Fanregratinib

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 company, today reports its financial results for the year ended December 31, 2023 and provides updates on key clinical and commercial developments. HUTCHMED to host results call and webcasts today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, February 29, 2024. All amounts are expressed in U.S. dollars unless otherwise stated. Strategic: global vision, commitment to patients and path to self-sustainability Executed our global vision of bringing our innovative medicines worldwide, as demonstrated through the Takeda1 partnership which brought $435 million in upfront and milestone payments plus manufacturing income and royalties on net sales, setting a strategic example for the rest of our pipeline.On track to be self-sustaining with a disciplined approach to leveraging our R&D2 expertise and creating value through licensing and commercialization. Pipeline: fruquintinib global and China expansion, sovleplenib China NDA3 review, savolitinib NSCLC4 enrolled Fruquintinib U.S. FDA5 approval three weeks ahead of PDUFA6 date for third-line CRC7, leading to a swift launch by Takeda, inclusion in NCCN8 guidelines and U.S. in-market sales9 of $15.1 million. Global regulatory progress with MAA10 filing to the EMA11 validated in June 2023 and NDA submitted to PMDA12 in September 2023.Fruquintinib NDA for second-line gastric cancer accepted for review in China. Registrations studies in China for 2L EMC13 and 2L RCC14 completed enrollment during 2023 for fruquintinib in combination with sintilimab, expecting NDA filing to the NMPA15 for EMC in early 2024 and topline results for RCC by end of 2024.NDA for sovleplenib, a novel Syk16 inhibitor, for primary ITP17 accepted and granted priority review in China, supported by data from Phase III trial (ESLIM-01), meeting all endpoints.SAVANNAH, the pivotal global Phase II trial for savolitinib in NSCLC, completed enrollment, to be followed by potential NDA filing to the U.S. FDA by AstraZeneca18 around the end of 2024. Outlook and financial: expecting strong product revenue growth and reduced expenses; substantial cash Total revenue up 97% (102% at CER19) to $838.0 million for 2023, with Oncology/​Immunology consolidated revenue up 223% (228% at CER) to $528.6 million at high end of guidance, including recognition of $280 million of the upfront payment from Takeda. Net income attributable to HUTCHMED of $100.8 million.2024 Oncology/Immunology consolidated revenue guidance of $300 million to $400 million, driven by 30% to 50% growth target in marketed product sales and royalties.R&D expenses focused in line with strategy targeting key projects.Strengthened cash balance, with $886.3 million at year end (2022: $631.0m), ensures HUTCHMED is well placed to deliver on its objective of becoming a self-sustaining business. 2023 FULL YEAR RESULTS & BUSINESS UPDATES Mr Simon To, Executive Chairman of HUTCHMED, said, “We have made significant progress throughout 2023. We executed against our commitment to bring our innovative medicines to patients worldwide with the U.S. FDA approval of FRUZAQLA™ in November 2023, while remaining dedicated to becoming a self-sustaining business. The Takeda partnership, which is one of the biggest small-molecule overseas licensing deals in the history of China biotech, strengthened our cash position by $435 million. Takeda delivered a successful U.S. launch within 48 hours of approval, and has subsequently seen strong early patient uptake.” “We will continue to deliver on our strategy in 2024. We will stay focused on our target of becoming sustainable through our balanced strategy of growing sales of our novel medicines in China, and advancing our medicines overseas with our partners. This, when combined with our other goals on pipeline progression and further business development, means that while the global macroeconomic environment remains uncertain, HUTCHMED is positioned to thrive and continue to deliver innovative medicines to ever more patients around the world.” Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “HUTCHMED delivered impressive financial results in 2023, with revenue up 97% to $838 million. This, alongside our significantly strengthened cash balance of $886 million, will enable us to continue advancing our pipeline and successfully executing our strategy.” “2023 was an important year for HUTCHMED, particularly for fruquintinib, for which we filed market authorization applications in the U.S., EU and Japan, based on the successful FRESCO-2 study. Following the U.S. FDA approval for third-line patients with advanced CRC, we continue to work together with Takeda to pursue additional launches in new markets worldwide. In China, we also filed an NDA for second-line gastric cancer based on the FRUTIGA study.” “Another milestone was the successful ESLIM-01 registration study in China in ITP patients for sovleplenib, our first potential novel medicine in immunological diseases. The NDA was accepted and granted priority review by the NMPA in January 2024. There are over 250,000 new and existing adult ITP patients in China20. The treatment options are limited to steroids and TPO/TPO-RAs21, representing an unmet medical need that sovleplenib could help address, with its new mechanism of action and favorable safety profile. Syk inhibition has the potential to target other major diseases such as rheumatoid arthritis. We are also planning to initiate clinical development of sovleplenib outside China in 2024.” “For savolitinib, we completed the confirmatory trial in NSCLC patients with MET22 exon 14 skipping alterations. An NDA submission is expected in the first quarter of 2024, with potential to expand the label indication to include first-line patients in China. Outside China, we will continue our work with AstraZeneca on the pivotal global savolitinib lung cancer trial SAVANNAH, which, subject to favorable data, can support a filing to the U.S. FDA for approval. This study completed enrollment with a potential NDA submission towards the end of 2024 in EGFR23 mutant NSCLC patients who progressed on TAGRISSO® treatment, which received U.S. FDA Fast Track designation in January 2023. We believe the convenient dosing, targeted efficacy and safety profile of savolitinib as an oral medicine in combination with TAGRISSO®, the leading oral third-generation EGFR TKI24, should position it well in a competitive market and address the unmet needs of MET+ NSCLC patients.” "Our China commercialization efforts progressed well, as we successfully renewed NRDL25 coverage for both fruquintinib and surufatinib without further price reduction. Their in-market sales saw strong growth in 2023. Over the next two years, we plan to continue growth in China through expanded indications and the launch of new products together with revenue from FRUZAQLA™ overseas commercialization.” I. COMMERCIAL OPERATIONS Total revenue increased 97% (102% at CER) to $838.0 million in 2023 (2022: $426.4m), driven by the Takeda partnership, our strong commercial progress in China, and growth in third-party distribution sales, resulting in a net income of $101 million for 2023. Oncology/Immunology consolidated revenue were up 223% (228% at CER) to $528.6 million (2022: $163.8m); towards the high end of our guidance, driven by recognition of $280.0 million in partnering revenue for the upfront payment, $32.0 million for U.S. FDA approval milestone payments from Takeda, and our strong product sales growth resulting from in-market sales up 28% (35% at CER) to $213.6 million (2022: $167.1m); ELUNATE® (fruquintinib China) in-market sales in 2023 increased 15% (22% at CER) to $107.5 million (2022: $93.5m), reflecting its continued lead in market share;FRUZAQLA™ (fruquintinib U.S.) in-market sales in 2023 were $15.1 million, reflecting its U.S. launch in November 2023;SULANDA® (surufatinib) in-market sales in 2023 increased 36% (43% at CER) to $43.9 million (2022: $32.3m), reflecting its growing market share after two years on the NRDL;ORPATHYS® (savolitinib) in-market sales in 2023 increased 12% (19% at CER) to $46.1 million (2022: $41.2m). Sales in the first quarter were impacted by customary channel fluctuations ahead of its NRDL inclusion on March 1, with the subsequent three quarters of 2023 up 30% compared to the same period in 2022;R&D services income up 116% (119% at CER) to $52.4 million (2022: $24.2m), now also including fees from our new partner Takeda for the management