#RemeGen #Santen #RC28-E

RemeGen and Santen Enter Exclusive Licensing Agreement for RC28-E

In a significant stride forward in the biopharmaceutical sector, RemeGen Co., Ltd. has announced its exclusive licensing agreement with Santen Pharmaceutical, allowing Santen to develop and commercialize the innovative drug RC28-E in Greater China and several other Asian markets. This collaboration strives to tackle ocular neovascular diseases, offering a brighter future for patients impacted by these conditions.

The Details of the Agreement

The newly formed alliance grants Santen China exclusive rights to RC28-E, not only in Mainland China but also extending to regions including Hong Kong, Macau, Taiwan, South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia. Meanwhile, RemeGen retains the global rights outside these specified territories. The financial implications of this deal are considerable, with RemeGen receiving an upfront payment of RMB 250 million, potential milestone payments reaching up to RMB 1.045 billion depending on regulatory and sales achievements, alongside tiered royalties based on net sales within these licensed territories.

Background on RC28-E

RC28-E is an advanced therapeutic option designed as a VEGF/FGF dual-target fusion protein aimed at treating ocular neovascular diseases. RemeGen has independently developed this promising drug, with impactful Phase II clinical trials already yielding encouraging outcomes, particularly for diabetic macular edema (DME). Results shared during the ARVO 2025 Annual Meeting highlighted that RC28-E not only improved visual acuity but was also well tolerated by patients, indicating its potential as a effective treatment.

Following the successful Phase II results, RemeGen has initiated Phase III clinical trials for RC28-E in conditions like wet age-related macular degeneration (wAMD) and DME. The company plans to file a Biologics License Application (BLA) for the DME indication in China within the second half of 2025, with a subsequent filing for wAMD expected in mid-2026.

Perspectives from Leadership

Dr. Jianmin Fang, CEO of RemeGen, expressed enthusiasm about the collaboration, emphasizing Santen's extensive expertise and established global sales network—a benefit that could greatly enhance RC28-E’s market reach. He remarked, "This partnership is poised to maximize the innovative potential of RC28-E, transforming the treatment landscape for retinal diseases and showcasing international recognition of RemeGen's drug development capabilities."

On the other hand, Takeshi Ito, President and CEO of Santen, highlighted RemeGen's commitment to innovation within the biopharmaceutical space. He asserted that RC28-E presents a groundbreaking therapeutic option, harnessing dual targeting to simultaneously address angiogenesis and fibrosis in fundus diseases. Santen's aim is to catalyze high-quality developments in ophthalmology and better serve unfulfilled patient needs.

About the Companies

Founded in Yantai, China, RemeGen is a leading biopharmaceutical firm committed to developing novel biologic drugs with a primary focus on autoimmune diseases, oncology, and ophthalmology. The company has made strides in the market, achieving dual listings on the Hong Kong and Shanghai stock exchanges, marking its ascent as an innovative player in the industry.

Santen, with over 130 years of experience, is a specialized pharmaceutical company dedicated to eye health. Their mission revolves around ensuring