March 17, 2026
Source: drugdu
28
Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a marketing authorization notice for carfilzomib issued by the National Medical Products Administration . This approval further enriches the company's anti-tumor active pharmaceutical ingredient (API) product line. The product, manufactured using the same production line and process, has also been submitted for US approval, providing a better option for domestic and international pharmaceutical formulation customers.
Carfilzomib, as a second-generation proteasome inhibitor, exerts significant anti-proliferative and pro-apoptotic effects on tumor cells by irreversibly binding to the 20S proteasome active site. Its high selectivity results in a lower risk of neurotoxicity, and it is well tolerated by patients. Clinical data confirm that it has a reliable safety advantage in the treatment of multiple myeloma and is the preferred clinical option.
Established in 2017, the International Drug R&D Center adheres to an international strategy of "based in China, radiating globally." It has currently obtained 32 formulation approvals in China, the US, and Europe, 67 formulation approvals in emerging markets, and 8 CEP certificates; it has submitted over 40 DMFs in Europe, the US, and Japan, and over 50 DMFs in other emerging markets. With the development and launch of more products, the company will accelerate its entry into the international market, enhance Lunan Pharmaceutical's brand image and reputation both domestically and internationally, lay the foundation for "Lunan Pharmaceutical's Healthy World" initiative, and contribute to the development of human health.
https://bydrug.pharmcube.com/news/detail/ca5d0a0c0d4cb5df10057541622bac5b
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