Fanregratinib

香港、上海和新泽西州弗洛勒姆公园 2024年7月31日 /美通社/ -- 和黄医药（中国）有限公司（简称" 和黄医药 "、"本公司"或"我们"）（纳斯达克/伦敦证交所：HCM；香港交易所：13）今日公布截至2024年6月30日止六个月的财务业绩以及提供关键临床项目和商业化发展的最新进展。 除另有说明外，所有金额均以美元列示。 收入增长势头持续，现金结余充裕支持扩展 重申 2024 年全年肿瘤 / 免疫业务综合收入财务指引为 3 亿至 4 亿美元，其中 2024 年上半年为 1.687 亿美元，得益于 59% （按固定汇率 [ 1] 计算为 64% ）的肿瘤产品收入增长。 FRUZAQLA® 2024 年上半年美国市场销售额 [ 2] 为 1.305 亿美元 ‒ 显示自2023年11月上市以来，强劲的市场需求和商业吸引力。 2024年上半年 净收益为 2,580 万美元 。截至2024年6月30日 现金余额为 8.025 亿美元 ，得益于我们持续提升关键研发 [3] 项目的优先级并提高商业效率。 呋喹替尼全球布局持续推进，管线进一步拓宽并取得切实进展 FRUZAQLA® 于 2024 年 6 月获欧盟委员会批准后，正在合作伙伴武田 [ 4] 的带领下为其在欧盟上市做准备 ‒ 在FRESCO-2研究的支持下，已在十几个国家和地区提交上市许可申请。 和黄医药正为索乐匹尼布在中国上市做准备，用于治疗免疫性血小板减少症 [5] ‒ 有望成为公司首款血液学药物，其新药上市申请 [6] 已于2024年1月获受理并获纳入优先审评。 基于SAVANNAH研究数据， 有望于年底在美国提交赛沃替尼用于治疗非小细胞肺癌 [ 7] 的新药上市申请 。 旨在在中国扩展沃瑞沙 ® 和爱优特 ® 的使用范围和达唯珂 ® 的新药或新适应症上市申请已获受理 — 分别用于治疗MET外显子14跳变 [8] 的非小细胞肺癌初治患者、子宫内膜癌患者和滤泡性淋巴瘤患者。 15 项关键后期注册试验已启动，目前正在进行 / 正在审评中 ‒ 涉及六种候选药物：索乐匹尼布用于治疗温抗体型自身免疫性溶血性贫血 [9] 的ESLIM-02研究， HMPL-306用于治疗急性髓系白血病 [10] 的RAPHAEL研究，以及索凡替尼用于治疗胰腺导管腺癌 [11] 的研究。 持续壮大的血液学产品组合， 在现有靶向Syk [12] 、EZH2 [13] 、IDH [14] 、BTK [15] 和CD47的抑制剂和抗体产品组合的基础上，新加入了靶向Menin和CD38的项目。 和黄医药非执行主席艾乐德（ Dan Eldar ）博士表示： "和黄医药在今年上半年表现强劲。团队继续实施我们的战略并取得了重要的进展，持续发现和开发创新及有效的药物；在中国本土市场和全球市场开展临床试验；及快速实现监管注册和商业目标。我很高兴看到我们与武田的合作继续取得成功，也很高兴看到公司为海外患者带来医疗获益的能力不断增强。在此期间，我们在美国的收入持续增长，预计未来数月还将迎来在更多其他国家的收入增长。我们还会充分发挥我们在中国将新药带向市场，以及为已上市药物扩展新适应症的良好经验，期望在未来几年取得多项潜在新药上市申请批准。" "我想借此机会向刚刚退休的杜志强先生表示衷心感谢，杜先生见证了和黄医药的创立，并作出了重大贡献，令和黄医药成长为一家全球性的创新型生物医药公司，致力于发现、开发和商业化癌症和免疫性疾病疗法，以改善全球患者的生活质量。我期待着带领公司迈入充满潜力与希望的新发展阶段。" 2024 年中期业绩及最新业务进展 和黄医药首席执行官兼首席科学官苏慰国博士表示： "和黄医药团队始终不懈努力，以保持我们近年来在临床及监管注册方面的良好势头，并推动已获批产品取得商业上的成功。我要感谢每个人的辛勤工作及投入。与2023年上半年相比，我们的 肿瘤产品收入增长了 59% ，与此同时，我们在推进研发管线时也更具侧重性，拥有巨大潜力创造更高价值。我们在今年新启动了三项关键性的后期研究，管线中目前共有十多项关键性研究正在进行中，有望在未来支持更多药物审批。" "我们为实现药物全球化而采取的合作战略，帮助我们在为内部研发引擎提供持续的动力，以及推动本土市场销售的同时，将我们的创新药物带向全球更多地区的患者。FRUZAQLA®在武田带领下的初步销售表现令人赞赏，证明了我们药物的品质及其在全球市场的潜力，以及验证了我们在海外市场采取合作战略的成效。" "下半年我们将继续推进各项注册研究。我们期待在年底左右在中国取得索乐匹尼布的注册批准，并在美国提交赛沃替尼的新药上市申请。我们将继续朝着成为一家可持续发展的生物医药企业这一目标迈进。" I. 商业营运 肿瘤业务市场销售额增长 140% （按固定汇率计算为 145% ）至 2.433 亿美元 （2023年上半年：1.013亿美元），得益于此，肿瘤产品综合收入强劲增长59%（按固定汇率计算为64%）至1.278亿美元（2023年上半年：8,010万美元），主要包括以下重点： FRUZAQLA® （呋喹替尼的海外商品名） 于2023年11月在美国上市， 市场销售额为 1.305 亿美元 （2023年上半年：无）。其强劲的业绩得益于在美国市场获患者快速接纳，以及销售渠道库存需求的拉动； 爱优特 ® （ ELUNATE® ，呋喹替尼的中国商品名）市场销售额增长 8% （按固定汇率计算为 13% ）至 6,100 万美元 （2023年上半年：5,630万美元），与结直肠癌 [16] 市场的增速一致，我们的市场份额在市场竞争加剧的情况下依然保持领先； 苏泰达 ® （ SULANDA® ，索凡替尼）市场销售额增长了 12% （按固定汇率计算为 17% ）至 2,540 万美元 （2023年上半年：2,260万美元），得益于医生对该产品的认知度持续提升，令对神经内分泌瘤患者的可及性及市场份额提高； 及 沃瑞沙 ® （ ORPATHYS® ，赛沃替尼）市场销售额增长了 18% （按固定汇率计算为 22% ）至 2,590 万美元 （2023年上半年：2,200万美元），得益于非小细胞肺癌患者中MET外显子14跳变检测及诊断的进步，以及在纳入国家医保药品目录 [17] 后第二年持续的增长势头。 肿瘤/免疫业务综合收入包括肿瘤综合产品收入，其中包括产品收入、商业服务费及特许权使用费，以及来自合作伙伴的研发收入，主要如下： 来自武田的首付款、里程碑及研发服务收入 3,380 万美元（ 2023 年上半年： 2.691 亿美元） ，其中包括从4.35亿美元的首付款和里程碑付款中确认的1,940万美元，该款项已于2023年以现金形式从武田收到。相比之下，去年同期确认的款项为2.587亿美元。 因此， 肿瘤 / 免疫业务综合收入总额为 1.687 亿美元 （2023年上半年：3.592亿美元）。包括其他业务收入，总收入为3.057亿美元（2023年上半年：5.329亿美元）。 （未经审核， 百万美元） 市场销售额 * 综合收入 ** 2024 年上半年 2023 年上半年 %Δ ( 固定汇率 ) 2024 年上半年 2023 年上半年 %Δ ( 固定汇率 ) FRUZAQLA® 130.5 — — 42.8 — — 爱优特® 61.0 56.3 +8 % (+13 %) 46.0 42.0 +9 % (+14 %) 苏泰达® 25.4 22.6 +12 % (+17 %) 25.4 22.6 +12 % (+17 %) 沃瑞沙® 25.9 22.0 +18 % (+22 %) 13.1 15.1 -14 % (-10 %) 达唯珂® 0.5 0.4 +40 % (+46 %) 0.5 0.4 +40 % (+46 %) 肿瘤产品 243.3 101.3 +140 % (+145 %) 127.8 80.1 +59 % (+64 %) 武田首付款、里程碑及研发服务收入 33.8 269.1 -87 % (-87 %) 其他研发服务收入 7.1 10.0 -29 % (-27 %) 肿瘤 / 免疫业务合计 168.7 359.2 -53 % (-52 %) 其他业务 137.0 173.7 -21 % (-18 %) 收入总额 305.7 532.9 -43 % (-41 %) * = 就 FRUZAQLA® 、爱优特 ® 和沃瑞沙 ® ，主要分别代表武田、礼来 [ 18] 和阿斯利康提供的对第三方的总销售额。 ** =就FRUZAQLA®，代表武田支付的药品供应和特许权使用费；就爱优特®，代表礼来向和黄医药支付的药品供应、 商业服务费和特许权使用费以及由和黄医药开具发票的对其他第三方的销售额；就沃瑞沙®，代表阿斯利康向和黄 医药支付的药品供应和特许权使用费以及由和黄医药开具发票的对其他第三方的销售额；以及就苏泰达®及达唯珂 ®，代表公司对第三方的产品销售额。 II. 注册审批进展 中国 赛沃替尼用于一线 和二线治疗MET外显子14跳变非小细胞肺癌的 新适应症上市申请 [ 19] 于 2024 年获国家药监局 [ 20] 受理 ； 2024年1月， 呋喹替尼在中国香港获批用于三线治疗结直肠癌 ； 呋喹替尼用于二线治疗子宫内膜癌的新适应症上市申请于 2024年年初 获国家药监局受理并获纳入优先审评 ； 2024年5月， 他泽司他在中国香港获批用于治疗复发 / 难治性 [ 21] 滤泡性淋巴瘤 ；及 2024年7月， 他泽司他用于治疗复发 / 难治性滤泡性淋巴瘤的新药上市申请获国家药监局受理并获纳入优先审评。 中国以外 呋喹替尼 于2024年4月取得欧洲药品管理局 [22] 人用药品委员会的积极意见，用于治疗经治的转移性结直肠癌，并随后 于 2024 年 6 月在欧盟获批 。 III. 后期临床项目进展 赛沃替尼（中国商品名：沃瑞沙 ® ）是一种高选择性口服的 MET [23] 抑制剂 完成 SAVANNAH 研究的患者招募 （NCT03778229），该关键性全球II期研究在因MET扩增或过表达导致泰瑞沙®治疗后疾病进展的非小细胞肺癌患者中展开，已获快速通道开发项目资格，并有望于美国申请加速审批。在该患者群体中进行的一项小型平行研究（NCT04606771）于AACR [24] 年会上发表的数据亦证实了该联合疗法拥有更高的临床活性，且安全性与各项治疗的已知特征保持一致；及 多项研究继续入组中，包括 SAFFRON 研究 （NCT05261399），这项在该患者群体中展开的与泰瑞沙®联合疗法的全球关键性III期研究，将为SAVANNAH研究提供进一步支持； SACHI 研究 （NCT05015608），一项在EGFR [25] 抑制剂治疗后疾病进展的中国患者中开展的类似的关键性III期研究，以及 SANOVO 研究（NCT05009836），一项用于一线治疗伴有EGFR突变和MET过表达的中国患者的关键性III期研究。 赛沃替尼潜在的临床和监管关键进展： 于2024年年底 完成 SACHI 研究的患者招募 ；及 于2024年年底左右，基于 SAVANNAH 研究（若取得积极结果） 向美国 FDA [26] 提交新药上市申请 。 呋喹替尼（中国商品名：爱优特 ® ，海外商品名： FRUZAQLA® ）是一种高选择性的 VEGFR [27] 1/2/3 口服抑制剂，旨在提高激酶选择性，从而降低脱靶毒性 FRUSICA-1 研究结果公布 ，这是一项与信迪利单抗（sintilimab）联合疗法用于治疗伴有pMMR [28] 状态的子宫内膜癌患者的II期注册研究，无论既往是否接受过贝伐珠单抗（bevacizumab）治疗，该联合疗法均展现出具有意义的疗效改善及可控的毒性特征（NCT03903705）； FRESCO-2 研究的亚组分析 于ASCO [29] 年会公布 、 生物标志物分析 于AACR年会公布，及 生活质量分析于 ASCO GI [30] 会议公布（NCT04322539）。分析表明，无论既往接受的治疗种类或顺序如何，该疗法均是有效的，癌胚抗原 [31] 反应可能是疗效改善的早期预测因素，以及在既往接受治疗的结直肠癌患者中展现出具有临床意义的生活质量调整后的生存获益；及 继于ASCO全体大会系列会议上首次公布后， FRUTIGA 研究结果于《自然 ž 医学》及 ASCO 年会上同步发表 （NCT03223376），这是一项与紫杉醇联合疗法用于治疗胃癌患者的中国研究。PFS [32] 、ORR [33] 和DCR [34] 均取得具有统计学意义的显著改善，尽管整体OS [35] 改善未达统计学意义，但在排除接受后续抗肿瘤治疗的患者后的预设分析中，OS改善达到了统计学意义上的显著改善。 呋喹替尼潜在的临床和监管关键进展： 于2024年年底 完成 治疗经治转移性结直肠癌的 PMDA [36] 新药上市申请审评 ；及 若到达所需的PFS事件数量，于年底左右公布用于治疗 肾透明细胞癌 [ 37] 的 II/III 期注册研究 FRUSICA-2 的顶线结果 （NCT05522231）。 索乐匹尼布（ HMPL-523 ）是一种研究性的高选择性口服 Syk 抑制剂， Syk 是 Fc 受体和 B 细胞受体信号传导通路的关键组成部分 ESLIM-01 研究结果于《柳叶刀 • 血液病学》及 EHA [38] 年会上同步发表， 这是一项用于治疗原发性免疫性血小板减少症成人患者的中国研究 （ NCT05029635 ） 。索乐匹尼布治疗不仅展现出具有临床意义的快速且持久的48.4%的持续应答率以及可耐受的安全性特征，还显著改善了患者的生活质量，且无论患者既往的治疗线数、既往TPO/TPO-RA [39] 治疗情况或类型，均带来一致的临床获益； 用于治疗温抗体型自身免疫性溶血性贫血患者的中国 II 期概念验证研究结果 于EHA年会上发表，展现出良好的安全性特征以及令人鼓舞的血红蛋白获益；及 基于这一积极的数据， 启动了该研究的 III 期阶段，即 ESLIM-02 研究 （NCT05535933）。 