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.
BeiGene Sees Expanded Coverage on China's National Reimbursement Drug List
Airsupra Approved in the US for Asthma
Amylyx Pharmaceuticals signs exclusive AMX0035 sistribution agreement with Neopharm
AstraZeneca's Tezspire approved for self-administration in the EU in a new pre-filled pen
Cambrian BioPharma launches Isterian Biotech
CF Foundation Invests Up to USD 15m in ReCode Therapeutics for Development of mRNA Therapy
Inogen Achieves Regulatory Milestones to Support Current and Future Products