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”) received the acceptance notice issued by the European drug administration, 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.
Abraxane, the original research drug of paclitaxel for injection (albumin binding type), was initiated and developed by abraxis Bioscience and later acquired by celgene. It is now a wholly-owned subsidiary of Bristol Myers Squibb. The European Medicines Agency has approved the first line treatment for breast cancer, metastatic pancreatic adenocarcinoma and non-small cell lung cancer.
According to the announcement, at present, there are only two companies selling paclitaxel for injection (albumin bound) in the EU: Bristol Myers Squibb, the original drug manufacturer, and ratiopharm GmbH (a subsidiary of Teva Pharmaceutical Industries Limited). 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.
