<ul>
<li><em>FDA 批准 FUROSCIX</em> <em>®</em> <em>用于体重在 43kg 或以上的儿童患者</em></li>
<li><em>USPTO 为 FUROSCIX ReadyFlow</em> <em>™</em> <em>自动注射器颁发五项专利</em></li>
</ul>
<p>加利福尼亚州西湖村和马萨诸塞州伯灵顿，2025 年 12 月 23 日（GLOBE NEWSWIRE）-- <strong>MannKind Corporation（纳斯达克代码：MNKD）</strong> 今天宣布了两项业务更新——FUROSCIX®（呋塞米）体内输注器获得儿童患者的批准，以及为正在研发阶段的 FUROSCIX ReadyFlow™自动注射器颁发额外的知识产权保护，该产品目前正在接受美国 FDA 的审查。</p>
<p><strong>FUROSCIX 为合适的儿童患者扩展治疗选择</strong></p>
<p>美国食品药品监督管理局（FDA）已批准 FUROSCIX®（呋塞米）体内输注器的补充新药申请（sNDA），将该产品的适应症扩展至体重在 43 公斤或以上的儿童患者。FUROSCIX 之前已获批准用于治疗成人的慢性心力衰竭（CHF）和慢性肾病（CKD）相关的水肿。这项额外的批准满足了《儿童研究公平法》下原始批准信中列出的所有上市后要求。</p>
<p>“我们很高兴能将 FUROSCIX 提供给儿童群体，这是一个高度特定的患者群体，为符合体重标准的患者提供了医院外的便利选择，” MannKind Corporation 首席医疗官 Ajay Ahuja 博士表示。</p>
<p><strong>五项新的美国专利为 FUROSCIX ReadyFlow 自动注射器提供保护</strong></p>
<p>美国专利商标局（USPTO）颁发了五项专利，保护 FUROSCIX ReadyFlow 自动注射器。这些专利涵盖了呋塞米的高浓度液体配方及相关的治疗方法，可能持续到 2040 年，进一步巩固了 MannKind 在这一创新药物 - 设备组合上的知识产权地位。如果 FUROSCIX ReadyFlow 自动注射器获得 FDA 批准，这些专利将被列入 FDA 的橙皮书。</p>
<p>新颁发的专利补充了之前支持 FUROSCIX 和 FUROSCIX ReadyFlow 自动注射器的专利，形成了一个强大的知识产权组合，旨在保护该配方和给药方式多年。</p>
<p><strong>FUROSCIX ReadyFlow 自动注射器可能将护理时间从小时缩短到秒</strong></p>
<p>MannKind 最近宣布，FDA 已接受其针对 FUROSCIX ReadyFlow 自动注射器用于治疗成人 CHF 或 CKD 水肿的 sNDA 申请进行审查。该申请已被分配了 2026 年 7 月 26 日的处方药用户费用法案（PDUFA）目标行动日期。</p>
<p>如果获得批准，FUROSCIX ReadyFlow 自动注射器将在 10 秒内提供等同于静脉注射的利尿剂剂量（皮下呋塞米注射 80 mg/mL），为 CHF 或 CKD 患者提供了一种在家中而非医院环境中管理液体积聚发作的新选择。FDA 批准的 FUROSCIX 体内输注器于 2022 年获批用于治疗成人慢性心力衰竭患者的水肿，并于 2025 年获批用于成人慢性肾病患者。</p>
<p>“FUROSCIX ReadyFlow 自动注射器有潜力重新定义患者管理液体超负荷发作的方式，” MannKind Corporation 首席执行官 Michael Castagna 博士表示。“通过在家中舒适的环境中在几秒钟内提供等同于静脉注射的利尿剂剂量，这项创新如果获得批准，可能显著减少住院次数，提高生活质量，并降低医疗成本——为患者、提供者和支付方创造有意义的价值。”</p>
<p><strong>关于 FUROSCIX</strong></p>
<p>FUROSCIX®（呋塞米注射液），80 mg/10 mL 用于皮下使用，适用于体重至少 43 kg 的儿童患者和患有慢性心力衰竭或慢性肾病（包括肾病综合征）的成人患者的水肿治疗。</p>
<p><strong>重要安全信息</strong></p>
<p>FUROSCIX 禁用于无尿症患者以及对呋塞米、FUROSCIX 配方的任何成分或医疗粘合剂有过敏史的患者。</p>
<p>呋塞米可能导致液体、电解质和代谢异常，特别是在接受高剂量治疗的患者、口服电解质摄入不足的患者以及老年患者中。在呋塞米治疗期间，应频繁监测血清电解质、CO2、BUN、肌酐、葡萄糖和尿酸。</p>
<p>过度利尿可能导致脱水和血容量减少，进而引发循环崩溃，可能导致血管血栓和栓塞，尤其是在老年患者中。</p>
<p>呋塞米可能导致脱水和氮质血症。如果在严重进展性肾病治疗期间出现氮质血症和少尿加重，应停止使用呋塞米。</p>
<p>有报告指出，呋塞米可能导致耳鸣和可逆或不可逆的听力损失和失聪。报告通常表明，呋塞米的耳毒性与快速注射、严重肾功能障碍、使用超过推荐剂量、低蛋白血症或与氨基糖苷类抗生素、依他克林酸或其他耳毒性药物的联合治疗有关。</p>
<p>在有严重尿潴留症状的患者（由于膀胱排空障碍、前列腺增生、尿道狭窄），使用呋塞米可能导致急性尿潴留，因尿液产生和滞留增加。这些患者在治疗初期需要仔细监测。</p>
<p>在治疗期间，接触水或其他液体以及某些患者的动作可能导致体内输注器提前终止输注。确保患者能够检测并响应警报。</p>
<p>在临床试验中，FUROSCIX 给药最常见的不良反应是注射部位和皮肤反应，包括红斑、淤血、水肿和注射部位疼痛。</p>
<p>请查看完整的 <strong>处方信息</strong> ( <strong>https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf</strong>) 和 <strong>使用说明</strong> ( <strong>https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf</strong>)。</p>