of regulatory activities;Takeda upfront payment of $400.0 million received, of which $280.0 million recognized in revenue during 2023, with the remainder to be recognized when services and performance obligations are completed; andSuccessful management of commercial operations to expand coverage of oncology hospitals and physicians, despite challenges from COVID-19-related disruptions around the start of the year, and from an anti-corruption crackdown of the healthcare sector in China in the second half of 2023. Hospital access and related activities became more restricted, but improved starting in October 2023. $’millionsIn-market Sales*Consolidated Revenue** 20232022%Δ(CER) 20232022%Δ(CER)ELUNATE®$107.5$93.5+15%(+22%)$83.2$69.9+19%(+26%)FRUZAQLA™$15.1– –$7.2– –SULANDA®$43.9$32.3+36%(+43%)$43.9$32.3+36%(+43%)ORPATHYS®$46.1$41.2+12%(+19%)$28.9$22.3+30%(+37%)TAZVERIK®$1.0$0.1>700% $1.0$0.1>700% Products Revenue$213.6$167.1+28%(+35%)$164.2$124.6+32%(+39%)Other R&D services income $52.4$24.2+116%(+119%)Upfront and milestone income $312.0$15.0 Total Oncology/​Immunology $528.6$163.8+223%(+228%)Other Ventures $309.4$262.6+18%(+24%)Total revenue $838.0$426.4+97%(+102%)* = For ELUNATE®, FRUZAQLA™ and ORPATHYS®, mainly represents total sales to third parties as provided by Lilly26, Takeda and AstraZeneca, respectively.** = For ELUNATE®, represents drug product supply, commercial service fees and royalties paid by Lilly, to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; for FRUZAQLA™, represents drug product supply and royalties paid by Takeda; for ORPATHYS®, represents drug product supply and royalties paid by AstraZeneca and sales to other third parties invoiced by HUTCHMED; for SULANDA® and TAZVERIK®, represents the Company’s sales of the products to third parties. II. REGULATORY UPDATES China Fruquintinib NDA accepted in combination with paclitaxel for second-line gastric cancer in April 2023;Sovleplenib NDA accepted for primary ITP in January 2024, after receiving priority review status in 2023;Fruquintinib received Breakthrough Therapy designation in combination with sintilimab for second-line endometrial cancer in July 2023;Fruquintinib received Hong Kong approval for third-line CRC in January 2024; andORPATHYS® (savolitinib) and TAZVERIK® (tazemetostat) received Macau approvals in March 2023. Ex-China Fruquintinib U.S. FDA approved in November 2023 for previously treated metastatic CRC, after the NDA was granted priority review in May 2023;Fruquintinib NDA submitted to the Japanese PMDA in September 2023;Fruquintinib MAA submission to the EMA validated in June 2023; andSavolitinib, in combination with TAGRISSO®, designated a U.S. FDA Fast Track program in January 2023 for the treatment of patients with NSCLC with MET overexpression and/or amplification, and who have had disease progression during or following prior TAGRISSO®. III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET being developed broadly across MET-driven patient populations in lung, gastric and papillary renal cell carcinomas Completed enrollment of a pivotal global Phase II study SAVANNAH (NCT03778229) for NSCLC patients who have progressed following TAGRISSO® due to MET amplification or overexpression designated as a Fast Track development program by the U.S. FDA, with the possibility of accelerated approval. Continued enrolling SAFFRON (NCT05261399), a global, pivotal Phase III study of the TAGRISSO® combination supporting SAVANNAH;Reported positive results from the confirmatory China Phase IIIb study (NCT04923945) first-line cohort in MET exon 14 skipping alteration NSCLC; completed enrollment in a second-line cohort; andInitiated the registration stage of a China Phase II study in third-line gastric cancer patients with MET amplification (NCT04923932).Potential upcoming clinical and regulatory milestones for savolitinib: Submit China NDA for first-line and second-line MET exon 14 skipping alteration NSCLC in early-2024;Complete enrollment of SACHI (NCT05015608), a pivotal Phase III study of the TAGRISSO® combination in China for NSCLC patients with MET amplification following progression on EGFR inhibitor treatment in late 2024;Complete enrollment of SANOVO (NCT05009836), a pivotal Phase III study of the TAGRISSO® combination in China in first-line NSCLC patients with EGFR mutation & MET overexpression in late 2024; andEngage U.S. FDA regarding possible NDA filing on SAVANNAH, subject to positive results, around year end 2024. Fruquintinib (ELUNATE® in China, FRUZAQLA™ in the U.S.), a highly selective oral inhibitor of VEGFR27 1/2/3 designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of a combination therapy Presented FRUTIGA (NCT03223376) results at ASCO28 Plenary in February 2024 in second-line gastric cancer patients on fruquintinib plus paclitaxel. PFS29, ORR30 and DCR31 endpoints showed statistically significant improvements. Although OS32 improvement was not statistically significant overall, it was statistically significant in a pre-specified analysis excluding patients taking subsequent antitumor therapy;Completed enrollment of FRUSICA-1 (NCT03903705), a China endometrial cancer registration cohort of a Phase II study of fruquintinib in combination with PD-133 antibody sintilimab in July 2023;Completed enrollment of FRUSICA-2 (NCT05522231), a China Phase II/III study of fruquintinib in combination with PD-1 antibody sintilimab in clear cell RCC in December 2023;Updated results from the clear cell RCC cohort of a China Phase II study on fruquintinib in combination with PD-1 antibody sintilimab at ASCO 2023 (NCT03903705); andPublished in peer-reviewed journal The Lancet positive results of the global Phase III FRESCO-2 registration trial (NCT04322539) in previously treated metastatic CRC patients in June 2023.Potential upcoming clinical and regulatory milestones for fruquintinib: Completion of EMA MAA review for previously-treated metastatic CRC in mid-2024;Completion of PMDA NDA review for previously-treated metastatic CRC in late-2024;Registration filing to the NMPA for second-line endometrial cancer in early 2024; andTop-line results from Phase II/III registration trial in clear cell RCC around year end 2024. Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR, FGFR34 and CSF-1R35 designed to inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation Reported data from the Phase Ib/II China toripalimab (PD-1 antibody) combination study at the 2023 AACR36 and ASCO annual meetings (NCT04169672); andReported encouraging early results at ASCO 2023 of an investigator-initiated trial of surufatinib in combination with a PD-1 antibody and chemotherapy in first-line treatment for pancreatic ductal adenocarcinoma. Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk, an important component of the Fc receptor and B-cell receptor signaling pathway Met primary endpoint and all secondary endpoints for a pivotal Phase III study (NCT05029635) in adult patients with primary ITP in China; andMet primary endpoint for a Phase II Proof-of-Concept study in warm AIHA37 in China (NCT05535933) with Phase III registration study being planned.Potential upcoming clinical milestones for sovleplenib: Submit ESLIM-01 results for publication and/or presentation in mid-2024; andInitiate a dose-finding study in ITP in the U.S./EU in mid-2024. Tazemetostat (TAZVERIK® in Macau and the China Hainan Pilot Zone), a first-in-class, oral inhibitor of EZH2 licensed from Ipsen38 Completed recruitment of a China bridging study in follicular lymphoma for conditional registration based on U.S. approvals in September 2023 (NCT05467943);Approved and launched in the Macau Special Administrative Region in March 2023; andPublished promising results from the Phase Ib portion of SYMPHONY-1, a global Phase 1b/III combination study in relapsed/refractory follicular lymphoma patients after at least two prior therapies (NCT04224493). ORR was 90.9%, and in the recommended Phase III dose cohort, 18-month PFS and DoR39 estimates were 94.4% and 100% with no dose-limiting toxicities.Potential upcoming clinical and regulatory milestones for tazemetostat: China NDA filing for relapsed/refractory 3L+ follicular lymphoma expected in mid-2024. HMPL-453, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3 Reported human data for the first time at the 2023 ASCO annual meeting; andAfter consultation with NMPA, initiated the registration phase of the ongoing Phase II trial for IHCC40 patients with FGFR 2 fusion (NCT04353375). Amdizalisib (HMPL-689), an investigative and highly selective oral inhibitor of PI3Kδ41 designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3Kδ inhibitors Met primary endpoint of ORR in the follicular lymphoma cohort of a China registration Phase II study with Breakthrough Therapy designation (NCT04849351). However, in recent discussions with China NMPA, it is clear that a randomized study is now required to support registration. In view of the changing regulatory requirement, we are currently evaluating the clinical development plan and regulatory guidance before deciding the regulatory strategy for this indication. IV. COLLABORATION UPDATES Closed Exclusive Worldwide License to Takeda for Fruquintinib Outside China Takeda is responsible for development, manufacturing and commercialization in all indications and territories outside of mainland China, Hong Kong and Macau; andHUTCHMED is eligible to receive up to $1.13 billion, including the $400 million upfront received in April 2023, and up to $730 million in additional potential payments relating to regulatory, development and commercial sales milestones, of which a $35 million milestone payment was received in December 2023 after the approval by the U.S. FDA, as well as manufacturing income and royalties on net sales. Further clinical progress by Inmagene42 with two candidates discovered by HUTCHMED Inmagene initiated two global Phase IIa trials with IMG-007, an anti-OX40 antibody, in adults with moderate-to-severe atopic dermatitis and in adults with alopecia areata. It was safe and well-tolerated in the completed Phase I study with no reports of pyrexia or chills, which are common adverse events of rocatinlimab, another anti-OX40 treatment;Inmagene completed a Phase I study with IMG-004, a reversible, non-covalent, highly selective oral BTK43 inhibitor designed to target immunological diseases. IMG-004 was safe and well-tolerated in this single-ascending-dose study, with a long half-life and sustained pharmacodynamic effects that are well above others in its class; andInmagene exercised options for an exclusive license to further develop, manufacture and commercialize these two drug candidates worldwide subject to completion of a share subscription agreement signed in February 2024 for approximately 7.5% of Inmagene shares (fully diluted). V. OTHER VENTURES Other Ventures include our profitable prescription drug marketing and distribution platforms Consolidated revenue increased by 18% (24% at CER) to $309.4 million (2022: $262.6m);SHPL44 non-consolidated joint venture revenue increased by 4% (10% at CER) to $385.5 million (2022: $370.6m);Consolidated net income attributable to HUTCHMED from our Other Ventures decreased by 8% (3% at CER) to $50.3 million (2022: $54.6m), which was primarily due to decrease on the net income contributed from SHPL of $47.4 million (2022: $49.9m) resulting from the impact of gradual price adjustment from volume-based procurement;Disposed interests in HHOHK45 and HSN46 for $5.1 million; andWe continue to explore opportunities to monetize the underlying value of our SHPL joint venture including various divestment and equity capital market alternatives. VI. SUSTAINABILITY HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders. In 2023, we continued to make progress, including: Satisfactory progress made in 11 short- to long-term goals and targets; sustainability performance on goals and targets continued to be incorporated into management’s performance-based remuneration;Enhanced climate actions by conducting Scope 3 emissions screening and measurement, and engaging with suppliers to gradually implement sustainability initiatives collaboratively. Following the climate risk assessment in 2022, regular monitoring and reviews on climate risks and opportunities have been undertaken; our climate actions continue to be disclosed in alignment with the recommendations of the Task Force on Climate-related Financial Disclosures (TCFD);Enhanced data quality by introducing a digital data collection platform to streamline collecting, managing, and reporting data, ensuring improved data reliability, comparability and transparency;Strengthened alignment in the five key sustainability pillars which encompassed the most relevant and material sustainability topics for HUTCHMED, including (i) climate action; (ii) access to healthcare; (iii) human capital; (iv) ethics and transparency; and (v) innovation;Marked improvements shown in major ESG ratings and awards, reflecting wider recognition of HUTCHMED’s efforts in sustainability; andEnhanced disclosure by referencing the latest sustainability disclosure standards and sector specific disclosure standards ahead of requirement. These efforts will continue to guide HUTCHMED towards a more sustainable future. The 2023 Sustainability Report will be published alongside our 2023 Annual Report in April 2024 and will include further information on HUTCHMED sustainability initiatives and their performance. VII. IMPACT OF COVID-19 While restrictive measures related to COVID-19 were gradually lifted in China starting from December 2022, COVꞮD-19 had some impact on our research, clinical studies and our commercial activities in the first few months of 2023. Measures were put in place to reduce the impact and, in the second quarter of 2023, these activities normalized. FINANCIAL HIGHLIGHTS Foreign exchange impact: The RMB depreciated against the U.S. dollar on average by approximately 5% during 2023, which has impacted our consolidated financial results as highlighted below. Cash, Cash Equivalents and Short-Term Investments were $886.3 million as of December 31, 2023 compared to $631.0 million as of December 31, 2022. Adjusted Group (non-GAAP47) net cash flows excluding financing activities in 2023 were $206.7 million (2022: -$297.9m) mainly due to the receipt of $435 million in upfront and milestone payments from Takeda; andNet cash generated from financing activities in 2023 totaled $48.7 million mainly due to the drawdowns of bank borrowings (2022: net cash used in financing activities of $82.8m). Revenue for the year ended December 31, 2023 were $838.0 million compared to $426.4 million in 2022. Oncology/Immunology consolidated revenue increased 223% (228% at CER) to $528.6 million (2022: $163.8m) resulting from: ELUNATE® revenue increased 19% (26% at CER) to $83.2 million (2022: $69.9m) due to continued market share gains, comprising of manufacturing revenue, promotion and marketing service revenue and royalties;FRUZAQLA™ revenue was $7.2 million, reflecting its U.S. launch in early November 2023, comprising of manufacturing revenue and royalties;SULANDA® revenue increased 36% (43% at CER) to $43.9 million (2022: $32.3m) from our continuing marketing activities, increasing patient access and longer durations of treatment;ORPATHYS® revenue increased 30% (37% at CER) to $28.9 million (2022: $22.3m) after inclusion in the NRDL effective from March 2023, comprising of manufacturing revenue and royalties;TAZVERIK® revenue was $1.0 million (2022: $0.1m) from further sales in the Hainan Pilot Zone;Partnering revenue of $312.0 million was the $280 million recognized portion of the $400 million upfront payment, and the $32 million recognized portion of the US$35 million milestone payment from Takeda; andOther R&D services income of $52.4 million (2022: $24.2m), primarily related to fees from AstraZeneca, Lilly and Takeda for the management of development and regulatory activities. Other Ventures consolidated revenue increased 18% (24% at CER) to $309.4 million (2022: $262.6m), mainly due to higher sales of prescription drugs. This excludes 4% (10% at CER) growth in non-consolidated revenue at SHPL of $385.5 million (2022: $370.6m). Net Expenses for 2023 were $737.2 million compared to $787.2 million in 2022. Cost of Revenue increased by 24% to $384.4 million (2022: $311.1m), of which cost of revenue from our Other Ventures increased by 21% to $292.7 million (2022: $241.9m) due to the increasing sales of third-party prescription drug products. Cost of revenue from Oncology/Immunology increased by 33% to $91.7 million (2022: $69.2m) due to the increase in product sales of our marketed products and the cost of provision of promotion and marketing services for ELUNATE® resulting from the increased sales force;R&D Expenses reduced 22% to $302.0 million (2022: $386.9m), mainly due to the completion of several large registration-enabling trials, the focus on ex-China