<p>/PRNewswire/ -- 四川凯伦生物医药科技有限公司（&#34;凯伦生物&#34;或&#34;公司&#34;）宣布，公司针对 TROP2 ADC 药物 sacituzumab tirumotecan（sac-TMT，也称为 SKB264/MK-2870）（佳泰莱®）的补充新药申请（sNDA）（&#34;申请&#34;）已被中国国家药品监督管理局（NMPA）药品审评中心（CDE）接受审查。该申请是针对 <strong>sac-TMT 与 MSD 的</strong> <strong>[1]</strong> <strong>抗 PD-1 单克隆抗体 pembrolizumab（KEYTRUDA</strong> <strong>®</strong> <strong>[2]</strong> <strong>）联合用于治疗 PD-L1 肿瘤比例评分（TPS）≥1% 且 EGFR 阴性和 ALK 阴性的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的首选治疗。</strong> 此次接受审查是基于 OptiTROP-Lung05 注册性 III 期研究的积极结果，该申请是 NMPA 接受的第五个 sac-TMT 适应症申请。</p>
<p>OptiTROP-Lung05 是一项随机、开放标签、多中心的 III 期临床研究，评估 sac-TMT 与 pembrolizumab 联合治疗与 pembrolizumab 单药治疗在 PD-L1 阳性局部晚期或转移性 NSCLC 患者中的疗效和安全性。根据预先设定的中期分析，该研究已达到其主要终点——无进展生存期（PFS），并由独立数据监测委员会（IDMC）得出统计学显著且临床有意义的改善结论。同时也观察到总体生存期（OS）的积极趋势。值得注意的是，<strong>OptiTROP-Lung05 研究是首个在一线 NSCLC 治疗中达到主要终点的免疫治疗与 ADC 联合的 III 期研究。该研究已被选为 2026 年美国临床肿瘤学会（ASCO）年会的口头报告（摘要编号#8506，肺癌——非小细胞转移性）。</strong></p>
<p>此前，sac-TMT 与静脉和皮下给药的 pembrolizumab 联合用于治疗 PD-L1 TPS≥1% 且 EGFR 阴性和 ALK 阴性的局部晚期或转移性 NSCLC 患者的首选治疗已获得 NMPA 的突破性疗法认定（BTD）。2026 年 4 月 9 日，CDE 的官方网站宣布该申请已进入优先审评和批准程序。这标志着第五个 sac-TMT 适应症进入 CDE 的优先审评和批准程序。通过这一程序，审评时间将显著缩短，可能加快其批准路径。</p>
<p>凯伦生物首席执行官 Michael Ge 博士表示：&#34;我们很高兴看到 sac-TMT 的第五个适应症申请被接受。与单独的免疫治疗相比，sac-TMT 与 KEYTRUDA®联合作为 PD-L1 阳性 NSCLC 的首选治疗，不仅在 PFS 上取得了积极结果，还在 OS 上显示出获益趋势。这一成就对改善当前肺癌治疗方案具有重要意义。我们将继续与合作伙伴合作，推进 sac-TMT 的临床开发和商业化，帮助更多肺癌患者，提高他们的生存结果。&#34;</p>
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<td>[1] MSD 是默克公司（Merck &amp; Co., Inc.）的商标，位于美国新泽西州拉威。</td>
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<td>[2] KEYTRUDA®（pembrolizumab）是默克夏普与多赫姆公司（Merck Sharp &amp; Dohme LLC，MSD）的注册商标，后者是默克公司的子公司，位于美国新泽西州拉威。</td>
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<p><strong>关于 sac-TMT</strong></p>
<p>Sac-TMT 是公司的核心产品，是一种新型人源性 TROP2 ADC，拥有公司的专有知识产权，针对包括非小细胞肺癌（NSCLC）、乳腺癌（BC）、胃癌（GC）、妇科肿瘤和泌尿生殖肿瘤等晚期实体肿瘤。Sac-TMT 采用独特的双功能连接子，最大化药物负载通过与抗 TROP2 单克隆抗体 sacituzumab 的不可逆连接以及在溶酶体中与 belotecan 衍生物拓扑异构酶 I 抑制剂负载的 pH 敏感裂解的方式输送到肿瘤细胞，药物与抗体比（DAR）为 7.4。Sac-TMT 通过重组抗 TROP2 人源化单克隆抗体特异性识别肿瘤细胞表面的 TROP2，随后被肿瘤细胞内吞并释放负载 KL610023。KL610023 作为拓扑异构酶 I 抑制剂，诱导肿瘤细胞的 DNA 损伤，进而导致细胞周期停滞和凋亡。此外，它还在肿瘤微环境中释放 KL610023。由于 KL610023 具有膜通透性，可以产生旁观者效应，换句话说，可以杀死相邻的肿瘤细胞。</p>
<p>2022 年 5 月，公司将 sac-TMT 的开发、使用、生产和商业化的独占权许可给 MSD（默克公司，位于美国新泽西州拉威），适用于大中华区以外的所有地区（包括中国大陆、香港、澳门和台湾）。</p>
