China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its COVID-19 treatment candidate, CX2101A. This marks a significant step forward in the development of new therapeutic options for COVID-19 in China.
CX2101A Technology and Development
CX2101A is a small molecule RNA-dependent RNA polymerase (RdRp) inhibitor that features the latest prodrug technology, BEPro. Previous studies have shown that this technology effectively improves oral availability and pharmacokinetics. Double-Crane Pharma obtained exclusive development, manufacturing, and commercialization rights to CX2101A through a licensing deal with US firm Ligand Pharmaceuticals Inc. in May of this year.
Market Context and Competition
The approval comes as several other COVID-19 therapies are already commercially available in China. Pfizer’s 3CLpro inhibitor Paxlovid (nirmatrelvir + ritonavir) and Genuine Bio’s RdRp inhibitor azvudine are both oral treatments for COVID-19. Additionally, several Chinese pharmaceutical companies, including Junshi Bio, Kintor Pharma, Simcere Pharma, Frontier Bio, Zhongsheng Pharma, Cosunter Pharma, Ascletis Pharma, Everest Medicines, Kexing Pharma, and Zelgen Biopharma, are actively developing similar products. This competitive landscape underscores the importance of CX2101A’s clinical progress.-Fineline Info & Tech