<p>/PRNewswire/ -- 康方生物（Akeso, Inc.）（HKEX: 9926.HK）宣佈，其 AK152 是一種新型雙特異性抗體，針對澱粉樣β（Aβ）和血腦屏障（BBB）表達的受體，已獲得國家藥品監督管理局（NMPA）批准，啓動阿爾茨海默病的臨牀試驗。</p>
<p>AK152 是中國開發的首個用於阿爾茨海默病疾病修飾治療的雙特異性抗體，標誌着該領域的重要突破。此外，它是康方生物首個旨在靶向中樞神經系統（CNS）的創新治療候選藥物。這一成就凸顯了康方生物在擴展其神經退行性疾病研究和開發管道方面的關鍵里程碑，並使公司能夠加強其作為全球綜合製藥公司的地位。</p>
<p>澱粉樣β（Aβ）的異常聚集和沉積是阿爾茨海默病的關鍵病理驅動因素。幾種針對 Aβ的單克隆抗體已獲得批准，臨牀數據顯示這些藥物可以通過清除腦內 Aβ斑塊來減緩認知衰退。然而，這些抗體的治療效果受到血腦屏障（BBB）穿透能力差的限制，導致腦部暴露不足，並引發重大安全隱患。</p>
<p>AK152 是一種雙特異性抗體，同時靶向 Aβ和在血腦屏障上高度表達的受體。AK152 的 Aβ結合臂與 Aβ斑塊結合，並對神經毒性可溶性 Aβ寡聚體表現出高選擇性。AK152 的受體結合臂利用受體介導的內吞 - 跨細胞轉運機制，顯著增強 AK152 的腦穿透能力。</p>
<p>前臨牀研究表明，AK152 具有強大的生物活性和良好的特性。與傳統的針對 Aβ的單克隆抗體相比，AK152 顯著改善了腦穿透能力，加速了 Aβ斑塊的清除，並在前臨牀模型中逆轉了與阿爾茨海默病相關的神經病理進展，為阿爾茨海默病患者提供了潛在的有前景的新治療選擇。中樞神經系統疾病長期以來在全球範圍內帶來了重大的治療挑戰。康方生物憑藉其在雙特異性抗體開發方面的深厚專業知識，處於創造新療法以解決中樞神經系統疾病中關鍵未滿足臨牀需求的前沿。</p>
<p><strong>關於 AK152</strong></p>
<p>AK152 是康方生物開發的一種雙特異性抗體，旨在同時靶向 Aβ和在血腦屏障（BBB）上高度表達的受體。在 Aβ方面，它不僅與 Aβ斑塊結合，還選擇性靶向更具神經毒性的可溶性 Aβ寡聚體。在 BBB 方面，它利用受體介導的內吞作用顯著增強腦穿透能力。前臨牀研究表明，AK152 表現出強大的生物活性和良好的安全性特徵，有效提高腦穿透能力，加速 Aβ斑塊清除，並在阿爾茨海默病小鼠模型中表現出優於單克隆抗體的治療效果。這些初步的有希望的結果表明，AK152 有潛力成為阿爾茨海默病的下一代疾病修飾治療。</p>
<p><strong>康方生物的前瞻性聲明</strong></p>
<p>康方生物（Akeso, Inc.）（9926.HK，&#34;康方生物&#34;）的本公告包含&#34;前瞻性聲明&#34;。這些聲明反映了康方生物管理層當前的信念和期望，並受到重大風險和不確定性的影響。這些聲明並不旨在構成任何投資決策或購買康方生物證券的依據。不能保證本公告中提到的藥物候選者或康方生物的其他管道候選者將獲得所需的監管批准或實現商業成功。如果基本假設不準確或風險或不確定性實現，實際結果可能與前瞻性聲明中所述的結果有重大差異。</p>
<p>風險和不確定性包括但不限於一般行業狀況和競爭；一般經濟因素，包括利率和匯率波動；中國、美國及國際製藥行業監管和醫療立法的影響；全球醫療成本控制的趨勢；競爭對手獲得的新產品和專利的技術進步；新產品開發中固有的挑戰，包括獲得監管批准；康方生物準確預測未來市場狀況的能力；製造困難或延誤；國際經濟的財務不穩定和主權風險；依賴於康方生物對創新產品的專利和其他保護的有效性；以及面臨訴訟，包括專利訴訟和/或監管行動的風險。</p>
<p>康方生物不承擔任何義務，公開修訂這些前瞻性聲明，以反映本公告日期之後的事件或情況，法律要求的除外。</p>
<p><strong>關於康方生物</strong></p>
