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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.
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Everest Medicines Announces Acceptance of the New Drug Application for VELSIPITY
Everest Medicines Limited
December 20, 2024
Everest Medicines announced NMPA acceptance of NDA for VELSIPITY(R) (etrasimod) to treat moderately to severely active UC.
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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.
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InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Waldenström’s Macroglobulinemia in China
March 14, 2022
InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced recently...
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China increases accessibility to rare disease treatment
NMPA/Xinhua
December 24, 2021
Two-and-half-year-old Xuanxuan survived a rare kidney disease in early December, thanks to fast-track approval of the transplant.
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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...
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Meeting on drug, medical device, cosmetic regulation in China held during 4th CIIE
NMPA
November 11, 2021
A meeting on the regulation of drugs, medical devices and cosmetics in China was held on Nov 6 in Shanghai during the fourth China International Import Expo (CIIE).
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NMPA releases 2nd group of key projects for China’s drug regulatory science action plan
October 25, 2021
The National Medical Products Administration (NMPA) issued a list of the second group of key projects for China's drug regulatory science action plan based on the summary of the implementation of the first group on June 24.
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Seminar held to boost drug regulatory cooperation between BRI countries
NMPA
September 23, 2021
Co-sponsored by China's National Medical Products Administration (NMPA) and Ministry of Commerce, the Seminar on Drug Regulation and Development Cooperation for Belt and Road Countries...
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6th China-ASEAN Summit for Drug Development and Cooperation opens in Guangxi
NMPA
September 22, 2021
Co-sponsored by China's National Medical Products Administration (NMPA) and the government of the Guangxi Zhuang autonomous region, the Sixth China-ASEAN Summit...