索乐匹尼布潜在的临床关键进展： 于2024年年中 在美国 / 欧洲启动一项用于治疗免疫性血小板减少症的剂量探索研究 （NCT06291415）；及 于年底左右 完成基于 ESLIM-01 研究的国家药监局新药上市申请审评 。 索凡替尼（中国商品名：苏泰达 ® ）是一种 VEGFR 、 FGFR [40] 及 CSF-1R [41] 的口服小分子抑制剂，旨在用于抑制肿瘤血管生成，并通过调节肿瘤相关巨噬细胞以促进对肿瘤细胞的免疫应答 在中国启动了一项用于治疗初治转移性胰腺导管腺癌的 II/III 期研究 ，联合PD-1 [42] 抗体卡瑞利珠单抗（camrelizumab）、白蛋白结合型紫杉醇（nab-paclitaxel）及吉西他滨（gemcitabine）（NCT06361888）。该研究展开的部分依据是一项类似的由研究者发起的联合疗法研究，其数据已于2024年ASCO GI会议上公布。据估计，每年全球约有51.1万名患者被诊断患有这种高度侵袭性的癌症。 他泽司他（中国海南、澳门及香港商品名：达唯珂 ® ）是一种同类首创 EZH2 口服抑制剂 有望 于2025年年中 完成中国新药上市申请审评 ，用于治疗复发/难治性滤泡性淋巴瘤。 HMPL-453 是一种新型、高选择性及强效的 FGFR 1/2/3 抑制剂 继续 II 期注册研究的患者招募， 用于治疗伴有FGFR 2融合的肝内胆管癌 [43] （NCT04353375）。 HMPL-306 是一种 IDH1 和 IDH2 酶的研究性高选择性口服双重抑制剂，而这些酶被认为是某些血液恶性肿瘤、神经胶质瘤和实体瘤的驱动因素 中国和美国 / 欧洲 I 期研究的结果于 EHA 年会公布 ，展现出其作为治疗IDH1和/或IDH2突变型复发/难治性急性髓系白血病的有效疗法的潜力（NCT04272957、NCT04764474）；及 启动 RAPHAEL 中国 III 期研究 ，用于治疗IDH1和/或IDH2突变的复发/难治性急性髓系白血病（NCT06387069）。 其他早期研究性候选药物 于AACR、ASCO和EHA年会上 公布 了ERK1/2 [44] 抑制剂HMPL-295、第三代BTK抑制剂HMPL-760、Menin抑制剂HMPL-506，以及CD38 抗体偶联药物 [45] HMPL-A067的 临床前和 I 期结果 ；及 于中国 启动 HMPL-506 的 I 期研究， 用于治疗血液恶性肿瘤（NCT06387082）。 IV. 合作最新进展 两款由和黄医药发现的候选药物在创响生物 [ 46] 的推动下取得进一步临床进展 继创响生物行使独家许可选择权以进一步开发、生产和商业化IMG-007（一种非消耗性抗OX40抗体）和IMG-004（一种可逆性、非共价、高选择性的口服BTK抑制剂）后， 获得创响生物约 7.5% （完全稀释）的股份 ； 创响生物宣布了 IMG-007 用于治疗特应性皮炎的 IIa 期试验的积极中期结果。 治疗令特应性皮炎患者的皮肤体征得到快速、显著和持久的改善，同时总体耐受性良好。最终结果预计将于2024年第三季度晚些时候公布。创响生物还 完成了斑秃 IIa 期试验的患者招募 ；及 创响生物宣布了 IMG-004 多剂量递增研究的积极顶线结果，表明每日一次给药的可行性。 该药物在每日一次的剂量范围内服用10天均能良好耐受，没有肝酶升高或出血事件报告。初步模型和数据支持每日一次50毫克作为潜在的治疗剂量，并进一步开发作为BTK介导的免疫性疾病的差异化治疗。 V. 其他业务 其他业务收入主要来自我们在中国的处方药营销及分销业务。综合收入下降了21%（按固定汇率计算为18%）至1.370亿美元（2023年上半年：1.737亿美元），主要是由于与新冠肺炎相关的处方药的分销销售额于2024年下降。 非合并合资企业上海和黄药业 [47] 的收入下降4%（按固定汇率计算为持平）至2.252亿美元（2023年上半年：2.353亿美元），主要受到麝香保心丸在几个高定价省份的定价降低影响，该举措旨在标准化麝香保心丸的定价结构，以为可能在全国范围实施的带量采购做好准备。 和黄医药应占其他业务的综合净收益减少8%（按固定汇率计算为4%）至3,410万美元（2023年上半年：3,720万美元），主要是由于上海和黄药业因带量采购价格影响及增加研发开支，导致其贡献的净收益减少，为3,380万美元（2023年上半年：3,510万美元）。 我们持续探索将合资企业上海和黄药业的潜在价值转化为实际价值的可能性，包括各种出售和合作备选方案。 VI. 可持续发展 和黄医药致力逐步将可持续发展融入各个营运方面，并为我们的持份者创造长远价值。2024年4月，我们发布了 2023年可持续发展报告 ，重点阐述我们在11项目标和指标方面取得的进展；气候行动的优化工作，包括进行了范围3排放筛选和测量，并加强与供应商合作；数据质量的提升；更具协调性的五大可持续发展支柱；以及提前参考最新披露标准及行业特定披露标准的可持续发展披露。 我们的努力亦得到了更广泛的认可。本地和国际上主要的可持续发展评级机构对和黄医药予以稳步提升的评级，这些评级来自恒生、ISS、MSCI、标普全球、Sustainalytics 和 Wind。近期，在标普全球ESG [48] 评分中，和黄医药更取得49分的佳绩，大幅高于同行业平均分31分。此外，我们还荣获了香港投资者关系协会颁发的"最佳 ESG(E)"、"彭博商业周刊－ESG领先企业"颁发的的两项殊荣、新城财经台颁发的"湾区企业可持续发展大奖"五项大奖，以及入选E药经理人中国医药上市公司ESG 竞争力20强等。 2024年，我们持续在上述方面努力，并通过进行更全面的气候风险评估，量化气候风险对我们主要业务的影响，进一步加强我们的气候行动；将可持续发展融入我们的企业文化；以及开始计划未来的目标和指标。 财务摘要 汇率影响： 2024年上半年，人民币兑美元平均贬值约4%，这影响了我们的综合财务业绩，要点如下。 于 2024 年 6 月 30 日，现金及现金等价物和短期投资合计为 8.025 亿美元，而于 2023 年 12 月 31 日为 8.863 亿美元。 于2024年上半年，不包括融资活动的调整后的集团（非GAAP [49] ）净现金流为-5,130万美元（2023年上半年：2.193亿美元），主要是由于经营活动所用净现金3,980万美元及资本支出1,010万美元；及 2024年上半年融资活动使用的净现金合计为3,260万美元，乃由于购买了3,610万美元的股权奖励（2023年上半年：融资活动产生的净现金为580万美元）。 截至 2024 年 6 月 30 日止六个月收入为 3.057 亿美元，而截至 2023 年 6 月 30 日止六个月为 5.329 亿美元。 肿瘤 / 免疫业务 综合 收入为 1.687 亿 美元（ 2023 年上半年： 3.592 亿 美元），包括： FRUZAQLA® 收入为 4,280 万美元， 反映了其自2023年11月初以来在美国成功上市，包括特许权使用费和生产收入； 于其上市以来的第六年内， 爱优特 ® 收入增长 9% （按固定汇率计算为 14% ）至 4,600 万美元 （2023年上半年：4,200万美元），包括生产收入、推广及营销服务收入以及特许权使用费，与结直肠癌市场的增速一致，我们的市场份额在市场竞争加剧的情况下依然保持领先； 苏泰达 ® 收入增长 12% （按固定汇率计算为 17% ）至 2,540 万美元 （2023年上半年：2,260万美元），国家医保药品目录续约后销售额持续增长，随着医生对该产品的认知度持续提升，令对神经内分泌瘤患者的可及性及市场份额提高； 沃瑞沙 ® 收入下降 14% （按固定汇率计算为 10% ）至 1,310 万美元 （2023年上半年：1,510万美元），主要由于生产收入减少至530万美元（2023年上半年：850万美元），但被特许权使用费增至780万美元（2023年上半年：660万美元）所抵消，这反映了18%（按固定汇率计算为22%）的强劲市场销售额增长； 达唯珂 ® 收入为 50 万美元 （2023年上半年：40万美元），主要来自海南先行区 [50] 的销售； 武田首付款，里程碑付款及研发服务收入减少至 3,380 万美元 （2023年上半年：2.691亿美元，即2023年4月从武田收到的4亿美元现金首付款中已确认的2.587亿美元部分）； 及 其他研发服务收入为 710 万美元 （2023年上半年：1,000万美元），主要与阿斯利康及礼来管理开发及监管活动的费用有关。 其他业务综合收入下降 21% （按固定汇率计算为 18% ）至 1.370 亿 美元 （2023年上半年：1.737亿美元），主要是由于与新冠肺炎相关的处方药的分销销售额于2024年减少。该收入不包括上海和黄药业的非综合收入2.252亿美元（2023年上半年：2.353亿美元）。 截至 2024 年 6 月 30 日止六个月净开支为 2.799 亿美元，而截至 2023 年 6 月 30 日止六个月为 3.643 亿美元，反映我们在成本控制方面作出的巨大努力。 收入成本 下降14%至1.801亿美元（2023年上半年：2.083亿美元），其中源自其他业务的收入成本下降，但是被我们已上市产品的销售额增加，以及因销售团队扩大而为爱优特®推广和营销服务的成本增加所抵消； 研发开支 减少34%至9,530万美元（2023年上半年：1.446亿美元），主要由于我们对管线产品，特别是中国境外的管线产品进行战略优先排序所致。美国和欧洲的临床和监管申报费用为1,490万美元（2023年上半年：5,560万美元），而中国的研发开支为8,040万美元（2023年上半年：8,900万美元）； 销售及行政开支 [51] 为5,780万美元（2023年上半年：6,830万美元），减少主要由于我们对支出进行了更严格的控制，同时利用现有的基础设施来推动进一步的收入增长；及 其他项目 主要包括上海和黄药业的合资企业权益收益、利息收入和支出，外汇和税务产生净收益5,330万美元（2023年上半年：5,690万美元），此下降主要由于该期间确认的汇兑收益降低。 截至 2024 年 6 月 30 日止六个月和黄医药应占净收益为 2,580 万美元，而截至 2023 年 6 月 30 日止六个月为 1.686 亿美元。 截至2024年6月30日止六个月，和黄医药应占净收益为每股普通股0.03美元/每份ADS [52] 0.15美元（2023年上半年：每股普通股0.20美元/每份ADS 1.00美元）。 财务指引 我们重申肿瘤/免疫业务综合收入的2024年全年指引为3亿至4亿美元，主要得益于已上市的肿瘤产品30%至50%的目标收入增长。在2024年以及往后，和黄医药的工作将得到其强劲的财务状况的支持。因此，公司完全有能力实现其建立自给自足可持续的业务，以及透过其在中国市场的销售网络和全球合作伙伴将创新药物带向全球患者的目标。 股东及投资者应注意： 我们不保证财务指引中包含的陈述将实现，或其中包含的财务结果将实现或可能实现；及 我们过去曾修订我们的财务指引，应参考我们在本公告刊发日期后就任何财务指引更新的公告。 非 G AAP 财务指标的使用和调节 —本公告中提及不包括融资活动的调整后集团净现金流及按照按固定汇率计算报告的财务指标均基于非GAAP财务指标。请参见"非GAAP财务指标的使用和调节"，以分别了解这些财务指标的解释，以及这些财务指标与最具可比性的GAAP指标调节的进一 步资料。 财务概要 简明综合资产负债表数据 （千美元） 于 2024 年 6 月 30 日 于 2023 年 12 月 31 日 （未经审核） 资产 现金及现金等价物和短期投资 802,453 886,336 应收账款 156,916 116,894 其他流动资产 88,891 93,609 物业、厂房及设备 94,815 99,727 合资企业权益 80,519 48,411 其他非流动资产 37,274 34,796 资产总额 1,260,868 1,279,773 负债及股东权益 应付账款 43,398 36,327 其他应付款、应计开支及预收款项 249,218 271,399 递延收入 108,777 127,119 银行贷款 82,100 79,344 其他负债 25,357 22,197 负债总额 508,850 536,386 本公司股东权益 740,084 730,541 非控股权益 11,934 12,846 负债及股东权益总额 1,260,868 1,279,773 简明综合经营表资料 （未经审核，千美元，股份和每股数据除外） 截至 6 月 30 日止六个月 2024 年 2023 年 收入： 肿瘤/免疫业务—上市产品 127,796 80,149 肿瘤/免疫业务—研发 40,841 279,034 肿瘤/免疫业务综合收入 168,637 359,183 其他业务 137,044 173,691 收入总额 305,681 532,874 经营开支： 收入成本 (180,135) (208,324) 研发开支 (95,256) (144,633) 销售及行政开支 (57,811) (68,263) 经营开支总额 (333,202) (421,220) (27,521) 111,654 其他收益净额 22,765 25,434 除所得税开支及合资企业权益收益前（亏损） / 收益 (4,756) 137,088 所得税开支 (2,886) (2,730) 所占合资企业权益除税后收益 33,807 35,110 净收益 26,165 169,468 减：非控股权益应占净收益 (364) (917) 和黄医药应占净收益 25,801 168,551 和黄医药应占每股普通股盈利（每股普通股，美元） — 基本 0.03 0.20 — 摊薄 0.03 0.19 计算每股普通股盈利所用的股份数 —基本 856,030,704 846,928,863 —摊薄 872,534,466 866,990,610 和黄医药应占每份 ADS 盈利（每份 ADS ，美元） — 基本 0.15 1.00 — 摊薄 0.15 0.97 计算每份ADS盈利所用的ADS份数 —基本 171,206,141 169,385,773 —摊薄 174,506,893 173,398,122 关于和黄医药 和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。