On January 23, Shan Dong Kexing Bioproducts Co.Ltd(688136) announced that its partner Zhejiang Haichang Biomedical Technology Co., Ltd. (hereinafter referred to as "Haichang biology") had received the acceptance notice issued by the European Drug Administration (hereinafter referred to as "EMA"), and EMA officially confirmed and accepted the application for marketing license (MAA) of paclitaxel for injection (albumin bound) jointly developed by the company and Haichang biology, And enter the technical review procedure.
Shan Dong Kexing Bioproducts Co.Ltd(688136) the drug 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. The quality indexes meet the international bioequivalence standard of complex injections and are consistent with the quality indexes of the original reference preparation.
At present, there are only two original drug manufacturers selling paclitaxel for injection (albumin bound) in the EU. 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, involving 27 EU Member States and Norway, Iceland and Liechtenstein, which has laid a solid foundation for the commercialization of the drug in Europe and opening the European market.
It is understood that Paclitaxel For Injection (albumin bound), developed by Shan Dong Kexing Bioproducts Co.Ltd(688136) and Hai Chang bio, is a broad-spectrum anti-tumor complex injection for metastatic breast cancer and other malignant tumors. It has the potential to combine with new immunization and targeted therapies. On April 26, 2021, Shan Dong Kexing Bioproducts Co.Ltd(688136) signed a drug cooperation agreement with Haichang biological. Haichang biological transferred the commercialization rights and interests outside the U.S. market with the R & D code of hc007 (i.e. the above albumin paclitaxel for injection) in its R & D product pipeline to Shan Dong Kexing Bioproducts Co.Ltd(688136) . The two sides intend to cooperate on the cooperative development, commercialization, technology transfer, industrialization and transfer of licensed rights and interests of the drug. On January 13, 2022, the registration and marketing license of the drug for domestic production was accepted by the State Food and drug administration.
