Table 1 Definitions and classifications of Category 1 innovative drugs in China

Category 1 chemical drugs

Innovative drugs that have not been marketed domestically or internationally. These drugs contain new, structurally defined compounds with pharmacological activity and clinical value.¹⁶

Category 1 preventive biological products (vaccines)

Vaccines that have not been marketed domestically or internationally.¹⁷

1.1 Vaccines for diseases with no effective preventive measures.

1.2 Vaccines developed from new antigen forms based on existing marketed vaccines.

1.3 Vaccines containing new adjuvants or novel adjuvant systems.

1.4 Multivalent or combined vaccines containing new antigens or new antigenic forms.¹⁷

Category 1 therapeutic biological products

Therapeutic biological products that have not been marketed domestically or internationally.¹⁷

Category 1 traditional Chinese medicines (TCMs)

New TCM formulations not included in the National Drug Standards, Drug Registration Standards, or the “Ancient Classical Formula Directory” issued by national TCM authorities. These formulations must have clinical value and not be marketed internationally.¹⁸

1.1 TCM compound formulations.

1.2 Extracts and their preparations derived from single substances such as plants, animals, or minerals.

1.3 New medicinal materials and their preparations.¹⁸