— Geographic expansion driving ex-
—
— Rapidly progressing groundbreaking ATTC technology, a source of novel drug candidates with broad therapeutic potential —
— Pursuing potential opportunities for partnering ATTC candidates with multinational pharmaceutical companies —
All amounts are expressed in US dollars unless otherwise stated. A glossary of abbreviations is on page 29.
Global commercial progress, delivery of sustainable growth and robust balance sheet
- FRUZAQLA® (fruquintinib ex-
China ) in-market sales by Takeda were up 26% to$366.2 million (2024:$290.6m ), propelled by successful launches, and additional reimbursement coverage, driven by need for novel non-chemotherapy treatments in CRC and ongoing positive experiences of oncologists in 3L+. - ELUNATE® (fruquintinib in
China ) in-market sales were$100.1 million (2024:$115.0m ), with strong growth in H2 (H2 up 33% vs. H1). - ORPATHYS® (savolitinib) triggered an
$11.0 million milestone payment from AstraZeneca for securingChina approval for its third lung cancer indication. - Net income attributable to
HUTCHMED of$456.9 million (2024:$37.7m ), with a cash balance of$1.4 billion at year end, boosted by a$415.8 million divestment gain net of tax.
Antibody-Targeted Therapy Conjugate (“ATTC”) platform advances into clinical trials, paving the way for a rich pipeline of new drug candidates entering the clinic
- Initiated first clinical trial on first ATTC drug candidate HMPL-A251 in
December 2025 , quickly following its pre-clinical data presentation atAACR-NCI-EORTC Conference inOctober 2025 . - Next ATTC drug candidates entered clinical trials, with the HMPL-A580 trial initiated in
March 2026 , and the third candidate HMPL-A830 aiming to begin Phase I by year end. - Pursuing potential opportunities for partnering ATTC drug candidates with multinational pharmaceutical companies in 2026.
Pipeline progress as planned across late-stage clinical portfolio
- Positive FRUSICA-2 Phase III (leading to NMPA sNDA acceptance) and PDAC Phase II results presented at ESMO and ESMO Asia. ELUNATE® with sintilimab in 2L kidney cancer achieved mPFS of 22.2 vs. 6.9 months with axitinib/?everolimus. SULANDA®-based combination in 1L metastatic PDAC also showed significant mPFS improvement and an OS benefit trend (data immature), leading to Phase III initiation.
- Positive ESLIM-02 Phase III wAIHA results for sovleplenib meeting primary endpoint of durable response rate within 24 weeks. ITP NDA was accepted by the NMPA in
February 2026 and wAIHA filing is planned in H1 2026. ESLIM-01 updated results at ASH showed maximum duration of response of 25.9 weeks with median duration of exposure of around 20 months under a tolerable safety profile. According toIQVIA , ITP has 41,000 new patients every year, on top of another 430,000 existing patients, while wAIHA adds another 26,000 per year inChina . - SACHI China and SAVANNAH global lung cancer trials of ORPATHYS® combined with TAGRISSO® presented at ASCO and ELCC conferences, with the data supporting approvals in
China andSwitzerland , respectively. Enrollments completed for SAFFRON global and SANOVO China Phase III trials with readouts expected within next 12 months.
Dr
Our Business Development team has encountered interest from multinational pharmaceutical companies to cooperate on the development and launch of novel drug candidates with potential to become global market leaders. Any such potential partnerships would further validate the scientific and commercial value of our new platforms, whilst allowing
Our company is at a pivotal point. We have repositioned our commercial team to better meet challenges in our environment and to spur sales growth in
Mr
Dr
2025 FULL YEAR RESULTS & BUSINESS UPDATES
I. COMMERCIAL OPERATIONS
Total in-market sales, including FRUZAQLA®, ELUNATE®, SULANDA® and ORPATHYS®, of
FRUZAQLA® in-market sales by Takeda were up 26% in 2025 at
Total consolidated revenue for oncology products decreased 21% to
Other Oncology/Immunology revenue, consisting of upfront, regulatory milestones, R&D services and licensing revenue was
| ($ in millions) | In-market Sales* | Consolidated Revenue** | ||||||
| 2025 | 2024 | % Change | (CER) | 2025 | 2024 | % Change | (CER) | |
| FRUZAQLA® | +26% | (+26%) | -19% | (-19%) | ||||
| ELUNATE® | -13% | (-13%) | -11% | (-11%) | ||||
| SULANDA® | -45% | (-45%) | -45% | (-45%) | ||||
| ORPATHYS® | -36% | (-36%) | -24% | (-24%) | ||||
| TAZVERIK® | +158% | (+156%) | +158% | (+156%) | ||||
| Oncology Products | $524.7 | $501.0 | +5% | (+5%) | $214.4 | $271.5 | -21% | (-21%) |
| Takeda upfront, regulatory milestones and R&D services | -23% | (-23%) | ||||||
| Other revenue (R&D services and licensing) | -21% | (-21%) | ||||||
| Total Oncology/?Immunology | $285.5 | $363.4 | -21% | (-21%) | ||||
| Other Ventures | -1% | (-1%) | ||||||
| Total Revenue | $548.5 | $630.2 | -13% | (-13%) | ||||
* FRUZAQLA®, ELUNATE® and ORPATHYS® mainly represent total sales to third parties as provided by Takeda, Eli Lilly and AstraZeneca, respectively.
