On January 15, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received the ANDA 219765 for oxaliplatin injection issued by the U.S. Food and Drug Administration (FDA). This signifies that the product has officially obtained the qualification for commercial sale in the U.S. market. This not only adds an international "passport" to Lunan Pharmaceutical's anti-tumor product line, but also demonstrates the company's strong capabilities in quality systems, technology research and development, and international compliance.
Oxaliplatin, in combination with 5-fluorouracil and leucovorin (formyltetrahydrofolate), is used in the following applications:
(1) Adjuvant therapy for stage III colon cancer after complete resection of the primary tumor.
(2) Treatment of advanced colorectal cancer. As an important component of combination chemotherapy regimens, oxaliplatin has less overlap in toxicity with many commonly used antitumor drugs, and has a good safety profile, especially in terms of hematologic and gastrointestinal toxicity.

To facilitate the smooth entry of the product into the US market, the R&D team strictly followed the requirements of US FDA regulations and technical guidelines, and built a comprehensive R&D and quality control system. It took only 11 months from application to approval, which reflects Lunan Pharmaceutical's solid R&D strength and ability to grasp international regulations, and lays a solid foundation for more commercial cooperation in the future.

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."
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