Henlius Biotech’s HLX3901 Wins NMPA Approval – First-in-Class Tetra-Specific Antibody Targets DLL3-Positive Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX3901, a first-in-class tetra-specific antibody targeting DLL3...
Clinical trial approval / initiation
Fosun Pharma’s HLX316 Wins NMPA Approval – First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that HLX316, a novel...
Hengrui’s HRS9531 Wins NMPA Approval for CKD Trial – Dual GIPR/GLP-1R Agonist Expands Beyond Diabetes and Obesity
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS9531, a novel dual...
Hengrui’s Adebrelimab Wins NMPA Approval for Two Perioperative Cancer Trials – PD-L1/CTLA-4 Combo Targets Rectal and Gastric/GEJ Cancers
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance for two pivotal...
Leads Biolabs’ Opamtistomig Enters Phase II in First-Line Esophageal Cancer – PD-L1/4-1BB Bispecific with BTD/ODD Designations
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced first patient enrollment in a Phase II...
CSPC’s SYH2059 Inhalation Powder Wins FDA IND Approval – PDE4B Inhibitor Targets Pulmonary Fibrosis with Enhanced Delivery
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced FDA clearance to initiate a clinical study for...
CF PharmTech Wins NMPA Approval for Olopatadine Mometasone Combo Trial – Fixed-Dose Nasal Spray Targets Moderate-to-Severe Allergic Rhinitis
CF PharmTech Inc. (HKG: 2652) announced NMPA clearance to initiate a clinical study for its...
Dongcheng Pharma Doses First Patient in 225Ac-LNC1011 Phase I/II Trial – PSMA-Targeted Alpha Radiotherapy for Metastatic Prostate Cancer
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced first subject enrollment in a Phase...
Bio-Thera Wins NMPA Approval for BAT8008 BAT1006 Trastuzumab Combo Trial – Dual HER2 Trop2 Targeting in Advanced Solid Tumors
Bio-Thera Solutions Ltd (SHA: 688177) announced NMPA clearance to initiate a clinical study evaluating BAT8008...
Fosun Pharma’s HLX97 Wins NMPA Phase I Approval – First-in-Class KAT6A/B Inhibitor Targets Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA: 600196, HKG: 2196) announced that HLX97,...
Insilico Medicine’s AI-Driven ISM4808 Hits Phase I Milestone – TaiGen Doses First Subject in CKD Anemia Trial
Insilico Medicine (HKG: 3696) announced that ISM4808, an AI-driven PHD inhibitor for chronic kidney disease...
HutchMed Initiates Phase I/IIa Trial for HMPL-A580 – Second Antibody-Targeted Triggered Conjugate Targets EGFR+ Solid Tumors
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I/IIa clinical...
Ab&B Bio-Tech Wins FDA IND Approval for mRNA Mpox Vaccine – China’s First U.S.-Cleared Candidate Targets Immunocompromised Populations
Ab&B Bio-Tech CO., LTD. JS (HKG: 2627) announced that the U.S. Food and Drug Administration...
Eli Lilly’s Eloralintide Wins CDE Approval for Phase III Trials in China – Weekly Amylin Agonist Targets Weight Management Market
Eli Lilly and Company (NYSE: LLY) announced that China’s Center for Drug Evaluation (CDE) under...
Pyrotech Therapeutics’ PTT-936 Wins NMPA Approval – Novel ALPK1 Agonist Targets Bladder Cancer
Pyrotech (Beijing) Biotechnology Co., Ltd. (“Pyrotech Therapeutics”) announced that its internally developed small‑molecule innate immune...
Konruns Pharma’s KC1036 Wins NMPA Approval – Dual‑Target VEGFR2/AXL Inhibitor Enters IO Combination Trials
Beijing Konruns Pharmaceutical Co., Ltd (SHA: 603590) announced that China’s National Medical Products Administration (NMPA) has...
Sichuan Biokin’s CD33 ADC BL-M11D1 Wins NMPA Approval – Expands into Myelodysplastic Syndromes
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that China’s National Medical Products Administration (NMPA) has...
CMS’s CMS-D008 Wins NMPA Approval – INHBE siRNA Targets Fat‑Selective Weight Loss
China Medical System Holdings Limited (CMS, HKG: 0867) announced clinical study approval from China’s National Medical...
ImmuneOnco’s IMM0306S Wins NMPA Approval – Subcutaneous CD47×CD20 Bispecific for Lupus Enters Clinic
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) announced clinical approval from China’s National Medical Products Administration...
Huadong Medicine’s DR30206 Wins NMPA Approval – Triple‑Target Fusion Protein for NSCLC Enters Phase II
Huadong Medicine Co., Ltd (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has approved...