Lingyi Biotech Showcases Innovative AAV Gene Therapies LY-M001 and LY-M003 at the 11th China (Shanghai) International Technology Fair
Lingyi Biotech
Gene Therapy Drug Developer
The 11th China (Shanghai) International Technology Fair (hereinafter referred to as "CSITF"), themed "Open Cooperation: Empowering New Quality Productivity and Sustainable Development," opened on June 11 at the World Expo Exhibition Hall. Gong Zheng, Mayor of Shanghai, attended and launched this year's CSITF, inspecting technological innovation achievements in fields such as biomedicine.
Dr. Lin Qing, founder and CEO of Lingyi Biotech, a company in the SimbayPark Xingbei Free Trade Zone, was invited to attend the opening ceremony as a corporate representative.
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Lingyi Biotech Focuses on Critical Clinical Needs in Metabolic and Central Nervous System Diseases, Driven by the Dual Engines of "AI + Gene Therapy". It has overcome key technical bottlenecks such as AAV vector targeting, gene capacity, and production processes, creating a globally unique AAV2.0 vector platform. At this year's China International Technology Fair, Lingyi Biotech showcased its self-developed AAV gene therapy drug LY-M001 injection for Type I Gaucher's disease and the gene therapy drug LY-M003 injection for Wilson’s disease (Hepatolenticular Degeneration), drawing significant attention.
Leaders of the Municipal Science and Technology Commission and media representatives visit the booth for inspection and guidance.
LY-M001 Injection – The World’s Leading Gene Therapy Drug for Gaucher Disease
LY-M001 Injection is the first self-developed AAV gene therapy drug in China targeting Type I Gaucher's disease. The drug uses an rAAV vector for single-dose administration.Intravenous infusion can achieve long-term expression of glucocerebrosidase, realizing the goal of single-dose administration with long-lasting efficacy. The development progress of LY-M001 injection is internationally leading, having obtained FDA Orphan Drug and Pediatric Rare Disease designations as well as IND approval from both NMPA and FDA. It is currently in Phase I/II clinical trials and has initiated the world's first clinical trial targeting pediatric Gaucher disease. Multiple patients have already been dosed, and preliminary clinical data indicates that it is safe and effective.
LY-M003 Injection – A New Generation of Controllable Gene Vector Technology
LY-M003 Injection is the first AAV gene therapy drug independently developed by Lingyi Biotech in China for Wilson's disease. It delivers the functional ATP7B gene through a single intravenous infusion, enabling long-term expression of the ATP7B protein with normal copper-transporting activity in hepatocytes, thereby restoring copper metabolism, reducing copper accumulation, and improving systemic symptoms to achieve the goal of long-term efficacy with a single administration. The drug carries a next-generation CREATE.TMTunable gene expression technology can better ensure the long-term safety and efficacy of gene therapy. LY-M003 injection has received FDA Orphan Drug and Pediatric Rare Disease Designation. Several cases of adult patients in IIT clinical studies have been completed, with preliminary data indicating good safety and efficacy. The IIT clinical study targeting pediatric hepatolenticular degeneration has also been initiated.
About SimbayPark
Shanghai FT1 Life Science Park (Abbreviation"Simbay Park, Star North · Free Trade Zone No.1") is located in the Waigaoqiao Bonded Area, the core of Shanghai's Pudong New Area Free Trade Zone. It is an innovative service-oriented characteristic industrial park under the Star North Group, focusing on the incubation, cultivation, and transformation of medical enterprises.The park relies on the unique "FTAs + bonded" outward-oriented economic regional advantages, and by gathering the whole industry chain service resources of CRO+CDMO+CSO+EHS in biopharmaceuticals, government innovation and entrepreneurship support policies, and numerous well-known investment institutions, it provides enterprises with truly in-depth technical incubation in the medical industry. It serves as a steward for enterprises in transforming their technological achievements, and strives to create an international biopharmaceutical industry innovation and entrepreneurship base.