Investment Rating - The investment rating for the company is "Outperform the Market" (maintained) [1][12][21] Core Views - The company has made progress in both clinical development and commercialization, with key products showing strong sales potential and positive clinical data [2][12] - The core product, Furquintinib, is experiencing rapid overseas sales growth, while the company expects to submit a new drug application for Savolitinib to the FDA based on positive clinical results [2][8] - The clinical data for Syk inhibitor, Solitomab, is promising, with expectations for approval in China by 2025 [3][6] Summary by Sections Clinical Development - Solitomab has shown a sustained response rate of 51.4% in adult ITP patients, with a median cumulative time of 38.9 weeks for platelet counts ≥50x10^9/L [3][6] - Furquintinib achieved over $200 million in sales in the U.S. during the first three quarters of the year and is expected to continue its sales growth in Japan and Europe [2][7] - Savolitinib has successfully renewed its listing in the national medical insurance directory and is expected to submit an application to the FDA based on positive results from the SAVANNAH clinical trial [8][12] Financial Forecast - Revenue projections for 2024-2026 are $659 million, $818 million, and $932 million, respectively, with year-on-year growth rates of -21.3%, 24.0%, and 14.0% [2][12] - The net profit attributable to the parent company is forecasted to be -$12 million, $61 million, and $108 million for the same period [2][12]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company successfully renewed the negotiation for the national medical insurance drug list for Savolitinib, with no price reduction in the recent negotiations. The drug is expected to be submitted for approval in the US by the end of 2024, following positive results from overseas Phase II clinical trials for second-line EGFRm+ MET-driven NSCLC [2] - The overseas sales of Fuzulopatinib continue to grow, and the company anticipates approval for new indications domestically. Fuzulopatinib is the first and only small molecule targeted drug approved for third-line mCRC in the US in the past decade, and it has been included in the NCCN guidelines. The drug has achieved net sales of $200 million overseas in the first three quarters of this year [2] - The potential best-in-class Syk inhibitor, Solitomab, has commenced overseas clinical trials. The number of existing ITP patients in China is expected to exceed 300,000 by 2027, with 67% of patients entering second-line treatment. The competition landscape is favorable due to limited innovative therapies [3] - The revenue forecasts for 2024-2026 are $665 million, $808 million, and $969 million, respectively, with profitability expected in 2025. The company has multiple catalysts in play, and the overseas market is opening up, indicating high growth certainty [3] Financial Summary - Total revenue (in million USD) is projected to be $665.00 in 2024, $808.00 in 2025, and $969.00 in 2026, with a year-on-year growth rate of -20.64% in 2024, followed by 21.50% in 2025 and 19.93% in 2026 [1][3] - The net profit attributable to the parent company is expected to be -$41.78 million in 2024, $48.83 million in 2025, and $178.71 million in 2026, with significant year-on-year growth rates of 216.88% and 265.95% in 2025 and 2026, respectively [1][3] - The latest diluted EPS is projected to be -$0.05 in 2024, $0.06 in 2025, and $0.21 in 2026 [1][3]

股 票 研 究 海 外 公 司 （ 中 国 香 港 ） 证 券 研 究 报 告 投资要点： 国泰君安版权所有发送给上海东方财富金融数据服务有限公司.东财接收研报邮箱.ybjieshou@eastmoney.com p1 呋喹替尼日本顺利获批，海外放量可期 [Table_Invest] 评级： ——和黄医药跟踪报告 | --- | |----------------------------------------| | | | 股票研究 /[ Table_Date] 2024.09.26 | | 和黄医药 (0013) | | [Table_Industry] 医药 | | 增持 | | --- | --- | --- | --- | |----------|-----------------------------------|----------------------------|--------------------------| | | | | | | | [table_Authors] 丁丹 ( 分析师 ) | 甘坛焕 ( 分析师 ) | 付子阳 ( 研究助理 ) | | | 0755-23976 ...