集团旗下公司共有约5,000名员工，其中核心的肿瘤/免疫业务拥有约1,800人的团队。自成立以来，和黄医药致力于将自主发现的抗肿瘤候选药物带向全球患者，首三个癌症药物现已在中国上市，其中首个药物亦于美国上市。欲了解更多详情，请访问： www.hutch‑med.com 或关注我们的 领英 专页。 简称使用 除非文意另有所指外，否则本公告中所称 " 集团 " 、 " 公司 " 、 " 和黄医药 " 、 " 和黄医药集团 " 、 " 我们 " 和 " 我们的 " 指和黄医药（中国）有限公司及其附属公司，除非文中另有说明或指明。 过往业绩和前瞻性陈述 本公告所载本集团之表现和经营业绩属历史性质，且过往表现并不保证本集团之未来业绩。本公告包含符合 1995 年《美国私人证券诉讼改革法案》 " 安全港 " 条款中定义的前瞻性陈述。该等前瞻性陈述可以用诸如 " 将会 " 、 " 期望 " 、 " 预期 " 、 " 未来 " 、 " 打算 " 、 " 计划 " 、 " 相信 " 、 " 估计 " 、 " 筹备 " 、 " 可能 " 、 " 潜在 " 、 " 同类首创 " 、 " 同类最佳 " 、 " 旨在 " 、 " 目标 " 、 " 指导 " 、 " 追求 " 或类似术语，或通过对潜在候选药物、潜在候选药物适应症的明示或暗示讨论，或通过讨论战略、计划、预期或意图来识别。阁下请勿过分倚赖这些前瞻性陈述。该等前瞻性陈述反映了管理层根据目前的信念和期望而对未来事件的预期，并受到已知及未知风险与不确定性的影响。如若该等风险或不确定性中的一项或多项出现，或者基本假设被证明属不正确，则实际结果可能与前瞻性陈述中所载之结果有重大出入。和黄医药不能保证其任何候选药物均将会在任何市场上获准销售，也不能保证已获得的任何批准在未来继续有效，或者由和黄医药及 / 或其合作伙伴销售或以其他方式将产品商业化（统称 " 和黄医药产品 " ）将达到任何特定的收入或净收益水平。和黄医药管理层的预期可能会受到以下因素的影响：意料之外的监管行动或延迟或一般性的政府监管，其中包括和黄医药的 ADS 可能因《外国公司责任法案》及其下颁布的规则而被禁止在美国交易的风险；研究与开发中固有的不确定性，包括无法满足关键的关于受试者的注册率、时机和可用性的研究假设，其要符合研究的纳入及排除标准以及资金要求，临床方案的变更、意外不利事件或安全性、品质或生产方面的问题；候选药物无法满足硏究的主要或次要评估指标；候选药物无法获得不同司法管辖区的监管批准或和黄医药产品获得监管批准后的使用情况，市场认受性及商业成功；所发现、开发及 / 或商业化竞争产品和候选药物可能比和黄医药产品及候选药物更有优势或更具成本效益；政府当局和其他第三方的研究（无论由和黄医药或其他人士进行及无论属强制或自愿）或建议及指引对和黄医药产品及开发中的候选药物的商业成功的影响；和黄医药制造及管理多种产品及候选药物供应链的能力；和黄医药产品能否从第三方支付机构获得报销及获报销的程度，包括私人支付机构的医疗健康及保险计划以及政府保险计划；开发、生产及销售和黄医药产品的成本；和黄医药实现其任何财务预测或指引的能力以及该等预测或指引所依据的假设的变化；遏制医疗成本的全球趋势，包括持续的价格压力；实际和潜在法律程序的不确定性，其中包括实际或潜在产品责任诉讼、有关销售和行销行为的诉讼和调查、知识产权纠纷以及一般性的政府调查；以及整体经济和行业状况，包括许多国家持续疲弱的经济和金融环境影响的不确定性、未来全球汇率的不确定性以及流行病和疾病暴发的影响的不确定性。有关前述各项和其他风险的进一步讨论，请参阅和黄医药向美国证券交易委员会、伦敦证券交易所和香港交易所 53 提交的文件。和黄医药在本公告中提供之资料截至本公告日期，并且不承担因新的资料、未来事件或其他原因而更新任何前瞻性陈述的义务。 此外，本公告包含和黄医药从行业出版物和第三方市场研究公司作出的报告中获得的统计数据和估计。尽管和黄医药认为该等出版物、报告和调查研究是可靠的，但是和黄医药尚未独立验证该等数据，不能保证该等数据的准确性或完整性。请阁下注意不要过度考虑该等数据。该等数据涉及风险和不确定性，并可能根据各种因素（包括前述因素）有所更改。 内幕消息 本公告载有条例（欧盟）第 596/2014 号（由于其构成 2018 年脱离欧盟法所界定保留欧盟法例的一部分）第 7 条所指的内幕消息。 医疗信息 本公告所提到的产品可能并未在所有国家上市，或可能以不同的商标进行销售，或用于不同的病症，或采用不同的剂量，或拥有不同的效力。本文中所包含的任何信息都不应被视为是任何处方药的申请、推广或广告，包括那些正在研发的药物。 [1] 固定汇率 = Constant exchange rate (CER) 。我们亦报告按固定汇率 (CER) ，一种非 GAAP 指标，计算业绩变化。请参阅下文的「非 GAAP 财务指标的使用和调节」，以分别了解这些财务指标的解释，以及这些财务指标与最具可比性的 GAAP 指标的对账 [2] 市场销售额 = 由礼来（爱优特 ® ）、武田（ FRUZAQLA® ）、阿斯利康（沃瑞沙 ® ）及和黄医药（爱优特 ® 、苏泰达 ® 、沃瑞沙 ® 及达唯珂 ® ）向第三方的总销售额 [3] 研发 = 研究与发现 (R&D) [4] 武田 = Takeda Pharmaceuticals International AG ， Takeda Pharmaceutical Company Limited 的附属公司 [5] 免疫性血小板减少症 = Immune thrombocytopenia purpura (ITP) [6] 新药上市申请 = New Drug Application (NDA) [7] 非小细胞肺癌 = Non-small cell lung cancer (NSCLC) [8] MET 外显子 14 = MET 外显子 14 跳变（ MET exon 14 skipping alterations ， METex14) [9] 自身免疫性溶血性贫血 = Autoimmune hemolytic anemia (AIHA) [10] 急性髓系白血病 = Acute myeloid leukemia (AML) [11] 胰腺导管腺癌 = Pancreatic ductal adenocarcinoma (PDAC) [12] Syk = 脾酪氨酸激酶 (Spleen tyrosine kinase) [13] EZH2 = zeste 基因增强子同源物 2 (Enhancer of zeste homolog 2) [14] IDH = 异柠檬酸脱氢酶 (Isocitrate dehydrogenase) [15] BTK = 布鲁顿酪氨酸激酶 (Bruton's tyrosine kinase) [16] 结直肠癌 = Colorectal cancer (CRC) [17] 国家医保药品目录 = 《中国国家基本医疗保险、工伤保险和生育保险药品目录》 (NRDL) [18] 礼来 = 礼来公司 (Eli Lilly and Company) [19] 新适应症上市申请 = Supplemental New Drug Application (sNDA) [20] 国家药监局 = 中国国家药品监督管理局 (China National Medical Products Administration, NMPA) [21] 复发 / 难治性 = 复发及 / 或难治性 (Relapsed and/or refractory, R/R) [22] EMA = 欧洲药品管理局 (European Medicines Agency) [23] MET = 间充质上皮转化因子 (Mesenchymal epithelial transition factor) [24] AACR = 美国癌症研究协会 (American Association for Cancer Research) [25] EGFR = 表皮生长因子受体 (Epidermal growth factor receptor) [26] FDA = 美国食品药品监督管理局 (Food and Drug Administration) [27] VEGFR = 血管内皮生长因子受体 (Vascular endothelial growth factor receptor) [28] pMMR = 错配修复完整 (Proficient mismatch repair) [29] ASCO = 美国临床肿瘤学会 (American Society of Clinical Oncology) [30] ASCO GI = 美国临床肿瘤学会胃肠道肿瘤研讨会 [31] 癌胚抗原 = Carcinoembryonic antigen (CEA) [32] PFS = 无进展生存期 (Progression-free survival) [33] ORR = 客观缓解率 (Objective response rate) [34] DCR = 疾病控制率 (Disease control rate) [35] OS = 总生存期 (Overall survival) [36] PMDA = 日本医药品和医疗器械局 (Pharmaceuticals and Medical Devices Agency) [37] 肾细胞癌 = Renal cell carcinoma (RCC) [38] EHA= 欧洲血液学协会 (European Hematology Association) [39] TPO = 血小板生成素 (thrombopoietin); TPO-RA = 血小板生成素受体激动剂 (thrombopoietin receptor agonists) [40] FGFR = 成纤维细胞生长因子受体 (Fibroblast growth factor receptor) [41] CSF-1R = 集落刺激因子 -1 受体 (Colony-stimulating factor 1 receptor) [42] PD-1 = 程序性细胞死亡蛋白 -1 (Programmed cell death protein-1) [43] 肝内胆管癌 = Intrahepatic cholangiocarcinoma (IHCC) [44] ERK = 细胞外信号调节激酶 (Extracellular signal-regulated kinase) [45] 抗体偶联药物 = Antibody-drug conjugate (ADC) [46] 创响生物 = Inmagene Biopharmaceuticals [47] 上海和黄药业 = 上海和黄药业有限公司 (Shanghai Hutchison Pharmaceuticals Limited, SHPL) [48] ESG = 环境、社会及管治 (Environmental, Social and Governance) [49] GAAP = 一般公认会计原则 (Generally Accepted Accounting Principles) [50] 海南先行区 = 海南博鳌乐城国际医疗旅游先行区 (Hainan Boao Lecheng International Medical Tourism Pilot Zone, Hainan Pilot Zone ) [51] 销售及行政开支 = Selling and administrative expenses (S&A) [52] ADS = 美国预托证券 (American depositary share) [53] 香港交易所 = 香港联合交易所有限公司主板

