JHL Biotech revealed on Thursday that it has received an encouraging Scientific Advice related to the EU approval pathway for its proposed JHL1149 bevacizumab biosimilar for the treatment of patients with non-small cell lung cancer (NSCLC).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted the principle of a step-wise approach and the totality of the evidence from all studies in regulating the development and approval of the company's proposed bevacizumab biosimilar, JHL1149, for the treatment of patients with non-small cell lung cancer (NSCLC).
Based on the EMA's review of the company's development approach, clinical development proposal and the successful completion of the global Phase III clinical study for JHL1149 in patients with non-small cell lung cancer (NSCLC), the results of the Phase III clinical study will be acceptable for the submission of a Marketing Authorization Application as a biosimilar product.
According to the biopharmaceutical company, it is focused on research and development of new protein-based therapies and biosimilars through its experienced leadership team, ongoing global clinical trials and two Asia-based world-class biologics manufacturing facilities.
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