Corxel Secures FDA IND Clearance for CX11 Phase 2 Trial in Type 2 Diabetes
Corxel Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has cleared...
Drug
Jiangsu Hengrui’s Rezvilutamide Clears NMPA Hurdle, Moves Into Phase III Prostate‑Cancer Trial
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced today that its second‑generation androgen‑receptor inhibitor...
Legend Biotech Reports $524 M CARVYKTI Sales, FDA Updates & Q3 Loss
Legend Biotech (NASDAQ: LEGN) published the unaudited financial results for fiscal Quarter 3 2025 (2025Q3) on 12 Nov 2025. The flagship...
Tonghua Dongbao Secures Dominican Republic Market Launch for Insulin Aspart
Tonghua Dongbao Pharmaceuticals Co., Ltd. (SHA: 600867) announced that its Insulin Aspart Injection 3 ml : 300 IU pre‑filled...
BCHT Receives NMPA Approval for First Adult DTaP Vaccine Covering Pertussis, Diphtheria, and Tetanus
Changchun BCHT Biotechnology Co., Ltd. (SHA: 688276) announced that its Adsorbed Acellular Pertussis (Two‑Component) Diphtheria...
EirGenix Secures $152 M Licensing Deal for EG1206A Breast‑Cancer Biosimilar from Sandoz
EirGenix Inc. (TPE: 6589) announced a second, worldwide exclusive licensing agreement with Sandoz AG (SWX:...
Humanwell Initiates Phase 2 Trial of HW231019 Tablets for Post‑Abdominal Surgery Analgesia
Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that it has begun a Phase 2 clinical...
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...
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)...