Hong Kong, Shanghai, & Florham Park, NJ — Friday, July 30, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX: 13) hereby notifies the market that as at July 30, 2021, the issued share capital of HUTCHMED consisted of 864,115,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury.
The above figure of 864,115,660 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.
For illustrative purposes only, the 864,115,660 ordinary shares would be equivalent to 864,115,660 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 172,823,132 American depositary shares (each equating to five ordinary shares) which are traded on Nasdaq.
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. A dedicated organization of over 1,300 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
|
| Americas | |
| Brad Miles, Solebury Trout | +1 (917) 570 7340 (Mobile) bmiles@troutgroup.com |
| Europe | |
| Ben Atwell / Alex Shaw, FTI Consulting |
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com |
| Asia | |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
爱优特®市场销售额 1增长186%，反映自有销售团队的贡献
收到沃瑞沙®于中国的首个批准及苏泰达®于中国的第二个批准
索凡替尼美国及欧盟申请均获接纳
公司于今日下午8时正（香港时间）/下午1时正（格林尼治时间）/上午8时正（东部夏令时间）举行中期业绩电话会议及网络直播
和黄医药（中国）有限公司（简称“和黄医药”）今日宣布自本年度截至2021年6月30日止六个月的未经审核财务业绩以及提供自年初以来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。
和黄医药主席杜志强先生表示：“和黄医药取得非常出色的进展。我们的创新药物发现及开发引擎保持快速发展。我们不仅在中国迎来了的第三和第四个创新肿瘤药物的NDA4获批，我们向FDA5及EMA6提交的上市申请亦获受理。”
“基于在单药及免疫疗法/TKI7联合疗法概念验证研究中取得令人鼓舞的数据，我们五个全球领先创新药物的十项注册研究将在今年开始。此外，早期阶段的产品管线包括IDH1/28、ERK9及第三代BTK10抑制剂均于今年开始临床开发。”
“同时，我们正在快速推进肿瘤商业化业务。”
“我们在中国拥有一个约540人的团队营销爱优特®(ELUNATE®)以及苏泰达®(SULANDA®)，2021年上半年市场销售额11达 4,810万美元。在美国，我们正在建立肿瘤商业团队，以支持可能于2022年上市的索凡替尼（surufatinib）及于2023年上市的呋喹替尼（fruquintinib）。对于沃瑞沙®( ORPATHYS®)，我们的合作伙伴阿斯利康12利用其在肺癌方面的巨大商业化能力以销售该重要的同类首创药物。”
“在公司层面，我们于上半年采取若干重要举措，以支持我们的全球计划。我们将公司名称更改为HUTCHMED（中文：和黄医药），将若干旧有的集团及营运名称合并成为一个统一、完整的全球企业品牌。我们亦通过在香港交易所IPO13及剥离非核心的OTC14药品业务，累积约12亿美元的现金及资源结余。”
“未来三年，我们将继续迅速建立我们的全球研发15及商业团队，以支持我们多个创新肿瘤药物的预期全球上市。”
中国
美國及歐洲
索凡替尼(中国商品名：苏泰达®)是一种VEGFR 22、 FGFR 23及 CSF-1R 24的小分子抑制剂，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人体对肿瘤细胞的免疫应答；现已于中国获批上市。
索凡替尼潜在的临床和监管关键进展：
呋喹替尼 (中國商品名：愛優特®)是一種高選擇性的VEGFR 1/2/3小分子抑制劑，旨在提高激酶選擇性，將脫靶毒性減至最低，從而提高耐受性；現已於中國獲批上市
呋喹替尼潜在的临床和监管关键进展：
赛沃替尼 (沃瑞沙®)是一种高选择性的小分子MET抑制剂，正广泛地于MET驱动的肺癌、胃癌和肾细胞癌患者群体中进行临床开发
赛沃替尼潜在的临床和注册关键进展：
HMPL-689是一种研究性及高选择性小分子PI3Kδ42抑制剂，旨在解决目前已获批及处于临床研究阶段的PI3Kδ抑制剂相关的胃肠道疾病和肝毒性
HMPL-689潜在的临床和监管关键进展：
HMPL-523是一种研究性及高选择小分子Sy性k44抑制剂，用于治疗血液癌和免疫性疾病。其靶点Syk是B细胞受体信号传导通路的重要组成部分
HMPL-523潜在的临床和监管关键进展：
HMPL-453是一种研究性及高选择性小分子FGFR 1/2/3抑制剂
HMPL-453潜在的临床和注册关键进展﹕
HMPL-306是一种研究性及高选择性小分子IDH1/2双重抑制剂，旨在解决对目前已上市IDH抑制剂的耐药问题
HMPL-306潜在的临床和注册关键进展﹕
HMPL-295是一种靶向MAPK信号通路 49中ERK的研究性及高选择性小分子抑制剂，有潜力解决上游机理（例如RAS-RAF-MEK）带来的原发性或获得性耐药问题。
HMPL-760是一种研究性、高选择性、比第一代BTK抑制剂更有效的第三代小分子BTK抑制剂，对野生型及C481S突变激酶具有更高活性
HMPL-760潜在的临床和监管关键进展:
药物发现，我们所有十一种临床候选药物由我们自有的科学团队自主发现，包括三款已获批的肿瘤药物﹕爱优特®、苏泰达®及沃瑞沙®
药物发现潜在的关键发展﹕
迄今为止，新冠肺炎疫情于2021年并无对我们的临床研究产生重大影响。我们将继续密切关注不断变化的疫情。
简明综合资产负债表数据
（千美元）
| 于2021年6月30日 | 于2020年12月31日 | |||
| （未经审核） | ||||
| 2021年 | 2020年 | |||
| 资产 | ||||
| 现金及现金等价物和短期投资 | 950,448 | 435,176 | ||
| 应收账款 | 58,878 | 47,870 | ||
| 其他流动资产 | 81,848 | 47,694 | ||
| 物业、厂房及设备 | 29,168 | 24,170 | ||
| 合资企业权益 | 118,316 | 139,505 | ||
| 其他非流动资产 | 34,231 | 29,703 | ||
| 资产总额 | 1,272,889 | 724,118 | ||
| 负债及股东权益 | ||||
| 应付账款 | 28,513 | 31,612 | ||
| 其他应付款、应计开支及预收款项 | 181,610 | 120,882 | ||
| 银行贷款 | 26,883 | 26,861 | ||
| 其他负债 | 22,188 | 25,814 | ||
| 负债总额 | 259,194 | 205,169 | ||
| 本公司股东权益总额 | 984,795 | 484,116 | ||
| 非控股权益 | 28,900 | 34,833 | ||
| 负债及股东权益总额 | 1,272,889 | 724,118 |
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 | |||
| 2021年 | 2020年 | ||
| 收入: | |||
| 肿瘤╱免疫业务 – 上市产品 | 37,795 | 8,645 | |
| 肿瘤╱免疫业务 – 研发 | 5,056 | 7,747 | |
| 肿瘤╱免疫业务综合收入 | 42,851 | 16,392 | |
| 其他业务 | 114,511 | 90,373 | |
| 收入总额 | 157,362 | 106,765 | |
| 经营开支: | |||
| 收入成本 | (123,249) | (83,572) | |
| 研发开支 | (123,050) | (73,974) | |
| 销售及行政开支 | (54,797) | (27,384) | |
| 经营开支总额 | (301,096) | (184,930) | |
| 经营亏损 | (143,734) | (78,165) | |
| 其他收益 | 3,287 | 1,585 | |
| 除所得税开支及合资企业权益收益前亏损 | (140,447) | (76,580) | |
| 所得税开支 | (1,859) | (2,032) | |
| 所占合资企业权益除税后收益 | 42,966 | 30,366 | |
| 净亏损 | (99,340) | (48,246) | |
| 减：非控股权益应占净收益 | (3,057) | (1,448) | |
| 和黄医药应占净亏损 | (102,397) | (49,694) | |
| 和黄医药应占每股亏损 － 基本及摊薄 | (0.14) | (0.07) | |
| 计算每股亏损所用的股份数 － 基本及摊薄 | 729,239,181 | 685,285,841 | |
| 和黄医药应占每份ADS亏损 － 基本及摊薄 | (0.70) | (0.35) | |
| 计算每份ADS亏损所用的ADS份数 － 基本及摊薄 | 145,847,836 | 137,057,168 | |
除非另有说明，所有金额均以美元表示。
于2021年上半年，我们爱优特®、苏泰达®和现在的沃瑞沙®商业化进展符合预期。尽管结果令人鼓舞，我们仍保持指引不变。
| 2021年上半年实际 | 2021年当前指引 | 调整对比过往指引 | |
| 肿瘤/免疫业务综合收入 | 4,290 万美元 | 1.1 – 1.3亿美元 | 无 |
非GAAP 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指标调节的进一步数据。
—–
电话会议和音频网络直播演讲预计于今天香港时间晚上8时正/格林尼治时间下午1时正/东部夏令时间上午8时正举行 — 投资者可按如下号码﹕+852 3027 6500 (香港) / +44 20 3194 0569 (英国) / +1 646 722 4977 (美国)参与电话会议，或透过访问和黄医药网站www.hutch-med.com/event/参与会议的现场音频网络直播。
和黄医药网站亦提供查阅其他拨入号码。请使用参与者接入代码“45675713#”。
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。超过1,300人的专业团队已将自主发现的11个候选癌症药物推进到在全球开展临床研究，其中首三个创新肿瘤药物现已获批上市。欲了解更多详情，请访问：www.hutch-med.com或关注我们的领英专页。
投资者谘询 |
|
| 李健鸿，资深副总裁 | +852 2121 8200 |
| 郑嘉惠，副总裁 | +1 (973) 567 3786 |
媒体谘询 |
|
| 美洲 | |
| Brad Miles, Solebury Trout |
+1 (917) 570 7340（手機） bmiles@troutgroup.com |
| 欧洲 | |
| Ben Atwell / Alex Shaw, FTI Consulting |
+44 20 3727 1030 / +44 7771 913 902（手機）/ +44 7779 545 055（手機） HUTCHMED@fticonsulting.com |
| 亞洲 | |
| 周怡, 博然思维集团 |
+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
任命保荐人 |
|
| Atholl Tweedie / Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
除非文意另有所指，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”是指和黄医药（中国）有限公司及其并表的附属公司和合资企业，除非文中另有说明或指明。
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》中“安全港”条款定义的前瞻性陈述。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”、“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，或者在任何特定时间获得批准，或者任何候选药物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; 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、质量或生产方面的问题; 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获得监管批准后无法获得商业认可；全球医疗成本遏制趋势，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、有关销售和营销行为的诉讼和调查、智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新冠肺炎疫情的影响的不确定性。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提交的文件。和黄医药在本公告中提供之讯息截至本公告日期，并且不承担因新的讯息、未来事件或其他原因而更新任何前瞻性陈述的义务。
此外，本公告还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。
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。
結束
| 公告发布：2021年7月28日（星期三） |
| 香港时间 晚上7点（12 noon BST / 7am EDT ） |
| >> 查看公告 << |
| 中期业绩简报会 网络直播及电话会议 |
| 时间：香港时间 晚上8点（1pm BST / 8am EDT ） |
| 会议语言：英语 |
To participate by phone, please use one of the following numbers.
