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 ...

Financial Performance - Total revenue for 2022 increased by 20% to $426.4 million, driven by the commercialization of three self-developed oncology drugs in China[14]. - Other business revenue grew by 11% to $262.6 million in 2022, with Shanghai Hengrui's non-consolidated joint venture revenue also increasing by 11% to $370.6 million[27]. - The company reported a net loss attributable to the company of $360.8 million in 2022, compared to a net loss of $194.6 million in 2021, resulting in a loss per share of $0.43[36]. - The company’s total revenue for the tumor/immunology business was $296.6 million in 2022, compared to $(306.3) million in 2021[106]. - The revenue from prescription drugs was $237.3 million in 2022, a 16% increase from $204.1 million in 2021[107]. - The company’s revenue from Shanghai Huanong Pharmaceutical was $370.6 million in 2022, an 11% increase from $332.6 million in 2021[107]. Oncology/Immunology Business - Revenue from oncology/immunology business grew by 37% (41% at constant exchange rates), aligning with financial guidance[7]. - Oncology/immunology business revenue grew by 37% to $163.8 million, with significant contributions from key products[15]. - Fruquintinib (爱优特) sales increased by 32% to $93.5 million, reflecting a growing market share, especially in second and third-tier cities[14]. - Surufatinib (苏泰达) sales surged by 178% to $32.3 million, benefiting from its inclusion in the national medical insurance catalog[14]. - Savolitinib (沃瑞沙) sales rose by 159% to $41.2 million, recognized as China's first selective MET inhibitor[14]. Clinical Trials and Drug Development - The FRESCO-2 Phase III international study for fruquintinib in treating refractory metastatic colorectal cancer achieved its primary endpoint, with rolling submission for new drug application to the US FDA initiated[7]. - Over 15 registration/registration intention studies involving six products are currently ongoing[7]. - The FRUTIGA Phase III study for fruquintinib in gastric cancer reached the PFS endpoint, with supplementary application for new indication underway[7]. - The company has advanced 13 oncology candidate drugs into clinical trials in China, with four also undergoing clinical development in the US and Europe[40]. - The company is developing six early-stage oncology candidates, including HMPL-306, a selective oral IDH1/2 dual inhibitor, and HMPL-760, a third-generation oral BTK inhibitor[23]. Strategic Partnerships and Collaborations - The company successfully entered into a licensing agreement with Takeda Pharmaceuticals, marking a significant strategic step[8]. - The collaboration with Takeda Pharmaceuticals for furmonertinib includes a potential total of up to $1.13 billion, with an initial payment of $400 million and up to $730 million in milestone payments[25]. - The company has established a partnership with Eli Lilly for the marketing and promotion of Aiyoute in China, receiving 70-80% of the production revenue, service fees, and royalties from sales[41]. Research and Development - R&D expenses increased to $386.9 million in 2022 from $299.1 million in 2021, primarily due to the expansion of innovative oncology drug development[35]. - The company plans to continue early development projects for candidates with global differentiation advantages, including sovleplenib, in the US, Europe, and Japan[11]. - The company is investing $50 million in R&D for new technologies and product development in the upcoming year[144]. Market Expansion and Future Outlook - A new strategic focus was announced in November to accelerate the establishment of a sustainable and profitable business[10]. - Future outlook includes a projected revenue growth of 15% for the next fiscal year, driven by new product launches and market expansion strategies[144]. - Plans for market expansion include entering three new international markets by the end of 2024, targeting a 20% increase in market share[144]. Financial Position and Cash Flow - As of December 31, 2022, cash and cash equivalents totaled $631 million, down from $1.011 billion in 2021[34]. - The company reported a net cash outflow from financing activities of $82.8 million in 2022, compared to a net cash inflow of $650 million in 2021[34]. - The total assets decreased to $1.029 billion as of December 31, 2022, from $1.373 billion in 2021[37]. Corporate Governance and Management - The company has seen changes in its board composition, with several directors transitioning to new roles or resigning from previous positions[155]. - The company’s board members have extensive experience in the pharmaceutical and financial sectors, enhancing its governance and strategic direction[154][156]. - The company emphasizes the importance of high-quality human resources to maintain market leadership and offers competitive salaries and benefits[1]. Sustainability and Social Responsibility - The company has established a comprehensive sustainability governance framework and set 11 sustainability goals and indicators[29]. - The board has approved a new sustainability strategy aimed at reducing carbon emissions by 40% by 2030[144]. - The group donated approximately $2.7 million to charitable organizations in the year ended December 31, 2022, compared to about $1.89 million in 2021, representing an increase of approximately 42%[176].

