Livzon Pharmaceutical Group Inc. was informed from the website of the National Medical Products Administration that the application for drug marketing authorisation submitted by Livzon MABPharm Inc., a controlling subsidiary of the Company, for the Tocilizumab Injection Atvtia was approved. The Company hereby announced the relevant details: Common name of the drug: Tocilizumab Injection; Trade name: Atvtia; Dosage form: Injection; Specification: 80 mg/4 ml; Application: Drug registration (domestic production); Category of registration: Therapeutic biological products; Applicant: Livzon MABPharm Inc. R&D OF THE DRUG AND RELEVANT DETAILS: Atvtia is a Tocilizumab injection developed on the basis of biosimilars with Tocilizumab (Actemra) of Roche as the reference drug. The application for registration for marketing was accepted in December 2021 (acceptance number: CXSS2101056 Guo).

The product is indicated for the treatment of rheumatoid arthritis. Atvtia is a recombinant humanised monoclonal antibody targeting interleukin-6 receptor (IL-6R) that specifically binds to soluble and membrane-binding IL-6 receptor (sIL-6R and mIL-6R) and inhibits signaling mediated by sIL-6R or mIL-6R. Through comprehensive quality similarity study, preclinical study, clinical pharmacokinetics comparison study, and clinical efficacy and safety comparison study, Atvtia has been well demonstrated to be highly similar in terms of quality, safety and efficacy to Actemra, the reference drug.

After approval for marketing, Atvtia could further benefit autoimmune patients in China. At present, Tocilizumab Injection has been included in the Diagnosis and Treatment Plan for Novel Coronavirus Infection (Tenth Edition for Trial Implementation) and the Diagnosis and Treatment Plan for Severe Cases of Novel Coronavirus Infection (Fourth Edition for Trial Implementation). It can be given a tryout for severe cases with significant increase in level of IL-6 in laboratory testing.