Santen Pharmaceutical Co., Ltd.

Johnson & Johnson's manufacturing pact with Fujifilm Biotechnologies, three Indian companies' drug recalls, and an eye disease deal between Santen Pharmaceutical and RemeGen made our news this week. Johnson & Johnson is spending part of its big U.S. investment at a Fujifilm Biotechnologies site. Three Indian drugmakers issued U.S. drug recalls in recent weeks due to impurities. Japan's Santen Pharma licensed a VEGF/FGF bispecific from RemeGen. And more.1. In US manufacturing push, J&J earmarks $2B for Fujifilm in 10-year deal in North CarolinaJohnson & Johnson has committed $2 billion over the next 10 years to secure a 160,000-plus-square-foot facility at Fujifilm Biotechnologies’ biomanufacturing campus in Holly Springs, North Carolina. The deal will create about 120 new jobs in the state, J&J said. The pact followed a $3 billion arrangement Fujifilm recently made with Regeneron.2. Alembic, Sun and Glenmark issue US drug recalls due to the presence of carcinogens or foreign matterThree Indian drugmakers—Alembic, Sun Pharma and Glenmark—have issued separate U.S. drug recalls in recent weeks. Alembic recalled 9,492 bottles of doxepin hydrochloride due to an impurity of the potential human carcinogen nitrosamine. In addition, Sun recalled 11,328 bottles of spironolactone due to the presence of aluminum, and Glenmark issued three recalls, including two covering carvedilols because of the presence of a nitrosamine.3. China's RemeGen sells Asia rights to VEGF/FGF eye drug in $180M dealJapanese eye disease specialist Santen Pharmaceutical is paying 250 million Chinese yuan ($34.8 million) for certain Asia rights to a VEGF/FGF fusion protein by China’s RemeGen. The drug, coded RC28-E, is already in phase 3 development in diabetic macular edema and wet age-related macular degeneration. The deal could eventually be worth about $180 million.4. GC’s Made Scientific opens cell therapy facility in New Jersey (release)Made Scientific, a U.S.-based cell therapy CDMO subsidiary of Korea’s GC Holdings, has opened its 60,000-square-foot facility and headquarters in Princeton, New Jersey. The opening marked the completion of a $12 million initial investment in the site. The company plans to add 12,000 square feet in additional clean room space to support late-stage and commercial programs.

Santen CEO Takeshi Ito said RC28-E \"offers differentiated advantages.\"\n China’s RemeGen has sold certain Asia rights to its phase 3-stage eye disease drug to Japan’s Santen Pharmaceutical for 250 million Chinese yuan ($34.8 million) upfront.The drug in question, dubbed RC28-E, is a VEGF/FGF dual-target fusion protein being aimed at ocular neovascular diseases. RemeGen has already taken RC28-E into phase 3 studies for diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) off the back of a phase 2 study in DME the company said had demonstrated improved vision and reduced retinal thickness.RemeGen’s plan is to submit a China approval application for RC28-E in DME later this year, followed by an application in wAMD around mid-2026, according to an Aug. 18 release.This morning’s deal means that Santen’s China subsidiary now has the rights to develop and commercialize RC28-E in greater China as well as as South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia and Malaysia.As well as the upfront fee, RemeGen could be in line for up to 520 million yuan ($72.4 million) in development and regulatory milestones, as well as 525 million yuan ($73 million) in sales milestones and then tiered royalties on sales in the licensed territories.RemeGen CEO Jianmin Fang, Ph.D., said the partnership with Japanese vision care company Santen “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.” While a number of approved eye disease drugs—such as Roche’s Lucentis and Vabysmo as well as Regeneron and Bayer’s Eylea—already target vascular endothelial growth factor (VEGF), RC28-E is also designed to work on fibroblast growth factors (FGFs), which play a significant role in eye development and disease.Santen CEO Takeshi Ito said 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.” 

The RC28-E intravitreal injection is a dual-target fusion protein aimed at treating retinal diseases. Credit: Sai Thaw Kyar/Shutterstock.com. Santen Pharmaceutical has signed a licensing agreement with RemeGen for the RC28-E intravitreal injection, a dual-target fusion protein designed to treat retinal diseases. The agreement, facilitated through Santen’s subsidiary in China, grants the company exclusive rights to develop, manufacture and market RC28-E across Hong Kong, Macau, Mainland China, Indonesia, Malaysia, the Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam. RemeGen will receive an upfront payment of 250m yuan ($34.8m), milestone payments for development and regulatory achievements totalling up to 520m yuan ($72.3m), and up to 525m yuan ($73.09m) sales milestone payments. The company will also receive additional net sales-based royalties. RemeGen CEO Dr Fang Jianmin stated: “Santen brings over 130 years of ophthalmic expertise and a robust global commercial network spanning more than 60 countries and regions. “As RemeGen independently developed a Category 1 innovative drug, RC28-E is approaching the critical stage of BLA submission.” GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence RC28-E is a bi-specific fusion protein that targets vascular endothelial growth factor and fibroblast growth factor. It is currently under clinical development for conditions such as diabetic macular oedema, wet age-related macular degeneration and diabetic retinopathy. Recent findings from a Phase II clinical trial of RC28-E for diabetic macular oedema were presented at the 2025 Annual Meeting of the Association for Research in Vision and Ophthalmology. Results indicated that the treatment improved best-corrected visual acuity while reducing central subfield thickness, and was well-tolerated by patients. Santen president and CEO Takeshi Ito stated: “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.” Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now