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Guide: This approval will enable the company's 20mg, 100mg specifications of 20mg, 100mg all through the consistent evaluation.
. On September 9th, the company announced that it had recently received approval from the State Drug Administration to issue a "Drug Supplemental Application Approval Notice" on "Tymoamine Capsules" (20mg), and that the Company's Tymoamine Capsules (20mg) had been evaluated for consistency of quality and efficacy of generic drugs (hereinafter referred to as "Consistency Evaluation").
Company's tymoamine capsule (20mg) was approved for drug registration in December 2011 and is listed as a Class B product in the National Health Insurance Directory.
23, 2018, the supplementary application for the conformity evaluation of the variety was accepted by the National Drug Review Center.
disclosed on September 1, 2020 that it had obtained a drug registration certificate for the thymosamine capsule (100mg) (as if it had passed a consistency evaluation).
Tytoxamide is clinically used to treat newly diagnosed polymorphic glioblastoma and polymorphic glioblastoma or mesozoic astrocyte tumors that relapse or progress after routine treatment, is a first-line treatment drug for cerebral glioma, recommended for the 2012 and 2015 editions of the Guidelines for diagnosis and treatment of gliomas in the central nervous system of China.
In addition, tymoamine has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guide for Central Nervous System Oncology, The Chinese Guidelines for the Diagnosis and Treatment of Gliomas (2018 Edition), the China Melanoma Guidelines (2019 Edition), and the Consensus of Experts on Brain Metastasis in Lung Cancer (2017 Edition).
At present, only three of the domestic tetroamine capsules, including the original research was approved for listing, namely, the United States Merca East Company's "Tai Dao", Jiangsu Tianshili Diyi Pharmaceutical Co., Ltd.'s "Tiqing" and Beijing Shuangyi Pharmaceutical Co., Ltd.'s "Yinning."
2019 Pharmaceutical Rubik's Cube 758 sample hospital CPT data, in 2019 the company's tymoamine (20mg, sales revenue of 113 million yuan) accounted for about 6.06% of the market share, days ShiliTiyi Pharmaceuticals (5mg, 20mg, 50mg, 100mg) accounted for approximately 52.94 per cent and Summerton (20mg, 100mg) approximately 40.79 per cent.
this approval will enable the company's 20mg, 100mg specifications all through the consistent evaluation.
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