<ul>
<li><em>FDA 批准 FUROSCIX</em> <em>®</em> <em>用於體重在 43kg 或以上的兒童患者</em></li>
<li><em>USPTO 為 FUROSCIX ReadyFlow</em> <em>™</em> <em>自動注射器頒發五項專利</em></li>
</ul>
<p>加利福尼亞州西湖村和馬薩諸塞州伯靈頓，2025 年 12 月 23 日（GLOBE NEWSWIRE）-- <strong>MannKind Corporation（納斯達克代碼：MNKD）</strong> 今天宣佈了兩項業務更新——FUROSCIX®（呋塞米）體內輸注器獲得兒童患者的批准，以及為正在研發階段的 FUROSCIX ReadyFlow™自動注射器頒發額外的知識產權保護，該產品目前正在接受美國 FDA 的審查。</p>
<p><strong>FUROSCIX 為合適的兒童患者擴展治療選擇</strong></p>
<p>美國食品藥品監督管理局（FDA）已批准 FUROSCIX®（呋塞米）體內輸注器的補充新藥申請（sNDA），將該產品的適應症擴展至體重在 43 公斤或以上的兒童患者。FUROSCIX 之前已獲批准用於治療成人的慢性心力衰竭（CHF）和慢性腎病（CKD）相關的水腫。這項額外的批准滿足了《兒童研究公平法》下原始批准信中列出的所有上市後要求。</p>
<p>“我們很高興能將 FUROSCIX 提供給兒童羣體，這是一個高度特定的患者羣體，為符合體重標準的患者提供了醫院外的便利選擇，” MannKind Corporation 首席醫療官 Ajay Ahuja 博士表示。</p>
<p><strong>五項新的美國專利為 FUROSCIX ReadyFlow 自動注射器提供保護</strong></p>
<p>美國專利商標局（USPTO）頒發了五項專利，保護 FUROSCIX ReadyFlow 自動注射器。這些專利涵蓋了呋塞米的高濃度液體配方及相關的治療方法，可能持續到 2040 年，進一步鞏固了 MannKind 在這一創新藥物 - 設備組合上的知識產權地位。如果 FUROSCIX ReadyFlow 自動注射器獲得 FDA 批准，這些專利將被列入 FDA 的橙皮書。</p>
<p>新頒發的專利補充了之前支持 FUROSCIX 和 FUROSCIX ReadyFlow 自動注射器的專利，形成了一個強大的知識產權組合，旨在保護該配方和給藥方式多年。</p>
<p><strong>FUROSCIX ReadyFlow 自動注射器可能將護理時間從小時縮短到秒</strong></p>
<p>MannKind 最近宣佈，FDA 已接受其針對 FUROSCIX ReadyFlow 自動注射器用於治療成人 CHF 或 CKD 水腫的 sNDA 申請進行審查。該申請已被分配了 2026 年 7 月 26 日的處方藥用户費用法案（PDUFA）目標行動日期。</p>
<p>如果獲得批准，FUROSCIX ReadyFlow 自動注射器將在 10 秒內提供等同於靜脈注射的利尿劑劑量（皮下呋塞米注射 80 mg/mL），為 CHF 或 CKD 患者提供了一種在家中而非醫院環境中管理液體積聚發作的新選擇。FDA 批准的 FUROSCIX 體內輸注器於 2022 年獲批用於治療成人慢性心力衰竭患者的水腫，並於 2025 年獲批用於成人慢性腎病患者。</p>
<p>“FUROSCIX ReadyFlow 自動注射器有潛力重新定義患者管理液體超負荷發作的方式，” MannKind Corporation 首席執行官 Michael Castagna 博士表示。“通過在家中舒適的環境中在幾秒鐘內提供等同於靜脈注射的利尿劑劑量，這項創新如果獲得批准，可能顯著減少住院次數，提高生活質量，並降低醫療成本——為患者、提供者和支付方創造有意義的價值。”</p>
<p><strong>關於 FUROSCIX</strong></p>
<p>FUROSCIX®（呋塞米注射液），80 mg/10 mL 用於皮下使用，適用於體重至少 43 kg 的兒童患者和患有慢性心力衰竭或慢性腎病（包括腎病綜合徵）的成人患者的水腫治療。</p>
<p><strong>重要安全信息</strong></p>
<p>FUROSCIX 禁用於無尿症患者以及對呋塞米、FUROSCIX 配方的任何成分或醫療粘合劑有過敏史的患者。</p>
<p>呋塞米可能導致液體、電解質和代謝異常，特別是在接受高劑量治療的患者、口服電解質攝入不足的患者以及老年患者中。在呋塞米治療期間，應頻繁監測血清電解質、CO2、BUN、肌酐、葡萄糖和尿酸。</p>
<p>過度利尿可能導致脱水和血容量減少，進而引發循環崩潰，可能導致血管血栓和栓塞，尤其是在老年患者中。</p>
<p>呋塞米可能導致脱水和氮質血癥。如果在嚴重進展性腎病治療期間出現氮質血癥和少尿加重，應停止使用呋塞米。</p>
<p>有報告指出，呋塞米可能導致耳鳴和可逆或不可逆的聽力損失和失聰。報告通常表明，呋塞米的耳毒性與快速注射、嚴重腎功能障礙、使用超過推薦劑量、低蛋白血癥或與氨基糖苷類抗生素、依他克林酸或其他耳毒性藥物的聯合治療有關。</p>
<p>在有嚴重尿瀦留症狀的患者（由於膀胱排空障礙、前列腺增生、尿道狹窄），使用呋塞米可能導致急性尿瀦留，因尿液產生和滯留增加。這些患者在治療初期需要仔細監測。</p>
