cancer Combo
Adagene Inc. (NASDAQ: ADAG) announced that the U.S. Food and Drug Administration (FDA) granted Fast...
Aficamten Wins China Approval as HCM Drug in Global First for Sanofi
Sanofi (NASDAQ: SNY) announced that aficamten, a second‑generation cardiac myosin inhibitor, received marketing approval from...
Haisco Wins NMPA Clinical Approval for Four Category 1 Drugs, Advancing Pipeline
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...
Orelabrutinib First BTK Inhibitor to Hit Phase 3 in Lupus as InnoCare NMPA Filing Cleared
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that its self‑developed novel BTK inhibitor orelabrutinib...
Saizeng Medical Licenses TSHR Antibody to Yarrow for $1.4B in Graves’ Disease Deal
Saizeng Medical Technology Co. Ltd, a subsidiary of Changchun High‑Tech Industry (Group) Co., Ltd. (SHE:...
Zhicheng’s TAVR Robotic System Enters NMPA Innovation Pathway
Zhicheng Medical Technology (Jiaxing) Co., Ltd. announced that its self‑developed ReachTact Transcatheter Aortic Valve Replacement...
ENHERTU Wins FDA Approval as First-Line HER2 Breast Cancer Therapy
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) announced that ENHERTU (fam-trastuzumab deruxtecan-nxki) in...
FDA Removes Key RWE Limitation, Allowing Drug and Device Submissions Without Individual Patient Data
The U.S. Food and Drug Administration (FDA) announced a major policy shift to accept Real-World...
Sanofi’s Tolebrutinib Fails Phase 3 PPMS Endpoint, Halting Registration Plans
Sanofi (NASDAQ: SNY) announced that the Phase 3 PERSEUS study (NCT04458051) of tolebrutinib in primary progressive...
Konruns Doses First Patient in Phase 2 Esophageal Cancer Trial for KC1036
Konruns Pharmaceutical Co., Ltd. (SHA: 603590) announced first patient dosing in the Phase 2 KC1036‑COM‑01...
Johnson & Johnson’s TECVAYLI Gets FDA Priority Review for Myeloma Combo
Johnson & Johnson (NYSE: JNJ) announced that the U.S. FDA selected the teclistamab MajesTEC‑3 supplemental...