development through partnerships, and the ongoing strategic prioritization of our pipeline. Our international clinical and regulatory operations in the U.S. and Europe incurred expenses of $106.9 million (2022: $170.9m), while R&D expenses in China were $195.1 million (2022: $216.0m);SG&A48 Expenses were $133.2 million (2022: $136.1m), which decreased primarily due to the restructuring of our U.S. Oncology/Immunology commercial operations at the end of 2022 while our China commercial infrastructure was able to support further revenue growth; andOther Items mainly comprised of equity in earnings of SHPL, interest income and expense, FX and taxes, generated net income of $82.4 million (2022: $46.9m), which increased primarily due to higher interest income after receiving the $400 million Takeda upfront payment. Net Income attributable to HUTCHMED for 2023 was $100.8 million compared to Net Loss attributable to HUTCHMED of $360.8 million in 2022. The net income attributable to HUTCHMED in 2023 was $0.12 per ordinary share / $0.59 per ADS49, compared to net loss attributable to HUTCHMED of $0.43 per ordinary share / $2.13 per ADS in 2022. FINANCIAL SUMMARY Condensed Consolidated Balance Sheets Data(in $’000) As of December 31, 2023 2022Assets Cash and cash equivalents and short-term investments886,336 630,996Accounts receivable116,894 97,988Other current assets93,609 110,904Property, plant and equipment99,727 75,947Investments in equity investees48,411 73,777Other non-current assets34,796 39,833Total assets1,279,773 1,029,445Liabilities and shareholders’ equity Accounts payable36,327 71,115Other payables, accruals and advance receipts271,399 264,621Deferred revenue127,119 13,537Bank borrowings79,344 18,104Other liabilities22,197 25,198Total liabilities536,386 392,575Company’s shareholders’ equity730,541 610,367Non-controlling interests12,846 26,503Total liabilities and shareholders’ equity1,279,773 1,029,445 Condensed Consolidated Statements of Operations Data(in $’000, except share and per share data) Year Ended December 31, 2023 2022 Revenue: Oncology/Immunology – Marketed Products164,165 124,642 Oncology/Immunology – R&D364,451 39,202 Oncology/Immunology consolidated revenue528,616 163,844 Other Ventures309,383 262,565 Total revenue837,999 426,409 Operating expenses: Cost of revenue(384,447) (311,103)Research and development expenses(302,001) (386,893)Selling and general administrative expenses(133,176) (136,106)Total operating expenses(819,624) (834,102) Other income/(expense), net39,933 (2,729)Income/(loss) before income taxes and equity in earnings of equity investees58,308 (410,422)Income tax (expense)/benefit(4,509) 283 Equity in earnings of equity investees, net of tax47,295 49,753 Net income/(loss)101,094 (360,386)Less: Net income attributable to non-controlling interests(314) (449)Net income/(loss) attributable to HUTCHMED100,780 (360,835) Earnings/(losses) per share attributable to HUTCHMED (US$ per share) – basic 0.12 (0.43)– diluted0.12 (0.43)Number of shares used in per share calculation – basic849,654,296 847,143,540 – diluted869,196,348 847,143,540 Earnings/(losses) per ADS attributable to HUTCHMED (US$ per ADS) – basic 0.59 (2.13)– diluted0.58 (2.13)Number of ADSs used in per share calculation – basic169,930,859 169,428,708 – diluted173,839,270 169,428,708 OUTLOOK AND FINANCIAL GUIDANCE 2023 was an impressive year for HUTCHMED, in large part due to the upfront payment of $400 million received from Takeda, of which $280 million was recognized in revenue during 2023, with the remainder to be recognized when services and performance obligations are completed over approximately three years. Full year 2024 guidance for Oncology/Immunology consolidated revenue is $300 million to $400 million, driven by 30% to 50% growth target in oncology marketed product revenue. HUTCHMED’s work in 2024 and beyond will be supported by its strong balance sheet, which grew by $255 million to $886 million in Cash, Cash Equivalents and Short-Term Investments as of December 31, 2023. The Company is thus well placed to deliver against its target to become a self-sustaining business and its goal to bring its innovative medicines to patients globally through its own sales network in China markets and through partners worldwide. Shareholders and investors should note that: we do not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; andwe have in the past revised our financial guidance and reference should be made to any announcements published by us regarding any updates to the financial guidance after the date of publication of this announcement. Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively. Conference calls and audio webcast presentations scheduled today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English. In addition to the usual English webcast, there will also be a Chinese (Putonghua) webcast at 8:30 a.m. HKT on Thursday, February 29, 2024. After registering, investors may access a live audio webcast of the call via HUTCHMED’s website at www.hutch-med.com/event/. Participants who wish to join the call by telephone and ask a question must register. Upon registration, each participant will be provided with dial-in numbers and a unique PIN. FINANCIAL STATEMENTS HUTCHMED will today file with the U.S. Securities and Exchange Commission its Annual Report on Form 20-F. About HUTCHMED HUTCHMED (Nasdaq/AIM: ​HCM; HKEX: ​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology medicines now approved marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Contacts Investor Enquiries+852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon+44 (20) 7886 2500 References Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context. Past Performance and Forward-Looking Statements The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which have been obtained will continue to remain valid and effective in the future, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, “HUTCHMED’s Products”) will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally, including, among others, the risk that HUTCHMED’s ADSs could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED’s Products after obtaining regulatory approval; discovery, development and/or commercialization of competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED’s Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED’s Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED’s Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED’s Products; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates and uncertainties regarding the impact of pandemics and disease outbreaks. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on HKEX50. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above. Inside Information This announcement contains inside information for the purposes of Article 7 of Regulation (E.U.) No 596/2014 (as it forms part of retained E.U. law as defined in the European Union (Withdrawal) Act 2018). Medical Information This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. This announcement in its entirety is available at: http://ml.globenewswire.com/Resource/Download/2764a8e2-c30d-4c40-ae43-56309cc71d54 REFERENCES AND ABBRIVATIONS 1. Takeda = Takeda Pharmaceuticals International AG, a subsidiary of Takeda Pharmaceutical Company Limited.2. R&D = Research and development.3. NDA = New Drug Application.4.NSCLC = Non-small cell lung cancer.5.FDA = Food and Drug Administration.6.PDUFA = U.S. Prescription Drug User Fee Act.7.CRC = Colorectal cancer.8.NCCN = National Comprehensive Cancer Network.9.In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), Takeda (FRUZAQLA™), AstraZeneca (ORPATHYS®) and HUTCHMED (ELUNATE®, SULANDA®, ORPATHYS® and TAZVERIK®).10.MAA = Marketing Authorization Application.11.EMA = European Medicines Agency.12.PMDA = Pharmaceuticals and Medical Devices Agency.13.EMC = Endometrial cancer.14.RCC = Renal cell carcinoma.15.NMPA = National Medical Products Administration.16.Syk = Spleen tyrosine kinase.17.ITP = Immune thrombocytopenia purpura.18.AstraZeneca = AstraZeneca AB, a subsidiary of AstraZeneca plc.19.CER = Constant exchange rate. We also report changes in performance at CER which is a non-GAAP measure. Please refer to “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures.20.Source: IQVIA. Report on file.21.TPO = Thrombopoietin; TPO-RAs = Thrombopoietin receptor agonists.22.MET = Mesenchymal epithelial transition factor.23.EGFR = Epidermal growth factor receptor.24.TKI = Tyrosine kinase inhibitor.25.NRDL = National Reimbursement Drug List.26.Lilly = Eli Lilly and Company.27.VEGFR = Vascular endothelial growth factor receptor.28.ASCO = American Society of Clinical Oncology.29.PFS = Progression free survival.30.ORR = Objective response rate.31.DCR = Disease control rate.32.OS = Overall survival.33.PD-1 = Programmed cell death protein-1.34.FGFR = Fibroblast growth factor receptor.35.CSF-1R = Colony-stimulating factor 1 receptor.36.AACR = American Association for Cancer Research.37.AIHA = Autoimmune hemolytic anemia.38.Ipsen = Ipsen SA, parent of Epizyme Inc.39.DoR = Duration of response.40.IHCC = Intrahepatic cholangiocarcinoma.41.PI3Kδ = Phosphoinositide 3-kinase delta.42.Inmagene = Inmagene Biopharmaceuticals.43.BTK = Bruton tyrosine kinase.44.SHPL = Shanghai Hutchison Pharmaceuticals Limited.45.HHOHK = Hutchison Hain Organic (Hong Kong) Limited.46.HSN = HUTCHMED Science Nutrition Limited.47.GAAP = Generally Accepted Accounting Principles.48.SG&A= Selling, general, and administrative expenses.49.ADS = American depositary share.50.HKEX = The Main Board of The Stock Exchange of Hong Kong Limited.