Revenue Growth - Total revenue for the first half of 2022 increased by 28% to $202 million, driven by the commercialization of three self-developed oncology drugs[10]. - Oncology/immunology business revenue grew by 113% to $91.1 million compared to $42.9 million in the first half of 2021[10]. - The sales of ELUNATE® (fruquintinib) in the first half of 2022 reached $50.4 million, a 26% increase from $40.1 million in the same period last year[10]. - Sales of SULANDA® (surufatinib) amounted to $13.6 million in the first half of 2022, up from $8 million in the first half of 2021[10]. - ORPATHYS® (savolitinib) generated sales of $23.3 million in the first half of 2022, marking its first revenue since its launch in late 2021[10]. - The combined revenue from tumor/immunology business was $9,110 million, reflecting a 113% increase from $4,290 million year-over-year[11]. - The sales of Aiyoute® reached $5,040 million, up 26% from $4,010 million in the first half of 2021[11]. - The sales of Sutai Da® increased by 69% to $1,360 million from $800 million in the same period last year[11]. - Revenue from the oncology/immunology business for marketed products was $63.517 million, up from $37.795 million in 2021, representing a 68.2% increase[31]. Clinical Trials and Research Development - The company is advancing multiple key early-stage studies and ongoing late-stage clinical trials, including the SAVANNAH study, which is expected to report encouraging data in August[8]. - The company initiated the SAFFRON global Phase III study for the combination therapy of Saiwo Tini and Tagrisso®[15]. - The FRESCO-2 global Phase III study is set to announce top-line results after reaching the predefined number of OS events, involving 691 patients across 14 countries[16]. - The company plans to submit the marketing application for Aiyoute® to the FDA, EMA, and PMDA in the second half of 2022[16]. - The company has advanced 13 oncology candidates into clinical trials in China, with seven also undergoing clinical development in the US and Europe[34]. - The ongoing global phase III SAFFRON study is currently recruiting patients, focusing on the efficacy of Savolitinib in combination with other therapies[41]. - The company has initiated a Phase I clinical trial for HMPL-760 in China for advanced hematological malignancies[18]. - The company has started a Phase I clinical trial for HMPL-295 in China for advanced solid tumors[18]. - The company has launched a Phase I clinical trial for HMPL-653 in China for advanced malignant solid tumors and tenosynovial giant cell tumors[18]. Financial Performance - The net loss attributable to the company for the first half of 2022 was $162.9 million, compared to a net loss of $102.4 million for the same period in 2021[28]. - The company reported a net cash outflow from operating activities of $110.9 million for the first half of 2022, compared to a cash outflow of $63.1 million in the first half of 2021[27]. - The company reported a 3% decrease in comprehensive income from other businesses to $110.9 million in the first half of 2022, compared to $114.5 million in the same period of 2021[22]. - The company reported a total comprehensive loss of $(167,047) thousand for the six months ended June 30, 2022, compared to $(98,256) thousand in 2021, an increase of 69.9%[169]. - The net cash used in operating activities was $(89.9) million for the six months ended June 30, 2022, compared to $(71.3) million in the same period of 2021[101]. - The company reported a net loss of approximately $5,000 for other joint ventures in the first half of 2022, compared to a net profit of $79,000 in the same period of 2021[189]. Regulatory Approvals and Milestones - The company received approval for Aiyoute® and Sutai Da® in Macau, marking a significant regulatory milestone[12]. - The FDA requested a new international multi-center clinical trial for Sovantib, indicating the need for more representative data for the U.S. patient population[13]. - The company received fast track designation from the FDA for fuquintinib, indicating potential expedited review for market approval[61]. - The company plans to conduct a Phase II clinical trial for severe COVID-19 patients, targeting approximately 80 patients to assess the treatment's effectiveness[76]. Market Expansion and Strategic Initiatives - The company expanded its commercial team in China to approximately 820 employees, covering about 3,000 oncology hospitals and 30,000 oncologists[10]. - The company remains optimistic about future growth opportunities, particularly with the expected revenue increase from ORPATHYS®, SULANDA®, and ELUNATE® in the Chinese market[9]. - The company is constructing a new flagship production facility in Shanghai, aiming to increase production capacity for innovative drug products by over five times, with equipment installation planned for completion by the end of 2022[21]. - The company is exploring the potential for accelerated approval in the U.S. based on the results from the SAVANNAH study[42]. Corporate Governance and Sustainability - The company has established a sustainability committee at the board level to support its sustainability initiatives and has published its second sustainability report in May 2022[124]. - The company emphasizes the importance of high-quality human resources to maintain market leadership and offers competitive salaries and benefits[123]. - The company has complied with all provisions of the Corporate Governance Code as set out in Appendix 14 of the Hong Kong Listing Rules for the six months ended June 30, 2022[126]. - The company is committed to continuous improvement of governance standards and practices across its operations[161].

