Everest Medicines Receives Investigational New Drug Application Approval from China’s NMPA for EVER001, a Novel BTK Inhibitor in Development for the Treatment of Kidney Disease


Advancement highlights Everest’s potential in delivering world-class therapies to patients worldwide with glomerular disease

SHANGHAI, September 25, 2022 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest” or the “Company”), a biopharmaceutical company focused on developing and commercializing transformative pharmaceuticals to address critical unmet needs in Asia Pacific markets, today announced that the Drug Evaluation Center of China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for a phase 1b study of EVER001 (formerly known as XNW1011), a next-generation reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor in development for the treatment of glomerular diseases.

The planned phase 1b clinical study will evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of EVER001 in patients China with glomerular disease characterized by proteinuria, a common cause of chronic kidney disease. Under an exclusive license agreement with Sinovent Pharmaceuticals and SinoMab BioScience in September 2021, Everest holds the worldwide rights to develop, produce and commercialize EVER001 for the treatment of kidney disease. Based on a phase 1 study in healthy subjects China conducted by SinoMab, EVER001 showed high selectivity, excellent pharmacokinetic properties and a robust safety profile and target engagement.

“Advancing the clinical development of EVER001 for glomerular diseases represents one of the potentially first-class therapeutic opportunities that exist within Everest’s broad portfolio and highlights our long-term growth strategy to advance therapies innovative and high quality for the benefit of patients. around the world with unmet demand,” said Zhengying Zhu, Ph.D., chief medical officer of internal medicine at Everest Medicines. “Chronic kidney disease is a major global public health issue and will remain one of Everest Medicines’ primary areas of therapeutic focus. The launch of this phase 1b The clinical trial, alongside the pivotal development of Nefecon, our lead kidney disease asset, reinforces the company’s commitment to this area and we look forward to advancing these important potential therapies as quickly as possible. . »


EVER001 (formerly known as XNW1011) is a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor in global development for the treatment of kidney disease. BTK is an essential component of B cell receptor signaling pathways that regulate B cell survival, activation, proliferation and differentiation. Targeting BTK with small molecule inhibitors has been shown to be a effective treatment option for B-cell lymphomas and autoimmune diseases. Based in part on results of a completed Phase 1 study in healthy subjects conducted by SinoMab in ChinaEVER001 exhibited high selectivity, excellent pharmacokinetic properties, robust target engagement, and a safety profile that supports continued clinical development.

Under an exclusive license agreement with Sinovent Pharmaceuticals and SinoMab BioScience, Everest owns the worldwide rights to develop, produce and commercialize EVER001 for the treatment of kidney disease.

About drugs Everest

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address the critical unmet medical needs of patients in Asian markets. Everest Medicines’ management team has deep expertise and extensive experience in high quality clinical development, regulatory affairs, CMC, business development and operations in both China and with leading global pharmaceutical companies. Everest Medicines has built a pipeline of potentially world-first or best-in-class molecules, many of which are in late-stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune diseases, cardio-renal diseases and infectious diseases. For more information, please visit their website at www.everestmedicines.com.

Forward-looking statements:

This press release may contain statements that constitute forward-looking statements, including descriptions regarding the current intention, belief or expectations of the Company or its officers with respect to the Company’s business activities and financial condition. , which can be identified by terminology such as “will”, “expect”, “anticipate”, “future”, “intend”, “plan”, “believe”, “estimate”, ” trust” and similar statements. These forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the Company’s control and cannot be predicted. Therefore, actual results may differ from those in forward-looking statements due to various factors and assumptions, such as future changes and developments in our business, the competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives is under no obligation and does not undertake to revise any forward-looking statements to reflect new information, future events or circumstances after the date of this press release, except as required by law. .

SOURCE Everest Medicines


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