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 Markets Day in Q4 this year HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., July 31, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical company, today reports its unaudited financial results for the six months ended June 30, 2023 and provides updates on key clinical and commercial developments. All amounts are expressed in U.S. dollars unless otherwise stated. Strategic: clinical, financial, and regulatory progress demonstrates strong delivery on the strategy Focusing on driving near-term value creation and establishing a self-sustaining business over the long term, with the goal of bringing innovative medicines to patients around the world.Significant progress towards bringing medicines to patients outside China through global partnerships: closed fruquintinib license agreement with Takeda1 in March, which can potentially bring in up to $1.13 billion in payments including $400 million upfront payment received, plus royalties on net sales. Product & pipeline: fruquintinib advancing to global launches, with continued progress across portfolio NDA2 for fruquintinib granted priority review by the U.S. FDA3, with a PDUFA4 goal date of November 30, 2023. Takeda preparing for fruquintinib launches worldwide with MAA5 validated by the EMA6 in June and the Japan NDA submission planned this year. Global regulatory filings supported by results from FRESCO-2, recently published in The Lancet, and data from FRESCO.Fruquintinib NDA for second-line gastric cancer accepted in China, where fruquintinib is available and reimbursed under the brand name ELUNATE® for the treatment of metastatic CRC7; Breakthrough Therapy Designation in endometrial cancer.All three HUTCHMED medicines marketed in China now included in the NRDL8.Registration study readouts expected in the second half for two potential new medicines in China, sovleplenib and amdizalisib. New registration studies initiated for savolitinib in gastric cancer and HMPL-453 for IHCC9; over 15 registration studies ongoing, across seven drug candidates.Productive discovery research continues, with another novel drug candidate in clinical development (SHP210 inhibitor HMPL-415). Financial: HUTCHMED remains on track to become self-sustaining in 2025 Total revenues up 164% (173% at CER11) to $532.9 million for the first half of 2023, with Oncology/​Immunology consolidated revenues up 294% (301% at CER) to $359.2 million.Strategy has allowed HUTCHMED to conserve cash and significantly reduce costs, with a substantial cash balance of $856.2 million on June 30, 2023 including $400 million received from Takeda.$258.7 million of the Takeda upfront payment recognized as revenue in the first half of 2023, resulting in net income of $168.6 million; we expect to recognize approximately $280 million of this payment for the full year.R&D12 expenses decreased primarily due to our portfolio optimization efforts, while the reduction in SG&A expenses13 was mainly due to decreased administrative expenses after restructuring our U.S. operations. 2023 INTERIM RESULTS & BUSINESS UPDATES Mr Simon To, Executive Chairman of HUTCHMED, said, “The first half of 2023 has been successful for HUTCHMED. In late 2022, we announced our pipeline prioritization plan and intention to seek global partners to bring our medicines to help patients outside of China. Six months later, this strategy is already delivering significant results to our operations. We are successfully navigating the current challenging capital markets, while making significant progress towards our goal of becoming a self-sustaining, truly global biopharma company. Crucially, it means that we are well positioned to reach more patients than ever with our medicines.” “In March, we closed a licensing deal for fruquintinib with Takeda and we are confident that they have the commitment, expertise, and commercial infrastructure to successfully roll out this innovative medicine to patients across the globe. The FDA Priority Review PDUFA date for fruquintinib is now set for November 30 this year, reflecting its potential to deliver significant improvement over currently available treatments.” Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “With the sharpening of our goals and priorities, we now have more resources to advance our assets and drive near-term value, and we are pleased to report on the important progress made so far this year. We have over 15 registration/​registration-intent studies ongoing with seven drug candidates. Alongside this, our team has presented data at a number of leading medical conferences, including AACR14, ASCO15, ASCO GI16, EHA17 and ICML18, showcasing the productivity of our world class R&D engine. Furthermore, commercial performance has remained strong this year, with robust sales growth of our in-house developed oncology products in China. All three marketed medicines are now included on the NRDL, in line with our commitment to patient access. Moreover, our strategy means we are in a strong financial position as we look to continue developing our clinical programs. We started the second half of 2023 with $856 million in cash resources, including the $400 million received from Takeda.” “HUTCHMED is now well placed for further successful product launches and life cycle extensions. In particular, we look forward to continuing the positive momentum with fruquintinib regulatory reviews around the world, and readouts from our registration studies for sovleplenib and amdizalisib later this year. As the last six months have shown, HUTCHMED clearly has the right strategy, leadership team, and vision to become a truly global biopharma, and I am confident that HUTCHMED will continue to deliver on this potential.” I. COMMERCIAL OPERATIONS Total revenues increased 164% (173% at CER) to $532.9 million in the first half of 2023 (H1-22: $202.0m), driven by Oncology/Immunology partnering, its strong commercial progress in China, and growth in third-party distribution sales. Oncology/Immunology consolidated revenues were up 294% (301% at CER) to $359.2 million (H1-22: $91.1m); driven by recognition of $258.7 million in partnering revenue for the upfront payment from Takeda, and our strong product sales growth resulting from in-market sales19 up 16% (25% at CER) to $101.3 million (H1-22: $87.4m); ELUNATE® (fruquintinib) in-market sales in the first half of 2023 increased 12% (20% at CER) to $56.3 million (H1-22: $50.4m), reflecting its continued lead in market share;SULANDA® (surufatinib) in-market sales in the first half of 2023 increased 66% (79% at CER) to $22.6 million (H1-22: $13.6m), reflecting the build-up in patients on treatment over 18 months on the NRDL;ORPATHYS® (savolitinib) in-market sales in the first half of 2023 decreased 5% (increased 2% at CER) to $22.0 million (H1-22: $23.3m). Sales in the first quarter were impacted by customary channel fluctuations ahead of its NRDL inclusion on March 1, subsequently followed by an increase in sales volume, with the second quarter of 2023 up 84% compared to the second quarter of 2022;R&D services income up 62% (66% at CER) to $20.4 million (H1-22: $12.6m), now also including fees from our new partner Takeda for the management of regulatory activities;Takeda upfront payment of $400.0 million received, of which $250.1 million (62%) attributable to the license was recognized immediately. The remaining balance will be recognized when ongoing services and performance obligations are completed. Up to June 2023, we have recognized an aggregate of $258.7 million to revenue and expect around $280 million by year end; andSuccessful management of commercial operations to expand coverage of oncology hospitals and physicians despite challenges of pandemic-related disruptions around the start of the year. $’millionsIn-market Sales*Consolidated Revenues** H1 2023H1 2022 %Δ(CER)H1 2023H1 2022 %Δ(CER) Unaudited Unaudited ELUNATE® $56.3$50.4+12%(+20%)$42.0$36.0+16%(+25%)SULANDA® $22.6$13.6+66%(+79%)$22.6$13.6+66%(+79%)ORPATHYS® $22.0$23.3-5%(+2%)$15.1$13.8+10%(+17%)TAZVERIK®$0.4$0.1+560%(+583%)$0.4$0.1+560%(+583%)Products Sales$101.3$87.4+16%(+25%)$80.1$63.5+26%(+35%)Other R&D services income $20.4$12.6+62%(+66%)Upfront and milestone income $258.7$15.0 Total Oncology/​Immunology $359.2$91.1+294%(+301%)Other Ventures $173.7$110.9+57%(+67%)Total revenues $532.9$202.0+164%(+173%)* = For ELUNATE® and ORPATHYS®, represents total sales to third parties as provided by Lilly20 and AstraZeneca, respectively; and their sales to other third parties as invoiced by HUTCHMED.