<p>/PRNewswire/ -- 康方生物（Akeso, Inc.）（HKEX: 9926.HK）宣布，其 AK152 是一种新型双特异性抗体，针对淀粉样β（Aβ）和血脑屏障（BBB）表达的受体，已获得国家药品监督管理局（NMPA）批准，启动阿尔茨海默病的临床试验。</p>
<p>AK152 是中国开发的首个用于阿尔茨海默病疾病修饰治疗的双特异性抗体，标志着该领域的重要突破。此外，它是康方生物首个旨在靶向中枢神经系统（CNS）的创新治疗候选药物。这一成就凸显了康方生物在扩展其神经退行性疾病研究和开发管道方面的关键里程碑，并使公司能够加强其作为全球综合制药公司的地位。</p>
<p>淀粉样β（Aβ）的异常聚集和沉积是阿尔茨海默病的关键病理驱动因素。几种针对 Aβ的单克隆抗体已获得批准，临床数据显示这些药物可以通过清除脑内 Aβ斑块来减缓认知衰退。然而，这些抗体的治疗效果受到血脑屏障（BBB）穿透能力差的限制，导致脑部暴露不足，并引发重大安全隐患。</p>
<p>AK152 是一种双特异性抗体，同时靶向 Aβ和在血脑屏障上高度表达的受体。AK152 的 Aβ结合臂与 Aβ斑块结合，并对神经毒性可溶性 Aβ寡聚体表现出高选择性。AK152 的受体结合臂利用受体介导的内吞 - 跨细胞转运机制，显著增强 AK152 的脑穿透能力。</p>
<p>前临床研究表明，AK152 具有强大的生物活性和良好的特性。与传统的针对 Aβ的单克隆抗体相比，AK152 显著改善了脑穿透能力，加速了 Aβ斑块的清除，并在前临床模型中逆转了与阿尔茨海默病相关的神经病理进展，为阿尔茨海默病患者提供了潜在的有前景的新治疗选择。中枢神经系统疾病长期以来在全球范围内带来了重大的治疗挑战。康方生物凭借其在双特异性抗体开发方面的深厚专业知识，处于创造新疗法以解决中枢神经系统疾病中关键未满足临床需求的前沿。</p>
<p><strong>关于 AK152</strong></p>
<p>AK152 是康方生物开发的一种双特异性抗体，旨在同时靶向 Aβ和在血脑屏障（BBB）上高度表达的受体。在 Aβ方面，它不仅与 Aβ斑块结合，还选择性靶向更具神经毒性的可溶性 Aβ寡聚体。在 BBB 方面，它利用受体介导的内吞作用显著增强脑穿透能力。前临床研究表明，AK152 表现出强大的生物活性和良好的安全性特征，有效提高脑穿透能力，加速 Aβ斑块清除，并在阿尔茨海默病小鼠模型中表现出优于单克隆抗体的治疗效果。这些初步的有希望的结果表明，AK152 有潜力成为阿尔茨海默病的下一代疾病修饰治疗。</p>
<p><strong>康方生物的前瞻性声明</strong></p>
<p>康方生物（Akeso, Inc.）（9926.HK，&#34;康方生物&#34;）的本公告包含&#34;前瞻性声明&#34;。这些声明反映了康方生物管理层当前的信念和期望，并受到重大风险和不确定性的影响。这些声明并不旨在构成任何投资决策或购买康方生物证券的依据。不能保证本公告中提到的药物候选者或康方生物的其他管道候选者将获得所需的监管批准或实现商业成功。如果基本假设不准确或风险或不确定性实现，实际结果可能与前瞻性声明中所述的结果有重大差异。</p>
<p>风险和不确定性包括但不限于一般行业状况和竞争；一般经济因素，包括利率和汇率波动；中国、美国及国际制药行业监管和医疗立法的影响；全球医疗成本控制的趋势；竞争对手获得的新产品和专利的技术进步；新产品开发中固有的挑战，包括获得监管批准；康方生物准确预测未来市场状况的能力；制造困难或延误；国际经济的财务不稳定和主权风险；依赖于康方生物对创新产品的专利和其他保护的有效性；以及面临诉讼，包括专利诉讼和/或监管行动的风险。</p>
<p>康方生物不承担任何义务，公开修订这些前瞻性声明，以反映本公告日期之后的事件或情况，法律要求的除外。</p>
<p><strong>关于康方生物</strong></p>
<p>康方生物（HKEX: 9926.HK）是一家领先的生物制药公司，致力于全球首个或最佳创新生物药物的研究、开发、生产和商业化。公司成立于 2012 年，创建了一个独特的综合研发创新体系，以全面的端到端药物开发平台（ACE 平台）和双特异性抗体药物开发技术（Tetrabody）为核心，拥有符合 GMP 标准的生产系统和先进运营模式的商业化系统，逐渐发展成为一家全球竞争力的生物制药公司，专注于创新解决方案。康方生物拥有全面整合的多功能平台，内部正在积极推进 50 多个创新资产的强大管线，涵盖癌症、自身免疫疾病、炎症、代谢疾病及其他重大疾病。其中，24 个候选药物已进入临床试验（包括 15 个双特异性/多特异性抗体和双特异性 ADC）。此外，7 种新药已实现商业化。通过高效且突破性的研发创新，康方生物始终整合全球优质资源，开发首个和最佳的新药，为全球患者提供可负担的治疗性抗体，并不断创造更多商业和社会价值，成为全球领先的生物制药企业。</p>
<p>欲了解更多信息，请访问 https://www.akesobio.com/en/about-us/corporate-profile/ 并关注我们的 Linkedin。</p>
<p>来源：康方生物。</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMTE2Jk5ld3NJdGVtSWQ9Q04yNTc5NCZUcmFuc21pc3Npb25fSWQ9MjAyNTExMTYyMTI5UFJfTkVXU19VU1BSX19fX19DTjI1Nzk0?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMTE2Jk5ld3NJdGVtSWQ9Q04yNTc5NCZUcmFuc21pc3Npb25fSWQ9MjAyNTExMTYyMTI5UFJfTkVXU19VU1BSX19fX19DTjI1Nzk0"/></p>

