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Everest Medicines Announces NMPA Full Approval of NEFECON, Broadening Treatment Access for IgA Nephropathy Patients in China ACN Newswire
May 07, 2025
Everest Medicines announced that the supplemental New Drug Application (sNDA) for NEFECON has received full approval from the China National Medical Products Administration (NMPA).
InnoCare’s Zurletrectinib Receives Priority Review from China’s NMPA PharmaSources
May 06, 2025
InnoCare Pharma announced today that its new generation pan-TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the CDE of China NMPA.
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.
Kelun-Biotech's Radionuclide-Drug Conjugate (RDC) SKB107 Receives NMPA Approval For The Treatment of Bone Metastases in Solid Tumors PR Newswire
March 26, 2025
Kelun-Biotech's RDC drug SKB107 got clinical trial approval for bone metastases. It's jointly developed, with expected advantages.
NMPA Accepts NDA and Grants Priority Review Designation to Innovent's Ipilimumab Injection, China's First Domestic CTLA-4 Inhibitor, in Combination with Sintilimab as Neoadjuvant Treatment for Colon C PR Newswire
February 24, 2025
Innovent's NDA for ipilimumab with sintilimab as neoadjuvant for MSI-H/dMMR colon cancer is accepted and gets Priority Review, based on trial results.
Innovent and ASK Pharm Jointly Announce NMPA Approval of Limertinib, a Third-generation EGFR TKI for the Treatment of Lung Cancer PR Newswire
January 21, 2025
Innovent and ASK Pharm jointly announce NMPA's approval of limertinib for treating lung cancer, with efficacy and safety proven and first - line treatment review ongoing.
Innovent Receives NMPA Breakthrough Therapy Designation for IBI343 (Anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer PRNewswire
January 16, 2025
Innovent Biologics, Inc. announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343.