** = For ELUNATE®, represents manufacturing fees, commercial service fees and royalties paid by Lilly, to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; for ORPATHYS® represents manufacturing fees and royalties paid by AstraZeneca and sales to other third parties invoiced by HUTCHMED; for SULANDA® and TAZVERIK®, represents the Company’s sales of the products to third parties. II. REGULATORY UPDATES China NDA accepted in China in second-line gastric cancer for fruquintinib in combination with paclitaxel in April 2023;Designated Breakthrough Therapy in China for fruquintinib in combination with sintilimab in July 2023 for the treatment of advanced endometrial cancer;Consulted with NMPA21 on the registration study plan of HMPL-453 for IHCC in March 2023;Consulted with NMPA on registration study plan of savolitinib for gastric cancer in March 2023; andReceived Macau approvals for tazemetostat and savolitinib in March 2023. Ex-China Fruquintinib submission to U.S. FDA accepted in May 2023 and granted Priority Review for previously treated metastatic CRC. The PDUFA goal date assigned by the FDA is November 30, 2023;Fruquintinib submission to the EMA was validated in June 2023;Fruquintinib submission to the Japanese PMDA22 expected to be completed in 2023;Savolitinib, in combination with TAGRISSO®, designated a U.S. FDA Fast Track program in January 2023 for the treatment of patients with NSCLC23 with MET24 overexpression and/or amplification, and who have had disease progression during or following prior TAGRISSO®; andFollowing dialogue with the PMDA regarding surufatinib, we have decided not to file a Japanese NDA on the basis of the clinical trial data available. III. CLINICAL DEVELOPMENT ACTIVITIES Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET being developed broadly across MET-driven patient populations in lung, gastric and papillary renal cell carcinomas Aligned with FDA and enrolling the pivotal Phase II study SAVANNAH for potential accelerated approval of the TAGRISSO® combination for NSCLC MET patients following progression on TAGRISSO® (NCT03778229);Completed enrollment of the confirmatory China Phase IIIb study in MET exon 14 skipping alteration NSCLC in both first-line and second-line and above patients (NCT04923945);After consultation with NMPA, initiated the registration stage of a China Phase II study in second-line gastric cancer patients with MET amplification (NCT04923932); andContinued enrolling five other registration studies, including SAFFRON, the global, pivotal Phase III study of the TAGRISSO® combination supporting SAVANNAH (NCT05261399); SACHI, a pivotal Phase III study of the TAGRISSO® combination in China for NSCLC patients with MET amplification following progression on EGFR25 inhibitor treatment (NCT05015608); SANOVO, a pivotal Phase III study of the TAGRISSO® combination in China in first-line NSCLC patients harboring EGFR mutation and MET overexpression (NCT05009836); and SAMETA, a global Phase III study in MET-driven PRCC26 (NCT05043090).Potential upcoming clinical and regulatory milestones for savolitinib: Complete enrollment of SAVANNAH pivotal Phase II study in 2023;Complete enrollment of SOUND, a China Phase II study of the IMFINZI® combination in EGFR wild-type NSCLC patients with MET alterations (NCT05374603) around year end 2023; andComplete recruitment of SACHI, a pivotal Phase III study of the TAGRISSO® combination in China for NSCLC patients with MET amplification following progression on EGFR inhibitor treatment (NCT05015608) in mid-2024. Fruquintinib (ELUNATE® in China), a highly selective oral inhibitor of VEGFR27 1/2/3 designed to improve kinase selectivity to minimize off-target toxicity and thereby improve tolerability Completed recruitment of the endometrial cancer cohort of a China Phase II study of fruquintinib in combination with PD-128 inhibitor sintilimab in July 2023 for potential registration (NCT03903705);Published in peer-reviewed journal The Lancet positive results of the global Phase III FRESCO-2 registration trial (NCT04322539) in previously treated metastatic CRC patients in June 2023; andUpdated results from the clear cell RCC29 cohort of a China Phase II study of fruquintinib in combination with PD-1 inhibitor sintilimab at ASCO 2023, these results led to the Phase II/III trial (NCT05522231).Potential upcoming clinical and regulatory milestones for fruquintinib: Complete NDA submission to the Japanese PMDA in 2023;Submit FRUTIGA results for presentation at a scientific conference (NCT03223376);Consult with NMPA on the results of the ongoing endometrial cancer sintilimab combination Phase II study, which may lead to NDA submission in the first half of 2024; andComplete enrollment of China Phase II/III study of combination with PD-1 inhibitor sintilimab in clear cell RCC (NCT05522231) around year end 2023. Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR, FGFR30 and CSF-1R31 designed to inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation Reported data from the Phase Ib/II China toripalimab combination study at the 2023 AACR and ASCO annual meetings (NCT04169672). Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk32, an important component of the Fc receptor and B-cell receptor signaling pathway Completed enrollment of a Phase II Proof-of-Concept study in warm AIHA33 in China (NCT05535933).Potential upcoming clinical milestones for sovleplenib: Report top-line results from ESLIM-01 China Phase III in primary ITP34 (NCT03951623) in 2023;Decide whether to proceed into Phase I in ITP in US depending on the outcome of China Phase III; andDecide whether to proceed into Phase III in warm AIHA in China or continue dose escalation, depending on the outcome of an upcoming analysis of a Phase II Proof-of-Concept study in warm AIHA. Amdizalisib (HMPL-689), an investigative and highly selective oral inhibitor of PI3Kδ35 designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3Kδ inhibitors Completed recruitment of patients for China registration Phase II study for the treatment of follicular lymphoma (with Breakthrough Therapy Designation) in February 2023 (NCT04849351); andInitiated combination trial with tazemetostat in China in February 2023 (NCT05713110).Potential upcoming clinical and regulatory milestones for amdizalisib: Report top-line results from the China registration Phase II study for the treatment of follicular lymphoma in late 2023. Tazemetostat (TAZVERIK® in Macau and the Hainan Pilot Zone), a first-in-class, oral inhibitor of EZH2 licensed from Ipsen36 subsidiary Epizyme37 in China Approved and launched in the Macau Special Administrative Region in March 2023.Potential upcoming clinical and regulatory milestones for tazemetostat: Complete recruitment of a China bridging study in follicular lymphoma for conditional registration based on U.S. approvals in H2 2023 (NCT05467943). HMPL-453, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3 Reported human data for the first time at the 2023 ASCO annual meeting; andAfter consultation with NMPA, initiated the registration phase of the ongoing Phase II trial for IHCC patients with FGFR 2 fusion (NCT04353375). Earlier stage investigational drug candidates In addition to the seven drug candidates being developed