<p>在治療期間，接觸水或其他液體以及某些患者的動作可能導致體內輸注器提前終止輸注。確保患者能夠檢測並響應警報。</p>
<p>在臨牀試驗中，FUROSCIX 給藥最常見的不良反應是注射部位和皮膚反應，包括紅斑、淤血、水腫和注射部位疼痛。</p>
<p>請查看完整的 <strong>處方信息</strong> ( <strong>https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf</strong>) 和 <strong>使用説明</strong> ( <strong>https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf</strong>)。</p>
<p><strong>關於 MannKind</strong></p>
<p>MannKind Corporation（納斯達克代碼：MNKD）是一家生物製藥公司，致力於通過創新的以患者為中心的解決方案來改變慢性疾病的護理。我們專注於心代謝和孤兒肺病，開發和商業化滿足嚴重未滿足醫療需求的治療方案，包括糖尿病、肺動脈高壓以及心力衰竭和慢性腎病中的液體超負荷。</p>
<p>憑藉在藥物 - 設備組合方面的深厚專業知識，MannKind 旨在提供與日常生活無縫契合的治療方案。</p>
<p>瞭解更多信息，請訪問 mannkindcorp.com。</p>
<p><strong>前瞻性聲明</strong></p>
<p>本新聞稿包含前瞻性聲明，這些聲明涉及風險和不確定性，包括關於潛在監管行動日期的聲明、關於專利保護潛在持續時間的聲明以及關於通過自動注射器給藥的潛在好處的聲明，這些聲明涉及提供者、患者和支付方。諸如 “相信”、“預期”、“計劃”、“期望”、“打算”、“將”、“目標”、“潛在” 等類似表達旨在識別前瞻性聲明。這些前瞻性聲明基於 MannKind 當前的預期。實際結果和事件的時機可能因各種風險和不確定性而與這些前瞻性聲明中預期的結果有實質性差異，包括但不限於，FDA 審查過程中出現的問題可能導致我們面臨意外延遲或阻止我們獲得市場批准的風險，我們可能無法保護我們的專有權利的風險，以及在 MannKind 向證券交易委員會提交的文件中詳細説明的其他風險，包括在截至 2024 年 12 月 31 日的年度報告的 “風險因素” 標題下，以及後續的 10-Q 表格定期報告和 8-K 表格當前報告。您被警告不要對這些前瞻性聲明過度依賴，這些聲明僅在本新聞稿日期時有效。所有前瞻性聲明均受到此警示聲明的全面限制，MannKind 沒有義務修訂或更新任何前瞻性聲明，以反映本新聞稿日期之後的事件或情況。</p>
<p>FUROSCIX 是 scPharmaceuticals 的註冊商標，scPharmaceuticals 是 MannKind Corporation 的全資子公司。</p>
<p>MANNKIND 是 MannKind Corporation 的註冊商標。</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 聯繫人：媒體關係：Christie Iacangelo（818）292-3500 media@mnkd.com 投資者關係：Kate Miranda（781）301-6869 ir@mnkd.com
</code></pre>

曼恩凱德生物醫療

<p>曼恩凱德生物醫療宣佈，FDA 已批准 FUROSCIX® On-body Infusor 用於體重在 43 公斤或以上的兒童患者，擴大了其在慢性心力衰竭和腎病成人患者之外的應用。此外，美國專利商標局（USPTO）為 FUROSCIX ReadyFlow™ 自動注射器頒發了五項專利，增強了其知識產權保護。該自自動注射器正在接受 FDA 審查，可能通過在幾秒鐘內提供利尿劑劑量來改變護理方式，從而減少住院次數並改善患者的生活質量</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>用於體重在 43kg 或以上的兒童患者</em></li>
<li><em>USPTO 為 FUROSCIX ReadyFlow</em> <em>™</em> <em>自動注射器頒發五項專利</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>加利福尼亞州西湖村和馬薩諸塞州伯靈頓，2025 年 12 月 23 日（GLOBE NEWSWIRE）-- <strong>MannKind Corporation（納斯達克代碼：MNKD）</strong> 今天宣佈了兩項業務更新——FUROSCIX®（呋塞米）體內輸注器獲得兒童患者的批准，以及為正在研發階段的 FUROSCIX ReadyFlow™自動注射器頒發額外的知識產權保護，該產品目前正在接受美國 FDA 的審查。</p>
</div><p><strong>FUROSCIX Expanded Treatment Options for Appropriate Pediatric Patients</strong></p>