Investment Rating and Valuation - The report initiates coverage with a **BUY** rating for Hutchmed, with a target price of HK$35.4, implying a 33% upside potential [4][10] - Revenue is forecasted to reach $650M in 2024E, $810M in 2025E, and $950M in 2026E, with oncology/immunology business contributing $370M, $530M, and $650M respectively [4][10] - Net profit is expected to turn positive in 2025E, with forecasts of -$13M in 2024E, $39M in 2025E, and $120M in 2026E [4][10] Core Products and Commercialization - **Fruquintinib (Fruzaqla)**: Approved by the FDA in November 2023 for metastatic colorectal cancer (mCRC), with overseas sales reaching $15M in 2023 and $131M in 1H24 [4][7] - **Savolitinib**: Expected to file an NDA with the FDA by the end of 2024 for EGFRm/MET+ NSCLC, potentially becoming the second overseas product [4][7] - **Sovleplenib**: NDA for second-line immune thrombocytopenia (ITP) accepted by NMPA in January 2024, with peak sales in China estimated at $110M [11] Pipeline and R&D Progress - Hutchmed has 13 oncology drugs in clinical stages, with **HMPL-306 (IDH1/2)** entering Phase III for AML in May 2024 [4][7] - **Tazemetostat**: NDA for third-line follicular lymphoma accepted by NMPA in July 2024, with rights licensed in Greater China [4][7] - **Fruquintinib**: Additional indications under development include gastric cancer, endometrial cancer, and renal cell carcinoma [25][26] Market and Competitive Landscape - Fruquintinib is the first and only highly selective VEGFR inhibitor approved in the US for mCRC, with peak overseas sales potential of $670M [11][24] - In China, Fruquintinib holds a 47% market share in third-line mCRC as of 2Q24, with monthly treatment costs of ¥7,541, lower than Regorafenib's ¥14,488 [35][36] - Regorafenib, a competitor, saw a 15% decline in global sales to €523M in 2023 due to generic competition and Fruquintinib's market entry [38][39] Strategic Partnerships - Hutchmed partnered with **Takeda** for Fruquintinib's global commercialization (excluding China), receiving $400M upfront and up to $730M in milestone payments [4][12] - **AstraZeneca** is responsible for Savolitinib's marketing in China and is expected to file an NDA with the FDA by end of 2024 [4][7] - Collaboration with **Ipsen** for Tazemetostat's development and commercialization in Greater China [17]

Financial Performance - The total comprehensive revenue for the oncology/immunology business was $168.7 million, down from $359.2 million in the first half of 2023[15]. - Total revenue decreased by 43% to $305.7 million in the first half of 2024, down from $532.9 million in the same period of 2023[16]. - The comprehensive net profit attributable to Hutchison China MediTech's other businesses decreased by 8% to $34.1 million, mainly due to reduced contributions from Shanghai Hutchison Pharmaceuticals[33]. - The company reported a significant decline in service revenue, which fell by 87% to $33.8 million in the first half of 2024[16]. - The net income attributable to the company was $25.8 million, down from $168.6 million in the first half of 2023, representing a decrease of approximately 84.7%[43]. - The company reported a net loss of $4.8 million before tax expenses and equity earnings, compared to a profit of $137.1 million in the first half of 2023[43]. - The total comprehensive income for the six months ended June 30, 2024, was $305.7 million, a decrease of 43% compared to $532.9 million in 2023[128]. - The revenue from the oncology/immunology business was $168.7 million, down 53% from $359.2 million in the previous year[128]. Oncology Product Sales - The oncology business market sales increased by 140% to $243.3 million, with a comprehensive revenue growth of 59% to $127.8 million compared to the first half of 2023[15]. - The sales of ORPATHYS® (savolitinib) grew by 18% to $25.9 million, driven by advancements in MET exon 14 skipping mutation testing and continued growth momentum after inclusion in the national health insurance drug list[15]. - FRUZAQLA® achieved market sales of $130.5 million in the first half of 2024, a significant increase from $0 in the same period of 2023[16]. - ELUNATE® (爱优特®) market sales grew by 8% to $61.0 million, with a 13% increase at fixed exchange rates, compared to $56.3 million in the first half of 2023[17]. - SULANDA® (苏泰达®) market sales increased by 12% to $25.4 million, reflecting a 17% growth at fixed exchange rates, up from $22.6 million in the first half of 2023[17]. - The sales of innovative oncology products by the company grew by 140% to $243.3 million in the first half of 2024, driven primarily by the launch of FRUZAQLA®[46]. - The sales of 爱优特® in China reached $61 million in the first half of 2024, an 8% increase from $56.3 million in