China's National Medical Products Administration (NMPA) has given approval to test Kynomycin, an antibiotic drug developed by researchers at the University of Hong Kong (HKU) in Mainland China.
Having received a Notice of Approval for Drug Clinical Trials from the NMPA, Kynomycin will be tested on human subjects.
Professor Li Xuechen led the team at HKU that developed a new type of cyclic lipopeptide category I drug with a new chemical structure.
The drug's patent is licensed to a pharmaceutical company in Mainland China by HKU’s Technology Transfer Office through Versitech, a subsidiary of the university.
Treatment options for complex skin and soft tissue infections (cSSTI) caused by bacteria have become limited, as these bacterial pathogens are clinically resistant.
The development of Kynomycin was intended to improve the efficacy and safety of cyclic lipopeptide antibiotics and offer a new choice for clinical treatment by targeting cSSTI.
After receiving approval for its initial trial, Kynomycin will undergo Phase I, II and III clinical studies.
Once all the studies are completed, the NMPA will assess and approve the drug prior to its production and marketing.
Li Xuechen’s research covers synthetic method development, biological studies and the discovery of drugs, with the aim of developing new therapeutics.
HKU’s Technology Transfer Office provides licencing, patenting and other commercialisation support to researchers and inventors at the university, as well as managing the use of HKU's intellectual property assets.
Last month, the NMPA approved a clinical trial application from AffaMed Therapeutics for Risuteganib (Luminate), an investigational medicinal product indicated for dry age-related macular degeneration.
Risuteganib is an integrin regulator that controls several pathways of oxidative stress response, such as mitochondrial dysfunction.
The drug is expected to become the first candidate for this indication to enter Phase III development in China.
The clinical trial will investigate Risuteganib's efficacy and safety.
