Shanghai, China — April. 26, 2024 — Everest Medicines’ (HKEX 1952.HK, “Everest”, or the "Company”) partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study across endpoints of urine protein to creatinine ration (UPCR) and estimated glomerular filtration rate (eGFR) at 9 months across all IgAN patients, including those who had previously received Nefecon® in the NefIgArd study.

“The positive results of the global OLE study to the Phase 3 NefIgArd study further confirms that Nefecon® is the disease-modifying treatment for patients with IgAN. These topline results also support the study thesis that the response to retreatment with Nefecon® was unaffected by previous treatment cycles, providing a solid scientific foundation for the potential long-term maintenance treatment，”said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.“ The Asian population has high prevalence of IgAN, and Nefecon® is the world's first-in-disease therapy which targets the origin of the disease. Following its NDA approval in mainland China, Macau, China and Singapore, we now look forward to Nefecon’s imminent commercial launch to make the drug available to 5 million IgAN patients in China to meet their urgent clinical needs.”

NefIgArd was a global, Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of Nefecon® 16 mg once daily vs placebo in adult patients with primary IgAN as an addition to optimized RASi therapy. Patients were randomized 1:1 to receive 16 mg/day of Nefecon® or matching placebo for 9 months, followed by a 15-month observational follow-up period without the study drug. The NefIgArd study achieved both its primary and key secondary endpoints and was the basis for full approval by the FDA in December 2023. The full data set was published in The The Lancet.

The OLE study was designed to provide 9 months of treatment with Nefecon® for all patients who completed the NefIgArd study and who at that time had > 1g/g of proteinuria over 24h and>30 ml/min of eGFR. All enrolled OLE patients continued on optimized RAS inhibitor therapy (ACEs and/or ARBs) and were treated for 9 months with Nefecon® 16mg per day, with a follow-up visit three months after completion of treatment. Primary assessment was based on UPCR and eGFR at 9 months. A total of 119 patients were enrolled, of whom 45 had previously had active treatment.

Topline data from the OLE study showed that the treatment response was consistent with the NefIgArd study’s findings regarding the endpoints of UPCR and eGFR at nine months across all patients, irrespective of whether they had previously been treated with Nefecon® or with placebo. The safety data after 9 months of treatment or retreatment with Nefecon® in patients who completed the NefIgArd study were consistent with previously reported safety data.

“The positive results of the global OLE study to the Phase 3 NefIgArd study further confirms that Nefecon® is the disease-modifying treatment for patients with IgAN. These topline results also support the study thesis that the response to retreatment with Nefecon® was unaffected by previous treatment cycles, providing a solid scientific foundation for the potential long-term maintenance treatment，”said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.“ The Asian population has high prevalence of IgAN, and Nefecon® is the world's first-in-disease therapy which targets the origin of the disease. Following its NDA approval in mainland China, Macau, China and Singapore, we now look forward to Nefecon’s imminent commercial launch to make the drug available to 5 million IgAN patients in China to meet their urgent clinical needs.”

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.

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