Chongqing Precision Biotech Wins NMPA Approval for pCAR‑19B – China’s First Humanised CD19 CAR‑T Therapy for Pediatric B‑ALL
Chongqing Precision Biotech Co., Ltd. announced that its pCAR‑19B cell‑based product has received National Medical...
Drug
Laekna and Qilu Pharma Sign Exclusive China License for AKT Inhibitor LAE002 (Afuresertib)
Sino-US biotech Laekna Therapeutics (HKG: 2105) and Qilu Pharmaceutical Co., Ltd. announced today an exclusive...
NMPA Grants Marketing Authorisation to Hefei Amvite’s Memantine Hydrochloride ODT for Alzheimer’s Disease
The National Medical Products Administration (NMPA) has approved Memantine Hydrochloride Orally Disintegrating Tablets (ODT) produced...
Shanghai Henlius Biotech Secures UK MHRA Approval for Denosumab Biosimilars BILDYOS & BILPREVDA
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the United Kingdom’s Medicines and Healthcare Products...
Huadong Medicine Files NDA for Roflumilast Cream (ZORYVE) – First PDE‑4 Topical for Atopic Dermatitis in Greater China
Huadong Medicine Co., Ltd. (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has...
Grand Pharmaceutical & Glenmark Specialty Secure China NMPA Approval for Ryaltris Nasal Spray
Grand Pharmaceutical Group Limited (HKG: 0512) together with Glenmark Specialty S.A. announced that the Ryaltris...
Lepu Biopharma Secures FDA IND Clearance for CDH17‑Targeted ADC MRG007
Lepu Biopharma Co., Ltd. (HKG: 2157) announced that the U.S. Food and Drug Administration (FDA)...
Novartis Wins FDA Approval for Remibrutinib Tablets – First BTK Inhibitor for Chronic Spontaneous Urticaria
Novartis AG (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has granted...
DualityBio Secures FDA Fast‑Track Designation for EGFR/HER3 Bispecific ADC AVZO‑1418
Duality Biotherapeutics, Inc. (DualityBio, HKG: 9606) announced that its co‑developed EGFR/HER3 bispecific antibody‑drug conjugate (ADC),...
Roche Announces Positive Phase III Results for Fenebrutinib in Relapsing & Primary‑Progressive Multiple Sclerosis
Roche Holding AG (SWX: ROG, OTCMKTS: RHHBY) reported that both pivotal Phase III trials of its...
Simcere Launches Phase II Trial of T‑Reg‑Selective IL‑2 Fusion (SIM0278) for Moderate‑to‑Severe Atopic Dermatitis in China
Simcere Pharmaceutical Group Ltd. (HKG: 2096) announced that the Phase II clinical study of its proprietary...
Mabwell’s 9MW3811 Gains NMPA Approval to Launch World‑First IL‑11‑Targeting Phase 2 Trial for Pathological Scarring
Mabwell Bioscience (SHA: 688062) announced that its proprietary monoclonal antibody 9MW3811 has received clearance from...
Innovent Biologics & Sanegene Bio USA Report First‑in‑Human Success for IBI3016 siRNA Hypertension Therapy
Innovent Biologics, Inc. (HKG: 1801) and Sanegene Bio USA Inc. announced today the first‑in‑human (FIH)...
Hangzhou Bio‑Sincerity Secures NMPA Approval for BIOS‑0625 Tablet – First‑in‑Class Ulcerative Colitis Therapy
Hangzhou Bio‑Sincerity Co., Ltd. (SHE: 301096) announced today that its BIOS‑0625 tablet, a Class 1 small‑molecule...
Gilead Sciences’ Tro Delvy Fails to Meet Primary Endpoint in ASCENT‑07 Metastatic Breast Cancer Trial
Gilead Sciences Inc. (NASDAQ: GILD) today disclosed that the Phase III ASCENT‑07 study, which compared Trodelvy...
Jiangsu Hengrui Pharmaceuticals Announces HRS‑2430 Injection Approval for Clinical Trials
China‑listed Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced today that its novel intravenous...
Humanwell Healthcare Secures NMPA Approval to Launch First Fixed‑Dose Combination for Pulmonary Arterial Hypertension
Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced that its investigational compound HWH217 has received...
Eli Lilly & Novo Nordisk Reach U.S. Deal to Cut Obesity‑Drug Prices, Unlock Medicare & Medicaid Access
Eli Lilly (NYSE: LLY) and Novo Nordisk (NYSE: NVO) announced a historic agreement with the...
CStone Pharmaceuticals to Unveil CS2015 Data at 2025 ACAAI Meeting
China‑based CStone Pharmaceuticals (HKG: 2616) announced that the pre‑clinical results for its bispecific biologic CS2015...
Sinotau Receives FDA NDA Approval for MK‑6240 Tau PET Imaging Agent
Beijing Sinotau International Pharmaceutical Technology Co., Ltd. announced today that the New Drug Application (NDA) for...