Ocugen, Inc. and Kwangdong Pharmaceutical Co., Ltd. Complete License Agreement of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea
Rhea-AI Summary
Ocugen (NASDAQ: OCGN) has executed a licensing agreement with Kwangdong Pharmaceutical for the exclusive Korean rights to OCU400, its modifier gene therapy for retinitis pigmentosa (RP). The deal includes upfront fees and near-term development milestone payments of up to $7.5 million, plus potential sales milestones of $180 million or more in the first 10 years of commercialization.
The agreement features 25% royalties on net sales and Ocugen will manufacture the commercial supply. The Korean market represents approximately 7,000 RP patients, about 7% of the U.S. market. Ocugen is currently advancing OCU400 through Phase 3 clinical development with a target U.S. BLA filing in 2026, which Kwangdong will leverage for Korean regulatory approval.
Positive
- Significant deal value with up to $7.5 million in upfront and near-term milestone payments
- Attractive 25% royalty rate on net sales
- Potential sales milestones of $180 million or more in first 10 years
- Ocugen retains manufacturing rights for commercial supply
- Strategic entry into Korean market with a top 5 pharmaceutical company
Negative
- Korean market represents only 7% of U.S. market size
- BLA filing not expected until 2026, indicating lengthy timeline to commercialization
News Market Reaction
On the day this news was published, OCGN gained 12.15%, reflecting a significant positive market reaction. Argus tracked a peak move of +9.6% during that session. Our momentum scanner triggered 22 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $42M to the company's valuation, bringing the market cap to $387M at that time. Trading volume was exceptionally heavy at 5.1x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
- Upfront fees and near-term development milestone payments totaling up to
$7.5 million - Potential sales milestones of
$180 million or more in first 10 years of commercialization - Royalties equaling
25% of net sales - Ocugen to manufacture and supply OCU400
MALVERN, Pa., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today executed a licensing agreement with Kwangdong Pharmaceutical, Co., Ltd., (“Kwangdong”) one of the leading pharmaceutical companies in Korea, for the exclusive Korean rights to OCU400—Ocugen’s novel modifier gene therapy for retinitis pigmentosa (RP).
Pursuant to the License Agreement, Ocugen will receive upfront license fees and near-term development milestones equaling up to
There are an estimated 7,000 individuals in the Republic of Korea with RP, which represents approximately
“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.”
Kwangdong, a top five pharmaceutical and healthcare company in Korea, has a diverse portfolio of products including prescription pharmaceuticals and over-the-counter healthcare products. The company is actively involved in research and development innovation including 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. Once the ongoing clinical trial of OCU400 is completed, Kwangdong will make every effort to bring the product to the Korean market as quickly as possible.”
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.
About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.
About Kwangdong Pharmaceutical Co., Ltd
Kwangdong Pharmaceutical Co., Ltd is a South Korean human healthcare company founded in 1963. The company focuses on the development, manufacture, and sale of pharmaceutical products, as well as health drinks and functional foods. The company's business is segmented into Pharmacy Sales, Hospital Sales, Distribution Sales, and Water Sales, each focusing on different aspects of the healthcare market. Kwangdong Pharmaceutical's vision is to become a leading human healthcare brand company with a strong focus on innovation, research, and development. Kwangdong is consistently ranked as one of the top 10 pharmaceutical and healthcare companies in Korea by multiple metrics.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated benefits to Ocugen of the definitive license agreement, qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that the license agreement with Kwangdong will not lead to the current anticipated benefits to Ocugen, including projected sales royalties and milestones, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU400 to perform in humans in a manner consistent with nonclinical or preclinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com
FAQ
What are the financial terms of Ocugen's (OCGN) licensing deal with Kwangdong Pharmaceutical?
What is the market size for OCU400 in Korea?
When does Ocugen (OCGN) expect to file for OCU400 approval?
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What is OCU400 designed to treat?
