浦银国际研究 公司研究 | 医药行业 和黄医药（HCM.US/13.HK）：呋喹替尼销售 阳景 超预期，海外首发成绩亮眼 浦 首席医药分析师 银 Jing_yang@spdbi.com 国 和黄医药2023全年业绩超预期，主要由呋喹替尼销售好于预期驱动， (852) 2808 6434 际 反映了公司强大的商业化能力，我们认为 2024 年肿瘤收入指引（3- 4 亿美元）可实现性高。此外，公司国际化进程再进一步，赛沃替尼 胡泽宇 CFA 年底将于美国申报二线非小细胞肺癌，有望成为公司第二个海外获 医药分析师 批药物。随着现有药物加速商业化的进程，我们相信公司正在稳步实 ryan_hu@spdbi.com 现盈利的轨道上。维持“买入”评级，目标价为 25美元/39 港元。 (852) 2808 6446 2023 全年业绩超预期，2024 年肿瘤收入指引 3-4 亿美元：2023 年  公司全年总收入达到 8.38 亿美元（+97% YoY），其中肿瘤业务实现收 2024年2月29日 公 入 5.29 亿美元（+223% YoY，包括 2.8 亿美元武田首付款），强于我 司 们的预期，亦高过公司之前给的中位数 ...

公司研 究 证 券研究 报 告 医药 2024年3月1日 和 黄医药（00013.HK）2023年报点评 推 荐 （维持） 目标价：35.38港元 销售稳健增长，呋喹替尼海外迅速放量 当前价：24.10港元 事项： 华创证券研究所  2024年2月28日，和黄医药公布2023年全年业绩。总收入8.38亿美元（按 证券分析师：刘浩 固定汇率计算+102%），其中肿瘤/免疫业务综合收入5.286亿美元（+228%）。 截至2023年底现金及现金等价物和短期投资合计8.863亿美元。 邮箱：liuhao@hcyjs.com 执业编号：S0360520120002 评论： 证券分析师：张艺君  已上市产品稳定增长，商业化实力强劲。公司已上市产品销售稳定增长，2023 年全年销售额2.136亿美元（+35%）。呋喹替尼销售额1.075亿美元（+22%）， 邮箱：zhangyijun@hcyjs.com 在三线结直肠癌市场占有率稳步提升，2023 年二季度已达到 47%，展现强劲 执业编 号：S0360524020002 竞争力。赛沃替尼销售额4610万美元（+19%），于2023年初纳入医保，进一 步提升了患者的可 ...

