DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that the U.S.

康涅狄格州丹伯里（DANBURY）和加利福尼亚州西湖村（WESTLAKE VILLAGE），2024年5月6日（Global NEWSWIRE）——曼金公司（Nasdaq:MNKD），一家专注于为内分泌和孤儿肺病患者开发和商业化创新吸入治疗产品和设备的公司，今天宣布美国。

Food and Drug Administration (FDA) has granted Fast Track designation of Clofazimine Inhalation Suspension (MNKD-101) for the treatment of nontuberculous mycobacterial (NTM) lung disease. Fast track designation is intended to facilitate the development, and expedite the review, of medicines to treat serious conditions and fill an unmet medical need..

美国食品和药物管理局（FDA）已批准用于治疗非结核分枝杆菌（NTM）肺病的氯法齐明吸入混悬液（MNKD-101）的快速通道指定。快速通道指定旨在促进药物的开发和加速审查，以治疗严重疾病并满足未满足的医疗需求。。

“We are pleased with the FDA’s decision to grant Fast Track designation for Clofazimine Inhalation Suspension, providing us an opportunity to accelerate our efforts to potentially bring an important medicine to patients living with NTM,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation.

MannKind Corporation首席执行官迈克尔·卡斯塔尼亚（MichaelCastagna）说：“我们很高兴FDA决定批准氯法齐明吸入混悬液的快速通道，这为我们提供了一个机会，以加速我们的努力，为NTM患者带来一种重要的药物。”。

“We are looking forward to the progression of the ICoN-1 study as well as an expedited review with a rolling submission.”.

“我们期待着ICoN-1研究的进展以及滚动提交的快速审查。”。

ICoN-1 is a multi-national, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Clofazimine Inhalation Suspension when added to guideline-based therapy in adults with refractory NTM lung disease caused by Mycobacterium Avium Complex (MAC), followed by an open-label extension.

ICoN-1是一项多国，随机，双盲，安慰剂对照试验，用于评估氯法齐明吸入混悬液在成人难治性NTM肺病（由鸟分枝杆菌复合体（MAC）引起）的指南治疗中的疗效和安全性，然后是开放标签扩展。

This single registrational study anticipates getting underway in June 2024 in the U.S., and internationally in the second half of 2024..

这项单一的注册研究预计将于2024年6月在美国进行，并于2024年下半年在国际上进行。。

The U.S. FDA previously designated Clofazimine Inhalation Suspension as both an orphan drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections. A drug that receives orphan drug exclusivity receives seven years of exclusivity, and one that also earns QIDP designation, may receive an additional five years of market exclusivity..

美国FDA先前将氯法齐明吸入混悬液指定为孤儿药和合格的传染病产品（QIDP），用于治疗肺部NTM感染。获得孤儿药独家经营权的药物可获得七年的独家经营权，同时获得QIDP称号的药物可获得额外五年的市场独家经营权。。

Pulmonary NTM infection is recognized as a major global health concern due to its rising prevalence worldwide, association with shortened life span and significant impact on patients’ daily living. NTM is a group of bacteria naturally found in our environment, including water and soil, that can lead to cough, fatigue, a reduction in lung function, and poor quality of life.

肺部NTM感染被认为是全球主要的健康问题，因为它在全球范围内的流行率不断上升，寿命缩短，对患者的日常生活产生重大影响。NTM是在我们的环境（包括水和土壤）中自然发现的一组细菌，可导致咳嗽，疲劳，肺功能下降和生活质量下降。

While most people are exposed to NTM daily, the organisms generally do no harm. Individuals with underlying conditions such as COPD, asthma, and bronchiectasis are prone to NTM getting established in the lungs, creating an infection and progressive worsening of lung function..

虽然大多数人每天都接触NTM，但这些生物通常不会造成伤害。患有COPD，哮喘和支气管扩张等潜在疾病的个体容易在肺部建立NTM，从而导致感染和肺功能逐渐恶化。。

NTM lung disease is more common in women over the age of 65, with a predominance in those of Caucasian and Asian descent. In 2022, there were approximately 122,000 and 159,000 patients living with NTM in the U.S. and Japan, respectively, with as much as 20% of those cases being refractory. The disease state is on the rise, with an estimated annual growth rate averaging 8%..

NTM肺病在65岁以上的女性中更为常见，在白种人和亚洲人后裔中占主导地位。2022年，美国和日本分别有大约122000和159000名NTM患者，其中多达20%的患者是难治性的。疾病状态呈上升趋势，估计年平均增长率为8%。。

About MannKind

关于曼金德

MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.

曼金公司（Nasdaq:MNKD）专注于创新吸入治疗产品和设备的开发和商业化，以解决内分泌和孤儿肺部疾病患者严重未满足的医疗需求。

We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication..

我们致力于利用我们的配方能力和设备工程能力来减轻糖尿病，非结核分枝杆菌（NTM）肺病，肺纤维化和肺动脉高压等疾病的负担。我们的标志性技术-干粉制剂和吸入装置-可以快速方便地将药物输送到深肺，根据目标适应症，药物可以在局部发挥作用或进入体循环。。

With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.

我们的使命是让人们控制自己的健康和生活自由，在全国范围内有一支充满激情的男性主义者团队合作。

Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram.

请访问mannkindcorp.com了解更多信息，并在LinkedIn、Facebook、X或Instagram上关注我们。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements about the initiation of a clinical study and a planned regulatory submission that involve risks and uncertainties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements.

本新闻稿包含关于启动临床研究的前瞻性声明以及涉及风险和不确定性的计划监管提交。诸如“相信”，“预期”，“计划”，“预期”，“打算”，“意志”，“目标”，“潜力”等词语以及类似的表达都是为了识别前瞻性陈述。

These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that continued testing of an investigational drug product may not yield successful results or results that are consistent with earlier testing, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K.

这些前瞻性声明基于曼金德目前的期望。由于各种风险和不确定性，实际结果和事件发生的时间可能与此类前瞻性声明中预期的结果存在重大差异，这些风险和不确定性包括但不限于继续测试研究药品可能无法产生成功结果或与早期测试一致的结果的风险，以及曼金德向美国证券交易委员会提交的文件中详述的其他风险，包括其截至2023年12月31日的年度报告10-K表以及随后的10-Q表定期报告和8-K表当前报告。

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release..

提醒您不要过度依赖这些前瞻性声明，这些声明仅在本新闻稿发布之日起生效。所有前瞻性声明均受本警示声明的限制，曼金德没有义务修改或更新任何前瞻性声明，以反映本新闻稿发布日期后的事件或情况。。

MNKD-101 is an investigational product that is not approved for any use in any country.

MNKD-101是一种未经批准在任何国家使用的研究产品。

MANNKIND is a registered trademark of MannKind Corporation.

MANNKIND是MANNKIND Corporation的注册商标。

For MannKind: Christie Iacangelo, Corporate Communications (818) 292-3500 Email: media@mannkindcorp.com Rose Alinaya, Investor Relations (818) 661-5000 Email: ir@mannkindcorp.com

曼金德：克里斯蒂·亚坎杰洛，企业通讯（818）292-3500电子邮件：media@mannkindcorp.comRose Alinaya，投资者关系（818）661-5000电子邮件：ir@mannkindcorp.com