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健友股份(603707.SH)子公司产品奥沙利铂注射液获药品注册证书

The subsidiary of Nanjing King-Friend Biochemical Pharmaceutical (603707.SH), the product Oxaliplatin Injection, has obtained the pharmaceutical registration certificate.

Zhitong Finance ·  Sep 9 17:00

Jianyou Co., Ltd. (603707.SH) issued an announcement. The company's subsidiary Jianjin Pharmaceutical Co., Ltd. (hereinafter referred to as “Jianjin...

Zhitong Finance App News, Jianyou Co., Ltd. (603707.SH) issued an announcement. The company's subsidiary Jianjin Pharmaceutical Co., Ltd. (hereinafter referred to as “Jianjin Pharmaceutical”) recently received a notice from the State Drug Administration to approve the issuance of drug registration certificates for oxaliplatin injections (specifications: 10ml: 50mg and 20ml: 100mg) (drug approval number: Sinopharm license H20244822 and Sinopharm license H20244821).

Oxaliplatin injection indications: (1) Combined use with 5-fluorouracil and folic acid (formyltetrahydrofolate) in: - First-line treatment of metastatic colorectal cancer. - Adjuvant treatment for stage III (Duke's stage) colon cancer after complete removal of the primary tumor. - Treatment of locally advanced and metastatic hepatocellular carcinoma (HCC) that is not suitable for surgical resection or topical treatment. (2) Combined with capecitabine (XELOX) for adjuvant chemotherapy after radical resection in patients with stage II or stage III gastric adenocarcinoma.

The company's subsidiary Jianjin Pharmaceutical Oxaliplatin Injection obtained a drug registration certificate from the State Drug Administration, indicating that the company is qualified to sell this drug in the domestic market, further enriching the company's product line and helping to enhance the market competitiveness of the company's products. According to relevant national policies, Jianjin Pharmaceutical's oxaliplatin injections are approved for production according to the new 3 categories, which are deemed to have passed the consistency evaluation, and appropriate support is provided in terms of medical insurance payments. Medical institutions should prioritize procurement and priority selection in clinical practice, which is conducive to expanding the market sales of products and has a positive impact on the company's business performance.

The translation is provided by third-party software.


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