China’s NMPA Approves Pilot Plan to Streamline Clinical Trial Reviews for Innovative Drugs
In a meeting chaired by Party Secretary and Director of the National Medical Products Administration...
Clinical trial filings
Sichuan Huiyu’s HY07121 Antifungal Protein Earns NMPA Review for Clinical Trials
Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a Chinese biopharmaceutical company, has announced that the...
Shanghai Junshi Biosciences’ HDAC Inhibitor JS125 Clinical Trial Application Accepted by NMPA
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical...
Medigene AG Secures Chinese Patent for TCR-T Therapy Targeting NY-ESO-1 and LAGE 1a
Medigene AG (ETR: MDG1), a biopharmaceutical company based in Germany, has announced that it has...
AIM Vaccine Submits Pre-IND Applications for mRNA Vaccines Targeting RSV and Herpes Zoster to NMPA
AIM Vaccine Co., Ltd (HKG: 6660), a biopharmaceutical company based in China, has announced the...
Mabwell’s 9MW2821 ADC for Triple Negative Breast Cancer Accepted for Review by NMPA
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced...
InnoCare Pharma Receives IND Approval in China for BCL2 Inhibitor Combo Therapy
InnoCare Pharma (HKG: 9969; SHA: 688428), a Beijing-based biotech company, has announced that it has...
Sino-US Laekna’s LAE102 Clinical Trial Filing Accepted for Review in Obesity and Metabolic Disorders
Sino-US Laekna (HKG: 2105) has announced that its clinical trial application for LAE102, an antibody...
Phanes Therapeutics’ First-in-Class BsAb PT217 Accepted for Review by China’s CDE
Sino-US biotechnology company Phanes Therapeutics Inc. has announced that the Investigational New Drug (IND) filing...
Everest Medicines Secures IND Review for Zetomipzomib in China
Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for zetomipzomib...
Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter
Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE)...
SinoMab BioScience’s Suciraslimab IND Accepted for Review by China’s NMPA
SinoMab BioScience Ltd (HKG: 3681), a Hong Kong-based biotechnology company, has announced that the National...
Sirius Therapeutics Pursues First-in-Human Trial for SRSD107 in Australia
Sino-US biotech Sirius Therapeutics has announced its pursuit of Investigational New Drug (IND) approval in...
Wyze Biotech’s RJMty19 Injection Accepted for CDE Review for r/r B-Cell NHL
Wyze Biotech Co., Ltd, a Guangdong-based developer of off-the-shelf universal DNT cell therapies, has announced...
Jiangsu Aidea’s HIV-1 Drug ACC017 Accepted for NMPA Review in China
China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products...
Shanghai Fudan-Zhangjiang’s ADC FZ-AD005 Accepted for NMPA Review in Advanced Solid Tumors
China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505) has announced that the National...
Haisco Pharmaceutical’s HSK21542 Accepted for NMPA Review in Postoperative Pain Management
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its clinical trial filing...
Hainan Poly Pharm’s PL002 Accepted for FDA Review for Liver Cancer Surgery
China-based pharmaceutical company Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that the Investigational...
Konruns Pharmaceutical’s KC1036 Pediatric Indication Accepted for NMPA Review
Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced that the National Medical Products Administration...
Sino Biopharmaceutical Submits IND Application for AT2R Antagonist TRD205 to FDA
Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biotech company, has announced the filing of...