EirGenix unterzeichnete die kommerzielle Lizenzvereinbarung für sein zweites HER2-Biosimilar EG1206A
EirGenix and Sandoz Partnership: EirGenix Inc. has signed a global exclusive licensing agreement with Sandoz AG for the marketing of its breast cancer biosimilar EG1206A, which is a pertuzumab biosimilar. The agreement excludes several Asian markets and includes potential payments of up to $152 million to EirGenix.
Regulatory Approvals and Development: EG1206A has completed its pharmacokinetic clinical study and received positive feedback from both the FDA and EMA, allowing for a shortened development path without Phase III comparative efficacy studies. This marks a significant milestone in EirGenix's biosimilar development efforts.
Market Potential for HER2-positive Breast Cancer: With approximately 20% of the 2.3 million breast cancer patients being HER2-positive, the combination therapy of trastuzumab and pertuzumab is the current standard treatment. The introduction of EG1206A is expected to enhance treatment options for these patients.
EirGenix's Growth and Competitiveness: EirGenix is leveraging reverse-engineering technologies to develop multiple biosimilars and is expanding its product pipeline. The company is positioned to become a key player in the global biosimilar market, supported by increasing demand and favorable regulatory trends.
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