<p>截至目前，sac-TMT 在中国已获批并上市的适应症有四个：1）不可切除的局部晚期或转移性三阴性乳腺癌（TNBC），患者已接受至少两种先前的系统治疗（其中至少一种用于晚期或转移性治疗）；2）EGFR 突变阳性的局部晚期或转移性非鳞状 NSCLC，在 EGFR-TKI 治疗和铂类化疗后进展；3）EGFR 突变阳性的局部晚期或转移性非鳞状 NSCLC，在 EGFR-TKI 治疗后进展；4）不可切除或转移性 HR+/HER2-（IHC 0、IHC 1+ 或 IHC 2+/ISH-）乳腺癌，患者在晚期治疗中已接受过内分泌治疗和至少一线化疗。上述前两个适应症已纳入中国国家医保药品目录（NRDL）。这一纳入预计将为更多乳腺癌和非小细胞肺癌患者带来临床意义重大的益处。此外，sac-TMT 已获得 NMPA 的六项突破性疗法认定（BTD）。</p>
<p>Sac-TMT 是全球首个获批用于肺癌的 TROP2 ADC 药物。针对 PD-L1 TPS≥1% 且 EGFR 阴性和 ALK 阴性的局部晚期或转移性非小细胞肺癌患者，Sac-TMT 联合 pembrolizumab（KEYTRUDA®）作为一线治疗的新适应症申请已被国家药品监督管理局接受审查，并已进入优先审评和批准流程。截至目前，凯伦生物科技已在中国启动了 9 项注册临床研究。默沙东已启动 17 项正在进行的全球 III 期临床研究，研究 Sac-TMT 作为单药或与 pembrolizumab 或其他抗癌药物联合用于多种癌症。这些研究由默沙东赞助和主导。</p>
<p><strong>关于凯伦生物科技</strong></p>
<p>凯伦生物科技（6990.HK）是凯伦制药的控股子公司，专注于创新生物药物和小分子药物的研发、生产、商业化及全球合作。凯伦生物科技专注于实体肿瘤、自身免疫和代谢疾病等主要疾病领域，并建立全球化的药物开发和产业化平台，以满足中国及全球的未满足医疗需求。凯伦生物科技致力于成为创新药物领域的全球领先企业。目前，凯伦生物科技有超过 30 项正在进行的关键创新药物项目，其中 4 项项目的 8 个适应症已获批上市，1 项项目处于 NDA 阶段，超过 10 项项目处于临床阶段。凯伦生物科技已建立全球领先的专有 ADC 和新型 DC 平台 OptiDC™，并有 2 项 ADC 项目获得 5 个适应症的上市批准，以及多个 ADC 和新型 DC 资产处于临床或临床前研究阶段。有关更多信息，请访问 https://en.kelun-biotech.com/。</p>
<p>来源：凯伦生物科技</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTA4Jk5ld3NJdGVtSWQ9Q041NDgzMyZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDgwNjQwUFJfTkVXU19VU1BSX19fX19DTjU0ODMz?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-RGF0ZUlkPTIwMjYwNTA4Jk5ld3NJdGVtSWQ9Q041NDgzMyZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDgwNjQwUFJfTkVXU19VU1BSX19fX19DTjU0ODMz"/></p>

科伦博泰生物

<p>四川科伦博泰生物制药有限公司宣布，针对与帕博利珠单抗联合使用的沙利度胺（sac-TMT）的补充新药申请（sNDA）已被中国国家药品监督管理局（NMPA）接受审查。该申请旨在针对 PD-L1 阳性非小细胞肺癌（NSCLC）患者的一线治疗。此次接受审查是基于 OptiTROP-Lung05 III 期研究的积极结果，该研究达到了无进展生存期的主要终点。这标志着沙利度胺进入 NMPA 优先审查流程的第五个适应症，可能加快批准进程</p>

<p>, /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (&#34;Kelun-Biotech&#34; or the &#34;Company&#34;) announced that the sNDA (the &#34;Application&#34;) for the Company's TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. The application is for <strong>sac-TMT in combination with MSD's</strong> <strong>[1]</strong> <strong>anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA</strong> <strong>®</strong> <strong>[2]</strong> <strong>) as first‑line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have PD-L1 tumor proportion score (TPS) ≥1% and are EGFR-negative and ALK-negative.</strong> This acceptance is based on the positive results from the OptiTROP-Lung05 registrational Phase III study, and the application is the fifth indication application for sac-TMT that has been accepted by the NMPA.</p>