the same period of 2023[49]. - The sales of 索凡替尼 (苏泰达®) increased by 12% to $25.4 million in the first half of 2024, maintaining a 21% prescription share in the neuroendocrine tumor treatment market[52]. - The sales of 沃瑞沙® reached $25.9 million in the first half of 2024, an 18% increase from $22 million in the same period of 2023[53]. Research and Development - The company has initiated three key late-stage studies this year, with over ten critical studies currently ongoing in the pipeline[13]. - The company plans to submit a new drug application for EZH240 in mid-2025 for the treatment of relapsed/refractory follicular lymphoma[26]. - The company is actively recruiting patients for the SACHI study, expected to complete by the end of 2024[24]. - The company has 13 oncology candidates currently in clinical trials, with three drugs already approved in mainland China[45]. - The company is expanding its product pipeline with new indications for existing drugs, including applications for endometrial cancer and non-small cell lung cancer[22]. - The company has initiated a Phase III study for IDH1/2 mutant relapsed/refractory acute myeloid leukemia in China[30]. - The company has initiated a phase II/III trial for savolitinib combined with chemotherapy in previously untreated metastatic pancreatic cancer, with an additional 500 patients expected to be recruited[86]. - The company supports approximately 130 clinical trials for the investigational drug Surufatinib in China, focusing on various solid tumors[88]. Regulatory Approvals - The company expects to achieve registration approval for solitomab in China by the end of the year and plans to submit a new drug application for savolitinib in the U.S.[13]. - The company received positive opinions from the European Medicines Agency for FRUZAQLA® in April 2024, leading to its approval in the EU in June 2024[19]. - The company plans to submit a new drug application to the FDA based on the SAVANNAH study results by the end of 2024, pending positive outcomes[24]. - The new indication for Savolitinib for treating locally advanced or metastatic non-small cell lung cancer with MET exon 14 alteration has been accepted for review by the National Medical Products Administration in March 2024[67]. Financial Position - The cash and cash equivalents totaled $802.5 million as of June 30, 2024, down from $886.3 million at the end of 2023[35]. - Total liabilities decreased to $508.9 million as of June 30, 2024, from $536.4 million at the end of 2023[41]. - The company’s cash and cash equivalents and short-term investments totaled $802.5 million as of June 30, 2024, down from $886.3 million at the end of 2023[41]. - The company has utilized RMB 405.5 million ($55.6 million) from a 10-year fixed asset loan agreement with Bank of China as of June 30, 2024[139]. - The company has a capital commitment of $1.6 million for property, plant, and equipment as of June 30, 2024[143]. - The company has no outstanding bank loans from its non-consolidated joint venture, Shanghai Hutchison Pharmaceuticals, as of June 30, 2024[139]. - The company has not paid dividends from Shanghai Hutchison Pharmaceuticals in the first half of 2024, compared to $14.6 million in the same period of 2023[123]. Shareholder Information - The largest shareholder, CK Hutchison Global Investments Limited, holds 332,574,650 shares, accounting for 38.17% of the total shares[175]. - The company has a total of 332,478,770 shares held by Hutchison Healthcare Holdings Limited, which also represents 38.16% of the total shares[175]. - The total number of shares held by the beneficial owner, Su Weiguo, is 10,125,817, which includes options that may convert into shares upon meeting vesting conditions[174]. - The total number of shares held by the directors includes 19,000 ordinary shares and 22,456 American Depositary Shares (ADS), with each ADS equivalent to five shares[174]. - The company has a total of 69,688,835 shares held by Deutsche Bank Aktiengesellschaft, representing approximately 8.01% of the total shares[175]. Employee and Incentive Plans - The company employed approximately 1,970 full-time employees as of June 30, 2024, with total employee expenses amounting to USD 101.9 million for the six months ended June 30, 2024[163]. - The company has established a strategic partnership with Chuangxiang Biotech to develop innovative clinical candidates for autoimmune diseases, with a 7.5% equity stake acquired in July 2024[111]. - The long-term incentive plan aims to attract and retain skilled personnel, with rewards linked to performance metrics and vesting schedules[190][191]. - The company has a long-term incentive plan that includes non-performance-related rewards, with vesting occurring on specified dates[197].

