Lunan Pharmaceutical Announces Approval of Three Generic Drugs Including First-to-File Axitinib Tablets Deemed Bioequivalent

On May 25, Lunan Pharmaceutical announced in a press release that three drugs developed by its subsidiary, Shandong New Time Pharmaceutical Co., Ltd.—Axitinib Tablets, Tenofovir Disoproxil Fumarate Tablets, and Alpha-Lipoic Acid Injection—have been approved for market launch and are deemed to have passed the consistency evaluation.

AxitinibApproved for the treatment of adult patients with advanced renal cell carcinoma (RCC) following failure of prior therapy with one tyrosine kinase inhibitor or cytokine. The approval of the first generic Axitinib Tablets by Lunan Pharmaceutical will provide additional treatment options for patients with advanced renal cancer.

Axitinib is a small-molecule tyrosine kinase inhibitor (TKI). As the first targeted therapy for patients with advanced renal cell carcinoma (RCC) who have failed prior treatment, it is indicated for adult patients with advanced RCC. On April 19, 2019, the U.S. FDA approved the first-line combination therapy of the PD-1 inhibitor pembrolizumab and axitinib for patients with advanced RCC. On May 14, 2019, the U.S. FDA approved the first-line combination therapy of the PD-L1 inhibitor avelumab and axitinib for patients with advanced RCC. Axitinib tablets were included in the national medical insurance reimbursement list in 2018. According to the 《CSCO Guidelines for the Diagnosis and Treatment of Renal Cell Carcinoma 2020》 for metastatic RCC, the recommendation levels are: pembrolizumab + axitinib (Category 1A), avelumab + axitinib (Category 1A), and axitinib (Category 2A).

Alpha-Lipoic Acid InjectionListed as a Class B drug in the National Medical Insurance catalog, it is primarily indicated for sensory abnormalities caused by diabetic peripheral neuropathy. Alpha-lipoic acid reduces lipid peroxidation in nervous tissue, inhibits protein glycation, and suppresses aldose reductase, thereby preventing the conversion of glucose or galactose into sorbitol. It is used for diabetes prevention, blood glucose control, and the prevention of hyperglycemia-induced neuropathy. Clinical indication: sensory abnormalities caused by diabetic peripheral neuropathy.

Tenofovir Disoproxil FumarateIt is an acyclic nucleoside phosphonate diester structural analog of adenosine monophosphate. It is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults; it is also indicated for the treatment of chronic hepatitis B in adults and pediatric patients aged 12 years and older.

Executive Editor: Liuli

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