<p>Unicycive Therapeutics, Inc.（纳斯达克：UNCY）是一家生物科技公司，致力于为肾脏疾病患者开发新型治疗方案。在与 <em>AlphaStreet</em> 的电子邮件采访中，首席执行官 Shalabh Gupta 博士分享了 Unicycive 的商业战略和管道进展。</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>问：<em>您能简要介绍一下 Unicycive Therapeutics 及其运营吗？</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 是一家临床阶段的生物科技公司，专注于开发满足肾脏护理中最大未满足需求的治疗方案。我们的团队流程专注于发现患者需求高而现有选择不足的机会，然后努力推进能够快速通过开发的疗法。</p>
<p>我们的管道集中在两个项目上：<strong>Oxylanthanum Carbonate (OLC) –</strong> 一种新一代的实验性基于镧的磷酸盐结合剂，采用专有的纳米颗粒技术。它正在为患有慢性肾病并面临高磷血症的人群开发。<strong>Uni-494 –</strong> 一种针对急性肾损伤的实验性疗法。如果获得批准，它将成为专门为该病症设计的首个可用药物。</p>
<p>在这两个项目中，公司将科学严谨性与精简的开发模式相结合，旨在更快地将经过良好验证的技术交到患者及其提供者手中。</p>
<p><strong>问：<em>Unicycive 在肾脏护理方面有什么独特之处？</em></strong></p>
<p>Unicycive 全力投入肾脏护理，特别关注那些未被充分服务的领域，这些领域对患者和提供者的影响潜力最大。</p>
<p>我们的方法有几个定义要素：</p>
<ul>
<li><strong>针对最大未满足需求。</strong> 我们专注于治疗选择有限或过时但需求巨大的领域：高磷血症、急性肾损伤和慢性肾病。对这些特定健康挑战的坚定关注和承诺，可能会改变美国超过七分之一成人的日常护理，他们被估计患有肾病。</li>
</ul>
<ul>
<li><strong>行业领先的生物科技专家团队。</strong> Unicycive 团队汇聚了在研究、临床开发、监管战略和肾脏病学方面拥有丰富经验的行业资深人士，为公司提供了罕见的深度洞察。这种结合的明星经验帮助我们做出更明智的决策，并有目的地推进项目。</li>
</ul>
<ul>
<li><strong>为速度和效率而构建的开发模式。</strong> Unicycive 寻找被他人忽视的高潜力科学，然后通过专注、高效的开发路径进行精炼和推进。</li>
</ul>
<ul>
<li><strong>通往实用疗法的清晰路径。</strong> Unicycive 优先考虑能够现实地到达患者的创新：科学上强大、可制造且临床上有意义。通过这样做，我们专注于为最需要的患者提供潜在解决方案，目标是快速将其推向市场。</li>
</ul>
<p>这些优先事项共同为我们在肾脏护理领域提供了独特的位置：用精准科学和高效的开发思维解决被忽视的问题。</p>
<p><strong><em>另请阅读：</em> 与 CERo Therapeutics Holdings 首席执行官的采访</strong></p>
<p><strong>问：<em>FDA Type A 会议的具体反馈如何影响您对 OLC 的重新提交策略？</em></strong></p>
<p>FDA Type A 会议确认 OLC CRL 中唯一的问题是第三方制造供应商的缺陷，未对 OLC 的前临床、临床、安全数据或 CMC 表达任何担忧。这一清晰度，加上我们与供应商的持续讨论及其合规进展，指导了我们的重新提交策略，该策略仍按计划在年末进行，并为 OLC 2026 年的潜在批准做好了准备。</p>
<p><strong>问：<em>您能为我们讲解一下 OLC 的商业化路线图吗——在批准后您优先考虑哪些里程碑？</em></strong></p>
<p>我们的商业化路线图在 OLC 获得批准后，战略性地专注于在几个关键优先事项上成功推出。</p>
<p>OLC 批准后的商业化路线图：</p>
<ul>
<li><strong>供应准备：</strong> 我们的商业制造、包装和质量流程将在批准时完全验证并准备就绪，确保推出时有一致、可靠的供应。</li>
</ul>
<ul>
<li><strong>市场准入和报销：</strong> 我们的目标是确保广泛覆盖和强大的处方位置。我们将与关键利益相关者接触，包括商业保险公司、CMS（医疗保险和医疗补助服务中心）、透析组织和肾脏病网络，强调 OLC 较低的药丸负担如何满足磷管理中的重大需求。</li>
</ul>
<ul>
<li><strong>针对性教育：</strong> 我们将投资于对开处方者和患者的教育。我们的商业团队将专注于向肾脏病专家、营养师、药剂师和透析团队等有影响力的人物传达 OLC 的临床特征、剂量和整体价值。</li>