Investment Rating - The report maintains a "Recommended" rating for the company [1][3]. Core Views - The overseas sales of Furmonertinib exceeded expectations, indicating strong demand. The drug received FDA approval for third-line treatment of colorectal cancer, marking it as the first targeted therapy approved in the U.S. for metastatic colorectal cancer in over a decade. In the first half of 2024, overseas sales reached $130.5 million [1]. - The company is accelerating clinical research, with a second drug expected to submit for overseas registration by the end of the year. The company has multiple new drug applications and indications in progress, showcasing its strong clinical execution capabilities [1]. - The company is expected to have over 15 potential new drug applications and indications in the next three years, reflecting its efficient R&D progress [1]. Financial Summary - Total revenue for 2024 is projected at $621 million, with a year-on-year decrease of 25.9%. The net profit attributable to the parent company is expected to be -$3 million in 2024, with a significant recovery projected in 2025 and 2026 [2][6]. - The company’s cash and cash equivalents totaled $802.5 million as of June 30, 2024 [1]. - The estimated valuation for the company is HKD 35 billion, with a target price of HKD 40.15 per share [1][3].

买入（维持） 所属行业：医疗保健业/药品及生物科技 当前价格(港币)：28.80 元 证券分析师 周新明 资格编号：S0120524060001 邮箱：zhouxm＠tebon.com.cn 李霁阳 资格编号：S0120523080003 邮箱：lijy7＠tebon.com.cn 市场表现 和黄医药 恒生指数 -29% -14% 0% 14% 29% 43% 57% 2023-08 2023-12 2024-04 | --- | --- | --- | --- | |--------------|-------|-------|-------| | 恒生指数对比 | 1M | 2M | 3M | | 绝对涨幅(%) | 6.08 | -2.21 | -6.65 | | 相对涨幅(%) | 10.71 | 4.07 | 0.28 | 资料来源：德邦研究所，聚源数据 相关研究 1.《和黄医药(00013.HK)：呋喹替尼美 国销售超预期，产品催化密集》， 2024.5.11 2.《和黄医药(0013.HK)：业绩符合预 期，销售有望稳定增长》，2024.3.4 3.《和黄医药(0013.HK)：呋喹替尼美 国 ...

