Hengrui Medicine publishes the results of phase II clinical trial of pyrrolidine

Source: Sina Pharmaceutical News on December 10, 2017, Jiangsu Hengrui Pharmaceutical Co., Ltd (hereinafter referred to as "Hengrui pharmaceutical") issued a notice that Hengrui pharmaceutical and its holding subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd have recently completed the phase II clinical trial of pyrrolidine maleate tablets for the expression of positive HER2 in advanced or metastatic breast cancer The results showed that the objective remission rate of pyrrolidine maleate combined with capecitabine was 78.5%, the objective remission rate of rapatinib mesylate combined with capecitabine was 57.1% Compared with lapatinib group, the objective remission rate of pyrrolidine group was increased by about 21% The median progression free survival was 18.1 months in the pyrrolidine group and 7.0 months in the lapatinib group The median progression free survival of pyrrolidine group was significantly longer than that of rapatinib group (P < 0.0001) The risk of disease progression or death was 63.7% lower in the pyrrolidine group than in the lapatinib group (HR = 0.363) Moreover, the tolerance was good while the curative effect was improved Based on the efficacy and safety data obtained from the current phase II clinical trial, the State Food and drug administration has agreed to accept the application for conditional listing of pyrrolidine maleate tablets submitted by Hengrui medicine At present, the company has two phase III clinical trials of pyrrolidine maleate in the treatment of HER2 positive breast cancer patients, and the company will further verify the conclusions of the preliminary trials On May 9, 2011, the clinical trial application submitted by Hengrui pharmaceutical and Shanghai Hengrui Pharmaceutical Co., Ltd to Jiangsu food and drug administration was accepted The drug can be used to treat advanced or metastatic breast cancer with positive HER2 expression It is reported that at present, the EGFR / HER2 small molecule inhibitors listed abroad for breast cancer treatment include tykerb (lapatinib) and nerlynx (neratinib) Tykerb ® is developed by GlaxoSmithKline company, with the specification of 250mg / tablet It is used for the treatment of HER2 positive advanced or metastatic breast cancer, and has been imported and listed in China Nerlynx ® was developed by puma biotechnology, Inc with a specification of 40mg / tablet, for extended adjuvant treatment of HER2 positive early breast cancer In 2016, the sales volume of tykerb ® in China was about US $2.653 million, and the global sales volume was about US $160 million; nerlynx ® was approved for listing in 2017, and there is no sales data yet Up to now, Hengrui pharmaceutical has invested about 520 million yuan in the research and development of pyrrolidine maleate and tablets.