<p>, /PRNewswire/ -- Akeso, Inc. (9926.HK)（&#34;Akeso&#34;或&#34;公司&#34;）今天宣佈，其首個同類 PD-1/CTLA-4 雙特異性抗體 cadonilimab 與化療聯合用於晚期胰腺導管腺癌（PDAC）的一線治療的 COMPASSION-26 研究的積極 II 期結果在 2026 年美國癌症研究協會（AACR）年會上發佈。</p>
<p>截至 2025 年 10 月 20 日的數據截止，cadonilimab 加化療的組合在中位隨訪超過兩年的情況下，繼續提供強勁和持久的生存獲益。在局部晚期疾病患者中，結果尤其顯著，中位無進展生存期（PFS）達到 11.1 個月，中位總生存期（OS）超過 23 個月。該組的標誌性生存率包括 12 個月 OS 率為 91.7% 和 24 個月 OS 率為 44.1%。</p>
<p>cadonilimab 方案在整體研究人羣中也提供了強大的腫瘤控制。在可評估療效的患者中（95% 至少有一次基線後腫瘤評估），客觀緩解率（ORR）為 33.9%，疾病控制率（DCR）達到 96.4%。局部晚期和轉移性疾病患者的反應率相似，表明兩個亞組均有一致的獲益。</p>
<p>未發現新的安全信號，cadonilimab 組合的整體安全性特徵仍然良好且可控。</p>
<p>Cadonilimab 是全球首個獲得批准的癌症免疫治療雙特異性抗體，已於 2022 年獲得市場批准。在廣泛的真實世界臨牀實踐和多項 III 期研究中，它在所有患者羣體中均顯示出臨牀上有意義的獲益，無論 PD-L1 表達狀態如何，滿足了重大的未滿足醫療需求，並獲得了醫生和患者的廣泛認可。</p>
<p>作為腫瘤免疫治療 2.0 時代的基石療法，cadonilimab 不僅在廣泛的患者羣體中提供了顯著的臨牀獲益優勢，還在難治性疾病和免疫學上&#34;冷&#34;的腫瘤等困難治療環境中展示了重要的突破潛力。Akeso 充分利用其在腫瘤學雙特異性抗體開發方面的全球領導地位，繼續解決重大未滿足的臨牀需求，並推動具有變革性的治療選擇，為面臨挑戰的癌症患者提供幫助。</p>
<p><strong>關於 Akeso</strong></p>
<p>Akeso（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，建立了以其四抗體技術平台、人工智能驅動的藥物研發平台、雙保護抗體藥物偶聯物（ADC）技術平台、雙鎖 T 細胞結合劑（TCE）技術平台、組織智能 siRNA/mRNA 技術平台和細胞治療技術平台為中心的強大研發創新生態系統。在全球標準的 GMP 製造基礎設施和高效、集成的商業化模式的支持下，公司已發展成為一家專注於創新解決方案的全球競爭力生物製藥企業。憑藉全面集成的多功能平台，Akeso 正在內部開發超過 50 個創新資產的強大管線，涵蓋癌症、自身免疫疾病、炎症、代謝疾病和其他重大疾病。其中，27 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 種新藥已上市。通過高效和突破性的研發創新，Akeso 始終整合優質的全球資源，開發首個和最佳的新藥，為全球患者提供可負擔的治療抗體，並不斷創造更多的商業和社會價值，成為全球領先的生物製藥企業。</p>
<p><strong>前瞻性聲明</strong></p>
<p>Akeso, Inc.（9926.HK，&#34;Akeso&#34;）的本公告包含&#34;前瞻性聲明&#34;。這些聲明反映了 Akeso 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。這些聲明並不旨在作為任何投資決策或購買 Akeso 證券的依據。不能保證本公告中提到的藥物候選者或 Akeso 的其他管線候選者將獲得所需的監管批准或實現商業成功。如果基礎假設被證明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；競爭對手獲得的技術進步、新產品和專利；新產品開發中固有的挑戰，包括獲得監管批准；Akeso 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 Akeso 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>Akeso 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>來源：Akeso, Inc.</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNDIwJk5ld3NJdGVtSWQ9Q04zOTM0OCZUcmFuc21pc3Npb25fSWQ9MjAyNjA0MjAyMjU0UFJfTkVXU19VU1BSX19fX19DTjM5MzQ4?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-RGF0ZUlkPTIwMjYwNDIwJk5ld3NJdGVtSWQ9Q04zOTM0OCZUcmFuc21pc3Npb25fSWQ9MjAyNjA0MjAyMjU0UFJfTkVXU19VU1BSX19fX19DTjM5MzQ4"/></p>

