<p><em>— NDA 获得了中国患者积极的第二阶段注册研究数据的支持；紧随 2023 年获得的突破性疗法认定 —</em></p>
<p><em>— Savolitinib 有潜力成为中国首个针对 MET 扩增胃癌的选择性 MET 抑制剂 —</em></p>
<p>香港、上海和新泽西州弗洛拉姆公园，2025 年 12 月 30 日（GLOBE NEWSWIRE）-- 药明康德（中国）有限公司（“药明康德”）（纳斯达克/AIM:​HCM；香港交易所:​13）今天宣布，针对局部晚期或转移性胃癌或胃食管交界（GC/GEJ）腺癌患者的 Savolitinib 新药申请（“NDA”）已被中国国家药品监督管理局（“NMPA”）接受并获得优先审评。</p>
<p>该 NDA 得到了在中国进行的 Savolitinib 针对 MET 扩增的胃癌患者的单臂、多中心、开放标签的第二阶段注册研究数据的支持。该研究已通过独立审查委员会（IRC）（RECIST 1.1）达成其主要终点，即客观缓解率（ORR）。更多详细信息可在 clinicaltrials.gov 上找到，标识符为 NCT04923932。</p>
<p>胃癌仍然是中国最常见的癌症之一，也是癌症死亡的主要原因。MET 驱动的胃癌预后非常差。1 据估计，MET 扩增约占胃癌患者的 4-6%。2,3 MET 扩增胃癌的年发病率在中国估计约为 18,000 例。4</p>
<p>NMPA 于 2023 年授予 Savolitinib 这一潜在适应症突破性疗法认定。NMPA 将这一认定授予这一新治疗方法，因为临床证据显示其在治疗严重疾病方面相较于现有疗法具有显著优势。</p>
<p><strong>关于 Savolitinib</strong></p>
<p>Savolitinib 是一种口服、强效且高度选择性的 MET 酪氨酸激酶抑制剂（TKI），由阿斯利康和药明康德共同开发，并由阿斯利康进行商业化。MET 是一种在正常细胞发育中起重要作用的酪氨酸激酶受体。5 Savolitinib 阻断由于突变（如外显子 14 跳跃改变或其他点突变）、基因扩增或蛋白质过表达而导致的 MET 受体酪氨酸激酶通路的非典型激活。</p>
<p>Savolitinib 在中国已获批准，并由我们的合作伙伴阿斯利康以 ORPATHYS®的品牌名称进行市场推广，成为中国首个获批的选择性 MET 抑制剂。自 2023 年 3 月以来，它已被纳入中国国家医保药品目录（NRDL）。</p>
<p>目前，它正在针对多种肿瘤类型进行临床开发，包括肺癌、肾癌和胃癌，作为单一治疗和与其他药物联合使用。</p>
<p><strong>关于药明康德</strong></p>
<p>药明康德（纳斯达克/AIM:​HCM；香港交易所:​13）是一家创新的商业阶段生物制药公司。它致力于癌症和免疫疾病的靶向治疗和免疫治疗的发现、全球开发和商业化。自成立以来，它专注于将药物候选物从内部发现带给全球患者，其首三种药物在中国上市，其中第一种药物也在全球范围内获得批准，包括美国、欧洲和日本。有关更多信息，请访问：www.hutch-med.com 或在 LinkedIn 上关注我们。</p>
<p><strong><em>前瞻性声明</em></strong></p>
<p><em>本新闻稿包含根据 1995 年美国私人证券诉讼改革法案 “安全港” 条款的前瞻性声明。这些前瞻性声明反映了药明康德对未来事件的当前预期，包括其对 NMPA 审查 Savolitinib 用于胃癌治疗的 NDA 的预期及该审查的时间、Savolitinib 在胃癌患者治疗中的治疗潜力以及 Savolitinib 在此及其他适应症的进一步开发。前瞻性声明涉及风险和不确定性。这些风险和不确定性包括但不限于对临床研究的时间和结果的假设，以及支持 Savolitinib 用于胃癌患者或其他适应症的 NDA 批准的临床数据的充分性，其获得监管机构快速批准的潜力或根本没有获得批准的可能性，Savolitinib 的安全性特征，药明康德和/或其合作伙伴资助、实施和完成 Savolitinib 的进一步临床开发和商业化计划的能力及这些事件的时间。现有和潜在投资者被提醒不要过度依赖这些前瞻性声明，这些声明仅在本日期有效。有关这些和其他风险的进一步讨论，请参见药明康德向美国证券交易委员会、香港联合交易所和 AIM 的提交文件。药明康德没有义务更新或修订本新闻稿中包含的信息，无论是由于新信息、未来事件或情况或其他原因。</em></p>
<p><strong><em>医学信息</em></strong></p>
<p><em>本新闻稿包含有关可能在所有国家不可用的产品的信息，或可能以不同商标、不同适应症、不同剂量或不同强度提供。此处所含内容不应被视为对任何处方药（包括正在开发中的药物）的招揽、推广或广告。</em></p>
<p><strong>联系方式</strong></p>
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<p>\<em>\</em>\___________________</p>
<p><strong>参考文献</strong></p>
<p>1 Catenacci DV, Ang A, Liao WL, 等. MET 酪氨酸激酶受体表达和扩增作为胃食管腺癌生存的预后生物标志物. <em>癌症</em>. 2017;123(6):1061-1070. doi:10.1002/cncr.30437</p>
<p>2 Lee J, Kim ST, Kim K, 等. 肿瘤基因组分析指导转移性胃癌患者接受靶向治疗：VIKTORY 伞形试验. <em>癌症发现</em>. 2019;9(10):1388-1405. doi:10.1158/2159-8290.CD-19-044</p>