Participant Access Code is : “45675713#“
| United Kingdom (Toll-Free) | 0800 026 1542 |
| United Kingdom (Toll) | +44 203 194 0569 |
| United States (Toll-Free) | 1 855 824 5644 |
| United States (Toll) | +1 646 722 4977 |
| China Mainland (Toll-Free) | 800 988 0563 |
| China Mainland (Toll) | 400 821 0637 |
| Hong Kong SAR, China | +852 3027 6500 |
| Singapore (Toll-Free) | 800 120 6853 |
| Switzerland (Toll-Free) | 0800 800 732 |
— 基于沃瑞沙®在亚洲开展的包括 VIKTORY 在内的多项II 期研究，
结果显示伴有MET扩增的胃癌患者的客观缓解率 (ORR) 为 50% —
中国香港、上海和美国新泽西州：2021年7月28日（星期三）：和黄医药（中国）有限公司（简称“和黄医药”或“HUTCHMED”）（纳斯达克/伦敦证交所：HCM；香港交易所：13）与阿斯利康（LSE/STO/Nasdaq: AZN）已启动一项沃瑞沙®（通用名：赛沃替尼/Savolitinib；英文商品名：ORPATHYS®）的 II 期临床试验。沃瑞沙®是一种强效、高选择性的口服小分子间质上皮转化因子（“MET”，一种受体酪氨酸激酶）抑制剂，用于治疗MET 扩增的晚期或转移性胃癌或胃食管结合部腺癌患者。首名患者已于2021 年 7 月27日接受给药治疗。
该项II 期研究是一项开放标签及两队列的多中心临床试验，旨在评估沃瑞沙®在至少接受过一线标准治疗后疾病进展的局部晚期或转移性胃癌或胃食管结合部腺癌患者中的疗效、安全性和药代动力学特征。研究的主要终点是独立审查委员会评估的客观缓解率（“ORR”）。其他终点包括 12 周和 6 个月的无进展生存（“PFS”） 率、中位 PFS、缓解持续时间（“DoR”）、疾病控制率（“DCR”）、中位总生存期（“OS”）、安全性、药代动力学特征以及生活质量。
该项研究由北京大学肿瘤医院主导。主要研究者是沈琳博士。该研究的其他详情，请浏览clinicaltrials.gov ，检索注册号NCT04923932查看。
MET驱动的胃癌预后一般较差。[i] 该项临床试验是继沃瑞沙®多项在亚洲治疗MET驱动的胃癌的 II 期研究后启动的，其中包括VIKTORY研究。2 VIKTORY 是一项由研究者发起于韩国进行的针对胃癌的 II 期伞式研究，共有 715 名患者接受测序后纳入分子驱动的患者组，其中包括伴有MET 扩增的胃癌患者。 伴有MET 扩增的患者接受沃瑞沙®单药治疗，结果显示ORR 为 50%（10/20名，95%置信区间 [“CI”]：28.0, 71.9）。
据估计，约有4-6%的胃癌患者伴有MET 扩增。[ii],[iii] 中国每年约新增24,000例MET扩增的胃癌病例。[iv]
沃瑞沙®（通用名：赛沃替尼/savolitinib，旧称沃利替尼）是一种强效、高选择性的口服MET酪氨酸激酶抑制剂，在晚期实体瘤中表现出临床活性。沃瑞沙®可阻断因突变（例如外显子14跳跃突变或其他点突变）或基因扩增而导致的MET受体酪氨酸激酶信号通路的异常激活。
沃瑞沙®在中国获批上市用于治疗接受全身性治疗后疾病进展或无法接受化疗的MET外显子14跳跃突变的非小细胞肺癌（“NSCLC”）患者。目前，沃瑞沙®正作为单药疗法或与其他药物的联合疗法，开发用于治疗包括肺癌、肾癌和胃癌在内的多种肿瘤类型。
继沃瑞沙®由和黄医药自主研发及初步开发后，2011年，和黄医药与阿斯利康达成一项全球许可协议，旨在共同开发沃瑞沙®并促进其商业化。和黄医药与阿斯利康合作负责沃瑞沙®的临床开发，在中国由和黄医药主导，在海外则由阿斯利康主导。此外，和黄医药负责沃瑞沙®在中国的上市许可、生产和供应，而阿斯利康则负责实现沃瑞沙®在中国乃至全球范围内的商业化。沃瑞沙®的销售收入将由阿斯利康确认。
沃瑞沙®单药治疗MET 外显子14跳跃突变NSCLC的 II 期研究 （NCT02897479）– 沃瑞沙®于2021年6月获国家药品监督管理局（“国家药监局”）批准用于治疗MET外显子14跳跃突变的NSCLC。此获批是基于一项中国II期试验，其研究结果已于2020年5月举行的美国临床肿瘤学会（“ASCO”）2020年网上年会中公布，并于2021年6月于《柳叶刀·呼吸医学》[v]上发表了更新结果。中位随访时间为17.6个月时，所有使用沃瑞沙®治疗的受试者的ORR为42.9%（95% CI 31.1-55.3)，中位PFS为6.8个月（95% CI 4.2-9.6）。PFS在各亚组中具有临床意义，并且ORR结果与既往治疗或肿瘤组织情况无关，肿瘤组织亚型包括肺肉瘤样癌亚型患者（40.0%，95% CI 21.1-61.3）和其他NSCLC亚型患者（44.4%，95% CI 29.6-60.0）。整个研究人群的DCR 为 82.9%（95% CI 72.0-90.8）。沃瑞沙®的安全性和耐受性特征与之前的研究结果一致，没有发现新的安全性问题。持续批准取决于在该患者人群中成功完成确证性试验 (NCT04923945)。
SAVANNAH II 期研究：沃瑞沙®联合泰瑞沙®（TAGRISSO®）用于治疗因 MET 扩增或过表达引起的泰瑞沙®治疗后进展的患者 （NCT03778229） – SAVANNAH 研究是一项针对接受过泰瑞沙®治疗的伴有MET扩增或过表达的表皮生长因子受体（EGFR）突变阳性的 NSCLC 患者的单臂、开放标签的全球性研究。泰瑞沙®是阿斯利康的一种表皮生长因子受体酪氨酸激酶抑制剂（“EGFR-TKI”）。
III期研究：沃瑞沙®联合泰瑞沙®用于因 MET 扩增引起的EGFR-TKI治疗后进展的患者（计划中） – SACHI研究是一项在中国开展的随机、开放标签研究，针对接受EGFR-TKI治疗后进展的伴有MET扩增的EGFR突变阳性的NSCLC患者。
III期研究：沃瑞沙®联合泰瑞沙®用于治疗初治的伴有MET过表达的EGFR突变阳性NSCLC患者（计划中）– SANOVO研究是一项在中国开展的随机、盲性研究，针对MET阳性的未接受治疗的不可切除或转移性EGFR突变阳性的NSCLC患者。
SAVOIR研究：沃瑞沙®单药治疗MET驱动的乳头状肾细胞癌（NCT03091192） – 2020年5月， 在MET驱动的乳头状肾细胞癌患者中比较沃瑞沙®单药治疗与舒尼替尼单药治疗的这项全球研究中60名患者的研究数据于ASCO 2020网上年会发表，并同步发表于《美国医学会杂志•肿瘤学（JAMA Oncology）》[vi] 。沃瑞沙®表现出令人鼓舞的疗效，ORR为27％，而舒尼替尼的ORR则为7％。至数据截止时，对沃瑞沙®有反应的患者均未出现疾病进展，总生存期（OS）的风险比（HR）为0.51（95% CI：0.21–1.17; p=0.110），中位生存期尚未到达。
CALYPSO I/II 期研究：沃瑞沙®联合英飞凡®（IMFINZI®）PD-L1 抑制剂用于治疗肾细胞癌（NCT02819596） – CALYPSO 研究是一项由研究者发起的开放标签的 I/II 期沃瑞沙®与英飞凡®联合疗法研究，英飞凡®是阿斯利康的一种PD-L1抗体。该研究旨在评估沃瑞沙®/英飞凡®联合治疗乳头状肾细胞癌患者和肾透明细胞癌患者的安全性和疗效。在 ASCO 2021年网上年会上[vii] ，公布了一项该研究中对转移性乳头状肾细胞癌患者（PRCC） 队列 41 名患者的分析，其中显示 14 名 MET 驱动患者的确认反应率为 57%，中位DoR 为 9.4 个月，中位 PFS 为 10.5 个月，中位 OS 为 27.4 个月。而在该研究中没有出现新的安全信号。
III期研究： 联合英飞凡® PD-L1 抑制剂用于治疗MET 驱动且不可切除的局部晚期或转移性 PRCC （计划中） – 鉴于SAVOIR和 CALYPSO 的研究成果令人鼓舞，我们计划启动一项开放标签、随机对照的全球 III 期研究，评估沃瑞沙®与英飞凡®联合疗法对比舒尼替尼单药疗法或英飞凡®单药疗法，用于治疗 MET驱动的肿瘤不可切除的局部晚期或转移性乳头状肾细胞癌患者。
通过研究者发起的临床试验，沃瑞沙®在包括非小细胞肺癌、胃癌和结直肠癌在内的其他多种MET驱动的肿瘤中的应用潜力也在继续探索中。
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。超过1,300人的专业团队已将自主发现的11个候选癌症药物推进到在全球开展临床研究，其中首三个创新肿瘤药物现已获批。欲了解更多详情，请访问：www.hutch-med.com或关注我们的领英专页。
本新闻稿包含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。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对沃瑞沙®用于治疗胃癌患者的治疗潜力的预期，沃瑞沙®针对此适应症及其他适应症的进一步临床研究计划，对此类研究是否能达到其主要或次要终点的预期，以及对此类研究完成时间和结果发布的预期。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：支持沃瑞沙®获批用于在中国治疗胃癌的新药上市申请的数据充足性，沃瑞沙®在美国、欧洲和日本等其他地区获得快速审批的潜力，沃瑞沙®的安全性，沃瑞沙®成为治疗胃癌患者治疗新标准的潜力、实现及完成沃瑞沙®进一步临床开发计划的能力，在中国或其他地区推出上市沃瑞沙®的可能性，上述事件的时间，以及新冠肺炎全球大流行对整体经济、监管及政治状况带来的影响等。此外，由于某些研究依赖于泰瑞沙®和英飞凡®作为与沃瑞沙®的联合疗法，此类风险和不确定性包括下列假设：泰瑞沙®和英飞凡®的安全性、有效性、供应和持续监管批准。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、AIM及香港联合交易所有限公司提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。
[i] Catenacci DV, Ang A, Liao WL, et al. MET tyrosine kinase receptor expression and amplification as prognostic biomarkers of survival in gastroesophageal adenocarcinoma. Cancer. 2017;123(6):1061-1070. doi:10.1002/cncr.30437
[ii] Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405. doi:10.1158/2159-8290.CD-19-044
[iii] 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
[iv] Global Cancer Observatory. China Fact Sheet. gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
[v] Lu S, et al. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021 Jun 21:S2213-2600(21)00084-9. doi: 10.1016/S2213-2600(21)00084-9.
[vi] Choueiri TK, et al. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218.
[vii] Powles T, et al. A phase II study investigating the safety and efficacy of savolitinib and durvalumab in metastatic papillary renal cancer (CALYPSO). J Clin Oncol 37, 2019 (suppl 7S; abstr 545). doi: 10.1200/JCO.2019.37.7_suppl.545.
