Cellusion and Celregen, a member of Fosun Pharma, Enter into Exclusive License Agreement of CLS001 for a Corneal Endothelial Cell Regenerative Therapy in the Greater China Region

Celregen Obtains the Exclusive Rights to Develop, Manufacturing and Commercialize CLS001 in Greater China Region; Cellusion Retains Other Regional Rights.
The Deal is Worth up to over $100 Million, including Upfront, Development and Sales Milestone Payments, and Tiered Royalties.

TOKYO & HANGZHOU, China & SHANGHAI--(BUSINESS WIRE)--Cellusion Inc. (CEO: Shin Hatou, M.D. Ph.D., “Cellusion”), a Japanese regenerative medicine startup aiming to solve the global corneal transplant waiting list problem with a unique differentiation induction method from iPS cells to Corneal Endothelial Cell Substitute from iPS Cells (CECSi Cells) for bullous keratopathy novel treatment (PJ code: CLS001), and Hangzhou Celregen Therapeutics Ltd. (Chairman: Cui Zhiping, “Celregen”), a member of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (CEO: Wen Deyong, 600196.SH, 02196.HK, “Fosun Pharma”) ,and focus on regenerative medicine and cell therapy and incubated by New Drug Fund of Fosun Health Capital (CEO: Cui Zhiping,“Fosun New Drug Fund”) , today announced an exclusive license agreement (“Agreement”) in the Greater China region for Celregen to develop, manufacture and commercialize CLS001.

Under the Agreement, Celregen will have the exclusive right to develop, manufacture and commercialize CLS001 for bullous keratopathy in the Greater China region, including Mainland China, Hong Kong, Macau and Taiwan. On the other hand, Cellusion retains the rights of development, manufacturing and commercialization of CLS001 in other regions including Japan, the USA, and EU.

Under the terms of the agreement, Cellusion will potentially receive over 100 million US dollars including upfront payment, development milestones and sales milestones as well as tiered royalties.

“We are very enthusiastic about combining our knowledge of the underlying iPS cellular biology with Celregen and Fosun Pharma in the development and commercialization of innovative medicine in China.” said Shin Hatou, M.D. Ph.D., CEO of Cellusion. “Together, we are committed to make best efforts on launching CLS001 for the patient suffering from bullous keratopathy due to the cornea donor shortage in the greater China region.”

“Today’s announcement with a global industry leader in iPS cells derived corneal endothelial regenerative therapy such as Cellusion, is an important and strategic step to build a long-term foundation for cell therapy in China,” said Cui Zhiping, the Chairman of Celregen, Fosun Global Partner, Chief Consultant of VC investment of Fosun Pharma and CEO of Fosun New Drug Fund. “This partnership, which leverages each company’s respective strengths, will help us bring novel regenerative medicine products to patients in greater China.”

According to reports, there are about millions of people in China who are blind due to corneal diseases, and this number is increasing at a rate of 100,000 per year. Most of the patients with corneal blindness need corneal transplantation to restore their sight, but only less than 20,000 corneal transplants are conducted due to severe donor cornea shortage issues.

Cellusion has already announced that the patient recruitment began for the First-in-Human Investigator-Initiated Study of CLS001 to initiate in 2022 at the Keio University Hospital and has been preparing to start Cellusion initiated clinical trial in Japan within a few years followed by global studies in the US and EU region.

[About CLS001]

In spite of the fact that more than 13 million waiting patients for potential blinding diseases such as Bullous Keratopathy, which can only be prevented by corneal transplantation, only about 180,000 corneal transplants are performed annually worldwide. The reason for such a large medical supply-demand gap generated is because current treatments require donor corneas, skilled corneal transplant ophthalmologists, and Eye Banks.
Cellusion is developing CLS001, CECSi cells for Corneal Endothelial regeneration to cure Bullous Keratopathy which is applied to more than half of all cases of corneal transplantation. CLS001 is expected to replace the current supply limitations by combining “CECSi Cells made from iPS cells with excellent proliferative properties” and “a simple injection cell delivery procedure without needs of human expertise.”

[About Celregen]

Celregen, incubated by New Drug Fund of Fosun Health Capital, focuses on stem cell and transformed cellular regenerative medicine. This platform adopts a variety of modes of cooperation with leading biotech and scientists. It is expected to be a head biotech in regenerative medicine in China.

[About Fosun Pharma]

Founded in 1994, Fosun Pharma is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, and central nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, oncolytic viruses, gene therapy and PROTAC, to enhance its innovation capabilities. Guided by the 4IN strategy (Innovation, Internationalization, Integration, and Intelligentization), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth,” with the mission of creating shareholder values as well as promoting the global networks through strengthening its innovative R&D and in-licensing ability and enriching its product pipelines. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global medical and health market.

For more information, please visit their official website: www.fosunpharma.com.

[About Fosun New Drug Fund]

New Drug Fund, under the management of Fosun Health Capital, is the first VC established by Fosun Pharma. The Fund focuses on innovative biopharmaceutical-based drug fields at the start-up and expansion stages, including gene therapy, cell therapy, bio-conjugate drugs, and medical aesthetics, etc. The Fund has committed to incubate cutting-edging science and revolutionary technologies from world top universities, research institutes and biotech, through which path we can establish and adopt a variety of models of cooperation.

[About Cellusion]

Cellusion is a regenerative medicine startup born from the Department of Ophthalmology, Keio University School of Medicine in 2015. Cellusion aims to contribute to the improvement of health and well-being around the world by solving unmet medical needs in medicine with its cutting-edge cell therapy technologies, including a unique differentiation induction method from iPS cells to CECSi endothelial cells. Cellusion’s mission is to give the worldwide community a clear vision of the future with the cellular technology breakthrough.

Company: Cellusion Inc.
CEO: Shin Hatou, M.D., Ph.D.
Headquarters: 8-6 Nihonbashi-Kobuna, Chuo, Tokyo 103-0024, JAPAN
Founded: January 2015
URL: https://cellusion.jp/en/

Joji Hayashida
SVP & COO
Cellusion Inc.
hayashida@cellusion.jp
+81-3-5843-1785

Jialei Ma
the IR manager
New Drug Fund of Fosun Health Capital
majialei@fosunpharma.com
+86-21-33987239

For further information: please ask us through the contact form on our website.