<p>Unicycive Therapeutics, Inc.（納斯達克：UNCY）是一家生物科技公司，致力於為腎臟疾病患者開發新型治療方案。在與 <em>AlphaStreet</em> 的電子郵件採訪中，首席執行官 Shalabh Gupta 博士分享了 Unicycive 的商業戰略和管道進展。</p>
<p><img src="https://imageproxy.pbkrs.com/https://cdn.news.alphastreet.com/wp-content/uploads/2023/09/Interview.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="1280" height="853" original-src="https://imageproxy.pbkrs.com/https://cdn.news.alphastreet.com/wp-content/uploads/2023/09/Interview.jpg"/></p>
<p><strong>問：<em>您能簡要介紹一下 Unicycive Therapeutics 及其運營嗎？</em></strong></p>
<p><img src="https://imageproxy.pbkrs.com/https://cdn.news.alphastreet.com/wp-content/uploads/2025/12/ShalabhGuptaHeadshot.jpeg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="240" height="240" original-src="https://imageproxy.pbkrs.com/https://cdn.news.alphastreet.com/wp-content/uploads/2025/12/ShalabhGuptaHeadshot.jpeg"/></p>
<p>Unicycive Therapeutics 是一家臨牀階段的生物科技公司，專注於開發滿足腎臟護理中最大未滿足需求的治療方案。我們的團隊流程專注於發現患者需求高而現有選擇不足的機會，然後努力推進能夠快速通過開發的療法。</p>
<p>我們的管道集中在兩個項目上：<strong>Oxylanthanum Carbonate (OLC) –</strong> 一種新一代的實驗性基於鑭的磷酸鹽結合劑，採用專有的納米顆粒技術。它正在為患有慢性腎病並面臨高磷血癥的人羣開發。<strong>Uni-494 –</strong> 一種針對急性腎損傷的實驗性療法。如果獲得批准，它將成為專門為該病症設計的首個可用藥物。</p>
<p>在這兩個項目中，公司將科學嚴謹性與精簡的開發模式相結合，旨在更快地將經過良好驗證的技術交到患者及其提供者手中。</p>
<p><strong>問：<em>Unicycive 在腎臟護理方面有什麼獨特之處？</em></strong></p>
<p>Unicycive 全力投入腎臟護理，特別關注那些未被充分服務的領域，這些領域對患者和提供者的影響潛力最大。</p>
<p>我們的方法有幾個定義要素：</p>
<ul>
<li><strong>針對最大未滿足需求。</strong> 我們專注於治療選擇有限或過時但需求巨大的領域：高磷血癥、急性腎損傷和慢性腎病。對這些特定健康挑戰的堅定關注和承諾，可能會改變美國超過七分之一成人的日常護理，他們被估計患有腎病。</li>
</ul>
<ul>
<li><strong>行業領先的生物科技專家團隊。</strong> Unicycive 團隊匯聚了在研究、臨牀開發、監管戰略和腎臟病學方面擁有豐富經驗的行業資深人士，為公司提供了罕見的深度洞察。這種結合的明星經驗幫助我們做出更明智的決策，並有目的地推進項目。</li>
</ul>
<ul>
<li><strong>為速度和效率而構建的開發模式。</strong> Unicycive 尋找被他人忽視的高潛力科學，然後通過專注、高效的開發路徑進行精煉和推進。</li>
</ul>
<ul>
<li><strong>通往實用療法的清晰路徑。</strong> Unicycive 優先考慮能夠現實地到達患者的創新：科學上強大、可製造且臨牀上有意義。通過這樣做，我們專注於為最需要的患者提供潛在解決方案，目標是快速將其推向市場。</li>
</ul>
<p>這些優先事項共同為我們在腎臟護理領域提供了獨特的位置：用精準科學和高效的開發思維解決被忽視的問題。</p>
<p><strong><em>另請閲讀：</em> 與 CERo Therapeutics Holdings 首席執行官的採訪</strong></p>
<p><strong>問：<em>FDA Type A 會議的具體反饋如何影響您對 OLC 的重新提交策略？</em></strong></p>
<p>FDA Type A 會議確認 OLC CRL 中唯一的問題是第三方製造供應商的缺陷，未對 OLC 的前臨牀、臨牀、安全數據或 CMC 表達任何擔憂。這一清晰度，加上我們與供應商的持續討論及其合規進展，指導了我們的重新提交策略，該策略仍按計劃在年末進行，併為 OLC 2026 年的潛在批准做好了準備。</p>
<p><strong>問：<em>您能為我們講解一下 OLC 的商業化路線圖嗎——在批准後您優先考慮哪些里程碑？</em></strong></p>
<p>我們的商業化路線圖在 OLC 獲得批准後，戰略性地專注於在幾個關鍵優先事項上成功推出。</p>
<p>OLC 批准後的商業化路線圖：</p>
<ul>
<li><strong>供應準備：</strong> 我們的商業製造、包裝和質量流程將在批准時完全驗證並準備就緒，確保推出時有一致、可靠的供應。</li>
</ul>
<ul>
<li><strong>市場準入和報銷：</strong> 我們的目標是確保廣泛覆蓋和強大的處方位置。我們將與關鍵利益相關者接觸，包括商業保險公司、CMS（醫療保險和醫療補助服務中心）、透析組織和腎臟病網絡，強調 OLC 較低的藥丸負擔如何滿足磷管理中的重大需求。</li>
</ul>
<ul>
<li><strong>針對性教育：</strong> 我們將投資於對開處方者和患者的教育。我們的商業團隊將專注於向腎臟病專家、營養師、藥劑師和透析團隊等有影響力的人物傳達 OLC 的臨牀特徵、劑量和整體價值。</li>
</ul>
