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

Investment Rating - The report maintains a "Buy" recommendation for Hutchison China MediTech (0013.HK) [3][8]. Core Views - The approval expectations for the second-line gastric cancer indication of furmonertinib are optimistic, with potential peak sales expected to exceed 2 billion yuan [6][8]. - The company is focusing on expanding its pipeline, with several key products expected to receive approvals or submit NDA applications in 2024 [8]. - The sales growth of furmonertinib is driven by its expansion into new indications and accelerated commercialization in overseas markets [8]. Summary by Sections Company Overview - Hutchison China MediTech is primarily engaged in the pharmaceutical industry, focusing on oncology [3]. Product Performance - Furmonertinib has maintained a leading position in the third-line colorectal cancer market, with 2023 sales reaching $108 million, a year-on-year increase of 15% [5][12]. - The drug was approved in the U.S. in November 2023, marking it as the first innovative targeted therapy for metastatic colorectal cancer in over a decade [5][14]. Market Potential - The demand for effective treatments for gastric cancer is high, with nearly 400,000 new cases reported annually in China [6][16]. - Furmonertinib's oral administration method offers better patient compliance compared to its competitor, ramucirumab, which requires intravenous administration [18][20]. Clinical Data - Clinical trials show that furmonertinib combined with paclitaxel significantly improves progression-free survival (PFS) and overall response rate (ORR) compared to paclitaxel alone [22][25]. - The median overall survival (OS) for furmonertinib plus paclitaxel is 9.6 months, compared to 8.4 months for the control group, although this difference did not reach statistical significance [24][25]. Financial Projections - The revenue forecasts for the company have been adjusted, with expected revenues of $671 million, $861 million, and $1.027 billion for 2024, 2025, and 2026 respectively [7][8]. - The overall valuation of the company is estimated at $4.058 billion, translating to a target price of HKD 36.43 per share [8].

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research ("AACR") Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California. Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiate ...

ROCKVILLE, Md. and SUZHOU, China, April 2, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today jointly announce that the New Drug Application ("NDA") for the combination of sintilimab and fruquin ...

Regulatory and Clinical Developments - The New Drug Application (NDA) for the combination of fruquintinib and sintilimab for advanced endometrial cancer has been accepted and granted priority review by the China National Medical Products Administration (NMPA) [1] - This is the first regulatory filing for fruquintinib in combination with an immune checkpoint inhibitor [3] - The NMPA granted Breakthrough Therapy designation to the combination in July 2023, recognizing its potential to address a serious condition with no effective treatment options [3] - The NDA is supported by data from the FRUSICA-1 study, a Phase II trial investigating the combination in endometrial cancer patients who failed prior systemic therapy [2] Endometrial Cancer Overview - Endometrial cancer is a common gynecological malignancy, with an estimated 417,000 global cases and 97,000 deaths in 2020 [4] - In China, approximately 82,000 people were diagnosed with endometrial cancer, resulting in 17,000 deaths in 2020 [4] - Recurrent and metastatic endometrial cancer remains an area of high unmet need with limited treatment options [4] Fruquintinib Profile - Fruquintinib is a selective oral inhibitor of VEGFR-1, -2, and -3, designed to inhibit tumor angiogenesis with enhanced selectivity and manageable safety [5] - It is approved in China for metastatic colorectal cancer and included in the National Reimbursement Drug List (NRDL) since January 2020 [6][7] - In the US, fruquintinib (marketed as FRUZAQLA™) received approval in November 2023 for metastatic colorectal cancer, supported by Phase III trials FRESCO and FRESCO-2 [8] Sintilimab Profile - Sintilimab, marketed as TYVYT® in China, is a PD-1 monoclonal antibody co-developed by Innovent and Eli Lilly [9] - It is approved in China for seven indications, including non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma [9] - The combination of sintilimab and fruquintinib for advanced endometrial cancer has been granted priority review by the NMPA [10] Company Overview - HUTCHMED is a biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases, with approximately 5,000 employees globally [11] - Innovent is a leading biopharmaceutical company with a mission to provide affordable biologics, having launched 10 products and with multiple assets in clinical development [12] Clinical Trial Data - The FRUSICA-1 study evaluated fruquintinib in combination with sintilimab in endometrial cancer patients, with primary and secondary endpoints including ORR, DCR, DoR, PFS, and OS [2] - Data from FRUSICA-1 will be presented at an upcoming medical conference [2]

— Oral presentation at the European Lung Cancer Congress 2024 of Phase IIIb data demonstrating median PFS of 13.7 months and median OS not reached in treatment-naïve patients — — If approved, would confirm 2021 conditional approval and expand indication to more patients — HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the supplemental New Drug Application ("sNDA") for savolitinib, ...

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated the registration stage of the Phase II/III clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia ("wAIHA") in China. This follows positive data from the proof-of-concept Phase II stage of the trial and subsequent consultation with the China National Medical Products Administratio ...

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 ...

[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% ...