Nearly 2,000 Generic Drugs Pass Consistency Evaluation; Qilu, Healthcare Yuan, and CSPC Achieve Significant Milestones with Over 130 First-to-Pass Products

　　【Pharmaceutical Network Industry Dynamics】The consistency evaluation of quality and efficacy of generic drugs refers to the process of conducting phased and batch evaluations on already approved generic drugs according to the principle of consistency in quality and efficacy with the original research drug. This means that generic drugs must reach the same level of quality and efficacy as the original research drug. Carrying out the consistency evaluation of quality and efficacy of generic drugs can not only save medical costs but also improve the overall quality of China's generic drugs and the development level of the pharmaceutical industry, ensuring the safety and effectiveness of public medication.
 

According to data statistics, in the first half of 2024, China had 1,927 acceptance numbers pass or be deemed to pass the consistency evaluation, involving more than 650 varieties (counted by product name) and over 570 pharmaceutical companies (counted by group). Among them, Fosun Pharma, CR Pharmaceutical, and Shijiazhuang No.4 Pharmaceutical each had 27 varieties pass the evaluation, while China National Pharmaceutical Group and Qilu Pharmaceutical Co., Ltd. had 25 and 23 varieties pass the evaluation, respectively.
 

According to data statistics, in the first half of 2024, 131 varieties welcomed their first companies to pass the evaluation (counted by product name, including ties for first place, the same below).
 

Among them, Qilu Pharmaceutical has five leading varieties that passed the evaluation, with Tafamidis Methylglucamine Soft Capsules and Eltrombopag Ethanolamine Tablets being the first generics plus the first to pass the evaluation. According to the website of the National Medical Products Administration on June 18, Qilu Pharmaceutical's neurological disease treatment drug, Tafamidis Methylglucamine Soft Capsules, officially received marketing approval. Data shows that Tafamidis Methylglucamine Soft Capsules can be used to treat adult patients with stage I symptoms of transthyretin amyloidosis polyneuropathy (ATTR-PN) and can effectively delay peripheral nerve function damage.
 

Industry experts indicate that the launch of Qilu Pharmaceutical's Tafamidis Meglumine Soft Capsules will bring greater hope for the treatment of patients with transthyretin amyloidosis polyneuropathy and significantly reduce the financial burden of treatment. With improved drug accessibility, an increasing number of patients will receive more standardized treatment, thereby slowing disease progression, improving quality of life, and extending life expectancy.
 

Eltrombopag Ethanolamine Tablets, a non-peptide thrombopoietin receptor agonist developed by Novartis, are used to treat chronic immune (idiopathic) thrombocytopenia (ITP) that has previously shown poor response to treatments such as glucocorticoids and immunoglobulins. On January 16, four pharmaceutical companies, including Qilu Pharmaceutical Co., Ltd., obtained drug registration certificates on the same day. The other three companies are Jiangsu Aosaikang Pharmaceutical, Zhengdatianqing Pharmaceutical, and Sichuan Kelun Pharmaceutical.
 

In addition, Wuhu Daorun Pharmaceutical has four leading varieties that have passed the evaluation, all of which are drugs for the blood and hematopoietic system. Health Yuan Pharmaceutical, CSPC Group, Xincheng Chemical, and Zhongda Pharmaceutical each have three varieties that have either passed the evaluation or are considered to have passed. Betta Pharmaceuticals, Kelun Pharmaceuticals, Fuan Pharmaceuticals, Fosun Pharma, Topcare Pharmaceutical, Sinopharm Group, CR Pharmaceutical, Aosaikang, Lunan Pharmaceutical, Tianjin Pharmaceutical and more than 10 other enterprises each have two varieties that have either passed the evaluation or are considered to have passed.
 

Among them, the Roxadustat Capsules of CSPC was the first generic version + the first to pass the evaluation. Data shows that Roxadustat is a Hypoxia-Inducible Factor–Prolyl Hydroxylase Inhibitor (HIF-PHI), suitable for anemia caused by Chronic Kidney Disease (CKD) in patients undergoing dialysis and non-dialysis treatment. As a new-generation oral renal anemia treatment drug with a completely new mechanism, Roxadustat corrects anemia by activating the HIF pathway, promoting endogenous Erythropoietin (EPO) production, downregulating hepcidin levels, and improving iron absorption, transport, and utilization.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.