Ocugen, Inc. and Kwangdong Pharmaceutical Co., Ltd. Complete License Agreement of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea
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.
Ocugen (NASDAQ: OCGN) ha stipulato un accordo di licenza con Kwangdong Pharmaceutical per i diritti esclusivi in Corea su OCU400, la sua terapia genica modificatrice per la retinite pigmentosa (RP). L'accordo prevede oneri iniziali e pagamenti di milestone di sviluppo a breve termine fino a 7,5 milioni di dollari, oltre a potenziali milestone di vendita di 180 milioni di dollari o più nei primi 10 anni di commercializzazione.
L'accordo prevede royalties del 25% sui netti delle vendite e Ocugen produrrà la fornitura commerciale. Il mercato coreano comprende circa 7.000 pazienti RP, circa il 7% del mercato statunitense. Ocugen sta attualmente avanzando OCU400 attraverso sperimentazioni cliniche di Fase 3 con un'ipotesi di presentazione della BLA negli Stati Uniti nel 2026, che Kwangdong sfrutterà per l'approvazione regolatoria in Corea.
Ocugen (NASDAQ: OCGN) ha ejecutado un acuerdo de licencia con Kwangdong Pharmaceutical para los derechos exclusivos en Corea de OCU400, su terapia génica modificadora para la retinitis pigmentosa (RP). El acuerdo incluye honorarios iniciales y pagos de hitos de desarrollo a corto plazo de hasta 7,5 millones de dólares, además de posibles hitos de ventas de 180 millones de dólares o más durante los primeros 10 años de comercialización.
El acuerdo contempla regalías del 25% sobre las ventas netas y Ocugen fabricará el suministro comercial. El mercado coreano representa aproximadamente 7.000 pacientes con RP, alrededor del 7% del mercado de EE. UU. Ocugen está actualmente avanzando OCU400 a través de desarrollo clínico de Fase 3 con una presentación de BLA en EE. UU. para 2026, que Kwangdong aprovechará para la aprobación regulatoria en Corea.
Ocugen (NASDAQ: OCGN)은 독점적인 한국 내 OCU400 권리에 대해 Kwangdong Pharmaceutical와 라이선스 계약을 체결했습니다. 이는 RP(망막색막증)를 위한 그들의 변형 유전자 치료제입니다. 이 계약에는 최초 수수료와 향후 단기 개발 마일스톤 지불이 최대 750만 달러가 포함되며, 상용화 초기에 판매 마일스톤으로 1억 8천만 달러 이상도 가능하게 됩니다.
계약은 순매출의 25% 로열티를 특징으로 하며, Ocugen이 상업적 공급을 제조합니다. 한국 시장은 약 7,000명의 RP 환자로 미국 시장의 약 7%에 해당합니다. Ocugen은 현재 OCU400을 3상 임상 개발 단계로 진행 중이며, 미국에서 2026년 BLA 제출을 목표로 하고 있으며, Kwangdong은 이를 한국의 규제 승인을 위한 체계로 활용할 것입니다.
Ocugen (NASDAQ: OCGN) a conclu un accord de licence avec Kwangdong Pharmaceutical pour les droits exclusifs en Corée sur OCU400, sa thérapie génique modifiée pour la rétinite pigmentaire (RP). L'accord comprend des frais initiaux et des paiements de jalons de développement à court terme allant jusqu’à 7,5 millions de dollars, ainsi que des jalons potentiels de ventes de 180 millions de dollars ou plus au cours des 10 premières années de commercialisation.
L’accord prévoit des redevances de 25 % sur les ventes nettes et Ocugen fabriquera l’approvisionnement commercial. Le marché coréen représente environ 7 000 patients RP, soit environ 7 % du marché américain. Ocugen poursuit actuellement OCU400 dans le cadre d’un développement clinique de phase 3 avec une soumission BLA américaine envisagée pour 2026, que Kwangdong utilisera pour l’approbation réglementaire en Corée.
