证券研究报告 医药生物 首次覆盖报告 2024年04月27日 和黄医药 (0013.HK) 买入 ——海外销售势头强劲，全球化布局创新管线 （首次覆盖） 投资要点： 证券分析师 ➢ 走向全球的小分子领军创新药企。和黄医药成立于2000年，专注于肿瘤和免疫系统疾病创新 刘闯 药的研发，已有13种创新药物正在临床试验阶段。三款药物（呋喹替尼、索凡替尼及赛沃替 S1350524030002 尼）均已在中国获得批准上市，呋喹替尼亦在美国获批。公司还与阿斯利康、武田制药等跨国 liuchuang@huayuanstock.com 巨头药企合作推进核心产品全球化进程。 市场表现： ➢ 呋喹替尼海外销售势头强劲，国内胃癌获批在即。1）国内：2018年9月国内获批3L CRC， 2023年国内销售1.075亿美元，市占率已近50%。针对二线胃癌适应症的NDA已于23年 和黄医药 恒生指数 23% 4月获CDE受理，有望24H2国内获批上市，带来新的销售增长动力，预计国内销售峰值5 11% 亿美元。2）海外：美国3L CRC于23年11月8日获批，23年销售1510万美元(~50天)， 0% -11% 商业化进度超预期，美国定 ...

公 医药 司 2024年04月 09日 报 和黄医药(0013.HK) 告 23年业绩符合预期，全球创新管线密集催化 推荐（维持） 事项： 2024 年 4 月 8 日，和黄医药公布 2023 年年报，公司总收入 8.38 亿美元 股价：26.85 港元 （yoy+97%），其中肿瘤/免疫业务综合收入5.29亿美元（yoy+223%），受与武 田确认合作收入 3.12 亿美元影响，公司归母净利润为 1.01 亿美元，首次实现 公 主要数据 盈利，业绩符合预期。 司 行业 医药 平安观点： 年 公司网址 www.hutch-med.com 大股东/持股 Hutchison Healthcare Holding  核心产品销售额保持较快增长，呋喹替尼美国上市后放量迅速。公司3款 报 Limited/38.39% 核心产品中，1）呋喹替尼凭借优异的临床效果，23年国内收入增长19% 点 实际控制人 长江和记实业 至 8320 万美元（按固定汇率计算为 26%），在国内三线结直肠癌市场保 总股本(百万股) 871 评 流通A股(百万股) 0 持领导地位。2）索凡替尼持续进行市场推广活动，23年收入增长36%至 流通 ...

Financial Performance - Total revenue in 2023 increased by 97% (102% at constant exchange rates) to $838 million, with oncology/immunology integrated revenue growing 223% (228% at constant exchange rates) to $528.6 million, nearing the upper end of financial guidance, including $280 million from the upfront payment received from Takeda[9] - The company's net profit attributable to Hutchmed reached $100.8 million in 2023[9] - Cash balance at the end of 2023 was $886.3 million, up from $631 million in 2022, ensuring steady progress towards becoming a self-sustaining company[9] - Revenue in 2023 reached $838 million, a 97% increase year-over-year, with a cash balance of $886 million[11] - Tumor/Immunotherapy business revenue surged 223% to $528.6 million, driven by a $280 million upfront payment from Takeda and strong product sales growth[15] - The company's 2024 financial guidance for oncology/immunology integrated revenue is $300 million to $400 million, targeting 30% to 50% growth in sales and royalties from marketed oncology products[9] - Total revenue for the year ended December 31, 2023, was $838 million, compared to $426.4 million in 2022[30] - Oncology/Immunology business revenue increased by 223% (228% at constant exchange rates) to $528.6 million in 2023, compared to $163.8 million in 2022[30] - FRUZAQLA™ revenue was $7.2 million, reflecting its launch in the U.S. in early November 2023[30] - The company's net cash flow from operating activities, excluding financing activities, was $206.7 million in 2023, compared to a negative $297.9 million in 2022[30] - Net income attributable to the company was $100.8 million in 2023, compared to a net loss of $360.8 million in 2022[32] - R&D expenses decreased by 22% to $302 million in 2023, compared to $386.9 million in 2022[31] - Total assets increased to $1.28 billion as of December 31, 2023, from $1.03 billion as of December 31, 2022[33] - Total liabilities increased to $536.4 million as of December 31, 2023, from $392.6 million as of December 31, 2022[33] - The company's equity attributable to shareholders increased to $730.5 million as of December 31, 2023, from $610.4 million as of December 31, 2022[33] - Total revenue for 2023 reached $837.999 million, a significant increase from $426.409 million in 2022[34] - Oncology/Immunology business revenue surged to $528.616 million in 2023, up from $163.844 million in 2022[34] - Net income attributable to Hutchison China MediTech for 2023 was $100.780 million, compared to a net loss of $360.835 million in 2022[34] - Adjusted group net cash flow excluding financing activities was $206.7 million in 2023, compared