** FRUZAQLA® represents manufacturing revenue, royalties and commercial milestone paid by Takeda to
II. 2025 REGULATORY UPDATES
- Savolitinib MAA approved (temporary authorization) by
Swissmedic combined with TAGRISSO® for 2L EGFRm NSCLC with MET amplification and/or overexpression inFebruary 2026 . - Savolitinib sNDA accepted by NMPA with priority review for 3L GC with MET amplification in December.
- Savolitinib sNDA approved by NMPA combined with TAGRISSO® for 2L EGFRm NSCLC with MET amplification in June, triggering
$11.0 million milestone from AstraZeneca. - Savolitinib sNDA approved by NMPA for 1L and 2L (converted from conditional to full approval) METex14 NSCLC in January, and approved in
Hong Kong for under the 1+ Mechanism in February. - Fanregratinib NDA accepted by NMPA with priority review in 2L IHCC in December.
- Fruquintinib sNDA accepted by NMPA combined with sintilimab for 2L renal cell carcinoma in June.
- Tazemetostat NDA conditionally approved by NMPA for 3L R/R follicular lymphoma with EZH2 mutation in March.
III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES
Savolitinib (ORPATHYS® in
- Published SACHI China Phase III results in
The Lancet after presentation at ASCO 2025 for 2L EGFRm NSCLC patients with MET amplification, in combination with TAGRISSO®, showing mPFS of 8.2 months compared to 4.5 months with chemotherapy in ITT population (HR 0.34), and 6.9 months compared to 3.0 months in post third-generation EGFR TKI-treated subgroup (HR 0.32, both p<0.0001) (NCT05015608). - Presented SAVANNAH global Phase II results at ELCC 2025 for 2L EGFRm NSCLC patients with MET amplification or overexpression, in combination with TAGRISSO®, showing ORR of 56%, mPFS of 7.4 months and mDoR of 7.1 months (NCT03778229).
- Completed enrollment of SAFFRON global Phase III study for 2L EGFRm NSCLC patients with MET amplification or overexpression (NCT05261399); and completed enrollment of SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression (NCT05009836).
- SAFFRON topline results expected in H2 2026, which could support global filings.
- SANOVO topline results expected in late 2026 or early 2027.
- Achieved positive data in Phase ?? 3L gastric cancer registration cohort for MET-amplified patients, supporting the China NDA (NCT04923932).
Fruquintinib (ELUNATE® in
- Presented FRUSICA-2 registration Phase III results at ESMO 2025 for 2L RCC, in combination with TYVYT® achieving mPFS of 22.2 months versus 6.9 months with axitinib/everolimus (HR 0.373; p<0.0001), and ORR of 60.5% vs 24.3%, with mDoR of 23.7 vs 11.3 months (NCT05522231).
Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk
- Achieved positive results in Phase III part of ESLIM-02 trial for warm AIHA in
China inJanuary 2026 , having met its primary endpoint of durable response rate within 24 weeks of treatment. A sNDA submission to the NMPA is planned in the first half of 2026 (NCT05535933). - Resubmitted NDA for ESLIM-01 ITP with additional stability studies in
February 2026 , to meet NMPA stipulation of a lower impurity limit. Rolling data planned to be submitted in the second half of 2026. The company is pursuing potential partnership to continue overseas development.
Surufatinib (SULANDA® in
- Presented Phase II part results of a China Phase II/III for 1L metastatic PDAC patients at ESMO Asia, combined with camrelizumab, nab-paclitaxel and gemcitabine, achieving mPFS of 7.2 months vs 5.5 months with nab-paclitaxel and gemcitabine alone (HR 0.499; p=0.0407), and ORR of 67.7% vs 41.9%. Initiated Phase III part in
December 2025 (NCT06361888).
Tazemetostat (TAZVERIK® in
- Continued enrolling SYMPHONY-1
China portion of the Phase III portion of the global study, in combination with lenalidomide and rituximab, in 2L follicular lymphoma patients (NCT04224493).
Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3
- Positive Phase II registration study data supporting NDA accepted by the NMPA with priority review for IHCC with FGFR2 fusion/rearrangement in
December 2025 (NCT04353375).
IV. ANTIBODY-DRUG CONJUGATES RESEARCH & DEVELOPMENT
HMPL-A251, a first-in-class PI3K/PIKK-HER2 ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker
- First ATTC drug candidate, based on our PI3K/PIKK inhibitor payload to address the significant challenges faced in targeting this pathway, including on-target toxicities that restrict dosing and feedback loops that enable pathway reactivation. PI3K/PIKK inhibitor payload ATTCs are designed to enhance targeted delivery directly to tumor cells, maximizing therapeutic benefit while minimizing systemic exposure.
- Presented preclinical data at AACR-NCI-EORTC in
October 2025 , showing robust antitumor activity with synergistic and bystander killing effects, including compared to co-administration of antibody and payload. - Initiated global Phase I/IIa trial in
December 2025 , evaluating HMPL-A251 in adult patients with unresectable, advanced or metastatic HER2-expressing solid tumors, with sites in the US andChina .
HMPL-A580, a first-in-class PI3K/PIKK-EGFR ATTC comprising of a PI3K/PIKK inhibitor payload linked to a humanized anti-EGFR IgG1 antibody, via a cleavable linker
- Second ATTC based on the PI3K/PIKK inhibitor payload. EGFR is a well-recognized driver in tumor formation and disease progression. Modulation of the PI3K/AKT/mTOR pathway is required for EGFR-mediated tumorigenesis or resistance to EGFR-targeted therapy.
- Preclinical data have shown that PAM pathway inhibition synergizes with anti-EGFR therapy to enhance anti-tumor activity, and will be presented at an upcoming scientific conference.
- Initiated global trial in
March 2026 , evaluating in EGFR solid tumors, with US andChina sites.
Further preclinical progress with antibody drug conjugates
- Progressed ATTC drug candidate HMPL-A830, with plans for global IND filings and clinical trial initiations in 2026.
V. COLLABORATION UPDATES
Further progress with ImageneBio on drug candidate IMG-007, discovered by
- Initiated ADAPTIVE Phase IIb trial for moderate-to-severe atopic dermatitis, a randomized, placebo-controlled dose-finding study in approximately 220 patients (NCT07037901). Presented at ISDS positive results from the US/Canada Phase IIa study, showing rapid onset and durable clinical activity after four weeks, well tolerated safety profile without pyrexia or chills, and an extended half-life (NCT05984784).
- Presented positive results of a US/Canada Phase IIa trial for severe alopecia areata at ISDS, showing clinical signal of hair regrowth, progressive reduction in scalp hair loss without plateauing by week 36, partial restoration of hair keratins in the scalp, and a well-tolerated safety profile (NCT06060977).
VI. OTHER VENTURES
- Other Ventures consolidated revenue, predominantly from the prescription drug distribution business in
China , were steady at$263.0 million . HUTCHMED divested a 45.0% equity interest in SHPL for$608.5 million in cash inApril 2025 , retaining a 5.0% equity interest. As a result, HUTCHMED’s share of equity in earnings of SHPL in 2025 decreased to$24.6 million .- Consolidated net income attributable to
HUTCHMED fromOther Ventures decreased to$25.5 million (2024:$47.7m ), primarily due to the equity interest disposal in SHPL.
VII. SUSTAINABILITY
The 2025 Sustainability Report will be published in
In 2024 and 2025, the Company conducted a thorough climate risks financial impact assessment, focusing on both physical risks, particularly flood risks and heat stress; and transition risks, such as policy changes. In response to the risks and opportunities identified, we developed targeted mitigation measures to address potential damage and business interruptions. Our transition planning is integrated with the new targets planning, ensuring effective management of risks while capitalizing on the opportunities outlined in the assessments.
