Ocugen Licenses OCU400 to Kwangdong in Korea

Ocugen, Inc. and Kwangdong Pharmaceutical have completed a licensing agreement granting Kwangdong exclusive rights to commercialize OCU400, Ocugen’s modifier gene therapy candidate for retinitis pigmentosa (RP), in South Korea.

Agreement Terms and Financial Structure

The finalization of this agreement follows an announcement earlier this year that Ocugen had signed a binding term sheet with a major Korean pharmaceutical company, now publicly confirmed as Kwangdong Pharmaceutical.

According to a press release from Ocugen, the terms of the agreement include:

• Upfront license fees and near-term development milestones totaling up to $7.5 million

• Sales milestones of $1.5 million for every $15 million in Korean sales

• Royalty payments of 25% on net sales of OCU400 generated by Kwangdong

• Commercial supply production of OCU400 to be handled by Ocugen

Kwangdong’s Role and Strategic Alignment

Kwangdong, one of the top five pharmaceutical and healthcare companies in Korea, is recognized for its ongoing investments in late-stage, high-impact technologies and innovation in drug development.

“Kwangdong is very excited to have the opportunity to provide a new treatment option to Korean patients suffering from RP and the healthcare professionals treating them,” said SungWon Choi, CEO and Chairman of Kwangdong.

OCU400: A Modifier Gene Therapy for Retinitis Pigmentosa

OCU400 is a potential one-time gene therapy designed to treat retinitis pigmentosa (RP) by targeting the genetic mutations underlying the disease. The therapy uses a modifier gene approach that aims to broadly address multiple genetic variants of RP.

“OCU400 is a potential one-time therapy for life to treat RP, and upon local regulatory approval, patients in Korea with this devastating condition will be able to access OCU400 through Kwangdong,” said Shankar Musunuri, PhD, MBA, Chairman, CEO, and Co-founder of Ocugen.

Clinical Development and Efficacy Data

Earlier this year, Ocugen released positive 2-year safety and efficacy results from its Phase 1/2 clinical trial of OCU400. The study evaluated the therapy in both pediatric and adult patients with early to advanced stages of RP.

Key Finding:

• Demonstrated a meaningful 2-line gain (10 letters on the ETDRS chart) in low-luminance visual acuity (LLVA) in treated eyes compared to untreated fellow eyes

Currently, Ocugen is advancing OCU400 through Phase 3 clinical development under the liMeliGhT trial, with a Biologics License Application (BLA) filing planned for mid-2026.

Kwangdong intends to utilize Ocugen’s clinical data and U.S. regulatory filing as the foundation for their regulatory submission in Korea.