<ul>
<li><strong>患者支持：</strong> 我們計劃推出一項患者支持計劃，旨在簡化獲取、提高可負擔性並鼓勵治療依從性。</li>
</ul>
<ul>
<li><strong>高效的商業規模擴展：</strong> 鑑於腎臟病市場的集中性質，我們將建立一個專注的商業足跡，使我們能夠高效地擴展商業能力，同時持續評估未來的地理擴展機會。</li>
</ul>
<ul>
<li><strong>運營和財務啓動準備：</strong> 我們在運營和財務上為推出做好了準備。我們強大的現金狀況為我們提供了到 2027 年的資金保障，確保我們能夠以財務紀律執行推出並支持長期增長。</li>
</ul>
<p><strong>（免責聲明：</strong> <em>本次採訪中表達的觀點僅代表受訪者個人觀點，並不一定反映 AlphaStreet 的觀點或意見。僅供信息參考，不構成投資建議、財務指導或買賣任何證券的推薦。）</em></p>
<p>Unicycive 全力投入腎臟護理，專注於服務不足的領域：首席執行官首次出現在 AlphaStreet。</p>

UNCY

<p>Unicycive Therapeutics, Inc.（納斯達克股票代碼：UNCY）是一家專注於開發腎臟疾病治療方案的生物科技公司，特別是在服務不足的領域。首席執行官 Shalabh Gupta 博士強調了他們的產品管線，包括用於高磷血癥的 Oxylanthanum Carbonate 和用於急性腎損傷的 Uni-494。該公司旨在實現高效開發和快速市場進入，並在 OLC 獲批後製定戰略商業化路線圖，重點關注供應準備、市場準入、教育和患者支持</p>

<p>Unicycive Therapeutics, Inc. (NASDAQ: UNCY) is a biotech firm engaged in the development of novel treatment options for patients with renal diseases. In an email interview with <em>AlphaStreet</em>, CEO Dr. Shalabh Gupta shared insights into Unicycive’s business strategy and pipeline progress.</p>
<div class="lb-trans"><p>Unicycive Therapeutics, Inc.（納斯達克：UNCY）是一家生物科技公司，致力於為腎臟疾病患者開發新型治療方案。在與 <em>AlphaStreet</em> 的電子郵件採訪中，首席執行官 Shalabh Gupta 博士分享了 Unicycive 的商業戰略和管道進展。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://cdn.news.alphastreet.com/wp-content/uploads/2023/09/Interview.jpg" alt="" original-src="https://cdn.news.alphastreet.com/wp-content/uploads/2023/09/Interview.jpg"/></p>
<p><strong>Q: <em>Can you provide a brief overview of Unicycive Therapeutics and its operations?</em></strong></p>
<div class="lb-trans"><p><strong>問：<em>您能簡要介紹一下 Unicycive Therapeutics 及其運營嗎？</em></strong></p>
</div><p><img src="https://imageproxy.pbkrs.com/https://cdn.news.alphastreet.com/wp-content/uploads/2025/12/ShalabhGuptaHeadshot.jpeg" alt="" original-src="https://cdn.news.alphastreet.com/wp-content/uploads/2025/12/ShalabhGuptaHeadshot.jpeg"/></p>
<p>Unicycive Therapeutics is a clinical-stage biotech company focused on developing treatments for the biggest unmet needs in kidney care. Our team’s process focuses on uncovering opportunities where patient needs are high and current options fall short, then working to advance therapies that can move quickly through development.</p>
<div class="lb-trans"><p>Unicycive Therapeutics 是一家臨牀階段的生物科技公司，專注於開發滿足腎臟護理中最大未滿足需求的治療方案。我們的團隊流程專注於發現患者需求高而現有選擇不足的機會，然後努力推進能夠快速通過開發的療法。</p>
</div><p>Our pipeline centers on two programs: <strong>Oxylanthanum Carbonate (OLC) –</strong> a next-generation, investigational lanthanum-based phosphate binder that uses proprietary nanoparticle technology. It’s being developed for people with chronic kidney disease who struggle with hyperphosphatemia. <strong>Uni-494 –</strong> an investigational therapy for acute kidney injury. If it reaches approval, it would be the first available drug designed specifically for this condition.</p>
