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Everest Medicines宣布批准NEFECON®用于IgA肾病治疗

Everest Medicines Announces Approval of NEFECON® for IgA Nephropathy Treatment

PHARMA FOCUS ASIA 等信源发布 2024-11-29 19:31

可切换为仅中文


Everest Medicines today announced NEFECON®'s inclusion in China's National Reimbursement Drug List (NRDL) effective from 1 January 2025.NEFECON® is a patented, oral, delayed-release formulation of budesonide, a corticosteroid specifically designed to target the distal ileum, where the disease is believed to originate.NEFECON®, the world's first approved treatment for IgA nephropathy, addresses a significant unmet medical need in China, with an estimated 5 million patients and over 100,000 new diagnoses annually.

珠穆朗玛峰药品公司今天宣布,自2025年1月1日起,NEFECON®被纳入中国国家报销药物清单(NRDL)。NEFECON®是布地奈德的专利口服缓释制剂,布地奈德是一种专门针对回肠远端的皮质类固醇,据信该疾病起源于回肠远端。NEFECON®是世界上第一个获得批准的IgA肾病治疗方法,它解决了中国尚未满足的重大医疗需求,估计每年有500万患者和超过100000例新诊断。

Inclusion in the NRDL is expected to improve patient access to this novel treatment.'NEFECON®'s inclusion in the NRDL recognises its value in improving patient care for IgA nephropathy,' said Everest Medicines' CEO, Rogers Yongqing Luo. The company will collaborate with government departments to ensure effective implementation of medical insurance policies for the benefit of Chinese IgAN patients.IgA nephropathy is a prevalent kidney disease in China, particularly impacting young adults, with faster progression and poorer prognosis compared to Western populations.

纳入NRDL有望改善患者获得这种新型治疗的机会。”Everest Medicines首席执行官罗杰斯·永清(Rogers Yongqing Luo)说,NEFECON®被纳入NRDL认可了其在改善IgA肾病患者护理方面的价值。该公司将与政府部门合作,确保有效实施医疗保险政策,造福中国IgAN患者。IgA肾病是中国普遍存在的肾脏疾病,尤其影响年轻人,与西方人群相比,进展更快,预后较差。

As the first approved etiological treatment in China, NEFECON® has already demonstrably benefited patients.Results from the Phase 3 NefIgArd clinical trial in China showed a 66% reduction in kidney function decline and a projected delay of 12.8 years in disease progression to dialysis or transplantation.

作为中国第一个获得批准的病因治疗,NEFECON®已明显使患者受益。中国NefIgArd 3期临床试验的结果显示,肾功能下降减少66%,预计疾病进展至透析或移植的延迟时间为12.8年。

NEFECON®'s innovative mechanism of action and clinical benefits have led to its recommendation in multiple treatment guidelines, solidifying its position as a first-line therapy for IgAN.NEFECON® has been available in mainland China since May 2024. It is also approved in Macau, Hong Kong, Taiwan, South Korea, and Singapore under the trade name Nefegan®.Originally approved by the US FDA in December 202.

NEFECON®的创新作用机制和临床益处已导致其在多种治疗指南中的推荐,巩固了其作为IgAN一线治疗的地位。自2024年5月以来,NEFECON®已在中国大陆上市。它还在澳门、香港、台湾、韩国和新加坡以商品名Nefegan®获得批准。最初由美国FDA于202年12月批准。