</ul>
<ul>
<li><strong>患者支持：</strong> 我们计划推出一项患者支持计划，旨在简化获取、提高可负担性并鼓励治疗依从性。</li>
</ul>
<ul>
<li><strong>高效的商业规模扩展：</strong> 鉴于肾脏病市场的集中性质，我们将建立一个专注的商业足迹，使我们能够高效地扩展商业能力，同时持续评估未来的地理扩展机会。</li>
</ul>
<ul>
<li><strong>运营和财务启动准备：</strong> 我们在运营和财务上为推出做好了准备。我们强大的现金状况为我们提供了到 2027 年的资金保障，确保我们能够以财务纪律执行推出并支持长期增长。</li>
</ul>
<p><strong>（免责声明：</strong> <em>本次采访中表达的观点仅代表受访者个人观点，并不一定反映 AlphaStreet 的观点或意见。仅供信息参考，不构成投资建议、财务指导或买卖任何证券的推荐。）</em></p>
<p>Unicycive 全力投入肾脏护理，专注于服务不足的领域：首席执行官首次出现在 AlphaStreet。</p>

UNCY

<p>Unicycive Therapeutics, Inc.（纳斯达克股票代码：UNCY）是一家专注于开发肾脏疾病治疗方案的生物科技公司，特别是在服务不足的领域。首席执行官 Shalabh Gupta 博士强调了他们的产品管线，包括用于高磷血症的 Oxylanthanum Carbonate 和用于急性肾损伤的 Uni-494。该公司旨在实现高效开发和快速市场进入，并在 OLC 获批后制定战略商业化路线图，重点关注供应准备、市场准入、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.（纳斯达克：UNCY）是一家生物科技公司，致力于为肾脏疾病患者开发新型治疗方案。在与 <em>AlphaStreet</em> 的电子邮件采访中，首席执行官 Shalabh Gupta 博士分享了 Unicycive 的商业战略和管道进展。</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>问：<em>您能简要介绍一下 Unicycive Therapeutics 及其运营吗？</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 是一家临床阶段的生物科技公司，专注于开发满足肾脏护理中最大未满足需求的治疗方案。我们的团队流程专注于发现患者需求高而现有选择不足的机会，然后努力推进能够快速通过开发的疗法。</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>我们的管道集中在两个项目上：<strong>Oxylanthanum Carbonate (OLC) –</strong> 一种新一代的实验性基于镧的磷酸盐结合剂，采用专有的纳米颗粒技术。它正在为患有慢性肾病并面临高磷血症的人群开发。<strong>Uni-494 –</strong> 一种针对急性肾损伤的实验性疗法。如果获得批准，它将成为专门为该病症设计的首个可用药物。</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>在这两个项目中，公司将科学严谨性与精简的开发模式相结合，旨在更快地将经过良好验证的技术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>问：<em>Unicycive 在肾脏护理方面有什么独特之处？</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 全力投入肾脏护理，特别关注那些未被充分服务的领域，这些领域对患者和提供者的影响潜力最大。</p>
</div><p>A few things define our approach:</p>
<div class="lb-trans"><p>我们的方法有几个定义要素：</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>针对最大未满足需求。</strong> 我们专注于治疗选择有限或过时但需求巨大的领域：高磷血症、急性肾损伤和慢性肾病。对这些特定健康挑战的坚定关注和承诺，可能会改变美国超过七分之一成人的日常护理，他们被估计患有肾病。</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>行业领先的生物科技专家团队。</strong> Unicycive 团队汇聚了在研究、临床开发、监管战略和肾脏病学方面拥有丰富经验的行业资深人士，为公司提供了罕见的深度洞察。这种结合的明星经验帮助我们做出更明智的决策，并有目的地推进项目。