NMPA
Listing Approval:
1. On August 30, according to the official website of CDE, Xuanzhu Biopharm's Class 1 new drug piroctinib tablets were declared for marketing, which is intended to be used in combination with fulvestrant for the treatment of HR+/HER2- advanced breast cancer that has progressed after previous endocrine therapy. Piroctinib is a selective CDK4/6 inhibitor independently developed by Xuanzhu Biologics.
2. On August 30, according to the official website of CDE, BeiGene's PD-1 monoclonal antibody tislelizumab injection was declared for marketing for the 13th indication. Tislelizumab has been approved for 11 indications in China, covering non-small cell lung cancer (NSCLC), classical Hodgkin lymphoma, urothelial carcinoma, hepatocellular carcinoma, esophageal squamous cell carcinoma (ESCC), nasopharyngeal carcinoma, gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, etc.
3. On August 31, according to the official website of CDE, Qilu Pharmaceutical's Class 3 generic drug enzalutamide tablets were declared for marketing, intended for prostate cancer, and Qilu also became the first pharmaceutical company to report production. Enzalutamide is an androgen receptor inhibitor jointly developed by Astellas and Medivation, and was approved for marketing in China in November 2019.
4. On August 31, according to the official website of the NMPA, Chia Tai Tianqing's recombinant human coagulation factor VIII. for injection (trade name: Anhengji) was approved for marketing for the prevention of bleeding in patients aged 12 years and above with hemophilia A (congenital coagulation factor VIII deficiency). ANHENGJI uses human cells HEK293 for production, which will not cause hypersensitivity reactions caused by non-human proteins.
5. On September 1, according to the official website of the NMPA, AstraZeneca's aclotinib capsule (trade name: Calquence) was approved for a new indication, and the monotherapy is suitable for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior treatment. Acotinib is a next-generation selective BTK inhibitor.
6. On September 1, Zai Lab's magetuximab injection was approved for marketing on the official website of the NMPA for the treatment of patients with metastatic HER2-positive breast cancer in the third line and above. Magituximab is an Fc-optimized monoclonal antibody developed by MacroGenics for the purpose of human epidermal growth factor receptor 2 (HER2).
7. On September 1, according to the official website of the NMPA, Zhifei's 23-valent pneumococcal polysaccharide vaccine was approved for marketing for the treatment of children and adults aged 2 years and above to prevent infectious diseases caused by pneumococcus. Pneumococcus is an important pathogen that causes community-acquired pneumonia in people of all age groups.
8. On September 1, according to the official website of CDE, Cynogen's Class 3 generic drug bumetanide injection was declared for marketing, and its main function is diuretic. Sajing Biopharma is the sixth pharmaceutical company to apply for the listing of Class 3 generic drugs. Bumetanide is a derivative of m-aminobenzene sulfonamide, developed by Validus Pharms, and no imported drugs have been approved in China, nor have Class 3 generic drugs been approved.
9. On September 5, according to the official website of CDE, Hainan SinoMab BioScience Class 1 therapeutic biological product sucilimab injection was declared for marketing, which is predicted to be used for the treatment of rheumatoid arthritis (RA). Sucilimab is a monoclonal antibody targeting the unique B-cell target CD22, and it is also the first CD22 monoclonal antibody to be applied for marketing in China.
10. On September 5, according to the official website of CDE, Merck & Co., Ltd. 3.1 class prevention biological product nine-valent human papillomavirus vaccine (Saccharomyces cerevisiae) was declared for marketing for a new indication. The vaccine is a 9-valent vaccine made of virus-like particles (VLPs) using recombinant Saccharomyces cerevisiae CANADE3C-5 (strain 1895) expressing recombinant human papillomavirus (HPV) L1 proteins 6, 11, 16, 18, 31, 33, 45, 52 and 58, respectively, purified and...
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