<p>康方生物（HKEX: 9926.HK）是一家領先的生物製藥公司，致力於全球首個或最佳創新生物藥物的研究、開發、生產和商業化。公司成立於 2012 年，創建了一個獨特的綜合研發創新體系，以全面的端到端藥物開發平台（ACE 平台）和雙特異性抗體藥物開發技術（Tetrabody）為核心，擁有符合 GMP 標準的生產系統和先進運營模式的商業化系統，逐漸發展成為一家全球競爭力的生物製藥公司，專注於創新解決方案。康方生物擁有全面整合的多功能平台，內部正在積極推進 50 多個創新資產的強大管線，涵蓋癌症、自身免疫疾病、炎症、代謝疾病及其他重大疾病。其中，24 個候選藥物已進入臨牀試驗（包括 15 個雙特異性/多特異性抗體和雙特異性 ADC）。此外，7 種新藥已實現商業化。通過高效且突破性的研發創新，康方生物始終整合全球優質資源，開發首個和最佳的新藥，為全球患者提供可負擔的治療性抗體，並不斷創造更多商業和社會價值，成為全球領先的生物製藥企業。</p>
<p>欲瞭解更多信息，請訪問 https://www.akesobio.com/en/about-us/corporate-profile/ 並關注我們的 Linkedin。</p>
<p>來源：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>康方生物宣佈，其雙特異性抗體 AK152 已獲得中國阿爾茨海默病臨牀試驗的批准，AK152 針對澱粉樣蛋白β（Aβ）和血腦屏障（BBB）表達的受體。這是中國開發的首個針對阿爾茨海默病的雙特異性抗體，標誌着一個重要的突破。它增強了腦部滲透性並加速了 Aβ斑塊的清除，顯示出良好的臨牀前結果。這一批准將擴展康方生物在神經退行性疾病領域的研發管線</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）宣佈，其 AK152 是一種新型雙特異性抗體，針對澱粉樣β（Aβ）和血腦屏障（BBB）表達的受體，已獲得國家藥品監督管理局（NMPA）批准，啓動阿爾茨海默病的臨牀試驗。</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 是中國開發的首個用於阿爾茨海默病疾病修飾治療的雙特異性抗體，標誌着該領域的重要突破。此外，它是康方生物首個旨在靶向中樞神經系統（CNS）的創新治療候選藥物。這一成就凸顯了康方生物在擴展其神經退行性疾病研究和開發管道方面的關鍵里程碑，並使公司能夠加強其作為全球綜合製藥公司的地位。</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>澱粉樣β（Aβ）的異常聚集和沉積是阿爾茨海默病的關鍵病理驅動因素。幾種針對 Aβ的單克隆抗體已獲得批准，臨牀數據顯示這些藥物可以通過清除腦內 Aβ斑塊來減緩認知衰退。然而，這些抗體的治療效果受到血腦屏障（BBB）穿透能力差的限制，導致腦部暴露不足，並引發重大安全隱患。</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 是一種雙特異性抗體，同時靶向 Aβ和在血腦屏障上高度表達的受體。AK152 的 Aβ結合臂與 Aβ斑塊結合，並對神經毒性可溶性 Aβ寡聚體表現出高選擇性。AK152 的受體結合臂利用受體介導的內吞 - 跨細胞轉運機制，顯著增強 AK152 的腦穿透能力。</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>前臨牀研究表明，AK152 具有強大的生物活性和良好的特性。與傳統的針對 Aβ的單克隆抗體相比，AK152 顯著改善了腦穿透能力，加速了 Aβ斑塊的清除，並在前臨牀模型中逆轉了與阿爾茨海默病相關的神經病理進展，為阿爾茨海默病患者提供了潛在的有前景的新治療選擇。中樞神經系統疾病長期以來在全球範圍內帶來了重大的治療挑戰。康方生物憑藉其在雙特異性抗體開發方面的深厚專業知識，處於創造新療法以解決中樞神經系統疾病中關鍵未滿足臨牀需求的前沿。</p>
</div><p><strong>About AK152</strong></p>
