Northland Bio’s HGF naked plasmid therapy for severe lower limb ischemia begins commercial distribution in China
On October 14, 2026, Yaohai Bio-Pharma held a ceremony at its manufacturing site in Jiangsu to mark the first nationwide shipment of Huasuoling® (Donaperminogene Seltoplasmid Injection), an innovative Class 1 therapeutic biologic developed by Beijing Northland Biotechnology Co., Ltd. (Northland Bio).
Huasuoling® is the world’s first HGF naked plasmid gene therapy for severe lower limb ischemia. It offers a new treatment option for patients who cannot undergo revascularization surgery or whose surgical outcomes have been inadequate, addressing a gap in disease-targeted treatment for severe lower limb ischemia in China.
Management teams from both companies attended the ceremony. Northland Bio was represented by Chairman Xu Songshan, Executive Vice President Nie Liya, Vice President Gao Jie, subsidiary general manager Wang Yongjiang, and Shanghai branch deputy general manager Xu Lanying. Yaohai Bio-Pharma was represented by Managing Director Wang Manchao and Director and Senior Business Director Zhu Ruidong, among others. Together, they marked this milestone in the product’s commercialization.
In his remarks, Yaohai Bio-Pharma Managing Director Wang Manchao congratulated Northland Bio and expressed his respect for the team’s efforts. He said Huasuoling® is China’s first and currently only approved gene therapy drug that promotes angiogenesis, as well as the world’s first HGF gene therapy for severe lower limb ischemia. He emphasized the significance of this treatment.
Yaohai Bio-Pharma is the sole contract manufacturer for Huasuoling® worldwide. It has completed the full industrialization process, including technology transfer, process validation, and GMP-scale manufacturing, and established a dedicated GMP production line and project team. The company will uphold stringent quality standards, manage production carefully, and lay the groundwork for a stable supply to ensure that every dose of Huasuoling® is safe and effective for patients.
Yaohai Bio-Pharma will continue to support Northland Bio’s commercialization plans and deepen the companies’ long-term strategic partnership. Together, they aim to build on China’s first approved gene therapy and help the country maintain a leading position in the field.
Huasuoling® is the world’s first HGF naked plasmid gene therapy to receive regulatory approval. With no international precedent and no mature domestic pathway for commercial-scale production, bringing Huasuoling® to market required close collaboration between the Northland Bio and Yaohai Bio-Pharma teams. Northland Bio Chairman Xu Songshan specifically recognized Yaohai Bio-Pharma as the product’s sole contract manufacturer worldwide and a trusted partner in its industrialization. The successful release of the first commercial batch demonstrates the companies’ ability to manufacture Huasuoling® reliably at commercial scale.
The two companies will continue to work closely, uphold strict quality standards, and maintain a stable, reliable supply of Huasuoling®. They aim to deliver the medicine safely and promptly to people with severe lower limb ischemia, bringing hope for restored blood flow and a return to normal life.
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.
