Will be on the market this year?! Pyrrolidine maleate, the third innovative drug of Hengrui, won the priority review

Source: CPHI pharmaceutical online September 26, 2017, CDE officially announced the 23rd batch of drugs to be included in the priority review process Pyrrolidine maleate, which was just reported last month, was listed in the list The relevant information that the author inquired on the CDE website is as follows: speed up! Pyrrolidine maleate of Hengrui was only put into production on August 24, and got the priority review on September 26 It's not a dream to be approved for listing in the year It is worth mentioning that this progress is more than one year faster than the previous expected IPO in the first half of 2019 TKI pyrrolidine maleate, which took only 6 years from the first application to the report of labor, is an oral, irreversible and pan erbB receptor tyrosine kinase inhibitor (TKI) with anti EGFR / HER1, HER2 and HER4 activities At present, the drug has 9 clinical trials registered in China Phase I, II and III clinical trials are carried out at the same time, involving three indications of HER2 expression in advanced or metastatic breast cancer, HER2 mutation in advanced non-small cell lung adenocarcinoma and HER2 expression in advanced gastric cancer Among them, the indication of breast adenocarcinoma is the main one, which has entered phase III clinical The way to declare the medicine is fast Hengrui applied for the first time in May 2011, obtained the first clinical approval document in May 2012, received the acceptance of CDE in August 24, 2017, and obtained the priority review on September 26, 2017, which took only six years The information about the acceptance of pyrrolidine maleate delivery reported by the author on the relevant website is as follows: when the breast cancer anticancer drug, whose clinical effect is obviously better than that of other competing drugs, reported delivery of pyrrolidine maleate last month, the author wrote an article entitled "here comes the oral Herceptin?! Hengrui's 1 billion level new drug pyrrolidine maleate has been put on the market "Interested readers can take a look at it step by step In this article, I would like to emphasize the important advantages of pyrrolidine maleate in the following two aspects: on the one hand, there are only two competing products of pyrrolidine maleate in the world (with breast cancer as indication) At present, lapatinib of GSK and lenatinib of Puma company are the global competitors with the same target and similar indications In terms of physicochemical properties, pyrrolidine maleate is a derivative of lenatinib; in terms of indications, pyrrolidine maleate is closer to lapatinib On the other hand, the clinical effect of pyrrolidine maleate is better than that of lapatinib A phase I clinical result of Hengrui showed that the PFS of pyrrolidine maleate combined with capecitabine in the treatment of HER2 positive advanced breast cancer was 35.4 weeks, while the clinical data published by lapatinib in the early stage was about 27 weeks It can be seen that the clinical effect of pyrrolidine maleate is obviously due to lapatinib In addition, some people in the industry think that the phase II and phase III clinical trials registered in 2016 and later should not be completed at present, considering the time point and the time required for clinical patients to enter the group The labor report is likely to be based on the "phase I / II clinical study of pyrrolidine maleate combined with capecitabine on pirapatinib combined with capecitabine in the treatment of HER2 positive metastatic breast cancer" registered in June 2015 Pyrrolidine maleate, the third largest innovative drug of Hengrui with a market scale of "1 billion", is mainly used for breast cancer, and is in clinical research on gastric cancer and lung cancer The incidence rate of breast cancer, gastric cancer and other tumor indications and the cost of pyrrolidone maleate were analyzed The annual sales volume of the drug is expected to exceed 1 billion yuan, and the market potential is huge If it is approved to be listed successfully, pyrrolidine maleate will become the third major innovative drug of Hengrui after arixib and apatinib I will pay close attention to the approval of pyrrolidine maleate, please wait for me.