康方生物

<p>康方生物宣布，其双特异性抗体 AK152 已获得中国阿尔茨海默病临床试验的批准，AK152 针对淀粉样蛋白β（Aβ）和血脑屏障（BBB）表达的受体。这是中国开发的首个针对阿尔茨海默病的双特异性抗体，标志着一个重要的突破。它增强了脑部渗透性并加速了 Aβ斑块的清除，显示出良好的临床前结果。这一批准将扩展康方生物在神经退行性疾病领域的研发管线</p>

<p>, /PRNewswire/ -- Akeso, Inc. (HKEX: 9926.HK) announced that its AK152, a novel bispecific antibody targeting both amyloid-beta (Aβ) and blood-brain barrier (BBB) expressed receptor, has been granted approval by the National Medical Products Administration (NMPA) to initiate clinical trials for Alzheimer's Disease.</p>
<div class="lb-trans"><p>/PRNewswire/ -- 康方生物（Akeso, Inc.）（HKEX: 9926.HK）宣布，其 AK152 是一种新型双特异性抗体，针对淀粉样β（Aβ）和血脑屏障（BBB）表达的受体，已获得国家药品监督管理局（NMPA）批准，启动阿尔茨海默病的临床试验。</p>
</div><p>AK152 is the first bispecific antibody developed in China for disease-modifying therapy in Alzheimer's Disease, marking a significant breakthrough in the field. Furthermore, it is Akeso's first innovative therapeutic candidate designed to target the central nervous system (CNS). This achievement underscores a critical milestone in expanding Akeso's research and development pipeline into neurodegenerative diseases and positions the company to strengthen its presence as a globally comprehensive pharmaceutical company.</p>
<div class="lb-trans"><p>AK152 是中国开发的首个用于阿尔茨海默病疾病修饰治疗的双特异性抗体，标志着该领域的重要突破。此外，它是康方生物首个旨在靶向中枢神经系统（CNS）的创新治疗候选药物。这一成就凸显了康方生物在扩展其神经退行性疾病研究和开发管道方面的关键里程碑，并使公司能够加强其作为全球综合制药公司的地位。</p>
</div><p>The abnormal aggregation and deposition of amyloid-beta (Aβ) is a key pathological driver of Alzheimer's Disease. Several monoclonal antibodies targeting Aβ have received approval, and clinical data show that these agents can slow cognitive decline by clearing cerebral Aβ plaques. However, the therapeutic efficacy of these antibodies is limited by poor blood-brain barrier (BBB) penetration, resulting in insufficient brain exposure and raises significant safety concerns.</p>
<div class="lb-trans"><p>淀粉样β（Aβ）的异常聚集和沉积是阿尔茨海默病的关键病理驱动因素。几种针对 Aβ的单克隆抗体已获得批准，临床数据显示这些药物可以通过清除脑内 Aβ斑块来减缓认知衰退。然而，这些抗体的治疗效果受到血脑屏障（BBB）穿透能力差的限制，导致脑部暴露不足，并引发重大安全隐患。</p>
</div><p>AK152 is a bispecific antibody that simultaneously targets both Aβ and a receptor highly expressed on the blood-brain barrier. The Aβ-binding arm of AK152 binds to Aβ plaques and exhibits high selectivity for the neurotoxic soluble Aβ oligomers. The receptor-binding arm of AK152 leverages the receptor-mediated endocytosis-transcytosis mechanism to significantly enhance the brain penetration of AK152.</p>