Throughout 2025, our sustainability initiatives garnered significant recognition, resulting in 10 prestigious awards from leading industry organizations and consistently strong performance in major ESG ratings. Notably, we were honored as an ESG Leading Enterprise for a third consecutive year and received accolades for Leading Environmental Initiatives and Leading Social Initiatives from Bloomberg Businessweek. Our commitment is reflected in our maintained A ratings from both MSCI and Wind, and A- rating from Hang Seng Corporate Sustainability; our upgrade to B- Prime (top decile rank) from ISS; and ESG Risk rating score further reduced to 21.9 (10th percentile, lower is better) by Sustainalytics. Additionally, we were included in the S&P Global Sustainability Yearbook 2025 as one of the top industry performers. Our efforts were further validated as we ranked third in ESG Excellence in Extel’s
FINANCIAL HIGHLIGHTS
Revenue for the year ended
- Oncology/?Immunology consolidated revenue amounted to
$285.5 million (2024:$363 .4m):- FRUZAQLA® revenue was
$89.4 million (2024:$110.8m ), impacted primarily due to$20 million commercial payment recognized from Takeda in 2024. In-market sales by Takeda were$366.2 million (up 26%) driven by strong growth following approvals in 38 countries to date, including over 15 in 2025. - ELUNATE® revenue was
$76.9 million (2024:$86.3m ), which reflects our initiatives to enhance controls over commercial operations to align with the evolving regulatory landscape and uphold the highest compliance standards. We also streamlined our sales force to build a more efficient commercial organization and to enhance productivity. These initiatives only temporarily weighed on performance, with revenue growth of 29% in the second half of 2025 compared to the first half. This recovery was supported by refocusing on top-tier hospitals and high-potential provinces to maintain our leading market share position in 3L mCRC, and the contribution from the EMC indication that successfully broadened the addressable patient population for ELUNATE®. - SULANDA® revenue was
$27.0 million (2024:$49.0m ), which reflects competition from new NRDL entries. In response, we have transformed our marketing strategies which allowed us to maintain the leading position of SULANDA® in the NET TKI market and stabilize sales in the second half of 2025 (H2 up 13% vs H1 2025). - ORPATHYS® revenue was
$18.6 million (2024:$24.5m ), impacted by strong competition in the METex14 skipping NSCLC setting. However, sales stabilized in the second half of 2025 as AstraZeneca continues its efforts to increase MET testing as the standard-of-care for late-stage NSCLC. - TAZVERIK® revenue was
$2.5 million (2024:$0.9m ) with increased sales in mainlandChina sinceJuly 2025 following its approval inMarch 2025 . - Takeda upfront, regulatory milestones and R&D services revenue were
$51.6 million (2024:$67.0m ), due to less R&D and regulatory support services since FRUZAQLA® is now fully launched. - Other revenue of
$19.5 million (2024:$24.9m ), includes$8.5 million (2024:$13.9m ) cost reimbursement from partners, which decreased as trials advanced into later stage of development, and a regulatory milestone of$11.0 million from AstraZeneca following China NDA approval for SACHI.
- FRUZAQLA® revenue was
- Other Ventures consolidated revenue of
$263.0 million (2024:$266.8m ) remained flat.
Net Expenses for the year ended
- Cost of Revenue was
$336.3 million (2024:$348.9m ), generally aligned with lower Oncology/?Immunology revenue. Cost of revenue as a percentage of oncology product revenue remained stable at 39% (2024: 34%). - R&D Expenses were
$148.3 million (2024:$212.1m ) as we complete higher costs late-stage trials for our assets which have led to NDA applications and approvals. As a result,China and US R&D spending reduced by$36.2 million and$27.6 million , respectively. Nevertheless, we maintain and are committed to ongoing investment in discovery to deliver sustained innovation and have plans to accelerate investment in the global clinical trials of our earlier-stage ATTC programs. - S&A Expenses were
$103.0 million (2024:$112.9m ). The decrease was mainly due to a reduction in S&A expenses for oncology products which was$33.8 million or 15.8% of oncology product revenue (2024:$45.1m or 16.6%). This efficiency improvement highlights the successful streamlining of the sales force structure and the implementation of spending controls. - Other Items generated net income of
$80.2 million (2024:$81.4m ), which mainly includes interest income and expense, foreign exchange, equity in earnings of SHPL and taxes.
Gain on divestment of SHPL, net of tax was
Net Income attributable to
$0.53 basic earnings per ordinary share /$2.66 basic earnings per ADS in 2025 (2024:$0.04 basic earnings per ordinary share /$0.22 basic earnings per ADS).
Cash, Cash Equivalents and Short-Term Investments were
Adjusted Group (non-GAAP) net cash inflows excluding financing activities in 2025 were$523.3 million mainly due to the receipt of$608.5 million gross proceeds from the partial divestment of SHPL offset by a related$59.5 million capital gain tax payment;$10.0 million regulatory approval milestone payment; and$14.1 million in capital expenditures (2024: net cash outflow of$19.5m mainly due to$17.9m of capital expenditures).- Net cash generated from financing activities in 2025 totaled
$7.8 million mainly due to$6.3 million net amount drawn from bank borrowings (2024: net cash outflow of$30.7m mainly due to purchases for equity awards of$36.1m ).
