On November 11th, according to the latest announcement on the NMPA official website, Sichuan Kelun Pharmaceutical Co., Ltd. approved the submission of avatranipal maleate tablets. Since the beginning of this year, 24 varieties of Kelun Pharmaceutical (including its subsidiaries) have been evaluated.

The original research and development company of Avastin Maleate Tablets is AkaRx, a company based in the United States. It is the world's first oral thrombopoietin receptor agonist (TPO-RA) approved by the US Food and Drug Administration (FDA) for chronic liver disease-related thrombocytopenia, mainly suitable for adult patients with chronic liver disease-related thrombocytopenia undergoing elective diagnostic procedures or surgery. According to the database, the sales revenue of Avastin Maleate Tablets in the national in-hospital market exceeded 500 million yuan in 2023, with a year-on-year growth of 40.97%.

Previously, there were 8 pharmaceutical companies in China, including Qilu Pharmaceutical, Chengdu Beite Pharmaceutical, and Nanjing Zhengda Tianqing Pharmaceutical, that had production approvals for Avaripapa Maleate tablets. In terms of evaluation, currently 8 pharmaceutical companies including Kelun Pharmaceutical, Qilu Pharmaceutical, and Nanjing Zhengda Tianqing Pharmaceutical have been evaluated.

In terms of generic drug layout, in addition to Kelun Pharmaceutical, 16 pharmaceutical companies including Yunnan Xianshi Pharmaceutical and Jiangsu Wanbang Biopharmaceutical Group have submitted generic applications for Avatranib Maleate tablets, all of which are under review and approval.

As of now, Kelun Pharmaceutical (including its subsidiaries) has over 140 products that have been evaluated, with over 40 of the first product being evaluated. Since the beginning of this year, Kelun Pharmaceutical (including its subsidiaries) has evaluated 24 varieties, among which three varieties, namely Meropenem/Sodium Chloride Injection for Injection, Omega-3 Triglyceride (2%) Medium Long Chain Fat Emulsion/Amino Acid (16%)/Glucose (16%) Injection, and Etriptyline Tablets, are the first imitations in China.

Source: https://pharm.jgvogel.cn/c1460605.shtml