NANJING, China, May 28, 2026 — Yaohai Bio-Pharma congratulates its strategic partner, Beijing Northland Biotechnology Co., Ltd. (“Northland Bio”), on the NMPA approval of Donaperminogene Seltoplasmid Injection (Huasuoling®). As China’s first approved naked plasmid DNA gene therapy, the product marks a major milestone for the country’s gene therapy industry and advances the commercialization of plasmid-based therapeutics.
As the core CDMO partner and exclusive manufacturing service provider, Yaohai supported the program throughout development and commercialization. Leveraging its GMP plasmid manufacturing platform and industrialization expertise, the company provided support in process development, scale-up, quality management, and commercial manufacturing.
Addressing an Unmet Medical Need
Donaperminogene Seltoplasmid Injection is an innovative naked plasmid DNA therapy designed for localized gene expression. The product treats limb ulcers caused by Critical Limb Ischemia (CLI), a severe condition with limited treatment options for many patients.
For patients who cannot undergo surgery or have poor outcomes from existing procedures, the therapy offers a new treatment approach. Its approval expands treatment options and brings new hope to patients living with this debilitating disease.
Advancing Plasmid DNA Manufacturing
The approval highlights the importance of scalable and reliable manufacturing in gene therapy commercialization. Throughout the program, Yaohai provided integrated support across technology transfer, GMP manufacturing, quality systems, and commercial supply preparation.
By applying its plasmid production expertise and established manufacturing platform, Yaohai helped ensure product quality, process consistency, and regulatory compliance. This achievement further demonstrates the company’s ability to support innovative therapies from development through commercial launch.
About Northland Bio
Founded in 2004, Northland Bio is an innovative biopharmaceutical company focused on gene therapies, recombinant proteins, and ophthalmic drugs. The company develops therapies for cardiovascular, metabolic, rare, and ophthalmic diseases.
About Yaohai Bio-Pharma
Yaohai Bio-Pharma is a CRDMO specializing in microbial expression technologies. The company provides end-to-end services for recombinant proteins, plasmid DNA, nucleic acid drugs, nanobodies, and innovative vaccines, supporting global partners from development through commercial manufacturing.
