2026-09-03
Kuleweibai Monoclonal Antibody Injection (brand name: Yingmule), for which Beijing Huayao Kechuang Pharmaceutical Technology Development Co., Ltd. (hereinafter referred to as Huayao Kechuang) provided Phase I‑III clinical trial technical services and biological sample testing services, has today been officially approved for marketing via the priority review and approval pathway by the National Medical Products Administration.
Leveraging its technical strengths, Huayao Kechuang has been deeply involved in the full‑chain work including medical protocol design, study site operation, medical management, data statistical analysis and biological sample testing since undertaking this project in 2022. Rooted in the pharmaceutical R&D service sector, we accelerate innovative drug launch with professional technical capabilities and high‑quality services.
Kuleweibai monoclonal antibody is a fully‑human long‑acting monoclonal antibody targeting the F‑protein of Respiratory Syncytial Virus (RSV). It is approved for neonates and infants with a gestational age of ≥35 weeks who are about to enter or are born during their first RSV season, for the prevention of RSV‑caused lower respiratory tract infection (not applicable to children suffering from chronic lung disease (CLD), bronchopulmonary dysplasia (BPD), or children with clinically significant congenital respiratory tract abnormalities). Optimized for extended half‑life, this product delivers sustained protection throughout the entire RSV season with a single injection, marking a major breakthrough in passive immunization against RSV for infants and young children in China.

