On November 23, 2021, Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA), approved the New Drug Application (NDA) of the oral tablet and intravenous injection of Lefamulin produced by  Sumitomo Pharma (Suzhou) Co., Ltd.(Suzhou) Co., Ltd. (hereinafter referred to as "Sumitomo Pharma (Suzhou) Co., Ltd.") for the treatment of community-acquired pneumonia (CAP).

Lefamulin, belonging to a class of antibacterial drugs called pleuromutilins and developed by Nabriva Therapeutics Ireland Designated Activity Company (headquartered in Dublin, Ireland), has a mechanism of action that differs from those of existing antibiotics. Resistance and cross-resistance are less likely to be developed to the new anti-infective drug Lefamulin. The drug has been approved by U.S. Food and Drug Administration (FDA), Health Canada and European Medicines Agency (EMA) for the treatment of community-acquired bacterial pneumonia in adults, and is currently marketed under the name "XENLETA" in the United States. Lefamulin is one of four new products announced by Sumitomo Pharma (Suzhou) Co., Ltd. in May 2021 with exclusive development and sales rights in mainland China, Hong Kong, China and Taiwan, China.

Since the introduction of the first anti-infective product meropenem for injection (trade name: Mepem^®) in the 1990s,  Sumitomo Pharma (Suzhou) Co., Ltd.has been focusing on developing anti-infectives as one of its main areas of effort. At the same time, bacterial resistance is a growing problem in clinical anti-infective therapy. As a multinational pharmaceutical company with its roots in China, Sumitomo Pharma (Suzhou) Co., Ltd. has been actively seeking additional, better and more accessible health solutions for Chinese patients with a "patient-oriented" mission. We expect that this new antibiotic with a different mechanism of action will facilitate the empirical monotherapy of patients with CAP in China and confer more clinical benefits.

About Nabriva Therapeutics Plc:

Nabriva is a biopharmaceutical company dedicated to the development and commercialization of innovative anti-infective drugs for the treatment of severe infections.

About Community-acquired Pneumonia (CAP):

Community-acquired pneumonia (CAP) is a common infectious disease with an annual incidence rate of 7.13 per 1,000 people in China. This incidence rate gradually increases with age in adults, reaching 14.98 per 1,000 people in the elderly population aged 80 years and over [1]. Despite significant advances in medical technology, the mortality rate of CAP remains high. According to World Health Organization (WHO), CAP is the 4th deadliest disease and the first deadliest infectious disease [2]. Many Chinese CAP patients are elderly with combined underlying diseases. In many existing empirical treatments, common CAP-related pathogenic bacteria have developed resistance to antibiotics with irreversible safety risk. Therefore, new antimicrobial drugs with unique mechanisms of action, antimicrobial spectrum covering common CAP pathogens, good clinical efficacy, acceptable safety, and both intravenous and oral dosage forms are urgently needed in clinical practice.

About Mepem^® (Meropenem):

Developed by the parent company of Sumitomo Pharma (Suzhou) Co., Ltd., meropenem is the first carbapenem antibiotic in the world that can be administered alone. Meropenem maintains potent and broad-spectrum antimicrobial activity with reliable efficacy and significantly improved safety in the central nervous system and kidney compared with its earlier counterparts. Meropenem has been used in China since 1999, and after years of clinical application, it has become one of the important drugs for the treatment of severe infections in China.

About Sumitomo Pharma (Suzhou) Co., Ltd.:

Since its establishment in China in the 1990s,  Sumitomo Pharma (Suzhou) Co., Ltd.has developed China as one of its key market operating bases. The company has introduced advanced international manufacturing technologies to China and has provided high-quality products and pharmaceutical solutions in the fields of central nervous system disorders,  infection prevention, cardiovascular diseases and digestive diseases, benefiting numerous patients over the years. At the same time, the company also actively participates in various social welfare projects and fully supports the further development of health care in China. Sumitomo Pharma (Suzhou) Co., Ltd. adheres to its corporate mission of "Based in China, we will continue to create and contribute new value to human health and happiness", and will continue to provide high-quality pharmaceutical products with a "patient-oriented" mission to contribute to the long-term development of China's medical industry.

[Declarations]

1. The information in this document is for reference only. Please follow the advice or guidance of your physician or other health care professional.

2. The purpose of this article is to transmit frontier information and research progress in medicine, and does not constitute commercial promotion of any drugs or recommendation of treatment plans.

3. If you want to know more about the disease or need information about drugs and treatment, please consult a health care professional.

4. Please refer to the product specifications for the drug products mentioned in this article.

[References]

[1] Sun Y, Li H, Pei Z, et al. Incidence of community-acquired pneumonia in urban China: A national population-based study [J]. Vaccine, 2020, 38 (52): 8362-8370.

[2] Chen L, Han X, Li Y, et al. [Incidence and risk factors for cardiovascular events in patients hospitalized with community-acquired pneumonia] [J]. Chinese Journal of Cardiology, 2020 (03): 228-229-230-231-232-233-234-235.

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