<div class="lb-trans"><p>/PRNewswire/ -- 四川凯伦生物医药科技有限公司（&#34;凯伦生物&#34;或&#34;公司&#34;）宣布，公司针对 TROP2 ADC 药物 sacituzumab tirumotecan（sac-TMT，也称为 SKB264/MK-2870）（佳泰莱®）的补充新药申请（sNDA）（&#34;申请&#34;）已被中国国家药品监督管理局（NMPA）药品审评中心（CDE）接受审查。该申请是针对 <strong>sac-TMT 与 MSD 的</strong> <strong>[1]</strong> <strong>抗 PD-1 单克隆抗体 pembrolizumab（KEYTRUDA</strong> <strong>®</strong> <strong>[2]</strong> <strong>）联合用于治疗 PD-L1 肿瘤比例评分（TPS）≥1% 且 EGFR 阴性和 ALK 阴性的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的首选治疗。</strong> 此次接受审查是基于 OptiTROP-Lung05 注册性 III 期研究的积极结果，该申请是 NMPA 接受的第五个 sac-TMT 适应症申请。</p>
</div><p>The OptiTROP-Lung05 is a randomized, open-label, multicenter, Phase III clinical study that evaluates the efficacy and safety profile of sac-TMT in combination with pembrolizumab versus pembrolizumab monotherapy as first-line treatment for PD-L1-positive locally advanced or metastatic NSCLC. At a pre-specified interim analysis, the study has met its primary endpoint of progression-free survival (PFS) and demonstrated a statistically significant and clinically meaningful improvement as concluded by the Independent Data Monitoring Committee (IDMC). A positive trend in overall survival (OS) was also observed. Notably, <strong>the OptiTROP-Lung05 study is the first Phase III study of an immunotherapy and ADC combination to meet its primary endpoint in first-line NSCLC treatment. The study has been selected for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract number #8506, Lung Cancer –Non-Small Cell Metastatic).</strong></p>
<div class="lb-trans"><p>OptiTROP-Lung05 是一项随机、开放标签、多中心的 III 期临床研究，评估 sac-TMT 与 pembrolizumab 联合治疗与 pembrolizumab 单药治疗在 PD-L1 阳性局部晚期或转移性 NSCLC 患者中的疗效和安全性。根据预先设定的中期分析，该研究已达到其主要终点——无进展生存期（PFS），并由独立数据监测委员会（IDMC）得出统计学显著且临床有意义的改善结论。同时也观察到总体生存期（OS）的积极趋势。值得注意的是，<strong>OptiTROP-Lung05 研究是首个在一线 NSCLC 治疗中达到主要终点的免疫治疗与 ADC 联合的 III 期研究。该研究已被选为 2026 年美国临床肿瘤学会（ASCO）年会的口头报告（摘要编号#8506，肺癌——非小细胞转移性）。</strong></p>
</div><p>Previously, sac-TMT in combination with intravenous and subcutaneous pembrolizumab for the first-line treatment of patients with locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and ALK-negative was granted Breakthrough Therapy Designation (BTD) by the NMPA. On April 9, 2026, the CDE's official website announced that the Application has entered the priority review and approval process. This marks the fifth sac-TMT indication to enter the CDE's priority review and approval process. Through this process, the review time will be significantly shortened, potentially expediting its approval pathways.</p>
