Roche’s Xofluza Wins NMPA Approval for Pediatric Expansion – Oral Suspension Cleared for Children Under 5 Years
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that Xofluza (baloxavir marboxil) has received expanded NMPA approval...
Drug
J&J’s TECVAYLI Wins FDA Approval in Earlier-Line Myeloma – BCMA BiTE Plus Daratumumab Combo Expands Addressable Market
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA)...
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...
AbbVie’s SKYRIZI Hits AFFIRM Study Endpoints in Crohn’s Disease – 55% Clinical Remission vs. 30% Placebo at Week 12
AbbVie Inc. (NYSE: ABBV) announced positive topline results from the Phase 3 AFFIRM study evaluating risankizumab...
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...
Novo Nordisk’s CagriSema Fails Non‑Inferiority Test Against Lilly’s Zepbound in Phase III REDEFINE 4 Trial – 23% vs. 25.5% Weight Loss
Novo Nordisk A/S (NYSE: NVO) announced that its Phase III REDEFINE 4 study (NCT06131437) failed...
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...
Sihuan Pharma’s Bireociclib Wins NMPA Approval for First‑Line HR+/HER2‑ Breast Cancer – CDK2/4/6 Inhibitor Expands Label
Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that Xuanyuening (bireociclib), a Category 1 CDK2/4/6 inhibitor developed...
Bio-Thera’s Stelara Biosimilar Usymro Wins UK Approval – Expands European Market Access via Gedeon Richter
Bio-Thera Solutions Ltd (SHA: 688177) announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)...
Kexing Biopharma’s GB19 Wins NMPA Approval for Cutaneous Lupus – BDCA2‑Targeted Therapy Expands Autoimmune Pipeline
Kexing Biopharm Co., Ltd. (SHA: 688136) announced clinical trial approval from China’s National Medical Products Administration...
J&J’s Nipocalimab Wins FDA Fast Track for Lupus – FcRn Blocker Targets Autoantibody Diseases
Johnson & Johnson (J&J, NYSE: JNJ) announced that its investigational drug nipocalimab has received Fast Track...
Asieris Pharma’s Cevira Wins NMPA Approval – World’s First Non‑Surgical Photodynamic Therapy for Cervical Lesions
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176), a urogenital cancer specialist, announced marketing approval from China’s...
Antengene Licenses ATG-201 to UCB in $1.1B+ Deal – CD19/CD3 T‑Cell Engager Targets Autoimmune Diseases
Antengene Corp., Ltd (HKG: 6996) announced a licensing agreement with UCB (EBR: UCB), granting the Belgium‑based biopharma...
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...