On September 26, 2024, our company’s independently developed Class 1 therapeutic biological product—a new drug called Donaperminogene Seltoplasmid Injection, or “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” (code name NL003)—received the “Drug Registration Inspection Report” and the “Review Opinion on Drug Registration Inspection Standards” issued by the China National Institute for Food and Drug Control. The report stated: “This product, when tested according to the declared quality standards, has met all specified requirements.” This marks that both the bulk substance and the finished formulation of NL003 have successfully passed the pre-registration inspection, confirming that the product meets the required quality standards and bringing the new drug registration review one step closer to completion.

Drug registration testing is an important stage in the drug registration review process, and passing such testing is a prerequisite for obtaining a drug registration certificate. Based on applications submitted by drug registration applicants, the National Medical Products Administration conducts rigorous testing and evaluation of multiple aspects related to drug quality in accordance with statutory procedures, thereby ensuring the quality and safety of pharmaceutical products. NL003 has successfully passed the registration testing, indicating that it has established a production and quality control system compliant with GMP standards, with stable manufacturing processes and controllable quality.

NL003 is the first domestically developed naked plasmid-based gene therapy drug independently researched and developed by our company. It is a Class 1 innovative biologic product intended for the treatment of severe lower-limb ischemic disease. The Phase III clinical trial for NL003 is being conducted separately for two indications: ulcer and resting pain. The registration application for the ulcer indication was officially accepted in July 2024. The blinded study for the resting pain indication was officially unblinded in August 2024, and the primary results have met expectations. Our company is currently organizing statistical analyses and preparing the clinical trial summary report, and we will submit a new drug registration application within this year. In accordance with the requirements of the registration review process, our company will fully cooperate with the drug regulatory authorities to carry out on-site inspections and other related tasks. At the same time, we are actively preparing for commercialization to accelerate the launch of NL003.