<p>3 Van Cutsem E, Karaszewska B, Kang YK, 等. 一项多中心 II 期研究 AMG 337 在 MET 扩增的胃/胃食管交界/食管腺癌及其他 MET 扩增实体瘤患者中的应用. 临床癌症研究. 2019;25(8):2414-2423. doi:10.1158/1078-0432.CCR-18-1337</p>
<p>4 全球癌症观察. 中国情况说明. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. 访问日期：2025 年 4 月 7 日。</p>
<p>5 Uchikawa E, <em>等</em>. c-MET 受体激活的结构基础. <em>自然通讯。</em> 2021;12(4074).</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZeE9ERTBNeU0zTXpNNU5UQTRJekl3T1RZM01UVT0?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://www.globenewswire.com/newsroom/ti/query-bmY9T1RZeE9ERTBNeU0zTXpNNU5UQTRJekl3T1RZM01UVT0"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/OTE4MDQxNDMtNGIxNS00MTIzLWI1NTgtZTIyZTc5NjViMDZiLTExMDgyODYtMjAyNS0xMi0zMC1lbg==/tiny/HUTCHMED-China-Limited.png?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://ml.globenewswire.com/media/OTE4MDQxNDMtNGIxNS00MTIzLWI1NTgtZTIyZTc5NjViMDZiLTExMDgyODYtMjAyNS0xMi0zMC1lbg==/tiny/HUTCHMED-China-Limited.png"/></p>

和黄医药

<p>和黄医药宣布，其针对治疗具有 MET 扩增的胃癌患者的新的药物申请（NDA）已被中国国家药品监督管理局（NMPA）接受，并获得优先审评状态。这一进展是在 2023 年获得积极的二期研究结果和突破性疗法认定之后。Savolitinib 有望成为中国首个针对该适应症的选择性 MET 抑制剂，满足了预后较差的患者群体的重大医疗需求</p>

<p><em>— NDA supported by positive Phase II registration study data in Chinese patients; follows Breakthrough Therapy Designation granted in 2023 —</em></p>
<div class="lb-trans"><p><em>— NDA 获得了中国患者积极的第二阶段注册研究数据的支持；紧随 2023 年获得的突破性疗法认定 —</em></p>
</div><p><em>— Savolitinib has the potential to become the first selective MET inhibitor in China for MET-amplified gastric cancer —</em></p>
<div class="lb-trans"><p><em>— Savolitinib 有潜力成为中国首个针对 MET 扩增胃癌的选择性 MET 抑制剂 —</em></p>
</div><p>HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 30, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application (“NDA”) for savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).</p>
<div class="lb-trans"><p>香港、上海和新泽西州弗洛拉姆公园，2025 年 12 月 30 日（GLOBE NEWSWIRE）-- 药明康德（中国）有限公司（“药明康德”）（纳斯达克/AIM:​HCM；香港交易所:​13）今天宣布，针对局部晚期或转移性胃癌或胃食管交界（GC/GEJ）腺癌患者的 Savolitinib 新药申请（“NDA”）已被中国国家药品监督管理局（“NMPA”）接受并获得优先审评。</p>
</div><p>This NDA is supported by data from a single-arm, multi-center, open-label, Phase II registration study of savolitinib in gastric cancer patients with MET amplification in China. The study has met its primary endpoint of objective response rate (ORR) by the Independent Review Committee (IRC) (RECIST 1.1). Additional details may be found at clinicaltrials.gov using identifier NCT04923932.</p>
<div class="lb-trans"><p>该 NDA 得到了在中国进行的 Savolitinib 针对 MET 扩增的胃癌患者的单臂、多中心、开放标签的第二阶段注册研究数据的支持。该研究已通过独立审查委员会（IRC）（RECIST 1.1）达成其主要终点，即客观缓解率（ORR）。更多详细信息可在 clinicaltrials.gov 上找到，标识符为 NCT04923932。</p>
