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JECHO’ s First Therapeutical Biological Drug JL14002 Approved for Clinical Trial by NMPA, CHINA

Expected to benefit 8 million patients with wAMD

 

Recently, JECHO ’s biosimilar drug, named JL14002, a recombinant anti-VEGF humanized monoclonal antibody Fab fragment injection, has been approved by the Center for Drug Evaluation, NMPA, to conduct a clinical trial. JL14002 is the first ranibizumab biosimilar independently developed in China. And it is also the first drug developed by Tianjin local biopharmaceutical company to receive IND approval as an antibody-drug.

The clinical indication of JL14002 is wet Age-related Macular Degeneration (wAMD) and diabetic macular degeneration, which are eye diseases with increasing clinical need in the incoming aging society. After successful development and marketing, it will bring affordable treatment choices to potential 8 million patients in China. The global market value will be 20 billion RMB per year.

JECHO has the independent technology and resource to engage the innovative R&D and sponsor the clinical trials of first-in-class or biosimilar products, including monoclonal antibodies, bispecific antibodies, cytokine, fusion proteins, immunotoxins, and oncolytic viruses. JECHO also provides GMP-compliant CDMO services to the customers and partners and has achieved success in supporting IND approval for clinical trials by US FDA. Notably, Dr. Jianwei Zhu, the CEO and CSO of JECHO leads his R&D team to develop first-in-class products, including oncolytic virus, to treat brain cancer and the therapeutic antibodies against COVID-19. These products have been in Pre-IND review in NMPA or FDA, and the IND approval would be reached by the end of 2021.

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