TAIPEI, Nov. 12, 2025 /PRNewswire/ -- EirGenix Inc.(TWSE: 6589) today announced that it has entered into a second global exclusive licensing agreement with international biosimilar leader Sandoz AG (SIX:SDZ/OTCQX:SDZNY) for the commercialization of its independently developed breast cancer biosimilar, EG1206A (Pertuzumab Biosimilar to Roche Perjeta®), covering all territories except Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, and Japan. The agreement further strengthens the two companies' collaborative development of the HER2 biosimilar product. Under the terms of the agreement, EirGenix will receive a total up to USD 152 million of upfront and milestone payments. In addition, EirGenix will also be entitled to a profit share once the product is launched in the licensed territory plus potential sales incentives based on market performance. EirGenix will be responsible for product development, manufacturing, and supply.

EG1206A has completed its pharmacokinetic (PK) clinical study, and last month received positive feedback from both the U.S. FDA and the European Medicines Agency (EMA), confirming that the product qualifies for an abbreviated development pathway, allowing for the waiver of Phase III comparative efficacy trials. This agreement marks another major milestone and breakthrough in EirGenix's biosimilar development efforts. This partnership further strengthens the existing collaboration between Sandoz and EirGenix. The two companies previously signed a global commercialization agreement for EG12014 (Trastuzumab Biosimilar in both 150 mg and 420 mg formulations). EG12014 has already been approved by the European Commission and is currently under BLA review by the U.S. FDA.

Globally, there are approximately 2.3 million breast cancer patients, of which about 20% are diagnosed with HER2-positive disease. The Trastuzumab and Pertuzumab combination therapy has become the current standard of care for these patients. Recent studies also suggest that Pertuzumab combined with Trastuzumab deruxtecan (Enhertu®) may become the new first-line treatment for HER2-positive metastatic breast cancer, indicating strong potential for future market expansion of EG1206A. In addition to its first-generation product EG12014 already on the market, the launch of second-generation EG1206A will further enhance treatment options for patients with HER2-positive breast cancer. According to Roche's 2024 annual report, global sales of Perjeta® reached CHF 3.62 billion (~ USD 4 billion).

Sandoz is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world's first oral penicillin in 1951, and the world's first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.

EirGenix has successfully utilized reverse engineering technologies to develop multiple biosimilar products. This new agreement underscores EirGenix's global competitiveness, technical excellence, and internationalization capabilities. With regulatory trends increasingly favorable, EirGenix is accelerating the development of four HER2-targeted antibody programs, expanding its in-house product pipeline as well as CDMO services for additional biosimilar projects. As global demand for biosimilar R&D and manufacturing continues to grow, EirGenix's technical expertise, production capacity, and large-scale facilities have attracted strong attention from international pharmaceutical companies. The increased utilization of EirGenix's two commercial production lines in Zhubei further demonstrates its rapid progress. EirGenix is poised to become a key development and manufacturing partner in the global biosimilar landscape and continue its strong growth trajectory.

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SOURCE EirGenix, Inc.