Sinovant Sciences is an innovative biopharmaceutical company based in Shanghai, Beijing and Hongkong. We are dedicated to creating unique value for the Chinese biopharma industry. 

Sinovant Sciences has a diverse pipeline of 11 therapeutic candidates in the areas of infectious diseases, oncology, and general medicine, including three late-stage therapeutics: lefamulin, vibegron, and derazantinib. In addition to the three registrational programs below, Sinovant Sciences is also exploring development of other indications and has the rights to eight other earlier-stage therapeutics targeting significant unmet needs in a broad range of therapeutic areas.


ANNOUNCEMENTS

  • Sinovant Sciences HK Limited announced today the submission of a New Drug Application (NDA) for Lefamulin for the treatment of patients with CABP in Taiwan
  • 2021-01-05
  • Jan 5, 2021 Sinovant Sciences HK Limited announced today the submission of a New Drug Application (NDA) for Lefamulin for the treatment of patients with community-acquired bacterial pneumonia (CABP) in Taiwan. The second NDA was submitted for this drug in Greater China by Sinovant. Lefamulin is the first human systematic drug in a new class of antibiotics, pleuromutilin. It is active against a wide spectrum of common pathogens found in the respiratory system (including gram-positive, gram-negative, and atypical pathogens). The results of in vitro experiments showed that Lefamulin has low propensity for development of bacterial resistance and cross-resistance due to the multiple binding sites on the bacterial ribosome. The efficacy and safety of lefamulin compared with the current standard of care, moxifloxacin was demonstrated in a total of 1,289 patients with CABP in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials. Lefamulin, including intravenous and tablet formulations, was approved for marketing by the U.S. Food and Drug Administration (FDA) in 2019 and by the European Medicines Agency (EMA) in 2020. These formulations offer the possibility of treating diseases in various settings, including hospital inpatient, outpatient, inpatient-to-outpatient settings, and community clinics, etc. and can better cope with the treatment needs caused by COVID-19. ...
  • Sinovant Sciences HK Limited today announced the submission of a New Drug Application (NDA) for Lefamulin in Hong Kong
  • 2021-01-04
  • Jan 4, 2021 Sinovant Sciences HK Limited today announced the submission of a New Drug Application (NDA) for Lefamulin for the treatment of patients with community-acquired bacterial pneumonia (CABP) to the Department of Health, Hong Kong (HK) Special Administrative Region, China. This is a significant milestone accomplished in this young company, with close collaboration from our partner Nabriva. Once approved, patients in HK will be able to receive a brand-new class of antibiotic treatment choice after their lower respiratory system being infected with bacteria commonly found in the communities outside of the hospital. It is an essential advance in the field of anti-bacteria, where many pathogens have already developed or in the process of developing resistance with the old classes of antibiotics. Having a new class of antibiotics what is convenient to use to treat CABP is especially important at the time of COVID-19. Lefamulin is developed in both IV and oral formulation, enabling patients to be treated in various settings including inpatient and outpatient hospital settings, inpatient-to-outpatient settings, and clinics, etc. Lefamulin is a first-in-class antibiotic for systemic administration in humans. The efficacy and safety of Lefamulin was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials against the current treatment standard moxifloxacin in a total of 1,289 patients with CABP. Lefamulin, including both intravenous and tablet formulations, has already been approved for marketing by the U.S. Food and Drug Agency in 2019 and by the European Medicines Agency (EMA) in 2020. We look forward to bringing this product to Hong Kong patients soon. ...