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

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 ...

Financial Data and Key Metrics Changes - The company ended 2023 with a strong cash position of over $880 million, bolstered by a $400 million upfront payment from Takeda, of which $280 million has been recognized and the remaining $120 million will be recognized over the next three years [6][29] - Total revenue doubled to over $830 million, with oncology consolidated revenue around $530 million, meeting the high end of guidance [6][7] - The company reported a profit of over $100 million, attributed to restructuring of U.S. operations, prioritizing R&D investments, and controlling operating expenses [6][7] Business Line Data and Key Metrics Changes - FRUZAQLA achieved $15 million in market sales in the U.S. within the first seven weeks post-FDA approval [7] - ELUNATE sales exceeded $100 million in 2023, with an expanded market share over STIVARGA [8] - SULANDA maintained strong growth with a 43% increase compared to the previous year [9] Market Data and Key Metrics Changes - The commercial environment in China has improved with new policies supporting access to innovative medicines, including accelerated review processes for breakthrough drugs [8] - ORPATHYS, commercialized by AstraZeneca, achieved 19% growth despite a 38% price reduction after NRDL inclusion [9] Company Strategy and Development Direction - The company focuses on global registration and launch of fruquintinib, aiming for profitability by 2025, with plans for near-term and mid-term product launches in China [4][30] - The strategy includes expanding the product portfolio and entering new markets, supported by a new manufacturing facility in Shanghai that increases capacity fivefold [10][11] - The company is also pursuing regulatory approvals for savolitinib and sovleplenib, targeting unmet medical needs in various indications [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving self-sustainability by 2025, with a focus on regulatory activities to ensure a steady flow of new approvals [30][31] - The company is optimistic about the potential of sovleplenib for immune thrombocytopenia, addressing a significant unmet medical need in China [30][31] Other Important Information - The company has made significant advancements in its clinical pipeline, with multiple ongoing registration trials and expected NDA filings in 2024 and beyond [13][28] - The new Shanghai facility is equipped with solar panels to reduce electricity usage and emissions, reflecting the company's commitment to sustainability [11] Q&A Session Summary Question: What has been learned from the U.S. launch of FRUZAQLA? - The partnership with Takeda was effective, with well-prepared launch strategies leading to quick market entry post-approval [34][35] Question: What are the key readouts and events to focus on in the pipeline? - Key focus includes sovleplenib for ITP and additional compounds moving into registration studies [36] Question: What is the go-to-market strategy for sovleplenib if approved? - A special team will be built to support the launch, leveraging existing commercial infrastructure [40][41] Question: How significant will sovleplenib be in the 2024 revenue guidance? - Contribution is expected to be minimal in 2024, with more significant impact anticipated in 2025 [40][41] Question: What is the commercial opportunity for savolitinib in the frontline population? - The first-line population is believed to be much larger, presenting significant commercial opportunities [43] Question: How will the company approach global development for ITP? - Discussions with the FDA are ongoing to clarify the development plan, with potential partnerships being explored [41][50]

