Hengrui has good news, and will carry out clinical trials of 5 billion varieties in the near future

[industry trends of pharmaceutical network] on December 6, Hengrui pharmaceutical released a notice on obtaining the notice of clinical trial According to the announcement, the company and its subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd recently received the notice of clinical trial approved and issued by the State Food and drug administration, and will carry out the clinical trial in the near future According to the announcement, the 50 mg, 125 mg and 150 mg shr6390 tablets of Hengrui (calculated according to c25h30n6o2) meet the relevant requirements of drug registration after examination, and it is agreed to approve this product to carry out a treatment of recurrent or metastatic breast cancer with shr6390 tablets combined with fluvectin for HR positive and HER2 negative after endocrine treatment From the perspective of acceptance progress, Hengrui's shr6390 tablets were accepted on July 24, 2019 After more than four months of review, Hengrui was finally able to carry out clinical trials After review and approval, Hengrui could be put on the market Shr6390 is a class 1 new drug developed by Jiangsu Hengrui Pharmaceutical Co., Ltd It is an oral and selective small molecule CDK4 / 6 inhibitor In breast cancer MCF-7 / aro transplantation model, the combination of shr6390 and letrozole can significantly enhance the anti-tumor effect of single drug Up to now, the R & D cost of the product project has been about 91.34 million yuan The data shows that 1 / 10 of the domestic breast cancer patients are diagnosed as advanced every year, and the five-year survival rate is about 20% In all breast cancer patients, hormone receptor positive breast cancer patients and HER2 negative breast cancer patients account for more than 70% of all breast cancer patients At present, the target or pathway of breast cancer targeted treatment mainly includes HER-2, VEGF, EGFR, PARP, PI3K / Akt / mTOR, CDK4 / 6, etc Among them, CDK4 / 6 (selective inhibition of cyclin dependent kinase 4 and 6) inhibitor is a new type of selective drug Its G1 phase induces cell cycle arrest to prevent tumor progression It can be used to treat a variety of tumors, including breast cancer Therefore, it has become a hot target area of tumor targeted therapy in recent years CDK4 / 6 inhibitor was first developed by Pfizer company, called palbociclib, with the trade name of ibrance In February 2015, it was approved by the U.S Food and Drug Administration for listing through the accelerated review approach, and in February 2016, it was approved to treat HR + / HER2 - advanced breast cancer with new indications combined with fluvectin At present, ibrance has been listed in European Union, Japan and other countries and regions; in July 2018, Pfizer's palbociclib was approved in China, under the trade name of aiboxin, for the treatment of HR positive HER2 negative local advanced or metastatic breast cancer In addition to Pfizer, other FDA approved CDK4 / 6 inhibitors include ribociclib of Novartis and abemaciciclib of Lilly Among them, Lilly's abemaciclib is the third CDK4 / 6 inhibitor approved by FDA, and it is also the only CDK4 / 6 inhibitor that can be used alone or in combination in the field of metastatic breast cancer treatment Lilly's abemaciclib tablet was declared for production in China in November 2019, and its current status is under review and approval According to the current domestic market situation, no other CDK4 / 6 inhibitor has been approved except Pfizer's piperacillin capsule In addition to Hengrui pharmaceutical, domestic CDK4 / 6 compressor research enterprises also include politeness Qinghe, Beida pharmaceutical, Fosun Pharmaceutical, Sihuan pharmaceutical, cornerstone pharmaceutical, Shanghai beierda, Guangzhou Bibei, etc at present, only Hengrui pharmaceutical shr6390 tablets have taken the lead in clinical trials It is found that the global sales of similar products of this product in 2018 is about USD 4.851 billion.