Abbisko Therapeutics Wins FDA Orphan Drug Designation for ABSK061 – Oral FGFR2/3 Inhibitor Targets Achondroplasia in Pediatric Patients
Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that ABSK061 received Orphan Drug Designation (ODD) from...
Drug
Huahai Pharmaceutical Initiates Phase III Trial for HB0025 – PD-L1/VEGF Bispecific Targets First-Line Endometrial Cancer
Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced the initiation of a Phase III clinical...
Konruns Pharma Wins NMPA Phase III Approval for KC1036 – Multi-Target VEGFR2/AXL Inhibitor Targets Thymic Carcinoma
Konruns Pharmaceutical Co., Ltd. (SHA: 603590) received National Medical Products Administration (NMPA) approval to initiate...
InventisBio’s D-2570 Wins FDA Phase II Clearance – Oral TYK2 Inhibitor Targets Moderate-to-Severe Plaque Psoriasis
InventisBio (Shanghai) Co., Ltd. (SHA: 688382) announced FDA clearance to initiate a Phase II clinical...
Kintor Pharma’s KX-826 Hits Phase III Endpoint in Hair Loss – Androgen Receptor Antagonist Tincture Shows 15.33 Hairs/cm² Growth vs. Placebo
Suzhou Kintor Pharmaceuticals, Inc. (HKG: 9939) announced that its pivotal Phase III clinical study for...
J&J’s Icotyde Wins FDA Approval – First Oral IL-23 Receptor Antagonist Targets Moderate-to-Severe Plaque Psoriasis
Johnson & Johnson (J&J, NYSE: JNJ) announced FDA marketing approval for Icotyde (icotrokinra), an interleukin-23...
Sanofi’s Venglustat Wins FDA Breakthrough Therapy Designation – Oral Brain-Penetrant GCSi Targets Gaucher Disease Type 3 Neurological Symptoms
Sanofi (NASDAQ: SNY) announced that venglustat received Breakthrough Therapy Designation (BTD) from the U.S. Food...
TransThera Sciences Doses First Patient in Phase II Tinengotinib Combination Study – Multi-Kinase Inhibitor Plus Fulvestrant Targets HR+/HER2- Breast Cancer
TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced first patient dosing in a Phase II clinical...
Jiuyuan Gene Engineering Secures NMPA Approval for JY47 – SIRPα Antibody Enters MASH Clinical Development
Hangzhou Jiuyuan Gene Engineering Co., Ltd. (HKG: 2566) announced receiving tacit clinical approval from China’s...
Pfizer Reports Positive FOURLIGHT-1 Results for Atirmociclib – CDK4 Inhibitor Shows PFS Benefit in Post-CDK4/6 Breast Cancer
Pfizer Inc. (NYSE: PFE) announced positive topline results from the Phase II FOURLIGHT-1 study, demonstrating...
AstraZeneca Secures EU Approval for Imfinzi in Gastric Cancer – Perioperative Regimen Cuts Death Risk 22% in MATTERHORN Trial
AstraZeneca PLC (NASDAQ: AZN) announced European Union marketing approval for Imfinzi (durvalumab) in combination with...
UniXell Bio Secures FDA Approval for UX‑GIP001 – First iPSC Allogeneic Cell Therapy for Epilepsy Enters US Clinical Trials
Shanghai UniXell Biotechnology Co., Ltd. announced that its iPSC‑derived allogeneic cell therapy UX‑GIP001 has received...
Eli Lilly Rolls Out USD 299 Zepbound KwikPen via LillyDirect – Self‑Pay Pricing for Dual‑Target Obesity Drug
Eli Lilly and Company (NYSE: LLY) announced that patients can now access the single‑patient‑use Zepbound...
Henlius Wins NMPA Approval for HLX07 Combination Trial – Anti-EGFR Biologic Plus Serplulimab Targets Squamous NSCLC
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that subsidiary Shanghai Henlius...
CSPC Pharma Secures Dual NMPA‑FDA Approval for PDE4B Inhaler SYH2059 – First‑in‑Class ILD Candidate Enters Global Clinical Development
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that its highly selective PDE4B inhibitor SYH2059 powder...
Alphamab Oncology Doses First Patient in JSKN027 Phase I Trial – First‑in‑Class PD‑L1/VEGFR2 Bispecific ADC Enters Clinic
Alphamab Oncology (HKG: 9966) has successfully dosed the first patient in the Phase I clinical...
Ascentage Pharma and Haisco Secure CDE SPARK Inclusion for Pediatric Oncology Candidates – APG‑115 and HSK42360 Target High‑Unmet‑Need Childhood Cancers
China’s Center for Drug Evaluation (CDE) has selected two innovative oncology assets for its Support...
Sino Biopharm’s TRD221 Wins NMPA Approval – Novel Polysaccharide Drug Targets Osteoarthritis via Complement Inhibition
Sino Biopharmaceutical Limited (HKG: 1177) announced that TRD221, a Category 1 innovative polysaccharide drug co-developed...
CMS Secures NMPA Approval for Desidustat – First Domestic HIF-PHI for Non-Dialysis CKD Anemia Enters China Market
China Medical System Holdings (CMS; HKG: 0867) announced marketing approval from China’s National Medical Products...
Hengrui’s Irinotecan Liposome (II) Wins NMPA Phase II Approval – Adjuvant Pancreatic Cancer Study vs. Gemcitabine/Capecitabine
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a...