Financial Performance - Total revenue for 2023 reached $838 million, representing a 97% increase (102% at constant exchange rates) compared to the previous year[2]. - Net income for the year was $101 million, with a significant contribution from the oncology/immunology business, which saw a 223% revenue increase to $528.6 million[6]. - The company has a strong cash position, ending 2023 with $886.3 million, up from $631 million in 2022[6]. - Total revenue for 2023 increased by 97% to $838 million, driven by collaboration with Takeda and strong commercialization in China[9]. - The oncology/immunology business revenue grew by 223% to $528.6 million, benefiting from a $280 million collaboration revenue from Takeda and strong product sales growth[10]. - The company reported a net cash flow of $206.7 million for 2023, a significant improvement from a negative $297.9 million in 2022[33]. - The company’s total assets grew to $1.28 billion in 2023, up from $1.03 billion in 2022[36]. - The net income attributable to Hutchmed per ordinary share was $0.12 in 2023, compared to a loss of $0.43 per share in 2022[38]. - The company’s cash, cash equivalents, and short-term investments increased by $255 million to $886.34 million as of December 31, 2023[39]. - The company’s net expenses for 2023 were $737.2 million, a decrease from $787.2 million in 2022[33]. Product Development and Approvals - The FDA approved the drug FRUZAQLA™ (fruquintinib) for third-line colorectal cancer, leading to a market launch by Takeda with initial sales of $915.1 million[5]. - The new drug application for sovleplenib for primary immune thrombocytopenia has been accepted in China and is under priority review[6]. - The company plans to submit a new drug application for fruquintinib in second-line gastric cancer in China, with recruitment for clinical trials completed[6]. - The successful ESLIM-01 study for Syk inhibitor in immune thrombocytopenia has led to a new drug application accepted for priority review in January 2024[8]. - The company aims to submit a new drug application for savolitinib in Q1 2024, expanding its label indications in China[8]. - The new drug application for the combination therapy of fruquintinib and paclitaxel for second-line treatment of gastric cancer was accepted in April 2023[16]. - Fruquintinib received FDA approval in November 2023 for the treatment of previously treated metastatic colorectal cancer patients[16]. - The EMA submission for the treatment of previously treated metastatic colorectal cancer is expected to be completed by mid-2024[18]. - The company plans to submit a new drug application for the treatment of primary immune thrombocytopenia in mid-2024[21]. - The company has initiated a Phase II study for gastric cancer patients with MET amplification in China[17]. Strategic Collaborations and Partnerships - The company is focused on advancing its product pipeline and strategic partnerships, evidenced by a $435 million upfront and milestone payments from Takeda[5]. - The strategic collaboration with Takeda is noted as one of the largest small molecule licensing deals in China's biopharmaceutical history, enhancing the company's cash flow[7]. - Takeda is responsible for the global development, production, and commercialization of furmonertinib outside of mainland China, Hong Kong, and Macau, with potential payments to the company of up to $1.13 billion[26]. - The company received a $400 million upfront payment from Takeda in April 2023, along with potential milestone payments totaling up to $730 million[26]. Research and Development - The company has 13 oncology candidates currently in clinical trials, supported by a team of approximately 900 scientists and staff[51]. - The company continues to maintain the same pricing for 爱优特® in the national medical insurance drug list for the new two-year agreement starting January 2024[53]. - The company has initiated three Phase III studies for Savolitinib, including the SACHI and SANOVO studies launched in 2021 and the SAFFRON global pivotal study started in 2022[65]. - The company has successfully obtained FDA approval for Furmonertinib in November 2023, marking a significant milestone in its global market strategy[63]. - The company is exploring the use of furmonertinib in various solid tumors, with approximately 90 ongoing clinical trials in China[86]. Market Performance - Market sales of ELUNATE® (furmonertinib) in China increased by 15% to $107.5 million, maintaining a leading market share[10]. - FRUZAQLA™ (furmonertinib) generated $15.1 million in market sales following its U.S. launch in November 2023[10]. - Sales of SULANDA® (surufatinib) rose by 36% to $43.9 million, reflecting increased market share two years after inclusion in the national medical insurance catalog[12]. - ORPATHYS® (savolitinib) sales grew by 12% to $46.1 million, with a 30% increase in sales in the last three quarters of 2023 compared to the same period in 2022[12]. - The market sales of innovative oncology products grew by 28% to $213.6 million in 2023, compared to $167.1 million in 2022, with a fixed exchange rate growth of 35%[52]. Operational Highlights - The company aims to establish a self-sustaining business model while navigating global economic uncertainties[7]. - The company has completed patient recruitment for a Phase II study of furmonertinib in July 2023, with plans to submit a new drug application to the National Medical Products Administration by mid-2024 if results are positive[84]. - The company has received fast track designation from the FDA for savolitinib for treating pancreatic and non-pancreatic neuroendocrine tumors, although a new drug application was not approved[89]. - The company has conducted clinical trials of savolitinib in approximately 2,900 patients, with promising data from several studies presented at ASCO and ESMO conferences in 2023[88]. Sustainability and Governance - The independent 2023 sustainability report will be published alongside the 2023 annual report in April 2024, detailing the company's sustainability measures and performance[165]. - The company has complied with all applicable provisions of the Corporate Governance Code as of December 31, 2023[168]. - The company is committed to transparency and has complied with the ethical responsibilities outlined in the professional code of conduct[183].

Revenue grew 97% (102% CER) to US$838 million, with net income of US$101 million First U.S. FDA approval of our self-developed medicine, FRUZAQLA™ (fruquintinib) Sovleplenib for ITP accepted for NDA review in China, with Priority Review status and Breakthrough Therapy designation HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical co ...

