CAMBRIDGE, England & SAN DIEGO--(BUSINESS WIRE)--Mundipharma and Cidara Therapeutics (Nasdaq: CDTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.1.

剑桥，英格兰和圣地亚哥-（商业电线）-Mundipharma和Cidara Therapeutics（纳斯达克股票代码：CDTX）今天宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）采纳了积极意见对于雷扎芬净（醋酸雷扎芬净）治疗成人侵袭性念珠菌病。

The CHMP based its positive opinion on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority* for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. This finding was supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.2,3 The ReSTORE trial provides evidence of the efficacy and safety of rezafungin as a potential new treatment option for invasive candidiasis with a once-weekly dosing schedule.2.

CHMP基于其对关键性ReSTORE III期临床试验结果的积极意见，该试验证明了雷扎芬净的统计学非劣效性*，每周一次给药，与目前的护理标准卡泊芬净相比，每日给药一次。这一发现得到了STRIVE II期临床试验和广泛的非临床开发计划的支持.2,3 ReSTORE试验提供了雷扎芬净作为侵袭性念珠菌病潜在新治疗选择的有效性和安全性的证据，每周一次给药方案。

Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues.5,6 It affects seriously ill people, especially those with a weakened immune system where the mortality rate can be 40% or more.7,8 There is a clear need for alternative options to treat this disease, particularly as there have been no new treatment options over the last decade.4,9.

侵袭性念珠菌病是一种严重的，危及生命的血液和/或深部/内脏组织感染.5,6它影响重症患者，特别是免疫系统较弱的患者，死亡率可达40%或更高.7,8显然需要替代方案来治疗这种疾病，特别是因为过去十年没有新的治疗方案.4,9。

Professor Oliver Cornely, Head of the European Excellence Centre for Medical Mycology at the University Hospital Cologne, Germany, and Data Review Committee member in the Phase III ReSTORE trial, said, “This positive opinion is welcome news for patients who suffer from invasive candidiasis in the European Union where the mortality rate for patients with invasive candidiasis remains high.

德国科隆大学医院欧洲医学真菌学卓越中心主任Oliver Cornely教授和第三阶段ReSTORE试验数据审查委员会成员表示：“这一积极意见对于患有侵袭性念珠菌病的患者来说是个好消息。在欧盟，侵袭性念珠菌病患者的死亡率仍然很高。

A new treatment option for these serious infections is a much-needed addition.”.

这些严重感染的新治疗方案是一个非常需要的补充。”。

“We would like to thank the CHMP for their careful consideration of the use of rezafungin. This positive opinion represents an important step on the journey towards approval and brings us closer to providing clinicians with an alternative treatment option for invasive Candida infections, giving hope to patients battling this infection and their families,” said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma..

“我们要感谢CHMP仔细考虑使用雷扎芬净，这一积极意见代表了批准之旅中的重要一步，使我们更接近为临床医生提供侵入性念珠菌感染的替代治疗选择，给患者带来希望与这种感染作斗争的患者及其家属，“Brian Sheehan博士说。，Mundipharma首席科学官。。

“Following the FDA approval of rezafungin in the United States earlier this year, the positive CHMP opinion reinforces the benefit of rezafungin and marks an important milestone in our drive to help patients with deadly Candida infections in the European Union,” said Taylor Sandison, M.D. M.P.H, Chief Medical Officer at Cidara..

“在今年早些时候美国FDA批准雷扎芬净之后，积极的CHMP意见加强了雷扎芬净的益处，并标志着我们帮助欧盟致命念珠菌感染患者的努力的一个重要里程碑，”Cidara首席医疗官Taylor Sandison说。。

The CHMP’s positive opinion on rezafungin for the treatment of serious fungal infections, such as invasive candidiasis in adults, will be referred to the European Commission (EC), which will deliver a final decision in approximately two months.

CHMP对雷扎芬净治疗严重真菌感染（如成人侵袭性念珠菌病）的积极意见将提交欧盟委员会（EC），该委员会将在约两个月内作出最终决定。

Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.

Cidara Therapeutics与Mundipharma合作，Mundipharma在美国和日本以外拥有rezafungin的商业权利。

*To meet the pre-specified limit of non-inferiority, the upper (for all-cause mortality) and lower (for global cure) 95% confidence limits for the difference between arms must be within 20%. Both endpoints met the pre-specified 20% limit, establishing non-inferiority.2

*为了达到非劣效性的预定限度，手臂差异的上限（全因死亡率）和下限（全球治愈率）95%置信区间必须在20%以内。两个端点均符合预先规定的20%限制，建立非劣效性。2

*ENDS*

*结束*

About invasive candidiasis

关于侵袭性念珠菌病

Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%.7,8 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.10.

侵袭性念珠菌病（IC）仍然是一个尚未得到满足的重要领域，特别是对于医院危重病人和免疫系统受损患者。尽管有许多可用的治疗方法，侵袭性念珠菌病患者的死亡率高达40%.7,8 IC的特征是严重的，危及生命的全身念珠菌感染血流和/或深/内脏组织，称为念珠菌血症和深层组织念珠菌病。

About rezafungin

关于雷扎芬金

Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia. Cidara has completed a Phase III clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial).11.

