China’s NMPA Introduces Comprehensive Medical Device Classification Reforms with 2-5 Year Transitional Periods
China’s National Medical Products Administration (NMPA) released two landmark regulatory announcements this week: the “Announcement...
Rallybio to Merge with Avenzo Therapeutics in $215 Million Deal, Creating Pipeline-Rich Entity Focused on Chinese-Origin Oncology Assets
Rallybio Corporation (NASDAQ: RLYB) announced a definitive agreement to acquire Avenzo Therapeutics, Inc. through a...
Simcere Pharmaceutical Secures Exclusive Rights to PrimeGenX’s Pumecitinib Gel for Atopic Dermatitis in Greater China
Simcere Pharmaceutical Group Limited (HKG: 2096) announced a strategic commercial partnership with PrimeGenX Therapeutics Co.,...
Amgen’s Tarlatamab Receives EC Approval for Extensive-Stage SCLC with 40% Mortality Reduction in Phase III Trial
Amgen Inc. (NASDAQ: AMGN) announced that the European Commission (EC) has granted marketing approval for...
Servier Group Acquires Edgewise Therapeutics’ Muscular Dystrophy Business for Up to $2.65 Billion
Servier Group, the French pharmaceutical company, announced a definitive agreement to acquire the muscular dystrophy...
Alphamab Oncology’s HER3×TROP2 Bispecific ADC JSKN016 Shows 64.5% Response Rate in Triple-Negative Breast Cancer at ASCO 2026
Alphamab Oncology (HKG: 9966) presented groundbreaking Phase I clinical data at the 2026 American Society...
Sino Biopharmaceutical’s Saitanxin Shows 32.4% Response Rate in CDK4/6 Inhibitor-Resistant Breast Cancer at ASCO 2026
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Ltd. (HKG:...
HemaCell Therapeutics Secures $44 Million Series B to Advance World’s First Megakaryocyte Injection for Platelet Regeneration
Suzhou HemaCell Therapeutics (HemaCell), a pioneering cell therapy developer focused on platelet regeneration, announced the...
Haisco Pharmaceutical Secures FDA Approval for Cypsedo as First Chinese-Developed Intravenous Anesthetic in US Market
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced it has received marketing approval from the...
Shionogi’s XOCOVA Becomes First Oral COVID-19 Post-Exposure Prophylaxis Approved by FDA
Shionogi & Co., Ltd. (TYO: 4507) announced that the U.S. Food and Drug Administration (FDA)...
BMS’ Camzyos Receives FDA Priority Review for Adolescent Obstructive HCM Treatment
Bristol-Myers Squibb Co. (BMS, NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA)...
Livzon Pharmaceutical Secures NMPA Approval for LZM012/XKH004, China’s First IL-17A/F Dual Inhibitor for Ankylosing Spondylitis
Livzon Pharmaceutical Group Inc. (HKG: 1513) announced it has received marketing approval from China’s National...
Changchun High & New Tech Secures FDA Approval for GenSci145, Mutation-Selective PI3Kα Inhibitor for PIK3CA-Mutant Solid Tumors
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced it has received clinical...
Changchun High & New Tech Secures FDA Clearance for GenSci136 Clinical Study in Generalized Myasthenia Gravis
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced it has received Investigational...
Legend Biotech Unveils First-in-Human Data for DLL3-Targeted CAR-T Therapy LB2102 in Relapsed Small Cell Lung Cancer at ASCO 2026
Legend Biotech Corporation (NASDAQ: LEGN) presented groundbreaking first-in-human (FIH) clinical data at the 2026 American...
Zelgen Biopharma Unveils Breakthrough Data for Bispecific and Trispecific Antibodies at ASCO 2026
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) presented compelling clinical data at the 2026 American...
Novartis’ Scemblix Demonstrates Sustained Superiority Over Standard TKIs in Chronic Myeloid Leukemia with 144-Week ASC4FIRST Data
Novartis AG (NYSE: NVS) announced compelling long-term efficacy data from the pivotal ASC4FIRST Phase III...
Haisco Pharmaceutical and Eli Lilly Forge $3 Billion Drug Discovery Alliance Spanning Multiple Therapeutic Areas
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) and Eli Lilly and Company (NYSE: LLY) announced...
BMS Secures EC Approval for Opdivo-AVD Combination in Advanced Classical Hodgkin Lymphoma
Bristol-Myers Squibb Co. (BMS, NYSE: BMY) announced that the European Commission (EC) has granted marketing...
D3 Bio’s Next-Gen KRAS G12C Inhibitor Elisrasib Shows 81% Response Rate in First-Line NSCLC at ASCO 2026
D3 Bio, a China-based biotechnology company, presented updated Phase I/II clinical data for elisrasib (D3S-001),...