Ocugen (NASDAQ: OCGN) hat eine Lizenzvereinbarung mit Kwangdong Pharmaceutical für die exklusiven koreanischen Rechte an OCU400 getroffen, seiner modifizierten Gentherapie für Retinopathia pigmentosa (RP). Die Vereinbarung umfasst Vorauszahlungen und kurzfristige Entwicklungsmeilensteinzahlungen von bis zu 7,5 Mio. USD, sowie potenzielle Verkaufsmeilensteine von 180 Mio. USD oder mehr in den ersten 10 Jahren der Kommerzialisierung.
Die Vereinbarung sieht 75% Tantiemen auf Nettoumsatz vor und Ocugen wird die kommerzielle Versorgung herstellen. Der koreanische Markt umfasst ca. 7.000 RP-Patienten, ca. 7% des US-Marktes. Ocugen treibt OCU400 derzeit in Phase-3‑Entwicklung voran, mit einem US‑BLA‑Einreichungsziel im Jahr 2026, welches Kwangdong für die regulatorische Zulassung in Korea nutzen wird.
Ocugen (بورصة ناسداك: OCGN) أبرمت اتفاقية ترخيص مع Kwangdong Pharmaceutical للحصول على حقوق حصرية في كوريا لـ OCU400، علاجا جينيا معدّلا لمرض التنكس العصبي الشبكي الصبغي RP. تتضمن الصفقة رسوم مقدمة ومدفوعات معلم تطوير طويلة الأجل تصل إلى 7.5 مليون دولار، بالإضافة إلى احتمالية وصول معالم مبيعات تبلغ 180 مليون دولار أو أكثر في السنوات العشر الأولى من التسويق.
تتميز الاتفاقية ب إتاوات قدرها 25% من صافي المبيعات وستقوم Ocugen بتصنيع الإمدادات التجارية. يمثل السوق الكوري حوالي 7,000 مريض RP، نحو 7% من السوق الأمريكية. حالياً تخطط Ocugen لتطوير OCU400 في مرحلة 3 من التطوير السريري مع هدف تقديم BLA في الولايات المتحدة في 2026، والتي ستستفيد منها Kwangdong للموافقة التنظيمية في كوريا.
Ocugen (NASDAQ: OCGN) 已与 Kwangdong Pharmaceutical 签署许可协议，获得在韩国对 OCU400 的独家权利，该药为其用于视网膜色素变性的改造基因疗法（RP）。该协议包括 前期费用及近端开发里程碑支付，最高达 750 万美元，以及在最初 10 年商业化期内潜在的销售里程碑达 1.8 亿美元或以上 。
协议规定对净销售额的 25% 提成，Ocugen 将负责商业供应的生产。韩国市场约有 7,000 名 RP 患者，约为美国市场的 7%。Ocugen 目前正在将 OCU400 推进至 III 期临床开发，目标在 2026 年向美国提交 BLA，Kwangdong 将利用这一点来获得韩国监管批准。
- 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
- Korean market represents only 7% of U.S. market size
- BLA filing not expected until 2026, indicating lengthy timeline to commercialization
Insights
Ocugen secures Korean licensing deal for OCU400 gene therapy worth up to $187.5M plus 25% royalties, enhancing revenue potential.
Ocugen's licensing agreement with Kwangdong Pharmaceutical represents a significant commercial milestone for its OCU400 modifier gene therapy program. The deal structure includes
The Korean market, with approximately 7,000 retinitis pigmentosa patients (
This deal demonstrates external validation of OCU400's potential from an established pharmaceutical company while providing Ocugen with non-dilutive capital during its Phase 3 clinical development. The agreement's structure, with Kwangdong leveraging Ocugen's clinical data and future BLA filing for Korean regulatory submission, creates operational efficiency by eliminating the need for duplicate clinical trials.
With OCU400 targeting a 2026 BLA filing in the U.S., this regional partnership establishes a blueprint for similar agreements in other territories, potentially unlocking significant value from Ocugen's modifier gene therapy platform without diverting resources from its core U.S. market strategy.
- 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
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