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The product 100mg specification according to the new 4 categories to obtain drug registration approval, as if through the consistent evaluation.
tytoxamide is an anti-tumor-active alkane agent with methamphetamine, bio-utilization is close to 100%, in the body can spontaneously and rapidly degrade to produce the active metabolite MTIC (3-methyl-1-) mimite-4-methylamine and produce anti-tumor effect.
the solubility and small molecular weight of tetamine, it can quickly pass through the blood-brain barrier, absorb quickly and completely, and reach the peak concentration of blood medicine for an average of 0.5-1.5 hours.
are clinically used to treat newly diagnosed polygonal glioblastomas and polygonal glioblastomas or mesodiotic ascytomas that relapse or progress after routine treatment.
is a first-line treatment drug for cerebral glioma, and is recommended for the 2012 and 2015 editions of the Guidelines for the 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 Guidelines for Central Nervous System Tumors, 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 of Lung Cancer in China (2017 Edition).
At present, only three domestic tetroamine capsules, including the original research, have been 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, according to CPT data from 758 sample hospitals in the 2019 Pharmaceutical Rubik's Cube, the company's 2019 tymoamine (20mg, sales revenue of 113 million yuan) accounted for about 6.06 percent of the market share. Lidiyi Pharmaceuticals (5mg, 20mg, 50mg, 100mg) accounted for approximately 52.94 per cent and Summerton (20mg, 100mg) approximately 40.79 per cent.
company's tymoamine capsules (20mg, yining ®) in December 2011 to obtain a drug registration approval, the original 20mg specification is too small clinical use inconvenience.
company's 20mg and 100mg capsules were consistent with the original study in terms of in-body solubility, BE and quality in the consistency evaluation.
announced that the company's 100mg of tymoamine capsule approved for listing will be more convenient for patients with 20mg specifications to take, will improve the market competitiveness of the product and market share, has become the company's main profit varieties, the company's future operating performance has a positive impact.
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