<p><strong>关于 MannKind</strong></p>
<p>MannKind Corporation（纳斯达克代码：MNKD）是一家生物制药公司，致力于通过创新的以患者为中心的解决方案来改变慢性疾病的护理。我们专注于心代谢和孤儿肺病，开发和商业化满足严重未满足医疗需求的治疗方案，包括糖尿病、肺动脉高压以及心力衰竭和慢性肾病中的液体超负荷。</p>
<p>凭借在药物 - 设备组合方面的深厚专业知识，MannKind 旨在提供与日常生活无缝契合的治疗方案。</p>
<p>了解更多信息，请访问 mannkindcorp.com。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含前瞻性声明，这些声明涉及风险和不确定性，包括关于潜在监管行动日期的声明、关于专利保护潜在持续时间的声明以及关于通过自动注射器给药的潜在好处的声明，这些声明涉及提供者、患者和支付方。诸如 “相信”、“预期”、“计划”、“期望”、“打算”、“将”、“目标”、“潜在” 等类似表达旨在识别前瞻性声明。这些前瞻性声明基于 MannKind 当前的预期。实际结果和事件的时机可能因各种风险和不确定性而与这些前瞻性声明中预期的结果有实质性差异，包括但不限于，FDA 审查过程中出现的问题可能导致我们面临意外延迟或阻止我们获得市场批准的风险，我们可能无法保护我们的专有权利的风险，以及在 MannKind 向证券交易委员会提交的文件中详细说明的其他风险，包括在截至 2024 年 12 月 31 日的年度报告的 “风险因素” 标题下，以及后续的 10-Q 表格定期报告和 8-K 表格当前报告。您被警告不要对这些前瞻性声明过度依赖，这些声明仅在本新闻稿日期时有效。所有前瞻性声明均受到此警示声明的全面限制，MannKind 没有义务修订或更新任何前瞻性声明，以反映本新闻稿日期之后的事件或情况。</p>
<p>FUROSCIX 是 scPharmaceuticals 的注册商标，scPharmaceuticals 是 MannKind Corporation 的全资子公司。</p>
<p>MANNKIND 是 MannKind Corporation 的注册商标。</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZeE5qUXpNaU0zTXpNek5qTXpJekl3TURneE1EYz0?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="1" height="1" original-src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZeE5qUXpNaU0zTXpNek5qTXpJekl3TURneE1EYz0"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/NTY2ZjcwY2UtMWM1ZS00M2ZlLThkMWQtMWRmMWRiNzJiN2Q4LTEwMTk2ODAtMjAyNS0xMi0yMy1lbg==/tiny/MannKind.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="1" height="1" original-src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/NTY2ZjcwY2UtMWM1ZS00M2ZlLThkMWQtMWRmMWRiNzJiN2Q4LTEwMTk2ODAtMjAyNS0xMi0yMy1lbg==/tiny/MannKind.png"/></p>
<pre><code>MannKind 联系人：媒体关系：Christie Iacangelo（818）292-3500 media@mnkd.com 投资者关系：Kate Miranda（781）301-6869 ir@mnkd.com
</code></pre>

曼恩凯德生物医疗

<p>曼恩凯德生物医疗宣布，FDA 已批准 FUROSCIX® On-body Infusor 用于体重在 43 公斤或以上的儿童患者，扩大了其在慢性心力衰竭和肾病成人患者之外的应用。此外，美国专利商标局（USPTO）为 FUROSCIX ReadyFlow™ 自动注射器颁发了五项专利，增强了其知识产权保护。该自自动注射器正在接受 FDA 审查，可能通过在几秒钟内提供利尿剂剂量来改变护理方式，从而减少住院次数并改善患者的生活质量</p>

<ul>
<li><em>FDA approves FUROSCIX</em> <em>®</em> <em>for use in pediatric patients weighing 43kg or above</em></li>
<li><em>USPTO issues five patents for FUROSCIX ReadyFlow</em> <em>™</em> <em>Autoinjector</em></li>
</ul>
<div class="lb-trans"><ul>
<li><em>FDA 批准 FUROSCIX</em> <em>®</em> <em>用于体重在 43kg 或以上的儿童患者</em></li>
<li><em>USPTO 为 FUROSCIX ReadyFlow</em> <em>™</em> <em>自动注射器颁发五项专利</em></li>
</ul>
