SIMCERE PHARMA (02096.HK): RSV preventive biologic Yimule approved for marketing in China

NewTimeSpace News: On 3 September 2026, Simcere Pharmaceutical Group Limited (stock code: 02096) announced that Kulaiweibai injection (brand name: Yimule), a domestic Class 1 innovative biologic developed under strategic cooperation between the Group and Ruiyang (Shandong) Biopharmaceutical Co., Ltd., has been approved by the National Medical Products Administration (NMPA) for marketing in China, for use in neonates and infants with gestational age of no less than 35 weeks who are about to enter or are born during their first respiratory syncytial virus (RSV) season, for the prevention of lower respiratory tract infection caused by RSV (excluding children with chronic lung disease (CLD), including bronchopulmonary dysplasia (BPD), or clinically significant congenital respiratory tract abnormalities). The Group entered into a strategic cooperation with Ruiyang on 20 August 2026, obtaining exclusive commercialisation rights for Yimule in Greater China.

Kulaiweibai is a recombinant humanised IgG1κ monoclonal antibody that provides passive immunity mainly by targeting epitope II of the RSV F protein, with Fc engineering to extend the antibody half-life, offering sustained protection covering the entire RSV season to neonates and infants through a single intramuscular injection. Data from the pivotal Phase III study supporting this approval showed that, at 150 days after administration, Kulaiweibai demonstrated 85.32% protective efficacy against RSV-associated lower respiratory tract infection requiring medical intervention (outpatient, emergency or hospitalisation) and 83.27% protective efficacy against RSV-associated hospitalisation compared with placebo; at 240 days after administration, the two efficacy figures were 82.04% and 78.44% respectively. In addition, a Phase IIIb study in toddlers aged 1 to 2 years is ongoing to further expand the applicable age range.

Ruiyang (Shandong) Biopharmaceutical Co., Ltd. is principally engaged in the R&D and industrialisation of antibody-based biological macromolecular drugs, focusing on passive immunisation prevention and treatment in the infectious disease field, while also laying out innovative directions such as tumour immunology. Simcere Pharmaceutical is an innovation- and R&D-driven pharmaceutical company focusing on neuroscience, oncology, autoimmune diseases and anti-infection.

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