Human Fu Pharma Receives "Drug Clinical Trial Approval" for RF-A089 Capsules
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, thePharmaceutical(issued a notice) said that the "
Drug(ClinicalTrial) approved by the StateMedicines(the Supervisory Authority) has been issued
RF-A089 is jointly applied byCompany(and holding subsidiary Hubei Biopharmaceutical Industry Technology Research Institute Co., Ltd(54.81%) for locallate or metastatic non-small cell lung cancer with ALK-positive indicationsabout RF-A089
RF-A089 for a new generation of metastatic lymphoma kinase ("ALK") inhibitors, belonging to the chemical class 1new drug(this application is proposed for ALK-positive local late-stage or metastatic non-small cell lung cancer, has the potential to extend the indications to other ALK-positive tumors other than small cell lung cancer
RF-A089 submitted a clinical registration application in February 2018 and received it, and has invested about 15 million yuan so far apply for drugs as follows: , drug name: RF-A089 capsule
II, batch number: 2018L02618, 2018L02619
III, dosage form: capsule , specifications: 5mg, 1 5mg
5, application matters: domestic drug registration six, registration classification: chemical sin category 1 seven, applicants: Hubei Biopharmaceutical Industry technology research co., Ltd., Renfu Pharmaceutical Group Co., Ltd 8, approval conclusion: after examination, this product meets the relevant requirements of drug registration, approved this product for clinical trials
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