in over 15 registration studies above, HUTCHMED is developing six further oncology candidates in early-stage clinical trials. These are HMPL-306, a highly selective oral inhibitor of IDH1/238 designed to address resistance to currently marketed IDH inhibitors; HMPL-760, a highly selective, third-generation oral inhibitor of BTK39 with improved potency versus first generation BTK inhibitors against both wild type & C481S mutant enzymes; HMPL-295, a highly selective oral inhibitor of ERK40 in the MAPK pathway41 with the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS-RAF-MEK; HMPL-653, an oral, highly selective, and potent CSF-1R inhibitor designed to target CSF-1R driven tumors as a monotherapy or in combinations; HMPL-A83, a differentiated, red blood cell sparing anti-CD47 antibody; and HMPL-415, a novel SHP2 allosteric inhibitor that entered clinical trials in July 2023. Subject to data and consultation with the CDE42, several of these earlier stage drug candidates have potential to move into registration trials in the next 12 months. IV. COLLABORATION UPDATES Closed Exclusive Worldwide License to Takeda for Fruquintinib Outside China Takeda is responsible for development, manufacturing and commercialization in all indications and territories outside of mainland China, Hong Kong and Macau; andHUTCHMED is eligible to receive up to $1.13 billion, including the $400 million upfront received in April 2023, and up to $730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales. Further clinical progress by Inmagene with two candidates discovered by HUTCHMED Inmagene initiating a global, Phase II trial in adults with moderate-to-severe atopic dermatitis with IMG-007, an anti-OX40 antibody. It was safe and well-tolerated in the completed Phase I study with no reports of pyrexia or chills, which are common adverse events of rocatinlimab, another anti-OX40 treatment.Inmagene completed a Phase I study with IMG-004, a reversible, non-covalent, highly selective oral BTK inhibitor designed to target immunological diseases. IMG-004 was safe and well-tolerated in this single-ascending-dose study, with a long half-life and sustained pharmacodynamic effects that are well above others in its class. V. OTHER VENTURES Other Ventures include our profitable prescription drug marketing and distribution platforms Other Ventures consolidated revenues increased by 57% (67% at CER) to $173.7 million (H1-22: $110.9m);SHPL43 non-consolidated joint venture revenues increased by 11% (19% at CER) to $235.3 million (H1-22: $212.4m);Consolidated net income attributable to HUTCHMED from our Other Ventures increased by 5% (12% at CER) to $37.2 million (H1-22: $35.4m), which was primarily due to the net income contributed from SHPL of $35.1 million (H1-22: $33.6m); andWe are exploring opportunities to monetize the underlying value of our SHPL joint venture including various divestment and equity capital market alternatives. VI. IMPACT OF COVID-19 While restrictive measures related to COVID-19 were gradually lifted in China starting from December 2022, COVꞮD-19 had some impact on our research, clinical studies and our commercial activities in the first months of 2023. Measures were put in place to reduce the impact and, in the second quarter of 2023, these activities normalized. VII. SUSTAINABILITY At HUTCHMED, we are committed to a progressive journey as we continue to grow. This includes embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders, including our staff, our communities and our shareholders. In April 2023, we published our 2022 Sustainability Report alongside our 2022 Annual Report. This year we continue to make progress in line with the commitments and outcomes outlined in the report, including achieving satisfactory progress to date towards the 11 short- to long-term sustainability goals and targets and following the recommended disclosure framework of the Task Force on Climate-related Financial Disclosures (TCFD) in line with the risks assessment. In the second half of 2023, we continue enhancing our climate risks action by conducting scope 3 emissions screening, introducing a digital data collection platform, and further strengthening our sustainability-related disclosures. FINANCIAL HIGHLIGHTS Foreign exchange impact: The RMB depreciated against the U.S. dollar on average by approximately 7% during the six months ended June 30, 2023, which has impacted our consolidated financial results as highlighted below. Cash, Cash Equivalents and Short-Term Investments were $856.2 million as of June 30, 2023 compared to $631.0 million as of December 31, 2022. Adjusted Group (non-GAAP44) net cash flows excluding financing activities in the first half of 2023 were $219.3 million (H1-22: -$110.9m) mainly due to receipt of a $400 million payment from Takeda; andNet cash generated from financing activities in the first half of 2023 totaled $5.8 million mainly due to the proceeds of bank borrowings (H1-22: net cash used in financing activities of $74.6m mainly due to the repayment of bank borrowings and purchases of ADSs45 by a trustee for the settlement of equity awards). Revenues for the six months ended June 30, 2023 were $532.9 million compared to $202.0 million in the six months ended June 30, 2022. Oncology/Immunology consolidated revenues increased 294% (301% at CER) to $359.2 million (H1-22: $91.1m) resulting from: ELUNATE® revenues increased 16% (25% at CER) to $42.0 million (H1-22: $36.0m) due to continued market share gain, comprising of manufacturing revenues, promotion and marketing service revenues and royalties;SULANDA® revenues increased 66% (79% at CER) to $22.6 million (H1-22: $13.6m) from our continuing marketing activities, increasing patient access after inclusion on the NRDL in January 2022 and long duration of treatment;ORPATHYS® revenues increased 10% (17% at CER) to $15.1 million (H1-22: $13.8m) after inclusion in the NRDL effective from March 2023 and comprises of manufacturing revenues and royalties;TAZVERIK® revenues were $0.4 million (H1-22: $0.1m) from further sales in the Hainan Pilot Zone;Partnering revenue of $258.7 million was the first half recognized portion of the $400 million upfront payment from Takeda; andOther R&D services income of $20.4 million (H1-22: $12.6m), primarily related to fees from AstraZeneca, Lilly and Takeda for the management of development and regulatory activities. Other Ventures consolidated revenues increased 57% (67% at CER) to $173.7 million (H1-22: $110.9m), mainly due to higher sales of prescription drugs. This excludes 11% (19% at CER) growth in non-consolidated revenues at SHPL of $235.3 million (H1-22: $212.4m). Net Expenses for the six months ended June 30, 2023 were $364.3 million compared to $364.9 million for the six months ended June 30, 2022. Costs of Revenues increased by 52% to $208.3 million (H1-22: $137.3m), of which cost of revenues from our Other Ventures increased by 63% to $164.8 million (H1-22: $101.0m) due to the increasing sales of third-party prescription drug products, and cost of revenues from Oncology/Immunology increased by 20% to $43.5 million (H1-22: $36.3m) due to the increasing sales of ELUNATE®, SULANDA® and ORPATHYS®;R&D Expenses reduced 20% to $144.6 million (H1-22: $181.7m), mainly as a result of the strategic prioritization of our pipeline. Our international clinical and regulatory operations in the U.S. and Europe incurred expenses of $55.6 million (H1-22: $83.6m), while R&D expenses in China were $89.0 million (H1-22: $98.1m);SG&A Expenses were $68.3 million (H1-22: $79.8m), which decreased primarily due to the restructuring of our U.S. Oncology/Immunology commercial operations at the end of 2022 while our China commercial infrastructure was able to support further revenue growth; andOther Items generated net income of $56.9 million (H1-22: $33.9m), which increased primarily due to higher interest income earned after receiving the $400 million Takeda upfront payment in April 2023 and foreign currency exchange gains. Net Income attributable to HUTCHMED for the six months ended June 30, 2023 was $168.6 million (which include $258.7 million of the upfront payment recognized from Takeda) compared to Net Loss attributable to HUTCHMED of $162.9 million for the six months ended June 30, 2022. The net income attributable to HUTCHMED for the six months ended June 30, 2023 was $0.20 per ordinary share / $1.00 per ADS, compared to net loss attributable to HUTCHMED of $0.19 per ordinary share / $0.96 