Xtalpi-Backed Signet Therapeutics Secures FDA IND Approval for World’s First Pan-TEAD Inhibitor SIGX2649 Ahead of Schedule
Signet Therapeutics, an AI-driven biotechnology company incubated by Xtalpi Inc. (HKG: 2228), announced it has...
Legend Biotech’s In Vivo CAR-T Therapy LB2501 Shows 100% Response Rate in Relapsed/Refractory B-Cell Lymphoma with No Serious Safety Events
Legend Biotech Corporation (NASDAQ: LEGN) announced preliminary clinical data for LB2501, its investigational first-in-class CD19/CD20...
Kelun-Biotech’s Novel B7-H3 ADC SKB500 Shows 42.7% Response Rate Across Multiple Solid Tumors in First-in-Human ASCO 2026 Presentation
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) unveiled first-in-human clinical data for its investigational B7-H3-targeting...
AbbVie’s AQUIPTA (Atogepant) Receives European Commission Approval for Acute Migraine Treatment, Expanding Beyond Preventive Use
AbbVie Inc. (NYSE: ABBV) announced that the European Commission (EC) has granted marketing authorization for...
Xtalpi’s AI Biology Spin-off INFevo Secures Tens of Millions in Angel Funding to Build Virtual Cell System for Drug Discovery
Xtalpi Inc. (HKG: 2228) announced that its AI biology subsidiary INFevo has completed an angel...
Roche’s Oral SERD Giredestrant Receives FDA Priority Review for Early Breast Cancer Adjuvant Treatment
Roche Holding AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration...
CSPC Pharmaceutical Receives NMPA Approval for First-in-Class mRNA-LNP Dual-Target CAR-T Therapy SYS 6063 in Systemic Lupus Erythematosus
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced it has received clinical trial approval from China’s...
AstraZeneca’s Next-Gen SERD Camizestrant Shows 55% Reduction in Progression Risk and Superior ctDNA Clearance in Phase III SERENA-6 Trial
AstraZeneca plc (NYSE: AZN) announced updated results from the Phase III SERENA-6 clinical trial, demonstrating...
SystImmune and Bristol Myers Squibb’s Dual-Targeted ADC Izalontamabbrengitecan Shows Significant Survival Benefit in Two Phase III Trials
Izalontamabbrengitecan (iza-bren), an EGFR and HER3-targeted antibody-drug conjugate (ADC) jointly developed by SystImmune (a subsidiary...
CSPC Pharmaceutical’s B7-H3 ADC SYS 6043 Shows 41.8% Response Rate in Phase I Solid Tumor Study
CSPC Pharmaceutical Group Ltd. (HKG: 1093) presented Phase I clinical data for SYS 6043, a...
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)...