Foreign exchange impact: The RMB appreciated against the US dollar on average by approximately 0.4% during 2025, which has impacted consolidated financial results as highlighted.
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” for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.
Financial Statements –
FINANCIAL GUIDANCE
- The Company does 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; and
- The Company has in the past revised its financial guidance and reference should be made to announcements it publishes regarding any updates to the financial guidance after the publication of this announcement.
FINANCIAL SUMMARY
Condensed Consolidated Balance Sheets Data
| (in $’000) | As of | ||
| 2025 | 2024 | ||
| Assets | |||
| Cash and cash equivalents and short-term investments | 1,367,275 | 836,110 | |
| Accounts receivable | 126,750 | 155,537 | |
| Other current assets | 73,317 | 74,908 | |
| Property, plant and equipment | 94,623 | 92,498 | |
| Investment in equity investees | 10,865 | 77,765 | |
| Other non-current assets | 80,267 | 37,378 | |
| Total assets | 1,753,097 | 1,274,196 | |
| Liabilities and shareholders’ equity | |||
| Accounts payable | 45,533 | 42,521 | |
| Other payables and accruals | 208,892 | 256,124 | |
| Bank borrowings | 93,160 | 82,806 | |
| Deferred revenue | 51,547 | 98,503 | |
| Other liabilities | 102,703 | 22,389 | |
| Total liabilities | 501,835 | 502,343 | |
| Company’s shareholders’ equity | 1,237,926 | 759,929 | |
| Non-controlling interests | 13,336 | 11,924 | |
| Total liabilities and shareholders’ equity | 1,753,097 | 1,274,196 | |
Condensed Consolidated Statements of Operations Data
| (in $’000, except share and per share data) | Year Ended | ||||
| 2025 | 2024 | ||||
| Revenue: | |||||
| Oncology/?Immunology – Marketed Products | 214,356 | 271,534 | |||
| Oncology/?Immunology – R&D | 71,183 | 91,831 | |||
| Oncology/?Immunology Consolidated Revenue | 285,539 | 363,365 | |||
| Other Ventures | 262,973 | 266,836 | |||
| Total revenue | 548,512 | 630,201 | |||
| Operating expenses: | |||||
| Cost of revenue | (336,349 | ) | (348,884 | ) | |
| Research and development expenses | (148,295 | ) | (212,109 | ) | |
| Selling and administrative expenses | (103,028 | ) | (112,913 | ) | |
| Total operating expenses | (587,672 | ) | (673,906 | ) | |
| Gain on divestment of an equity investee | 476,896 | — | |||
| Other income, net | 60,955 | 42,598 | |||
| Income/(loss) before income taxes and equity in earnings of equity investees | 498,691 | (1,107 | ) | ||
| Income tax expense | (2,477 | ) | (7,192 | ) | |
| Income tax expense – Divestment of an equity investee | (61,133 | ) | — | ||
| Equity in earnings of equity investees, net of tax | 22,651 | 46,469 | |||
| Net income | 457,732 | 38,170 | |||
| Less: Net income attributable to non-controlling interests | (823 | ) | (441 | ) | |
| Net income attributable to | 456,909 | 37,729 | |||
| Earnings per share attributable to | |||||
| – basic | 0.53 | 0.04 | |||
| – diluted | 0.52 | 0.04 | |||
| Number of shares used in per share calculation | |||||
| – basic | 858,276,608 | 855,351,683 | |||
| – diluted | 872,891,120 | 872,829,129 | |||
| Earnings per ADS attributable to | |||||
| – basic | 2.66 | 0.22 | |||
| – diluted | 2.62 | 0.22 | |||
| Number of ADSs used in per ADS calculation | |||||
| – basic | 171,655,322 | 171,070,337 | |||
| – diluted | 174,578,224 | 174,565,826 | |||
About
Contacts
| Investor Enquiries | +852 2121 8200 / ir@hutch-med.com |
| Media Enquiries | |
| FTI Consulting – | +44 20 3727 1030 / HUTCHMED@fticonsulting.com |
| Ben Atwell / Tim Stamper | +44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile) |
| Brunswick – | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor and Joint Broker | |
| Atholl Tweedie / Emma Earl / Rupert Dearden | +44 20 7886 2500 |
| Cavendish | Joint Broker |
| Geoff Nash / Nigel Birks | +44 20 7220 0500 |
| Deutsche Numis | Joint Broker |
| Freddie Barnfield / Jeffrey Wong / Duncan Monteith | +44 20 7260 1000 |
References
Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean
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 US 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
In addition, this announcement contains statistical data and estimates that
Inside Information
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Medical Information
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