<div class="lb-trans"><p>我們的管道集中在兩個項目上：<strong>Oxylanthanum Carbonate (OLC) –</strong> 一種新一代的實驗性基於鑭的磷酸鹽結合劑，採用專有的納米顆粒技術。它正在為患有慢性腎病並面臨高磷血癥的人羣開發。<strong>Uni-494 –</strong> 一種針對急性腎損傷的實驗性療法。如果獲得批准，它將成為專門為該病症設計的首個可用藥物。</p>
</div><p>Across both programs, the company pairs scientific rigor with a lean development model aimed at getting well-validated technologies into the hands of patients and their providers faster.</p>
<div class="lb-trans"><p>在這兩個項目中，公司將科學嚴謹性與精簡的開發模式相結合，旨在更快地將經過良好驗證的技術交到患者及其提供者手中。</p>
</div><p><strong>Q: <em>What sets Unicycive apart in kidney care?</em></strong></p>
<div class="lb-trans"><p><strong>問：<em>Unicycive 在腎臟護理方面有什麼獨特之處？</em></strong></p>
</div><p>Unicycive is all-in on kidney care, specifically focusing on underserved areas with the greatest potential for patient and provider impact.</p>
<div class="lb-trans"><p>Unicycive 全力投入腎臟護理，特別關注那些未被充分服務的領域，這些領域對患者和提供者的影響潛力最大。</p>
</div><p>A few things define our approach:</p>
<div class="lb-trans"><p>我們的方法有幾個定義要素：</p>
</div><ul>
<li><strong>Targeting the biggest unmet needs.</strong> We concentrate on areas where treatment options are limited or outdated, but the need is outsized: hyperphosphatemia, acute kidney injury, and chronic kidney disease. An unwavering focus and commitment to these specific health challenges present the potential to change everyday care for the more than one in seven adults in the US who are estimated to have kidney disease.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>針對最大未滿足需求。</strong> 我們專注於治療選擇有限或過時但需求巨大的領域：高磷血癥、急性腎損傷和慢性腎病。對這些特定健康挑戰的堅定關注和承諾，可能會改變美國超過七分之一成人的日常護理，他們被估計患有腎病。</li>
</ul>
</div><ul>
<li><strong>An industry-leading team of biotech experts.</strong> The Unicycive team brings together industry veterans with expertise across research, clinical development, regulatory strategy, and nephrology, giving the company a rare depth of insight. This combined all-star experience helps us make sharper decisions and move programs forward with purpose.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>行業領先的生物科技專家團隊。</strong> Unicycive 團隊匯聚了在研究、臨牀開發、監管戰略和腎臟病學方面擁有豐富經驗的行業資深人士，為公司提供了罕見的深度洞察。這種結合的明星經驗幫助我們做出更明智的決策，並有目的地推進項目。</li>
</ul>
</div><ul>
<li><strong>A development model built for speed and efficiency.</strong> Unicycive looks for high-potential science that others have overlooked, then refines and advances it through a focused, efficient development path.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>為速度和效率而構建的開發模式。</strong> Unicycive 尋找被他人忽視的高潛力科學，然後通過專注、高效的開發路徑進行精煉和推進。</li>
</ul>
</div><ul>
