Policy & Regulation
Everest Medicines' EVER001 Investigational New Drug Application receives Chinese regulatory approval
26 September 2022 -

Everest Medicines (HKEX 1952.HK), a China-based biopharmaceutical company, announced on Sunday that it has received approval from the China National Medical Products Administration (NMPA)'s Centre for Drug Evaluation for the Investigational New Drug (IND) application for a Phase 1b study of EVER001 (earlier called XNW1011).

EVER001 is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor, which is in development and which is intended to treat glomerular diseases.

The proposed Phase 1b clinical study is intended to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of EVER001 in patients in China with glomerular disease characterised by proteinuria.

According to a licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience formed in September 2021, Everest has the global rights to develop, produce and commercialise EVER001 for the treatment of renal diseases. It is claimed to have indicated high selectivity, excellent pharmacokinetics properties and safety profile and robust target engagement based on a phase one study in healthy subjects in China conducted by SinoMab.

Zhengying Zhu, Ph.D., chief medical officer for Internal Medicine at Everest Medicines, said, 'The advancement in clinical development of EVER001 for glomerular diseases represents one of the potentially first-in-class therapeutic opportunities that exist across Everest's broad pipeline and highlights our long-term growth strategy to advance innovative and high-quality therapies for the benefit of patients worldwide with unmet demand. Chronic kidney disease is a leading global public health problem and will remain as a top area of therapeutic focus for Everest Medicines. The initiation of this Phase 1b trial, alongside the pivotal-stage development of Nefecon, our lead asset in renal disease, strengthens the Company's commitment in this space and we look forward to progressing these important potential therapies as quickly as possible.'