Lisheng PharmaceuticalOn the evening of July 15, it was announced that two specifications of Perindopril Amlodipine Tablets developed by Lisheng Pharmaceutical have recently been approved for marketing by the National Medical Products Administration. Perindopril Amlodipine Tablets (I) is the second in China and Perindopril Amlodipine Tablets (III) is the fourth in China. Generic drugs approved according to the new registration classification of chemical drugs are deemed to have passed the consistency evaluation. The specification of Perindopril Amlodipine Tablets (I) is 5 mg of perindopril arginine and 5 mg of amlodipine besylate per tablet (calculated as C20H25ClN2O5). Lisheng Pharmaceutical is the first company in China to obtain approval for generic drugs of this specification. The approval of Perindopril Amlodipine Tablets will further enrich the company's product structure and help expand the company's business areas.

In January 2024, Lisheng Pharmaceutical submitted an application for registration and marketing authorization of Perindopril Amlodipine Tablets to the National Medical Products Administration and was accepted. It also recently received the approved and issued "Drug Registration Certificate" for Perindopril Amlodipine Tablets.

Perindopril Amlodipine Tablets are a compound preparation. The components of Perindopril Amlodipine Tablets (III) are: each tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine besylate (calculated as C20H25ClN2O5); the components of Perindopril Amlodipine Tablets (I) are: each tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine besylate (calculated as C20H25ClN2O5).

It is understood that there are currently four types of perindopril single/compound preparations on the market in my country, namely perindopril tert-butylamine tablets, perindopril amlodipine tablets (III), perindopril amlodipine tablets (I), and perindopril indapamide tablets. According to statistics from the More Entropy Pharmaceutical Database, my country's national sales of perindopril exceeded 1 billion yuan for the first time in 2018, and reached a sales peak of 1.262 billion yuan in 2020. The Minnet database shows that the domestic sales of perindopril amlodipine tablets in 2023 and 2024 will be 382 million yuan and 436 million yuan respectively.

The company stated that the marketing authorization application for Perindopril Amlodipine Tablets has been approved, especially Perindopril Amlodipine Tablets (I), each tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine besylate (calculated as C20H25ClN2O5), which is the first generic drug specification approved in China, which brings opportunities to seize the domestic market and has positive social and economic benefits.

Lisheng Pharmaceutical introduced that since 2020, the company has vigorously promoted the research and development of new products, and has made new breakthroughs in the development of multiple drugs. Among them, 11 generic products such as valsartan amlodipine (Ⅰ), rivaroxaban tablets, indapamide sustained-release tablets, doxazosin mesylate sustained-release tablets, perindopril indapamide tablets, ticagrelor dispersible tablets and perindopril amlodipine tablets have successively obtained the "Drug Registration Certificate", 22 products have passed the consistency evaluation, and 9 have obtained the " Chemical Raw Materials Certificate ".In November 2024, the company's arginine perindopril API was the first to be approved, ensuring supply chain security and cost optimization. The approval of perindopril amlodipine tablets is a key move in the company's "raw materials + preparations" strategy, marking that Lisheng Pharmaceutical has achieved a full-chain breakthrough in the field of cardiovascular and cerebrovascular treatment of "raw materials independence + dosage form differentiation + production scale", which is expected to open up incremental market space for the company and add new profit growth points. In the future, the company will continue to deepen the synergy between R&D and industrialization, provide patients with high-quality and accessible drugs, and create long-term value for investors.

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