</div><p>WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- <strong>MannKind Corporation (Nasdaq: MNKD)</strong> today announced two business updates—approval of the FUROSCIX® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage FUROSCIX ReadyFlow™ Autoinjector, which is currently under review by the U.S. FDA.</p>
<div class="lb-trans"><p>加利福尼亚州西湖村和马萨诸塞州伯灵顿，2025 年 12 月 23 日（GLOBE NEWSWIRE）-- <strong>MannKind Corporation（纳斯达克代码：MNKD）</strong> 今天宣布了两项业务更新——FUROSCIX®（呋塞米）体内输注器获得儿童患者的批准，以及为正在研发阶段的 FUROSCIX ReadyFlow™自动注射器颁发额外的知识产权保护，该产品目前正在接受美国 FDA 的审查。</p>
</div><p><strong>FUROSCIX Expanded Treatment Options for Appropriate Pediatric Patients</strong></p>
<div class="lb-trans"><p><strong>FUROSCIX 为合适的儿童患者扩展治疗选择</strong></p>
</div><p>The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for FUROSCIX® (furosemide) On-body Infusor, expanding the indication of this product to include pediatric patients weighing 43 kg or more. FUROSCIX was previously approved for the treatment of edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults. This additional approval fulfills all post-marketing requirements outlined in the original approval letter under the Pediatric Research Equity Act.</p>
<div class="lb-trans"><p>美国食品药品监督管理局（FDA）已批准 FUROSCIX®（呋塞米）体内输注器的补充新药申请（sNDA），将该产品的适应症扩展至体重在 43 公斤或以上的儿童患者。FUROSCIX 之前已获批准用于治疗成人的慢性心力衰竭（CHF）和慢性肾病（CKD）相关的水肿。这项额外的批准满足了《儿童研究公平法》下原始批准信中列出的所有上市后要求。</p>
</div><p>“We are pleased to make FUROSCIX available to the pediatric population, a highly specific patient group, offering a convenient option outside the hospital setting for those who meet the weight criteria,” said Dr. Ajay Ahuja, Chief Medical Officer of MannKind Corporation.</p>
<div class="lb-trans"><p>“我们很高兴能将 FUROSCIX 提供给儿童群体，这是一个高度特定的患者群体，为符合体重标准的患者提供了医院外的便利选择，” MannKind Corporation 首席医疗官 Ajay Ahuja 博士表示。</p>
</div><p><strong>Five New U.S. Patents Provide Protection to FUROSCIX ReadyFlow Autoinjector</strong></p>
<div class="lb-trans"><p><strong>五项新的美国专利为 FUROSCIX ReadyFlow 自动注射器提供保护</strong></p>
</div><p>The U.S. Patent and Trademark Office (USPTO) issued five patents with claims that protect the FUROSCIX ReadyFlow Autoinjector. These patents cover the high-concentration liquid compositions of furosemide and associated methods of treatment potentially through 2040, further reinforcing MannKind’s intellectual property position around this innovative drug-device combination. The patents would be listed in the FDA’s Orange Book, if the FUROSCIX ReadyFlow Autoinjector is approved by the FDA.</p>