<div class="lb-trans"><p><strong>FUROSCIX 為合適的兒童患者擴展治療選擇</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>美國食品藥品監督管理局（FDA）已批准 FUROSCIX®（呋塞米）體內輸注器的補充新藥申請（sNDA），將該產品的適應症擴展至體重在 43 公斤或以上的兒童患者。FUROSCIX 之前已獲批准用於治療成人的慢性心力衰竭（CHF）和慢性腎病（CKD）相關的水腫。這項額外的批准滿足了《兒童研究公平法》下原始批准信中列出的所有上市後要求。</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>“我們很高興能將 FUROSCIX 提供給兒童羣體，這是一個高度特定的患者羣體，為符合體重標準的患者提供了醫院外的便利選擇，” MannKind Corporation 首席醫療官 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>五項新的美國專利為 FUROSCIX ReadyFlow 自動注射器提供保護</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>美國專利商標局（USPTO）頒發了五項專利，保護 FUROSCIX ReadyFlow 自動注射器。這些專利涵蓋了呋塞米的高濃度液體配方及相關的治療方法，可能持續到 2040 年，進一步鞏固了 MannKind 在這一創新藥物 - 設備組合上的知識產權地位。如果 FUROSCIX ReadyFlow 自動注射器獲得 FDA 批准，這些專利將被列入 FDA 的橙皮書。</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>新頒發的專利補充了之前支持 FUROSCIX 和 FUROSCIX ReadyFlow 自動注射器的專利，形成了一個強大的知識產權組合，旨在保護該配方和給藥方式多年。</p>
</div><p><strong>FUROSCIX ReadyFlow Autoinjector Could Transform Care from Hours to Seconds</strong></p>
<div class="lb-trans"><p><strong>FUROSCIX ReadyFlow 自動注射器可能將護理時間從小時縮短到秒</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 最近宣佈，FDA 已接受其針對 FUROSCIX ReadyFlow 自動注射器用於治療成人 CHF 或 CKD 水腫的 sNDA 申請進行審查。該申請已被分配了 2026 年 7 月 26 日的處方藥用户費用法案（PDUFA）目標行動日期。</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>如果獲得批准，FUROSCIX ReadyFlow 自動注射器將在 10 秒內提供等同於靜脈注射的利尿劑劑量（皮下呋塞米注射 80 mg/mL），為 CHF 或 CKD 患者提供了一種在家中而非醫院環境中管理液體積聚發作的新選擇。FDA 批准的 FUROSCIX 體內輸注器於 2022 年獲批用於治療成人慢性心力衰竭患者的水腫，並於 2025 年獲批用於成人慢性腎病患者。</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 自動注射器有潛力重新定義患者管理液體超負荷發作的方式，” MannKind Corporation 首席執行官 Michael Castagna 博士表示。“通過在家中舒適的環境中在幾秒鐘內提供等同於靜脈注射的利尿劑劑量，這項創新如果獲得批准，可能顯著減少住院次數，提高生活質量，並降低醫療成本——為患者、提供者和支付方創造有意義的價值。”</p>
</div><p><strong>About FUROSCIX</strong></p>
<div class="lb-trans"><p><strong>關於 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 用於皮下使用，適用於體重至少 43 kg 的兒童患者和患有慢性心力衰竭或慢性腎病（包括腎病綜合徵）的成人患者的水腫治療。</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 禁用於無尿症患者以及對呋塞米、FUROSCIX 配方的任何成分或醫療粘合劑有過敏史的患者。</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>呋塞米可能導致液體、電解質和代謝異常，特別是在接受高劑量治療的患者、口服電解質攝入不足的患者以及老年患者中。在呋塞米治療期間，應頻繁監測血清電解質、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>過度利尿可能導致脱水和血容量減少，進而引發循環崩潰，可能導致血管血栓和栓塞，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>呋塞米可能導致脱水和氮質血癥。