</div><p>Gastric cancer remains one of the most common cancers and leading causes of cancer death in China. MET-driven gastric cancer has a very poor prognosis.1 It is estimated that MET amplification accounts for approximately 4-6% of gastric cancer patients.2,3 The annual incidence of MET amplification gastric cancer is estimated to be approximately 18,000 in China.4</p>
<div class="lb-trans"><p>胃癌仍然是中国最常见的癌症之一，也是癌症死亡的主要原因。MET 驱动的胃癌预后非常差。1 据估计，MET 扩增约占胃癌患者的 4-6%。2,3 MET 扩增胃癌的年发病率在中国估计约为 18,000 例。4</p>
</div><p>The NMPA has granted Breakthrough Therapy Designation to savolitinib for this potential indication in 2023. The NMPA granted this designation to this new treatment that could target a serious condition where clinical evidence demonstrates substantial advantages over existing therapies.</p>
<div class="lb-trans"><p>NMPA 于 2023 年授予 Savolitinib 这一潜在适应症突破性疗法认定。NMPA 将这一认定授予这一新治疗方法，因为临床证据显示其在治疗严重疾病方面相较于现有疗法具有显著优势。</p>
</div><p><strong>About Savolitinib</strong></p>
<div class="lb-trans"><p><strong>关于 Savolitinib</strong></p>
</div><p>Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an essential role in normal cell development.5 Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.</p>
<div class="lb-trans"><p>Savolitinib 是一种口服、强效且高度选择性的 MET 酪氨酸激酶抑制剂（TKI），由阿斯利康和药明康德共同开发，并由阿斯利康进行商业化。MET 是一种在正常细胞发育中起重要作用的酪氨酸激酶受体。5 Savolitinib 阻断由于突变（如外显子 14 跳跃改变或其他点突变）、基因扩增或蛋白质过表达而导致的 MET 受体酪氨酸激酶通路的非典型激活。</p>
</div><p>Savolitinib is approved in China and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023.</p>
<div class="lb-trans"><p>Savolitinib 在中国已获批准，并由我们的合作伙伴阿斯利康以 ORPATHYS®的品牌名称进行市场推广，成为中国首个获批的选择性 MET 抑制剂。自 2023 年 3 月以来，它已被纳入中国国家医保药品目录（NRDL）。</p>
</div><p>It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.</p>
<div class="lb-trans"><p>目前，它正在针对多种肿瘤类型进行临床开发，包括肺癌、肾癌和胃癌，作为单一治疗和与其他药物联合使用。</p>
</div><p><strong>About HUTCHMED</strong></p>
<div class="lb-trans"><p><strong>关于药明康德</strong></p>
</div><p>HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.</p>
<div class="lb-trans"><p>药明康德（纳斯达克/AIM:​HCM；香港交易所:​13）是一家创新的商业阶段生物制药公司。它致力于癌症和免疫疾病的靶向治疗和免疫治疗的发现、全球开发和商业化。自成立以来，它专注于将药物候选物从内部发现带给全球患者，其首三种药物在中国上市，其中第一种药物也在全球范围内获得批准，包括美国、欧洲和日本。有关更多信息，请访问：www.hutch-med.com 或在 LinkedIn 上关注我们。</p>
</div><p><strong><em>Forward-Looking Statements</em></strong></p>
<div class="lb-trans"><p><strong><em>前瞻性声明</em></strong></p>