Rezafungin是一种新型的每周一次的棘白菌素，用于治疗和预防严重的真菌感染，如侵袭性念珠菌病和念珠菌血症。Cidara已经完成了雷扎芬净的III期临床试验，用于一线治疗念珠菌血症和/或侵袭性念珠菌病（ReSTORE试验）.11。

In this ReSTORE trial, rezafungin met the primary endpoint for the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorisation Application (MAA) submission of global cure at Day 14.

在ReSTORE试验中，雷扎芬净在第30天达到了美国食品和药物管理局（FDA）新药申请（NDA）提交全因死亡率的主要终点，也达到了欧洲药品管理局（EMA）上市许可的主要终点申请（MAA）在第14天提交全球治愈。

Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly versus caspofungin dosed once-daily, the current standard of care. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.2.

两项结果均显示，每周一次给药的雷扎芬净与每日一次给药的卡泊芬净（目前的护理标准）的统计学非劣效性。Rezafungin一般耐受性良好，与卡泊芬净具有相似的安全性。

Cidara is also currently conducting a second Phase III clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).

Cidara目前还在进行rezafungin的第二阶段III临床试验，以预防接受同种异体血液和骨髓移植的患者的侵袭性真菌病（ReSPECT试验）。

Rezafungin was first approved for the treatment of candidemia and invasive candidiasis in individuals with limited or no alternative treatment options by the FDA in March 2023.12

Rezafungin于2023年3月首次被批准用于治疗FDA有限或无替代治疗选择的个体的念珠菌血症和侵袭性念珠菌病.12

About Cidara Therapeutics

关于Cidara疗法

Cidara is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system.

Cidara正在使用其专有的Cloudbreak®平台开发新型药物-Fc偶联物（DFCs）。这些靶向免疫疗法提供了独特的机会来创建由靶向小分子和与人抗体片段（Fc）偶联的肽组成的“单分子混合物”。DFC旨在通过抑制特定疾病目标同时参与免疫系统来挽救生命并提高面临癌症和其他严重疾病的患者的护理标准。

In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialise in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com..

此外，Cidara还获得了FDA批准REZZAYO™ （rezafungin for injection），它已授权多个合作伙伴在美国商业化，前美国Cidara总部设在加利福尼亚州圣地亚哥。欲了解更多信息，请访问www.cidara.com。。

About Mundipharma

关于Mundipharma

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma是一家全球医疗保健公司，遍布非洲，亚太地区，加拿大，欧洲，拉丁美洲和中东地区。

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease and consumer healthcare as well as other severe and debilitating disease areas. Their guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything they do.

Mundipharma致力于为疼痛管理，传染病和消费者医疗保健以及其他严重和使人衰弱的疾病领域的患者提供创新治疗。他们以诚信和以病人为中心的指导原则是他们所做一切的核心。

For more information visit www.mundipharma.com..

欲了解更多信息，请访问www.mundipharma.com。。

Forward-Looking Statements

前瞻性声明

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbour provisions of the Private Securities Litigation Reform Act of 1995.

本版本包含1933年“证券法”第27A条（经修订）和1934年“证券交易所法”第21E条（经修订）含义内的“前瞻性陈述”，此类前瞻性陈述是根据1995年“私人证券诉讼改革法”安全港规定。

“Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin; whether it will be approved for marketing in the EU; and the likelihood that rezafungin, if approved in the EU, will be prescribed by physicians or approved for reimbursement.

“前瞻性陈述”描述未来的期望，计划，结果或策略，通常在前面加上“预期”，“期望”，“可能”，“计划”或“意志”等词语。本版本中的前瞻性声明包括但不限于与雷扎芬净是否存在未满足的医疗需求有关的声明；是否将被批准在欧盟上市；如果在欧盟获得批准，雷扎芬净将由医生开具处方或批准报销的可能性。

Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission.

这些陈述受到多种风险和不确定性的影响，可能导致未来的情况，事件或结果与前瞻性陈述中预测的结果大不相同。这些风险和其他风险在Cidara最近的10-Q季度报告以及随后与证券交易委员会提交的其他文件中的“风险因素”标题下确定。

All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise..

本新闻稿中包含的所有前瞻性声明仅在其作出之日起发表，并且基于管理层迄今为止的假设和估计。Cidara不承担任何公开更新任何前瞻性陈述的义务，无论是由于收到新信息，发生未来事件还是其他原因。。

References:

参考文献：

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4.Ham YY，et al.Future Microbiology 2021；16(1):27–36.

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11. Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and invasive candidiasis. Available at https://www.mundipharma.com/Cidara-Therapeutics-and-Mundipharma-Announce-Positive-Topline-Results-from-the-Global-Phase-3-Pivotal-ReSTORE-Trial-of-Rezafungin-for-the-Treatment-of-Candidemia-and-Invasive-Candidiasis (last accessed October 2023)..

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SciA-RZF-2300034

SciA-RZF-2300034

Date of preparation: October 2023

准备日期：2023年10月