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HUTCHMED Receives ELUNATE® (fruquintinib) Marketing Approval in Hong Kong for Treatment of Metastatic Colorectal Cancer
Newsfilter· 2024-01-30 04:53
— First medicine approved under new "1+" mechanism by HKSAR Government, providing an important treatment option to patients in Hong Kong — — ELUNATE® is the first oral targeted therapy approved in Hong Kong for metastatic colorectal cancer regardless of biomarker status or prior types of therapies in almost a decade — — Fruquintinib already approved in mainland China, Macau SAR and the United States — HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Jan. 29, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limit ...
HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Treatment of Primary Immune Thrombocytopenia with Priority Review Status
Newsfilter· 2024-01-11 00:00
— NDA accepted and granted Priority Review following its Breakthrough Therapy designation granted in January 2022 — — NDA is supported by data from successful Phase III ESLIM-01 trial in patients with adult primary immune thrombocytopenia who have received at least one previous therapy — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 10, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application ("NDA") for sovleplenib for th ...
和黄医药(00013) - 2023 - 中期财报
2023-08-16 08:30
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].
HUTCHMED(HCM) - 2023 Q2 - Earnings Call Transcript
2023-07-31 16:33
HUTCHMED (China) Limited (NASDAQ:HCM) Q2 2023 Earnings Conference Call July 31, 2023 8:00 AM ET Company Participants Mark Lee - SVP, Corporate Finance & Development Wei-Guo Su - CEO, Chief Scientific Officer & Executive Director Johnny Cheng - CFO & Executive Director Chen Hong - SVP & Chief Commercial Officer, China Mike Shi - EVP, Head, R&D and Chief Medical Officer Karen Atkin - EVP & COO Conference Call Participants Alec Stranahan - Bank of America Merrill Lynch Paul Choi - Goldman Sachs Group Mike Mitc ...
和黄医药(00013) - 2023 - 中期业绩
2023-07-31 11:00
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 ...
HUTCHMED(HCM) - 2023 Q2 - Quarterly Report
2023-07-30 16:00
Exhibit 99.1 HUTCHMED Reports 2023 Interim Results and Provides Business Updates Strong execution on strategic direction, delivering near-term value while charting a path for growth, exemplified by global partnership with Takeda Revenue grew 164% (173% CER) to US$533 million, with net income to HUTCHMED of US$169 million (which include US$259 million of the upfront recognized from Takeda) Company to Host Interim Results Call & Webcast Today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT Company to host a Capital M ...
和黄医药(00013) - 2022 - 年度财报
2023-04-11 08:32
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].
HUTCHMED(HCM) - 2023 Q1 - Quarterly Report
2023-03-30 16:00
Exhibit 99.1 Press Release HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer — NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China — — FRESCO-2 showed fruquintinib treatment reduced the risk of death by 34% in refractory metastatic colorectal cancer (0.66 HR), consistent with the 35% reduction in the risk of death ...
HUTCHMED(HCM) - 2022 Q4 - Earnings Call Transcript
2023-02-28 19:43
HUTCHMED (China) Limited (NASDAQ:HCM) Q4 2022 Earnings Conference Call February 28, 2023 8:00 AM ET Company Participants Mark Lee - SVP Corporate Finance and Development Weiguo Su - CEO and Chief Scientific Officer Hong Chen - Chief Commercial Officer Johnny Cheng - CFO Karen Atkin - COO Mike Shi - Chief Medical Officer and Head of R&D Conference Call Participants Kelly Shi - Jefferies Louise Chen - Cantor Alec Stranahan - Bank of America Merrill Lynch Yang Huang - Credit Suisse Mike Mitchell - Panmure Gor ...
HUTCHMED(HCM) - 2022 Q4 - Annual Report
2023-02-27 16:00
Exhibit 99.1 HUTCHMED Reports 2022 Full Year Results and Provides Business Updates Landmark licensing deal with Takeda for fruquintinib outside of China, bringing HUTCHMED up to US$1.13 billion, plus royalties, and demonstrating execution of the new global strategy Record Full Year 2022 oncology/immunology revenues driven by significant increase in China in-market sales of ELUNATE, SULANDA and ORPATHYSalongside clinical and strategic progress Company to Host Annual Results Call & Webcast Today at 9 p.m. HKT ...