<p>/PRNewswire/ -- 康方生物（Akeso, Inc.）（9926.HK）欣然宣布，其全球首创的双特异性抗体 ivonescimab，针对 PD-1 和 VEGF，已获得国家药品监督管理局（NMPA）药品审评中心（CDE）颁发的第五个突破性疗法认定（BTD）。该最新认定适用于 ivonescimab 与化疗联合用于晚期胆道癌（BTC）的一线治疗。</p>
<p>这一里程碑标志着 ivonescimab 获得的第五个 BTD，此前在肺癌适应症中获得了三个认定，并在三阴性乳腺癌（TNBC）中获得一个认定。重复的认可突显了 ivonescimab 在多种高未满足需求肿瘤类型中的广泛临床潜力。</p>
<p>一项随机、对照、多中心的注册性 III 期临床研究（AK112-309/HARMONi-GI1）正在评估 ivonescimab 加化疗与 durvalumab（PD-L1 抑制剂）加化疗在晚期 BTC 一线治疗中的效果。患者入组已完成，该适应症的 BTD 状态强调了 ivonescimab 的良好临床特征。BTD 状态预计将加速正在进行的临床开发和中国的监管审查过程。</p>
<p>在 2024 年美国临床肿瘤学会（ASCO）年会上展示的 1b/II 期研究的鼓舞人心的结果支持 ivonescimab 联合治疗作为晚期 BTC 的优越一线治疗的潜力。在该研究中，ivonescimab 加化疗的客观缓解率（ORR）为 63.6%，疾病控制率（DCR）为 100%。ivonescimab 方案还显示出中位无进展生存期（mPFS）为 8.5 个月，中位总生存期（mOS）为 16.8 个月。</p>
<p>这些引人注目的 II 期结果为正在进行的 III 期注册试验提供了坚实的基础，并强化了 ivonescimab 在满足晚期 BTC 显著未满足需求方面的潜力，目前的治疗选择往往只能提供有限的持久反应。</p>
<p><strong>康方生物的前瞻性声明</strong> 康方生物（Akeso, Inc.）（9926.HK，&#34;康方&#34;）的本公告包含&#34;前瞻性声明&#34;。这些声明反映了康方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。这些声明并不旨在作为任何投资决策或购买康方证券的依据。不能保证本公告中提到的药物候选人或康方的其他管线候选人将获得所需的监管批准或实现商业成功。如果基础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保健立法的影响；全球医疗保健成本控制的趋势；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；依赖于康方的专利和其他创新产品保护的有效性；以及面临的诉讼风险，包括专利诉讼和/或监管行动。</p>
<p>除法律要求外，康方不承担任何公开修订这些前瞻性声明以反映此后事件或情况的义务。</p>
<p><strong>关于康方生物</strong></p>
<p>康方生物（Akeso）（HKEX: 9926.HK）是一家领先的生物制药公司，致力于全球首创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，建立了以其专有的四抗体双特异性抗体平台、抗体药物偶联物（ADC）技术、siRNA/mRNA 模式和细胞治疗为核心的强大研发创新生态系统。在全球标准的 GMP 生产基础设施和高效、集成的商业化模式的支持下，公司已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。康方内部正在开发超过 50 个创新资产的强大管线，涵盖癌症、自身免疫疾病、炎症、代谢疾病和其他重大疾病。其中，26 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 种新药已上市。通过高效和突破性的研发创新，康方始终整合优质的全球资源，开发首创和最佳的新药，为全球患者提供可负担的治疗性抗体，并不断创造更多的商业和社会价值，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 <strong>https://www.akesobio.com/en/about-us/corporate-profile/</strong> 并关注我们的 <strong>Linkedin</strong>。</p>
<p><strong>康方联系方式</strong> <strong>:</strong> 媒体: [email protected]</p>
<p>投资者: [email protected]</p>
<p>来源：康方生物（Akeso, Inc.）</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMjA1Jk5ld3NJdGVtSWQ9Q044MjM1NCZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMDUyMTI2UFJfTkVXU19VU1BSX19fX19DTjgyMzU0?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-RGF0ZUlkPTIwMjYwMjA1Jk5ld3NJdGVtSWQ9Q044MjM1NCZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMDUyMTI2UFJfTkVXU19VU1BSX19fX19DTjgyMzU0"/></p>

<p>康方生物（Akeso, Inc.）已获得国家药品监督管理局（NMPA）颁发的第五个突破性疗法认定（Breakthrough Therapy Designation），用于 ivonescimab，这是一种针对 PD-1 和 VEGF 的双特异性抗体，适用于晚期胆道癌的一线治疗。这一认定是在之前针对肺癌和三阴性乳腺癌的认可之后获得的。目前正在进行第三阶段临床研究，初步结果显示客观缓解率为 63.6%，疾病控制率为 100%。突破性疗法认定状态预计将加速在中国的临床开发和监管审查</p>

