Merck's Prevymis® (Letermovir) Two Formulations Approved for Extended 200-Day Dosing Regimen in China
MSD
Pharmaceutical R&D and Manufacturer
Shanghai, China,2025Year 8Nov 11Day——MSD (the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, U.S.) announced its novel non-nucleoside cytomegalovirus (CMV) inhibitor, Prevymis.®(Prevymis) Two formulations – Prevymis tablets and Prevymis injection – have been approved by the China National Medical Products Administration (NMPA) for an additional 200-day dosing regimen, allowing continued use of Prevymis in adult patients at risk of delayed CMV infection and CMV disease.®(Letermovir) up to 200 days post-HSCT.
Purui Ming®(Letermovir) has been approved for the prevention of cytomegalovirus (CMV) infection and cytomegalovirus disease in CMV-seropositive adult recipients and pediatric recipients aged 6 months and above with a body weight ≥6kg who are undergoing allogeneic hematopoietic stem cell transplantation (HSCT) [R+]. Previously, the approved duration of continuous treatment for adult and pediatric patients was up to 100 days post-HSCT. The recent approval of the extended dosing regimen for adult patients will provide longer protection against CMV infection for adult patients at risk of late-onset CMV infection and CMV disease.
MSD Global Senior Vice President and MSD China President Tang Kaiyu (Kyle Tattle）Said: "We are very pleased to see that the approval of this extended dosing regimen for adult patients further optimizes PrEM.®The clinical practice of (Letermovir) will support clinicians in choosing a more personalized cytomegalovirus (CMV) prevention plan based on the actual needs of patients. We will continue to maintain close cooperation with all partners, committed to safeguarding patients' "journey without CMV" and protecting the hope for more lives."
Hematopoietic stem cell transplantation has become a highly promising treatment for various malignant hematological tumors. However, due to the impact of immunosuppressants, patients are at high risk of CMV infection after transplantation. CMV infection can not only cause severe CMV end-organ disease but may also lead to graft failure, graft-versus-host disease (GVHD), bacterial and fungal infections, and even life-threatening complications.[1]The highest risk period for CMV infection is usually the first 100 days after HSCT.[2]However, data show that 12% of adult patients who discontinued letermovir after 100 days post-HSCT still developed clinically significant CMV infections.[3]These patients who develop delayed CMV infection and CMV disease still have unmet medical needs in the management of CMV prevention.
"CMV infection is one of the main complications in HSCT recipients, which can directly lead to an increase in transplantation-related mortality."[4]"With the development of preventive CMV drugs, the management of CMV within 100 days post-transplant has become increasingly standardized, achieving clinically significant progress."Professor Hu Yu, President of the Hematology Society of the Chinese Medical Association and Director of the Institute of Hematology, Huazhong University of Science and TechnologyRepresents "Purui Ming®(The approval of the new 200-day usage of letermovir further fills the gap in CMV prevention after 100 days, providing crucial protection over a longer window of immune reconstitution for adult patients with late-onset CMV infection.)
Dr. Zhengqing Li, Senior Vice President of MSD Global and President of MSD China Research and Development CenterSaid: "This year, MSD®(Letermovir) has been successively approved for expanded use in pediatric patients and for extended prophylaxis in adult patients at risk of late-onset CMV infection post-HSCT, fully demonstrating our active response to patient needs in the field of cytomegalovirus (CMV) prevention. This also marks another significant advancement in our research and development in the anti-infective field. MSD will continue to be driven by innovative research and development, providing Chinese patients with more long-term and effective anti-infective solutions to meet the diverse needs of different patients."
Letermovir Tablets and Letermovir Injection have been included in the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2022)." Currently, they are restricted to adult recipients [R+] who are cytomegalovirus (CMV) seropositive and undergoing allogeneic hematopoietic stem cell transplantation (HSCT) for the prevention of cytomegalovirus infection and cytomegalovirus disease.
About MSD
At MSD (the corporate name of Merck & Co., Inc. in New Jersey, U.S.), we unite in pursuit of a shared mission: harnessing the power of leading-edge science to save and improve lives around the world. For over 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We are committed to being a top-tier research-intensive biopharmaceutical company — today, we stand at the forefront of innovation, delivering pioneering solutions to advance the prevention and treatment of diseases in humans and animals. We have built a diverse and inclusive global workforce that operates responsibly every day, ensuring 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 the people of China with high-quality innovative medicines, vaccines, and services for the benefit of Chinese society. For more information, please visit MSD China's official website or follow MSD China's official social media account on WeChat.
MSD Forward-Looking Statements
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 necessary 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.
Risks and uncertainties include, but are not limited to, general industry conditions and competition, general economic factors (including interest rate and currency fluctuations), the impact of pharmaceutical industry regulations and healthcare policies in the United States and other countries, global trends toward healthcare cost containment, technological advances, new products and patents attained by competitors, inherent challenges in new product development (including obtaining regulatory approval), MSD's ability to accurately predict future market conditions, difficulties or delays in production, instability in international economic and financial conditions and sovereign risks, reliance on the effectiveness of MSD's patent and other innovative product protections, and the risk of patent litigation and/or regulatory actions against the company.
MSD has no obligation to publicly update any forward-looking statements due to new information, future events, or other reasons. Other factors may cause actual results to materially differ from forward-looking statements; see MSD's 2024 Annual Report on Form 10-K and other documents filed with the U.S. Securities Exchange Commission (available at www.sec.gov).
[1]Wei Zhongling, Qian Xiaowen, Zhai Xiaowen. Research status of drug-resistant cytomegalovirus infection after hematopoietic stem cell transplantation [J]. International Journal of Blood Transfusion and Hematology, 2021, 44(6): 467-473. DOI: 10.3760/cma.j.cn511693-20210615-00126.
[2] Cytomegalovirus Infection Post-Allogeneic Stem Cell Transplantation: Experience from a Country with High Seropositivity
Iftikhar, Raheel et al.Transplantation and Cellular Therapy, Official Publication of the American Society for Transplantation and Cellular Therapy, Volume 29, Issue 8, 521.e1 – 521.e7
[3] Efficacy and safety of extended duration letermovir prophylaxis in recipients of haematopoietic stem-cell transplantation at risk of cytomegalovirus infection: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
[4] Azevedo LS, Pierrotti LC, Abdala E, Costa SF, Strabelli TM, Campos SV, Ramos JF, Latif AZ, Litvinov N, Maluf NZ, Caiaffa Filho HH, Pannuti CS, Lopes MH, Santos VA, Linardi Cda C, Yasuda MA, Marques HH. Cytomegalovirus infection in transplant recipients. Clinics (Sao Paulo). 2015 Jul;70(7):515-23. doi: 10.6061/clinics/2015(07)09. Epub 2015 Jul 1. PMID: 26222822; PMCID: PMC4496754.