<p>/PRNewswire/ -- 康方生物（Akeso, Inc.）（9926.HK）（&#34;康方&#34;或&#34;公司&#34;）今天宣佈已與紀念斯隆凱特琳癌症中心（MSKCC）達成合作，以推進一項評估基於 cadonilimab 的聯合方案用於局部晚期、可切除的 HER2 陰性胃癌或胃食管交界腺癌（GEJ）的圍手術期治療的二期臨牀研究。Cadonilimab 是康方開發的全球首個 PD-1/CTLA-4 雙特異性抗體。</p>
<p>該研究由 MSKCC 的全球知名胃腸惡性腫瘤專家 Yelena Janjigian 博士領導。目前正在美國積極招募患者。</p>
<p>這項二期研究將生成強有力的臨牀證據，以支持未來啓動 cadonilimab 聯合方案用於 GC/GEJ 腺癌圍手術期治療的國際多中心三期試驗。</p>
<p>作為首個具有突破性全球臨牀價值的雙特異性抗體，cadonilimab 和 ivonescimab 已引起國際醫學界的廣泛關注和認可。這些創新的 IO 2.0 療法越來越受到全球合作伙伴的青睞，成為各種癌症聯合方案和新治療範式的首選基礎。它們的全球治療價值正在通過持續的臨牀數據和新研究不斷被科學探索和實現。</p>
<p>基於 cadonilimab 獨特的雙靶點協同機制，這項二期研究得到了來自三期 COMPASSION-15 試驗和之前胃/GEJ 腺癌新輔助研究的強有力證據支持。</p>
<p>胃癌是全球第五大常見惡性腫瘤，每年新發病例近百萬。對於局部晚期、可切除的胃或胃食管交界（GEJ）腺癌患者，標準的圍手術期 FLOT 化療僅實現 48% 的三年總生存率。儘管將 PD-1 抑制劑添加到 FLOT 已成為新的標準治療，但病理完全緩解（pCR）率仍然有限，約為 19%，近三分之一的患者在兩年內經歷疾病復發或死亡。雙重 PD-1/CTLA-4 抑制由於重疊毒性和早期死亡率增加而顯示出有限的益處。對更有效且耐受性更好的治療選擇仍然存在顯著的未滿足醫療需求。</p>
<p>作為首個獲批的癌症免疫治療雙特異性抗體，cadonilimab 在多項關鍵研究中展示了突破性的臨牀益處，目前已廣泛應用於臨牀實踐。全球目前正在進行超過 12 項 cadonilimab 的註冊或三期研究，其中包括由康方主導的兩項國際多中心註冊/三期試驗。</p>
<p>此外，康方還與 INOVIO 合作，探索在 Dana-Farber 癌症研究所和麻省總醫院使用 INOVIO 的 DNA 治療進行膠質母細胞瘤（GBM）的新聯合方案。公司繼續通過與領先的治療機構和機構的戰略合作，加速 cadonilimab 的全球開發。</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，致力於研發、生產和商業化全球首個或最佳的創新生物藥物。康方成立於 2012 年，建立了一個以其專有的 Tetrabody 抗體技術平台、AI 驅動的藥物研發平台、Dual-Shield ADC 技術平台、Dual-Lock T 細胞結合劑（TCE）技術平台、Tissue-Smart siRNA/mRNA 技術平台和細胞治療技術平台為基礎的綜合研發創新生態系統。</p>
<p>憑藉世界級的 GMP 製造設施和高效的綜合商業化系統，康方已發展成為一傢俱有全球競爭力的生物製藥企業。利用其全面集成的多功能平台，公司保持着超過 50 個創新資產的強大管道，針對癌症、自身免疫疾病、炎症、代謝紊亂和其他主要治療領域。其中，27 個候選藥物已進入臨牀試驗，包括 15 個雙特異性或多特異性抗體和雙特異性 ADC，8 個創新藥物已達到商業階段。</p>
<p>通過高效且突破性的研發，康方整合全球頂尖資源，開發變革性藥物，向全球患者提供高質量、可負擔的治療抗體，並在努力成為全球生物製藥創新領導者的過程中創造持續的商業和社會價值。</p>
<p><strong>前瞻性聲明</strong></p>
<p>康方生物（Akeso, Inc.）（9926.HK，&#34;康方&#34;）的本公告包含&#34;前瞻性聲明&#34;。這些聲明反映了康方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證券的決定的基礎。不能保證本公告中提到的藥物候選者或康方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、美國及國際上製藥行業的監管和醫療保健立法的影響；全球醫療成本控制的趨勢；競爭對手的技術進步、新產品和獲得的專利；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性和主權風險；對康方生物專利及其他創新產品保護措施有效性的依賴；以及面臨訴訟的風險，包括專利訴訟和/或監管行動。</p>
<p>康方生物不承擔任何義務公開修訂這些前瞻性聲明，以反映本日期之後的事件或情況，法律要求的情況除外。</p>
<p>來源：康方生物（Akeso, Inc.）</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNzE0Jk5ld3NJdGVtSWQ9Q04wMzk3NyZUcmFuc21pc3Npb25fSWQ9MjAyNjA3MTQwNDE4UFJfTkVXU19VU1BSX19fX19DTjAzOTc3?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-RGF0ZUlkPTIwMjYwNzE0Jk5ld3NJdGVtSWQ9Q04wMzk3NyZUcmFuc21pc3Npb25fSWQ9MjAyNjA3MTQwNDE4UFJfTkVXU19VU1BSX19fX19DTjAzOTc3"/></p>

康方生物

<p>康方生物（Akeso, Inc.）宣佈與紀念斯隆凱特琳癌症中心（Memorial Sloan Kettering Cancer Center）合作，在美國啓動針對 cadonilimab（一種 PD-1/CTLA-4 雙特異性抗體）的第二階段臨牀試驗。該研究評估這種聯合治療方案在局部晚期、可切除的 HER2 陰性胃癌或胃食管交界腺癌的圍手術期治療中的效果。試驗由 Yelena Janjigian 博士領導，旨在生成支持未來國際第三階段研究的證據</p>

<p>, /PRNewswire/ -- Akeso, Inc. (9926.HK) (&#34;Akeso&#34; or the &#34;Company&#34;) today announced that it has entered into a collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) to advance a Phase II clinical study evaluating a cadonilimab-based combination regimen for the perioperative treatment of locally advanced, resectable HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Cadonilimab is the world's first PD-1/CTLA-4 bispecific antibody developed by Akeso.</p>