<div class="lb-trans"><p><strong>關於 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 是康方生物開發的一種雙特異性抗體，旨在同時靶向 Aβ和在血腦屏障（BBB）上高度表達的受體。在 Aβ方面，它不僅與 Aβ斑塊結合，還選擇性靶向更具神經毒性的可溶性 Aβ寡聚體。在 BBB 方面，它利用受體介導的內吞作用顯著增強腦穿透能力。前臨牀研究表明，AK152 表現出強大的生物活性和良好的安全性特徵，有效提高腦穿透能力，加速 Aβ斑塊清除，並在阿爾茨海默病小鼠模型中表現出優於單克隆抗體的治療效果。這些初步的有希望的結果表明，AK152 有潛力成為阿爾茨海默病的下一代疾病修飾治療。</p>
</div><p><strong>Forward-Looking Statement of Akeso, Inc.</strong></p>
<div class="lb-trans"><p><strong>康方生物的前瞻性聲明</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;前瞻性聲明&#34;。這些聲明反映了康方生物管理層當前的信念和期望，並受到重大風險和不確定性的影響。這些聲明並不旨在構成任何投資決策或購買康方生物證券的依據。不能保證本公告中提到的藥物候選者或康方生物的其他管道候選者將獲得所需的監管批准或實現商業成功。如果基本假設不準確或風險或不確定性實現，實際結果可能與前瞻性聲明中所述的結果有重大差異。</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>風險和不確定性包括但不限於一般行業狀況和競爭；一般經濟因素，包括利率和匯率波動；中國、美國及國際製藥行業監管和醫療立法的影響；全球醫療成本控制的趨勢；競爭對手獲得的新產品和專利的技術進步；新產品開發中固有的挑戰，包括獲得監管批准；康方生物準確預測未來市場狀況的能力；製造困難或延誤；國際經濟的財務不穩定和主權風險；依賴於康方生物對創新產品的專利和其他保護的有效性；以及面臨訴訟，包括專利訴訟和/或監管行動的風險。</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>康方生物不承擔任何義務，公開修訂這些前瞻性聲明，以反映本公告日期之後的事件或情況，法律要求的除外。</p>
</div><p><strong>About Akeso</strong></p>
<div class="lb-trans"><p><strong>關於康方生物</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）是一家領先的生物製藥公司，致力於全球首個或最佳創新生物藥物的研究、開發、生產和商業化。公司成立於 2012 年，創建了一個獨特的綜合研發創新體系，以全面的端到端藥物開發平台（ACE 平台）和雙特異性抗體藥物開發技術（Tetrabody）為核心，擁有符合 GMP 標準的生產系統和先進運營模式的商業化系統，逐漸發展成為一家全球競爭力的生物製藥公司，專注於創新解決方案。康方生物擁有全面整合的多功能平台，內部正在積極推進 50 多個創新資產的強大管線，涵蓋癌症、自身免疫疾病、炎症、代謝疾病及其他重大疾病。其中，24 個候選藥物已進入臨牀試驗（包括 15 個雙特異性/多特異性抗體和雙特異性 ADC）。此外，7 種新藥已實現商業化。通過高效且突破性的研發創新，康方生物始終整合全球優質資源，開發首個和最佳的新藥，為全球患者提供可負擔的治療性抗體，並不斷創造更多商業和社會價值，成為全球領先的生物製藥企業。</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>欲瞭解更多信息，請訪問 https://www.akesobio.com/en/about-us/corporate-profile/ 並關注我們的 Linkedin。</p>
</div><p>SOURCE Akeso, Inc.</p>
<div class="lb-trans"><p>來源：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>

康方生物的雙特異性抗體，靶向 Aβ和血腦屏障表達的受體，已獲批在中國開展阿爾茨海默病的臨牀試驗