— 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 ...

HUTCHMED (China) Limited (NASDAQ:HCM) Q4 2023 Results Conference Call February 28, 2024 7:30 AM ET Company Participants Mark Lee - Senior Vice President of Corporate Management & Communications Dr. Wei-Guo Su - CEO, Chief Scientific Officer Johnny Cheng - CFO Zhenping Wu - Executive Vice President of Pharmaceutical Science & Manufacturing Michael Shi - Executive VP, Head of R&D and Chief Medical Officer Conference Call Participants Louise Alesandra Chen - Cantor Fitzgerald & Co Alec Warren Stranahan - Bank ...

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].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark one) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

Shares of HUTCHMED (HCM) have gained 2.2% over the past four weeks to close the last trading session at $14.59, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $25.54 indicates a potential upside of 75.1%.The average comprises five short-term price targets ranging from a low of $14.60 to a high of $45, with a standard deviation of $12.20. While the lowest estimate indicates an i ...

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announces that data from FRUTIGA, HUTCHMED's Phase III trial of fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric cancer in China, were presented at the American Society of Clinical Oncology ("ASCO") Plenary Series Session on February 6, 2024. The full presentation can be found here. Fruquintinib is a selec ...

Inmagene exercised its option under the previously announced collaboration agreement to obtain an exclusive, royalty-bearing license for IMG-007, an anti-OX40 monoclonal antibody (mAb) and IMG-004, a Bruton Tyrosine Kinase (BTK) inhibitor Inmagene retains rights to develop and commercialize both assets worldwide SAN DIEGO, Feb. 2, 2024 /PRNewswire/ -- Inmagene Biopharmaceuticals ("Inmagene" or the "Company"), a clinical stage biotechnology company developing innovative and differentiated therapies for imm ...

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announced that, Inmagene Biopharmaceuticals ("Inmagene") has exercised options to license two drug candidates discovered by HUTCHMED, IMG-007 and IMG-004 (the "Options") pursuant to the terms of the strategic partnership announced on January 11, 2021. Following the exercise of the Options and subject to receipt by HUTCHMED of ordinary shares represen ...