NANJING, China – August 20, 2026 – Today, Simcere Pharmaceutical Group Limited (2096.HK) announced a strategic partnership with Reyoung (Shandong) Biopharmaceutical Co., Ltd. ("Reyoung Bio") for Clulevibart Injection, a domestically developed Category 1 biologic new drug. Under the agreement, Simcere will obtain exclusive commercialization rights for Clulevibart in Greater China. The New Drug Application (NDA) for Clulevibart has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) and has been granted priority review status. This collaboration will further enrich and strengthen Simcere’s portfolio in the anti-infection therapeutic area.
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections in infants and a primary pathogen for hospitalization due to bronchiolitis and pneumonia, posing a significant threat to children aged 0-2. It imposes a substantial disease burden on child health, families, and healthcare systems. Current pharmacological interventions for RSV primarily include symptomatic treatments for active infections and monoclonal antibody monoprophylaxis. China’s market for the prophylactic monoclonal antibodies remains dominated by imported products, underscoring the substantial clinical and public health value of novel therapies with greater accessibility.
Clulevibart is a fully human, half-life extended RSV monoclonal antibody developed by Reyoung Bio. It targets the RSV fusion (F) protein and incorporates half-life extension technology to prolong its duration of action in vivo. Designed to provide season-long protection against RSV with a single injection, the product aims to enhance convenience and compliance while potentially reducing the burden of RSV-related diseases on infants’ family and the healthcare system.
The NDA for Clulevibart has been accepted by the CDE and included in the priority review process. Concurrently, a Phase IIIb clinical study in infants and toddlers aged 1-2 years is underway to further expand the product’s eligible age range. Upon approval, Clulevibart is poised to become the first domestically produced long-acting RSV prophylactic monoclonal antibody in China. It will broaden preventive options for infants and improve accessibility to such therapies.
Mr. Gaobo Zhou, Chief Investment Officer of Simcere Pharmaceutical Group, stated, "We are delighted to partner with Reyoung Bio on this collaboration. Clulevibart is a domestically innovative biologic drug with differentiated clinical value, aligning strongly with Simcere’s strategic focus in the infectious diseases. By combining our respective strengths, we will actively advance the commercialization and market access of this product, making this innovative preventive option available to more infants and their families as soon as possible."
Dr. Xuelian Zhao, Chief Executive Officer of Reyoung Bio, commented, "Simcere is a key player in China’s innovative pharmaceutical landscape, with extensive product portfolio, commercialization expertise, and broad market coverage in the infectious disease field. We believe this deep collaboration will fully unlock the clinical and societal value of Clulevibart, enabling this homegrown innovation to reach infants and families in need rapidly and broadly, truly realizing the vision of 'Innovated in China, Accessible in China'."
About Simcere
Simcere Pharmaceutical Group Limited（2096.HK）is a pharmaceutical company driven by innovation and focusing on four therapeutic areas including Neuroscience, Oncology, Autoimmune Diseases and Infectious Disease. We proactively explore areas with significant unmet needs, and our mission is ‘For patients, for life’. Driven by our in-house R&D efforts and synergistic innovation, Simcere has established strategic cooperation partnerships with many innovative companies and research institutes. Learn more atwww.simcere.com.
About Reyoung Bio
Reyoung (Shandong) Biopharmaceutical Co., Ltd. specializes in the R&D and commercialization of antibody-based biologic drugs, with a core focus on passive immunization for prophylaxis and treatment of infectious diseases, alongside exploratory programs in tumor immunotherapy. Guided by its mission "nourishing life, warming families”, the company utilizes proprietary technology platforms and the identification and screening of rare elite samples to discover and develop first-in-class antibody drugs characterized by high specificity, high affinity, and broad-spectrum activity. Reyoung Bio is committed to delivering differentiated and innovative solutions for major diseases. For more information, please visit: www.reyoungbio.com