於開曼群島註冊成立之有限公司 2025 中期報告 2025 中期報告 公司資料 董事會 主席兼非執行董事 艾樂德BA, MA, MA, PhD 執行董事 蘇慰國BSc, PhD 首席執行官兼首席科學官 鄭澤鋒BEc, CA(ANZ) 首席財務官 非執行董事 施熙德BSE, MA, MA, EdM, Solicitor, FCG, HKFCG 楊凌BA, BSc, MBA 獨立非執行董事 莫樹錦BMSc, MD, FRCPC, FHKCP, FHKAM, FRCP(Edin), FASCO (1) 高級兼首席獨立非執行董事 言思雅MBBS, MBA 卡博樂BA, FCMA (2) 胡朝紅BSc, PhD 蓆紀倫BCom, CA(ANZ), FCPA (3) 黃德偉BCom, FCPA, CA(ANZ) 審核委員會 蓆紀倫 （主席） (3) 黃德偉 （主席） (4) 言思雅 卡博樂 (2) 胡朝紅 (5) 提名委員會 莫樹錦 （主席） 艾樂德 胡朝紅 蓆紀倫 (3) 附註： (1) 於 2025年 5月 13日獲委任為高級兼首席獨立非執行董事 薪酬委員會 卡博樂 （主席） (2) 言思雅 （主席） (6) 蓆紀倫 ...

Investment Rating - The report maintains a "Buy" rating for the company [3][6]. Core Insights - The company is experiencing steady growth in overseas markets while facing short-term pressure on domestic sales. The revenue for the first half of 2025 reached 278 million USD, with tumor business revenue at 144 million USD, reflecting a 29% decline year-on-year due to increased competition [9]. - New product approvals and the expansion of new indications are expected to drive a second growth curve. The sales of Furmonertinib reached 206 million USD in the first half of 2025, with overseas sales growing by 25% year-on-year [9]. - The new generation technology platform ATTC is set to initiate a wave of innovative drug development, with the first candidate expected to enter clinical development in the second half of the year [9]. Financial Forecasts and Investment Recommendations - The company has adjusted its revenue forecasts for 2025-2027 to 600.43 million USD, 705.84 million USD, and 796.91 million USD respectively, down from previous estimates [3]. - The target price is set at 38.32 HKD for 2026, based on a comparable company PS of 6.06 times [3]. - Key financial metrics include a projected net profit of 456.58 million USD in 2025, reflecting a significant year-on-year increase of 1110.15% [5].

8月21日，和黄医药(US ADR)(HCM)盘中上涨2.33%，截至22:23，报16.25美元/股，成交4.48万美元，总 市值28.34亿美元。 作者：行情君 财务数据显示，截至2025年06月30日，和黄医药(US ADR)收入总额2.78亿美元，同比减少9.16%；归母 净利润4.55亿美元，同比增长1663.32%。 资料显示，和黄医药(中国)有限公司(原名:和黄中国医药科技有限公司)是中国首家专注于全球市场的创 新型医药研发企业之一。在过去的20年里,公司建立了具有世界一流的发现和开发能力的全面整合的研 发创新平台。自成立以来,公司致力于将自主发现的抗肿瘤候选药物带向全球患者,首三个药物现已在中 国上市,其中首个药物亦于美国上市。公司还在中国市场建立了深入的具盈利的商业平台,在中国生产、 营销及经销自主研发的创新肿瘤药物,以及处方药和消费保健产品。和黄医药于纳斯达克全球精选市 场、香港交易所以及伦敦证交所的AIM市场上市(纳斯达克/伦敦证交所:HCM;香港交易所:13)。 本文源自：金融界 ...

