Setback For Athenex, Hanmi As CRL Requests New Trial
Another US Delay For Korean Firm's Assets
Hanmi partner Athenex has had a US complete response letter for its oral paclitaxel plus encequidar product for the treatment of metastatic breast cancer, amid concerns of safety risks associated with an increase in neutropenia-related sequelae. While the decision marks another setback for Hanmi in the US, Athenex is aiming to resolve the issues.
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Hanmi’s novel, long-acting neutropenia drug gets world-first approval in South Korea, setting it up to be the first product using the company's proprietary platform technology to be commercialized. An FDA manufacturing inspection also seems to bode well for the pending US approval.
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