On January 24, 2024, Lingyi (Hangzhou) Biotechnology Co., Ltd. (hereinafter referred to as “Lingyi Biotech “) announced that its independently developed injection, LY-M001, has been granted Investigational New Drug (IND) approval by the U.S. Food and Drug Administration (FDA) with the IND number 30210.

This recent achievement marks another pivotal advancement for the LY-M001 injection, following its provisional approval for an Investigational New Drug (IND) application by the National Medical Products Administration (NMPA) of China. This milestone not only underscores Lingyi Biotech’s exceptional proficiency in drug research and development but also highlights the successful execution of the company’s strategy, which emphasizes original innovation, adherence to high-quality standards, and a commitment to a global operational framework.

Dr. Lin Qing, the esteemed founder and CEO of Lingyi Biotech, shared his enthusiasm about this significant development. “The IND approval of our inaugural innovative medication, the LY-M001 injection, in both China and the United States, represents a monumental leap for our company. It reaffirms our team’s capability in pioneering innovation. We are steadfast in our commitment to fostering international partnerships and advancing the clinical trials of LY-M001 injection. Our goal is to expedite the availability of a treatment option that is not only safer and more efficacious but also more accessible to patients globally. The company is dedicated to addressing critical clinical needs, propelling our pipeline towards clinical application, and contributing positively to the evolution of the pharmaceutical sector.”


About LY-M001 Injection:

The LY-M001 injection stands as the inaugural adeno-associated virus (AAV) gene therapy drug autonomously developed in China, targeting Gaucher’s disease type I or III. This innovative product employs a recombinant adeno-associated virus (rAAV) as the delivery vector. It is engineered to enable patients to produce glucocerebrosidase after a solitary intravenous infusion, vital for those afflicted by the disease. Lingyi Biotech has pioneered the development of a modified glucocerebrosidase gene therapy vector, boasting exclusive intellectual property rights. This vector is designed for stable in vivo expression and prolonged degradation of detrimental glycolipid metabolites, aiming for a sustained therapeutic effect in treating Gaucher disease. The Investigator-Initiated Trial (IIT) clinical study, orchestrated by Dean Huang He of the First Affiliated Hospital of Zhejiang University School of Medicine, has commenced successfully. To date, the administration of the drug to two subjects has yielded promising preliminary data from the IIT, showcasing LY-M001’s efficacy and safety, with no adverse events reported thus far.

About Lingyi Biotech:

Founded in February 2021, Lingyi Biotech has rapidly ascended as a global frontrunner in the innovative drug development landscape, specifically focusing on monogenic inherited disorders. The company prides itself on a world-class team, deeply committed to the discovery, research, and industrialization of gene therapy. With a keen focus on the clinical demands in metabolic, central nervous system, and ophthalmic disease domains, Lingyi Biotech is pioneering in source innovation. The company is dedicated to offering comprehensive, one-time solutions that adhere to the most stringent quality standards, starting from critical technologies like animal models for genetic diseases, all the way to the industrialization of the FIC gene therapy pipeline.


About Polyplus

Polyplus, part of Sartorius, is a leading upstream solutions provider for advanced biologic and cell and gene therapy production from research to commercial scale. The legacy nucleic acid delivery portfolio features process-centric transfection reagents, kits, and support services including bioproduction industry standard, PEIpro® and FectoVIR®-AAV. In 2020, the company began focusing on upstream bioprocess economic optimization with the addition of custom plasmid vector design, GMP transfection reagent and plasmid manufacturing with an internalized supply chain designed to meet strict scientific and regulatory standards. Headquartered in Europe, the Polyplus team continues to grow globally with operations in the United States and Asia.

Xpress Biologics is an established Belgian microbial CDMO acquired by Polyplus in 2022 and providing R&D to GMP grade plasmid and protein manufacturing services.


Media Contact Information:

Géraldine Guérin-Peyrou
Marketing and Communication Director at Polyplus