如果在嚴重進展性腎病治療期間出現氮質血癥和少尿加重，應停止使用呋塞米。</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>有報告指出，呋塞米可能導致耳鳴和可逆或不可逆的聽力損失和失聰。報告通常表明，呋塞米的耳毒性與快速注射、嚴重腎功能障礙、使用超過推薦劑量、低蛋白血癥或與氨基糖苷類抗生素、依他克林酸或其他耳毒性藥物的聯合治療有關。</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>在有嚴重尿瀦留症狀的患者（由於膀胱排空障礙、前列腺增生、尿道狹窄），使用呋塞米可能導致急性尿瀦留，因尿液產生和滯留增加。這些患者在治療初期需要仔細監測。</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>在治療期間，接觸水或其他液體以及某些患者的動作可能導致體內輸注器提前終止輸注。確保患者能夠檢測並響應警報。</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>在臨牀試驗中，FUROSCIX 給藥最常見的不良反應是注射部位和皮膚反應，包括紅斑、淤血、水腫和注射部位疼痛。</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>請查看完整的 <strong>處方信息</strong> ( <strong>https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf</strong>) 和 <strong>使用説明</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>關於 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（納斯達克代碼：MNKD）是一家生物製藥公司，致力於通過創新的以患者為中心的解決方案來改變慢性疾病的護理。我們專注於心代謝和孤兒肺病，開發和商業化滿足嚴重未滿足醫療需求的治療方案，包括糖尿病、肺動脈高壓以及心力衰竭和慢性腎病中的液體超負荷。</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>憑藉在藥物 - 設備組合方面的深厚專業知識，MannKind 旨在提供與日常生活無縫契合的治療方案。</p>
</div><p>Learn more at mannkindcorp.com.</p>
<div class="lb-trans"><p>瞭解更多信息，請訪問 mannkindcorp.com。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性聲明</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>本新聞稿包含前瞻性聲明，這些聲明涉及風險和不確定性，包括關於潛在監管行動日期的聲明、關於專利保護潛在持續時間的聲明以及關於通過自動注射器給藥的潛在好處的聲明，這些聲明涉及提供者、患者和支付方。諸如 “相信”、“預期”、“計劃”、“期望”、“打算”、“將”、“目標”、“潛在” 等類似表達旨在識別前瞻性聲明。這些前瞻性聲明基於 MannKind 當前的預期。實際結果和事件的時機可能因各種風險和不確定性而與這些前瞻性聲明中預期的結果有實質性差異，包括但不限於，FDA 審查過程中出現的問題可能導致我們面臨意外延遲或阻止我們獲得市場批准的風險，我們可能無法保護我們的專有權利的風險，以及在 MannKind 向證券交易委員會提交的文件中詳細説明的其他風險，包括在截至 2024 年 12 月 31 日的年度報告的 “風險因素” 標題下，以及後續的 10-Q 表格定期報告和 8-K 表格當前報告。您被警告不要對這些前瞻性聲明過度依賴，這些聲明僅在本新聞稿日期時有效。所有前瞻性聲明均受到此警示聲明的全面限制，MannKind 沒有義務修訂或更新任何前瞻性聲明，以反映本新聞稿日期之後的事件或情況。</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 的註冊商標，scPharmaceuticals 是 MannKind Corporation 的全資子公司。</p>
</div><p>MANNKIND is a registered trademark of MannKind Corporation.</p>
<div class="lb-trans"><p>MANNKIND 是 MannKind Corporation 的註冊商標。</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 聯繫人：媒體關係：Christie Iacangelo（818）292-3500 media@mnkd.com 投資者關係：Kate Miranda（781）301-6869 ir@mnkd.com
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