</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>为速度和效率而构建的开发模式。</strong> Unicycive 寻找被他人忽视的高潜力科学，然后通过专注、高效的开发路径进行精炼和推进。</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>通往实用疗法的清晰路径。</strong> Unicycive 优先考虑能够现实地到达患者的创新：科学上强大、可制造且临床上有意义。通过这样做，我们专注于为最需要的患者提供潜在解决方案，目标是快速将其推向市场。</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>这些优先事项共同为我们在肾脏护理领域提供了独特的位置：用精准科学和高效的开发思维解决被忽视的问题。</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>另请阅读：</em> 与 CERo Therapeutics Holdings 首席执行官的采访</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>问：<em>FDA Type A 会议的具体反馈如何影响您对 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 会议确认 OLC CRL 中唯一的问题是第三方制造供应商的缺陷，未对 OLC 的前临床、临床、安全数据或 CMC 表达任何担忧。这一清晰度，加上我们与供应商的持续讨论及其合规进展，指导了我们的重新提交策略，该策略仍按计划在年末进行，并为 OLC 2026 年的潜在批准做好了准备。</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>问：<em>您能为我们讲解一下 OLC 的商业化路线图吗——在批准后您优先考虑哪些里程碑？</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>我们的商业化路线图在 OLC 获得批准后，战略性地专注于在几个关键优先事项上成功推出。</p>
</div><p>Commercialization Roadmap Post-OLC Approval:</p>
<div class="lb-trans"><p>OLC 批准后的商业化路线图：</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>供应准备：</strong> 我们的商业制造、包装和质量流程将在批准时完全验证并准备就绪，确保推出时有一致、可靠的供应。</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>市场准入和报销：</strong> 我们的目标是确保广泛覆盖和强大的处方位置。我们将与关键利益相关者接触，包括商业保险公司、CMS（医疗保险和医疗补助服务中心）、透析组织和肾脏病网络，强调 OLC 较低的药丸负担如何满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>针对性教育：</strong> 我们将投资于对开处方者和患者的教育。我们的商业团队将专注于向肾脏病专家、营养师、药剂师和透析团队等有影响力的人物传达 OLC 的临床特征、剂量和整体价值。</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> 我们计划推出一项患者支持计划，旨在简化获取、提高可负担性并鼓励治疗依从性。</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>高效的商业规模扩展：</strong> 鉴于肾脏病市场的集中性质，我们将建立一个专注的商业足迹，使我们能够高效地扩展商业能力，同时持续评估未来的地理扩展机会。</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>运营和财务启动准备：</strong> 我们在运营和财务上为推出做好了准备。我们强大的现金状况为我们提供了到 2027 年的资金保障，确保我们能够以财务纪律执行推出并支持长期增长。</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>（免责声明：</strong> <em>本次采访中表达的观点仅代表受访者个人观点，并不一定反映 AlphaStreet 的观点或意见。仅供信息参考，不构成投资建议、财务指导或买卖任何证券的推荐。）</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 全力投入肾脏护理，专注于服务不足的领域：首席执行官首次出现在 AlphaStreet。</p>
</div>

Unicycive 全力投入肾脏护理，专注于未被充分服务的领域：CEO