Northland Biotech's Innovative Gene Therapy Sedomin Injection (Huasueling®), China's First Treatment for Critical Limb Ischemia, Receives Market Approval

(Source:Northland）

2026YearMay 28,Beijing Northland Biotechnology Co., Ltd. (hereinafter referred to as"Northland"Stock Code:920047）Independently Developed Therapeutic Biological ProductsClass 1 Innovative Drug—Sedominji Injection (Brand Name: Huasuoling®) Officially Approved for Marketing by the National Medical Products AdministrationApprovedDocument No.:NMPA Approval No.S20260032. This drug is the first and currently only approved gene therapy drug for promoting angiogenesis in China, itsAdopting innovative"Therapeutic Angiogenesis" Strategy,for patients in China with severe lower limb ischemia who are unsuitable for revascularization surgery or have suboptimal surgical outcomes (CLI）providing patients with a novel treatment regimen, filling the gap in ChinaThe gap in etiological treatment for CLI in clinical practice.

Professor Zheng Yuehong, Director of the Department of Vascular Surgery at Peking Union Medical College Hospital, stated：“Led by Peking Union Medical College HospitalSedomin InjectionPhase III Clinical TrialThe success of the study validated the feasibility of therapeutic angiogenesis strategies.，The drug has demonstrated encouraging positive outcomes in promoting ulcer healing and reducing the risk of amputation, filling“Unresectable” CLI patients’ clinical treatment gap, providingAllNew Treatment Strategy. As a domestically developed gene therapy drug in China, the successful approval of Sedomingji Injection has injected new vitality into clinical practice.，for ChinaGlobalCLITherapeutic Areasgained significant influence.”

Mr. Xu Songshan, Chairman of the Board of Directors, stated:“The development of Sedominji Injection has taken 22This year, today's approval marks an important milestone in the company’s journey of innovative development. As the first approved in ChinaCLI Gene Therapy Drug: We have overcome a series of technical challenges, including gene transfection efficiency, localized precise drug delivery, and large-scale production, demonstrating Northland’s comprehensive technical capabilities in the field of bioengineered drug development.。We extend our gratitude to all employees who have contributed to the research and development of new drugs; we thank all research institutions, investigators, and subjects involved in the clinical trials; we appreciate the long-term supportTo Our Trusted Investors and Partners。The approval of Sedominji is not onlyNorthlandvictory, but also China'sPharmaceutical Industry Adheres toA Microcosm of Innovation and Challenging the Global Technological Frontier.We will make every effort to fully commercialize Sedominji.Preparation, strive toLet this innovationFacilitating the Early Clinical Application of the Product to Benefit the General PublicCLIPatients with the disease.We will take the market launch of Cedominji as an opportunity,Continue to Deepen CultivationCell and Gene Therapy Sector,Continuously enrich the product pipeline and promote the research and development of more innovative drugs,forHealthChina contributes its strength.”