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Hong Kong, Shanghai & Florham Park, NJ — Friday, July 23, 2021: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM; HKEX: 13) announces that the stabilization period in connection with the Global Offering ended on July 23, 2021, being the 30th day after the last day for the lodging of applications under the Hong Kong Public Offering on June 23, 2021. The stabilizing actions undertaken by Morgan Stanley Asia Limited, as the Stabilizing Manager (or any person acting for it) during the stabilization period were:
(1) over-allocations of an aggregate of 15,600,000 Offer Shares in the International Offering, representing approximately 15% of the total number of the Offer Shares initially available under the Global Offering before any exercise of the Over-allotment Option;
(2) borrowing of an aggregate of 15,600,000 Shares by Morgan Stanley & Co. International plc (an affiliate of Morgan Stanley Asia Limited) from Hutchison Healthcare Holdings Limited (an indirect wholly-owned subsidiary of CK Hutchison Holdings Limited) pursuant to the Stock Borrowing Agreement dated June 23, 2021, to cover over-allocations in the International Offering; and
(3) the full exercise of the Over-allotment Option by the Joint Global Coordinators, on behalf of the International Underwriters, on July 12, 2021, in respect of an aggregate of 15,600,000 Offer Shares, representing approximately 15% of the total number of the Offer Shares initially available under the Global Offering before any exercise of the Over-allotment Option, at the Offer Price, to facilitate the return to Hutchison Healthcare Holdings Limited of all the borrowed Shares under the Stock Borrowing Agreement which were used to cover over-allocations in the International Offering.
There has been no purchase or sale of any Shares on the market for the purpose of price stabilization by the Stabilizing Manager during the stabilization period.
For further details of the full exercise of the Over-allotment Option, please refer to the HUTCHMED announcement dated July 12, 2021.
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. A dedicated organization of over 1,300 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Unless otherwise defined herein, capitalized terms used in this announcement shall have the same meanings as those defined in the prospectus dated Friday, June 18, 2021 (the “Prospectus”) of HUTCHMED.
This announcement is for information purposes only and does not constitute an offer or an invitation to induce an offer by any person to acquire, purchase or subscribe for any securities. Potential investors should read the Prospectus for detailed information about the Company and the Global Offering before deciding whether or not to invest in the Offer Shares.
This announcement is not for release, publication, distribution, directly or indirectly, in or into the United States (including its territories and possessions, any state of the United States and the District of Columbia) or to any U.S. person (as defined in Regulation S under the U.S. Securities Act of 1933, as amended from time to time, (the “U.S. Securities Act”) or any other jurisdiction where such distribution is prohibited by law. This announcement does not constitute or form a part of any offer to sell or solicitation to purchase or subscribe for securities in Hong Kong, the United States or elsewhere. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act. Any public offering of the Company’s securities outside of the public offering in Hong Kong will be made (i) pursuant to the shelf registration statement on Form F-3ASR that was filed with the U.S. Securities and Commission and became effective on April 6, 2020 and (ii) in respect of securities to be sold to certain cornerstone investors, in reliance on Rule 901 of Regulation S under the U.S. Securities Act or pursuant to another exemption from the registration requirements of the U.S. Securities Act, as described in the section headed “Structure of the Global Offering – The International Offering” in the Prospectus.
No prospectus required for the purposes of Regulation (EU) 2017/1129 (“EU Prospectus Regulation”) or Regulation (EU) 2017/1129 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018) (“UK Prospectus Regulation”) or admission document (as defined in the AIM Rules for Companies published by the London Stock Exchange plc) will be made available in connection with the matters contained in this announcement. In any member state of the European Economic Area, this announcement is only addressed to and directed at qualified investors in that member state as defined in article 2(e) of the EU Prospectus Regulation.
This announcement, insofar as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the U.K. Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the Global Offering, is being directed only at (i) persons who are outside the United Kingdom or (ii) if in the United Kingdom, persons who are qualified investors as defined in article 2(e) of the UK Prospectus Regulation who also (a) have professional experience in matters relating to investments who fall within Article 19(5) (investment professionals) of the U.K. Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (b) fall within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iii) any other person to whom it may lawfully be communicated (all such persons in (i) to (iii) together being referred to as “specified persons”). This announcement is directed only at specified persons and must not be acted on or relied on in the United Kingdom by persons who are not specified persons. Any investment or investment activity to which this announcement relates is available only to specified persons and will be engaged in only with specified persons.
