China Resources Shuanghe subsidiary finasteride tablets passed the consistency announcement

On September 26, China Resources Shuanghe Pharmaceutical Co., Ltd (hereinafter referred to as "China Resources Shuanghe"), a wholly-owned subsidiary of China Resources Shuanghe Pharmaceutical Co., Ltd (hereinafter referred to as "China Resources SECCO"), received finasteride tablets (5mg) (hereinafter referred to as "finasteride tablets") issued by the State Drug Administration (hereinafter referred to as "the State Drug Administration") Hereinafter referred to as "the drug") (approval document No.: 2019b03869), approving the drug to pass the quality and efficacy conformity assessment of generic drugs (hereinafter referred to as "conformity assessment") Two * other drugs, the drug is mainly used for the treatment of symptomatic benign prostatic hyperplasia (BPH):1, improve symptoms; 2, reduce the risk of acute urinary retention; 3, reduce the need for transurethral resection of prostate (TURP) and prostate resection risk The main dosage forms of finasteride include tablets and capsules, with the specifications of 1mg and 5mg China Resources SECCO started the consistency evaluation of the drug in 2016, submitted the application for consistency evaluation to the former State Food and Drug Administration on December 10, 2018, obtained the acceptance notice on December 17, 2018, and passed the approval of the State Food and Drug Administration on September 18, 2019 It is the first enterprise that has passed the consistency evaluation of finasteride tablets (5mg) Since the consistency evaluation, the cumulative R & D investment of Cr Secco is RMB 9.5262 million (Unaudited) 3、 Market situation of similar drugs: the original manufacturer of finasteride tablets was mosadong company, with the trade name of "baoliezhi ®" It was first listed in the UK in 1992 and approved to be listed in China in 1994 At present, other production and sales data of the drug in the international market are not available from public channels In the domestic market, 28 finasteride tablet manufacturers, 1 dispersive tablet manufacturer and 9 capsule manufacturers have been approved for listing in mainland China, among which 5 mg finasteride tablets and capsules are listed in China's national essential drug catalog In 2018, the sales volume of the top 20 brands of generic finasteride was 1.37 billion yuan, accounting for 97.4% of the national sales volume The top five enterprises in the market share pattern were: Hangzhou moshadong Pharmaceutical Co., Ltd 90.18%, Guangdong Luote Pharmaceutical Co., Ltd 2.11%, Wuhan humanwell Pharmaceutical Co., Ltd 1.43%, Tianfang Pharmaceutical Co., Ltd 1.06%, Shanghai Modern Pharmaceutical Co., Ltd 0.92% 。 In 2018, the sales revenue of China Resources SECCO finasteride tablets (5mg) was RMB 2613000 (audited) 4、 Influence on the company and Risk Reminder: according to the relevant national policies, for the drug varieties passing the consistency evaluation, appropriate support shall be given in the aspect of medical insurance payment The medical institutions shall give priority to purchasing and selecting in clinical practice If more than three manufacturers pass the consistency evaluation for the same kind of drugs, they shall no longer choose the drugs failing the consistency evaluation in the aspect of centralized purchasing Varieties Therefore, it will be beneficial for the future market sales and market competition of the drug to pass the consistency evaluation for the first time in the same variety of China Resources SECCO finasteride tablets (5mg), and accumulate valuable experience for the consistency evaluation, which will have a positive impact on the business performance of China Resources Shuanghe This article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.