</div><p><em>This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the review of a NDA for savolitinib for the treatment of gastric cancer with the NMPA and the timing of such review, therapeutic potential of savolitinib for the treatment of patients with gastric cancer and the further development of savolitinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support NDA approval of savolitinib for the treatment of patients with gastric cancer or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the safety profile of savolitinib, HUTCHMED and/or its partner’s ability to fund, implement and complete its further clinical development and commercialization plans for savolitinib and the timing of these events. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.</em></p>
<div class="lb-trans"><p><em>本新闻稿包含根据 1995 年美国私人证券诉讼改革法案 “安全港” 条款的前瞻性声明。这些前瞻性声明反映了药明康德对未来事件的当前预期，包括其对 NMPA 审查 Savolitinib 用于胃癌治疗的 NDA 的预期及该审查的时间、Savolitinib 在胃癌患者治疗中的治疗潜力以及 Savolitinib 在此及其他适应症的进一步开发。前瞻性声明涉及风险和不确定性。这些风险和不确定性包括但不限于对临床研究的时间和结果的假设，以及支持 Savolitinib 用于胃癌患者或其他适应症的 NDA 批准的临床数据的充分性，其获得监管机构快速批准的潜力或根本没有获得批准的可能性，Savolitinib 的安全性特征，药明康德和/或其合作伙伴资助、实施和完成 Savolitinib 的进一步临床开发和商业化计划的能力及这些事件的时间。现有和潜在投资者被提醒不要过度依赖这些前瞻性声明，这些声明仅在本日期有效。有关这些和其他风险的进一步讨论，请参见药明康德向美国证券交易委员会、香港联合交易所和 AIM 的提交文件。药明康德没有义务更新或修订本新闻稿中包含的信息，无论是由于新信息、未来事件或情况或其他原因。</em></p>
</div><p><strong><em>Medical Information</em></strong></p>
<div class="lb-trans"><p><strong><em>医学信息</em></strong></p>
</div><p><em>This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.</em></p>
<div class="lb-trans"><p><em>本新闻稿包含有关可能在所有国家不可用的产品的信息，或可能以不同商标、不同适应症、不同剂量或不同强度提供。此处所含内容不应被视为对任何处方药（包括正在开发中的药物）的招揽、推广或广告。</em></p>
</div><p><strong>CONTACTS</strong></p>
<div class="lb-trans"><p><strong>联系方式</strong></p>
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<div class="lb-trans"><table>
<thead>
<tr>
<th></th>
<th></th>
</tr>
</thead>
<tbody>
<tr>
<td><strong>投资者咨询</strong></td>
<td>+852 2121 8200 / ir@hutch-med.com</td>
</tr>
<tr>
<td></td>
<td></td>
</tr>
<tr>
<td><strong>媒体咨询</strong></td>
<td></td>
</tr>
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<td>FTI Consulting –</td>
<td>+44 20 3727 1030 / HUTCHMED@fticonsulting.com</td>
</tr>
<tr>
<td>Ben Atwell / Tim Stamper</td>
<td>+44 7771 913 902 (手机) / +44 7421 898 348 (手机)</td>
</tr>
<tr>
<td>Brunswick – Zhou Yi</td>
<td>+852 9783 6894 (手机) / HUTCHMED@brunswickgroup.com</td>
</tr>
<tr>
<td></td>
<td></td>
</tr>
<tr>
<td><strong>Panmure Liberum</strong></td>
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<td>Atholl Tweedie / Emma Earl / Rupert Dearden</td>
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<tr>
<td></td>
