(Yicai) Sept. 3 -- Chinese regulators approved two domestically developed monoclonal antibody drugs for the prevention of respiratory syncytial virus infections in children today, ending the dominance of imported products in the market.

The Clulevibart injection, developed by Reyoung (Shandong) Biopharmaceutical, and the Retavibart injection, developed by Zhuhai Trinomab Pharmaceutical, have received the green light to go to market, the National Medical Products Administration said today. Both drugs are indicated for the prevention of RSV-related lower respiratory tract infections in newborns and infants.

RSV is one of the leading causes of respiratory infections among children under the age of five and can lead to bronchiolitis and pneumonia. In very young infants, infections can develop into more severe illness and in some cases may have long-term health consequences.

There are currently no RSV vaccines available globally. Instead, RSV prevention relies on monoclonal antibody drugs which directly provide people with antibodies. China had previously given the go-ahead to two imported RSV monoclonal antibodies, namely Nirsevimab, developed by the UK’s AstraZeneca and France’s Sanofi, and Clesrovimab, developed by the US’ Merck Sharp & Dohme.

The approval of the two domestic drugs is expected to intensify competition in China's RSV monoclonal antibody market. As these products are authorized as drugs rather than vaccines, however, their use requires a prescription from a clinical physician and their distribution and uptake differ from those of vaccines. As a result, the adoption of these drugs in China still has room for improvement.

A small number of regions in China have begun pilot programs for the use of RSV monoclonal antibodies in community health service centers but hospitals remain the primary points for administration in most parts of the country, Yicai has learned.

Editors: Dou Shicong, Kim Taylor