to $(297.9) million in 2022[105] - Total revenue increased by 97% to $838.0 million in 2023, with oncology/immunology business revenue growing 223% to $528.6 million[106] - FRUZAQLA™ contributed $7.2 million in revenue in 2023, marking its first full year of sales[106] - Net profit attributable to Hutchison China MediTech was $100.8 million in 2023, compared to a net loss of $360.8 million in 2022[108] - Cash and cash equivalents plus short-term investments totaled $886.3 million as of December 31, 2023[108] - The company had $79.3 million in bank loans and $68.1 million in unused bank financing as of December 31, 2023[108] - Net cash generated from operating activities was $219.3 million for the year ended December 31, 2023, compared to a net cash used of $268.6 million in 2022, a change of $487.9 million[111][112] - Net cash used in investing activities was $291.1 million for 2023, compared to net cash generated of $296.6 million in 2022, a change of $587.7 million[113][112] - Net cash generated from financing activities was $48.7 million for 2023, compared to net cash used of $82.8 million in 2022, a change of $131.5 million[114][112] Product Sales and Market Performance - Fruquintinib (FRUZAQLA™) was approved by the US FDA for third-line colorectal cancer, achieving $151 million in US market sales and included in the NCCN guidelines[8] - ELUNATE® (fruquintinib) sales in China grew 15% to $107.5 million, maintaining its leading market position[15] - FRUZAQLA™ (fruquintinib) achieved $15.1 million in sales in the U.S. following its November 2023 launch[15] - ORPATHYS® (savolitinib) sales increased 12% to $46.1 million, with a 30% growth in the last three quarters of 2023[16] - SULANDA® (surufatinib) sales rose 36% to $43.9 million, reflecting increased market penetration after two years in the national reimbursement drug list[17] - Fruquintinib (FRUZAQLA™) achieved $107.5 million in sales in China for 2023, a 15% increase from $93.5 million in 2022[37] - Fruquintinib (FRUZAQLA™) generated $15.1 million in sales in the US within two months of its launch in November 2023[38] - Surufatinib (Sulanda®) sales grew 36% to $43.9 million in 2023, up from $32.3 million in 2022[39] - Savolitinib (brand name: Orpathys®) achieved a 12% increase in market sales to $46.1 million in 2023, with a 104% growth in sales volume after its inclusion in the National Reimbursement Drug List (NRDL) in March 2023[40] - The price of Orpathys® was reduced by 38% after its inclusion in the NRDL, improving patient accessibility[40] - Tazverik® (tazemetostat) was approved in Macau, China, in March 2023 and is included in the 2023 CSCO follicular lymphoma treatment guidelines[40] - Surufatinib (brand name: Sulanda®) maintained its price in the NRDL for the new two-year term starting January 2024[40] R&D and Clinical Trials - Fruquintinib's new drug application for second-line gastric cancer treatment was accepted in China, with plans to submit applications for endometrial cancer and renal cell carcinoma in 2024[8] - Sovleplenib's new drug application for primary immune thrombocytopenia was accepted in China and included in the priority review[8] - Savolitinib's global Phase II clinical trial for non-small cell lung cancer completed patient enrollment, with a potential new drug application submission by AstraZeneca to the US FDA by the end of 2024[8] - The company submitted new drug applications for fruquintinib in the U.S., Europe, and Japan, and for savolitinib in China for first-line NSCLC patients[11][13] - HMPL-523 (sovleplenib) received priority review in China for immune thrombocytopenia, targeting an estimated 250,000 adult