Approval of innovative traditional Chinese medicines: The National Medical Products Administration has approved three category 1 new traditional Chinese medicines, including Xuanqi Jiangu Tablets of Fangsheng Pharmaceutical, Qizhi Yishen Capsules of Phoenix Pharmaceutical, and Kunxinning Granules of Tasly. These innovative traditional Chinese medicines are all developed based on traditional Chinese medicine clinical empirical prescriptions. They have obtained safety and effectiveness evidence through clinical trials, providing new treatment options for patients with related diseases.
Approval of bevacizumab biosimilars: Bevacizumab injection from Hisun Biopharma/Beta Pharma, AOBiome Pharmaceuticals, and Henlius has been approved successively. Bevacizumab is an anti-vascular endothelial growth factor monoclonal antibody. The original drug has been approved for multiple indications globally. The approval of these three biosimilars will further enrich the drug choices in the domestic market.
Approval of a new rare disease drug from BeiGene: On December 2, Siltuximab for Injection from BeiGene was approved by the National Medical Products Administration for import registration. It is used for adult patients with multicentric Castleman's disease (MCD) who are negative for human immunodeficiency virus (HIV) and human herpesvirus 8 (HHV-8). The listing of this variety provides treatment options for patients with rare diseases.
Declaration and listing of an imported drug by Simcere: The application for marketing approval of Traxexil for Injection, an innovative bone marrow protection drug submitted by Simcere to the National Medical Products Administration, has been accepted. This drug is a short-acting CDK4/6 inhibitor developed by G1 Therapeutics. It has been previously listed in the United States. The indication for this application is for preventive use in patients with extensive-stage small cell lung cancer receiving a platinum-containing drug combined with etoposide regimen to reduce the incidence of chemotherapy-induced bone marrow suppression.