EirGenix Signs Licensing and Commercialization Agreement with Japanese Pharmaceutical Company for EG1206A in Japan

Taipei, June 29 — EirGenix Inc. (TWSE: 6589) has signed a global exclusive licensing agreement with Sandoz AG 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. 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 has announced that it has signed a licensing and commercialization agreement with a leading Japanese pharmaceutical company for EG1206A in Japan.

Partnering with Japanese Allies to Unlock NTD 1.32 Billion in Potential Commercial Value

The Japanese partner is a well-established pharmaceutical company with deep industry expertise, proven execution capabilities, and a strong understanding of Japan’s pharmaceutical environment, which are expected to support the regulatory pathway and commercial launch preparation for EG1206A in Japan. Under the agreement, EirGenix will provide CMC-related know-how and product-related information necessary for regulatory activities, while remaining responsible for product development, manufacturing, and commercial supply. The Japanese partner will lead regulatory approval activities and commercialization in Japan.

Based on the agreement, the project is expected to create potential commercial value of approximately NTD 1.32 billion for EirGenix, including upfront payment, development, regulatory milestones, and profit share after launch. Actual revenue recognition will depend on development progress, regulatory review, launch timing, market performance, and the agreement terms.

EG1206A has completed its pharmacokinetic clinical study and has received positive feedback from both the U.S. Food and Drug Administration and the European Medicines Agency regarding the feasibility of an abbreviated development pathway, including the waiver of Phase III comparative efficacy trials. This agreement marks an important milestone for EirGenix’s biosimilar business and global oncology biosimilar portfolio.

Accelerating the Commercialization of EG1206A in the Japanese Market and Advancing Biosimilar Expansion

Pertuzumab is an important HER2 targeted therapy for breast cancer. Japan is one of Asia’s major oncology markets, where product quality, regulatory confidence, and stable supply are key considerations for biologic therapies. The evolving HER2-positive breast cancer treatment landscape also continues to support the clinical relevance of pertuzumab-based regimens. As demand for high quality and cost-effective biologic treatment options continues to grow, biosimilars are expected to play an increasingly important role globally. According to Roche’s 2025 annual report, global sales of Perjeta^® reached CHF 2.968 billion, approximately NTD 117 billion, and the sales of Perjeta in Japan was CHF 69 million, around NTD 2.7 billion.

EirGenix stated that this agreement is expected to accelerate EG1206A’s development, regulatory submission, and commercialization preparation in Japan. Both parties will advance the program in accordance with Japanese regulatory requirements, with the goal of providing patients with HER2 positive breast cancer greater access to high quality and cost-effective treatment options.

Leveraging its biosimilar development expertise, GMP manufacturing capabilities, and established quality system, EirGenix will continue to advance EG1206A and its broader portfolio, including biosimilar candidates, ADC-related programs, and proprietary subcutaneous formulation technologies.

The reference products corresponding to these broader portfolio opportunities represent a sizable global market, with an estimated potential reference market size of USD 50 billion. Through these efforts, EirGenix will continue to expand international collaboration opportunities in biologic life cycle management and oncology therapeutics.

Author

Steven Chung

紅杏枝頭春意鬧固然是眾人所追求的風景，但我願意說，青蘿拂行衣更能湧生感嘆。 願在海量晦澀的生醫資訊中，為您點亮一座心燈塔。鐘煌翔