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),...
Drug
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...
UCB Wins FDA Approval for KYGEVVI in Rare Mitochondrial Disease TK2d
UCB (EBR: UCB) announced that KYGEVVI received FDA approval for the treatment of adult and...
Dizal Highlights Breakthrough Findings for golidocitinib and birelentinib at ASH 2025
Dizal Pharmaceutical Co., Ltd. (SHA: 688192) announced that multiple research updates for its two core...
Jiangsu Vcare’s VC004 Joins NMPA’s SPARK Oncology Program
The Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has officially...
Jiangsu Hengrui Secures Priority Review for HRS‑5965 in China’s Rare‑Disease Portfolio
Jiangsu Hengrui Pharmaceuticals (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA)...
Pluvicto Radioligand Therapy Receives Dual NMPA Approvals in China
Novartis (NYSE: NVS) has announced that its Lutetium‑177‑labelled therapy Pluvicto (lutetium ¹⁷⁷Lu‑vipivotide tetraxetan) now holds...
Sichuan Biokin Secures Breakthrough Therapy Designation for HER2‑Targeted ADC T‑Bren
China’s Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its proprietary antibody‑drug conjugate (ADC)...
Shenzhen Kangtai Biological Products Launches Phase I Trial for Infant Influenza Vaccine
China‑based Shenzhen Kangtai Biological Products Co., Ltd. (SHE: 300601) has entered the clinical stage with...
MSD Secures Full Global Rights to MK‑8690 After $150 Million Settlement with Falk Pharma
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK), through its 2023 acquisition of Prometheus BioSciences,...