<div class="lb-trans"><p>美国专利商标局（USPTO）颁发了五项专利，保护 FUROSCIX ReadyFlow 自动注射器。这些专利涵盖了呋塞米的高浓度液体配方及相关的治疗方法，可能持续到 2040 年，进一步巩固了 MannKind 在这一创新药物 - 设备组合上的知识产权地位。如果 FUROSCIX ReadyFlow 自动注射器获得 FDA 批准，这些专利将被列入 FDA 的橙皮书。</p>
</div><p>The newly issued patents complement previously issued patents supporting FUROSCIX and the FUROSCIX ReadyFlow Autoinjector, creating a robust IP portfolio that is designed to protect the formulation and delivery approach for years to come.</p>
<div class="lb-trans"><p>新颁发的专利补充了之前支持 FUROSCIX 和 FUROSCIX ReadyFlow 自动注射器的专利，形成了一个强大的知识产权组合，旨在保护该配方和给药方式多年。</p>
</div><p><strong>FUROSCIX ReadyFlow Autoinjector Could Transform Care from Hours to Seconds</strong></p>
<div class="lb-trans"><p><strong>FUROSCIX ReadyFlow 自动注射器可能将护理时间从小时缩短到秒</strong></p>
</div><p>MannKind recently announced that the FDA accepted for review its sNDA for the FUROSCIX ReadyFlow Autoinjector for the treatment of edema in adults with CHF or CKD. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.</p>
<div class="lb-trans"><p>MannKind 最近宣布，FDA 已接受其针对 FUROSCIX ReadyFlow 自动注射器用于治疗成人 CHF 或 CKD 水肿的 sNDA 申请进行审查。该申请已被分配了 2026 年 7 月 26 日的处方药用户费用法案（PDUFA）目标行动日期。</p>
</div><p>If approved, the FUROSCIX ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/mL) in under 10 seconds, providing a new option for patients with CHF or CKD to manage fluid buildup episodes from the convenience of their home rather than in a hospital setting. The FDA-approved FUROSCIX On-body Infusor was approved in 2022 for the treatment of edema in adult patients with chronic heart failure and, in 2025, for adult patients with chronic kidney disease in 2025.</p>
<div class="lb-trans"><p>如果获得批准，FUROSCIX ReadyFlow 自动注射器将在 10 秒内提供等同于静脉注射的利尿剂剂量（皮下呋塞米注射 80 mg/mL），为 CHF 或 CKD 患者提供了一种在家中而非医院环境中管理液体积聚发作的新选择。FDA 批准的 FUROSCIX 体内输注器于 2022 年获批用于治疗成人慢性心力衰竭患者的水肿，并于 2025 年获批用于成人慢性肾病患者。</p>
</div><p>“FUROSCIX ReadyFlow Autoinjector has the potential to redefine how patients manage fluid overload episodes,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “By delivering an IV-equivalent diuretic dose in seconds from the comfort of home, this innovation, if approved, could significantly reduce hospital visits, improve quality of life, and lower healthcare costs—creating meaningful value for patients, providers, and payers alike.”</p>
<div class="lb-trans"><p>“FUROSCIX ReadyFlow 自动注射器有潜力重新定义患者管理液体超负荷发作的方式，” MannKind Corporation 首席执行官 Michael Castagna 博士表示。“通过在家中舒适的环境中在几秒钟内提供等同于静脉注射的利尿剂剂量，这项创新如果获得批准，可能显著减少住院次数，提高生活质量，并降低医疗成本——为患者、提供者和支付方创造有意义的价值。”</p>
</div><p><strong>About FUROSCIX</strong></p>
<div class="lb-trans"><p><strong>关于 FUROSCIX</strong></p>
