Zai Lab's first anti-infective new drug listing application was accepted by the National Medical Products Administration

On February 10, 2020, zaiding Pharmaceutical (NASDAQ Code: zlab) announced that the State Drug Administration has accepted its new drug marketing application of omadacycline toluene sulfonate for the treatment of community-acquired bacterial pneumonia (CaBP) and acute bacterial skin and skin structure infection (absssi) Dr Du Ying, founder and CEO of zaiding pharmaceutical, said: "the acceptance of the application for listing of new drugs means that we have taken another important step towards becoming a fully integrated biomedical company This is our third product listing application submitted to the State Drug Administration, and also our first anti infective new drug listing application, which shows our pipeline strength in the field of treatment beyond cancer Due to the increasingly serious problem of bacterial resistance, there is still a huge unmet demand in the field of anti infection in China, and patients need innovative antibiotics Dr Harald Reinhart, chief medical officer in the field of autoimmunity and anti infection of zaiding medicine, added: "olmacycline toluene sulfonate has broad-spectrum antibacterial activity and high activity against drug-resistant strains, which is suitable for the treatment of Chinese patients with CaBP and absssi Olmacycline toluenesulfonate has two dosage forms, i.e intravenous infusion and oral administration It can provide a sequential intravenous oral treatment scheme, which can help patients greatly reduce the number of days in hospital and reduce the risk of nosocomial infection At present, there is limited choice for the treatment of drug-resistant strains in China As an innovative antibiotic, olmecycline mesylate can solve the unmet medical needs Olmacycline toluene sulfonate was initially developed by paratek pharmaceuticals, a partner of zaiding pharmaceutical According to a comprehensive clinical study involving more than 2000 patients, the US Food and Drug Administration (FDA) approved its listing application for CaBP and absssi in October 2018 The State Food and drug administration has included olmacycline toluenesulfonate into a class of new drugs, which will be produced in China in the future.