Core Insights - Colorectal cancer (CRC) is the second most common malignant tumor in China, with 517,100 new cases in 2022, accounting for 10.7% of all cancer cases, and 240,000 deaths, representing 9.3% of all cancer deaths [1][12] - The global colorectal cancer drug market is projected to grow from $16.9 billion in 2019 to $25.4 billion by 2024, indicating significant market potential [1][13] - The Chinese colorectal cancer drug market is expected to reach 24.21 billion yuan by 2024, with an 18.5% year-on-year growth [1][16] - The market is characterized by a competitive landscape with multiple companies across different tiers, including leading firms like Junshi Biosciences and others [1][18] Industry Overview - Colorectal cancer drugs include traditional chemotherapy, targeted therapies, and immunotherapies, which are crucial for extending patient survival [2] - The burden of colorectal cancer in China is significant, with over 80% of patients diagnosed at advanced stages, leading to high treatment demands [1][16] - The market is expected to continue growing, with projections of 37.3 billion yuan by 2027 and nearly 60 billion yuan by 2031 [1][20] Competitive Landscape - The colorectal cancer drug industry features a tiered structure: - First tier: Junshi Biosciences - Second tier: Maibao Pharmaceutical, Hutchison China MediTech - Third tier: JAKS Pharmaceuticals, Jinfang Pharmaceutical [1][18] - Over 10 innovative therapies have been approved globally for colorectal cancer treatment, with more in clinical trials [1][18] Future Trends - The market is expected to see a shift towards precision medicine, with targeted and immunotherapies becoming mainstream [1][22] - Domestic innovative pharmaceutical companies are rapidly emerging, enhancing their product lines through independent research and global collaborations [1][23] - Upgraded patient needs will drive innovations in service models, focusing on unmet clinical demands and improving treatment experiences [1][25]

Core Viewpoint - Hutchison China MediTech Limited (和黄医药) announced the completion of patient enrollment for the SANOVO Phase III study, which evaluates the combination therapy of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for first-line treatment of specific non-small cell lung cancer patients with EGFR mutations and MET overexpression [1] Group 1 - The last patient was enrolled on August 18, 2025, marking the completion of the SANOVO study's patient recruitment [1] - Topline results from the SANOVO study are expected to be announced in the second half of 2026, with plans to submit the findings to relevant academic conferences [1] - If the results are favorable, the company plans to submit a new indication application to the National Medical Products Administration of China [1] Group 2 - ORPATHYS® is a potent and highly selective oral MET tyrosine kinase inhibitor developed in collaboration with AstraZeneca and commercialized by AstraZeneca [1] - TAGRISSO® is an irreversible third-generation EGFR TKI [1]

和黄医药(00013)发布公告，沃瑞沙(ORPATHYS，赛沃替尼/savolitinib)和泰瑞沙(TAGRISSO，奥希替 尼/osimertinib)的联合疗法用于一线治疗伴有表皮生长因子受体(EGFR)突变及MET过表达的特定非小细 胞肺癌患者的SANOVO中国III期研究已完成患者入组。该研究的最后一名患者已于2025年8月18日完成 入组。 SANOVO研究的顶线结果预计将于2026年下半年公布，并将随即提交研究结果于适当的学术会议发 表。若取得理想的结果，和黄医药将启动计划向中国国家药品监督管理局(国家药监局)递交新适应症上 市申请。 沃瑞沙是一种强效、高选择性的口服MET酪氨酸激酶抑制剂(TKI)，由阿斯利康与和黄医药共同开发， 并由阿斯利康商业化。泰瑞沙是一种不可逆的第三代EGFR TKI。 该项III期研究是一项在伴有EGFR激活突变及MET过表达的未经过治疗的局部晚期或转移性非小细胞肺 癌患者中开展的盲法、随机对照的临床试验。该研究将评估泰瑞沙与沃瑞沙联合疗法对比泰瑞沙单药 (当前此类患者的标准疗法)的疗效及安全性。研究的主要终点是研究者评估的无进展生存期(PFS)。其他 终点包括独立审 ...

