RemeGen and Santen Enter into Exclusive Licensing Agreement for Ophthalmic Innovative Drug RC28-E in Greater China and Asian countries
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.
RemeGen (REGMY) ha stipulato un accordo di licenza esclusiva con Santen Pharmaceutical per RC28-E, una proteina di fusione a doppio bersaglio VEGF/FGF destinata alle malattie neovascolari oculari. Secondo l'accordo, Santen ottiene i diritti esclusivi per sviluppare, produrre e commercializzare RC28-E nella Grande Cina e in sette paesi asiatici.
L'intesa prevede un pagamento iniziale di 250 milioni di RMB, potenziali pagamenti per milestone di sviluppo e regolatori fino a 520 milioni di RMB, pagamenti per milestone legati alle vendite fino a 525 milioni di RMB, oltre a royalties su più livelli. Le sperimentazioni di fase II per l'edema maculare diabetico (DME) hanno mostrato miglioramenti significativi dell'acuità visiva e una riduzione dello spessore della regione centrale. RemeGen prevede di presentare le domande BLA per DME nella seconda metà del 2025 e per la forma umida della degenerazione maculare senile (wet AMD) a metà 2026.
RemeGen (REGMY) ha firmado un acuerdo de licencia exclusiva con Santen Pharmaceutical para RC28-E, una proteína de fusión de doble diana VEGF/FGF para enfermedades neovasculares oculares. Según el acuerdo, Santen obtiene los derechos exclusivos para desarrollar, fabricar y comercializar RC28-E en la Gran China y siete países asiáticos.
El acuerdo incluye un pago inicial de 250 millones de RMB, posibles pagos por hitos de desarrollo y regulatorios de hasta 520 millones de RMB, pagos por hitos de ventas de hasta 525 millones de RMB, además de regalías escalonadas. Los ensayos clínicos de fase II en edema macular diabético (DME) mostraron mejoras significativas en la agudeza visual y una reducción del grosor del campo central. RemeGen planea presentar las solicitudes BLA para DME en la segunda mitad de 2025 y para la AMD húmeda (wet AMD) a mediados de 2026.
RemeGen (REGMY)은 Santen Pharmaceutical과 망막 신생혈관 질환 치료용 VEGF/FGF 이중 표적 융합 단백질 약물 RC28-E에 대해 독점 라이선스 계약을 체결했습니다. 본 계약에 따라 Santen은 중화권(Greater China) 및 아시아 7개국에서 RC28-E의 개발, 제조 및 상업화에 대한 독점 권리를 확보합니다.
계약에는 초기 지급금 2.5억 위안(RMB), 개발·규제 관련 마일스톤으로 최대 5.2억 위안(RMB), 매출 관련 마일스톤으로 최대 5.25억 위안(RMB) 지급 및 단계별 로열티가 포함됩니다. 당뇨성 황반부종(DME) 대상 2상 임상에서 시력 개선과 중심 맥락막 두께 감소 등 유의한 효과가 관찰되었습니다. RemeGen은 DME에 대한 BLA 신청을 2025년 하반기에, 습성 연령 관련 황반변성(wet AMD)에 대해서는 2026년 중반에 제출할 계획입니다.
RemeGen (REGMY) a conclu un accord de licence exclusif avec Santen Pharmaceutical pour RC28-E, une protéine de fusion ciblant à la fois VEGF et FGF, destinée aux maladies néovasculaires oculaires. Conformément à l'accord, Santen obtient les droits exclusifs de développer, fabriquer et commercialiser RC28-E en Grande Chine et dans sept pays asiatiques.
L'accord prévoit un paiement initial de 250 millions de RMB, des paiements conditionnels pour étapes de développement et réglementaires pouvant atteindre 520 millions de RMB, des paiements liés aux ventes jusqu'à 525 millions de RMB, ainsi que des redevances échelonnées. Les essais cliniques de phase II sur l'œdème maculaire diabétique (DME) ont montré des améliorations significatives de l'acuité visuelle et une réduction de l'épaisseur de la zone centrale. RemeGen prévoit de déposer les dossiers BLA pour le DME au second semestre 2025 et pour la DMLA exsudative (wet AMD) à la mi-2026.
RemeGen (REGMY) hat eine exklusive Lizenzvereinbarung mit Santen Pharmaceutical für RC28-E geschlossen, ein VEGF/FGF-Dual-Target-Fusionsprotein zur Behandlung okulärer Neovaskularisationen. Im Rahmen der Vereinbarung erhält Santen die exklusiven Rechte zur Entwicklung, Herstellung und Kommerzialisierung von RC28-E in der Großchina und sieben asiatischen Ländern.
Der Deal beinhaltet eine Anzahlung von 250 Millionen RMB, mögliche Entwicklungs- und Zulassungsmeilensteinzahlungen von bis zu 520 Millionen RMB, vertriebsabhängige Meilensteinzahlungen von bis zu 525 Millionen RMB sowie gestaffelte Lizenzgebühren. Phase-II-Studien bei diabetischem Makulaödem (DME) zeigten signifikante Verbesserungen der Sehschärfe und eine Verringerung der zentralen Netzhautdicke. RemeGen plant die Einreichung von BLA-Anträgen für DME in H2 2025 und für die feuchte altersbedingte Makuladegeneration (wet AMD) Mitte 2026.
- 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
- RemeGen gives up commercialization rights in key Asian markets
- Success of RC28-E still dependent on Phase III trial outcomes and regulatory approvals
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
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,
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
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