Akeso Announces Enrollment of First Patient in Ivonescimab Phase 3 Trial for Small Cell Lung Carcinoma
China-based Akeso Biopharma (HKG: 9926) announced that the first patient has been enrolled in the phase...
Clinical trial approval / initiation
Bio-Thera Solutions Receives NMPA Approval for Combination Therapy Clinical Trial in Advanced Solid Tumors
China-based Bio-Thera Solutions, Ltd. (SHA: 688177) announced that it has received a Drug Clinical Trial...
Haisco’s HSK47388 Receives NMPA Clinical Trial Approval for Autoimmune Diseases
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that it has received clinical trial...
Henlius’ HLX43 Approved by FDA for Phase 1 Trial in Thymic Carcinoma Treatment
China’s Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration...
Sino Biopharmaceutical’s LM-24C5 Receives NMPA Approval for Phase 2 Clinical Trials in CEACAM5-Positive Solid Tumors
Sino Biopharmaceutical Limited (HKG: 1177) announced that its independently developed LM-24C5 has received clinical trial...
Neowise Biotechnology’s NW-101C Receives NMPA Clinical Trial Approval for PRAME-Targeted TCR-T Therapy
China-based Neowise Biotechnology (Suzhou) Co., Ltd. announced that its self-developed PRAME-targeting autologous TCR-T cell therapy...
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...
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,...
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...
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...