Dizal Pharma’s DZD8586 Granted FDA Fast Track Designation for CLL/SLL Treatment
Dizal (Jiangsu) Pharmaceutical Co., Ltd (SHA: 688192) announced that its investigational product DZD8586 has been...
Drug
AstraZeneca’s Fasenra Approved for Pediatric Severe Eosinophilic Asthma in China
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced the official approval of a new indication...
Sino Biopharmaceutical’s Rovadicitinib Granted Breakthrough Therapy Designation for Chronic Graft-versus-Host Disease
China-based Sino Biopharmaceutical Limited (HKG: 1177) announced that its self-developed JAK/ROCK dual small molecule inhibitor,...
Hengrui’s Trastuzumab Rezetecan Granted FDA Orphan Drug Designation for Gastric Cancer Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that it has received...
Qyuns Therapeutics’ QX004N Enters Phase 3 Trials for Psoriasis and Crohn’s Disease
China-based Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509) announced that QX004N, an interleukin-23 subunit p19...
Sino Biopharmaceutical’s TQC3302 Approved for COPD Maintenance Treatment Clinical Trials
Sino Biopharmaceutical Limited (HKG: 1177) announced that its independently developed Category 2.3 modified new drug,...
Humanwell Healthcare Receives NMPA Approval for HW241045 IPF Clinical Trials
China-based Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that its wholly-owned subsidiary, Humanwell Innovation...
Everest Medicines’ Nefecon Granted Full Approval by Taiwan’s TFDA for IgA Nephropathy
China-based Everest Medicines (HKG: 1952) announced today that the Taiwan Food and Drug Administration (TFDA)...
CSPC Pharmaceutical’s Semaglutide Injection NMPA Marketing Application Accepted
China-based CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the marketing application for its semaglutide...
Hebei Senlang’s SENL103 CAR-T Therapy Approved for Refractory Generalized Myasthenia Gravis in China
Hebei Senlang Biotechnology Co., Ltd. announced that its SENL103 autologous T-cell infusion has received clinical...
Sichuan Huiyu’s HY05350 Achieves First Patient Dosing in Phase I Trial for MSLN-Positive Tumors
China-based Sichuan Huiyu Pharmaceutical Co., Ltd. (SHA: 688553) announced that its wholly-owned subsidiary, Huiyu Haiyue,...
Zhaoke Ophthalmology’s TONO-i Gains NMPA Approval for Glaucoma Management in China
China-based Zhaoke Ophthalmology Limited (HKG: 6622) announced that its innovative product, TONO-i, has received a...
Innovent Biologics’ IBI3032 Receives IND Approval From FDA and NMPA for GLP-1RA Clinical Trials
China-based Innovent Biologics (HKG: 1801) announced that its self-developed oral small molecule GLP-1 receptor agonist...
FDA Clears Elevidys Gene Therapy After Investigating 8-Year-Old Boy’s Death
The U.S. Food and Drug Administration (FDA) has completed its investigation into the death of...
Mabwell’s CDH17-Targeted ADC 7MW4911 Receives Clinical Trial Approval in China and IND Clearance in the US
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that its self-developed CDH17-targeted antibody-drug conjugate...
Cutia Therapeutics’ CU-40102 Approved in Hong Kong for Androgenetic Alopecia Treatment
China-based dermatology specialist Cutia Therapeutics (HKG: 2487) announced today that its CU-40102 (finasteride topical spray)...
UTC Therapeutics Gains FDA Clearance for CAR-T Therapy UCLM805 in MSLN-Positive Solid Tumors
China-based cell therapy biotech UTC Therapeutics announced receiving clearance from the US Food and Drug...
FDA Mandates Safety Labeling Changes for Opioid Pain Medications and Targets 7-OH Products
The U.S. Food and Drug Administration (FDA) is implementing new safety measures for opioid pain...
Luye Pharma’s LY03021 Completes Enrollment of First Healthy Subject in Phase I Trial
China-based Luye Pharma Group (HKG: 2186) announced on August 3, 2025, that its self-developed Class...
Lee’s Pharma’s Socazolimab Approved by NMPA for ES-SCLC First-Line Treatment
Lee’s Pharmaceutical Holdings Ltd. (HKG: 0950) announced that its in-licensed programmed-death ligand 1 (PD-L1) monoclonal...