Changchun GeneScience Secures China Approval for Long‑Acting FSH‑CTP Injection
China‑based Changchun GeneScience Pharmaceutical Co. Ltd. announced that its long‑acting recombinant human follicle‑stimulating hormone—CTP fusion...
Drug
Ipsen Launches BYLVAY in China for Rare Liver Disease
France‑based Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced the official commercial launch of its rare‑disease...
Simnova Secures FDA IND for CAR‑NK Therapy in SLE
Shanghai Simnova Biotech Co., Ltd. (Simnova) announced that its CD19‑targeted chimeric antigen receptor gene‑modified natural...
Sinopharm Secures NMPA Approval for QuadrivalentHPV Vaccine
China’s Sinopharm Group Co., Ltd. (Chengdu Institute of Biological Products, a subsidiary of the China...
Hua Medicine Secures Hong Kong NDA Acceptance for Dorzagliatin, First‑In‑Class Glucokinase Activator
China‑based Hua Medicine (HKG: 2552) announced that the Hong Kong Department of Health has accepted its...
Xinhua Pharma Wins China Trial Approval for Dual‑Mechanism PAH Drug LXH‑1211
Shandong Xinhua Pharmaceutical Co., Ltd. (HKG: 0719) announced that its pulmonary arterial hypertension (PAH) candidate...
Simcere Secures FDA Approval for ADC SIM0609 in Advanced Solid Tumors
Simcere Pharmaceutical Group Limited (HKG: 2096) announced that the U.S. Food and Drug Administration (FDA)...
CMS Wins NMPA Green Light for Phase‑3 Trial of MG‑K10 Anti‑IL‑4Rα in Chronic Urticaria
China Medical System Holdings Limited (CMS, HKG: 0867) announced that the National Medical Products Administration...
Eisai & Biogen Secure Leqembi China Maintenance Approval
Japanese drugmaker Eisai Co., Ltd. (TYO: 4523) and U.S. biopharma Biogen Inc. (NASDAQ: BIIB) announced...
HanX Biopharmaceuticals Secures NMPA Approval for HX044‑HX008 PD‑1 Therapy Combination in Advanced Solid Tumors
HanX Biopharmaceuticals (Wuhan) Co., Ltd., a fast‑growing Chinese biotech, announced that the National Medical Products...
Novatim Partners with VRise to Launch KQ‑2003 CAR‑T in India
Novatim Immune Therapeutics (Zhejiang) Co., Ltd., a leading Chinese cancer‑immunotherapy firm, announced an exclusive licensing...
CMS Announces Phase 3 Success of Ruxolitinib Cream in Atopic Dermatitis
China Medical System Holdings Limited (CMS, HKG: 0867) reported that its Phase 3, randomized, double‑blind, placebo‑controlled...
Leo Pharma Secures First Greater Bay Area Prescription for Anzupgo, a Novel Topical JAK Inhibitor
Denmark-based dermatology specialist LEO Pharma A/S announced that the Greater Bay Area’s first prescription of...
CSPC Pharma Secures NMPA Approval for Lecanemab Biosimilar, First of Its Kind in China
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the National Medical Products Administration (NMPA) has...
Trump Announces 100% Tariff on Branded Drugs, Exempts U.S.‑Built Pharmaceutical Factories
President Donald J. Trump announced via a social‑media post that the United States will impose a 100 % tariff...
Sichuan Biokin Secures Second Breakthrough Therapy Designation for Izalontamab Brengitecan in Advanced Urothelial Carcinoma
China‑based Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced today that the Center for Drug...
Fosun Pharma’s Alovatinib Enters China’s Pediatric Anti‑Tumor SPARK Pilot
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that...
Eli Lilly Halts Obesity Study of Experimental Drug Bimagrumab for Strategic Reasons
Eli Lilly & Co. (NYSE: LLY) announced that it has discontinued a phase I/II trial of...
AstraZeneca and Daiichi Sankyo Submit Priority‑Review sBLA for Enhertu as First‑Line Therapy for HER2‑Positive Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have filed a supplemental Biologics License...
Biogen Receives FDA Complete‑Response Letter on High‑Dose Nusinersen for SMA
Biogen Inc. (NASDAQ: BIIB) announced today that the U.S. Food & Drug Administration (FDA) has...