EirGenix a signé un accord de licence commerciale pour son deuxième actif biosimilaire HER2, l'EG1206A
Exclusive Licensing Agreement: EirGenix Inc. has signed a second exclusive global licensing agreement with Sandoz AG for the commercialization of its biosimilar EG1206A, a treatment for HER2-positive breast cancer, covering all territories except several Asian countries. EirGenix is set to receive up to $152 million in initial and milestone payments, along with a share of future profits.
Regulatory Progress: The EG1206A has completed its pharmacokinetic clinical study and received positive feedback from the FDA and EMA, allowing for a shortened development process without the need for Phase III comparative efficacy trials, marking a significant advancement in EirGenix's biosimilar development efforts.
Market Potential: With approximately 2.3 million breast cancer patients globally, of which 20% are HER2-positive, the combination therapy of trastuzumab and pertuzumab is the current standard of care, indicating a strong market potential for EG1206A as new treatment options emerge.
EirGenix's Growth and Capabilities: EirGenix is enhancing its portfolio with multiple HER2-targeting antibody programs and expanding its CDMO services, positioning itself as a key player in the global biosimilars market, supported by its advanced production capabilities and favorable regulatory trends.
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