[drug news] another tumor drug of Hengrui has been approved for clinical use, and humanwell depression drug has been approved by FDA

On October 9, Hengrui shr-1702 injection was approved for clinical use Hengrui pharmaceutical released a notice that it and its subsidiaries Shanghai Hengrui Pharmaceutical Co., Ltd and Suzhou shengdia biomedical Co., Ltd recently received the approval document for clinical trials of drugs (approval document No.: 2018l03040) approved and issued by the State Drug Administration on the product under development shr-1702 injection solution (specification: 2ml: 0.1g) Hengrui said it will carry out phase I clinical trials of the drug in the near future According to the drug intelligence data query, the drug obtained the undertaking of CDE in July this year, the review was completed on September 13, and "issued" was displayed on September 25 According to Hengrui announcement, the product is intended to be used for the treatment of advanced cancer At present, there are several similar target products in the clinical trial stage in foreign countries, but no similar target products in China are in the clinical trial stage No similar target products have been approved for listing at home and abroad, and there is no relevant sales data It can be said that the future potential of the drug is still unknown, and further clinical data are expected On October 10, humanwell released a notice that Yichang humanwell Pharmaceutical Co., Ltd., a holding subsidiary of humanwell, received the approval number (anda approval number: 210014) from the U.S Food and Drug Administration (FDA) for humanwell sustained release tablets (specification: 50mg, 100mg) The Anda application submitted by Yichang humanwell in 2017 was approved after one year Norvenlafaxine sustained release tablets were used to treat adult severe depression At present, Wyeth company holds two patents of norvenlafaxine sustained-release tablets, which expire on March 1, 2022 and July 5, 2027, respectively Up to now, no party believes that the norvenlafaxine sustained-release tablets of Yichang humanwell infringe the above patent rights According to IMS data statistics, the total sales volume of norvenlafaxine sustained-release tablets in the U.S market in 2017 was about US $350 million, with major manufacturers including Wyeth, Lupin, mylan, etc According to drug intelligence data, there is no approval document for drug registration of norvenlafaxine sustained-release tablets in China at present In addition, humanwell has not applied in China There are two domestic enterprises applying for norvenlafaxine sustained-release tablets, namely, Sinopharm group Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd and Beijing Kelaibo Pharmaceutical Development Co., Ltd., both of which have applied in accordance with the clinical application of class 3.1 new drugs In 2016, the two enterprises have been approved for clinical application Another 9 enterprises have applied for the clinical application of norvenlafaxine succinate sustained-release tablets, 8 of which have been approved and 1 is still under review and approval; the clinical application of norvenlafaxine fumarate sustained-release tablets applied by Jiangsu kefeiping Pharmaceutical Co., Ltd has also been approved It is worth mentioning that in 2015, Jiangsu Haosen applied for the listing of demethylvenlafaxine hydrochloride sustained-release tablets, which showed that "the enterprise withdrew" and was one step away from the listing Content source: Hengrui pharmaceutical announcement and humanwell pharmaceutical announcement statement: the viewpoint of this article only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.