Financial Performance - Total revenue for 2023 reached $838 million, representing a 97% increase (102% at constant exchange rates) compared to the previous year[2]. - Net income for the year was $101 million, with a significant contribution from the oncology/immunology business, which saw a 223% revenue increase to $528.6 million[6]. - The company has a strong cash position, ending 2023 with $886.3 million, up from $631 million in 2022[6]. - Total revenue for 2023 increased by 97% to $838 million, driven by collaboration with Takeda and strong commercialization in China[9]. - The oncology/immunology business revenue grew by 223% to $528.6 million, benefiting from a $280 million collaboration revenue from Takeda and strong product sales growth[10]. - The company reported a net cash flow of $206.7 million for 2023, a significant improvement from a negative $297.9 million in 2022[33]. - The company’s total assets grew to $1.28 billion in 2023, up from $1.03 billion in 2022[36]. - The net income attributable to Hutchmed per ordinary share was $0.12 in 2023, compared to a loss of $0.43 per share in 2022[38]. - The company’s cash, cash equivalents, and short-term investments increased by $255 million to $886.34 million as of December 31, 2023[39]. - The company’s net expenses for 2023 were $737.2 million, a decrease from $787.2 million in 2022[33]. Product Development and Approvals - The FDA approved the drug FRUZAQLA™ (fruquintinib) for third-line colorectal cancer, leading to a market launch by Takeda with initial sales of $915.1 million[5]. - The new drug application for sovleplenib for primary immune thrombocytopenia has been accepted in China and is under priority review[6]. - The company plans to submit a new drug application for fruquintinib in second-line gastric cancer in China, with recruitment for clinical trials completed[6]. - The successful ESLIM-01 study for Syk inhibitor in immune thrombocytopenia has led to a new drug application accepted for priority review in January 2024[8]. - The company aims to submit a new drug application for savolitinib in Q1 2024, expanding its label indications in China[8]. - The new drug application for the combination therapy of fruquintinib and paclitaxel for second-line treatment of gastric cancer was accepted in April 2023[16]. - Fruquintinib received FDA approval in November 2023 for the treatment of previously treated metastatic colorectal cancer patients[16]. - The EMA submission for the treatment of previously treated metastatic colorectal cancer is expected to be completed by mid-2024[18]. - The company plans to submit a new drug application for the treatment of primary immune thrombocytopenia in mid-2024[21]. - The company has initiated a Phase II study for gastric cancer patients with MET amplification in China[17]. Strategic Collaborations and Partnerships - The company is focused on advancing its product pipeline and strategic partnerships, evidenced by a $435 million upfront and milestone payments from Takeda[5]. - The strategic collaboration with Takeda is noted as one of the largest small molecule licensing deals in China's biopharmaceutical history, enhancing the company's cash flow[7]. - Takeda is responsible for the global development, production, and commercialization of furmonertinib outside of mainland China, Hong Kong, and Macau, with potential payments to the company of up to $1.13 billion[26]. - The company received a $400 million upfront payment from Takeda in April 2023, along with potential milestone payments totaling up to $730 million[26]. Research and Development - The company has 13 oncology candidates currently in clinical trials, supported by a team of approximately 900 scientists and staff[51]. - The company continues to maintain the same pricing for 爱优特® in the national medical insurance drug list for the new two-year agreement starting January 2024[53]. - The company has initiated three Phase III studies for Savolitinib, including the SACHI and SANOVO studies launched in 2021 and the SAFFRON global pivotal study started in 2022[65]. - The company has successfully obtained FDA approval for Furmonertinib in November 2023, marking a significant milestone in its global market strategy[63]. - The company is exploring the use of furmonertinib in various solid tumors, with approximately 90 ongoing clinical trials in China[86]. Market Performance - Market sales of ELUNATE® (furmonertinib) in China increased by 15% to $107.5 million, maintaining a leading market share[10]. - FRUZAQLA™ (furmonertinib) generated $15.1 million in market sales following its U.S. launch in November 2023[10]. - Sales of SULANDA® (surufatinib) rose by 36% to $43.9 million, reflecting increased market share two years after inclusion in the national medical insurance catalog[12]. - ORPATHYS® (savolitinib) sales grew by 12% to $46.1 million, with a 30% increase in sales in the last three quarters of 2023 compared to the same period in 2022[12]. - The market sales of innovative oncology products grew by 28% to $213.6 million in 2023, compared to $167.1 million in 2022, with a fixed exchange rate growth of 35%[52]. Operational Highlights - The company aims to establish a self-sustaining business model while navigating global economic uncertainties[7]. - The company has completed patient recruitment for a Phase II study of furmonertinib in July 2023, with plans to submit a new drug application to the National Medical Products Administration by mid-2024 if results are positive[84]. - The company has received fast track designation from the FDA for savolitinib for treating pancreatic and non-pancreatic neuroendocrine tumors, although a new drug application was not approved[89]. - The company has conducted clinical trials of savolitinib in approximately 2,900 patients, with promising data from several studies presented at ASCO and ESMO conferences in 2023[88]. Sustainability and Governance - The independent 2023 sustainability report will be published alongside the 2023 annual report in April 2024, detailing the company's sustainability measures and performance[165]. - The company has complied with all applicable provisions of the Corporate Governance Code as of December 31, 2023[168]. - The company is committed to transparency and has complied with the ethical responsibilities outlined in the professional code of conduct[183].

浦银国际研究 公司研究 | 医药行业 和黄医药（HCM.US/13.HK）：小分子靶向药 阳景 先行者，Syk 抑制剂有望年内获批 浦 首席医药分析师 银 Jing_yang@spdbi.com 国 首席医药分析师阳景恢复覆盖和黄医药（HCM.US/13.HK），维持“买 (852) 2808 6434 际 入”评级，目标价为 25美元/39 港元。公司在医药行业深耕 20余年， 目前已建立起一体化的新药研发和商业化平台。我们认为，随着呋喹 胡泽宇 CFA 替尼海外放量及新的创新药如索乐匹尼布的获批，公司发展有望再 医药分析师 上新台阶。 ryan_hu@spdbi.com 索乐匹尼布最快有望于年内获批：2024 年 1 月 11 日，公司宣布中 (852) 2808 6446  国药监局已受理索乐匹尼布（Syk抑制剂）用于治疗二线免疫性血小 板减少症（ITP）的上市申请并予以优先审评，我们预计索乐匹尼布 2024年2月23日 公 最快有望于 2024 年获批。我们预计该项适应症可贡献约人民币6 亿 司 元销售峰值。根据我们与公司的沟通，和黄医药将于年内逐步建设 和黄医药 研 ...