<p>, /PRNewswire/ -- Akeso, Inc. (9926.HK) is pleased to announce that ivonescimab, its global first-in-class bispecific antibody targeting PD-1 and VEGF, has been granted its fifth Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This latest designation applies to ivonescimab in combination with chemotherapy for the first-line treatment of advanced biliary tract cancer (BTC).</p>
<div class="lb-trans"><p>/PRNewswire/ -- 康方生物（Akeso, Inc.）（9926.HK）欣然宣布，其全球首创的双特异性抗体 ivonescimab，针对 PD-1 和 VEGF，已获得国家药品监督管理局（NMPA）药品审评中心（CDE）颁发的第五个突破性疗法认定（BTD）。该最新认定适用于 ivonescimab 与化疗联合用于晚期胆道癌（BTC）的一线治疗。</p>
</div><p>This milestone represents the fifth BTD awarded to ivonescimab by the NMPA, following three prior designations in lung cancer indications and one for triple-negative breast cancer (TNBC). The repeated recognition highlights ivonescimab's broad clinical potential across multiple high unmet need tumor types.</p>
<div class="lb-trans"><p>这一里程碑标志着 ivonescimab 获得的第五个 BTD，此前在肺癌适应症中获得了三个认定，并在三阴性乳腺癌（TNBC）中获得一个认定。重复的认可突显了 ivonescimab 在多种高未满足需求肿瘤类型中的广泛临床潜力。</p>
</div><p>A randomized, controlled, multicenter, registrational Phase III clinical study (AK112-309/HARMONi-GI1) is evaluating ivonescimab plus chemotherapy versus durvalumab (a PD-L1 inhibitor) plus chemotherapy for first-line treatment of advanced BTC. Patient enrollment has been completed, and the BTD status for this indication underscores the promising clinical profile of ivonescimab. The BTD status is expected to accelerate both the ongoing clinical development and the regulatory review process in China.</p>
<div class="lb-trans"><p>一项随机、对照、多中心的注册性 III 期临床研究（AK112-309/HARMONi-GI1）正在评估 ivonescimab 加化疗与 durvalumab（PD-L1 抑制剂）加化疗在晚期 BTC 一线治疗中的效果。患者入组已完成，该适应症的 BTD 状态强调了 ivonescimab 的良好临床特征。BTD 状态预计将加速正在进行的临床开发和中国的监管审查过程。</p>
</div><p>Encouraging results from a Phase 1b/II study, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual meeting, support the potential of the ivonescimab combination therapy as a superior first-line treatment for advanced BTC. In the study, ivonescimab plus chemotherapy achieved an Objective Response Rate (ORR) of 63.6% and a Disease Control Rate (DCR) of 100%. The ivonescimab regimen also demonstrated a median Progression-Free Survival (mPFS) of 8.5 months and a median Overall Survival (mOS) of 16.8 months.</p>
<div class="lb-trans"><p>在 2024 年美国临床肿瘤学会（ASCO）年会上展示的 1b/II 期研究的鼓舞人心的结果支持 ivonescimab 联合治疗作为晚期 BTC 的优越一线治疗的潜力。在该研究中，ivonescimab 加化疗的客观缓解率（ORR）为 63.6%，疾病控制率（DCR）为 100%。ivonescimab 方案还显示出中位无进展生存期（mPFS）为 8.5 个月，中位总生存期（mOS）为 16.8 个月。</p>
</div><p>These compelling Phase II results provide a robust foundation for the ongoing Phase III registrational trial and reinforce ivonescimab's potential to address the significant unmet needs in advanced BTC, where current treatment options often yield limited durable responses.</p>
