Everest Medicines a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the supplemental New Drug Application for NEFECON® has been granted full approval by the China National Medical Products Administration (NMPA).

Everest Medicine是一家专注于创新疗法的发现、临床开发、生产和商业化的生物制药公司，今天宣布NEFECON®的补充新药申请已获得中国国家药品监督管理局（NMPA）的全面批准。

NEFECON® is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression, irrespective of proteinuria levels. This approval marks NEFECON® as the first and only etiological treatment for IgA nephropathy (IgAN) to receive full approval in China.

NEFECON® 适用于降低原发性免疫球蛋白A肾病（IgAN）成人患者因疾病进展导致的肾功能丧失风险，无论其蛋白尿水平如何。此次获批标志着 NEFECON® 成为中国首个且唯一获得完全批准的IgA肾病（IgAN）病因治疗药物。

NEFECON® was first approved in November 2023 through NMPA’s priority review for the treatment of primary IgAN in adults at risk of disease progression..

NEFECON® 于2023年11月通过NMPA的优先审评，首次获批用于治疗有疾病进展风险的成人原发性IgAN。

'The full approval of NEFECON® in China marks a significant milestone, providing a foundational first-line treatment for IgAN patients, regardless of proteinuria levels, and addressing critical unmet clinical needs. As the first and only etiological treatment for IgAN in China to receive full approval from the NMPA, this further reinforces NEFECON®’s proven clinical efficacy and safety, providing a solid foundation for treatment decision-making,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.

“NEFECON®在中国获得完全批准标志着一个重要的里程碑，为IgAN患者提供了基础的一线治疗，无论蛋白尿水平如何，满足了关键的未满足临床需求。作为中国首个且唯一获得NMPA完全批准的IgAN病因治疗药物，这进一步证明了NEFECON®经过验证的临床疗效和安全性，为治疗决策提供了坚实的基础，”云顶医药首席执行官罗永庆表示。

“With over 5 million IgAN patients and more than 100,000 new cases diagnosed annually in China, there is a substantial unmet medical need. This approval allows NEFECON® to play a critical role in reducing the loss of kidney function in IgAN patients. NEFECON® has been included in the National Reimbursement Drug List (NRDL) and is now reimbursed across 31 provinces and cities.

“中国有超过500万IgAN患者，每年新增病例超过10万，存在巨大的未满足医疗需求。此次获批使NEFECON®能够在减缓IgAN患者肾功能丧失方面发挥关键作用。NEFECON®已被纳入国家医保药品目录（NRDL），并已在全国31个省市实现报销。”

We remain committed to improving the accessibility and affordability of NEFECON® to benefit more IgAN patients.”.

我们仍然致力于提高NEFECON®的可及性和可负担性，以使更多的IgAN患者受益。”

The full approval by the NMPA is based on data from the global Phase 3 NefIgArd clinical trial. The global Phase 3 NefIgArd clinical trial was a randomized, double-blind, multicenter study that evaluated the efficacy and safety of NEFECON® at a once-daily dose of 16 mg, compared to placebo in adult patients with primary IgAN on optimized RASi therapy.

NMPA的全面批准是基于全球III期NefIgArd临床试验的数据。全球III期NefIgArd临床试验是一项随机、双盲、多中心研究，评估了NEFECON®每日一次16毫克剂量与安慰剂相比，在接受优化RASi治疗的成年原发性IgAN患者中的疗效和安全性。

In the global study, NEFECON® demonstrated a statistically significant and clinically relevant benefit compared to placebo in estimated glomerular filtration rate (eGFR) over the two-year period of 9-months of treatment with NEFECON® and 15-months of follow-up off drug. The reduction in urine protein creatinine ratio (UPCR) observed with NEFECON® treatment was also durable and the proportion of patients with microhematuria in the NEFECON® group declined.

在全球研究中，与安慰剂相比，NEFECON®在两年时间内（包括9个月的NEFECON®治疗和15个月的停药随访）在估算肾小球滤过率（eGFR）方面显示出具有统计学意义和临床相关性的益处。NEFECON®治疗所观察到的尿蛋白肌酐比值（UPCR）降低效果也具有持久性，同时NEFECON®组中出现镜下血尿的患者比例有所下降。

Results from Phase 3 clinical study NefIgArd 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..

中国人群的III期临床研究NefIgArd结果显示，NEFECON®可将肾功能下降减少66%，并将疾病进展为透析或肾移植的时间延缓12.8年。

As the first IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), NEFECON® has been approved across all Everest Medicines’ territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan, China, as well as Singapore and South Korea.

作为首款获得美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）完全批准的IgAN病因治疗药物，NEFECON®已在所有Everest Medicines的领域内获得批准，包括中国大陆、香港特别行政区、澳门特别行政区、台湾、中国，以及新加坡和韩国。

It is now commercially available in mainland China, Hong Kong, Macau, and Singapore, with anticipated launches in Taiwan, China and South Korea later this year, benefiting IgAN patients in all authorized regions..

目前它已在中国大陆、香港、澳门和新加坡上市销售，预计在今年晚些时候将在中国台湾和韩国推出，造福所有授权地区内的IgAN患者。

About NEFECON®

关于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.

NEFECON® 是一种获得专利的口服布地奈德缓释制剂，布地奈德是一种具有强效糖皮质激素活性和较弱盐皮质激素活性的皮质类固醇，会经历显著的首过代谢。该制剂设计为缓释胶囊，带有肠溶包衣，使其在到达回肠末端释放布地奈德之前保持完整。

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..

每个胶囊含有布地奈德的包衣微丸，根据主要的发病机制模型，这些微丸靶向作用于疾病起源的回肠中存在的黏膜B细胞。

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

2019年6月，云顶新耀与Calliditas Therapeutics签订了独家的、基于特许权使用费的许可协议，该协议授予云顶新耀在中国大陆、香港、澳门、台湾和新加坡开发和商业化NEFECON®的独家权利。2022年3月，该协议扩展至包括韩国作为云顶新耀领域的一部分。

About Everest Medicines

关于 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是一家生物制药公司，专注于发现、开发、生产和商业化能够满足亚洲市场患者关键未满足医疗需求的变革性医药产品和疫苗。Everest Medicines的管理团队在高质量药物发现、临床开发、法规事务、CMC（化学、制造和控制）、业务发展及运营方面，拥有来自全球领先制药公司和中国本地制药公司的深厚专业知识和丰富成功经验。

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..

云顶新耀在其核心治疗领域——肾病、传染病和自身免疫性疾病，建立了潜在的全球首创或最佳分子组合。欲了解更多信息，请访问其网站 www.everestmedicines.com。