Group 1 - The core viewpoint of the news is that Hutchison China MediTech has completed patient enrollment for the SANOVO Phase III study, which evaluates the combination therapy of savolitinib and osimertinib for specific non-small cell lung cancer patients with EGFR mutations and MET overexpression [1][2] - The SANOVO study is a randomized controlled trial assessing the efficacy and safety of the combination therapy compared to osimertinib monotherapy, which is the current standard treatment for these patients [1] - The primary endpoint of the study is progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety [1] Group 2 - Topline results from the SANOVO study are expected to be announced in the second half of 2026, followed by submission of the results to appropriate academic conferences [2] - If the results are favorable, Hutchison China MediTech plans to submit a new indication application to the National Medical Products Administration of China [2] - Savolitinib is described as a potent and highly selective oral MET tyrosine kinase inhibitor developed jointly by AstraZeneca and Hutchison China MediTech, while osimertinib is characterized as an irreversible third-generation EGFR TKI [2]

Group 1 - The SANOVO Phase III study has completed patient enrollment for the combination therapy of savolitinib (ORPATHYS) and osimertinib (TAGRISSO) in treating specific non-small cell lung cancer patients with EGFR mutations and MET overexpression [1] - The study is a randomized, controlled trial assessing the efficacy and safety of the combination therapy compared to osimertinib monotherapy, which is the current standard treatment for these patients [1] - The primary endpoint of the study is progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety [1] Group 2 - Topline results from the SANOVO study are expected to be announced in the second half of 2026, followed by submission of results to appropriate academic conferences [2] - If the results are favorable, the company plans to submit a new indication application to the National Medical Products Administration of China [2] - Savolitinib is a potent, highly selective oral MET tyrosine kinase inhibitor developed jointly by AstraZeneca and the company, while osimertinib is an irreversible third-generation EGFR TKI [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不 對因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 HUTCHMED (China) Limited 和黃醫藥（中國）有限公司 和黃醫藥完成沃瑞沙® 和泰瑞沙® 聯合療法用於一線治療特定肺癌患者的 SANOVO中國III期研究患者入組 和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或「HUTCHMED」）今日宣佈沃瑞沙®（ORPATHYS®，賽沃替尼/ savolitinib）和泰瑞沙®（TAGRISSO®，奧希替尼/ osimertinib）的聯合療法用於一線治療伴有表皮生長因子受體 （「EGFR」）突變及MET過表達的特定非小細胞肺癌患者的SANOVO中國III期研究已完成患者入組。該研究的最後一 名患者已於2025年8月18日完成入组。 該項III期研究是一項在伴有EGFR激活突變及MET過表達的未經過治療的局部晚期或轉移性非小細胞肺癌患者中開 展的盲法、隨機對照的臨床試驗。該研究將評估泰瑞沙® 與沃瑞沙® 聯合療法對比泰瑞沙® 單藥（當前此類患者的標準 ...

Core Insights - HUTCHMED has completed patient enrollment for the SANOVO Phase III study, evaluating the combination of ORPATHYS and TAGRISSO in treating non-small cell lung cancer (NSCLC) patients with specific genetic mutations [1][2][3] Group 1: Study Details - The SANOVO trial is a randomized, controlled study focusing on previously untreated patients with locally advanced or metastatic NSCLC, specifically those with activating EGFR mutations and MET overexpression [2] - The primary endpoint of the study is progression-free survival (PFS), with additional endpoints including overall survival (OS), objective response rate (ORR), and safety assessments [2] - Topline results from the SANOVO study are expected in the second half of 2026, which may lead to a supplementary New Drug Application submission to China's National Medical Products Administration (NMPA) if results are favorable [3] Group 2: Drug Information - ORPATHYS (savolitinib) is a selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, while TAGRISSO (osimertinib) is a third-generation EGFR TKI [4][10] - ORPATHYS is already approved in China for specific NSCLC indications, including treatment for patients with MET exon 14 skipping alterations and in combination with TAGRISSO for EGFRm-positive NSCLC [8] - TAGRISSO has been used to treat over one million patients globally and has shown improved outcomes in various stages of NSCLC [10][11] Group 3: Market Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases, and a significant portion of patients diagnosed with advanced disease [5] - Approximately 10-15% of NSCLC patients in the US and Europe, and up to 40-50% in Asia, have EGFR-mutated NSCLC, highlighting a substantial market for targeted therapies [5][6] - The combination of ORPATHYS and TAGRISSO aims to address resistance mechanisms in advanced NSCLC, representing a promising treatment strategy [15][14]