Summary
[Kexing Pharmaceuticals and Haichang Biopharmaceutical Cooperative Drug Accepted by EMA]Kexing Pharmaceuticals announced on the evening of January 23 that the drug paclitaxel (albumin-bound) for injection jointly developed by the company and Zhejiang Haichang Biomedical Technology Co., Ltd. was launched. Authorization application (MAA), received the “Notice of Acceptance” issued by the European Medicines Agency (EMA), and entered the technical review process. (China Securities Journal)
Sinovac PharmaceuticalsPosted on the evening of January 23rdannouncement, the marketing authorization application (MAA) of the drug paclitaxel for injection (albumin-bound) jointly developed by the company and Zhejiang Haichang Biomedical Technology Co., Ltd. received the “Notice of Acceptance” issued by the European Medicines Agency (EMA), and entered Technical Review Procedure.
According to the announcement,Sinovac PharmaceuticalsThe drug paclitaxel for injection (albumin-bound) developed in cooperation with Haichang Biotechnology has been studied in accordance with the quality requirements of complex injections in the United States, the European Union and China. The quality indicators meet the international standards for bioequivalence of complex injections. Consistent on quality indicators.
The company stated that the EMA’s official acceptance of the drug’s marketing authorization application is another important progress made globally after the drug was accepted by the State Drug Administration on January 13, 2022. The European Union is an important region for the global commercialization of the drug. This marketing application is a centralized procedure (CP), which is applicable to all 27 EU member states and Norway, Iceland and Liechtenstein, laying a solid foundation for the European commercialization of the drug and the opening of the European market. The basics.
(Article source: Chinasecuritiesnewspaper)