SIMCERE PHARMA (02096): YingmuLe has been approved by the National Medical Products Administration for in China.
Xiansheng Pharmaceutical (02096) announced that on September 3, 2026, the Group's strategic collaboration with Ruiyang (Shandong) Biopharmaceutical Co., Ltd. (Ruiyang Biologics) has resulted in the approval by the National Medical Products Administration (NMPA) in China for the domestic Class I biopharmaceutical Kulaiweibai monoclonal antibody injection (trade name: Yingmu Le) to be marketed in China. It is intended for newborns and infants born at gestational age 35 weeks who are about to enter or have just been born during the first respiratory syncytial virus (RSV) epidemic season, to prevent lower respiratory tract infections caused by RSV, excluding children with chronic lung disease (CLD), including bronchopulmonary dysplasia (BPD) or those with clinically significant congenital airway abnormalities.
SIMCERE PHARMA (02096) announced that on September 3, 2026, the groups strategic collaboration with Ruian (Shandong) Biopharmaceutical Co., Ltd. (Ruian Bio) has led to the approval of the domestically developed Class 1 biopharmaceutical, Clavibumab injection (brand name: Yingmule), by the National Medical Products Administration (NMPA) for marketing in China. This product is intended for newborns and infants 35 weeks gestational age who are about to enter or have just been born during the first Respiratory Syncytial Virus (RSV) epidemic season, to prevent lower respiratory tract infections caused by RSV, excluding children with Chronic Lung Disease (CLD), including Bronchopulmonary Dysplasia (BPD), or those with clinically significant congenital respiratory anomalies. On August 20, 2026, the group reached a strategic cooperation agreement with Ruian Bio, obtaining exclusive commercialization rights for Yingmule in the Greater China region.
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