<div class="lb-trans"><p>/PRNewswire/ -- 康方生物（Akeso, Inc.）（9926.HK）（&#34;康方&#34;或&#34;公司&#34;）今天宣佈已與紀念斯隆凱特琳癌症中心（MSKCC）達成合作，以推進一項評估基於 cadonilimab 的聯合方案用於局部晚期、可切除的 HER2 陰性胃癌或胃食管交界腺癌（GEJ）的圍手術期治療的二期臨牀研究。Cadonilimab 是康方開發的全球首個 PD-1/CTLA-4 雙特異性抗體。</p>
</div><p>The study is being led by Dr. Yelena Janjigian, a globally renowned expert in gastrointestinal malignancies at MSKCC. It is now actively enrolling patients across the United States.</p>
<div class="lb-trans"><p>該研究由 MSKCC 的全球知名胃腸惡性腫瘤專家 Yelena Janjigian 博士領導。目前正在美國積極招募患者。</p>
</div><p>This Phase II study will generate robust clinical evidence to support the future initiation of an international multicenter Phase III trial of the cadonilimab combination regimen for the perioperative treatment of GC/GEJ adenocarcinoma.</p>
<div class="lb-trans"><p>這項二期研究將生成強有力的臨牀證據，以支持未來啓動 cadonilimab 聯合方案用於 GC/GEJ 腺癌圍手術期治療的國際多中心三期試驗。</p>
</div><p>Cadonilimab and ivonescimab, as first-in-class bispecific antibodies with breakthrough global clinical value, have garnered significant attention and recognition from the international medical community. These innovative IO 2.0 therapies are increasingly favored by global partners as the preferred backbone for combination regimens and novel treatment paradigms across a wide range of cancers. Their global therapeutic value continues to be scientifically explored and realized through ongoing clinical data and new studies.</p>
<div class="lb-trans"><p>作為首個具有突破性全球臨牀價值的雙特異性抗體，cadonilimab 和 ivonescimab 已引起國際醫學界的廣泛關注和認可。這些創新的 IO 2.0 療法越來越受到全球合作伙伴的青睞，成為各種癌症聯合方案和新治療範式的首選基礎。它們的全球治療價值正在通過持續的臨牀數據和新研究不斷被科學探索和實現。</p>
</div><p>Building on cadonilimab's unique dual-target synergistic mechanism, this Phase II study is supported by strong evidence from the Phase III COMPASSION-15 trial and previous Phase II neoadjuvant studies in gastric/GEJ adenocarcinoma.</p>
<div class="lb-trans"><p>基於 cadonilimab 獨特的雙靶點協同機制，這項二期研究得到了來自三期 COMPASSION-15 試驗和之前胃/GEJ 腺癌新輔助研究的強有力證據支持。</p>
</div><p>Gastric cancer is the fifth most common malignancy worldwide, with nearly one million new cases annually. For patients with locally advanced, resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma, standard perioperative FLOT chemotherapy achieves a 3-year overall survival rate of only 48%. Although the addition of PD-1 inhibitors to FLOT has become the new standard of care, the pathologic complete response (pCR) rate remains limited at approximately 19%, and nearly one-third of patients experience disease recurrence or death within two years. Dual PD-1/CTLA-4 inhibition has shown limited benefit due to overlapping toxicities and increased early mortality. A significant unmet medical need persists for more effective and better-tolerated treatment options.</p>
<div class="lb-trans"><p>胃癌是全球第五大常見惡性腫瘤，每年新發病例近百萬。對於局部晚期、可切除的胃或胃食管交界（GEJ）腺癌患者，標準的圍手術期 FLOT 化療僅實現 48% 的三年總生存率。儘管將 PD-1 抑制劑添加到 FLOT 已成為新的標準治療，但病理完全緩解（pCR）率仍然有限，約為 19%，近三分之一的患者在兩年內經歷疾病復發或死亡。雙重 PD-1/CTLA-4 抑制由於重疊毒性和早期死亡率增加而顯示出有限的益處。對更有效且耐受性更好的治療選擇仍然存在顯著的未滿足醫療需求。</p>
</div><p>As the first approved bispecific antibody for cancer immunotherapy, cadonilimab has demonstrated breakthrough clinical benefits across multiple pivotal studies and is now widely used in clinical practice. More than 12 registrational or Phase III studies of cadonilimab are currently underway globally, including two international multicenter registrational/Phase III trials led by Akeso.</p>