patients[12] - Fruquintinib (FRUZAQLA™) received FDA approval in November 2023 for the treatment of metastatic colorectal cancer patients who have undergone prior therapy[18] - Fruquintinib's global Phase III FRESCO-2 study results were published in The Lancet in June 2023, showing positive outcomes for metastatic colorectal cancer patients[21] - Savolitinib (Orpathys®) completed patient enrollment for the global Phase II SAVANNAH study in 2023, targeting MET-driven non-small cell lung cancer patients[18] - Fruquintinib's Phase II FRUTIGA study results presented at ASCO Plenary in February 2024 showed significant improvements in PFS, ORR, and DCR for gastric cancer patients[21] - Savolitinib is expected to submit a New Drug Application (NDA) in China for MET exon 14 skipping mutation NSCLC patients by early 2024[18] - Fruquintinib's EMA Marketing Authorization Application (MAA) for metastatic colorectal cancer is expected to complete review by mid-2024[21] - Savolitinib's Phase III SACHI study in China, targeting MET-amplified NSCLC patients, is expected to complete patient enrollment by the end of 2024[18] - Fruquintinib's Phase II FRUSICA-2 study for renal cell carcinoma completed patient enrollment in December 2023[21] - Savolitinib's Phase III SANOVO study in China, targeting EGFR-mutated and MET-overexpressing NSCLC patients, is expected to complete patient enrollment by the end of 2024[18] - Fruquintinib's NDA for endometrial cancer in China is expected to be submitted by early 2024[21] - SYMPHONY-1 global Ib/III study for relapsed or refractory follicular lymphoma showed an ORR of 90.9%, with 18-month PFS and DoR at 94.4% and 100% respectively in the recommended Phase III dose cohort[22] - HMPL-453, a novel FGFR 1/2/3 inhibitor, initiated Phase II registration stage for intrahepatic cholangiocarcinoma with FGFR 2 fusion after communication with NMPA[22] - Amdizalisib (HMPL-689) achieved ORR primary endpoint in China Phase II registration study for follicular lymphoma, but randomized study is now required for registration[22] - IMG-007 (anti-OX40 antibody) initiated global Phase IIa studies for atopic dermatitis and alopecia areata, showing good safety and tolerability[24] - IMG-004 (oral BTK inhibitor) completed Phase I study with favorable safety profile and long half-life, outperforming similar products[24] - The company has 13 oncology drug candidates in clinical trials, with four already approved in various regions[36] - The oncology/immunology R&D team consists of approximately 900 scientists and staff, with a dedicated commercial team of 930 employees[35] - Fruquintinib (FRUZAQLA™) was included in the 2023 NCCN Clinical Practice Guidelines for Colon and Rectal Cancer, enhancing its adoption among physicians and patients[38] - Fruquintinib (FRUZAQLA™) maintained its inclusion in China's National Reimbursement Drug List with unchanged pricing for the 2024-2025 period[37] - Savolitinib's clinical trials are ongoing globally, with over 2,500 patients enrolled in studies for non-small cell lung cancer, papillary renal cell carcinoma, and gastric cancer[40] - The SAVANNAH global Phase II study for Savolitinib in combination with Tagrisso® completed patient enrollment, with potential for accelerated approval in the U.S.