<li><strong>A clear path to practical therapies.</strong> Unicycive prioritizes innovations that can realistically reach patients: scientifically strong, manufacturable, and clinically meaningful. By doing so, we are heads-down on delivering potential solutions to patients who need them the most with the goal of bringing them to market fast.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>通往實用療法的清晰路徑。</strong> Unicycive 優先考慮能夠現實地到達患者的創新：科學上強大、可製造且臨牀上有意義。通過這樣做，我們專注於為最需要的患者提供潛在解決方案，目標是快速將其推向市場。</li>
</ul>
</div><p>Together, these priorities give us a distinct place in the kidney-care landscape: solving overlooked problems with precision science and an efficient development mindset.</p>
<div class="lb-trans"><p>這些優先事項共同為我們在腎臟護理領域提供了獨特的位置：用精準科學和高效的開發思維解決被忽視的問題。</p>
</div><p><strong><em>Also Read:</em> An Interview with the CEO of CERo Therapeutics Holdings</strong></p>
<div class="lb-trans"><p><strong><em>另請閲讀：</em> 與 CERo Therapeutics Holdings 首席執行官的採訪</strong></p>
</div><p><strong>Q: <em>What specific feedback from the FDA Type A meeting shaped your resubmission strategy for OLC?</em></strong></p>
<div class="lb-trans"><p><strong>問：<em>FDA Type A 會議的具體反饋如何影響您對 OLC 的重新提交策略？</em></strong></p>
</div><p>The FDA Type A meeting confirmed that the sole issue in the OLC CRL was a deficiency at a third-party manufacturing vendor, with no concerns regarding OLC’s preclinical, clinical, safety data, or CMC. This clarity, combined with our ongoing discussions with the vendor and its progress toward compliance, informed our resubmission strategy, which remains on track for year-end and positions OLC for a potential 2026 approval.</p>
<div class="lb-trans"><p>FDA Type A 會議確認 OLC CRL 中唯一的問題是第三方製造供應商的缺陷，未對 OLC 的前臨牀、臨牀、安全數據或 CMC 表達任何擔憂。這一清晰度，加上我們與供應商的持續討論及其合規進展，指導了我們的重新提交策略，該策略仍按計劃在年末進行，併為 OLC 2026 年的潛在批准做好了準備。</p>
</div><p><strong>Q:</strong> <em><strong>Can you walk us through your commercialization roadmap for OLC—what milestones are you prioritizing post-approval?</strong></em></p>
<div class="lb-trans"><p><strong>問：<em>您能為我們講解一下 OLC 的商業化路線圖嗎——在批准後您優先考慮哪些里程碑？</em></strong></p>
</div><p>Our commercialization roadmap, following OLC approval, is strategically focused on a successful launch across several key priorities.</p>
<div class="lb-trans"><p>我們的商業化路線圖在 OLC 獲得批准後，戰略性地專注於在幾個關鍵優先事項上成功推出。</p>
</div><p>Commercialization Roadmap Post-OLC Approval:</p>
<div class="lb-trans"><p>OLC 批准後的商業化路線圖：</p>
</div><ul>
<li><strong>Supply Readiness:</strong> Our commercial manufacturing, packaging, and quality processes will be fully validated and ready at approval, ensuring a consistent, reliable supply for launch.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>供應準備：</strong> 我們的商業製造、包裝和質量流程將在批准時完全驗證並準備就緒，確保推出時有一致、可靠的供應。</li>
</ul>
</div><ul>
