Therapy Areas: Respiratory
Nuance Pharma's MVA-BN RSV vaccine IND application receives Chinese regulatory approval for phase III clinical trial
14 November 2022 -

Nuance Pharma, a China-based biopharmaceutical company, announced on Sunday that it has received approval from the Center for Drug Evaluation (CDE) for the company's Investigational New Drug (IND) application supporting its pivotal phase III clinical trial of MVA-BN RSV vaccine against respiratory syncytial virus (RSV) in adults in mainland China.

The product is intended to prevent RSV in older adults. It includes five distinct RSV antigens to stimulate a wide immune response against both RSV subtypes (A and B), thus imitating the immune response observed subsequent to a natural response to an RSV infection. It is based on Bavarian Nordic's proven MVA-BN platform technology.

Dr Haijin Meng, Nuance Pharma CMO, stated that the firm is planning to carry out the pivotal Phase III study as an extension of the global MRCT in 2023.