EirGenix Strengthens Global Presence with New Biosimilar HER2 Licensing Agreement
On November 12, 2025, EirGenix Inc., noted under the stock ticker TWSE: 6589, made a significant announcement regarding its growth strategy in the biopharmaceutical industry. The company revealed that it has entered into a global exclusive licensing agreement with Sandoz AG, a leader in biosimilars, for its new biosimilar product EG1206A. This innovative drug targets HER2-positive breast cancer, continuing EirGenix's commitment to providing alternative treatment options for patients worldwide.
EG1206A is a biosimilar of Roche's pertuzumab, known by its market name Perjeta®. The licensing agreement excludes specific territories such as Taiwan, mainland China, and several Southeast Asian countries, thereby enabling EirGenix to enhance its market presence elsewhere. This second deal signifies a robust collaboration between EirGenix and Sandoz, aimed at expanding the reach and availability of biosimilar treatments for breast cancer, a condition affecting approximately 2.3 million women globally.
As part of the agreement, EirGenix is set to receive up to $152 million through initial payments and milestone achievements. Furthermore, the company will benefit from a profit-sharing structure following the product's launch in the licensed territories along with potential sales incentives based on market performance. As the developing company behind EG1206A, EirGenix is responsible for the product’s development, manufacturing, and supply chain management.
The clinical development of EG1206A has seen promising outcomes; it has recently completed its pharmacokinetic clinical study and has received favorable feedback from both the U.S. FDA and the European Medicines Agency (EMA). These endorsements allow EirGenix to pursue an abbreviated development pathway, bypassing the need for phase III comparative efficacy trials—a significant advantage in today’s fast-paced pharmaceutical environment. This trajectory places EirGenix in a competitive stance as it works towards bringing this crucial treatment to market.
This agreement follows the successful global commercialization deal for EG12014, another biosimilar produced by EirGenix, which targets trastuzumab formulations. EG12014 has already gained approval from the European Commission and is currently under review by the FDA for a Biologics License Application (BLA). The existing partnership between EirGenix and Sandoz enhances the potential for success and expedites bringing these essential treatments to patients.
The implications of EG1206A's development extend beyond commercial interests, emphasizing the growing need for effective therapies in oncology, particularly for patients diagnosed with HER2-positive breast cancer. The current standard-of-care treatments, including combined therapy with trastuzumab and pertuzumab, highlight the importance of continued innovation in this area. Recent studies suggest further advancements in treatment regimens, such as combining pertuzumab with trastuzumab deruxtecan, introducing opportunities for even more effective treatment strategies.
With the growing demand for innovative biosimilars, EirGenix is poised to expand its biosimilar pipeline with four targeted HER2 antibody programs. This not only broadens their product portfolio but also strengthens their capability in offering CDMO services for further biosimilar projects. In light of a favorable regulatory atmosphere, EirGenix has gained recognition among global pharmaceutical leaders for its technical expertise and large-scale production capabilities. The launch of two commercial production lines in Zhubei further illustrates EirGenix’s rapid evolution in response to market needs.
As the healthcare landscape undergoes transformations driven by research and development in biosimilars, EirGenix's strategic initiatives reinforce its position as a critical player in the industry, dedicated to improving patient access to high-quality therapeutic options. The successful collaboration with Sandoz marks another milestone in its mission, and as both companies leverage their strengths, more patients worldwide will benefit from innovative, affordable cancer treatments.
EG1206A is a biosimilar of Roche's pertuzumab, known by its market name Perjeta®. The licensing agreement excludes specific territories such as Taiwan, mainland China, and several Southeast Asian countries, thereby enabling EirGenix to enhance its market presence elsewhere. This second deal signifies a robust collaboration between EirGenix and Sandoz, aimed at expanding the reach and availability of biosimilar treatments for breast cancer, a condition affecting approximately 2.3 million women globally.
As part of the agreement, EirGenix is set to receive up to $152 million through initial payments and milestone achievements. Furthermore, the company will benefit from a profit-sharing structure following the product's launch in the licensed territories along with potential sales incentives based on market performance. As the developing company behind EG1206A, EirGenix is responsible for the product’s development, manufacturing, and supply chain management.
The clinical development of EG1206A has seen promising outcomes; it has recently completed its pharmacokinetic clinical study and has received favorable feedback from both the U.S. FDA and the European Medicines Agency (EMA). These endorsements allow EirGenix to pursue an abbreviated development pathway, bypassing the need for phase III comparative efficacy trials—a significant advantage in today’s fast-paced pharmaceutical environment. This trajectory places EirGenix in a competitive stance as it works towards bringing this crucial treatment to market.
This agreement follows the successful global commercialization deal for EG12014, another biosimilar produced by EirGenix, which targets trastuzumab formulations. EG12014 has already gained approval from the European Commission and is currently under review by the FDA for a Biologics License Application (BLA). The existing partnership between EirGenix and Sandoz enhances the potential for success and expedites bringing these essential treatments to patients.
The implications of EG1206A's development extend beyond commercial interests, emphasizing the growing need for effective therapies in oncology, particularly for patients diagnosed with HER2-positive breast cancer. The current standard-of-care treatments, including combined therapy with trastuzumab and pertuzumab, highlight the importance of continued innovation in this area. Recent studies suggest further advancements in treatment regimens, such as combining pertuzumab with trastuzumab deruxtecan, introducing opportunities for even more effective treatment strategies.
With the growing demand for innovative biosimilars, EirGenix is poised to expand its biosimilar pipeline with four targeted HER2 antibody programs. This not only broadens their product portfolio but also strengthens their capability in offering CDMO services for further biosimilar projects. In light of a favorable regulatory atmosphere, EirGenix has gained recognition among global pharmaceutical leaders for its technical expertise and large-scale production capabilities. The launch of two commercial production lines in Zhubei further illustrates EirGenix’s rapid evolution in response to market needs.
As the healthcare landscape undergoes transformations driven by research and development in biosimilars, EirGenix's strategic initiatives reinforce its position as a critical player in the industry, dedicated to improving patient access to high-quality therapeutic options. The successful collaboration with Sandoz marks another milestone in its mission, and as both companies leverage their strengths, more patients worldwide will benefit from innovative, affordable cancer treatments.
Topics Health）
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