Everest Medicines Announces Commercial Launch and First Prescription for NEFECON® in Mainland China

SHANGHAI, May 14, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative medicines and vaccines, today announced that NEFECON^®, a delayed release capsule, has been successfully launched in China with the first prescription issued. The official launch of NEFECON^® marks the inception of enhanced patient care in mainland China, heralding a new era in the treatment of IgA nephropathy (IgAN).

China has the highest prevalence of primary glomerular diseases in the world, with IgAN accounting for about 35% to 50% of cases. Studies^[1] show that a majority of IgAN patients face the risk of progressing to end-stage renal disease during their lifetime, often requiring dialysis or kidney transplantation. There is a significant unmet medical for effective treatments for IgAN patients in China and across Asia. Present non-targeted therapies, such as renin-angiotensin system (RAS) inhibitors, fail to address the underlying disease progression.

"The commercialization of NEFECON^® in the Chinese market represents a significant milestone for Everest and a breakthrough for IgAN patients in China. NEFECON^® has undergone a 20-year research and development process, become the first non-oncology therapeutic to receive Breakthrough Therapy Designation in China by the China National Medical Products Administration (NMPA), and the first ever treatment for IgAN to receive full approval from the U.S. Food and Drug Administration (FDA). It is also the first approved medicine with an IgAN indication by the NMPA in China. On behalf of the company, I would like to extend my gratitude to all parties who have assisted in obtaining the approval for NEFECON^®'s market entry and clinical use in mainland China, especially the clinical investigators and the 62 Chinese patients who participated in the global Phase 3 clinical trials. With approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We will actively engage with all stakeholders to improve the accessibility and affordability of this innovative therapy for IgAN. Moreover, we will contribute to improving nephropathy diagnosis, treatment, and disease management, ultimately benefiting more patients. As we advance the commercialization of NEFECON^® in China and Asia, we will also actively promote the development of other innovative drugs in the nephropathy field, extending benefits to more patients."

"IgAN is the most common primary glomerular disease, and occurs at a young age with a high possibility to progress to end-stage renal disease. Compared to European and American populations, Chinese IgAN patients experience faster disease progression, poorer prognosis, and impose a heavy burden on patients and society. The full results of the NefIgArd study demonstrate that NEFECON^® can protect renal function, delay progression to dialysis or kidney transplantation, significantly reduce urinary protein and hematuria, It is also safe and well-tolerated," said Professor Zhang Hong with Peking University First Hospital, a member of the global steering committee for the Phase 3 clinical study NefIgArd. "Data analysis of the Chinese population shows that NEFECON^® reduces kidney function decline by 66%, and delays disease progression to dialysis or kidney transplantation by 12.8 years. The approval of NEFECON^® fills the gap in targeted therapy for IgAN in China, benefiting Chinese patients, improving disease prognosis, and providing clinicians with new treatment options.

"IgAN is highly prevalent in Asia and is one of the main causes of kidney failure in young adults in China. Among IgAN patients, the risk of progressing to end-stage renal disease in Asian populations is 56% higher compared to other populations, and the disease progresses more rapidly, which will impose a significant medical burden on patients, families, and society as a whole. Therefore, more proactive treatment is needed to intervene and control the risk of disease progression, delaying the need for dialysis or kidney transplantation. For a long time, this disease has lacked targeted treatment options, resulting in significant unmet clinical needs," said Professor Xie Jingyuan, Chief Physician of the Department of Nephrology, Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine. "NEFECON^®, as the world's first-in-disease therapy for IgAN, has treated over one hundred patients in total through its early-access program in Boao in April last year. During the follow-up period, NEFECON^® was found to be effective in stabilizing renal function, reducing proteinuria and hematuria, and was well tolerated by the patients. It is of great significance for NEFECON^® to be officially commercialized in mainland China, helping patients with IgAN to initiate the treatment as early as possible."

The latest analysis, presented at the World Congress of Nephrology 2024, provides further evidence that NEFECON^® may provide even greater benefit in delaying kidney function decline in Chinese patients with more rapidly progressing disease, without compromising patients' quality of life^[2]. Positive results from the global Open Label Extension (OLE) study based on the NefIgArd Phase 3 study validated the efficacy and safety of re-treatment with NEFECON^® independent of prior treatment cycles^[3], providing a solid scientific basis for future long-term maintenance regimens of NEFECON^®.

NEFECON® received approval from China NMPA in November 2023 for the treatment of primary IgAN in adults at risk of disease progression. Additionally, NEFECON® has been approved in in multiple countries and territories across Europe, U.S., and Asia.

Everest Medicines has been committed to improving the accessibility and affordability through innovative approaches to meet the unmet clinical needs of IgAN patients. The first prescription of NEFECON^® was issued through an internet hospital, enhancing speed and convenience of delivering medication to patients and improving their accessibility. As part of the pre-launch preparation, Everest initiated an early access program in the Hainan Boao pilot zone, with approximately 700 registered patients. Following the NDA approval of NEFECON® in Macau, a patient assistance program (PAP) was launched through a charity foundation to provide financial assistance to Chinese mainland patients who were prescribed NEFECON® in Macau, with approximately registered 400 patients. In addition, over 20,000 Chinese patients have registered in an IgAN patient program funded through a charity foundation. These initiatives highlight the urgent and unmet medical needs for NEFECON^® in IgAN patients, and provides a foundation for the rapid adoption in mainland China.

With the approval and commercial launch of NEFECON^® in mainland China, a PAP program will be established to provide partial financial assistance in mainland China.

About NEFECON^®

NEFECON^® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.

In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines 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 from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com. 

Forward-Looking Statements:

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. 

source: Everest Medicines