China’s Betta Pharmaceuticals (SHE: 300558) has announced that a clinical trial filing for its Category 1 drug candidate BPI-452080 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of the drug, which is designed to treat advanced solid tumors.
BPI-452080 Profile
BPI-452080 is a new molecular entity (NME) and an oral small molecule hypoxia-inducible factor 2α (HIF-2α) inhibitor. Pre-clinical data has shown that BPI-452080 specifically blocks HIF-2α and HIF-1β heterodimerization, inhibiting the transcription and translation of downstream genes. This mechanism of action leads to the inhibition of tumor angiogenesis, cell proliferation, survival, and metastasis.
Preclinical Studies
Preclinical studies have demonstrated BPI-452080’s excellent in vitro activity and in vivo efficacy, along with good pharmacokinetic properties and safety profile. As of the disclosure date, only Belzutifan (Welireg, MK-6482, PT2977), another HIF-2α inhibitor, has been approved in the US for the treatment of von Hippel–Lindau (VHL) disease. The acceptance of BPI-452080 for review by the NMPA highlights Betta Pharmaceuticals’ commitment to advancing innovative cancer therapies.-Fineline Info & Tech