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| NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i | ||||||
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| 5. Date on which the threshold was crossed or reached vi: | 30 June 2021 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | 16 July 2021 | |||||
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| % of voting rights attached to shares (total of 8. A) | % of voting rights through financial instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights held in issuer (8.A + 8.B) vii | |||
| Resulting situation on the date on which threshold was crossed or reached | 3.17% | 0.00 | 3.17% | 26,883,270 | ||
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| Ordinary Shares KYG4672N1198 | 26,883,270 | 0 | 3.17% | 0.00 | |||||
| SUBTOTAL 8. A | 26,883,270 | 3.17% | |||||||
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| B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) | |||||||
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| SUBTOTAL 8.B.2 | N/A | N/A | |||||
| 9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||
| Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii | X | |||
| Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) xiv |
||||
| Name | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
| N/A | N/A | N/A | N/A | |
| 10. In case of proxy voting, please identify: | ||||
| Name of the proxy holder | N/A | |||
| The number and % of voting rights held | N/A | |||
| The date until which the voting rights will be held | N/A | |||
| 11. Additional information xvi | ||||
| N/A | ||||
| Place of completion | Hong Kong |
| Date of completion | 16 July 2021 |
– 欧洲药品管理局开始审评索凡替尼用于治疗晚期神经内分泌瘤的上市许可申请 –
–继索凡替尼于中国上市以及美国的上市申请进入审评阶段后，进一步扩大了其潜在全球可及范围–
中国香港、上海和美国新泽西州：2021年7月 16日（星期五）：和黄医药（中国）有限公司（简称“和黄医药”或“HUTCHMED”）（纳斯达克/伦敦证交所：HCM；香港交易所：13）今日宣布，欧洲药品管理局（“EMA”）已确认并受理索凡替尼用于治疗胰腺和胰腺外（非胰腺）神经内分泌瘤（NET）的上市许可申请（MAA）。EMA已确认提交材料的完整性，并且已准备好启动正式的审评程序。
该申请提交是遵循了EMA人用药品委员会（“CHMP”）提供的科学建议，其结论为：索凡替尼治疗胰腺和非胰腺神经内分泌瘤患者的两项成功的中国 III 期研究（SANET-p[i] 及 SANET-ep[ii] ，两项研究结果均已于《柳叶刀·肿瘤学》期刊上刊登）以及索凡替尼治疗美国非胰腺和胰腺神经内分泌瘤患者的现有数据，可以作为支持上市许可申请的依据。 和黄医药已于 2021 年 7 月 1 日宣布向美国食品药品监督管理局（“FDA”）提交新药上市申请并获受理。
和黄医药（国际）董事总经理兼首席医学官Marek Kania医学博士表示：“和黄医药的创新肿瘤药物管线正在全球范围内取得重要的进展。继美国FDA受理索凡替尼的美国新药上市申请后，我们相信此次EMA对该上市许可申请的确认，认可了相关申请材料的科学价值。今年早些时候，索凡替尼于中国上市，为神经内分泌瘤患者提供了重要的治疗新选择，现在我们希望很快能够将这种重要的治疗方法带向美国和欧洲的患者。”
神经内分泌瘤起源于与神经系统相互作用的细胞或产生激素的腺体。神经内分泌瘤可起源于体内各个部位，最常见于消化道或肺部，可为良性或恶性肿瘤。神经内分泌瘤通常分为胰腺神经内分泌瘤（pNET）和胰腺外（非胰腺）神经内分泌瘤（epNET）。
据 Frost & Sullivan 公司估计，2020 年美国神经内分泌瘤新诊断病例为 19,000 例。基于全球流行病学趋势的分析，整个欧盟 (EU) 的发病率与美国大致相近，而该分析同时显示神经内分泌瘤的全球发病率呈上升趋势。[iii] 重要的是，与其他肿瘤相比，神经内分泌瘤的生存期相对较长。 因此，据估计2020 年法国、德国、意大利、西班牙和英国约有 140,000 名神经内分泌瘤患者。[iv]
索凡替尼（surufatinib）是一种新型的口服酪氨酸激酶抑制剂，具有抗血管生成和免疫调节双重活性。索凡替 尼可通过抑制血管内皮生长因子受体（VEGFR）和成纤维细胞生长因子受体（FGFR）以阻断肿瘤血管生成， 并可抑制集落刺激因子 1 受体（CSF-1R），通过调节肿瘤相关巨噬细胞，促进机体对肿瘤细胞的免疫应答。索凡替尼独特的双重机制能产生协同抗肿瘤活性，使其为与其他免疫疗法的联合使用的理想选择。
和黄医药目前拥有索凡替尼在全球范围内的所有权利。
美国与欧洲神经内分泌瘤研究：索凡替尼的美国新药上市申请已于 2021 年 6 月获FDA受理，向EMA提交的上市许可申请亦于 2021 年 7 月获确认。以上申请均是基于已完成的SANET-ep和SANET-p研究，以及索凡替尼在美国治疗非胰腺和胰腺神经内分泌瘤患者的现有数据（clinicaltrials.gov 注册号NCT02549937）。在美国，索凡替尼于2020年4月被授予快速通道资格，用于治疗胰腺和非胰腺神经内分泌瘤，并于2019年11月被授予“孤儿药”资格，用于治疗胰腺神经内分泌瘤 。
中国非胰腺神经内分泌瘤研究：索凡替尼于2020年12月30日获中国国家药品监督管理局批准用于治疗非胰腺神经内分泌瘤。索凡替尼在中国市场以商品名苏泰达®销售。此获批是基于一项索凡替尼治疗晚期非胰腺神经内分泌瘤患者的中国III期临床试验SANET-ep的研究结果（clinicaltrials.gov注册号NCT02588170）。该研究在中期分析中成功达到无进展生存期（“PFS”）这一预设的主要终点。该研究的积极结果于2019年欧洲肿瘤内科学会(ESMO)年会上以口头报告的形式公布，并于2020年9月在《刺针·肿瘤学》上发表。[v] 索凡替尼治疗组患者的中位PFS显著延长为9.2个月，安慰剂组患者则为3.8个月（HR 0.334；95% CI：0.223 – 0.499；p <0.0001）。索凡替尼具有可接受的安全性特征，最常见的3级或以上治疗相关不良事件是高血压（索凡替尼组患者:36%; 安慰剂组患者:13%）、蛋白尿（索凡替尼组患者:19%; 安慰剂组患者: 0%）和贫血（索凡替尼组患者:5%; 安慰剂组患者:3%）。
中国胰腺神经内分泌瘤研究：索凡替尼于2021年6月18日获国家药监局批准用于治疗胰腺神经内分泌瘤。此获批是基于一项索凡替尼治疗晚期胰腺神经内分泌瘤患者的中国III期临床试验SANET-p（clinicaltrials.gov 注册号NCT02589821）的研究结果。该研究在预设的中期分析中成功达到PFS这一预设主要疗效终点，并以此为基础于2020年9月获国家药监局受理其第二项新药上市申请。该项研究的结果已于2020年ESMO在线年会上公布，并同步发表于《柳叶刀·肿瘤学》[vi]，证明索凡替尼将患者疾病进展或死亡风险降低了51％，中位PFS为10.9个月，而安慰剂组患者则为3.7个月（HR 0.491； 95％ CI：0.391-0.755； p = 0.0011）。 索凡替尼展示可控的安全性，并与先前研究中的观察结果一致。
中国胆道癌研究：和黄医药于2019年3月启动了一项IIb/III期临床试验，旨在对比绍凡替尼和卡培他滨治疗一线化疗后进展的晚期胆道癌患者。该研究的主要终点为总生存期（“OS”）（clinicaltrials.gov 注册号：NCT03873532）。
免疫联合疗法：和黄医药达成了数个合作协议，以评估索凡替尼与PD-1单克隆抗体联合疗法的安全性、耐受性和疗效，包括已于中国获批单药疗法的替雷利珠单抗（BGB-A317）、拓益®（特瑞普利单抗）和达伯舒®（信迪利单抗）。
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。超过1,300人的专业团队已将自主发现的10个候选癌症药物推进到在全球开展临床研究，其中首三个创新肿瘤药物现已获批上市。欲了解更多详情，请访问：http://www.hutch-med.com或关注我们的领英专页。
本新闻稿包含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。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括欧洲药品管理局审评索凡替尼用于治疗神经内分泌瘤的上市许可申请以及审评时间的预期，索凡替尼用于治疗神经内分泌瘤患者的治疗潜力的预期以及索凡替尼针对此适应症及其他适应症的进一步临床研究计划。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：支持索凡替尼获批用于在美国、中国及其他地区（如欧洲）治疗神经内分泌瘤的新药上市申请的数据充足性、获得监管部门快速审批的潜力，索凡替尼的安全性。和黄医药为索凡替尼进一步临床开发计划及商业化提供资金并实现及完成的能力，此类事件发生的时间，以及新冠肺炎全球大流行对整体经济、监管及政治状况带来的影响等。此外，由于部分研究赖于将卡培他滨、替雷利珠单抗、拓益®、达伯舒®与索凡替尼联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、AIM以及香港联合交易所有限公司提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。
[i] Surufatinib in advanced neuroendocrine tumors – pancreatic. (索凡替尼治疗晚期非胰腺神经内分泌瘤)
[ii] Surufatinib in advanced neuroendocrine tumors – extra-pancreatic (non-pancreatic). (索凡替尼治疗晚期胰腺神经内分泌瘤)
[iii] Fraenkel M, Kim M, Faggiano A, de Herder WW, Valk GD; Knowledge NETwork. Incidence of gastroenteropancreatic neuroendocrine tumours: a systematic review of the literature. Endocr Relat Cancer. 2014;21(3):R153-R163. Published 2014 May 6. doi:10.1530/ERC-13-0125.