<li><strong>Market Access and Reimbursement:</strong> Our goal is to secure broad coverage and strong formulary positioning. We will engage key stakeholders, including commercial insurers, CMS (Centers for Medicare and Medicaid Services), dialysis organizations, and nephrology networks, emphasizing how OLC’s lower pill burden addresses a significant need in phosphate management.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>市場準入和報銷：</strong> 我們的目標是確保廣泛覆蓋和強大的處方位置。我們將與關鍵利益相關者接觸，包括商業保險公司、CMS（醫療保險和醫療補助服務中心）、透析組織和腎臟病網絡，強調 OLC 較低的藥丸負擔如何滿足磷管理中的重大需求。</li>
</ul>
</div><ul>
<li><strong>Targeted Education:</strong> We will invest in educating prescribers and patients. Our commercial team will focus on communicating OLC’s clinical profile, dosing, and overall value to influential figures such as nephrologists, dietitians, pharmacists, and dialysis teams.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>針對性教育：</strong> 我們將投資於對開處方者和患者的教育。我們的商業團隊將專注於向腎臟病專家、營養師、藥劑師和透析團隊等有影響力的人物傳達 OLC 的臨牀特徵、劑量和整體價值。</li>
</ul>
</div><ul>
<li><strong>Patient Support:</strong> We plan to launch a patient support program designed to simplify access, enhance affordability, and encourage treatment adherence.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>患者支持：</strong> 我們計劃推出一項患者支持計劃，旨在簡化獲取、提高可負擔性並鼓勵治療依從性。</li>
</ul>
</div><ul>
<li><strong>Efficient Commercial Scale-Up:</strong> Given the concentrated nature of the nephrology market, we will build a focused commercial footprint, allowing us to scale our commercial capabilities efficiently while continuously evaluating future geographic expansion opportunities.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>高效的商業規模擴展：</strong> 鑑於腎臟病市場的集中性質，我們將建立一個專注的商業足跡，使我們能夠高效地擴展商業能力，同時持續評估未來的地理擴展機會。</li>
</ul>
</div><ul>
<li><strong>Operational and Financial Launch Readiness:</strong> We are operationally and financially prepared for the launch. Our strong cash position, which provides a runway into 2027, ensures we can execute the launch with financial discipline and support long-term growth.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>運營和財務啓動準備：</strong> 我們在運營和財務上為推出做好了準備。我們強大的現金狀況為我們提供了到 2027 年的資金保障，確保我們能夠以財務紀律執行推出並支持長期增長。</li>
</ul>
</div><p><strong>(Disclaimer:</strong> <em>The views expressed in this interview are solely those of the interviewee and do not necessarily reflect the views or opinions of AlphaStreet. It is for informational purposes only and does not constitute investment advice, financial guidance, or a recommendation to buy or sell any securities.)</em></p>
<div class="lb-trans"><p><strong>（免責聲明：</strong> <em>本次採訪中表達的觀點僅代表受訪者個人觀點，並不一定反映 AlphaStreet 的觀點或意見。僅供信息參考，不構成投資建議、財務指導或買賣任何證券的推薦。）</em></p>
</div><p>The post Unicycive is all-in on kidney care, focusing on underserved areas: CEO first appeared on AlphaStreet.</p>
<div class="lb-trans"><p>Unicycive 全力投入腎臟護理，專注於服務不足的領域：首席執行官首次出現在 AlphaStreet。</p>
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Unicycive 全力投入腎臟護理，專注於未被充分服務的領域：CEO