Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a GMP compliance inspection notification from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for its product Bilastin (MF registration number: 307MF10026), marking its official acquisition of commercial sales qualification in the Japanese market . This active pharmaceutical ingredient received approval for its marketing application in China in April 2025. It is the sixth MF approved in Japan, following miglitol, montelukast sodium, tegafur, isosorbide, and mosapride citrate. This successful acquisition of market access in Japan provides crucial qualifications for its expansion into the international market.

Bilastin is used for the symptomatic treatment of urticaria in adults and adolescents (12 years and older). It is a second-generation non-sedating long-acting histamine antagonist with selective peripheral H1 receptor antagonist affinity, no affinity for muscarinic receptors, no sedative effect, no cardiotoxicity, and does not interact with cytochrome P450 enzyme substrates. It is characterized by rapid, long-acting, and potent effects.

The Japan Pharmaceutical and Drug Administration (PMDA) is a globally recognized authority on drug regulation, imposing stringent review standards on registration applications. In this Japanese registration application process, the company leveraged its years of experience in international market applications, accurately assessed key review points and potential risks, and systematically advanced the entire R&D and application process, completing the entire process from application to approval in less than a year. This efficient outcome fully demonstrates the company's strong R&D capabilities, comprehensive quality control system, and mature international regulatory compliance capabilities, laying a solid foundation for the company's continued deep cultivation of the international high-end regulatory market.

Established in 2017, the International Drug R&D Center serves as a window for Lunan Pharmaceutical Group's internationalization. Adhering to the internationalization strategy of "based in China, radiating globally," it has currently obtained 31 formulation approvals in China, the US, and Europe, 66 formulation approvals in emerging markets, 8 CEP certificates, and submitted over 40 DMF (Drug Manufacturing File) applications in Europe, the US, and Japan, and over 50 DMF applications in other emerging markets. With the development and launch of more products, the center will undoubtedly accelerate the company's pace in entering the international market, enhance Lunan Pharmaceutical's brand image and reputation both domestically and internationally, and lay the foundation for "Lunan Pharmaceutical's vision of a healthy world."

https://mp.weixin.qq.com/s/dPlyj9Xo9jsLbkiETmLUmA