Leveraging our expertise in protein bioengineering, manufacturing capabilities, and in-house manufacturing facility, we are developing Fc-fusion protein molecules and biosimilars.
Our most advanced program is SCB-808 an Enbrel (etanercept) biosimilar in a ready-for-injection, pre-filled syringe formulation. Enbrel is indicated for the treatment of rheumatic diseases. We are conducting a pivotal Phase 3 clinical trial for SCB-808 in China, expect to submit an NDA to the NMPA in 2022, and commence commercialization thereafter, if approved.
In addition, we expect to initiate Phase 1 clinical trials in 2021 for SCB-420, an Eylea (aflibercept) biosimilar indicated for the treatment of certain large market ophthalmologic diseases, including wAMD, and SCB-219, a novel TPO-mimetic Fc-fusion protein being developed for chemotherapy-induced thrombocytopenia (CIT) and immune thrombocytopenic purpura (ITP).