MSD's Antifungal Drug Noxafil® Gains New Pediatric Indications in China to Address Invasive Fungal Infections
MSD
Pharmaceutical R&D and Manufacturer
Shanghai, China,2024Year12Month10Day——MSD (the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, USA) announced its antifungal drug Noxafil.®(Posaconazole Enteric-Coated Tablets, Posaconazole Injection) The new indications for these two formulations have been approved by the Center for Drug Evaluation of the China National Medical Products Administration, extending the prevention and treatment to pediatric patients, offering a safe and effective new treatment option for antifungal prophylaxis and treatment in children.
Among them, posaconazole enteric-coated tablets have been approved for the prevention of invasive aspergillosis and candidiasis in adult patients and pediatric patients aged ≥2 years with a body weight greater than 40kg who are at risk due to severe immunodeficiency, as well as for the treatment of invasive aspergillosis in patients aged ≥13 years.[1]；Posaconazole Injection has been approved for the prevention of invasive aspergillosis and candidiasis in adult and pediatric patients aged ≥2 years with severe immunodeficiency, and for the treatment of invasive aspergillosis in patients aged ≥13 years.[2]。
Invasive fungal infections pose a serious threat to patients' health and have become a global public health issue. In recent years, with the continuous increase in medical interventions, the widespread use of broad-spectrum antibiotics and glucocorticoids, as well as advancements in organ transplantation and catheterization techniques, the risk of fungal opportunistic infections has significantly increased, with children accounting for a considerable proportion.[3], especially in children undergoing hematopoietic stem cell transplantation who are in an immunosuppressed state, the incidence of invasive fungal infections can reach 25.3%.[4]. The overall mortality rate of fungal infections in children is relatively high.[3]The mortality rate of invasive mold disease in children is as high as about 50%.[5]Active antifungal prophylaxis can significantly reduce the incidence of invasive fungal infections and improve patient outcomes.[6],[7]。
"The clinical manifestations of invasive fungal infections in children are less specific and may only present as fever, which is difficult to distinguish from symptoms of other underlying diseases."[3]; The prognosis of infection is poor. Taking invasive pulmonary fungal infection (IPFI) as an example, the prognosis of IPFI in pediatric patients is worse than that of bacterial infections, with a higher mortality rate. Early diagnosis and treatment are key to improving the prognosis.[8]。”Professor Chen Jing from Shanghai Children's Medical Center, affiliated with Shanghai Jiao Tong University School of Medicine"The approval of posaconazole enteric-coated tablets and posaconazole injection for pediatric use will provide new options for the prevention and treatment of invasive aspergillosis in children, offering better protection for more young patients, especially given the limited therapeutic options available due to the unique nature of pediatric cases."
Anna Tian, Senior Vice President of MSD Global and President of MSD ChinaMSD said: "MSD has profound accumulation in the anti-infective field, with a complete product pipeline covering antifungal, antibacterial, and antiviral treatments. Nuokefei®Since its entry into China in 2013, it has become an important weapon in clinical combat against fungal infections. The recent approval of the pediatric indication is expected to further improve the diagnosis and treatment of invasive fungal infections in pediatric patients, bringing hope to more families."
"For the diagnosis and treatment of pediatric infections, the challenges faced by clinicians are often more severe."Dr. Li Zhengqing, Senior Vice President of MSD Global and President of MSD China R&D CenterSaid, "This approval further enriches Nuokefei®The combination of indications in China supports clinical needs for fungal treatment across different age groups. MSD will continue to focus on meeting patients' medical needs and explore more innovative treatment options in the anti-infective field."
Currently, Nokofei®Three formulations have been approved in China, including posaconazole oral suspension, posaconazole enteric-coated tablets, and posaconazole injection. All three formulations have been included in the "National Reimbursement Drug List for Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance (2023)."[9]。
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 through the development of vital medicines and vaccines. We are committed to being a leading research-intensive biopharmaceutical company—today, we stand at the forefront of innovation, delivering novel solutions to advance the prevention and treatment of diseases in 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 the MSD China official website or follow MSD China's official social media accounts on WeChat.
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MSD is the trade 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 products under development 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, the global trend toward controlling healthcare costs, technological advancements, new products and patents obtained 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, unstable international economic and financial conditions and sovereign risks, reliance on the effectiveness of MSD's patents 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 differ materially from the forward-looking statements. For more information, please refer to MSD's 2023 Annual Report on Form 10-K and other documents filed with the U.S. Securities Exchange Commission (available at www.sec.gov).
[1]Posaconazole Enteric-Coated Tablets Instructions
[2]Posaconazole Injection Instructions
[3]Li Yanbing, Xu Yingchun, Zhang Li. Non-negligible pediatric clarity fungal infections — Epidemiological status and diagnostic and treatment strategies[J]. Chinese Journal of Practical Pediatrics, 2024, 39(1): 2-6.
[4] Krzysztof Czyżewski , Jan Styczyński , Sebastian Giebel,et al. Age-dependent determinants of infectious complications profile in children and adults after hematopoietic cell transplantation: lesson from the nationwide study[J]. Ann Hematol. 2019 Sep;98(9):2197-2211.
[5] YeohDK，McMullanBJ，ClarkJE，et al. The challenge of diagnosing invasive pulmonary aspergillosis in children：a review of existing and emerging tools[J]． Mycopathologia， 2023， 188( 5)： 731- 743.
[6] Yan Li , Mingjuan Liu, Bing Zhai,et al. Primary antifungal prophylaxis: decrease of invasive fungal disease incidence and reduction of risk factors in haematological patients in a 5-year retrospective study[J]. Intern Med J. 2018 Jun;48(6):713-720.
[7] Lei Gao , Yuqian Sun , Fanyi Meng,et al. Antifungal prophylaxis of patients undergoing allogenetic hematopoietic stem cell transplantation in China: a multicenter prospective observational study[J]. J Hematol Oncol. 2016 Sep 23;9(1):97.
[8]Mu Faguang, He Hailan, Li Jing, et al. Analysis of Risk Factors for Invasive Pulmonary Fungal Infections in Children[J]. Chinese Journal of Contemporary Pediatrics, 2014, 16(8): 779-782.
[9]National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Directory (2023)