MSD：ENFLONSIA™Clesrovimab approved for marketing in China.

MSD’s Clesrovimab (MK-1654) has been approved in China today for the prevention of lower respiratory tract infections caused by respiratory syncytial virus (RSV) in neonates and infants who are about to enter or are born during their first RSV season. This long-acting monoclonal antibody, administered as a single fixed dose of 105 mg (regardless of body weight), provides rapid and durable protection throughout the entire RSV season.

In June 2025, Clesrovimab was first approved for marketing in the United States, becoming the first and only infant RSV prophylaxis regimen to use the same dose regardless of body weight. With this approval in China, it becomes the second RSV monoclonal antibody available in the country, following AstraZeneca/Sanofi’s Nirsevimab. In terms of pipeline development, domestic candidates — including TNM001 from Trinomab and RB0026 from Ruiyang Bio — have also entered the market review stage, signaling an accelerating pace of competition in the RSV prevention space.

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