Shan Dong Kexing Bioproducts Co.Ltd(688136) on January 23, it was announced that the application for marketing license (MAA) of paclitaxel for injection (albumin bound) developed by the company in cooperation with Zhejiang Haichang Biomedical Technology Co., Ltd. received the acceptance notice issued by the European Drug Administration (EMA) and entered the technical review procedure.
According to the announcement, Shan Dong Kexing Bioproducts Co.Ltd(688136) paclitaxel for injection (albumin binding type) developed in cooperation with Haichang biology has carried out relevant research according to the quality requirements of complex injections in the United States, the European Union and China, and the quality indicators comply with the international bioequivalence standard of complex injections and are consistent with the original reference preparations.
The company said that the formal acceptance of the application for marketing license of the drug by EMA is another important progress made globally after the drug was accepted by the State Drug Administration on January 13, 2022. The EU is an important region for the global commercialization of the drug. This listing 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 commercialization of the drug in Europe and opening the European market.
