“The Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” (Code: NL003) is an innovative gene therapy drug independently developed by our company. Its active ingredient consists of a DNA naked plasmid composed of the target gene for hepatocyte growth factor, which simultaneously expresses two isoforms, and a self-built gene vector. This substance was granted an International Nonproprietary Name (INN) by the WHO in 2017, and its generic name has been included in the 78th edition of the Drug Information Directory. The English generic name is “donaperminogene seltoplasmid,” and the Chinese generic name is “Sedomingji.”

The International Nonproprietary Name (INN), or the English Common Name, is the internationally recognized generic name for a drug established by the World Health Organization (WHO). It is a unique name—accepted worldwide—that the WHO, in collaboration with national nomenclature committees, assigns to each active substance marketed as a pharmaceutical product. In contrast, the Generic Name of a drug is a name formulated by the National Pharmacopoeia Committee according to specific principles; it is the legally recognized name for the drug. The key feature of the Generic Name is its universality: each drug has only one generic name, making it a unique, globally accepted, and publicly owned designation—the very definition of an INN.

In China, innovative drugs can have three types of names: the International Nonproprietary Name (INN)—the English generic name; the Chinese generic name; and the brand name. The INN of a drug’s active ingredient is a prerequisite for obtaining the drug’s generic name, while the drug’s generic name is a prerequisite for its brand name. All drugs have a generic name, but not every drug has a brand name. The “Measures for Drug Registration Management” explicitly stipulate that, with the exception of new chemical entities, new biological products, and drugs protected by compound patents, all other drugs—including active pharmaceutical ingredients, traditional Chinese medicines, and generic drugs—may not use brand names.

As an innovative drug, NL003 is classified as a Class 1 biological product for therapeutic use under China’s drug registration system. Its intended indication is the treatment of severe lower-limb ischemic disease, and it is currently undergoing Phase III clinical trials. This project has received major scientific and technological support under the national “11th Five-Year Plan,” “12th Five-Year Plan,” and “Major New Drug Development” programs, and it possesses independent intellectual property rights. NL003 has now been assigned an International Nonproprietary Name (INN) for its active substance, which will facilitate global sales and promotion after the drug’s market launch and help establish an independent brand for both the company and the product. The company is fully committed to accelerating the R&D and industrialization of the NL003 project, building a nationally recognized innovative brand, and making further contributions to the development of China’s pharmaceutical industry.