<div class="lb-trans"><p>AK152 是一种双特异性抗体，同时靶向 Aβ和在血脑屏障上高度表达的受体。AK152 的 Aβ结合臂与 Aβ斑块结合，并对神经毒性可溶性 Aβ寡聚体表现出高选择性。AK152 的受体结合臂利用受体介导的内吞 - 跨细胞转运机制，显著增强 AK152 的脑穿透能力。</p>
</div><p>Preclinical studies have demonstrated that AK152 possesses robust bioactivity and a favorable profile. Compared to conventional monoclonal antibodies targeting Aβ, AK152 significantly improves brain penetration, accelerates the clearance of Aβ plaques, and reverses the progression of Alzheimer's-related neuropathology in pre-clinical models, offering a potentially promising new treatment options for Alzheimer's patients. CNS disorders have long posed significant therapeutic challenges on a global scale. Akeso, with its deep expertise in bispecific antibody development, is at the forefront of creating novel therapies to address critical unmet clinical needs in CNS diseases.</p>
<div class="lb-trans"><p>前临床研究表明，AK152 具有强大的生物活性和良好的特性。与传统的针对 Aβ的单克隆抗体相比，AK152 显著改善了脑穿透能力，加速了 Aβ斑块的清除，并在前临床模型中逆转了与阿尔茨海默病相关的神经病理进展，为阿尔茨海默病患者提供了潜在的有前景的新治疗选择。中枢神经系统疾病长期以来在全球范围内带来了重大的治疗挑战。康方生物凭借其在双特异性抗体开发方面的深厚专业知识，处于创造新疗法以解决中枢神经系统疾病中关键未满足临床需求的前沿。</p>
</div><p><strong>About AK152</strong></p>
<div class="lb-trans"><p><strong>关于 AK152</strong></p>
</div><p>AK152 is a bispecific antibody developed by Akeso designed to simultaneously target Aβ and a receptor highly expressed at the blood-brain barrier (BBB). On the Aβ side, it not only binds to Aβ plaques but also selectively targets the more neurotoxic soluble Aβ oligomers. On the BBB side, it leverages receptor-mediated endocytosis to significantly enhance brain penetration. Preclinical studies have shown that AK152 demonstrates strong bioactivity and a favorable safety profile, effectively increasing brain penetration, accelerating Aβ plaque clearance, and exhibiting superior therapeutic efficacy over monoclonal antibodies in AD mouse models. These initial promising results suggest that AK152 has the potential to become a next-generation disease-modifying therapy for Alzheimer's disease.</p>
<div class="lb-trans"><p>AK152 是康方生物开发的一种双特异性抗体，旨在同时靶向 Aβ和在血脑屏障（BBB）上高度表达的受体。在 Aβ方面，它不仅与 Aβ斑块结合，还选择性靶向更具神经毒性的可溶性 Aβ寡聚体。在 BBB 方面，它利用受体介导的内吞作用显著增强脑穿透能力。前临床研究表明，AK152 表现出强大的生物活性和良好的安全性特征，有效提高脑穿透能力，加速 Aβ斑块清除，并在阿尔茨海默病小鼠模型中表现出优于单克隆抗体的治疗效果。这些初步的有希望的结果表明，AK152 有潜力成为阿尔茨海默病的下一代疾病修饰治疗。</p>