[43] - The SAFFRON global Phase III study, evaluating Savolitinib in combination with Tagrisso®, has initiated in over 250 clinical centers across more than 20 countries[43] - Fruquintinib received U.S. FDA approval in November 2023, marking the company's success in global drug development and approval[40] - Two registration studies for MET-aberrant EGFR-mutated non-small cell lung cancer (NSCLC) in China are ongoing, with patient recruitment expected to be completed by 2024[44] - Savolitinib monotherapy for MET exon 14 skipping mutation NSCLC showed an ORR of 60.7% and DCR of 95.2% in a Phase IIIb study, with median PFS of 13.8 months[45] - In a Phase II study for MET-amplified gastric cancer, savolitinib demonstrated an ORR of 50% in the VIKTORY trial[47] - A Phase II study for MET-amplified advanced or metastatic gastric cancer showed an ORR of 45%, with a 50% ORR in patients with high MET gene copy numbers[49] - In the CALYPSO trial for MET-driven papillary renal cell carcinoma, the median PFS was 15.7 months and median OS was 27.4 months[50] - The SAMETA global Phase III study for MET-driven papillary renal cell carcinoma is ongoing, with patient recruitment across more than 140 centers in over 20 countries[50] - Fruquintinib, a selective oral VEGFR 1/2/3 kinase inhibitor, has been tested in approximately 5,700 patients across various clinical trials[52] - Fruquintinib received approval in the US in November 2023 and has ongoing registration-intent studies in China for combination therapies with chemotherapy and checkpoint inhibitors[51][52] - Fruquintinib (呋喹替尼) combined with sintilimab (达伯舒®) for endometrial cancer in China completed patient enrollment, with a new drug application expected to be submitted in early 2024[53] - Fruquintinib combined with sintilimab for renal cell carcinoma in China completed patient enrollment, with topline results expected by the end of 2024[53] - Fruquintinib monotherapy for colorectal cancer in the US showed positive results supporting the initiation of FRESCO-2, with data presented at ASCO GI 2022[53] - Fruquintinib combined with tislelizumab (替雷利珠单抗) for MSS colorectal cancer in the US completed patient enrollment and is under follow-up, with data to be submitted to academic conferences[53] - FRESCO-2 global Phase III study in 691 patients showed significant improvement in OS and PFS for fruquintinib compared to placebo, with a lower dose reduction rate (13.6% vs. 0.9%) and discontinuation rate (8.3% vs. 6.1%)[54] - FDA approved fruquintinib (FRUZAQLA™) on November 8, 2023, with a PDUFA target date of November 30, 2023, and EMA and PMDA submissions made in 2023[54] - Fruquintinib received approval in Hong Kong on January 26, 2024, under the new "1+" mechanism for treating metastatic colorectal cancer[54] - Fruquintinib combined with sintilimab for advanced renal cell carcinoma in China completed patient enrollment in December 2023, with topline results expected by the end of 2024[54] - Fruquintinib's Phase IV study in China involving 3,005 patients confirmed its safety profile consistent with previous clinical studies, with no new safety signals[54] - Fruquintinib combined with paclitaxel for gastric cancer showed updated data presented at ESMO 2023[55] - FRUTIGA study showed a median PFS of 5.6 months for the fruquintinib plus paclitaxel group compared to 2.7 months for the paclitaxel monotherapy group, with a stratified HR of 0.569 (p < 0.0001)[56] - Median OS was 9.6 months for the fruquintinib plus paclitaxel group versus 8.4 months for the paclitaxel monotherapy group, though the OS endpoint did not reach statistical significance[56] - 52.7% of patients in the fruquintinib plus paclitaxel group received subsequent anti-tumor therapy, compared to 72.2% in the paclitaxel monotherapy group[56] - In a prespecified sensitivity analysis, median OS was 6.9 months for the fruquintinib plus paclitaxel group versus 4.8 months for the paclitaxel monotherapy group in patients who did not receive subsequent anti-tumor therapy, with a stratified HR of 0.72 (p = 0.0422)[56] - Fruquintinib