Three drugs included in the priority review: fluzopali, etaxel and recombinant human coagulation factor VIII

Author: On December 6, CDE official website showed that three new class 1 drug applications were to be included in the priority review, namely, the new ovarian cancer drug fluzopali capsule of Hengrui medicine, the new systemic lupus erythematosus drug of Rongchang biology, and the recombinant human coagulation factor VIII of Shenzhou cell for injection Fluzopali is a PARP inhibitor, which can specifically kill BRCA mutant tumor cells The listing application of fluzopali submitted by Hengrui medicine was undertaken by CDE on October 29, 2019 The indication is to treat patients with recurrent ovarian cancer with BRCA1 / 2 pathogenicity or suspected pathogenicity mutation who have previously undergone second-line or above chemotherapy According to the scope of priority review (1) 3 innovative drugs with obvious treatment advantages, the listing application of fluzopali will be included in the priority review process At present, there are similar products in foreign countries, such as olapari, lucapari, nilapali and terazolapa, which are beneficial to the approved marketing in the United States In 2018, the global sales volume of the above drugs is about 672 million US dollars, and the sales volume in the United States is about 319 million US dollars Olapali was approved to be listed in China in August 2018 under the trade name of Lipitor In the review and approval of nirapari of zaiding pharmaceutical, pamiparib of Baiji, imp4297 of Yingpai pharmaceutical and hwh-340 of humanwell pharmaceutical are in the clinical trial stage The development of new drugs for systemic lupus erythematosus (SLE) is extremely difficult, and the clinical needs are far from being met Since hydroxychloroquine in 1955, FDA has approved only one new drug for SLE in the past 60 years, that is, berylumab of GSK, which was approved in China on July 20 this year Baileyuzumab is a BLyS inhibitor, while teracept can inhibit BLyS and April at the same time, effectively block the differentiation and maturation of B lymphocytes, inhibit excessive immune response, and achieve the purpose of treatment of related autoimmune diseases The listing application of taitasipu submitted by Rongchang biology was undertaken by CDE on November 13 According to the scope of priority review (1) 3 innovative drugs with obvious treatment advantages, the listing application of etaxel will be included in the priority review process Hemophilia A A is a kind of coagulation dysfunction caused by the lack of factor VIII protein Patients often face a high risk of disability or even life-threatening due to long-term and repeated joint hemorrhage and inflammation In 2018, the number of hemophilia patients in the world is about 774000, and there are about 140000 cases in China, of which about 85% are type a hemophilia patients Due to the poor thermal stability and low production of factor VIII protein, the production process of recombinant factor VIII protein has a high technical threshold and is difficult to produce At present, there is no domestic recombinant factor VII protein drug approved for marketing in China The domestic enterprises that are in the clinical stage of the product include Zhengda Tianqing, Chengdu Rongsheng and Furen pharmaceutical.