Revenue Growth - The comprehensive revenue from the oncology/immunology business increased nearly 4 times to $119.6 million in 2021, with this trend continuing into 2022 [15]. - Total revenue for 2021 increased by 56% to $356.1 million, driven by the commercialization of three self-developed oncology drugs [18]. - Other business revenue grew by 20% (CER: 13%) to $236.5 million in 2021, compared to $197.8 million in 2020 [31]. - The oncology/immunology business revenue for 2021 reached $119.6 million, a 296% increase compared to $30.2 million in 2020, aligning with the revenue guidance of $110 million to $130 million [18]. - The sales of Aiyoute® (Fruquintinib) in China grew by 111% to $71 million in 2021, reflecting strong management performance in medical communication and marketing [18]. - The sales of Vorasatinib® (Savolitinib) reached $15.9 million in 2021, as it became the first selective MET inhibitor in China, quickly gaining market recognition [18]. - The sales of Sunitinib® (Sofitinib) was launched in 2021 for treating neuroendocrine tumors, generating sales of $11.6 million, marking a promising start in the self-pay market [18]. Clinical Development - There are currently over 45 clinical studies ongoing globally, with seven innovative drug candidates undergoing clinical development outside of China [12][15]. - The company has initiated four Phase III studies and one Phase II study for the drug Vorasertib, which received its first approval in 2021, triggering a milestone payment of $40 million [15]. - The NDA application for Surufatinib for the treatment of advanced neuroendocrine tumors is in the late stages of registration review in the EU [15]. - The company has a pipeline of 12 innovative molecular drugs, with three already approved and successfully launched [11][13]. - In 2021, the company initiated several key clinical studies for its drug Savolitinib, including a global Phase III study (NCT05043090) in October for treating MET-driven unresectable and locally advanced or metastatic papillary renal cell carcinoma [23]. - The company plans to initiate a Phase III study (SURTORI-02) in China for the combination therapy of Savolitinib and Tuoyi® for esophageal cancer in the second half of 2022 [24]. - The company has initiated multiple Phase II studies for Furmonertinib in combination with other therapies for advanced or metastatic cancers, including colorectal and gastric cancers [24]. Financial Position - The company has over $1 billion in cash and plans to divest non-core assets to support its strategic initiatives [16]. - Cash and cash equivalents and short-term investments totaled $1.0117 billion as of December 31, 2021, compared to $435.2 million at the end of 2020 [38]. - The company reported a net loss attributable to shareholders of $194.6 million in 2021, compared to a net loss of $125.7 million in 2020, reflecting a 55.0% increase in losses [42]. - The total operating expenses for 2021 were $684.4 million, up from $424.6 million in 2020, indicating a 61.1% increase [42]. - The company’s total assets grew to $1.373 billion in 2021, compared to $724.1 million in 2020, a 89.8% increase [41]. Leadership Changes - The new CEO, Dr. Su Weiguo, has been appointed as part of the succession planning following the retirement of the previous CEO, Mr. He Jun [13][14]. - The company is expanding its leadership team with experienced professionals from the pharmaceutical industry, including former executives from Gilead Sciences and Takeda Pharmaceuticals [142][143]. Research and Development - R&D expenses increased to $299.1 million in 2021 from $174.8 million in 2020, marking a 70.9% growth due to the expansion of innovative oncology drug candidates [39]. - The company continues to prioritize employee development and community engagement through various training programs and initiatives [131]. - The company is focused on enhancing its corporate governance practices, with members holding senior positions in professional accounting and governance bodies [144]. Strategic Partnerships - The company has established a partnership with Hain Celestial for the marketing, distribution, and sales of its products, with pricing based on standard costs plus a profit margin [172]. - The company collaborates with Eli Lilly for fuzuloparib's rights outside of China, enhancing its market reach [64]. Sustainability and Governance - The company aims to enhance its sustainability practices and has established a sustainability committee at the board level [35]. - The company is committed to sustainable development, as indicated by the presence of a dedicated committee chaired by a board member [141]. - The company has a strong emphasis on research and development, particularly in innovative therapies for cancer [143][145]. Shareholder Information - The company reported a total shareholding of 332,574,650 shares, representing approximately 38.46% ownership by CK Hutchison Global Investments Limited [180]. - The company has adopted a share trading code for directors to disclose their interests and holdings [148]. - The company has a stock option plan adopted in 2015, which remains in effect [184].