Ocugen, Inc. has executed a licensing agreement with Kwangdong Pharmaceutical Co., Ltd., one of Korea's leading pharmaceutical companies, for exclusive Korean rights to OCU400, the company's novel modifier gene therapy for retinitis pigmentosa (RP). The partnership marks Ocugen's first regional licensing deal for its gene therapy platform and provides significant financial terms including upfront payments and substantial milestone opportunities.
Financial Terms and Commercial Structure
Under the licensing agreement, Ocugen will receive upfront license fees and near-term development milestones totaling up to $7.5 million. The company will be entitled to sales milestones of $1.5 million for every $15 million of sales in Korea, with projections reaching $180 million or more in the first 10 years of commercialization. Additionally, Ocugen will receive a 25% royalty on net sales of OCU400 generated by Kwangdong, while maintaining manufacturing and supply responsibilities under a separate supply agreement.
Market Opportunity and Clinical Development
The Korean market represents an estimated 7,000 individuals with retinitis pigmentosa, which constitutes approximately 7% of the U.S. market. OCU400 is positioned as a potential one-time therapy for life to treat this devastating condition that leads to vision loss.
"We are excited to partner with Kwangdong as our first regional partner in the development and commercialization of our modifier gene therapies across the globe," said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of 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."
Regulatory Timeline and Strategy
Ocugen is currently advancing OCU400 through Phase 3 clinical development with a target U.S. Biologics License Application (BLA) filing in 2026. Kwangdong intends to utilize Ocugen's clinical data and BLA filing as part of their regulatory submission for approval in Korea, potentially streamlining the approval process in the Korean market.
Strategic Partnership Benefits
Kwangdong, ranked as a top five pharmaceutical and healthcare company in Korea, brings significant market presence and expertise to the partnership. The company has a diverse portfolio including prescription pharmaceuticals and over-the-counter healthcare products, with active involvement in research and development innovation focusing on transformational late-stage, high-impact technologies.
"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 & Chairman of Kwangdong. "From the company's perspective, this deal with Ocugen is especially meaningful as it allows us to further strengthen our ophthalmology portfolio, alongside our existing pipeline for presbyopia and pediatric myopia."
Gene Therapy Platform Expansion
The agreement represents a significant milestone for Ocugen's modifier gene therapy platform, which utilizes a gene-agnostic approach to address significant unmet medical needs for large patient populations. Upon regulatory approval of OCU400 in Korea, Kwangdong is positioned to become a leader in the field of ophthalmic gene therapy in the Korean market.
Kwangdong has committed to bringing OCU400 to the Korean market as quickly as possible once the ongoing clinical trial is completed, demonstrating the urgency to address the unmet medical need for retinitis pigmentosa patients in Korea.