</div><p>FUROSCIX® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in pediatric patients who weigh at least 43 kg and adult patients with chronic heart failure or chronic kidney disease, including the nephrotic syndrome.</p>
<div class="lb-trans"><p>FUROSCIX®（呋塞米注射液），80 mg/10 mL 用于皮下使用，适用于体重至少 43 kg 的儿童患者和患有慢性心力衰竭或慢性肾病（包括肾病综合征）的成人患者的水肿治疗。</p>
</div><p><strong>IMPORTANT SAFETY INFORMATION</strong></p>
<div class="lb-trans"><p><strong>重要安全信息</strong></p>
</div><p>FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives.</p>
<div class="lb-trans"><p>FUROSCIX 禁用于无尿症患者以及对呋塞米、FUROSCIX 配方的任何成分或医疗粘合剂有过敏史的患者。</p>
</div><p>Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.</p>
<div class="lb-trans"><p>呋塞米可能导致液体、电解质和代谢异常，特别是在接受高剂量治疗的患者、口服电解质摄入不足的患者以及老年患者中。在呋塞米治疗期间，应频繁监测血清电解质、CO2、BUN、肌酐、葡萄糖和尿酸。</p>
</div><p>Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.</p>
<div class="lb-trans"><p>过度利尿可能导致脱水和血容量减少，进而引发循环崩溃，可能导致血管血栓和栓塞，尤其是在老年患者中。</p>
</div><p>Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.</p>
<div class="lb-trans"><p>呋塞米可能导致脱水和氮质血症。如果在严重进展性肾病治疗期间出现氮质血症和少尿加重，应停止使用呋塞米。</p>
</div><p>Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.</p>
<div class="lb-trans"><p>有报告指出，呋塞米可能导致耳鸣和可逆或不可逆的听力损失和失聪。报告通常表明，呋塞米的耳毒性与快速注射、严重肾功能障碍、使用超过推荐剂量、低蛋白血症或与氨基糖苷类抗生素、依他克林酸或其他耳毒性药物的联合治疗有关。</p>
</div><p>In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.</p>
<div class="lb-trans"><p>在有严重尿潴留症状的患者（由于膀胱排空障碍、前列腺增生、尿道狭窄），使用呋塞米可能导致急性尿潴留，因尿液产生和滞留增加。这些患者在治疗初期需要仔细监测。</p>
</div><p>Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.</p>
<div class="lb-trans"><p>在治疗期间，接触水或其他液体以及某些患者的动作可能导致体内输注器提前终止输注。确保患者能够检测并响应警报。</p>
</div><p>The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.</p>
<div class="lb-trans"><p>在临床试验中，FUROSCIX 给药最常见的不良反应是注射部位和皮肤反应，包括红斑、淤血、水肿和注射部位疼痛。</p>
</div><p>Please see the full <strong>Prescribing Information</strong> ( <strong>https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf</strong>) and <strong>Instructions for Use</strong> ( <strong>https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf</strong>).</p>
<div class="lb-trans"><p>请查看完整的 <strong>处方信息</strong> ( <strong>https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf</strong>) 和 <strong>使用说明</strong> ( <strong>https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf</strong>)。</p>
</div><p><strong>About MannKind</strong></p>
<div class="lb-trans"><p><strong>关于 MannKind</strong></p>
</div><p>MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.</p>
