Ocugen and Kwangdong complete licensing agreement for OCU400 gene therapy in Korea

(Image Credit: AdobeStock/diy13)

Ocugen and Kwangdong Pharmaceutical have entered into a licensing agreement for OCU400, Ocugen’s novel modifier gene therapy for retinitis pigmentosa (RP).¹

It was announced earlier this year² that Ocugen signed a binding term sheet to negotiate and enter into a licensing agreement with a “well-established leader in the pharmaceutical and healthcare sector in Korea” for exclusive Korean rights to OCU400, which has since been revealed to be Kwangdong Pharmaceutical.

According to a press release from Ocugen,¹ pursuant to the License Agreement, Ocugen will receive upfront license fees and near-term development milestones totaling up to $7.5 million. Ocugen will be entitled to sales milestones of $1.5 million for every $15 million of sales in Korea. Ocugen will also receive a royalty of 25% on net sales of OCU400 generated by Kwangdong. Ocugen will produce the commercial supply of OCU400 for Kwangdong under the terms of the agreement.

Kwangdong, a top 5 pharmaceutical and healthcare company in Korea, is actively involved in research and development innovation, including “transformational late-stage, high-impact technologies.”¹

SungWon Choi, CEO & chairman of Kwangdong, and Shankar Musunuri, PhD, MBA, chairman, CEO, and co-founder of Ocugen, commented on the partnership in a press release from Ocugen.

“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 Musunuri.

“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 Choi.

Earlier this year, Ocugen announced a positive 2-year safety and efficacy update for the phase 1/2 OCU400 clinical trial for the treatment of early to advanced RP in pediatric and adult populations. According to the company, OCU400 demonstrated meaningful improvement of a 2-line gain (10 letters on the ETDRS chart) in low-luminance visual acuity (LLVA) in treated eyes when compared to untreated fellow eyes.

Ocugen is currently advancing OCU400 through phase 3 clinical development (liMeliGhT) with a target Biologics License Application filing in mid-2026. Additionally, Kwangdong intends to utilize Ocugen’s clinical data and BLA filing as part of their regulatory submission for approval in Korea.

References:

1. Ocugen, Inc. and Kwangdong Pharmaceutical Co., Ltd. Complete License Agreement of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea. Published September 15, 2025. Accessed September 15, 2025. https://www.globenewswire.com/news-release/2025/09/15/3149790/0/en/Ocugen-Inc-and-Kwangdong-Pharmaceutical-Co-Ltd-Complete-License-Agreement-of-OCU400-Modifier-Gene-Therapy-for-Retinitis-Pigmentosa-in-Korea.html

2. Harp MD. Ocugen signs term sheet for korean licensing of OCU400 gene therapy. Published June, 5, 2025. Accessed September 15, 2025. https://www.ophthalmologytimes.com/view/ocugen-signs-term-sheet-for-korean-licensing-of-ocu400-gene-therapy