Everest Medicines a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the Department of Health of the Government of the Hong Kong Special Administrative Region, China, has officially approved the New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC)..

Everest Medicines是一家专注于发现、临床开发、制造和商业化创新疗法的生物制药公司，今天宣布中国香港特别行政区政府卫生署已正式批准VELSIPITY®（etrasimod）的新药申请（NDA），用于治疗中度至重度活动性溃疡性结肠炎（UC）成人患者。

Following approvals in Macau and Singapore, Hong Kong has become the third region within Everest Medicines’ licensed territory to approve VELSIPITY®. NMPA of China has also officially accepted the NDA for VELSIPITY® for the treatment of patients with moderately to severely active UC in December 2024..

在澳门和新加坡批准之后，香港已成为云顶医药授权区域内第三个批准VELSIPITY®的地区。中国国家药品监督管理局（NMPA）也于2024年12月正式接受了VELSIPITY®用于治疗中度至重度活动性溃疡性结肠炎（UC）患者的新药申请（NDA）。

VELSIPITY® is an effective and convenient, once-daily, oral treatment for adult patients with moderately to severely active UC that has already been approved in the U.S., E.U., and other countries by Everest’s licensing partner, Pfizer. The approval of the NDA was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12).

VELSIPITY® 是一种有效且方便的每日一次口服治疗药物，适用于中度至重度活动性溃疡性结肠炎（UC）的成年患者。该药物已由 Everest 的授权合作伙伴辉瑞公司在美国、欧盟及其他国家获得批准。新药申请（NDA）的批准基于 ELEVATE UC 3 期注册项目（ELEVATE UC 52 和 ELEVATE UC 12）的结果。

Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod. Etrasimod has been included in the AGA Living Clinical Practice Guideline on the pharmacological management of moderate-to-severe UC as one of the higher-efficacy medications suggested for first line use in advanced therapy-naïve patients..

两项研究均达到了所有主要和关键的次要疗效终点，其安全性良好，与之前对 etrasimod 的研究一致。Etrasimod 已被纳入 AGA 关于中至重度 UC 药物管理的临床实践指南，作为高效药物之一，建议用于未曾接受过先进治疗的患者的初始治疗。

“The approval of VELSIPITY® in Hong Kong marks an important milestone in bringing this innovative therapy to UC patients,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “In 2022, there were approximately 600,000 patients with UC in China, and the number is estimated to reach 1 million by 2030, reflecting the significant unmet need for advanced treatment options.

“VELSIPITY®在香港的获批标志着将这一创新疗法带给UC患者的重要里程碑，”云顶新耀首席执行官罗永庆表示。“2022年，中国约有60万名UC患者，预计到2030年，这一数字将达到100万，这反映出对先进治疗方案的巨大未满足需求。”

VELSIPITY® has already been introduced to hospitals in the Greater Bay Area through the ‘Hong Kong and Macau Medicine and Equipment Connect’ policy. With the NDA for VELSIPITY® officially accepted by the NMPA, we look forward to expanding patient access to this therapy.”.

VELSIPITY® 已通过“港澳药械通”政策引入大湾区的医院。随着 VELSIPITY® 的新药申请正式被国家药品监督管理局受理，我们期待扩大患者对这种疗法的可及性。

Prof. Wu Kaichun at the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod’s Asia clinical trial said: “As a next-generation selective S1P receptor modulator, once-daily oral etrasimod demonstrates robust efficacy across multiple endpoints, including mucosal healing, endoscopic normalization and histological remission.

空军军医大学第一附属医院、艾卓西莫德亚洲临床试验主要研究者吴开春教授表示：“作为新一代选择性S1P受体调节剂，每日一次口服艾卓西莫德在多个终点（包括黏膜愈合、内镜正常化和组织学缓解）上表现出强大的疗效。

UC is a chronic, relapsing, non-specific inflammatory disease, and as the disease progresses, the risk of disability and colorectal cancer incidence continues to rise. We look forward to its approval in more regions to benefit more patients.”.

UC是一种慢性、复发性、非特异性的炎症性疾病，随着疾病进展，患者残疾风险及结直肠癌发生率会不断升高。我们期待它在更多地区获批，从而惠及更多患者。”

As a core product of Everest Medicines, etrasimod is an innovative and advanced therapy that provides the chance for rapid onset of action, clinical remission and mucosal healing through an oral, once-daily regimen. Etrasimod has been commercially launched in Singapore and Macau in 2024. As Everest’s third commercialized product, VELSIPITY® has been officially approved by the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC.

作为云顶新耀的核心产品，依曲莫德是一种创新且先进的疗法，通过口服、每日一次的治疗方案，为患者提供快速起效、临床缓解和黏膜愈合的机会。依曲莫德已于2024年在新加坡和澳门上市。作为云顶新耀第三款商业化的药物，VELSIPITY® 已正式获得广东省药品监督管理局批准，用于治疗中度至重度活动性溃疡性结肠炎（UC）成人患者。

It is now available at medical institutions designated under the Connect Policy in the Greater Bay Area. Additionally, Everest has launched the construction project at its Jiashan factory to support the local production for VELSIPITY®..

目前该药品已通过大湾区“港澳药械通”政策在指定医疗机构使用。此外， Everest还启动了嘉善工厂的建设项目，以支持VELSIPITY®的本地化生产。

About VELSIPITY® (etrasimod)

关于VELSIPITY®（艾替莫德）

VELSIPITY® is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory approvals have been granted in US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel and the Macau SAR, China for VELSIPITY® in ulcerative colitis, as well as additional countries..

VELSIPITY® 是一种每日一次的口服鞘氨醇-1-磷酸（S1P）受体调节剂，可选择性结合S1P受体亚型1、4和5。VELSIPITY® 已在美国、欧盟、加拿大、澳大利亚、新加坡、英国、瑞士、以色列和中国澳门特别行政区等国家和地区获得监管批准用于治疗溃疡性结肠炎，并在其他国家也获得了额外的批准。

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的药物发现、临床开发、法规事务、CMC、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。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿可能包含构成前瞻性陈述的声明，包括关于公司或其高级管理人员对公司业务运营和财务状况的意图、信念或当前预期的描述，这些可以通过“将”、“预期”、“预计”、“未来”、“打算”、“计划”、“相信”、“估计”、“有信心”等术语及相关类似表述加以识别。

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.

此类前瞻性陈述并非对未来业绩的保证，且涉及风险和不确定性，或其他因素，其中一些因素超出公司的控制范围且无法预见。因此，实际结果可能因各种因素和假设而不同于前瞻性陈述中的内容，例如我们业务、竞争环境、政治、经济、法律和社会条件的未来变化和发展。

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..

公司或其任何附属公司、董事、高级职员、顾问或代表均无义务，也不承担修改前瞻性声明以反映本新闻稿发布日期之后的新信息、未来事件或情况的责任，除非法律要求。

Source: everestmedicines.com

来源：everestmedicines.com