AKRO

標普生物技術 ETF - SPDR

生物科技 ETF - VanEck Vectors

<p>Akeso, Inc. 宣佈了其雙特異性抗體 cadonilimab 在與化療聯合治療晚期胰腺癌的 COMPASSION-26 研究中取得了積極的 II 期結果。研究顯示顯著的生存獲益，局部晚期患者的中位無進展生存期為 11.1 個月，總生存期超過 23 個月。該治療顯示出 33.9% 的客觀反應率和 96.4% 的疾病控制率，且安全性良好。Akeso 旨在利用其雙特異性抗體的專業知識來滿足腫瘤學領域未滿足的臨牀需求</p>

<p>, /PRNewswire/ -- Akeso, Inc. (9926.HK) (&#34;Akeso&#34; or the &#34;Company&#34;) today announced that positive Phase II results from the COMPASSION-26 study evaluating cadonilimab, its first-in-class PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma (PDAC), were presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- Akeso, Inc. (9926.HK)（&#34;Akeso&#34;或&#34;公司&#34;）今天宣佈，其首個同類 PD-1/CTLA-4 雙特異性抗體 cadonilimab 與化療聯合用於晚期胰腺導管腺癌（PDAC）的一線治療的 COMPASSION-26 研究的積極 II 期結果在 2026 年美國癌症研究協會（AACR）年會上發佈。</p>
</div><p>As of the October 20, 2025 data cutoff, with a median follow-up of more than two years, the cadonilimab plus chemotherapy combination continued to deliver robust and durable survival benefits. Results were particularly strong in patients with locally advanced disease, where the median PFS reached 11.1 months and the median OS exceeded 23 months. Landmark survival rates in this group included a 12-month OS rate of 91.7% and a 24-month OS rate of 44.1%.</p>
<div class="lb-trans"><p>截至 2025 年 10 月 20 日的數據截止，cadonilimab 加化療的組合在中位隨訪超過兩年的情況下，繼續提供強勁和持久的生存獲益。在局部晚期疾病患者中，結果尤其顯著，中位無進展生存期（PFS）達到 11.1 個月，中位總生存期（OS）超過 23 個月。該組的標誌性生存率包括 12 個月 OS 率為 91.7% 和 24 個月 OS 率為 44.1%。</p>
</div><p>The cadonilimab regimen also provided strong tumor control across the overall study population. Of the patients evaluable for efficacy (95% had at least one post-baseline tumor assessment), the objective response rate (ORR) was 33.9% and the disease control rate (DCR) reached 96.4%. Response rates were similar between patients with locally advanced and metastatic disease, indicating consistent benefit across both subgroups.</p>
<div class="lb-trans"><p>cadonilimab 方案在整體研究人羣中也提供了強大的腫瘤控制。在可評估療效的患者中（95% 至少有一次基線後腫瘤評估），客觀緩解率（ORR）為 33.9%，疾病控制率（DCR）達到 96.4%。局部晚期和轉移性疾病患者的反應率相似，表明兩個亞組均有一致的獲益。</p>
</div><p>No new safety signals were identified, and the overall safety profile of the cadonilimab combination remained favorable and manageable.</p>
<div class="lb-trans"><p>未發現新的安全信號，cadonilimab 組合的整體安全性特徵仍然良好且可控。</p>
</div><p>Cadonilimab is the world's first approved bispecific antibody for cancer immunotherapy, having received marketing approval in 2022. In extensive real-world clinical practice and multiple Phase III studies, it has demonstrated clinically meaningful benefit across all patient populations regardless of PD-L1 expression status, addressing a significant unmet medical need and earning broad recognition from physicians and patients.</p>
<div class="lb-trans"><p>Cadonilimab 是全球首個獲得批准的癌症免疫治療雙特異性抗體，已於 2022 年獲得市場批准。在廣泛的真實世界臨牀實踐和多項 III 期研究中，它在所有患者羣體中均顯示出臨牀上有意義的獲益，無論 PD-L1 表達狀態如何，滿足了重大的未滿足醫療需求，並獲得了醫生和患者的廣泛認可。</p>