[iv] 根据Frost & Sullivan公司的数据，2020年美国神经内分泌瘤新诊断病例为19,000例，美国的神经内分泌瘤患者总数约为143,000名。
[v] Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4.
[vi] Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9.
投资者咨询 |
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| NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i | ||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii: | HUTCHMED (China) Limited | |||||
| 1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
| Non-UK issuer | X | |||||
| 2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
| An acquisition or disposal of voting rights | X | |||||
| An acquisition or disposal of financial instruments | ||||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify) iii: | ||||||
| 3. Details of person subject to the notification obligation iv | ||||||
| Name | Jean Eric Salata | |||||
| City and country of registered office (if applicable) | N/A | |||||
| 4. Full name of shareholder(s) (if different from 3.) v | ||||||
| Name | N/A | |||||
| City and country of registered office (if applicable) | N/A | |||||
| 5. Date on which the threshold was crossed or reached vi: | 30 June 2021 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | 13 July 2021 | |||||
| 7. Total positions of person(s) subject to the notification obligation | ||||||
| % of voting rights attached to shares (total of 8. A) | % of voting rights through financial instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights held in issuer (8.A + 8.B) vii | |||
| Resulting situation on the date on which threshold was crossed or reached | 3.06% | 25,993,445 | ||||
| Position of previous notification (if applicable) | ||||||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of shares ISIN code (if possible) |
Number of voting rights | % of voting rights | |||||||
| Direct (DTR5.1) | Indirect (DTR5.2.1) | Direct (DTR5.1) | Indirect (DTR5.2.1) | ||||||
| Ordinary Shares KYG4672N1198 | 25,993,445 | 3.06% | |||||||
| SUBTOTAL 8. A | 25,993,445 | 3.06% | |||||||
| B 1: Financial Instruments according to DTR5.3.1R (1) (a) | |||||||
| Type of financial instrument | Expiration date x |
Exercise/ Conversion Period xi |
Number of voting rights that may be acquired if the instrument is exercised/converted. | % of voting rights | |||
| SUBTOTAL 8. B 1 | |||||||
| B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) | |||||||
| Type of financial instrument | Expiration date x |
Exercise/ Conversion Period xi |
Physical or cash Settlement xii | Number of voting rights | % of voting rights | ||
| SUBTOTAL 8.B.2 | |||||||
| 9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||
| Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii | ||||
| Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) xiv |
X | |||
| Name | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
| Chain 1: Jean Eric Salata | 3.06% | 3.06% | ||
| Baring Private Equity Asia GP VII Limited | 3.06% | 3.06% | ||
| Baring Private Equity Asia GP VII, L.P. | 3.06% | 3.06% | ||
| The Baring Asia Private Equity Fund VII, L.P. | 3.06% | 3.06% | ||
| Baring Private Equity Asia Fund VII Limited | 3.06% | 3.06% | ||
| Rhapso Holding Limited | Less than 3% | Less than 3% | ||
| Rhapso Limited | Less than 3% | Less than 3% | ||
| Chain 2: Jean Eric Salata | 3.06% | 3.06% | ||
| Baring Private Equity Asia GP VII Limited | 3.06% | 3.06% | ||
| Baring Private Equity Asia GP VII, L.P. | 3.06% | 3.06% | ||
| The Baring Asia Private Equity Fund VII, L.P. | 3.06% | 3.06% | ||
| Baring Private Equity Asia Fund VII Limited | 3.06% | 3.06% | ||
| Pachytene Holding Limited | Less than 3% | Less than 3% | ||
| Pachytene Limited | Less than 3% | Less than 3% | ||
| 10. In case of proxy voting, please identify: | ||||
| Name of the proxy holder | ||||
| The number and % of voting rights held | ||||
| The date until which the voting rights will be held | ||||
| 11. Additional information xvi | ||||
| Place of completion | Hong Kong |
| Date of completion | 14 July 2021 |
中国香港、上海和美国新泽西州：2021年7月13日（星期二）：和黄医药（中国）有限公司（简称“和黄医药”或“HUTCHMED”）（纳斯达克/伦敦证交所：HCM；香港交易所：13）宣布沃瑞沙®（通用名：赛沃替尼/savolitinib）于2021 年 7 月 12日首次在中国进行商业销售。沃瑞沙®是一种强效、高选择性的口服小分子间质上皮转化因子（“MET”，一种受体酪氨酸激酶）抑制剂。
这距离沃瑞沙®在中国获批仅不到三星期时间。沃瑞沙®被批准用于治疗接受全身性治疗后疾病进展或无法接受化疗的MET外显子14跳跃突变的局部晚期或转移性非小细胞肺癌（“NSCLC”）患者。
根据和黄医药与阿斯利康（LSE/STO/Nasdaq: AZN）之间的许可和合作协议的条款，沃瑞沙®的首次商业销售将触发一笔2,500万美元的不可贷记、不可退还的里程碑付款。和黄医药负责沃瑞沙®在中国的临床开发、上市许可、生产和供应，而阿斯利康则负责其商业化。阿斯利康将根据沃瑞沙®在中国的全部销售额向和黄医药支付 30% 的固定特许权使用费。
中国肺癌患者人数占到全世界肺癌患者总数的三分之一以上，而MET 14外显子跳跃突变在NSCLC中的发生率约为2%-3%，这种突变是MET基因的一种靶向突变。[i],[ii],[iii] 这种突变在肺肉瘤样癌（PSC）中较为常见（13%-22%），肺肉瘤样癌是一种罕见的侵袭性NSCLC亚型，对传统化疗不敏感。[i],[iv]
沃瑞沙®（通用名：赛沃替尼/savolitinib，旧称沃利替尼）是一种强效、高选择性的口服MET酪氨酸激酶抑制剂，在晚期实体瘤中表现出临床活性。沃瑞沙®可阻断因突变（例如外显子14跳跃突变或其他点突变）或基因扩增而导致的MET受体酪氨酸激酶信号通路的异常激活。
沃瑞沙®在中国获批上市用于治疗接受全身性治疗后疾病进展或无法接受化疗的MET外显子14跳跃突变的NSCLC患者。目前，沃瑞沙®正作为单药疗法或与其他药物的联合疗法，临床开发用于治疗包括肺癌、肾癌和胃癌在内的多种肿瘤类型。
沃瑞沙®单药治疗MET 外显子14跳跃突变NSCLC的 II 期研究 （NCT02897479） – 沃瑞沙®于2021年6月获国家药品监督管理局（“国家药监局”）有条件批准用于治疗MET外显子14跳跃突变的NSCLC。此获批是基于一项中国II期试验，其研究结果已于2020年5月举行的美国临床肿瘤学会（“ASCO”）2020年网上年会中公布，并于2021年6月于《柳叶刀·呼吸医学》[v] 上发表了更新结果。中位随访时间为17.6个月时，所有使用沃瑞沙®治疗的受试者的客观缓解率（“ORR”）为42.9%（95%置信区间 [“CI”] 31.1-55.3)，中位无进展生存期 （“PFS”）为6.8个月（95% CI 4.2-9.6）。PFS在各亚组中具有临床意义，并且ORR结果与既往治疗或肿瘤组织情况无关，肿瘤组织亚型包括肺肉瘤样癌亚型患者（40.0%，95% CI 21.1-61.3）和其他NSCLC亚型患者（44.4%，95% CI 29.6-60.0）。整个研究人群的疾病控制率（“DCR”） 为 82.9%（95% CI 72.0-90.8）。沃瑞沙®的安全性和耐受性特征与之前的研究结果一致，没有发现新的安全性问题。
SAVANNAH II 期研究：沃瑞沙®联合泰瑞沙®用于治疗因 MET 扩增或过表达引起的泰瑞沙®治疗后进展的患者 （NCT03778229） – SAVANNAH 研究是一项针对接受过泰瑞沙®治疗的伴有MET扩增或过表达的表皮生长因子受体（EGFR）突变阳性的 NSCLC 患者的单臂、开放标签研究。泰瑞沙®是阿斯利康的一种表皮生长因子受体酪氨酸激酶抑制剂（“EGFR-TKI”）。
沃瑞沙®联合泰瑞沙®用于因 MET 扩增引起的EGFR-TKI治疗后进展患者的III期研究（计划中） – SACHI研究是一项在中国开展的随机、开放标签研究，针对接受EGFR-TKI治疗后进展的伴有MET扩增的EGFR突变阳性的NSCLC患者。
沃瑞沙®联合泰瑞沙®用于治疗初治的伴有MET过表达的EGFR突变阳性NSCLC患者的III期研究（计划中）– SANOVO研究是一项在中国开展的随机、盲性研究，针对MET阳性的未接受治疗的不可切除或转移性EGFR突变阳性的NSCLC患者。
SAVOIR研究：沃瑞沙®单药治疗MET驱动的乳头状肾细胞癌（PRCC）（NCT03091192） – 2020年5月， 在MET驱动的乳头状肾细胞癌患者中比较沃瑞沙®单药治疗与舒尼替尼单药治疗的这项全球研究中60名患者的研究数据于ASCO 2020网上年会发表，并同步发表于《美国医学会杂志•肿瘤学（JAMA Oncology）》[vi]。沃瑞沙®表现出令人鼓舞的疗效，ORR为27％，而舒尼替尼的ORR则为7％。至数据截止时，对沃瑞沙®有反应的患者均未出现疾病进展，总生存期（“OS ”）的风险比（HR）为0.51（95% CI：0.21–1.17; p=0.110），中位生存期尚未到达。
CALYPSO I/II 期研究：沃瑞沙®联合英飞凡® PD-L1 抑制剂用于治疗肾细胞癌（NCT02819596） – CALYPSO 研究是一项由研究者发起的开放标签的 I/II 期沃瑞沙®与英飞凡®联合疗法研究，英飞凡®是阿斯利康的一种PD-L1抗体。该研究旨在评估沃瑞沙®/英飞凡®联合治疗乳头状肾细胞癌患者和肾透明细胞癌患者的安全性和疗效。在 ASCO 2021年网上年会[vii]上，公布了一项该研究中对乳头状肾细胞癌患者队列 41 名患者的分析，其中显示 14 名 MET 驱动患者的确认反应率为 57%，中位缓解持续时间（“DoR”）为 9.4 个月，中位 PFS 为 10.5 个月及中位OS 为 27.4 个月。而在该研究中没有出现新的安全信号。
