Breakthroughs in Renal Disease Innovation with EVER001

On December 4, Everest Medicines announced positive results in preliminary analysis of Phase 1b/2a clinical trial of EVER001, its next-generation, globally owned covalent reversible Bruton’s Tyrosine Kinase (BTK) inhibitor. The trial focuses on primary membranous nephropathy (pMN), a common pathological type of nephrotic syndrome in adults with significant unmet medical needs. The prevalence of pMN in China has been increasing, making it the second most common cause of nephrotic syndrome after IgA nephropathy (IgAN). Currently, there are approximately 2 million patients with pMN in China, 80,000 to 100,000 in the United States, 80,000 in Europe, and 40,000 in Japan，with incidence rates rising in recent years, reflecting its growing global disease burden.

Unlike traditional covalent irreversible BTK inhibitors, EVER001 employs a novel covalent reversible mechanism that combines strong target binding with excellent selectivity, significantly reducing off-target toxicity. Positive results in preliminary analysis revealed promising outcomes, with over 90% reductions in anti-PLA2R antibodies and substantial improvements in proteinuria. Additionally, patients in the low-dose cohort who have completed 36 weeks of treatment, 81.8% achieved overall clinical remission, and 91% achieved immunological complete remission. In the high dose cohort, 85.7% patients achieved overall clinical remission and all patients achieved immunological complete remission by week 24. With no currently approved treatments for pMN, EVER001 represents a potentially best-in-class therapeutic candidate. These results highlight EVER001’s potential to deliver best-in-class efficacy and safety, making it a promising treatment not only for pMN but also for a range of other autoimmune glomerular diseases, including lupus nephritis (LN), IgAN, Minimal Change Disease (MCD), and focal segmental glomerulosclerosis (FSGS).

With broad indication potential, rising disease prevalence, and Everest Medicines’ global rights, EVER001 represents a high-value asset in a “Blue Ocean” area with significant commercial potential. Kidney disease therapeutics have become a hotspot for innovation and investment in recent years, attracting major multinational pharmaceutical companies. For example, Vertex Pharmaceuticals acquired Alpine Immune Sciences this April for $4.9 billion to access its kidney autoimmune disease therapies. Similarly, Novartis acquired Chinook Therapeutics in June 2023 for $3.5 billion, gaining access to two late-stage treatments for rare, severe chronic kidney diseases.

Driving Commercial Success with a Dual-Engine Strategy

Everest Medicines continues to strengthen its leadership in nephrology with NEFECON(R), the first FDA-approved treatment for IgAN and the first etiological therapy for IgAN in China. Its inclusion in the 2024 National Reimbursement Drug List (NRDL) marks a significant milestone, enhancing patient accessibility and driving market penetration starting January 1, 2025. Since its commercial launch in May 2024, NEFECON(R) has generated RMB167 million in sales within its first month. The product is also approved in Macau, Hong Kong, Taiwan, South Korea, and Singapore, further cementing Everest’s expertise in nephrology.

Everest’s diversified portfolio also includes XERAVA(R) and VELSIPITY(R). XERAVA(R), a novel broad-spectrum antibiotic, demonstrated an overall effectiveness rate of 90.9% after three days of treatment in the "Comprehensive Evaluation Project on the Clinical Application of Eravacycline", contributing RMB134 million in revenue in H1 2024. VELSIPITY(R), approved under the "Hong Kong and Macau Medicine and Equipment Connect" policy, is now available in three designated medical institutions within the Greater Bay Area. It has also received approvals in Macau and Singapore, with an NDA accepted in Hong Kong and plans for an NDA submission in Mainland China by year-end.

Everest is accelerating innovation through its proprietary mRNA platform, a cornerstone of its long-term R&D strategy. In August 2024, Everest launched an Investigator-Initiated Clinical Trial for EVM16, a personalized mRNA cancer vaccine, at Peking University Cancer Hospital and Fudan University Cancer Hospital. The company is also advancing mRNA-based in vivo CAR-T programs for cancer and autoimmune diseases, expanding its pipeline’s potential.

As of now, Everest Medicines reached a 52-week high of HKD 49.7, closing at HKD 47.85. Since announcing its mid-year results, the stock price has more than doubled, reflecting strong investor confidence. With its dual-engine strategy, Everest has positioned itself as a rising leader in the global biopharmaceutical industry, focusing on unmet medical needs, particularly in renal diseases, and breakthrough therapies like EVER001. Supported by strong financial momentum and a clear vision, Everest is poised for sustainable growth and lasting value for patients and shareholders.