</div><p>As a cornerstone therapy in the era of tumor immunotherapy 2.0, cadonilimab not only offers the significant advantage of clinical benefit across broad patient populations, but has also demonstrated important breakthrough potential in difficult-to-treat settings, including immunotherapy-refractory disease and immunologically &#34;cold&#34; tumors. Akeso is fully leveraging its global leadership in bispecific antibody development for oncology to continue addressing major unmet clinical needs and advancing transformative treatment options for patients with challenging cancers.</p>
<div class="lb-trans"><p>作為腫瘤免疫治療 2.0 時代的基石療法，cadonilimab 不僅在廣泛的患者羣體中提供了顯著的臨牀獲益優勢，還在難治性疾病和免疫學上&#34;冷&#34;的腫瘤等困難治療環境中展示了重要的突破潛力。Akeso 充分利用其在腫瘤學雙特異性抗體開發方面的全球領導地位，繼續解決重大未滿足的臨牀需求，並推動具有變革性的治療選擇，為面臨挑戰的癌症患者提供幫助。</p>
</div><p><strong>About Akeso</strong></p>
<div class="lb-trans"><p><strong>關於 Akeso</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 established a robust R&amp;D innovation ecosystem centered on its Tetrabody antibody technology platform, AI-powered drug R&amp;D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical 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, 27 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>Akeso（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，建立了以其四抗體技術平台、人工智能驅動的藥物研發平台、雙保護抗體藥物偶聯物（ADC）技術平台、雙鎖 T 細胞結合劑（TCE）技術平台、組織智能 siRNA/mRNA 技術平台和細胞治療技術平台為中心的強大研發創新生態系統。在全球標準的 GMP 製造基礎設施和高效、集成的商業化模式的支持下，公司已發展成為一家專注於創新解決方案的全球競爭力生物製藥企業。憑藉全面集成的多功能平台，Akeso 正在內部開發超過 50 個創新資產的強大管線，涵蓋癌症、自身免疫疾病、炎症、代謝疾病和其他重大疾病。其中，27 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 種新藥已上市。通過高效和突破性的研發創新，Akeso 始終整合優質的全球資源，開發首個和最佳的新藥，為全球患者提供可負擔的治療抗體，並不斷創造更多的商業和社會價值，成為全球領先的生物製藥企業。</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 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>Akeso, Inc.（9926.HK，&#34;Akeso&#34;）的本公告包含&#34;前瞻性聲明&#34;。這些聲明反映了 Akeso 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。這些聲明並不旨在作為任何投資決策或購買 Akeso 證券的依據。不能保證本公告中提到的藥物候選者或 Akeso 的其他管線候選者將獲得所需的監管批准或實現商業成功。如果基礎假設被證明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；競爭對手獲得的技術進步、新產品和專利；新產品開發中固有的挑戰，包括獲得監管批准；Akeso 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 Akeso 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>Akeso 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>SOURCE Akeso, Inc.</p>
<div class="lb-trans"><p>來源：Akeso, Inc.</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNDIwJk5ld3NJdGVtSWQ9Q04zOTM0OCZUcmFuc21pc3Npb25fSWQ9MjAyNjA0MjAyMjU0UFJfTkVXU19VU1BSX19fX19DTjM5MzQ4" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN39348&amp;Transmission_Id=202604202254PR_NEWS_USPR_____CN39348&amp;DateId=20260420"/></p>

22:54 ETCadonilimab Combination Demonstrates Promising Survival Benefit in Locally Advanced Pancreatic Cancer: Phase II COMPASSION-26 Data Presented at AACR 2026

prnewswire

Akero Therapeutics

動態生物技術與基因組 ETF - Invesco

醫藥突破 ETF - ALPS

醫療業 ETF - Vanguard

標普生物技術 3 倍做多 - Direxion

紐交所高增長板生物技術指數 ETF - First Trust

納斯達克生物科技指數 ETF - iShares Nasdaq

2 倍做多納斯達克生物技術 ETF - ProShares

Invesco Nasdaq Biotechnology ETF

基因改革 ETF - ARK

美國制藥 ETF - iShares

醫療業 ETF - SPDR

康方生物

Cadonilimab 聯合治療在局部晚期胰腺癌中展示出有前景的生存益處：COMPASSION-26 二期數據在 2026 年 AACR 會議上展示