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Block-buster Small Molecule Pharmaceuticals Approved by the NMPA in 2023 Yefenghong
March 06, 2024
According to data collated from the National Medical Products Administration (NMPA) official website, a total of more than 80 new drugs were granted inaugural approval within the domestic market.
NMPA's Progress in Joining PIC/S zhulikou431/PharmaSources
July 12, 2023
This article will introduce China NMPA's progress in joining PIC/S and the latest change in GMP guideline of PIC/S respectively.
Pharma packaging regulations of NMPA, EMA and FDA Muhammad Asim Niazi
March 21, 2023
There are various regulatory bodies globally that take part in constituting packaging regulations. The pharma manufacturer is requires to comply with the regulations of body, in which it intends to produce or market its manufactured drug.
Summary and Brief Analysis of New Drugs Approved by NMPA in 2021 PharmaSources/zhulikou431
March 29, 2022
With the revision and promulgation of the Drug Administration Law in 2019, Chinese drug review and approval system has been strengthened and improved.
Ascentage Pharma Announces a New Drug Application for Its Novel Bcl-2 Inhibitor Lisaftoclax Accepted and Recommended Priority Review Designation by CDE of China NMPA PR NEWSWIRE
November 22, 2024
Ascentage Pharma announced that a NDA for its inhouse developed investigational novel Bcl-2 selective inhibitor, lisaftoclax (APG-2575)has been accepted and recommended the Priority Review designation CDE and NMPA.
InnoCare Announces Priority Review of Orelabrutinib for the Treatment of R/R MZL by NMPA PharmaSources.com
September 06, 2022
So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and hope that orelabrutinib can fill the gap in this therapeutic area.
SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE PharmaSources.com
February 18, 2022
SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research...
I-Mab Announces IND Approval from China NMPA for Phase 2 Clinical Trial of Enoblituzumab in Combination with Pembrolizumab in Solid Tumors prnasia
December 28, 2021
I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, announced that the Center for Drug Evaluation...
Brii Bio Announces Amubarvimab/Romlusevimab Combination Received Approval from NMPA as First COVID-19 Neutralizing Antibody Combination Therapy in China prnasia
December 09, 2021
Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens...
NMPA Deputy Commissioner participates in ICMRA’s 2021 online summit NMPA
December 06, 2021
Other participants included related officials from the NMPA's Department of Science, Technology and International Cooperation, Department of Drug Registration, Department of Drug Regulation...