Aosaikang Subsidiary's Docetaxel Injection Receives Approval for Generic Drug Consistency Evaluation

On May 12, AOSAIKANG PHARM announced that its wholly-owned subsidiary recently received the "Notice of Approval for Supplementary Drug Application" for Docetaxel Injection, approved by the National Medical Products Administration (NMPA), approving the drug to pass the consistency evaluation of quality and efficacy for generic drugs.

It is understood that docetaxel is a semi-synthetic taxane antineoplastic drug developed by Sanofi of France. DocetTaisai Injection was approved for marketing in Mexico and Europe in 1995, and in the United States in May 1996;To date, it has been marketed in multiple countries worldwide for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric cancer, andmultiple indications, including head and neck tumors, and has become one of the most commonly used or standard treatments for these cancers.In 1998, the original docetaxel injection was launched and sold in China. In 2005, the subsidiary's docetaxel injectionInjection (Aomingrun) Approved for Marketing.

Docetaxel acts by disrupting the microtubule network that is essential for mitosis and interphase cellular functions.Exerting antitumor effects, docetaxel is more readily taken up by cells than paclitaxel, and its ability to inhibit microtubule depolymerization is that of paclitaxeltwice that of alcohol. Docetaxel injection is one of the commonly used drugs for tumor treatment in China, included in the "National Essential Medicines"National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance.” The specifications of the Docetaxel Injection developed by the subsidiaryAt a concentration of 1 mL:20 mg, it offers the advantages of eliminating the need for secondary dilution and facilitating clinical use. The PDB database shows that in 2020The annual sales at sample hospitals amounted to RMB 1.112 billion. The market for docetaxel injection is mature and substantial in scale.