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Specifically as follows: Drug Name: Apple acid Famini Capsule Dosage Form: Capsule Application: Clinical Trial Acceptance Number: CXHL2000271, CXHL2000272, CXHL2000273 Approval Conclusion: In accordance with the Drug Administration Law of the People's Republic of China and the relevant provisions, upon examination, the apple acid famini capsules accepted on June 10, 2020 met the relevant requirements for drug registration and agreed to conduct clinical trials of advanced gastrointestinal mesothelioma that failed to be treated with imatini.
specifically: a randomized, open, controlled, multi-center Phase III clinical study of the treatment of advanced gastrointestinal mesothelioma that failed to be treated with imatinitis.
the company's innovatively developed small molecule multi-target tyrosine kinase inhibitor.
inquiries, apple acid famini at home and abroad at home and abroad have Sorafini, Shoni tinini, Peezopani and other similar products have been approved for listing.
Sorafoni was developed by Bayer and approved for listing in the United States in 2005;
three multi-target inhibitors have been approved for listing in China.
IQVIA database, global sales of Soraphoni, Shonitini and Peropani will be approximately US$2,159 million in 2019.
, the cumulative research and development cost of the product is about 122.34 million yuan.
in accordance with the relevant laws and regulations of China's drug registration requirements, drugs after obtaining the drug clinical trial approval notice, still need to carry out clinical trials and by the State Drug Administration review, approval and approval before production and listing.
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