Domestic First! Anhui-Developed Innovative Drug XMVA09 Enters Phase II Clinical Trials

(Source: Market Star Newspaper)

Star News: On April 13, the reporter followed the "Remembering the Mission, Opening a New Chapter, and Advancing in Jianghuai" centralized interview team to visit the Advanced Technology Research Institute of the University of Science and Technology of China located in Hefei High-tech Zone. In the innovation achievements exhibition hall, a series of hardcore scientific and technological achievements such as high-speed quantum key generation terminals, precision-guided fire extinguishing bombs, and fully digital PET made a collective appearance, comprehensively showcasing Anhui's strong scientific and technological innovation capabilities and fruitful results.

As a new research and development institution co-built by Anhui Province, the Chinese Academy of Sciences, Hefei City, and the University of Science and Technology of China, the Advanced Research Institute of USTC always keeps in mind the earnest entrustment, taking innovation as the primary driving force for development. It closely aligns with regional industrial needs, focusing on the transformation of scientific and technological achievements and the incubation and cultivation of enterprises, paving a high-quality development path from the laboratory to the market and from technological breakthroughs to industrial applications.

During the interview, news came from StarryGene, a company incubated and grown at the institute: its core product, XMVA09 injection, has successfully advanced to Phase II clinical trials. It has become the world’s first AAV vector bispecific antibody gene therapy drug to enter Phase II clinical trials, as well as China's first novel capsid vector ophthalmic AAV gene therapy project to reach Phase II clinical trials, marking a critical breakthrough for high-end biotech innovative drugs produced in Anhui.

Xue Tian, Member of the Standing Committee of the University of Science and Technology of China (USTC) Party Committee, Assistant to the President, and Deputy Director of the National Key Laboratory of Vision Health, introduced that the product’s efficacy and safety have been confirmed in Phase I and Phase II clinical trials. The next step is to accelerate its progress, with the hope of bringing it to market as soon as possible. This will become the first gene therapy drug in Anhui Province.

According to reports, StarryGene settled in Hefei High-tech Zone in 2019. Empowered by the platform of the Academy of Advanced Research, it focuses on the research and development of AAV ophthalmic gene therapy drugs, targeting major indications such as wet/ dry age-related macular degeneration, thyroid eye disease, and glaucoma. It has built two core technology platforms: AAV antibody gene drugs and gene editing, and established multiple self-developed pipelines. From receiving platform support for financing during its start-up phase to completing multiple rounds of financing and advancing its core products into the critical clinical stage, the company is a vivid example of Anhui's "accelerated transformation" of scientific and technological achievements.

Data Speaks to the Confidence in Innovation. As of now, the Advanced Research Institute of the University of Science and Technology of China has cumulatively established 140 research institutions, including 54 engineering and technology centers and 86 joint laboratories; a total of 992 intellectual property rights applications have been filed, with 522 authorized. From 2018 to 2024, it has ranked among the top 100 patent holders in Anhui Province for seven consecutive years. Since the approval of the pilot program for statutory institution construction in 2020, it has completed the transformation of 25 scientific and technological achievements, converted 79 intellectual properties through equity valuation, incubated 32 enterprises with equity holdings, continuously improved the innovation ecosystem, and accelerated the gathering of industrial momentum.