<p>（第一财经）12 月 26 日——中国顶级药品监管机构已批准中国制药公司信达生物的癌症药物 Daboxin®（Ipilimumab N01 注射液）与另一种单克隆抗体联合使用，作为结肠癌的术前免疫治疗。这是全球首个，也是迄今为止唯一获批的双重免疫治疗新辅助方案，适用于可切除的 IIB 至 III 期 MSI-H/dMMR 结肠癌患者。</p>
<p>Daboxin®（Ipilimumab N01 注射液）也是中国首个获批的国产抗 CTLA-4 单克隆抗体，苏州的信达生物昨日表示。当与 Tyvyt®（Sintilimab 注射液）联合使用时，Tyvyt®是信达与美国礼来公司共同开发的创新 PD-1 抑制剂，短期的术前治疗可以显著提高病理完全缓解率，该指标用于衡量手术切除组织中是否仍存在可存活的肿瘤细胞，从而使大多数患者在手术后避免化疗。</p>
<p>这种双重免疫治疗新辅助方案主要针对可切除的 IIB 至 III 期结肠癌患者，这些患者具有微卫星不稳定性高或错配修复缺陷。通常，这些患者对化疗的反应较差，即使在标准的术后治疗后，约 10% 至 30% 的患者仍会经历疾病复发或转移。化疗的副作用也会显著影响他们的生活质量。</p>
<p>这一批准将改变临床实践，填补中国结肠癌术前治疗选择的空白，让更多 MSI-H/dMMR 患者受益，项目首席研究员、同时也是中国工程院院士和中山大学肿瘤中心院长的徐瑞华表示。</p>
<p>“局部晚期结肠癌的根治性手术往往困难、侵入性强，有时无法完全切除肿瘤，导致预后不良，” 中山大学肿瘤中心副院长、内科主任王峰对第一财经表示。“这一双重免疫治疗新辅助方案的批准为这些患者提供了新的选择。”</p>
<p>由于香港市场因圣诞假期关闭，信达生物的股票（HKG:1801）今天未进行交易。</p>
<p>编辑：唐诗华，金·泰勒</p>

信达生物

<p>中国药品监管部门已批准信达生物的 Daboxin®（伊匹单抗 N01 注射液）与另一种单克隆抗体联合用于结肠癌的术前免疫治疗。这是全球首个获批的针对可切除 IIB 至 III 期 MSI-H/dMMR 结肠癌的双重免疫治疗新辅助方案。该治疗旨在改善患者的治疗效果，并减少对传统治疗的化疗依赖，特别是针对对传统治疗反应较差的患者</p>

<p>(Yicai) Dec. 26 -- China's top drug regulator has approved Chinese pharmaceutical firm Innovent Biologics’ cancer drug Daboxin® (Ipilimumab N01 Injection) for use in combination with another monoclonal antibody as a pre-surgery immunotherapy for colon cancer. The treatment is the world’s first, and so far the only, approved dual-immunotherapy neoadjuvant regimen for patients with resectable stage IIB to III MSI-H/dMMR colon cancer.</p>
<div class="lb-trans"><p>（第一财经）12 月 26 日——中国顶级药品监管机构已批准中国制药公司信达生物的癌症药物 Daboxin®（Ipilimumab N01 注射液）与另一种单克隆抗体联合使用，作为结肠癌的术前免疫治疗。这是全球首个，也是迄今为止唯一获批的双重免疫治疗新辅助方案，适用于可切除的 IIB 至 III 期 MSI-H/dMMR 结肠癌患者。</p>
</div><p>Daboxin® (Ipilimumab N01 Injection) is also the first domestically developed anti-CTLA-4 monoclonal antibody approved in China, Suzhou-based Innovent Biologics said yesterday. When combined with Tyvyt® (Sintilimab Injection), an innovative PD-1 inhibitor co-developed by Innovent and the US' Eli Lilly and Company, the short course of preoperative treatment can significantly increase the pathological complete response rate, which measures if any viable tumor cells are still found in the surgically removed tissue, enabling most patients to avoid chemotherapy after the operation.</p>
<div class="lb-trans"><p>Daboxin®（Ipilimumab N01 注射液）也是中国首个获批的国产抗 CTLA-4 单克隆抗体，苏州的信达生物昨日表示。当与 Tyvyt®（Sintilimab 注射液）联合使用时，Tyvyt®是信达与美国礼来公司共同开发的创新 PD-1 抑制剂，短期的术前治疗可以显著提高病理完全缓解率，该指标用于衡量手术切除组织中是否仍存在可存活的肿瘤细胞，从而使大多数患者在手术后避免化疗。</p>
</div><p>This dual-immunotherapy neoadjuvant treatment regimen is mainly intended for patients with resectable stage IIB to III colon cancer patients with microsatellite instability-high or mismatch repair deficiency. These patients are generally less responsive to chemotherapy, and even after standard postoperative treatment, about 10 percent to 30 percent of them still experience disease recurrence or metastasis. The side effects of chemotherapy can also significantly affect their quality of life.</p>
<div class="lb-trans"><p>这种双重免疫治疗新辅助方案主要针对可切除的 IIB 至 III 期结肠癌患者，这些患者具有微卫星不稳定性高或错配修复缺陷。通常，这些患者对化疗的反应较差，即使在标准的术后治疗后，约 10% 至 30% 的患者仍会经历疾病复发或转移。化疗的副作用也会显著影响他们的生活质量。</p>
</div><p>The approval will change clinical practice and fill the gap in China’s pre-surgery treatment options for colon cancer, allowing more MSI-H/dMMR patients to benefit, said Xu Ruihua, lead researcher of the project who is also an academic at the Chinese Academy of Engineering and president of the Sun Yat-sen University Cancer Center.</p>
<div class="lb-trans"><p>这一批准将改变临床实践，填补中国结肠癌术前治疗选择的空白，让更多 MSI-H/dMMR 患者受益，项目首席研究员、同时也是中国工程院院士和中山大学肿瘤中心院长的徐瑞华表示。</p>
</div><p>&#34;Radical surgery for locally advanced colon cancer is often difficult, highly invasive and sometimes fails to achieve complete tumor removal, resulting in a poor prognosis,” Wang Feng, assistant to the president and director of the Department of Internal Medicine at the Sun Yat-sen University Cancer Center, told Yicai. “The approval of this dual-immunotherapy neoadjuvant treatment provides a new option for these patients.&#34;</p>
<div class="lb-trans"><p>“局部晚期结肠癌的根治性手术往往困难、侵入性强，有时无法完全切除肿瘤，导致预后不良，” 中山大学肿瘤中心副院长、内科主任王峰对第一财经表示。“这一双重免疫治疗新辅助方案的批准为这些患者提供了新的选择。”</p>
</div><p>Innovent's shares [HKG:1801] did not trade today as the Hong Kong market was closed for the Christmas holiday.</p>
<div class="lb-trans"><p>由于香港市场因圣诞假期关闭，信达生物的股票（HKG:1801）今天未进行交易。</p>
</div><p>Editors: Tang Shihua, Kim Taylor</p>
<div class="lb-trans"><p>编辑：唐诗华，金·泰勒</p>
</div>

中国批准全球首个结肠癌术前双免疫疗法