智通财经APP讯，和黄医药(00013)发布公告，创响生物(Inmagene Biopharmaceuticals)根据2021年1月11日所宣布的战略合作条款，已行使与和黄医药发现的两款候选药物IMG-007和IMG-004授权许可相关的选择权(以下简称“选择权”)。行使选择权并于和黄医药收到创响生物约7.5%的普通股股份(完全稀释)后，创响生物将取得在全球进一步开发、生产和商业化上述两款候选药物的独家权益。 作为合作协议的一部分，和黄医药向创响生物授予多种候选药物仅限于用于治疗免疫性疾病的独家选择权。自选择权协议实施以来，创响生物注入资金并领导将其中两款候选药物IMG-004和IMG-007推向临床开发。对于IMG004和IMG-007中的每款候选药物，和黄医药有权收取最高可达9250万美元的开发里程碑付款和最高可达1.35亿美元的潜在的商业销售里程碑付款，以及商业化后分成。 2023年，创响生物启动了两项IMG-007(一种研究性的OX40拮抗性单克隆抗体)用于治疗中度至重度特应性皮炎和斑秃的全球IIa期临床试验。它还完成了IMG-004的I期单次剂量递增(SAD)研究，IMG-004是一种可逆、非共 ...

Financial Performance - HUTCHMED reported a strong performance in the first half of 2023, with a focus on prioritizing pipeline products and seeking partnerships for global reach[5]. - Total revenue for the first half of 2023 increased by 164% to $532.9 million, compared to $202 million in the same period of 2022[8]. - The company confirmed $258.7 million of the $400 million upfront payment from Takeda, with total recognized revenue of $258.7 million as of June 2023[8]. - The company anticipates total recognized revenue from Takeda to reach approximately $280 million by the end of the year[8]. - The net income attributable to the company for the six months ended June 30, 2023, was $168.6 million, compared to a net loss of $162.9 million for the same period in 2022[21]. - The company reported a significant increase in revenue from its oncology/immunology business, reaching $359.2 million, up 294% from $91.1 million in the previous year[73]. - The net cash flow from operating activities, excluding financing activities, was $219.3 million for the first half of 2023, compared to a negative $110.9 million for the same period in 2022[20]. - The company reported a total comprehensive income of $163,223 thousand, compared to a comprehensive loss of $167,047 thousand in 2022[139]. Product Development and Pipeline - The company completed a licensing agreement with Takeda Pharmaceuticals for furmonertinib, with an FDA priority review PDUFA date set for November 30, 2023, indicating significant potential for improvement over existing therapies[5]. - HUTCHMED has over 15 registration/registration intention studies ongoing for seven candidate drugs, showcasing its robust R&D capabilities[6]. - The company is preparing for the successful launch of more products and lifecycle extensions, with key data announcements expected later this year for sugemalimab and andecaliximab[6]. - In July 2023, the combination therapy of Fuzulonib and Sintilimab for advanced endometrial cancer completed patient recruitment in a Phase II study in China, supporting potential new drug registration[10]. - The company plans to complete patient recruitment for the Phase II/III study of the combination therapy with Sintilimab for renal clear cell carcinoma by the end of 2023[11]. - The company is conducting a Phase II study of the combination therapy with Tazemetostat in China, which has been initiated in February 2023[11]. - The company has initiated a Phase II/III study for furmonertinib combined with sintilimab for second-line treatment of locally advanced or metastatic renal cell carcinoma, aiming to recruit about 260 patients[38]. Sales and Market Performance - The company achieved strong sales growth for its self-developed oncology products in China, with all three marketed products now included in the National Reimbursement Drug List[6]. - Market sales of ELUNATE® (fruquintinib) increased by 12% to $56.3 million, maintaining a leading market share[8]. - Market sales of SULANDA® (surufatinib) surged by 66% to $22.6 million, reflecting the accumulation of treated patients over the past 18 months[8]. - Total product sales for the first half of 2023 increased by 16% to $101.3 million, compared to $87.4 million in the same period of 2022[9]. - The comprehensive revenue from other businesses increased by 57% to $173.7 million, compared to $110.9 million in the first half of 2022[16]. Research and Development - Research and development expenses decreased by 20% to $144.6 million for the first half of 2023, down from $181.7 million in the same period in 2022[21]. - The company is committed to sustainable development and has made satisfactory progress on 11 short- to long-term sustainability goals and indicators[19]. - The company plans to enhance climate risk-related actions and disclosures in the second half of 2023, following the recommendations of the TCFD[19]. - The company has six investigational candidates for hematological malignancies currently in clinical studies, including HMPL-523, HMPL-689, and HMPL-760[44]. Financial Position and Cash Flow - HUTCHMED has $856 million in cash resources as of the beginning of the second half of 2023, including $400 million received from Takeda Pharmaceuticals[6]. - The total cash and cash equivalents, along with short-term investments, amounted to $856.2 million as of June 30, 2023, up from $630.996 million on December 31, 2022[22]. - The company’s cash flow from financing activities was positive at $5.8 million for the first half of 2023, contrasting with a cash outflow of $74.6 million in the same period of 2022[75]. - The company has sufficient cash, cash equivalents, short-term investments, and unused bank loan facilities to meet its funding needs for at least the next twelve months[143]. Corporate Governance and Shareholding - The major shareholder, CK Hutchison Global Investments Limited, holds 332,574,650 shares, representing approximately 38.40% of the total shares[108]. - The company’s stock ownership structure indicates significant control by major shareholders, particularly CK Hutchison and its affiliates[108]. - The company is committed to maintaining high corporate governance standards to enhance shareholder value and protect stakeholder interests[133]. Clinical Trials and Regulatory Approvals - The company has initiated three Phase III studies for Savolitinib® in patients with MET amplification or overexpression after disease progression on Tarceva®[29]. - The SAVANNAH global Phase II study is expected to complete patient recruitment in the second half of 2023[29]. - The company has received orphan drug designation for furmonertinib for treating pancreatic neuroendocrine tumors, with positive results from two Phase III studies in China[40]. - The company plans to submit a marketing application to the National Medical Products Administration in 2024 for the combination therapy for advanced endometrial cancer, following the completion of patient recruitment in July 2023[37].

