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基石药业-B(02616.HK):RET抑制剂普吉华(普拉替尼胶囊)由境外转移至境内生产的药品上市注册申请已获国家药监局药品审评中心受理

Cornerstone Pharmaceutical-B (02616.HK): The application for marketing registration of the RET inhibitor Pujihua (platinib capsules) transferred from overseas to domestically produced drugs has been accepted by the Drug Evaluation Center of the State Drug

Gelonghui Finance ·  Apr 8 20:05

Gelonghui April 9 | Cornerstone Pharmaceutical-B (02616.HK) issued an announcement. RET inhibitors are in PhuketThe application for marketing registration of (Platinib capsules) transferred to domestically produced drugs has been accepted by the China National Drug Administration (NMPA) Drug Evaluation Center. Previously, Cornerstone Pharmaceuticals' other precision treatment drug, Taijihua(Avatinib tablets) The application for marketing registration of drugs transferred to domestic production was accepted by the Drug Review Center in June 2023 and is currently under review. Domestic supply is expected to be achieved in 2024.

Dr. Yang Jianxin, CEO and Executive Director of Cornerstone Pharmaceuticals, said, “Phuket ChinaWith Tai Ji HuaThe two marketing registration applications transferred to domestic production have been accepted, which is of great significance to Cornerstone Pharmaceutical. It means that the company is expected to achieve localized production of the above two products in the short term. This will not only reduce pharmaceutical production costs by more than 50%, but also increase the flexibility of product supply, better meet domestic market needs, benefit more domestic patients, and further expand PhuketWith Tai Ji Huacompetitive advantage in the Chinese market. Recently, the country has successively introduced a series of supporting policies related to real estate, such as simplifying application data, clarifying the application path, and optimizing the application process. The NMPA made it clear in the new draft for comments on the optimization procedure that this type of real estate application applies priority review and approval procedures. As explorers of real estate drugs, we expect these policies to accelerate the approval and marketing process of real estate drugs, so that Cornerstone Pharmaceuticals can rapidly expand in PhuketWith Tai Ji Huarange of indications.”

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