沃瑞沙®联合英飞凡® PD-L1 抑制剂用于治疗MET 驱动且不可切除的局部晚期或转移性 PRCC 的III期研究：（计划中） – 鉴于SAVOIR和 CALYPSO 的研究成果令人鼓舞，我们计划启动一项开放标签、随机对照的全球 III 期研究，评估沃瑞沙®与英飞凡®联合疗法对比舒尼替尼单药疗法或英飞凡®单药疗法，用于治疗 MET驱动的肿瘤不可切除的局部晚期或转移性乳头状肾细胞癌患者。
沃瑞沙®用于治疗MET 扩增的晚期或转移性胃癌或胃食管交界处腺癌患者的II期研究（NCT04923932） – 该II 期研究是一项开放标签、单臂、两队列的多中心临床试验，旨在评估沃瑞沙®治疗至少接受过一线标准治疗后疾病进展的局部晚期或转移性胃癌或胃食管交界处癌腺癌患者的疗效、安全性和药代动力学特征。研究的主要终点是独立审查委员会评估的ORR。其他终点包括 12 周和 6 个月的PFS 概率、中位 PFS、DoR、DCR、中位OS、安全性、药代动力学特征以及生活质量。
该临床试验是继沃瑞沙®多项在亚洲治疗MET驱动的胃癌的 II 期研究后启动的，其中包括VIKTORY研究。[viii] VIKTORY 是一项由研究者发起于韩国进行的针对胃癌的 II 期伞式研究，共有 715 名患者接受测序后纳入分子驱动的患者组，其中包括伴有MET 扩增的胃癌患者。 MET 扩增患者接受沃瑞沙®单药治疗，结果显示ORR 为 50%（10/20名，95% CI：28.0-71.9），并达到预先指定的6周PFS率，值得开展进一步研究。
通过研究者发起的临床试验，沃瑞沙®在包括非小细胞肺癌、胃癌和结直肠癌在内的其他多种MET驱动的肿瘤中的应用潜力也在继续探索中。
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。超过1,300人的专业团队已将自主发现的10个候选癌症药物推进到在全球开展临床研究，其中首三个创新肿瘤药物现已获批上市。欲了解更多详情，请访问：www.hutch-med.com或关注我们的领英专页。
本公告包含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。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对沃瑞沙®于中国商业化上市的预期、和黄医药生产及供应沃瑞沙®的能力以及合作伙伴阿斯利康快速和广泛推广沃瑞沙®的能力的预期，沃瑞沙®在中国非小细胞肺癌患者中的潜在市场，以及沃瑞沙®在中国、美国和其他地区针对此适应症和其他适应症的进一步临床研究计划。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：阿斯利康有效地商业化沃瑞沙®的能力、所有接受沃瑞沙®处方的患者可获得与临床试验中使用沃瑞沙®达到相同的收益，不会出现任何可能导致国家药监局将沃瑞沙®从市场上撤出的未知副作用，和黄医药与阿斯利康为沃瑞沙®进一步临床开发计划提供资金幷实现及完成的能力，此类事件发生的时间，以及新冠肺炎全球大流行对整体经济、监管及政治状况带来的影响等。此外，由于某些研究依赖于泰瑞沙®和英飞凡®作为与沃瑞沙®的联合疗法，此类风险和不确定性包括下列假设：此类疗法的安全性、有效性、供应和持续监管批准。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本公告发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、AIM及香港联合交易所提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本公告所含讯息的义务。
[i] Vuong HG, et al. Clinicopathological implications of MET exon 14 mutations in non-small cell lung cancer – A systematic review and meta-analysis. Lung Cancer 2018; 123: 76-82. doi: 10.1016/j.lungcan.2018.07.006.
[ii] World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed June 2021.
[iii] World Health Organization. International Agency for Research on Cancer. Globocan China Fact Sheet 2020. Available at http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed June 2021.
[iv] Liu X, et al. Next-generation sequencing of pulmonary sarcomatoid carcinoma reveals high frequency of actionable MET gene mutations. J Clin Oncol 2016; 34: 794-802. doi: 10.1200/JCO.2015.62.0674.
[v] Lu S, et al. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021 Jun 21:S2213-2600(21)00084-9. doi: 10.1016/S2213-2600(21)00084-9.
[vi] Choueiri TK, et al. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218.
[vii] Powles T, et al. A phase II study investigating the safety and efficacy of savolitinib and durvalumab in metastatic papillary renal cancer (CALYPSO). J Clin Oncol 37, 2019 (suppl 7S; abstr 545). doi: 10.1200/JCO.2019.37.7_suppl.545.
[viii] Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405. doi:10.1158/2159-8290.CD-19-0442.
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Hong Kong, Shanghai, & Florham Park, NJ — Monday, July 12, 2021: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM, HKEX:13) today announces the full exercise of the over-allotment option of the Global Offering. The Joint Global Coordinators, on behalf of the International Underwriters, on July 12, 2021, fully exercised the Over-allotment Option, in respect of an aggregate of 15,600,000 offer shares (the “Over-allotment Shares”), representing approximately 15% of the total number of offer shares initially available under the Global Offering before any exercise of the Over-allotment Option to (among other things) facilitate the return to Hutchison Healthcare Holdings Limited (an indirect wholly owned subsidiary of CK Hutchison Holdings Limited) the borrowed shares under the Stock Borrowing Agreement which were used to cover over-allocations in the International Offering. The Company has been notified that following the return of such shares, the shareholding of CK Hutchison Holdings Limited in the Company will be 332,502,740 shares, representing 38.48% of the total number of voting rights of the Company as enlarged by the issuance of the Over-allotment Shares.
The Over-allotment Shares will be allotted and issued by the Company at HK$40.10 per offer share (exclusive of brokerage of 1%, Securities and Futures Commission transaction levy of 0.0027% and Hong Kong Stock Exchange trading fee of 0.005%), being the offer price per offer share under the Global Offering.
Approval for the listing of and permission to deal in the Over-allotment Shares has already been granted by the Listing Committee of the Hong Kong Stock Exchange. Listing of and dealings in the Over-allotment Shares are expected to commence on the Main Board of the Hong Kong Stock Exchange at 9:00 a.m. on Thursday, July 15, 2021.
The Company’s total number of issued shares as of the date of this announcement and immediately after the completion of the full exercise of the Over-allotment Option (assuming there are no other changes to the total number of issued shares since the date of this announcement) is 848,515,660 shares and 864,115,660 shares, respectively.
Application will be made to the London Stock Exchange for the 15,600,000 Over-allotment Shares to be admitted to the AIM market operated by the London Stock Exchange (“Admission”). It is expected that Admission will become effective at 8:00 a.m. UK time on July 16, 2021.
Following the above, the issued share capital of HUTCHMED will consist of 864,115,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. This figure may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules. For illustrative purposes only, 864,115,660 shares would be equivalent to 864,115,660 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 172,823,132 ADSs (each equating to five ordinary shares) which are traded on Nasdaq.
The gross proceeds to the Company from the Over-allotment Option, before deducting underwriting fees and the offering expenses, are expected to be approximately HK$625 million. The Company intends to apply the additional net proceeds towards the same purposes as set out in the section headed “Use of Proceeds” in the prospectus.
The Company will make a further announcement after the end of the stabilization period in connection with the Global Offering pursuant to Section 9(2) of the Securities and Futures (Price Stabilizing) Rules (Chapter 571W of the Laws of Hong Kong).
