Zejing Pharmaceutical's application for new indications of Donafinil Tosylate Tablets has been accepted for the treatment of thyroid cancer

Zejing Pharmaceutical issued an announcement that the company received the National Class 1 New Drug Donafinil Toluene Sulfate Tablets (referred to as "donafinil") issued by the National Medical Products Administration (NMPA) on October 15 for topical treatment "Notice of Acceptance" for new drug marketing applications for advanced/metastatic radioiodine refractory differentiated thyroid cancer indications
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This indication is the second indication applied for marketing after the indication for advanced hepatocellular carcinoma was approved for marketing
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The marketing application for this new indication is mainly based on the results of a multi-center, randomized, double-blind, placebo-controlled phase III clinical trial of Donafenib tablets in the treatment of locally advanced/metastatic radioiodine refractory differentiated thyroid cancer
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The results of the study show that Donafenib treatment has excellent anti-tumor effects.
While significantly prolonging the progression-free survival of patients with locally advanced/metastatic radioiodine refractory differentiated thyroid cancer, it also shows good safety and tolerability.
Sex
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Toluenesulfonate Donafenib Tablets is an oral multi-target, multi-kinase inhibitor, small molecule anti-tumor drug developed by the company.
It belongs to a class 1 new drug.
The company has independent intellectual property rights for this product
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Donafenib was approved for marketing in the first-line treatment of advanced hepatocellular carcinoma in June this year.
It has been proven to be a new targeted drug for the first-line treatment of advanced hepatocellular carcinoma with definite efficacy, good safety, patient accessibility, and well-balanced risks and benefits
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Donafenib tablets combined with daunorubicin and cytarabine in the treatment of recurrent acute myeloid leukemia (AML) phase I clinical trials are underway, and multiple clinical trials in combination with tumor immunotherapy drugs for advanced tumors are also underway In progress
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