RemeGen and Santen Enter into Exclusive Licensing Agreement for Ophthalmic Innovative Drug RC28-E in Greater China and Asian countries

Rhea-AI Summary

RemeGen (REGMY) has entered into an exclusive licensing agreement with Santen Pharmaceutical for RC28-E, a VEGF/FGF dual-target fusion protein drug for ocular neovascular diseases. Under the agreement, Santen gains exclusive rights to develop, manufacture, and commercialize RC28-E in Greater China and seven Asian countries.

The deal includes an upfront payment of RMB 250 million, potential development and regulatory milestone payments of up to RMB 520 million, and sales milestone payments up to RMB 525 million, plus tiered royalties. Phase II clinical trials for diabetic macular edema (DME) showed significant improvements in visual acuity and reduced central subfield thickness. RemeGen plans to submit BLA applications for DME in H2 2025 and wet AMD in mid-2026.

Positive

• Substantial deal value with RMB 250M upfront payment and up to RMB 1.045B in milestone payments
• Partnership with Santen brings 130+ years of ophthalmology expertise and access to 60+ countries
• Positive Phase II clinical trial results for RC28-E in diabetic macular edema
• Near-term catalysts with BLA submissions planned for 2025-2026

Negative

• RemeGen gives up commercialization rights in key Asian markets
• Success of RC28-E still dependent on Phase III trial outcomes and regulatory approvals

YANTAI, China, Aug. 18, 2025 /PRNewswire/ -- RemeGen Co., Ltd. (Stock Code: 688331.SH/09995.HK, "RemeGen"), a leading Chinese biopharmaceutical company, announced today that it has entered into an agreement with Santen Pharmaceutical (China) Co., Ltd. ("Santen China"), a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd. ("Santen"). Under the agreement, Santen China has obtained exclusive rights to develop, manufacture, and commercialize RC28-E in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan) as well as in South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia. RemeGen will retain global exclusive rights to RC28-E outside these regions. RemeGen will receive upfront payment of RMB 250 million, development and regulatory milestone payments of up to RMB 520 million, and sales milestone payments of up to RMB 525 million. In addition, RemeGen will be entitled to tiered royalties based on net sales of the product in the licensed territories.

RC28-E is a VEGF/FGF dual-target fusion protein drug for ocular neovascular diseases, independently developed by RemeGen. On May 7, 2025, the Phase II clinical trial results of RC28-E for diabetic macular edema (DME) were presented as an oral report at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting. The study demonstrated that RC28-E significantly improved best-corrected visual acuity (BCVA) and reduced central subfield thickness (CST), and was also well tolerated in patients with DME. In 2023, RemeGen initiated Phase III clinical trials for RC28-E in wet age-related macular degeneration (wAMD) and DME. RemeGen plans to submit a Biologics License Application (BLA) for the DME indication in China in the second half of 2025, followed by a BLA for wAMD in mid 2026.

Dr. Jianmin Fang, CEO of RemeGen, stated: "Santen brings over 130 years of expertise in ophthalmology and a robust global sales network spanning 60+ countries and regions. RC28-E, a Class 1 proprietary drug developed by RemeGen, is approaching the critical stage of BLA submission. We believe this collaboration will fully leverage the strengths of both parties to maximize the potential of RC28-E, providing innovative and effective solutions for retinal diseases. This partnership not only lays a solid foundation for the future commercialization of RC28-E but also reflects international recognition of RemeGen's capabilities in ophthalmic drug development. We look forward to jointly advancing this breakthrough therapy with Santen to open a new chapter in eye care."

Takeshi Ito, President & CEO of Santen, commented: "RemeGen has demonstrated outstanding capabilities and innovation in the field of novel drug development. As RemeGen's flagship pipeline in ophthalmology, RC28-E offers differentiated advantages by simultaneously targeting angiogenesis and fibrosis, potentially providing a new therapeutic approach and innovative option for the treatment of fundus diseases. Looking ahead, Santen are committed to strengthening cooperation and collaboration with all partners, by global-to-local synergy, to help advancing the high-quality development in ophthalmology, uncovering and addressing unmet patient needs, and aiming to realize 'Happiness with Vision 'for all."

About RemeGen:

RemeGen Co., Ltd. is a leading innovative biopharmaceutical company in China，headquartered in Yantai Economic & Technological Development Zone, China, with R&D centers and subsidiaries in Beijing, Shanghai, and California, USA. The company achieved dual listings on Main Board of The Stock Exchange of Hong Kong Limited (2020) and Shanghai Stock Exchange STAR Market (2022), becoming a dual-listed "A+H" company.

The company focuses on discovering, developing, manufacturing, and commercializing novel biologic drugs with independent intellectual property rights. Focusing on critical therapeutic areas including autoimmune diseases, oncology, and ophthalmology, the company has successfully developed multiple biologic drugs with significant clinical value.

In 2021, RemeGen's first-in-class drugs – Telitacicept (for systemic lupus erythematosus, rheumatoid arthritis, and myasthenia gravis) and Disitamab Vedotin (for gastric cancer, urothelial carcinoma, and breast cancer) – were approved for marketing with a total of 6 approved indications across these two innovative therapies. The company has established a comprehensive commercialization system encompassing production and sales, successfully initiating commercial transformation in both domestic and international markets.

For more information, please visit RemeGen's website https://remegen.com/

About Santen Pharmaceutical Co., Ltd.:

As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of "Happiness with Vision" by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its CORE PRINCIPLE, "Tenki ni sanyo suru," Santen has been committed to helping people maintain and improve their eye health for more than 130 years. Santen is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen's mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience "Happiness with Vision."

For more information, please visit Santen's website https://www.santen.com/en

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SOURCE RemeGen Co., Ltd

FAQ

What are the financial terms of RemeGen's licensing agreement with Santen for RC28-E?

The agreement includes an upfront payment of RMB 250 million, potential milestone payments totaling RMB 1.045 billion, and additional tiered royalties based on net sales.

Which territories are included in RemeGen's RC28-E licensing deal with Santen?

The agreement covers Greater China (mainland China, Hong Kong, Macau, Taiwan) and seven Asian countries: South Korea, Thailand, Vietnam, Singapore, Philippines, Indonesia, and Malaysia.

What are the clinical results for RemeGen's RC28-E in diabetic macular edema?

Phase II trials showed RC28-E significantly improved best-corrected visual acuity (BCVA) and reduced central subfield thickness (CST) in DME patients, with good tolerability.

When does RemeGen plan to submit BLA applications for RC28-E?

RemeGen plans to submit a BLA for diabetic macular edema in H2 2025 and for wet AMD in mid-2026.

What is RC28-E and how does it work?

RC28-E is a VEGF/FGF dual-target fusion protein drug developed for treating ocular neovascular diseases, targeting both angiogenesis and fibrosis pathways.