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Insights - The company's total revenue for H1 2024 was $310 million, aligning with expectations, with oncology business revenue of $169 million and other business revenue of $137 million. Key product sales included $131 million from furmonertinib overseas (up 52% quarter-on-quarter) and $61 million domestically (up 13% year-on-year) [3][4] - The guidance for total oncology/immunology revenue for 2024 remains unchanged at $300-400 million, representing a year-on-year increase of 30-50% [3] - Research and development expenses for H1 2024 were $95 million (down 34% year-on-year), while selling and administrative expenses were $58 million (down 15% year-on-year). The company has approximately $800 million in cash and equivalents, indicating strong cash flow [3] Revenue and Profit Forecast - The report forecasts total revenue of $665 million for 2024, $808 million for 2025, and $969 million for 2026, with expectations of profitability in 2025 [4][8] - The company is expected to achieve a net profit of $48.83 million in 2025 and $178.71 million in 2026, with significant growth rates projected for net profit [2][4] Product Development and Market Potential - Furmonertinib continues to gain traction overseas, with potential new indications expected to be approved domestically. It is the first and only small molecule targeted therapy approved in the U.S. for third-line mCRC and is included in the NCCN guidelines [3] - The company anticipates filing for the U.S. market approval of savolitinib, addressing clinical needs for EGFR TKI-resistant NSCLC, with ongoing clinical trials in seven global locations [3] - The potential best-in-class Syk inhibitor, solunatib, is set to begin overseas clinical trials, with a significant patient population expected in China by 2027 [3]

Investment Rating - The investment rating for the company is "Buy" and is maintained [3][6] Core Insights - The company's mid-year performance for 2024 met expectations, with significant growth in product sales and a strong cash position, indicating potential profitability by 2025 [3][5] - The core product, Furmonertinib, has exceeded sales expectations in overseas markets, contributing to a robust revenue outlook for the year [3][5] - The company has a rich pipeline of innovative products, with several key catalysts expected to drive future growth [3][5] Summary by Relevant Sections Company Events - On July 31, the company released its mid-year performance report for 2024, showing continued growth in product sales and a strong cash balance [3] Mid-Year Performance Insights - For the first half of 2024, total revenue reached $30.57 million, with a net profit of $2.58 million [5] - The oncology immunotherapy business generated $16.87 million in revenue, with a full-year guidance of $30-40 million [5] - Furmonertinib's sales in the U.S. for the first half of 2024 were $13 million, with expectations of over 100% growth in the new fiscal year [3][5] Future Catalysts - Furmonertinib's overseas sales are expected to continue growing, with a submission for market approval in Japan anticipated in the second half of 2024 [3] - The company has several upcoming product approvals that could provide new revenue streams, including submissions for various indications in both domestic and international markets [3][5] Earnings Forecast and Valuation - The company projects total revenue of $654 million, $871 million, and $1.121 billion for 2024, 2025, and 2026, respectively [5] - A discounted cash flow (DCF) analysis suggests a fair equity value of HKD 41.2 billion, based on a perpetual growth rate of 2% and a WACC of 8.94% [5]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 40.90, while the current price is HKD 30.25 [1]. Core Insights - The company's mid-year performance for 2024 met expectations, with a total revenue of USD 170 million in the oncology/immunology segment, reflecting a 140% increase in market sales to USD 240 million [2]. - The strong performance in the oncology sector is attributed to the rapid acceptance of the product in the U.S. market and increased inventory demand [2]. - The company anticipates significant developments in its product pipeline, including approvals and market entries in various regions [2][9]. Financial Summary - The projected revenues for the company from 2024 to 2026 are USD 640 million, USD 740 million, and USD 880 million respectively, with the oncology segment contributing USD 330 million, USD 430 million, and USD 580 million [9]. - The expected growth rates for revenue are -23.38% in 2024, followed by 14.78% in 2025, and 20.09% in 2026 [3]. - The net profit for the parent company is forecasted to be -USD 17.24 million in 2024, with a significant recovery to USD 74.51 million in 2025 and USD 134.20 million in 2026 [3]. Product Pipeline and Market Potential - The company’s product, Yimian Tea Ni, is expected to gain market approval in China in 2024, with projected revenues from colorectal cancer treatments reaching USD 2.6 billion by 2026 [8]. - The product Saiwo Tea Ni is anticipated to have a new drug application submitted to the FDA by the end of 2024, with significant market potential in non-small cell lung cancer [2][8]. - The company is also expected to submit a new drug application for Suofan Tea Ni in 2024, with projected revenues from various cancer treatments increasing significantly over the next few years [8][9]. Valuation Metrics - The company’s price-to-sales (PS) ratio is currently at 5.3, which is below the industry average of 9.3, indicating potential undervaluation [10]. - The report suggests a valuation of 7 times PS, leading to a target price of HKD 40.90, maintaining the "Buy" rating [10].