</div><p><strong>Forward-Looking Statement of Akeso, Inc.</strong></p>
<div class="lb-trans"><p><strong>康方生物的前瞻性声明</strong></p>
</div><p>This announcement by Akeso, Inc. (9926.HK, &#34;Akeso&#34;) contains &#34;forward-looking statements&#34;. These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.</p>
<div class="lb-trans"><p>康方生物（Akeso, Inc.）（9926.HK，&#34;康方生物&#34;）的本公告包含&#34;前瞻性声明&#34;。这些声明反映了康方生物管理层当前的信念和期望，并受到重大风险和不确定性的影响。这些声明并不旨在构成任何投资决策或购买康方生物证券的依据。不能保证本公告中提到的药物候选者或康方生物的其他管道候选者将获得所需的监管批准或实现商业成功。如果基本假设不准确或风险或不确定性实现，实际结果可能与前瞻性声明中所述的结果有重大差异。</p>
</div><p>Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.</p>
<div class="lb-trans"><p>风险和不确定性包括但不限于一般行业状况和竞争；一般经济因素，包括利率和汇率波动；中国、美国及国际制药行业监管和医疗立法的影响；全球医疗成本控制的趋势；竞争对手获得的新产品和专利的技术进步；新产品开发中固有的挑战，包括获得监管批准；康方生物准确预测未来市场状况的能力；制造困难或延误；国际经济的财务不稳定和主权风险；依赖于康方生物对创新产品的专利和其他保护的有效性；以及面临诉讼，包括专利诉讼和/或监管行动的风险。</p>
</div><p>Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.</p>
<div class="lb-trans"><p>康方生物不承担任何义务，公开修订这些前瞻性声明，以反映本公告日期之后的事件或情况，法律要求的除外。</p>
</div><p><strong>About Akeso</strong></p>
<div class="lb-trans"><p><strong>关于康方生物</strong></p>
</div><p>Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&amp;D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&amp;D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.</p>
<div class="lb-trans"><p>康方生物（HKEX: 9926.HK）是一家领先的生物制药公司，致力于全球首个或最佳创新生物药物的研究、开发、生产和商业化。公司成立于 2012 年，创建了一个独特的综合研发创新体系，以全面的端到端药物开发平台（ACE 平台）和双特异性抗体药物开发技术（Tetrabody）为核心，拥有符合 GMP 标准的生产系统和先进运营模式的商业化系统，逐渐发展成为一家全球竞争力的生物制药公司，专注于创新解决方案。康方生物拥有全面整合的多功能平台，内部正在积极推进 50 多个创新资产的强大管线，涵盖癌症、自身免疫疾病、炎症、代谢疾病及其他重大疾病。其中，24 个候选药物已进入临床试验（包括 15 个双特异性/多特异性抗体和双特异性 ADC）。此外，7 种新药已实现商业化。通过高效且突破性的研发创新，康方生物始终整合全球优质资源，开发首个和最佳的新药，为全球患者提供可负担的治疗性抗体，并不断创造更多商业和社会价值，成为全球领先的生物制药企业。</p>
</div><p>For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.</p>
<div class="lb-trans"><p>欲了解更多信息，请访问 https://www.akesobio.com/en/about-us/corporate-profile/ 并关注我们的 Linkedin。</p>
</div><p>SOURCE Akeso, Inc.</p>
<div class="lb-trans"><p>来源：康方生物。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMTE2Jk5ld3NJdGVtSWQ9Q04yNTc5NCZUcmFuc21pc3Npb25fSWQ9MjAyNTExMTYyMTI5UFJfTkVXU19VU1BSX19fX19DTjI1Nzk0" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN25794&amp;Transmission_Id=202511162129PR_NEWS_USPR_____CN25794&amp;DateId=20251116"/></p>

康方生物的双特异性抗体，靶向 Aβ和血脑屏障表达的受体，已获批在中国开展阿尔茨海默病的临床试验