demonstrated statistically significant improvements in secondary endpoints including ORR, DCR, and DoR[56] - The new drug application for fruquintinib was accepted by the NMPA in April 2023[58] - In March 2023, Hutchison MediPharma entered into an exclusive licensing agreement with Takeda for the global development and commercialization of fruquintinib outside of mainland China, Hong Kong, and Macau, with potential payments up to $1.13 billion[62] - Hutchison MediPharma received a $400 million upfront payment upon completion of the agreement in April 2023 and a $35 million milestone payment in December 2023 following FDA approval[62] - Surufatinib, an oral tyrosine kinase inhibitor, has been tested in approximately 2,900 patients and is approved in China[63] - Surufatinib has shown encouraging data in combination with PD-1 antibodies, with several Phase II and III studies ongoing or completed[64] - Surufatinib received Fast Track designation from the US FDA in April 2020 for pancreatic and non-pancreatic neuroendocrine tumors and Orphan Drug designation for pancreatic neuroendocrine tumors in November 2019[65] - Surufatinib combined with PD-1 antibody therapy showed a median PFS of 5.4 months and a 12-month OS rate of 71.0% in advanced endometrial cancer patients[66] - Surufatinib combined with camrelizumab and chemotherapy for pancreatic cancer showed a median PFS of 9.2 months and OS of 15.6 months, compared to 6.3 months and 8.6 months for chemotherapy alone[67] - HMPL-523, a selective oral Syk inhibitor, has been tested in approximately 600 patients for hematologic malignancies and immune diseases[68] - HMPL-523 completed patient enrollment for a Phase III study in China for primary immune thrombocytopenia in December 2022 and was designated as a Breakthrough Therapy[69] - HMPL-523's Phase III study (ESLIM-01) in China for primary immune thrombocytopenia achieved all endpoints in August 2023, with NDA submitted and accepted for priority review in January 2024[70] - HMPL-523's Phase II/III study for warm autoimmune hemolytic anemia in China completed Phase II patient recruitment

公 医药 司 2024年04月 07日 报 和黄医药(0013.HK) 告 大适应症获批预期持续催化，呋喹替尼进军胃癌蓝海 推荐（维持） 平安观点：  呋喹替尼在全球三线结直肠癌市场保持领导地位，美国上市后放量迅速。 股价：26.80 港元 呋喹替尼是一款具有优异靶点选择性的 VEGFR 抑制剂，于 2018 年在中 国获批上市，2023 年销售额 1.08 亿美元，同比增长 15%，按恒定汇率 公 主要数据 （CER）计算同比增长 22%，保持较高增速。凭借优异的临床疗效和安 司 全性特征，呋喹替尼在三线结直肠癌市场保持领导地位，并逐步拉大与瑞 行业 医药 深 公司网址 www.hutch-med.com 戈非尼市占率差距。武田制药拥有呋喹替尼除中国以外的全球销售权力， 大股东/持股 Hutchison Healthcare Holding 呋喹替尼在美国于2023年11月上市，是美国十多年来首个获批用于治疗 度 Limited/38.39% 转移性结直肠癌的创新靶向疗法，上市仅两个月，美国市场销售额已高达 报 实际控制人 长江和记实业 1510万美元，放量迅速。此外，呋喹替尼已于欧洲和日本提交NDA，有 ...

[Table_Main] 证券研究报告 | 公司点评 和黄医药(00013.HK) 2024年03月04日 买入（维持） 和黄医药(0013.HK)：业绩符合预 所属行业：医疗保健业/药品及生物科技 期，销售有望稳定增长 当前价格(港币)：24.35元 证券分析师 投资要点 陈铁林 资格编号：S0120521080001 年报业绩。2023年，公司总收入增长 97% (按固定汇率计算为 102%)至 8.38亿  邮箱：chentl＠tebon.com.cn 美元，肿瘤/免疫业务综合收入增长223% (按固定汇率计算为228%) 至5.286亿 美元，接近财务指引上限，包括确认自武田收取的首付款中的2.8亿美元。和黄医 市场表现 药应占净收益达到 1.008 亿美元。截至 2023 年年末现金余额为 8.863 亿美元。 2024年肿瘤/免疫业务综合收入财务指引为3.0亿至4.0亿美元，得益于已上市的 和黄医药 恒生指数 肿瘤产品销售额及特许权使用费30% 至 50%的目标增长。 23% 11% 0% 核心产品市占率不断提升，销售收入稳定增长。  -11% -23%  肿瘤/免疫业务综合收入增长223% ...

证券研究报告·海外公司点评·药品及生物科技(HS) 和黄医药（00013.HK） 2023 年年报点评：和黄医药业绩符合预期， 2024 年 03月 04日 海外逻辑逐步兑现 证券分析师 朱国广 买入（维持） 执业证书：S0600520070004 zhugg@dwzq.com.cn [Table_EPS] 盈利预测与估值 2022A 2023A 2024E 2025E 2026E 股价走势 营业总收入（百万美金） 426.41 838.00 665.00 808.00 969.00 同比 19.73% 96.52% -20.64% 21.50% 19.93% 和黄医药 恒生指数 归母净利润（百万美金） -360.84 100.78 -41.78 48.99 178.77 15% 10% 5% 同比 -85.38% 127.93% -141.46% 217.24% 264.94% 0% -5% EPS-最新摊薄（美金/股） -0.41 0.12 -0.05 0.06 0.21 -- 11 50 %% -20% P/E（现价&最新摊薄） - 208.35 - 428.63 117.45 --- 332 505 ...