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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. A dedicated organization of over 1,300 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including statements about the Global Offering and listing, the use of proceeds and the Company’s plans and objectives. Forward-looking statements involve risks and uncertainties. More information about the risks and uncertainties faced by HUTCHMED will be contained or incorporated by reference in the prospectus registered with The Stock Exchange of Hong Kong Limited (“SEHK”), prospectus and prospectus supplement that have been filed with the SEC and the international offering circular, in each case related to the Global Offering. 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 SEHK, U.S. Securities and Exchange Commission and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
In connection with the Global Offering, Morgan Stanley Asia Limited as stabilizing manager (the “Stabilizing Manager”) (or any person acting for it), on behalf of the underwriters, may effect transactions on the SEHK with a view to stabilizing or supporting the market price of the shares at a level higher than that which might otherwise prevail for a limited period after the listing date. However, there is no obligation on the Stabilizing Manager (or any person acting for it) to conduct any such stabilizing action, which, if taken, will be done at the absolute discretion of the Stabilizing Manager (or any person acting for it) and in what the Stabilizing Manager reasonably regards as the best interest of the Company and may be discontinued at any time. Any such stabilizing action is required to be brought to an end on the 30th day after the last day for lodging applications under the Hong Kong Public Offering.
Such stabilization action, if commenced, may be effected in all jurisdictions where it is permissible to do so, in each case in compliance with all applicable laws, rules and regulatory requirements, including the Securities and Futures (Price Stabilizing) Rules (Cap. 571W of the Laws of Hong Kong), as amended, made under the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong), Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018) and Regulation M under the U.S. Securities Exchange Act of 1934, as amended.
Potential investors should be aware that no stabilizing action can be taken on the SEHK to support the price of the shares for longer than the stabilization period which began on the listing date and is expected to expire on Friday, July 23, 2021, being the 30th day after the last day for lodging applications under the Hong Kong Public Offering. After this date, when no further stabilizing action may be taken, demand for the shares, and therefore the price of the shares, could fall.
中国香港、上海和美国新泽西州：2021年7月6日，星期二：和黄医药（中国）有限公司（简称“和黄医药”或“HUTCHMED”）（纳斯达克/伦敦证交所：HCM；香港交易所：13）宣布已启动一项HMPL-295的I期临床试验。HMPL-295是一种研究性和高选择性的口服细胞外信号调节激酶（“ERK”）抑制剂。ERK是RAS-MAPK[i]信号通路的下游组成部分。HMPL-295有潜力解决其上游通路（例如RAS、RAF及MEK）带来的原发性或获得性耐药问题。这是我们发现的靶向RAS-MAPK信号通路的多个候选药物中的首个。首名受试者已于2021年7月2日接受给药治疗。
该研究是一项多中心、开放标签的临床试验，旨在评估HMPL-295的安全性、耐受性、药代动力学和初步疗效特征，并确定晚期恶性实体瘤患者中的最大耐受剂量以及II期临床研究推荐剂量（RP2D）。在初始剂量递增阶段之后，额外 10 至 15 名患者将被纳入研究并接受 II期临床研究推荐剂量治疗，以进一步评估HMPL-295的安全性和初步疗效。此外，我们亦计划就HMPL-295的药代动力学生物标志物开展探索性研究。该项研究的其他详情可浏览clinicaltrials.gov，检索注册号NCT04908046查看。
和黄医药目前拥有HMPL-295在全球范围内的所有权利。
RAS-MAPK信号通路失调存在于多种人类疾病中，尤其是癌症，超过半数的癌症中均因突变或非遗传事件导致该信号通路过度激活。超过三成的癌症中会发生RAS基因激活突变。RAS和RAF突变在多种肿瘤中预示着较差的临床预后，介导对靶向治疗的耐药性，并降低对靶向治疗和免疫治疗等已获批的标准疗法的响应。在RAS-MAPK信号通路中，KRAS抑制剂正在临床评估中，且RAF/MEK靶向治疗出现获得性耐药。通过抑制ERK有潜力解决上述这些上游通路带来的原发性或获得性耐药问题。
和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）（前称：和黄中国医药科技）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。超过1,300人的专业团队已将自主发现的10个候选癌症药物推进到在全球开展临床研究，其中首三个创新肿瘤药物现已获批。欲了解更多详情，请访问：www.hutch-med.com或关注我们的领英专页。
本新闻稿包含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。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对HMPL-295治疗潜力的预期，HMPL-295的进一步临床研究计划，此类研究是否能达到其主要或次要终点的预期，以及对此类研究完成时间和结果发布的预期。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：入组率、满足研究入选和排除标准的受试者的时间和可用性、临床方案或监管要求变更、非预期不良事件或安全性问题、候选药物HMPL-295（包括作为联合治疗）达到研究的主要或次要终点的疗效、获得不同司法管辖区的监管批准、获得监管批准后获得上市许可、HMPL-295用于目标适应症的潜在市场和资金充足性以及新冠肺炎全球大流行对整体经济、监管及政治状况带来的影响等。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、AIM和香港联合交易所有限公司提交的文件。无论是否出现新信息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含信息的义务。
[i] MAPK: 丝裂原活化蛋白激酶
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| 美洲 | |
| Brad Miles, Solebury Trout |
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| Ben Atwell / Alex Shaw, FTI Consulting |
+44 20 3727 1030 / +44 7771 913 902（手机）/ +44 7779 545 055（手机） HUTCHMED@fticonsulting.com |
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| Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited |
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| NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i | ||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii: | HUTCHMED (China) Limited | |||||
| 1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
| Non-UK issuer | X | |||||
| 2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
| An acquisition or disposal of voting rights | X | |||||
| An acquisition or disposal of financial instruments | ||||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify) iii: | ||||||
| 3. Details of person subject to the notification obligation iv | ||||||
| Name | CA Fern Parent | |||||
| City and country of registered office (if applicable) | Mauritius | |||||
| 4. Full name of shareholder(s) (if different from 3.) v | ||||||
| Name | N/A | |||||
| City and country of registered office (if applicable) | N/A | |||||
| 5. Date on which the threshold was crossed or reached vi: | June 30, 2021 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | July 2, 2021 | |||||
| 7. Total positions of person(s) subject to the notification obligation | ||||||
| % of voting rights attached to shares (total of 8. A) | % of voting rights through financial instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights held in issuer (8.A + 8.B) vii | |||
| Resulting situation on the date on which threshold was crossed or reached | 4.81% | 40,847,500 | ||||
| Position of previous notification (if applicable) | N/A | N/A | N/A | |||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of shares ISIN code (if possible) |
Number of voting rights | % of voting rights | |||||||
| Direct (DTR5.1) | Indirect (DTR5.2.1) | Direct (DTR5.1) | Indirect (DTR5.2.1) | ||||||
| Ordinary Shares KYG4672N1198 | 40,847,500 | N/A | 4.81% | N/A | |||||
| SUBTOTAL 8. A | 40,847,500 | 4.81% | |||||||
| B 1: Financial Instruments according to DTR5.3.1R (1) (a) | |||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Number of voting rights that may be acquired if the instrument is exercised/converted. | % of voting rights | |||
| N/A | N/A | N/A | N/A | N/A | |||
| SUBTOTAL 8. B 1 | N/A | N/A | |||||
| B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) | |||||||
| Type of financial instrument | Expiration date x |
Exercise/ Conversion Period xi |
Physical or cash Settlement xii | Number of voting rights | % of voting rights | ||
| N/A | N/A | N/A | N/A | N/A | N/A | ||
| SUBTOTAL 8.B.2 | N/A | N/A | |||||
| 9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||
| Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii | ||||
| Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) xiv |
X | |||
| Name | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
| CAP V Mauritius Limited | 4.37% | N/A | 4.37% | |
| CAP V Coinvest Mauritius Limited | Less than 3% | N/A | Less than 3% | |
| Carlyle Asia PE Alternative Opportunities Mauritius Limited | Less than 3% | N/A | Less than 3% | |
| Carlyle Asia PE Alternative Opportunities II Mauritius Limited | Less than 3% | N/A | Less than 3% | |
| The Carlyle Group Inc. | 4.81% | N/A | 4.81% | |
| 10. In case of proxy voting, please identify: | ||||
| Name of the proxy holder | ||||
| The number and % of voting rights held | ||||
| The date until which the voting rights will be held | ||||
| 11. Additional information xvi | ||||
| CA Fern Parent is wholly owned by CAP V Mauritius Limited, CAP V Coinvest Mauritius Limited, Carlyle Asia PE Alternative Opportunities Mauritius Limited and Carlyle Asia PE Alternative Opportunities II Mauritius Limited, which are, by and through their control affiliates (including their respective general partners), ultimately controlled (directly or indirectly) by The Carlyle Group Inc., but The Carlyle Group Inc. has no beneficial interest in the underlying securities of HUTCHMED (China) Limited. | ||||
| Place of completion | Hong Kong |
| Date of completion | July 2, 2021 |
Hong Kong, Shanghai & Florham Park, NJ — Friday, July 2, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its interim results for the six months ended June 30, 2021 on Wednesday, July 28, 2021 at 12:00 noon British Summer Time (BST) (7:00 pm Hong Kong Time (HKT); 7:00 am Eastern Daylight Time (EDT)).
Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by HUTCHMED management.
The conference call and audio webcast will take place at 1:00 pm BST / 8:00 pm HKT / 8:00 am EDT on Wednesday, July 28, 2021 and will be webcast live via the company website at www.hutch-med.com/investors/event-information/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website. A replay will also be available on the website shortly after the event.