per ADS for the six months ended June 30, 2022. FINANCIAL SUMMARY Condensed Consolidated Balance Sheets Data (in $’000) As of June 30, 2023 As of December 31,2022 (Unaudited) Assets Cash and cash equivalents and short-term investments856,168 630,996Accounts receivable129,203 97,988Other current assets105,114 110,904Property, plant and equipment96,829 75,947Investments in equity investees37,740 73,777Other non-current assets72,443 39,833Total assets1,297,497 1,029,445Liabilities and shareholders’ equity Accounts payable54,575 71,115Other payables, accruals and advance receipts227,212 264,621Deferred revenue149,440 13,537Bank borrowings40,147 18,104Other liabilities26,106 25,198Total liabilities497,480 392,575Company’s shareholders’ equity782,039 610,367Non-controlling interests17,978 26,503Total liabilities and shareholders’ equity1,297,497 1,029,445 Condensed Consolidated Statements of Operations Data (Unaudited, in $’000, except share and per share data) Six Months Ended June 30 2023 2022 Revenues: Oncology/Immunology – Marketed Products80,149 63,517 Oncology/Immunology – R&D279,034 27,552 Oncology/Immunology consolidated revenues359,183 91,069 Other Ventures173,691 110,978 Total revenues532,874 202,047 Operating expenses: Costs of revenues(208,324) (137,318)Research and development expenses(144,633) (181,741)Selling and general administrative expenses(68,263) (79,742)Total operating expenses(421,220) (398,801) 111,654 (196,754)Other income/(expense), net25,434 (3,882)Income/(loss) before income taxes and equity in earnings of equity investees137,088 (200,636)Income tax (expense)/benefit(2,730) 4,215 Equity in earnings of equity investees, net of tax35,110 33,549 Net income/(loss)169,468 (162,872)Less: Net (income)/loss attributable to non-controlling interests(917) 11 Net income/(loss) attributable to HUTCHMED168,551 (162,861) Earnings/(losses) per share attributable to HUTCHMED (US$ per share) – basic 0.20 (0.19)– diluted0.19 (0.19)Number of shares used in per share calculation – basic846,928,863 849,283,553 – diluted866,990,610 849,283,553 Earnings/(losses) per ADS attributable to HUTCHMED (US$ per ADS) – basic 1.00 (0.96)– diluted0.97 (0.96)Number of ADSs used in per share calculation – basic169,385,773 169,856,711 – diluted173,398,122 169,856,711 FINANCIAL GUIDANCE Following the closing of the license with Takeda and having received from them the upfront payment of $400 million, we currently expect to recognize approximately $280 million in 2023. We provide financial guidance for Oncology/Immunology consolidated revenues, reflecting expected revenue growth of our oncology products in China; R&D services income from our partners AstraZeneca, Lilly and Takeda; potential milestone payments on fruquintinib U.S. regulatory approval; and the above-mentioned recognition of the upfront payment from Takeda. We believe that we remain on track to meet the 2023 guidance provided in the announcement of our 2022 full year results on February 28, 2023. H1 2022ActualH1 2023ActualFY 2022ActualFY 2023GuidanceAdjustments vs.Previous GuidanceOncology/​Immunology consolidated revenues$91.1 million$359.2 million$163.8 million$450 – $550 millionNil Shareholders and investors should note that: we do not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; andwe have in the past revised our financial guidance and reference should be made to any announcements published by us regarding any updates to the financial guidance after the date of publication of this announcement. Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively. Conference call and audio webcast presentation scheduled today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT. After registering, investors may access a live audio webcast of the call via HUTCHMED’s website at www.hutch-med.com/event/. Participants who wish to join the call by telephone and ask a question must register. Upon registration, each participant will be provided with dial-in numbers and a unique PIN. HUTCHMED intends to host a Capital Markets Day in the fourth quarter of this year to further update the market on its progress following the strategy change, and to showcase the exciting pipeline of drug candidates. About HUTCHMED HUTCHMED (Nasdaq/AIM: ​HCM; HKEX: ​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology medicines now approved and marketed in China. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Contacts Investor Enquiries Mark Lee, Senior Vice President+852 2121 8200Annie Cheng, Vice President+1 (973) 306-4490 Media Enquiries Americas – Brad Miles, Solebury Strategic Communications+1 (917) 570 7340 (Mobile) / bmiles@soleburystrat.comEurope – Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comAsia – Zhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon+44 (20) 7886 2500 References Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context. Past Performance and Forward-Looking Statements The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which are obtained will be obtained at any particular time, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, “HUTCHMED’s Products”) will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally, including, among others, the risk that HUTCHMED’s ADSs could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED’s Products after obtaining regulatory approval; competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED’s Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED’s Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED’s Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED’s Products; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates and uncertainties regarding the impact of COVID-19. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on HKEX46. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above. Inside Information This announcement contains inside information for the purposes of Article 7 of Regulation (E.U.) No 596/2014 (as it forms part of retained E.U. law as defined in the European Union (Withdrawal) Act 2018). This announcement in its entirety is available at: http://ml.globenewswire.com/Resource/Download/4a6834bd-1a7d-4ed8-83de-c19ac2fd523c ____________________ REFERENCES AND ABBREVIATIONS1Takeda = Takeda Pharmaceuticals International AG.2NDA = New Drug Application.3FDA = Food and Drug Administration.4PDUFA = U.S. Prescription Drug User Fee Act.5MAA = Marketing Authorization Application.6EMA = European Medicines Agency.7CRC = Colorectal cancer.8NRDL = National Reimbursement Drug List.9IHCC = Intrahepatic cholangiocarcinoma.10SHP2 = Src homology-2 domain-containing protein tyrosine phosphatase-2.11CER = Constant exchange rate. We also report changes in performance at CER which is a non-GAAP measure. Please refer to “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures.12R&D = Research and development.13SG&A expenses = Selling, general and administrative expenses.14AACR = American Association for Cancer Research.15ASCO = American Society of Clinical Oncology.16ASCO GI = ASCO (American Society of Clinical Oncology) Gastrointestinal Cancers Symposium.17EHA = European Hematology Association.18ICML = International Conference on Malignant Lymphoma.19In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), AstraZeneca (ORPATHYS®) and HUTCHMED (ELUNATE®, SULANDA®, ORPATHYS® and TAZVERIK®).20Lilly = Eli Lilly and Company.21NMPA = National Medical Products Administration.22PMDA = Pharmaceuticals and Medical Devices Agency.23NSCLC = Non-small cell lung cancer.24MET = Mesenchymal epithelial transition factor.25EGFR = Epidermal growth factor receptor.26PRCC = Papillary renal cell carcinoma.27VEGFR = Vascular endothelial growth factor receptor.28PD-1 = Programmed cell death protein-1.29RCC = Renal cell carcinoma.30FGFR = Fibroblast growth factor receptor.31CSF-1R = Colony-stimulating factor 1 receptor.32Syk = Spleen tyrosine kinase.33AIHA = Autoimmune hemolytic anemia.34ITP = Immune thrombocytopenia purpura.35PI3Kδ = Phosphoinositide 3-kinase delta.36Ipsen = Ipsen SA, parent of Epizyme Inc.37Epizyme = Epizyme Inc., a wholly owned subsidiary of Ipsen SA.38IDH = Isocitrate dehydrogenase.39BTK = Bruton’s tyrosine kinase.40ERK = Extracellular signal-regulated kinase.41MAPK pathway = RAS-RAF-MEK-ERK signaling cascade.42CDE = Center for Drug Evaluation.43SHPL = Shanghai Hutchison Pharmaceuticals Limited.44GAAP = Generally Accepted Accounting Principles.45ADS = American depositary share.46HKEX = The Main Board of The Stock Exchange of Hong Kong Limited.