<div class="lb-trans"><p>此前，sac-TMT 与静脉和皮下给药的 pembrolizumab 联合用于治疗 PD-L1 TPS≥1% 且 EGFR 阴性和 ALK 阴性的局部晚期或转移性 NSCLC 患者的首选治疗已获得 NMPA 的突破性疗法认定（BTD）。2026 年 4 月 9 日，CDE 的官方网站宣布该申请已进入优先审评和批准程序。这标志着第五个 sac-TMT 适应症进入 CDE 的优先审评和批准程序。通过这一程序，审评时间将显著缩短，可能加快其批准路径。</p>
</div><p>Dr. Michael Ge, CEO of Kelun-Biotech said, &#34;We are delighted to see the acceptance of the fifth indication application for sac-TMT. Compared to immunotherapy alone, the ADC combination with KEYTRUDA® as first-line treatment for PD-L1-positive NSCLC has achieved not only positive results in PFS, but also a trend toward benefit in OS. This achievement holds significant importance for improving current treatment regimens for lung cancer. We will continue to collaborate with our partners to advance the clinical development and commercialization of sac-TMT, to help more patients with lung cancer and enhance their survival outcomes.&#34;</p>
<div class="lb-trans"><p>凯伦生物首席执行官 Michael Ge 博士表示：&#34;我们很高兴看到 sac-TMT 的第五个适应症申请被接受。与单独的免疫治疗相比，sac-TMT 与 KEYTRUDA®联合作为 PD-L1 阳性 NSCLC 的首选治疗，不仅在 PFS 上取得了积极结果，还在 OS 上显示出获益趋势。这一成就对改善当前肺癌治疗方案具有重要意义。我们将继续与合作伙伴合作，推进 sac-TMT 的临床开发和商业化，帮助更多肺癌患者，提高他们的生存结果。&#34;</p>
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<td>[1] MSD is the tradename of Merck &amp; Co., Inc, Rahway, NJ, USA.</td>
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<td>[2] KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp &amp; Dohme LLC (MSD), a subsidiary of Merck &amp; Co., Inc., Rahway, NJ, USA.</td>
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<td>[1] MSD 是默克公司（Merck &amp; Co., Inc.）的商标，位于美国新泽西州拉威。</td>
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<td>[2] KEYTRUDA®（pembrolizumab）是默克夏普与多赫姆公司（Merck Sharp &amp; Dohme LLC，MSD）的注册商标，后者是默克公司的子公司，位于美国新泽西州拉威。</td>
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</div><p><strong>About sac-TMT</strong></p>
<div class="lb-trans"><p><strong>关于 sac-TMT</strong></p>
</div><p>Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.</p>
<div class="lb-trans"><p>Sac-TMT 是公司的核心产品，是一种新型人源性 TROP2 ADC，拥有公司的专有知识产权，针对包括非小细胞肺癌（NSCLC）、乳腺癌（BC）、胃癌（GC）、妇科肿瘤和泌尿生殖肿瘤等晚期实体肿瘤。Sac-TMT 采用独特的双功能连接子，最大化药物负载通过与抗 TROP2 单克隆抗体 sacituzumab 的不可逆连接以及在溶酶体中与 belotecan 衍生物拓扑异构酶 I 抑制剂负载的 pH 敏感裂解的方式输送到肿瘤细胞，药物与抗体比（DAR）为 7.4。Sac-TMT 通过重组抗 TROP2 人源化单克隆抗体特异性识别肿瘤细胞表面的 TROP2，随后被肿瘤细胞内吞并释放负载 KL610023。KL610023 作为拓扑异构酶 I 抑制剂，诱导肿瘤细胞的 DNA 损伤，进而导致细胞周期停滞和凋亡。此外，它还在肿瘤微环境中释放 KL610023。由于 KL610023 具有膜通透性，可以产生旁观者效应，换句话说，可以杀死相邻的肿瘤细胞。</p>
</div><p>In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck &amp; Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).</p>