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 （於開曼群島註冊成立的有限公司） （股份代號：13） 和黃醫藥公佈 2023 年中期業績及最新業務進展 戰略方向得以有力執行，在規劃增長道路的同時實現近期價值，以武田製藥的全球合作為例證 收入增長164%（按固定匯率計算為173%）至5.33億美元，和黃醫藥的淨收益為1.69億美元 （其中包括武田製藥支付的首付款中已確認的2.59 億美元） 公司將於今天中國香港時間晚上8時正/ 英國夏令時間下午1時正/ 美國東部夏令時間上午8時正 舉行中期業績電話會議及網絡直播 公司將於今年第四季度舉辦資本市場日（Capital Markets Day） 和黃醫藥（中國）有限公司（簡稱「和黃醫藥」、「本公司」或「我們」）是一家處於商業化階段的創新型生物醫 藥公司，今日公佈截至 2023 年 6 月 30 日止六個月的未經審核財務業績以及提供關鍵臨 ...

和黄醫藥 HUTCHMED 2022年 年報 HUTCHMED (CHINA) LIMITED 和黃醫藥(中國)有限公司 ( 於 開曼群島註冊之有限公司) HKEX: 13 | Nasdaq: HCM | AIM: HCM 公司資料 | --- | --- | |----------------------------------------------------------|-------| | | | | 董事會 | | | 執行董事 | | | 杜志強BSc, ACGI, MBA 主席 | | | 蘇慰國BSc, PhD | | | 首席執行官兼首席科學官 | | | 鄭澤鋒BEc, CA | | | 首席財務官 | | | 非執行董事 | | | 艾樂德BA, MA, MA, PhD 施熙德BSE, MA, MA, EdM, Solicitor, | | | FCG(CS, CGP), HKFCG(CS, CGP)(PE) | | | 孫樂非BSc, MA | | | 獨立非執行董事 | | | 卡博樂BA, FCMA | | | 高級獨立董事 | | | 費凱寧MD, BSc | | | 蓆紀倫B ...