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 31, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13) today reports its financial results for the six months ended June 30, 2024 and provides updates on key clinical and commercial developments. HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, August 1, 2024. After registration, investors may access the live webcast via HUTCHMED’s website at www.hutch-med.com/event. All amounts are expressed in US dollars unless otherwise stated. Continued revenue momentum with substantial cash balance to support growth Reiterate full year 2024 guidance for Oncology/Immunology consolidated revenue of $300 to $400 million, with $168.7 million in the first half of 2024, driven by 59% (64% at CER1) oncology product revenue growth.FRUZAQLA® US in-market sales2 of $130.5 million in the first half of 2024 – demonstrating strong demand and commercial traction since launch in November 2023.Net income of $25.8 million in the first half of 2024. Cash balance of $802.5 million as of June 30, 2024, as we continued to prioritize key R&D3 projects and enhance commercial efficiency. Globalization of fruquintinib continues, broader pipeline makes strong progress Preparation for EU launch of FRUZAQLA® underway led by partner Takeda4 after European Commission approval in June 2024 – Filings in over a dozen jurisdictions supported by FRESCO-2.HUTCHMED preparing for China launch of sovleplenib for ITP5 – potentially its first hematology medicine, after the NDA6 was accepted and granted Priority Review status in January 2024.Potential US NDA filing for savolitinib for NSCLC7 at year end, based on SAVANNAH trial readout.NDAs accepted to expand use of ORPATHYS® and ELUNATE®, and for TAZVERIK® in China – for treatment-naïve METex148 NSCLC, endometrial cancer and follicular lymphoma, respectively.Key late-stage registration trials initiated with 15 ongoing/under review – across six drug candidates: ESLIM-02 for sovleplenib in warm AIHA9, RAPHAEL for HMPL-306 in AML10, and for surufatinib in PDAC11.Growing hematology portfolio with new programs targeting Menin and CD38, joining the existing portfolio of inhibitors and antibodies targeting Syk12, EZH213, IDH14, BTK15 and CD47. Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, “HUTCHMED has delivered strong performance in the first half of this year. The team has made significant progress implementing our strategy in discovering and developing novel, effective medicines; conducting clinical trials in our home market and in the global markets; and rapidly advancing regulatory and commercial goals. I am very pleased with the ongoing success of our partnership with Takeda and with the growing ability of the Company to provide health benefits to patients overseas. We have grown our revenues from the US during this period and we expect to see revenue growth from many other countries in the coming months. We are also capitalizing on our proven track record of bringing new medicines and additional indications for our marketed medicines to China, with several potential NDA approvals for the next few years.” “I would like to take this opportunity to express my appreciation to Mr Simon To, my predecessor, who has recently retired. Mr To has stood at the cradle of HUTCHMED and has made a very significant contribution to grow the Company and turn it into a global innovative player, discovering, developing and commercializing therapies for the treatment of cancer and immunological diseases, improving the quality of life of patients around the world. I look forward to guiding the Company along its next phase of growth, which is full of potential and promise.” 2024 INTERIM RESULTS & BUSINESS UPDATES Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “The HUTCHMED team has been working tirelessly to continue the outstanding clinical and regulatory momentum that we have had in recent years, whilst importantly driving the commercial success of our approved products. I would like to extend my thanks to everyone for their hard work and commitment. Our oncology product revenue has grown 59% compared to the first half of 2023 and we are progressing a more focused R&D pipeline that has considerable potential for value creation. This year we initiated three key late-stage studies across our pipeline and are excited to be running over a dozen such studies that could support future drug approvals.” “The partnership strategy that we adopted for globalizing our medicines is allowing us to simultaneously fuel our in-house R&D engine, drive sales in our home market, and bring our medicines to patients in new geographies. Takeda’s impressive initial sales of FRUZAQLA® demonstrates both the quality of our medicines and their potential across the globe and our strategy of working with partners outside of our home market.” “We expect to advance our registration trials in the second half of the year. Around year end, we anticipate the potential approval of sovleplenib in China and potential NDA filing of savolitinib in the US. We will continue to progress towards becoming a self-sustaining biopharma business.” I. COMMERCIAL OPERATIONS Oncology in-market sales were up 140% (145% at CER) to $243.3 million (H1-23: $101.3m), which led to strong growth in consolidated oncology product revenue of 59% (64% at CER) to $127.8 million (H1-23: $80.1m), and mainly comprised of the following: FRUZAQLA® (fruquintinib ex-China) in-market sales were $130.5 million (H1-23: nil), which was launched in the US in November 2023. Its strong performance was due to rapid US patient uptake, as well as fulfilling sales channel inventory requirements;ELUNATE® (fruquintinib China) in-market sales increased 8% (13% at CER) to $61.0 million (H1-23: $56.3m), in line with CRC16 market growth, maintaining our leading market share position while weathering greater market competition;SULANDA® (surufatinib) in-market sales increased 12% (17% at CER) to $25.4 million (H1-23: $22.6m), as doctors’ awareness continues to increase, leading to greater NET patient access and market share; andORPATHYS® (savolitinib) in-market sales increased 18% (22% at CER) to $25.9 million (H1-23: $22.0m), as it benefited from improved testing and diagnosis for METex14 NSCLC and also ongoing growth momentum in the second year on the NRDL17. Oncology/​Immunology consolidated revenue comprised of consolidated oncology product revenue, which included product revenue, commercial service fees and royalties, as well as R&D income from our collaboration partners, mainly as follows: Takeda upfront, milestones and R&D services revenue were $33.8 million (H1-23: $269.1m), which included recognition of $19.4 million of the $435.0 million upfront and milestone payments already received from Takeda in cash during 2023. This compared to recognition of $258.7 million in the first half of 2023. As a result, total Oncology/Immunology consolidated revenue was $168.7 million (H1-23: $359.2m). Including Other Ventures revenue, total revenue was $305.7 million (H1-23: $532.9m). (Unaudited, $ in millions)In-market Sales*Consolidated Revenue** H1 2024H1 2023 %Δ(CER)H1 2024H1 2023 %Δ(CER)FRUZAQLA®$130.5 —— $42.8 —— ELUNATE® $61.0$56.3+8%(+13%)$46.0$42.0+9%(+14%)SULANDA® $25.4$22.6+12%(+17%)$25.4$22.6+12%(+17%)ORPATHYS® $25.9$22.0+18%(+22%)$13.1$15.1-14%(-10%)TAZVERIK®$0.5$0.4+40%(+46%)$0.5$0.4+40%(+46%)Oncology Products$243.3$101.3+140%(+145%)$127.8$80.1+59%(+64%)Takeda upfront, milestone and R&D services $33.8$269.1-87%(-87%)Other R&D services $7.1$10.0-29%(-27%)Total Oncology/​Immunology $168.7$359.2-53%(-52%)Other Ventures $137.0$173.7-21%(-18%)Total Revenue $305.7$532.9-43%(-41%) * = For FRUZAQLA®, ELUNATE® and ORPATHYS®, mainly represented total sales to third parties as provided by Takeda, Lilly18 and AstraZeneca, respectively.** = For FRUZAQLA®, represented drug product supply and royalties paid by Takeda; for ELUNATE®, represented drug product supply, commercial service fees and royalties paid by Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; for ORPATHYS®, represented drug product supply and royalties paid by AstraZeneca and sales to other third parties invoiced by HUTCHMED; for SULANDA® and TAZVERIK®, represented the Company’s sales of the products to third parties. II. REGULATORY UPDATES China Savolitinib sNDA19 accepted by NMPA20 for first-line and second-line METex14 NSCLC in 2024;Fruquintinib approved in Hong Kong for third-line CRC in January 2024;Fruquintinib sNDA accepted by NMPA with Priority Review for second-line endometrial cancer in early 2024;Tazemetostat approved in Hong Kong for R/R21 follicular lymphoma in May 2024; andTazemetostat NDA accepted by NMPA with Priority Review for R/R follicular lymphoma in July 2024. Ex-China Fruquintinib approved in the EU in June 2024, following positive opinion received from the EMA22 Committee for Medicinal Products for Human Use for previously-treated metastatic CRC in April 2024. III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET23 Completed enrollment of SAVANNAH (NCT03778229), a Fast Track-designated pivotal global Phase II study for NSCLC patients who have progressed following TAGRISSO® due to MET amplification or overexpression, which may file in the US for accelerated approval. A small parallel study (NCT04606771) in this patient population presented data at AACR24 also demonstrated higher clinical activity with the combination therapy, with safety consistent with the known profiles of each treatment; andContinued enrolling SAFFRON (NCT05261399), a global, pivotal Phase III study in this patient population of the TAGRISSO® combination supporting SAVANNAH; SACHI (NCT05015608), a similar pivotal Phase III study for patients in China that progressed on EGFR25 inhibitor treatment, and SANOVO (NCT05009836), a pivotal Phase III study for first-line patients in China with EGFR mutation & MET overexpression. Potential upcoming clinical and regulatory milestones for savolitinib: Complete enrollment of SACHI in late 2024; andFile FDA26 NDA on SAVANNAH, subject to positive results, around year end 2024. Fruquintinib (ELUNATE® in China, FRUZAQLA® outside of China), a highly selective oral inhibitor of VEGFR27 1/2/3 designed to have enhanced selectivity that limits off-target kinase activity Presented results of FRUSICA-1, the registration Phase II study combined with sintilimab for patients with endometrial cancer with pMMR28 status, which showed meaningful efficacy improvements regardless of prior bevacizumab treatment and a manageable toxicity profile (NCT03903705);Presented FRESCO-2 subgroup analyses at ASCO29, biomarker analysis at AACR and quality-of-life analysis at ASCO GI30 (NCT04322539). Analyses showed that the treatment was effective regardless of prior therapy or sequence, that CEA31 response may be an early predictor of improved efficacy, and that it demonstrated clinically meaningful quality-adjusted survival benefit in patients with previously-treated CRC; andPublished in Nature Medicine the results of FRUTIGA, the study combined with paclitaxel for gastric cancer patients in China, concurrently with ASCO and following initial presentation at ASCO Plenary (NCT03223376). PFS32, ORR33 and DCR34 showed statistically significant improvements, and although OS35 improvement was not statistically significant overall, it was statistically significant in a pre-specified analysis excluding patients taking subsequent antitumor therapy. Potential upcoming clinical and regulatory milestones for fruquintinib: Complete PMDA36 NDA review for previously-treated metastatic CRC in late-2024; andAnnounce top-line results from the FRUSICA-2 Phase II/III registration trial in clear cell RCC37 around year end if the requisite number of PFS events is reached (NCT05522231). Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk, an important component of the Fc receptor and B-cell receptor signaling pathways Published ESLIM-01 (NCT05029635) results in adult patients with primary ITP in China in Lancet Haematology concurrently with presentations at EHA38. In addition to demonstrating a clinically meaningful early and sustained durable response of 48.4% and a tolerable safety profile, it significantly improved quality of life and showed consistent clinical benefits regardless of prior lines of therapies, prior TPO/TPO-RA39 exposure or treatment types;Published results of the Phase II proof-of-concept stage of a study in patients with warm AIHA in China at EHA, demonstrating a favorable safety profile and encouraging hemoglobin benefits; andInitiated ESLIM-02, the Phase III stage of the study, as a result of this positive data (NCT05535933). Potential upcoming clinical milestones for sovleplenib: Initiate a dose-finding study in ITP in the US/EU in mid-2024 (NCT06291415); andComplete ESLIM-01 NMPA NDA review around year end. Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR, FGFR40 and CSF-1R41 designed to inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation Initiated a Phase II/III trial for treatment-naïve metastatic PDAC in China, in combination with PD-142 antibody camrelizumab, nab-paclitaxel and gemcitabine (NCT06361888). This study was informed in part by an investigator-initiated trial presented at ASCO GI 2024 of a similar combination. This highly aggressive form of cancer has an estimated 511,000 people diagnosed annually worldwide. Tazemetostat (TAZVERIK® in Hainan, Macau and Hong Kong), a first-in-class, oral inhibitor of EZH2 Potential to complete China NDA review for R/R follicular lymphoma in mid-2025. HMPL-453, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3 Continued enrolling the registrational Phase II trial for IHCC43 with FGFR 2 fusion (NCT04353375). HMPL-306, an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2 enzymes, which have been implicated as drivers of certain hematological malignancies, gliomas and solid tumors Presented results from China and US/European Phase I studies at EHA, showing it as an effective treatment for IDH1 and/or IDH2-mutated R/R AML (NCT04272957, NCT04764474); andInitiated RAPHAEL Phase III Trial for IDH1- and/or IDH2-mutated R/R AML in China (NCT06387069). Other early-stage investigational drug candidates Presented preclinical and Phase I results at AACR, ASCO and EHA for ERK1/244 inhibitor HMPL-295, third-generation BTK inhibitor HMPL-760, Menin inhibitor HMPL-506, and CD38 ADC45 HMPL-A067; andInitiated Phase I trial for HMPL-506 for hematological malignancies in China (NCT06387082). IV. COLLABORATION UPDATES Further clinical progress by Inmagene46 with two candidates discovered by HUTCHMED Received approximately 7.5% of shares (fully diluted) in Inmagene following exercise of its option for an exclusive license to further develop, manufacture and commercialize IMG-007, a nondepleting anti-OX40 antibody, and IMG-004, a reversible, non-covalent, highly selective oral BTK inhibitor;Inmagene announced positive interim results from a Phase IIa trial of IMG-007 for atopic dermatitis. Treatment led to rapid, marked, and durable improvement of skin signs in patients with atopic dermatitis, while remaining well-tolerated overall. Final results are anticipated later in the third quarter of 2024. Inmagene also completed enrollment of a Phase IIa trial for alopecia areata; andInmagene announced positive topline results of a multiple ascending dose study with IMG-004, indicating once daily dosing potential. It was well tolerated, without reports of liver enzyme elevation or bleeding events, across once daily doses ranges for 10 days. Preliminary modeling and data support 50mg once daily as a potential therapeutic dose and further development as a differentiated treatment for BTK-mediated immunological diseases. V. OTHER VENTURES Other Ventures revenue is predominantly from our prescription drug distribution operation in China. Consolidated revenue decreased by 21% (18% at CER) to $137.0 million (H1-23: $173.7m) primarily as a result of lower COVID-related prescription drug distribution sales in 2024.SHPL47, a non-consolidated joint venture, saw revenue decrease by 4% (flat at CER) to $225.2 million (H1-23: $235.3m) mainly due to pricing reduction in a few higher-priced provinces to standardize the pricing structure of MUSKARDIA® in preparation for potential national implementation of volume-based procurement.Consolidated net income attributable to HUTCHMED from our Other Ventures decreased by 8% (4% at CER) to $34.1 million (H1-23: $37.2m), which was primarily due to decrease on the net income contributed from SHPL of $33.8 million (H1-23: $35.1m) as a result of price reduction impact from volume-based procurement, as well as increase in R&D spending.We continue to explore opportunities to monetize the underlying value of our SHPL joint venture including various divestment and collaboration alternatives. VI. SUSTAINABILITY HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders. In April 2024, we published our 2023 Sustainability Report, which highlighted progress made in our 11 goals and targets; our enhanced climate actions including Scope 3 emissions screening and measurement and engaging with suppliers; our enhanced data quality; our strengthened alignment of our five most relevant and material sustainability pillars; and our enhanced disclosure and sector specific disclosure standards ahead of requirement. Wider recognition of HUTCHMED’s efforts have been reflected in steady improvements in major local and international sustainability ratings including from Hang Seng, ISS, MSCI, S&P Global, Sustainalytics and Wind. Recently, HUTCHMED scored 49 for S&P Global ESG48 Ratings, significantly higher than the industry average of 31. HUTCHMED also received the Best ESG(E) at the Hong Kong Investor Relations Association’s 10th Investor Relations Awards, two awards at Bloomberg Businessweek’s ESG Leading Enterprises event, five awards from Metro Finance’s GBA ESG Achievement Awards, and was listed amongst the Top 20 Chinese Pharmaceutical Listed Companies in ESG Competitiveness by Healthcare Executive. In 2024, we continue our efforts on the above areas and further strengthening our climate action by conducting a more comprehensive climate risk assessment to quantify the impact of climate risks in our major operations; incorporate sustainability into our corporate culture; and considering future goals and targets. FINANCIAL HIGHLIGHTS Foreign exchange impact: The RMB depreciated against the US dollar on average