<div class="lb-trans"><p>作為首個獲批的癌症免疫治療雙特異性抗體，cadonilimab 在多項關鍵研究中展示了突破性的臨牀益處，目前已廣泛應用於臨牀實踐。全球目前正在進行超過 12 項 cadonilimab 的註冊或三期研究，其中包括由康方主導的兩項國際多中心註冊/三期試驗。</p>
</div><p>In addition, Akeso is collaborating with INOVIO to explore a novel combination regimen using INOVIO's DNA-based therapy for glioblastoma (GBM) at Dana-Farber Cancer Institute and Mass General Brigham. The Company continues to accelerate the global development of cadonilimab through strategic partnerships with leading therapeutics and institutions.</p>
<div class="lb-trans"><p>此外，康方還與 INOVIO 合作，探索在 Dana-Farber 癌症研究所和麻省總醫院使用 INOVIO 的 DNA 治療進行膠質母細胞瘤（GBM）的新聯合方案。公司繼續通過與領先的治療機構和機構的戰略合作，加速 cadonilimab 的全球開發。</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, Akeso has built a comprehensive R&amp;D innovation ecosystem anchored by its proprietary 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.</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，致力於研發、生產和商業化全球首個或最佳的創新生物藥物。康方成立於 2012 年，建立了一個以其專有的 Tetrabody 抗體技術平台、AI 驅動的藥物研發平台、Dual-Shield ADC 技術平台、Dual-Lock T 細胞結合劑（TCE）技術平台、Tissue-Smart siRNA/mRNA 技術平台和細胞治療技術平台為基礎的綜合研發創新生態系統。</p>
</div><p>Backed by world-class GMP manufacturing facilities and a highly efficient, integrated commercialization system, Akeso has developed into a globally competitive biopharmaceutical enterprise. Leveraging its fully integrated, multi-functional platform, the company maintains a robust pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Of these, 27 candidates have advanced into clinical trials—including 15 bispecific or multispecific antibodies and bispecific ADCs—and 8 innovative drugs have reached commercial stage.</p>
<div class="lb-trans"><p>憑藉世界級的 GMP 製造設施和高效的綜合商業化系統，康方已發展成為一傢俱有全球競爭力的生物製藥企業。利用其全面集成的多功能平台，公司保持着超過 50 個創新資產的強大管道，針對癌症、自身免疫疾病、炎症、代謝紊亂和其他主要治療領域。其中，27 個候選藥物已進入臨牀試驗，包括 15 個雙特異性或多特異性抗體和雙特異性 ADC，8 個創新藥物已達到商業階段。</p>
</div><p>Through efficient and groundbreaking R&amp;D, Akeso integrates premier global resources to develop transformative medicines, deliver high-quality, affordable therapeutic antibodies to patients worldwide, and generate sustained commercial and societal value as it strives to become a global leader in biopharmaceutical innovation.</p>
<div class="lb-trans"><p>通過高效且突破性的研發，康方整合全球頂尖資源，開發變革性藥物，向全球患者提供高質量、可負擔的治療抗體，並在努力成為全球生物製藥創新領導者的過程中創造持續的商業和社會價值。</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>康方生物（Akeso, Inc.）（9926.HK，&#34;康方&#34;）的本公告包含&#34;前瞻性聲明&#34;。這些聲明反映了康方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證券的決定的基礎。不能保證本公告中提到的藥物候選者或康方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、美國及國際上製藥行業的監管和醫療保健立法的影響；全球醫療成本控制的趨勢；競爭對手的技術進步、新產品和獲得的專利；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性和主權風險；對康方生物專利及其他創新產品保護措施有效性的依賴；以及面臨訴訟的風險，包括專利訴訟和/或監管行動。</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，以反映本日期之後的事件或情況，法律要求的情況除外。</p>
</div><p>SOURCE Akeso, Inc.</p>
<div class="lb-trans"><p>來源：康方生物（Akeso, Inc.）</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNzE0Jk5ld3NJdGVtSWQ9Q04wMzk3NyZUcmFuc21pc3Npb25fSWQ9MjAyNjA3MTQwNDE4UFJfTkVXU19VU1BSX19fX19DTjAzOTc3" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN03977&amp;Transmission_Id=202607140418PR_NEWS_USPR_____CN03977&amp;DateId=20260714"/></p>

Cadonilimab（PD-1/CTLA-4）聯合療法的 II 期臨牀試驗在美國啓動，旨在用於胃癌的圍手術期治療