<div class="lb-trans"><p>2022 年 5 月，公司将 sac-TMT 的开发、使用、生产和商业化的独占权许可给 MSD（默克公司，位于美国新泽西州拉威），适用于大中华区以外的所有地区（包括中国大陆、香港、澳门和台湾）。</p>
</div><p>To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) BC who have received prior ET and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.</p>
<div class="lb-trans"><p>截至目前，sac-TMT 在中国已获批并上市的适应症有四个：1）不可切除的局部晚期或转移性三阴性乳腺癌（TNBC），患者已接受至少两种先前的系统治疗（其中至少一种用于晚期或转移性治疗）；2）EGFR 突变阳性的局部晚期或转移性非鳞状 NSCLC，在 EGFR-TKI 治疗和铂类化疗后进展；3）EGFR 突变阳性的局部晚期或转移性非鳞状 NSCLC，在 EGFR-TKI 治疗后进展；4）不可切除或转移性 HR+/HER2-（IHC 0、IHC 1+ 或 IHC 2+/ISH-）乳腺癌，患者在晚期治疗中已接受过内分泌治疗和至少一线化疗。上述前两个适应症已纳入中国国家医保药品目录（NRDL）。这一纳入预计将为更多乳腺癌和非小细胞肺癌患者带来临床意义重大的益处。此外，sac-TMT 已获得 NMPA 的六项突破性疗法认定（BTD）。</p>
</div><p>Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA®) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and ALK-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.</p>
<div class="lb-trans"><p>Sac-TMT 是全球首个获批用于肺癌的 TROP2 ADC 药物。针对 PD-L1 TPS≥1% 且 EGFR 阴性和 ALK 阴性的局部晚期或转移性非小细胞肺癌患者，Sac-TMT 联合 pembrolizumab（KEYTRUDA®）作为一线治疗的新适应症申请已被国家药品监督管理局接受审查，并已进入优先审评和批准流程。截至目前，凯伦生物科技已在中国启动了 9 项注册临床研究。默沙东已启动 17 项正在进行的全球 III 期临床研究，研究 Sac-TMT 作为单药或与 pembrolizumab 或其他抗癌药物联合用于多种癌症。这些研究由默沙东赞助和主导。</p>
</div><p><strong>About Kelun-Biotech</strong></p>
<div class="lb-trans"><p><strong>关于凯伦生物科技</strong></p>
</div><p>Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&amp;D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.</p>
<div class="lb-trans"><p>凯伦生物科技（6990.HK）是凯伦制药的控股子公司，专注于创新生物药物和小分子药物的研发、生产、商业化及全球合作。凯伦生物科技专注于实体肿瘤、自身免疫和代谢疾病等主要疾病领域，并建立全球化的药物开发和产业化平台，以满足中国及全球的未满足医疗需求。凯伦生物科技致力于成为创新药物领域的全球领先企业。目前，凯伦生物科技有超过 30 项正在进行的关键创新药物项目，其中 4 项项目的 8 个适应症已获批上市，1 项项目处于 NDA 阶段，超过 10 项项目处于临床阶段。凯伦生物科技已建立全球领先的专有 ADC 和新型 DC 平台 OptiDC™，并有 2 项 ADC 项目获得 5 个适应症的上市批准，以及多个 ADC 和新型 DC 资产处于临床或临床前研究阶段。有关更多信息，请访问 https://en.kelun-biotech.com/。</p>
</div><p>SOURCE Kelun-Biotech</p>
<div class="lb-trans"><p>来源：凯伦生物科技</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTA4Jk5ld3NJdGVtSWQ9Q041NDgzMyZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDgwNjQwUFJfTkVXU19VU1BSX19fX19DTjU0ODMz" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN54833&amp;Transmission_Id=202605080640PR_NEWS_USPR_____CN54833&amp;DateId=20260508"/></p>

06:40 ETThe sNDA for Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as First‑Line Treatment for PD-L1-positive NSCLC Accepted for Review by NMPA

06:40 ET Sacituzumab Tirumotecan（sac-TMT）与 Pembrolizumab 联合用于 PD-L1 阳性非小细胞肺癌（NSCLC）一线治疗的补充新药申请（sNDA）已被国家药品监督管理局（NMPA）接受审查