<div class="lb-trans"><p>这些引人注目的 II 期结果为正在进行的 III 期注册试验提供了坚实的基础，并强化了 ivonescimab 在满足晚期 BTC 显著未满足需求方面的潜力，目前的治疗选择往往只能提供有限的持久反应。</p>
</div><p><strong>Forward-Looking Statement of Akeso, Inc.</strong> 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><strong>康方生物的前瞻性声明</strong> 康方生物（Akeso, Inc.）（9926.HK，&#34;康方&#34;）的本公告包含&#34;前瞻性声明&#34;。这些声明反映了康方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。这些声明并不旨在作为任何投资决策或购买康方证券的依据。不能保证本公告中提到的药物候选人或康方的其他管线候选人将获得所需的监管批准或实现商业成功。如果基础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保健立法的影响；全球医疗保健成本控制的趋势；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；依赖于康方的专利和其他创新产品保护的有效性；以及面临的诉讼风险，包括专利诉讼和/或监管行动。</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>除法律要求外，康方不承担任何公开修订这些前瞻性声明以反映此后事件或情况的义务。</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 established a robust R&amp;D innovation ecosystem centered on its proprietary Tetrabody bispecific antibody platform, ADC (Antibody-Drug Conjugate) technologies, siRNA/mRNA modalities, and cell therapies. 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, 26 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（Akeso）（HKEX: 9926.HK）是一家领先的生物制药公司，致力于全球首创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，建立了以其专有的四抗体双特异性抗体平台、抗体药物偶联物（ADC）技术、siRNA/mRNA 模式和细胞治疗为核心的强大研发创新生态系统。在全球标准的 GMP 生产基础设施和高效、集成的商业化模式的支持下，公司已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。康方内部正在开发超过 50 个创新资产的强大管线，涵盖癌症、自身免疫疾病、炎症、代谢疾病和其他重大疾病。其中，26 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 种新药已上市。通过高效和突破性的研发创新，康方始终整合优质的全球资源，开发首创和最佳的新药，为全球患者提供可负担的治疗性抗体，并不断创造更多的商业和社会价值，成为全球领先的生物制药企业。</p>
</div><p>For more information, please visit <strong>https://www.akesobio.com/en/about-us/corporate-profile/</strong> and follow us on <strong>Linkedin</strong>.</p>
<div class="lb-trans"><p>欲了解更多信息，请访问 <strong>https://www.akesobio.com/en/about-us/corporate-profile/</strong> 并关注我们的 <strong>Linkedin</strong>。</p>
</div><p><strong>Akeso Contacts</strong> <strong>:</strong> Media: [email protected]</p>
<div class="lb-trans"><p><strong>康方联系方式</strong> <strong>:</strong> 媒体: [email protected]</p>
</div><p>Investors: [email protected]</p>
<div class="lb-trans"><p>投资者: [email protected]</p>
</div><p>SOURCE Akeso, Inc.</p>
<div class="lb-trans"><p>来源：康方生物（Akeso, Inc.）</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMjA1Jk5ld3NJdGVtSWQ9Q044MjM1NCZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMDUyMTI2UFJfTkVXU19VU1BSX19fX19DTjgyMzU0" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN82354&amp;Transmission_Id=202602052126PR_NEWS_USPR_____CN82354&amp;DateId=20260205"/></p>

21:26 ETAkeso Receives Fifth Breakthrough Therapy Designation from NMPA for Ivonescimab in First-Line Treatment of Advanced Biliary Tract Cancer

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康方生物获得国家药品监督管理局授予的第五个突破性疗法认定，用于伊沃司单抗在晚期胆道癌一线治疗中的应用