Academic Salon on Advances in CGT Therapy for Ophthalmic Diseases & Tongeye MedPharm-Shanghai General Hospital Cooperation Launch Ceremony

At 14:00 on October 28, 2025, the Academic Salon on Advances in CGT Therapy for Ophthalmic Diseases & the Launch Ceremony of the Cooperation between Tongeye MedPharm and Shanghai General Hospital (hereinafter referred to as “Shanghai General Hospital”) was grandly held at the Gongji Building of Shanghai General Hospital. The successful launch of the cooperation ceremony marks a new milestone in the collaboration between Tongeye MedPharm and the National Clinical Research Center for Ocular Diseases of Shanghai General Hospital (hereinafter referred to as the “Clinical Research Center”).

The launch ceremony was hosted by Mr. Yang Shu, COO of Tongeye MedPharm. At the beginning of the event, opening remarks were delivered respectively by Prof. Sun Xiaodong, Vice President of Shanghai General Hospital and Director of the Ophthalmology Center, Prof. Xu Guotong, Distinguished Professor at Tongji University, Founder and Chief Scientist of Tongeye MedPharm, and Mr. Zhuo Fumin, Founder and Chairman of Vertex Capital.

Vice President Sun Xiaodong emphasized that stem cells represent a key direction: gene therapy covers early-stage patients, cell therapy covers middle-to-late-stage patients, and end-stage patients now have access to treatments such as optogenetics and brain-computer interfaces, with clear positioning and division of roles for each modality. Ophthalmic diseases are highly suitable for CGT therapies, as the world’s first gene therapy drug was approved for ophthalmic indications. During the 13th Five-Year Plan period, Shanghai General Hospital was awarded the National Clinical Research Center for Ocular Diseases and subsequently established a GMP center. The Clinical Research Center has been rigorously tested in terms of patient recruitment efficiency, professionalism of the research team, and overall hospital hardware support. At present, the center continues to seek cooperation and looks forward to providing better services for more scientists, enterprises, and medical teams to accelerate clinical translation.

Chairman Xu Guotong stated that with the improvement of policies, uncertainties in the R&D and commercialization of gene and cell therapies have been greatly reduced, boosting the confidence of industry practitioners. From his past drug R&D experience, he deeply recognized that the success of drug development is closely linked to high-quality clinical design and implementation. The cooperation with Shanghai General Hospital has greatly enhanced the enterprise’s confidence. With the support of the hospital and investors, the company hopes to advance drug R&D more rapidly and with high quality to benefit clinical patients at an early date. Prof. Xu also revealed that Tongeye MedPharm’s core pipeline TE02102 (iPSC-nRPEC) for the treatment of dry age-related macular degeneration (AMD) will officially enter an Investigator-Initiated Trial (IIT), with patient recruitment expected to start by the end of 2025.

Mr. Zhuo Fumin brought strong encouragement from a capital perspective. He noted that while the Hong Kong stock market hit a trough at the end of last year, the biotech innovative drug sector is now in its prime. This shift fundamentally reflects a qualitative change in global recognition of China’s biopharmaceutical R&D capabilities. Booming BD transactions have driven current industrial prosperity, and the fund he leads will continue to support the R&D of early-stage original innovative drugs.

Subsequently, Tongeye MedPharm and Shanghai General Hospital held the official launch ceremony for strategic cooperation.

In the academic salon session, Chairman Xu Guotong, as the first speaker, introduced the GMP laboratory of the Clinical Research Center of Shanghai General Hospital. He stressed that the in-hospital GMP facility serves as a translational engine for clinicians, facilitating more efficient translation of scientific research achievements into clinical applications. The cooperation between Tongeye MedPharm and Shanghai General Hospital is timely and well-aligned with industry trends. The team boasts outstanding advantages in talent density and expertise, while the cost-effective GMP facility’s precision, efficiency, and accessibility strongly support IIT and Phase I clinical trials.

Dr. Ding Xueying, Director of the GCP Office of the Clinical Research Center of Shanghai General Hospital, delivered the second presentation. From the perspective of consolidating the connotation of the clinical research system and supporting the hospital’s transformative development, she comprehensively introduced the construction of Shanghai General Hospital’s clinical research system. She highlighted that scientific and technological innovation and high-quality clinical research are the engines of the hospital’s high-quality development. Amid evolving paradigms of medical technological innovation, Shanghai General Hospital is accelerating the construction of an innovative clinical research platform featuring a multi-campus cluster-based basic-clinical-translational research infrastructure and technology platform to fully support innovative R&D and disciplinary development.

The establishment of the Shanghai General Hospital Clinical Research Institute—an intensive, large-scale, and industrialized research support platform—is a key practice to realize this clinical innovation system. The Clinical Research Unit (CRU) under the institute, as its core functional carrier, began construction in 2016 with a total investment of over 90 million yuan, covering an area of 30,000 square meters. It is equipped with 77 research beds, 51 full-time research managers and support staff, and 5 clinical research information systems, with a cumulative total of 80 million yuan in superior research funding.

In addition, key support platforms include patient-centered, specialty-focused dual-campus demonstration smart research wards, smart radionuclide wards, early-phase clinical trial wards, a clinical research digital platform, a clinical sample resource center, an integrated GCP-GMP system and technology platform, and an AI-assisted diagnostic medical device evaluation platform. The hospital aims to build a world-leading, domestically top-tier innovation and translation center for cell and gene therapy in the future.

Against the backdrop of national emphasis on the development of new biomedical technologies and the successive introduction of regulatory regulations, there is an urgent need to explore how CGT therapies can smoothly progress from IIT to market approval. To address this, the salon specially invited Lawyer Liu Tingting from AllBright Law Offices to analyze key provisions of the Regulations for the Administration of Clinical Research and Clinical Translation and Application of New Biomedical Technologies (hereinafter referred to as the “Regulations”).

Lawyer Liu stated that the promulgation of the Regulations marks the official entry of IIT into a new stage of standardized and institutionalized supervision. As a top-level design document for a new regulatory system, the Regulations substantively stipulate clinical translation and application, while supporting detailed rules remain to be improved. She highlighted the absolute red lines defined in the Regulations: engagement in prohibited technologies will incur the most severe legal liabilities. The current regulatory approach shows a trend of “loose early, strict later”, yet full implementation will require overcoming multiple hurdles, with consolidated primary responsibility.

Furthermore, existing provisions do not clearly define specific standards for identical new technologies, specific criteria and rules for compliant charging, nor specific charging standards and implementation rules for clinical translation and application—all of which will be key focus areas going forward. Finally, Lawyer Liu expressed hope that relevant authorities will prepare and improve supporting systems in advance in accordance with the Regulations, and update and implement them promptly before new rules are issued, providing clearer guidance for stakeholders.

At the end of the meeting, Chairman Xu Guotong introduced the basic information and R&D progress of TongEye MedPharm Co., Ltd. The company’s core business focuses on innovative treatments for blinding eye diseases, with a main pipeline of iPSC-derived cell drugs (e.g., TE02102 for dry AMD) and a supporting pipeline of EPO ophthalmic preparations (for diabetic retinopathy and other indications).

Key technological highlights include:

In terms of financing, the company has raised 28 million yuan to date, and plans to raise 40–50 million yuan in the pre-A round for IND applications, R&D, and team building.

Finally, the academic salon concluded successfully with a group photo of all participating guests.