Duality Biologics’ HER2-Targeted ADC DB-1303 (BNT323) Enters NMPA Review for Metastatic Breast Cancer
Duality Biologics Co., Ltd. (HKG: 9606), a U.S.-China biotech specializing in antibody-drug conjugates (ADCs), announced...
Drug
Haisco Pharma’s HSK42360 Selected for NMPA SPARK Program – First BRAF V600 Inhibitor for Pediatric Glioma in China
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that its novel drug candidate HSK42360 has been...
Luye Pharma Doses First Patient in Phase II Study of LY03020 – World’s First Dual‑Target TAAR1/5‑HT2CR Agonist for Schizophrenia
Luye Pharma Group (HKG: 2186) announced first patient enrollment in a Phase II clinical study evaluating...
Sino Biopharm Wins FDA Approval for Pan‑KRAS Inhibitor TQB3205 – First‑in‑Human Trial in Advanced Malignancies
Sino Biopharmaceutical Ltd (HKG: 1177) announced that the US Food and Drug Administration (FDA) has granted...
GenFleet Therapeutics Secures First‑Ever NMPA Breakthrough Designation for KRAS G12D Inhibitor in Pancreatic Cancer
GenFleet Therapeutics (Shanghai) Inc. (HKG: 2595) announced that China’s National Medical Products Administration (NMPA) has granted...
Sino Biopharm’s Chia Tai Tianqing Secures GDMPA Approval for Naldemedine in Greater Bay Area – World’s First Oral OIC Therapy Enters China
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), a wholly‑owned subsidiary of Sino Biopharmaceutical Limited...
UniXell Biotechnology Secures NMPA IND Approval for UX-GIP001, World’s First iPSC-Derived Cell Therapy for Drug-Resistant Epilepsy
UniXell Biotechnology, a clinical-stage cell therapy innovator, announced that China’s National Medical Products Administration (NMPA)...
Shionogi Secures $119M BARDA Contract for Fetroja Antibiotic as Biothreat Countermeasure
Shionogi Co., Ltd. (TYO: 4507) announced that its U.S. subsidiary, Shionogi Inc., has been awarded...
Joincare Pharmaceutical Receives NMPA Approval to Initiate JKN2401 Clinical Study in CRSwNP, Expanding TSLP-Targeting Biologic Development Across Respiratory Indications
Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) announced that China’s National Medical Products Administration...
Haisco Pharmaceutical Secures NMPA Breakthrough Therapy Designation for HSK39004 Inhalation Powder in COPD, Following Successful Phase II Lung Function Data
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...
Sanofi’s Bispecific Nanobody Lunsekimig Achieves Primary Endpoints in Asthma and CRSwNP Phase II Studies, Shows Mixed Results in Atopic Dermatitis
Sanofi (NASDAQ: SNY) announced positive top-line results from two Phase II clinical studies of lunsekimig,...
Simcere’s CDH6-Targeting ADC SIM0505 Receives FDA Fast Track Designation for Platinum-Resistant Ovarian Cancer, Advancing Global Development with NextCure
Simcere Pharmaceutical Group Limited (HKG: 2096) announced that its subsidiary Simcere Zaiming has received Fast...
GSK’s Exdensur Secures Second NMPA Approval in China for Chronic Rhinosinusitis with Nasal Polyps, Expanding Type 2 Inflammation Portfolio
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that China’s National Medical Products Administration (NMPA) has granted...
Aidea Pharma’s Novel HIV-1 Capsid Inhibitor ACC085 Cleared for PrEP Trial in China, Targeting Long-Acting Prevention
Jiangsu Aidea Pharmaceutical Co., Ltd. (SHA: 688488) has secured clinical trial approval from China’s National...
Gan & Lee Pharmaceuticals Launches China’s First AR-Targeting PROTAC into Phase I Trial for Advanced Prostate Cancer
Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) has received IND approval from China’s National...
Amgen’s Subcutaneous Tepezza via On-Body Injector Meets Phase III Endpoint in Thyroid Eye Disease with 77% Proptosis Response
Amgen Inc. (NASDAQ: AMGN) announced positive top-line results from a Phase III clinical trial evaluating...
Zhuhai Rundu’s Higenamine Receives NMPA Approval as China’s First Category 1 Cardiac Stress Test Agent
China’s National Medical Products Administration (NMPA) has granted marketing approval for higenamine, a Category 1...
Youcare Pharma’s YKYY018 Inhalation Therapy Expands to COVID-19 Clinical Study Following RSV Development Success
Beijing Sun-Novo Pharmaceutical Research Co., Ltd. (SHA: 688621) announced it has received approval from China’s...
Youcare Pharma’s YKYY018 Inhalation Therapy Expands to COVID-19 Clinical Study Following RSV Development Success
Youcare Pharmaceutical Group (SHA: 688658) announced that its YKYY018 aerosolized inhalation formulation has received approval...
Merck’s KEYTRUDA Receives EU Approval for Platinum-Resistant Ovarian Cancer in Combination Regimen
Merck & Co., Inc. (MSD, NYSE: MRK) announced that the European Commission has granted marketing...