EirGenix announced on November 12 that it has entered a global exclusive licensing and sales agreement with international biosimilar giant Sandoz AG for its HER2-positive breast cancer biosimilar EG1206A (Pertuzumab Biosimilar to Roche Perjeta), following their previous collaboration on the breast cancer biosimilar EG12014. Under the agreement, EirGenix is set to receive a total of US$152 million in upfront signing and milestone payments, with additional sales incentives based on market performance and a share of sales revenue once the product is commercialized.
Globally, nearly 2.3 million breast cancer patients exist, of whom approximately 20% are diagnosed with HER2-positive disease. The current standard of care for these patients is Trastuzumab combined with Pertuzumab. Recent clinical studies suggest that the combination of Pertuzumab with Trastuzumab deruxtecan (Enhertu) may become a new first-line treatment standard for HER2-positive metastatic breast cancer, potentially expanding the market for EG1206A. According to Roche’s 2024 annual report, global sales of Pertuzumab reached CHF 3.616 billion (approximately US$4.003 billion).
EG1206A has completed pharmacokinetic clinical trials and, as of October, has been allowed by the U.S. FDA and the European Medicines Agency (EMA) to follow a streamlined development pathway, with the potential to be exempted from Phase III comparative efficacy trials.
EirGenix stated that this licensing deal marks a major milestone for the company, validating its success in developing multiple biosimilar products through reverse engineering. The agreement is expected to accelerate the progress of four ongoing HER2-positive breast cancer antibody programs, expand EirGenix’s proprietary product line, and enhance its CDMO capabilities for the development and manufacturing of additional biosimilars.
The renewed partnership with Sandoz further strengthens the collaboration between the two companies. Previously, they signed a global commercialization agreement for EG12014 (Trastuzumab Biosimilar in 150 mg and 420 mg formulations). EG12014 has already received approval from the European Commission and is under review by the U.S. FDA for a Biologics License Application (BLA).
Under the EG1206A global exclusive licensing and sales agreement—covering all markets except Taiwan, mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, and Japan—EirGenix will receive up to US$152 million in upfront and milestone payments, with potential additional sales incentives based on market performance and a share of profits after commercialization. EirGenix will be responsible for the product’s development, manufacturing, and supply.
Resource: 台康生技報喜！第二項乳癌相似藥再授權山德士，總簽約及里程碑金1.52億美元
