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...
Clinical trial approval / initiation
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...
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...
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...
Neurodawn’s Subsidiary Receives NMPA Approval for First LHI Treatment RK-4 Injection
China-based Neurodawn Pharmaceutical Co., Ltd.’s wholly-owned subsidiary, Fuzhou Ningdan Rongkang Biomedical Technology Co., Ltd. (Ningdan...
Chipscreen’s Next-Gen Brain-Penetrant Aurora B Inhibitor CS231295 Gains FDA Clearance for Advanced Solid Tumors
On July 31, 2025, the investigational new drug (IND) application for Shenzhen Chipscreen Biosciences Co.,...
Zhaoke Ophthalmology’s Melphalan Granted FDA Orphan Drug Designation for Pediatric Retinoblastoma
China-based Zhaoke Ophthalmology Ltd (HKG: 6622), a leader in ophthalmic solutions, today announced that its...
Shanghai Pharmaceuticals’ B019 Injection Approved for SLE Clinical Trials
Shanghai Pharmaceuticals Holding Co., Ltd’s (SPH, HKG: 2607, SHA: 601607) announced that it has received...
Huadong Medicine Receives NMPA Approval for Phase III Trial of Psoriasis Cream MC2-01
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received approval from the...
Ascletis Pharma Doses First Patients in U.S. Phase 2a Trial for Monthly GLP-1 Agonist ASC30
China-based Ascletis Pharma Inc. (HKG: 1672) announced that the first participants with obesity or overweight...
SinoCellTech’s SCT640C Injection Receives NMPA Approval for RA Clinical Trials
China-based SinoCellTech Group Ltd (SHA: 688520) announced today that its self-developed product, SCT640C injection, has...
Hengrui Pharmaceuticals’ HRS8179 and HRS-1893 Receive NMPA Clinical Trial Approval
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced today that it has received clinical...
GenFleet Therapeutics Announces Fast Track Designation for GFH375/VS-7375 in Pancreatic Cancer
China-based GenFleet Therapeutics announced on July 25, 2025, that its oral KRAS G12D inhibitor, GFH375/VS-7375,...
Kelun-Biotech’s SKB378/WIN378 Enters Global Phase II Trial for Asthma Treatment
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced on July 23, 2025, that its partner...
Sirius Therapeutics’ SRSD107 Receives EMA Approval for Phase II Clinical Trials in Thromboembolic Diseases
China-based Sirius Therapeutics announced on July 23, 2025, that its next-generation siRNA therapy, SRSD107, has...
Youcare Pharma’s YKYY029 Receives FDA IND Approval for Hypertension Treatment
China-based Youcare Pharmaceutical Group (SHA: 688658) announced on July 24, 2025, that its subsidiary, Beijing...
Shenzhen Beimei’s TWYNEO Receives NMPA Clinical Trial Approval for Acne Treatment
Shenzhen Beimei Pharmaceutical Co., Ltd. announced on July 22, 2025, that its drug TWYNEO (tretinoin...
CTTQ Doses First Patient in China for TQB6411 Phase I Clinical Trial
Subsidiary of China based Sino Biopharmaceutical Ltd (HKG: 1177) Jiangsu Chia Tai Tianqing Pharmaceutical Co.,...
Grand Pharma’s TLX591 Granted NMPA Approval for Phase III Prostate Cancer Trial
China-based Grand Pharmaceutical Group Limited (HKG: 0512) announced that its innovative radiolabeled drug conjugate (RDC)...
Abbisko Therapeutics Completes First Patient Dosing for PRMT5×MTA Inhibitor ABSK131
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced the completion of the first patient...