by approximately 4% during the first half of 2024, which has impacted our consolidated financial results as highlighted below. Cash, Cash Equivalents and Short-Term Investments were $802.5 million as of June 30, 2024 compared to $886.3 million as of December 31, 2023. Adjusted Group (non-GAAP49) net cash flows excluding financing activities in the first half of 2024 were ‑$51.3 million (H1-23: $219.3m), mainly due to $39.8 million net cash used in operating activities and $10.1 million of capital expenditure; andNet cash used in financing activities in the first half of 2024 totaled $32.6 million due to purchases for equity awards of $36.1 million (H1-23: net cash generated from financing activities of $5.8m). Revenue for the six months ended June 30, 2024 was $305.7 million compared to $532.9 million in the six months ended June 30, 2023. Oncology/Immunology consolidated revenue amounted to $168.7 million (H1-23: $359.2m) from: FRUZAQLA® revenue was $42.8 million, reflecting its successful US launch since early November 2023, comprising royalties and manufacturing revenue;ELUNATE® revenue increased 9% (14% at CER) to $46.0 million (H1-23: $42.0m) in its sixth year since launch, comprising of manufacturing revenue, promotion and marketing service revenue and royalties, which is in line with CRC market growth, maintaining our leading market share position while weathering greater market competition;SULANDA® revenue increased 12% (17% at CER) to $25.4 million (H1-23: $22.6m) continued sales growth after NRDL renewal as doctors’ awareness continues to increase, leading to greater NET patient access and market share;ORPATHYS® revenue decreased 14% (10% at CER) to $13.1 million (H1-23: $15.1m), due to a reduction in manufacturing revenue to $5.3 million (H1-23: $8.5m), offset by an increase in royalties to $7.8 million (H1-23: $6.6m) reflecting strong in-market sales growth of 18% (22% at CER);TAZVERIK® revenue was $0.5 million (H1-23: $0.4m) mainly from sales in the Hainan Pilot Zone50;Takeda upfront, milestones and R&D services revenue decreased to $33.8 million (H1-23: $269.1m, of which $258.7m was the recognized portion of the $400 million upfront cash payment received from Takeda in April 2023); andOther R&D services revenue of $7.1 million (H1-23: $10.0m), primarily related to fees from AstraZeneca and Lilly for the management of development and regulatory activities. Other Ventures consolidated revenue decreased 21% (18% at CER) to $137.0 million (H1-23: $173.7m), primarily as a result of lower COVID-related prescription drug distribution sales in 2024. This excluded non‑consolidated revenue at SHPL of $225.2 million (H1-23: $235.3m). Net Expenses for the six months ended June 30, 2024 were $279.9 million compared to $364.3 million in the six months ended June 30, 2023, reflecting our strong efforts on cost control. Cost of Revenue decreased by 14% to $180.1 million (H1-23: $208.3m), which was the net result of a reduction in cost of revenue from our Other Ventures, offset by the increase in product sales of our marketed products and the cost of promotion and marketing services for ELUNATE® resulting from the increased sales force;R&D Expenses reduced 34% to $95.3 million (H1-23: $144.6m), mainly due to the strategic prioritization of our pipeline, particularly outside China. Clinical and regulatory expenses in the US and Europe were $14.9 million (H1-23: $55.6m), while R&D expenses in China were $80.4 million (H1-23: $89.0m);S&A51 Expenses were $57.8 million (H1-23: $68.3m), which decreased primarily due to tighter control over our spending, while utilizing existing infrastructure to support further revenue growth; andOther Items mainly comprised of equity in earnings of SHPL, interest income and expense, FX and taxes, generated net income of $53.3 million (H1-23: $56.9m), which decreased primarily due to lower foreign currency exchange gains recognized in the period. Net Income attributable to HUTCHMED for the six months ended June 30, 2024 was $25.8 million compared to $168.6 million for the six months ended June 30, 2023. The net income attributable to HUTCHMED for the six months ended June 30, 2024 was $0.03 per ordinary share / $0.15 per ADS52, (H1-23: $0.20 per ordinary share / $1.00 per ADS). FINANCIAL GUIDANCE We reiterate full year 2024 guidance for Oncology/Immunology consolidated revenue is $300 million to $400 million, driven by 30% to 50% growth target in oncology marketed product revenue. HUTCHMED’s work in 2024 and beyond will be supported by its strong balance sheet. The Company is thus well placed to deliver against its target to become a self-sustaining business and its goal to bring its innovative medicines to patients globally through its own sales network in China markets and through partners worldwide. Shareholders and investors should note that: we do not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; andwe have in the past revised our financial guidance and reference should be made to any announcements published by us regarding any updates to the financial guidance after the date of publication of this announcement. Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively. FINANCIAL SUMMARY Condensed Consolidated Balance Sheets Data (in $’000)As ofJune 30, 2024 As ofDecember 31, 2023Assets(Unaudited) Cash and cash equivalents and short-term investments802,453 886,336Accounts receivable156,916 116,894Other current assets88,891 93,609Property, plant and equipment94,815 99,727Investment in an equity investee80,519 48,411Other non-current assets37,274 34,796Total assets1,260,868 1,279,773Liabilities and shareholders’ equity Accounts payable43,398 36,327Other payables, accruals and advance receipts249,218 271,399Deferred revenue108,777 127,119Bank borrowings82,100 79,344Other liabilities25,357 22,197Total liabilities508,850 536,386Company’s shareholders’ equity740,084 730,541Non-controlling interests11,934 12,846Total liabilities and shareholders’ equity1,260,868 1,279,773 Condensed Consolidated Statements of Operations Data (Unaudited, in $’000, except share and per share data)Six months ended June 30, 2024 2023 Revenue: Oncology/Immunology – Marketed Products127,796 80,149 Oncology/Immunology – R&D40,841 279,034 Oncology/Immunology consolidated revenue168,637 359,183 Other Ventures137,044 173,691 Total revenue305,681 532,874 Operating expenses: Cost of revenue(180,135) (208,324)Research and development expenses(95,256) (144,633)Selling and administrative expenses(57,811) (68,263)Total operating expenses(333,202) (421,220) (27,521) 111,654 Other income, net22,765 25,434 (Loss)/income before income taxes and equity in earnings of an equity investee(4,756) 137,088 Income tax expense(2,886) (2,730)Equity in earnings of an equity investee, net of tax33,807 35,110 Net income26,165 169,468 Less: Net income attributable to non-controlling interests(364) (917)Net income attributable to HUTCHMED25,801 168,551 Earnings per share attributable to HUTCHMED (US$ per share) – basic 0.03 0.20 – diluted0.03 0.19 Number of shares used in per share calculation – basic856,030,704 846,928,863 – diluted872,534,466 866,990,610 Earnings per ADS attributable to HUTCHMED (US$ per ADS) – basic 0.15 1.00 – diluted0.15 0.97 Number of ADSs used in per share calculation – basic171,206,141 169,385,773 – diluted174,506,893 173,398,122 About HUTCHMED HUTCHMED (Nasdaq/AIM: ​HCM; HKEX: ​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology medicines marketed in China, the first of which is also marketed in the US. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Contacts Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum+44 (20) 7886 2500 References Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context. Past Performance and Forward-Looking Statements The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement 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 can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which have been obtained will continue to remain valid and effective in the future, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, “HUTCHMED’s Products”) will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally, including, among others, the risk that HUTCHMED’s ADSs could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED’s Products after obtaining regulatory approval; discovery, development and/or commercialization of competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED’s Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED’s Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED’s Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED’s Products; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates and uncertainties regarding the impact of pandemics and disease outbreaks. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, on AIM and on HKEX53. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above. Inside Information This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018). Medical Information This announcement 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. This announcement in its entirety is available at:http://ml.globenewswire.com/Resource/Download/584882e0-cb55-4c65-8b21-f088947ccfee _________________ REFERENCES & ABBREVIATIONS1CER = Constant exchange rate. We also report changes in performance at CER which is a non-GAAP measure. Please refer to “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures.2In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), Takeda (FRUZAQLA®), AstraZeneca (ORPATHYS®) and HUTCHMED (ELUNATE®, SULANDA®, ORPATHYS® and TAZVERIK®).3R&D = Research and development.4Takeda = Takeda Pharmaceuticals International AG, a subsidiary of Takeda Pharmaceutical Company Limited.5ITP = immune thrombocytopenia purpura.6NDA = New Drug Application.7NSCLC = Non-small cell lung cancer.8METex14 = MET exon 14 skipping alterations.9AIHA = Autoimmune hemolytic anemia.10AML = Acute myeloid leukemia.11PDAC = Pancreatic ductal adenocarcinoma.12Syk = Spleen tyrosine kinase.13EZH2 = Enhancer of zeste homolog 2.14IDH = Isocitrate dehydrogenase.15BTK = Bruton’s tyrosine kinase.16CRC = Colorectal cancer.17NRDL = China National Reimbursement Drug List.18Lilly = Eli Lilly and Company.19sNDA = Supplemental New Drug Application.20NMPA = China National Medical Products Administration.21R/R = Relapsed and/or refractory.22EMA = European Medicines Agency.23MET = Mesenchymal epithelial transition factor.24AACR = American Association for Cancer Research Annual Meeting.25EGFR = Epidermal growth factor receptor.26FDA = Food and Drug Administration.27VEGFR = Vascular endothelial growth factor receptor.28pMMR = Proficient mismatch repair.29ASCO = American Society of Clinical Oncology Annual Meeting.30ASCO GI = ASCO Gastrointestinal Cancers Symposium.31CEA = Carcinoembryonic antigen.32PFS = Progression free survival.33ORR = Objective response rate.34DCR = Disease control rate.35OS = Overall survival.36PMDA = Pharmaceuticals and Medical Devices Agency.37RCC = Renal cell carcinoma.38EHA = European Hematology Association.39TPO/TPO-RA = Thrombopoietin and/or thrombopoietin receptor agonists.40FGFR = Fibroblast growth factor receptor.41CSF-1R = Colony-stimulating factor 1 receptor.42PD-1 = Programmed cell death protein-1.43IHCC = Intrahepatic cholangiocarcinoma.44ERK = Extracellular signal-regulated kinase.45ADC = Antibody-drug conjugate.46Inmagene = Inmagene Biopharmaceuticals.47SHPL = Shanghai Hutchison Pharmaceuticals Limited.48ESG = Environmental, Social and Governance.49GAAP = Generally Accepted Accounting Principles.50Hainan Pilot Zone = Hainan Boao Lecheng International Medical Tourism Pilot Zone.51S&A= Selling and administrative expenses.52ADS = American depositary share.53HKEX = The Main Board of The Stock Exchange of Hong Kong Limited.