On November 27th, according to the official website of NMPA, Sichuan Huiyu Pharmaceutical's application for the marketing of four types of generic drugs - morpholine nitrate sodium chloride injection - was approved and deemed to have passed the consistency evaluation, becoming the first domestic generic drug. At present, only Jiangsu Haosen Pharmaceutical Co., Ltd. has been approved as a new drug Class 1.1 for the injection of sodium methoxam and sodium chloride. There are currently no other companies approved for Class 4 generic drugs in China.

Morpholinenidazole sodium chloride injection is mainly used for antibacterial and anti-inflammatory purposes. It belongs to the third generation of nitroimidazole antibacterial drugs, and the national medical insurance class B, which is used to treat pelvic inflammation, appendicitis and other infectious diseases. It has a strong antibacterial effect on anaerobic bacteria and is widely used in clinical practice. According to the Moen Pharmaceutical Database, the sales revenue of morpholine nitrate sodium chloride injection exceeded 400 million yuan in 2022, and although there was a slight decline in 2023, the sales revenue still approached 400 million yuan.

At present, only Jiangsu Haosen Pharmaceutical Co., Ltd. has been approved as a Class 1.1 new drug for the injection of sodium methoxam and sodium chloride, and no other company has been approved as a Class 4 generic drug. Sichuan Huiyu Pharmaceutical Co., Ltd. has been approved for market and successfully won the first domestic generic and first review. In addition, in terms of the layout of generic drugs, more than 30 companies including Renhe Yikang Group, Shandong Qidu Pharmaceutical, Chengdu Beite Pharmaceutical, Hunan Kelun Pharmaceutical, Shijiazhuang Siyao, etc. have submitted generic applications for the injection of morpholine nitrate sodium chloride, all of which are under review and approval.

Since 2024, Sichuan Huiyu Pharmaceutical has received evaluations for 11 products, including methotrexate injection, decitabine injection, and calcium folinate injection. Among them, acetylcysteine injection, clarithromycin injection, and morpholinozeb sodium chloride injection were the first to receive evaluations.

Source: https://pharm.jgvogel.cn/c1466238.shtml