MSD Announces NMPA Approval of Prevymis® (Letermovir) for Pediatric CMV Prevention in China

Shanghai, China,2025Year6Month23Day——MSD (the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, USA) announced its new non-nucleoside cytomegalovirus (CMV) inhibitor, Prevymis.^®(Prevymis) Two formulations – Prevymis tablets and Prevymis injection – have been approved by the National Medical Products Administration (NMPA) of China for pediatric patients aged 6 months and above and weighing ≥6kg.

      The full indication approved this time is for the prevention of cytomegalovirus (CMV) infection and cytomegalovirus disease in CMV seropositive adult recipients [R+] and pediatric recipients aged 6 months and above with a body weight ≥6kg who are undergoing allogeneic hematopoietic stem cell transplantation (HSCT). This marks the...^®(Letermovir) becomes the first and currently the only CMV prevention regimen available in China for adult and pediatric patients undergoing HSCT, offering a new precise infection control option for relevant pediatric patients.

      "As the world's first preventive treatment regimen for CMV in this field, Prevymis^®"(Letermovir) has brought a positive and profound impact on the prevention and control of cytomegalovirus in allogeneic hematopoietic stem cell transplantation since it was first approved for use in adult patients in China in 2022."Ms. Anna Tian, Senior Vice President of MSD Global and President of MSD ChinaSaid: "Receiving hematopoietic stem cell transplantation is a new hope for many children suffering from malignant blood diseases and their families. We are very pleased to see that with this approval, Prevymis^®(Letermovir) will have the opportunity to provide preventive treatment for cytomegalovirus in pediatric patients, safeguarding their health and lives."

      Cytomegalovirus (CMV) is a widespread herpesvirus that poses a serious threat to the health and lives of patients undergoing hematopoietic stem cell transplantation. Studies have shown that CMV infection and CMV disease directly contribute to an increase in transplant-related mortality.^[1]In China, human cytomegalovirus infection is very widespread, with an antibody positivity rate of 60%-80% during infancy and early childhood.^[2]Due to the immature immune system in children, there may be a higher risk of CMV reactivation after transplantation.^[3]According to statistics, there were a total of 39,918 HSCT recipients in 2022 and 2023, of which 9,860 were children, equivalent to one child patient for every four patients receiving hematopoietic stem cell transplantation.^[4]。

      "Children, as an important group receiving hematopoietic stem cell transplantation, urgently require attention to the prevention and control of CMV infection post-treatment."Dr. Zhengqing Li, Senior Vice President of MSD Global and President of MSD China Research and Development CenterSaid: "This time, MSD^®(Letermovir) Approved for Expanded Use in Pediatric Patients, Further Enriching Prevymis^®(Letermovir) in China has an indication portfolio that supports clinical needs for CMV prophylactic treatment across different age groups. MSD will continue to focus on addressing patients' medical needs, exploring more innovative treatment solutions in the anti-infective field to benefit more patients in China."

About MSD

      At MSD (the corporate name of Merck & Co., Inc. in the United States, located in Rahway, New Jersey), we work together to pursue a common goal: harnessing the power of cutting-edge science to save lives and improve quality of life around the world. For over 130 years, we have brought hope to humanity by developing important medicines and vaccines. We are committed to being a leading research-intensive biopharmaceutical company — today, we stand at the forefront of research and development, delivering innovative solutions to advance the prevention and treatment of diseases in both humans and animals. We have built a diverse and inclusive global workforce, operating responsibly every day to ensure a safe, sustainable, and healthy future for all people and communities. For more information, visit www.msd.com and follow us on X (formerly Twitter), LinkedIn, and YouTube.

About MSD China

      China is a crucial part of MSD's global growth strategy. MSD’s China headquarters is located in Shanghai, with a research and development center in Beijing and manufacturing facilities in Hangzhou, Ningbo, and Tianjin, integrating R&D, manufacturing, and commercial operations. We are fully committed to providing high-quality innovative medicines, vaccines, and services to the people of China, benefiting Chinese society. For more information, please visit MSD China's official website or follow MSD China's official social media account on WeChat. 

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      MSD is the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, USA (hereinafter referred to as "the Company"). This press release contains "forward-looking statements" made under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. The content herein is based on the current views and expectations of the Company’s management and is subject to significant risks and uncertainties. MSD does not guarantee that its investigational products will receive the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate, or risks or uncertainties arise, actual results may differ materially from those anticipated in the forward-looking statements.

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[1] Zakhour, J., Allaw, F., Haddad, S.F. et al. The Ten Most Common Questions on Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Patients. Clin Hematol Int 5, 21–28 (2023). https://doi.org/10.1007/s44228-022-00025-3

[2]Pediatric Infectious Diseases Group of Chinese Medical Association, National Pediatric Clinical Viral Infection Cooperative Group, Editorial Board of Chinese Journal of Pediatrics. Recommendations for the Diagnosis and Prevention of Cytomegalovirus Diseases in Children [J]. Chinese Journal of Pediatrics, 2012, 50(4): 290-292.

[3]Jin Runming, Xu Jiawei, Jiang Qiong. Advances in the Diagnosis and Treatment of Cytomegalovirus Infection after Allogeneic Hematopoietic Stem Cell Transplantation in Children[J]. Chinese Journal of Infection and Chemotherapy, July 20, 2023, Vol. 23, No. 4, pp. 524-530.

[4] Xu, LP., Lu, PH., Wu, DP. et al. Hematopoietic stem cell transplantation activity in China 2022–2023. The proportions of peripheral blood for stem cell source continue to grow: a report from the Chinese Blood and Marrow Transplantation Registry Group. Bone Marrow Transplant (2024). https://doi.org/10.1038/s41409-024-02419-8.