Fosun Pharmaceutical's recombinant anti-VEGFR2 was approved by the US FDA for clinical approval

August 30, 2023

Fosun Pharmaceutical's recombinant anti-VEGFR2 was approved by the US FDA for clinical approval

September 07, 2017 Source: Sina

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The basic situation of the new drug:

Drug Name: HLX06

Dosage form: injection

Specification: 100mg/10ml/bottle

Application: New drug clinical trial application

Applicant: Henlix

Approval conclusion: agree to the clinical trial of this product in the United States

HLX06 is an innovative therapeutic biological product independently developed by Fosun Pharma and its subsidiaries, mainly used for solid tumor treatment. As of August 2017, the research and development expenses for this new drug have been about RMB 52 million.

In July 2017, Fuhong Hanlin Biotechnology Co., Ltd. (hereinafter referred to as “Fuhong Hanlin”) submitted a clinical trial application to the US FDA for the new drug for solid tumor treatment. The HLX06 for solid tumor treatment has been submitted to the State Food and Drug Administration for clinical trial applications by Fuhong Hanlin in China (excluding Hong Kong, Macao and Taiwan, the same below), and was accepted for registration and review in June 2017.

As of the date of this announcement, the VEGFR2 target monoclonal antibody drugs that have been marketed abroad include Eli Lilly's CyramzaTM (Ramucirumab), and there are no similar drugs in the country. According to the website of the Drug Evaluation Center of the State Food and Drug Administration, Eli Lilly has registered three clinical trials of CyramzaTM (Ramucirumab) in China, two of which are undergoing Phase III clinical trials; in addition, in addition to Fu Hong Hanlin, Sichuan Recombinant anti-VEGFR2 full-human monoclonal antibody injection of Columbotech Biopharmaceutical Co., Ltd., recombinant human anti-vascular endothelial growth factor receptor 2 (VEGFR2) monoclonal antibody for injection in Shandong Buddhism Shenzhou Pharmaceutical Co., Ltd. The application for clinical trials filed with the State Food and Drug Administration is still under review.

According to IMS MIDASTM, in 2016, CyramzaTM (Ramucirumab) had global sales of approximately $560 million.

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