<td></td>
</tr>
<tr>
<td><strong>Cavendish</strong></td>
<td><em>联合经纪人</em></td>
</tr>
<tr>
<td>Geoff Nash / Nigel Birks</td>
<td>+44 20 7220 0500</td>
</tr>
<tr>
<td></td>
<td></td>
</tr>
<tr>
<td><strong>Deutsche Numis</strong></td>
<td><em>联合经纪人</em></td>
</tr>
<tr>
<td>Freddie Barnfield / Jeffrey Wong / Duncan Monteith</td>
<td>+44 20 7260 1000</td>
</tr>
</tbody>
</table>
</div><p>\<em>\</em>\___________________</p>
<div class="lb-trans"><p>\<em>\</em>\___________________</p>
</div><p><strong>REFERENCES</strong></p>
<div class="lb-trans"><p><strong>参考文献</strong></p>
</div><p>1 Catenacci DV, Ang A, Liao WL, et al. MET tyrosine kinase receptor expression and amplification as prognostic biomarkers of survival in gastroesophageal adenocarcinoma. <em>Cancer</em>. 2017;123(6):1061-1070. doi:10.1002/cncr.30437</p>
<div class="lb-trans"><p>1 Catenacci DV, Ang A, Liao WL, 等. MET 酪氨酸激酶受体表达和扩增作为胃食管腺癌生存的预后生物标志物. <em>癌症</em>. 2017;123(6):1061-1070. doi:10.1002/cncr.30437</p>
</div><p>2 Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. <em>Cancer Discov</em>. 2019;9(10):1388-1405. doi:10.1158/2159-8290.CD-19-044</p>
<div class="lb-trans"><p>2 Lee J, Kim ST, Kim K, 等. 肿瘤基因组分析指导转移性胃癌患者接受靶向治疗：VIKTORY 伞形试验. <em>癌症发现</em>. 2019;9(10):1388-1405. doi:10.1158/2159-8290.CD-19-044</p>
</div><p>3 Van Cutsem E, Karaszewska B, Kang YK, et al. A Multicenter Phase II Study of AMG 337 in Patients with MET-Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma and Other MET-Amplified Solid Tumors. Clin Cancer Res. 2019;25(8):2414-2423. doi:10.1158/1078-0432.CCR-18-1337</p>
<div class="lb-trans"><p>3 Van Cutsem E, Karaszewska B, Kang YK, 等. 一项多中心 II 期研究 AMG 337 在 MET 扩增的胃/胃食管交界/食管腺癌及其他 MET 扩增实体瘤患者中的应用. 临床癌症研究. 2019;25(8):2414-2423. doi:10.1158/1078-0432.CCR-18-1337</p>
</div><p>4 Global Cancer Observatory. China Fact Sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed April 7, 2025.</p>
<div class="lb-trans"><p>4 全球癌症观察. 中国情况说明. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. 访问日期：2025 年 4 月 7 日。</p>
</div><p>5 Uchikawa E, <em>et al</em>. Structural basis of the activation of c-MET receptor. <em>Nat Commun.</em> 2021;12(4074).</p>
<div class="lb-trans"><p>5 Uchikawa E, <em>等</em>. c-MET 受体激活的结构基础. <em>自然通讯。</em> 2021;12(4074).</p>
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HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Savolitinib for the treatment of Gastric Cancer Patients with MET Amplification | HCM Stock News

和黄医药宣布其在中国提交的萨伏替尼用于治疗 MET 扩增的胃癌患者的新药申请已被接受，并获得优先审评资格 | HCM 股票新闻