<div class="lb-trans"><p>MannKind Corporation（纳斯达克代码：MNKD）是一家生物制药公司，致力于通过创新的以患者为中心的解决方案来改变慢性疾病的护理。我们专注于心代谢和孤儿肺病，开发和商业化满足严重未满足医疗需求的治疗方案，包括糖尿病、肺动脉高压以及心力衰竭和慢性肾病中的液体超负荷。</p>
</div><p>With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.</p>
<div class="lb-trans"><p>凭借在药物 - 设备组合方面的深厚专业知识，MannKind 旨在提供与日常生活无缝契合的治疗方案。</p>
</div><p>Learn more at mannkindcorp.com.</p>
<div class="lb-trans"><p>了解更多信息，请访问 mannkindcorp.com。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>This press release contains forward-looking statements that involve risks and uncertainties, including statements about a potential regulatory action date, statements regarding the potential duration of patent protection and statements regarding the potential benefits of the administration of furosemide via an autoinjector for providers, patients and payors. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. 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 issues that develop in the review by the FDA may subject us to unanticipated delays or prevent us from obtaining marketing approval, the risk that we may be unable to protect our proprietary rights as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. 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.</p>
<div class="lb-trans"><p>本新闻稿包含前瞻性声明，这些声明涉及风险和不确定性，包括关于潜在监管行动日期的声明、关于专利保护潜在持续时间的声明以及关于通过自动注射器给药的潜在好处的声明，这些声明涉及提供者、患者和支付方。诸如 “相信”、“预期”、“计划”、“期望”、“打算”、“将”、“目标”、“潜在” 等类似表达旨在识别前瞻性声明。这些前瞻性声明基于 MannKind 当前的预期。实际结果和事件的时机可能因各种风险和不确定性而与这些前瞻性声明中预期的结果有实质性差异，包括但不限于，FDA 审查过程中出现的问题可能导致我们面临意外延迟或阻止我们获得市场批准的风险，我们可能无法保护我们的专有权利的风险，以及在 MannKind 向证券交易委员会提交的文件中详细说明的其他风险，包括在截至 2024 年 12 月 31 日的年度报告的 “风险因素” 标题下，以及后续的 10-Q 表格定期报告和 8-K 表格当前报告。您被警告不要对这些前瞻性声明过度依赖，这些声明仅在本新闻稿日期时有效。所有前瞻性声明均受到此警示声明的全面限制，MannKind 没有义务修订或更新任何前瞻性声明，以反映本新闻稿日期之后的事件或情况。</p>
</div><p>FUROSCIX is a registered trademark of scPharmaceuticals, a wholly owned subsidiary of MannKind Corporation.</p>
<div class="lb-trans"><p>FUROSCIX 是 scPharmaceuticals 的注册商标，scPharmaceuticals 是 MannKind Corporation 的全资子公司。</p>
</div><p>MANNKIND is a registered trademark of MannKind Corporation.</p>
<div class="lb-trans"><p>MANNKIND 是 MannKind Corporation 的注册商标。</p>
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<pre><code>MannKind Contacts:Media Relations:Christie Iacangelo(818) 292-3500media@mnkd.comInvestor Relations:Kate Miranda(781) 301-6869ir@mnkd.com
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<div class="lb-trans"><pre><code>MannKind 联系人：媒体关系：Christie Iacangelo（818）292-3500 media@mnkd.com 投资者关系：Kate Miranda（781）301-6869 ir@mnkd.com
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