China-based Frontier Biotechnologies Inc. (SHE: 200342) announced a strategic partnership with Asymchem Laboratories (Tianjin) Co., Ltd (SHE: 002821), a Contract Development and Manufacturing Organization (CDMO), to advance the development of FB2001, its COVID-19 3CL protease inhibitor. The collaboration covers R&D, manufacturing, regulatory filing, and production support for pivotal clinical trials.
Partnership Details
Asymchem will provide production capacity for FB2001’s Phase II/III trials. If approved, the partnership will expand to commercial manufacturing. The drug, administered via intravenous injection, is in global multi-center trials for hospitalized COVID-19 patients.
Drug Profile
FB2001 demonstrated high efficacy against SARS-CoV-2 variants (Alpha, Beta, Delta, Omicron) in prior studies. Frontier is also developing an aerosol version for post-exposure prophylaxis, currently in an Investigator-Initiated Trial (IIT) to assess efficacy and safety.-Fineline Info & Tech