NORTHLAND’s innovative drug, China’s first gene therapy for severe lower-limb ischemia—cedomine injection (Huasuo Ling®)—has been officially approved, filling a critical gap in clinical causal treatment.

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2026-05-29


On May 28, 2026, Seltoplasmid Injection (trade name: Huasuoling®), a Class 1 innovative therapeutic biologic developed independently by Beijing Northland Biotechnology Co., Ltd. (hereinafter referred to as “NORTHLAND,” stock code: 920047), was officially approved for marketing by the National Medical Products Administration, with approval number:  S20260032. This drug is China’s first—and currently only—approved gene therapy for promoting angiogenesis. Employing an innovative “therapeutic angiogenesis” strategy, it will provide a completely new treatment option for Chinese patients with severe lower limb ischemia (CLI) who are unsuitable for revascularization surgery or whose surgical outcomes are suboptimal, thereby filling the gap in etiological treatment for CLI in China.

Professor Zheng Yuehong, Director of the Department of Vascular Surgery at Peking Union Medical College Hospital, stated: “The successful completion of the Phase III clinical trial of Seltoplasmid Injection, led by Peking Union Medical College Hospital, has validated the feasibility of a therapeutic angiogenesis strategy. The drug has demonstrated encouraging efficacy in promoting ulcer healing and reducing the risk of amputation, thereby filling a critical gap in the clinical management of CLI patients who are ineligible for surgery and offering a novel treatment approach. As an original Chinese‑developed gene therapy, the approval of Seltoplasid Injection has injected fresh momentum into clinical practice and strengthened China’s voice in the global arena of CLI treatment.”

Mr. Xu Songsan, Chairman of the company, stated: “The development of Seltoplasmid Injection took 22 years, and today’s approval marks an important milestone in our journey of innovative development. As China’s first approved CLI gene therapy drug, we have overcome a series of technical challenges, including gene transfection efficiency, localized precise delivery, and large-scale production, demonstrating NORTHLAND’s comprehensive technical capabilities in the field of bioengineering drug development. We extend our gratitude to all employees who contributed to the new drug’s research and development; to all research institutions, investigators, and participants involved in the clinical trials; and to our investors and partners who have placed their trust in us over the long term. The approval of Seltoplasmid is not only a victory for the people of NORTHLAND but also a microcosm of China’s pharmaceutical industry’s commitment to innovation and its pursuit of cutting-edge global technologies. We will spare no effort in preparing for the commercialization of Seltoplasmid, striving to bring this innovative product into clinical use at the earliest opportunity and benefit the vast number of patients suffering from CLI. Taking the launch of Seltoplasmid as an opportunity, we will continue to deepen our expertise in the cell and gene therapy arena, steadily expand our product pipeline, advance the development of more innovative drugs, and contribute to Healthy China.” 

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