Everest Medicines Receives Approval of Investigational New Drug Application from China NMPA for EVER001, a Novel BTK Inhibitor in Development for Treatment of Renal Diseases

Advancement highlights Everest’s potential in providing first-in-class therapies to global patients with glomerular disease

SHANGHAI, Sept. 26, 2022 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that the China National Medical Products Administration (NMPA)’s Center for Drug Evaluation has approved the Investigational New Drug (IND) application for a Phase 1b study of EVER001 (previously known as XNW1011), a next-generation covalent reversible 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 in China with glomerular disease characterized by proteinuria, a common cause of chronic kidney disease. Under an exclusive licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience in September 2021, Everest owns the global rights to develop, produce and commercialize EVER001 for the treatment of renal diseases. Based on a Phase 1 study in healthy subjects in China conducted by SinoMab, EVER001 exhibited high selectivity, excellent pharmacokinetics properties and safety profile as well as robust target engagement.

"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," said Zhengying Zhu, Ph.D., Chief Medical Officer for Internal Medicine at Everest Medicines. "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."

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

Under an exclusive licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience, Everest owns the global rights to develop, produce and commercialize EVER001 for the treatment of renal diseases.

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

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

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