HUTCHMED (Nasdaq/AIM: HCM; SEHK: 13) (formerly Hutchison China MediTech) 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. A dedicated organization of over 1,300 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Investor Enquiries |
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| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
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| Americas | |
| Brad Miles, Solebury Trout | +1 (917) 570 7340 (Mobile) bmiles@troutgroup.com |
| Europe | |
| Ben Atwell / Alex Shaw, FTI Consulting |
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com |
| Asia | |
| Joseph Chi Lo, Brunswick | +852 9850 5033 (Mobile) |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
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| Freddy Crossley /Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
– 美国FDA拟定的目标审评日期为2022 年 4 月 30日 –
– 如果获批，索凡替尼将成为和黄医药首个在海外市场上市的创新抗肿瘤药物 –
中国香港、上海和美国新泽西州：2021年7月1 日（星期四）：和黄医药（中国）有限公司（简称“和黄医药”或“HUTCHMED”）（纳斯达克/伦敦证交所：HCM；香港交易所：13）今日宣布美国食品药品监督管理局（“FDA”）已受理索凡替尼用于治疗胰腺和胰腺外（非胰腺）神经内分泌瘤（NET）的新药上市申请。 FDA 就该新药上市申请拟定的处方药用户付费法案（PDUFA） 目标审评日期为 2022 年 4 月30日。
索凡替尼于2020年4月获授予快速通道资格，用于治疗胰腺和非胰腺神经内分泌瘤，并于2019年11月获授予“孤儿药”资格，用于治疗胰腺神经内分泌瘤。
和黄医药（国际）董事总经理兼首席医学官Marek Kania表示：“此次索凡替尼在美国的新药上市申请获受理，是和黄医药的一项重大成就。我们正不断扩展全球业务版图，致力将创新肿瘤药物带给全球癌症患者。 FDA这次受理索凡替尼的新药上市申请突显该申请的临床价值，以及为美国神经内分泌瘤患者提供更多治疗方案的重要性。”
该新药上市申请是基于索凡替尼两项成功的中国III期胰腺和非胰腺神经内分泌瘤临床研究（SANET-p[i] 及SANET-ep[ii] 研究结果早前均于《柳叶刀·肿瘤学》期刊上刊登）以及美国一项索凡替尼研究的数据。[iii] 根据欧洲药品管理局（“EMA”）的人用药品委员会（CHMP）的科学建议，相关研究数据还将用作即将向EMA提交上市许可申请（MAA）的依据。
和黄医药已在美国启动一项扩充疗程方案（Expanded Access Protocol），确保治疗方案有限的神经内分泌瘤患者能够获得该疗法治疗。该扩充疗程方案已获FDA监管批准，项目已开放中心启用（clinicaltrials.gov 注册号：NCT04814732）。
神经内分泌瘤起源于与神经系统相互作用的细胞或产生激素的腺体。神经内分泌瘤可起源于体内各个部位，最常见于消化道或肺部，可为良性或恶性肿瘤。神经内分泌瘤通常分为胰腺神经内分泌瘤（pNET）和非胰腺神经内分泌瘤（epNET）。
据Frost & Sullivan公司估计，2020年美国神经内分泌瘤新诊断病例为19,000例。值得关注的是，与其他肿瘤相比，神经内分泌瘤患者的生存期相对较长。因此，据估计2020年美国神经内分泌瘤患者约143,000名。[iv]
索凡替尼（surufatinib）是一种新型的口服酪氨酸激酶抑制剂，具有抗血管生成和免疫调节双重活性。索凡替尼可通过抑制血管内皮生长因子受体（VEGFR）和成纤维细胞生长因子受体（FGFR）以阻断肿瘤血管生成，并可抑制集落刺激因子1受体（CSF-1R），通过调节肿瘤相关巨噬细胞，促进机体对肿瘤细胞的免疫应答。索凡替尼独特的双重机制能产生协同抗肿瘤活性，使其为与其他免疫疗法的联合使用的理想选择。
和黄医药目前拥有索凡替尼在全球范围内的所有权利。
美国与欧洲神经内分泌瘤研究：在美国，索凡替尼于2020年4月被授予快速通道资格，用于治疗胰腺和非胰腺神经内分泌瘤，并于2019年11月被授予“孤儿药”资格，用于治疗胰腺神经内分泌瘤 。索凡替尼的美国新药上市申请已于2021年4月向FDA提交，并计划其后向欧洲药品管理局（EMA）提交欧洲上市许可申请。以上申请均是基于已完成的SANET-ep和SANET-p研究，以及索凡替尼在美国治疗非胰腺和胰腺神经内分泌瘤患者的现有数据（clinicaltrials.gov 注册号NCT02549937）。
中国非胰腺神经内分泌瘤研究：索凡替尼于2020年12月30日获国家药品监督管理总局（“国家药监局”）批准用于治疗非胰腺神经内分泌瘤。索凡替尼在中国市场以商品名苏泰达®销售。此获批是基于一项索凡替尼治疗晚期非胰腺神经内分泌瘤患者的中国III期临床试验SANET-ep的研究结果（clinicaltrials.gov注册号NCT02588170）。该研究在中期分析中成功达到无进展生存期（“PFS”）这一预设的主要终点。该研究的积极结果于2019年欧洲肿瘤内科学会(ESMO)年会上以口头报告的形式公布，并于2020年9月在《柳叶刀·肿瘤学》上发表。[v]索凡替尼治疗组患者的中位PFS显着延长为9.2个月，安慰剂组患者则为3.8个月（HR 0.334；95% CI : 0.223 – 0.499；p <0.0001）。索凡替尼具有可接受的安全性特征，最常见的3级或以上治疗相关不良事件是高血压（索凡替尼组患者:36%; 安慰剂组患者:13%）、蛋白尿（索凡替尼组患者:19%; 安慰剂组患者: 0%）和贫血（索凡替尼组患者:5%; 安慰剂组患者:3%）。
中国胰腺神经内分泌瘤研究：索凡替尼于2021年6月18日获国家药监局批准用于治疗胰腺神经内分泌瘤。此获批是基于一项索凡替尼治疗晚期胰腺神经内分泌瘤患者的中国III期临床试验SANET-p的研究结果。该研究在预设的中期分析中成功达到PFS这一预设主要疗效终点（clinicaltrials.gov 注册号NCT02589821），并以此为基础于2020年9月获国家药监局受理其第二项新药上市申请。该项研究的结果已于2020年ESMO在线年会上公布，并同步发表于《柳叶刀·肿瘤学》[vi] ，证明索凡替尼将患者疾病进展或死亡风险降低了51％，中位PFS为10.9个月，而安慰剂组患者则为3.7个月（HR 0.491； 95％CI：0.391-0.755； p = 0.0011）。 索凡替尼展示可控的安全性，并与先前研究中的观察结果一致。
中国胆道癌研究：和黄医药于2019年3月启动了一项IIb/III期临床试验，旨在对比绍凡替尼和卡培他滨治疗一线化疗后进展的晚期胆道癌患者。该研究的主要终点为总生存期（OS）（clinicaltrials.gov 注册号：NCT03873532）。
免疫联合疗法：和黄医药达成了数个合作协议，以评估索凡替尼与PD-1单克隆抗体联合疗法的安全性、耐受性和疗效，包括已于中国获批单药疗法的替雷利珠单抗（BGB-A317）、拓益®（特瑞普利单抗）和达伯舒®（信迪利单抗）。
和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）（前称：和黄中国医药科技）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。超过1,300人的专业团队已将自主发现的10个候选癌症药物推进到在全球开展临床研究，其中首三个创新肿瘤药物现已获批。欲了解更多详情，请访问：www.hutch-med.com或关注我们的领英专页。
本新闻稿包含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。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对向FDA提交索凡替尼用于治疗神经内分泌瘤的新药上市申请以及提交时间的预期，索凡替尼用于治疗神经内分泌瘤患者的治疗潜力的预期、索凡替尼针对此适应症及其他适应症的进一步临床研究计划，以及和黄医药的扩张国际运营计划的预期。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：支持索凡替尼获批用于在美国、中国及其他地区（如欧洲）治疗神经内分泌瘤的新药上市申请的数据充足性、获得监管部门快速审批的潜力，索凡替尼的安全性。和黄医药为索凡替尼进一步临床开发计划及商业化提供资金并实现及完成的能力，此类事件发生的时间，以及新冠肺炎全球大流行对整体经济、监管及政治状况带来的影响等。此外，由于部分研究赖于将卡培他滨、替雷利珠单抗、拓益®、达伯舒®与索凡替尼联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本公告发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、AIM以及香港联合交易所提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。
[i] Surufatinib in advanced neuroendocrine tumors – pancreatic.
[ii] Surufatinib in advanced neuroendocrine tumors – extra-pancreatic (non-pancreatic).
[iii] ASCO 2021 J Clin Oncol 39, 2021 (suppl 15; abstr 4114)
[iv] According to Frost & Sullivan, in 2020, there were 19,000 newly diagnosed cases of NETs in the U.S. and an estimated 143,000 patients living with NETs. The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment options.
[v] Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4.
[vi] Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9.
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