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Chance Pharma Secures NMPA Acceptance for CXG87 Respiratory Drug NDA
Chance Pharma secures National Medical Products Administration acceptance of NDA for CXG87, marking its first filing and a key step toward commercialisation of a novel respiratory therapy.
Center For Drug Evaluation | 08/05/2026 | By News Bureau
China's CDE Grants Priority Review to Bayer's FXIa Inhibitor
China’s Center for Drug Evaluation (CDE) grants Priority Review (PR) to Bayer’s FXIa inhibitor, highlighting its potential clinical value in reducing stroke risk.
Center For Drug Evaluation | 08/05/2026 | By News Bureau
Lynk Pharmaceuticals Secures NMPA NDA Acceptance for Zemprocitinib
Lynk Pharmaceuticals announces NMPA acceptance of Zemprocitinib NDA, backed by positive results from a phase-III randomised, double-blind, placebo-controlled clinical trial in China.
Center For Drug Evaluation | 11/04/2026 | By News Bureau
Ascentage Pharma Gets NDA Approval for Bcl-2 Inhibitor Lisaftoclax
This NDA is based on results from a pivotal registrational Phase II study in China (APG2575CC201) that evaluated the efficacy and safety of lisaftoclax in patients with r/r CLL/SLL.
Center For Drug Evaluation | 18/11/2024 | By Aishwarya | 477
Mabwell Gets CDE Approval to Initiate Phase III Clinical Trial of 9MW2821
9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell, and it is the first of its kind in China to initiate clinical trials on the same target, with more than 400 subjects enrolled in the clinical studies for multiple indications.
Center For Drug Evaluation | 27/08/2024 | By Aishwarya | 417
WestGene Secures Dual IND Approvals for EB Virus-Related mRNA Therapeutic Cancer Vaccine
WestGene Biopharma has announced that its mRNA therapeutic cancer vaccine, WGc-043, has received dual IND approvals from China's National Medical Products Administration (NMPA) and the US FDA.
Center For Drug Evaluation | 09/08/2024 | By Aishwarya | 455
AusperBio Gets BTD for AHB-137 in Chronic Hepatitis B Treatment
AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. have announced that their investigational drug AHB-137 has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.
Center For Drug Evaluation | 11/07/2024 | By Aishwarya | 922
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