On August 18, 2025, our company officially submitted supplementary data for Donaperminogene Seltoplasmid Injection—a novel gene therapy drug we have developed—for the indication of “treating ulcers caused by severe lower-limb ischemic disease (CLI),” as required by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This marks a key milestone in the regulatory review process for Donaperminogene Seltoplasmid Injection’s market launch.

In July 2024, our company submitted a New Drug Application (NDA) for Donaperminogene Seltoplasmid Injection. During the technical review phase, we simultaneously underwent on-site inspections of both clinical and manufacturing facilities. In April 2025, we received a “Notice of Supplementary Information” from the CDE. Senior company leaders attached great importance to this matter and mobilized the R&D, clinical, medical, regulatory, and quality teams to fully commit their efforts. We conducted a detailed analysis of each requirement outlined in the supplementary notice and made comprehensive arrangements accordingly. After more than three months of intensive effort and stringent quality control, we have now completed the preparation of the supplementary materials and formally submitted them within the deadline set by the CDE. The timely and high-quality submission of these supplementary materials fully demonstrates our company’s outstanding execution capabilities and the collaborative prowess of our cross-functional teams. Throughout the preparation of the supplementary materials, our company maintained close communication with the CDE. Under the expert guidance of the review panel, our R&D team further strengthened the scientific evidence supporting the new drug registration of Donaperminogene Seltoplasmid Injection and refined our quality management system covering the entire lifecycle of the drug. Moving forward, our company will continue to fully cooperate with the CDE’s review process and look forward to its early approval and market launch, thereby providing a new treatment option for patients suffering from severe lower-limb ischemic disease.

Donaperminogene Seltoplasmid Injection is a novel naked plasmid-based gene therapy drug that employs entirely new target and mechanism of action. Through a unique R&D design characterized by "local administration, local expression, and local efficacy," it achieves therapeutic angiogenesis while minimizing or completely avoiding the adverse reactions and potential risks associated with conventional gene therapies. In addition to traditional revascularization procedures, Donaperminogene Seltoplasmid Injection offers a new therapeutic option, filling the current clinical gap in CLI treatment where no effective therapeutic drugs are available. In particular, it provides a groundbreaking treatment approach for patients who have poor outcomes from surgical interventions, cannot undergo surgery, have limited expected benefits following surgery, or suffer from thromboangiitis obliterans.

Xu Songshan, Chairman of the company, stated: “With guidance from CDE experts and the concerted efforts of all our staff, we have now successfully submitted the supplementary documentation. This marks an important milestone in our company’s journey of new drug development and signifies that Donaperminogene Seltoplasmid Injection is one step closer to becoming the world’s first human-use naked plasmid gene therapy product. We are confident and eagerly anticipate Sedominji’s early approval, so that we can offer a new treatment option to CLI patients who have been eagerly awaiting such a breakthrough. Our company is currently making rapid progress in preparing for commercialization across all fronts— including market access strategies, supply chain assurance, patient support systems, and specialized medical education—to ensure that, once approved, the drug can be brought to market and sold as quickly as possible, providing patients with a safe and effective treatment. This will also enable us to achieve commercial operations for our company’s first biologic product, generating greater economic and social benefits, and rewarding our employees, shareholders, and society at large.”