股 票 研 究 [Table_industryInfo] 医药 [ Table_Main[和I Tnaf 黄bol]e 医_Ti药tle]（ 0013） [评Tab级le_：Inv est] 增持 当前价格（港元）： 23.70 呋喹替尼放量可期，赛沃替尼即将出海 2024.03.01 海 [ 交Ta易bl数e_M据a rket] 外 丁丹(分析师) 甘坛焕(分析师) 52周内股价区间（港元） 17.68-32.45 当前股本（百万股） 871 公 0755-23976735 021-38675855 当前市值（百万港元） 20,649 司 dingdan@gtjas.com gantanhuan028803@gtjas.com 证书编号 S0880514030001 S0880523080007 （ [ Table_PicQuote] 中 本报告导读： 52周内股价走势图 国 业绩符合预期，肿瘤/自免综合收入接近2023年指引上限，呋喹替尼出海不足2月实 和黄医药 恒生指数 香 现0.15亿美元销售额，国内2L胃癌有望24H2上市，放量可期，维持“增持评级”。 26% 摘要： 港 14% [T able维 ...

[Table_StockInfo] 买入 2024年 03月 01日 （维持） 证券研究报告•2023年年报点评 当前价： 24.10港元 和黄医药（0013.HK） 医疗保健 目标价： 34.30港元 业绩符合预期，期待赛沃替尼美国 NDA 投资要点 西南证券研究发展中心 [T ab事le件_S：u2m月ma2r8y]日 ，和黄医药公布 2023年全年业绩，2023年总收入达 8.4亿美 [分Ta析bl师e_：Au杜th向or阳] 元（+97%），肿瘤/免疫业务综合收入5.3亿美元（+223%）。呋喹替尼市场销售 执业证号：S1250520030002 额达 1.07亿美元（+22%），索凡替尼市场销售额 4390万美元（+43%），赛沃 电话：021-68416017 替尼市场销售额 4610 万美元（+19%）。业绩符合预期，肿瘤/免疫业务综合收 邮箱：duxy@swsc.com.cn 入的 2024年全年指引为 3至4亿美元，主要得益于已上市的肿瘤产品 30%至 分析师：汤泰萌 50%的目标收入增长。 执业证号：S1250522120001 电话：021-68416017  呋喹替尼有望于 202 ...

研究报告Research Report 4 Mar 2024 和黄医药 Hutchmed (China) Limited (13 HK) 呋喹替尼美国上市顺利，赛沃替尼最快于 2024 年底递交 NDA Successful Launch of FRUZAQLA in the US, Potential Savolitinib NDA Submission in late-2024 [观Ta点bl聚e_焦yem Inevie1s] tment Focus [Tab维le_持Inf优o] 于大市Maintain OUTPERFORM (Please see APPENDIX 1 for English summary) 事件 评级 优于大市OUTPERFORM 现价 HK$24.10 和黄医药公布 2023 全年业绩：2023 年收入 8.4 亿美元，同比 目标价 HK$43.27 +97%，其中肿瘤/免疫业务综合收入 5.3 亿美元，同比+223%，包 HTI ESG 1.8-1.5-3.5 括产品销售的综合收入 1.6 亿美元（+32%）、确认的首付款及里 E-S-G: 0-5, (Please refer ...

M N 1 Mar 2024 CMB International Global Markets | Equity Research | Company Update Hutchmed (13 HK) A fruitful 2024 on the way Including US$312mn upfront and milestone payments from Takeda, HCM’s consolidated Target Price HK$34.31 revenues from oncology/immunology reached US$529mn in FY23 (vs US$164mn in (Previous TP HK$36.67) FY22), close to the upper limit of its US$450-550mn guidance. The in-market product Up/Downside 41.8% sales increased 28% YoY (35% at CER) to US$214mn in FY23, among which sales of Cu ...