Financial Performance - Total revenue increased by 97% (102% at CER) to $838 million for 2023, with net income of $101 million[7]. - Revenue for the year ended December 31, 2023, was $838.0 million, compared to $426.4 million in 2022, representing a significant increase[22]. - Total revenue for 2023 reached $837,999,000, a significant increase of 96.5% compared to $426,409,000 in 2022[180]. - Net income attributable to HUTCHMED for 2023 was $100.8 million, compared to a net loss of $360.8 million in 2022, resulting in earnings of $0.12 per ordinary share[25]. - The company reported a total comprehensive income of $94,502,000 for 2023, compared to a comprehensive loss of $368,855,000 in 2022[182]. - The company achieved a basic earnings per share of $0.12 in 2023, recovering from a loss of $0.43 in 2022[180]. Oncology/Immunology Revenue - Oncology/Immunology consolidated revenue rose by 223% (228% at CER) to $528.6 million, driven by a $280 million upfront payment from Takeda[4]. - Oncology/Immunology consolidated revenue increased 223% to $528.6 million, driven by strong sales of ELUNATE, FRUZAQLA™, and SULANDA[23]. - The company expects full year 2024 Oncology/Immunology consolidated revenue to be between $300 million and $400 million, driven by a growth target of 30% to 50% in oncology marketed product revenue[29]. - In-market sales for ELUNATE (fruquintinib in China) increased by 15% (22% at CER) to $107.5 million[7]. - In-market sales of HUTCHMED's oncology products grew by 28% to $213.6 million in 2023, compared to $167.1 million in 2022[40]. Research and Development - Fruquintinib received U.S. FDA approval for third-line colorectal cancer (CRC) in November 2023, leading to U.S. in-market sales of $15.1 million[2]. - Fruquintinib NDA for second-line gastric cancer accepted for review in China, with expected NDA filing for endometrial cancer in early 2024[3]. - Sovleplenib NDA for primary immune thrombocytopenia (ITP) accepted in China with priority review status, supported by Phase III trial data[3]. - Savolitinib's pivotal global Phase II trial (SAVANNAH) completed enrollment, with potential NDA filing to the U.S. FDA expected by the end of 2024[3]. - The company plans to submit an NDA for savolitinib in early 2024 and complete several pivotal studies by late 2024[11][12][13]. - Tazemetostat is expected to file for NDA in late 2024 for relapsed/refractory follicular lymphoma, following successful studies[15]. Cash and Financial Position - Cash balance strengthened to $886.3 million at year-end 2023, up from $631 million in 2022, positioning the company for self-sustainability[4]. - Cash, cash equivalents, and short-term investments were $886.3 million as of December 31, 2023, up from $631.0 million in 2022[22]. - The company reported net cash generated from operating activities of $219.3 million, a significant improvement from a net cash used of $268.6 million in 2022, reflecting a net change of $487.9 million[132]. - The company reported a net cash used in investing activities of $291.1 million for 2023, compared to net cash generated of $296.6 million in 2022, indicating a net change of $587.7 million[133]. - The company had a net cash generated from financing activities of $48.7 million in 2023, a significant improvement from a net cash used of $82.8 million in 2022[134]. Cost and Expenses - Cost of revenue increased by 24% to $384.4 million, with Oncology/Immunology costs rising by 33% to $91.7 million due to increased product sales[24]. - R&D expenses reduced by 22% to $302.0 million, reflecting the completion of several large trials and a strategic focus on partnerships[24]. - Operating expenses for 2023 totaled $819.624 million, a slight decrease from $834.102 million in 2022[28]. - The Group's total staff costs for the year ended December 31, 2023, were $213.7 million, a decrease from $227.2 million in 2022[156]. Partnerships and Collaborations - Takeda partnership generated $435 million in upfront and milestone payments, enhancing the company's cash position and strategic pipeline[2]. - The company has partnered with Takeda for the development and commercialization of fruquintinib outside of China, with potential payments up to $1.13 billion, including $400 million received upon closing the agreement[76]. - HUTCHMED has received $85 million from AstraZeneca as part of a collaboration agreement for savolitinib, with potential total payments of $140 million[52]. Market and Product Developments - FRUZAQLA™ launched in the U.S. on November 8, 2023, with in-market sales reaching $15.1 million by the end of 2023, exceeding expectations for new patient starts[42]. - SULANDA's in-market sales increased by 36% to $43.9 million in 2023, compared to $32.3 million in 2022, maintaining a 21% prescription share in NET treatment[44]. - ORPATHYS sales grew by 12% to $46.1 million in 2023, with a significant increase of 104% in volume during the latter part of the year following NRDL listing[48]. - ELUNATE continues to be included in the NRDL for a new two-year term starting January 2024 at the same price as 2023[42]. Clinical Trials and Results - Savolitinib's Phase II trial for MET exon 14 skipping alterations in NSCLC showed an overall response rate (ORR) of 60.7% and a disease control rate (DCR) of 95.2%[57]. - The VIKTORY study for savolitinib in MET-driven gastric cancer reported a 50% ORR in patients with MET amplification[59]. - The SAMETA study for MET-driven PRCC is ongoing, with over 140 sites in more than 20 countries enrolling patients[62]. - The FRESCO-2 study demonstrated a statistically significant increase in overall survival (OS) and progression-free survival (PFS) in 691 patients, with a median OS of 9.3 months for fruquintinib versus 6.6 months for placebo[65]. - In the FRUTIGA study, patients receiving fruquintinib combined with paclitaxel achieved a median PFS of 5.6 months compared to 2.7 months for the control group, with a hazard ratio (HR) of 0.569 and p < 0.0001[71]. Strategic Focus and Future Plans - The company has utilized 50% of net proceeds ($292.7 million) for advancing late-stage clinical programs and expanding its product portfolio in cancer and immunological diseases[166]. - 20% of net proceeds ($117.1 million) was directed towards strengthening commercialization, clinical, regulatory, and manufacturing capabilities, as well as potential global business development and strategic acquisitions[166]. - The company plans to submit results for tazemetostat in follicular lymphoma for NDA filing in late 2024[86].