AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody (mAb), has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season. With the first approved preventive option for RSV, AstraZeneca and Sanofi will dominate the market in China, says GlobalData, a leading data and analytics company.

In 2017, Sanofi entered into a collaboration agreement with MedImmune, LLC (AstraZeneca plc) to jointly develop and commercialize Beyfortus, for the prevention of RSV in newborns and infants.

The approval by the National Medical Products Administration (NMPA) is based on data from Phase IIb, Phase II/III (MEDLEY) and Phase III (MELODY) trials. In the MEDLEY trial, the safety profile of Beyfortus was similar to that of Synagis (palivizumab), a mAb which has been approved for RSV prophylaxis since the 1990s in markets outside of China. Moreover, Beyfortus has the advantage of an extended half-life, which means that a single dose of Beyfortus can provide protection for an entire RSV season (approximately five months) while Synagis needs to be administered monthly.

Nelluri Geetha, Pharma Analyst at GlobalData, comments: “RSV infection is a leading cause of viral lower respiratory tract infections, with a higher rate seen in children than in adults. RSV infection occurs most commonly in children below six months of age in China. Beyfortus is the first approved drug for RSV in a broad infant population, which includes healthy term, late preterm and preterm infants, as well as infants with specific health conditions that make them vulnerable to severe RSV disease. Hence, the approval addresses an urgent need for novel prophylactic treatment options for the pediatric population in China.”

GlobalData’s Respiratory Syncytial Virus (RSV) Forecast in Asia-Pacific Markets to 2028 reveals that Urban China will lead the Asia-Pacific (five growth markets*) market for RSV in 2028, accounting for 34.8% of the overall market size.

Geetha concludes: “Beyfortus is the only preventive option for RSV in the infant population meaning that the drug will continue to dominate the Chinese market in the near future. However, competition may intensify over the long-term as other drugs are in late-stage development for the pediatric population in this market. These include Merck & Co’s clesrovimab and Zhuhai Trinomab Biotechnology’s TNM-001 in Phase III development. These are mAbs in Phase III development for the prevention of RSV among pediatric patients.”

*Asia-Pacific (Five growth markets) countries — India, Urban China, Australia, South Korea, and Japan.