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HUTCHMED’s recent R&D update highlighted multiple catalysts expected over the next 12-24 months, including the launches of new products and regulatory decisions on new indications for existing products which will be key for near- and mid-term revenue growth in China. Ex-China, partner AstraZeneca has guided towards Phase III SAFFRON top-line data in H126, with savolitinib remaining on track to become HUTCHMED’s second global asset. Longer-term, the proprietary ATTC platform offers significant potential as a novel therapeutic class designed to circumvent the toxicity limitations of ADCs by combining a targeting antibody with a small molecule targeted drug payload. The first ATTC candidate, HMPL-A251, should enter the clinic by year-end. Our updated HUTCHMED valuation is $5.98bn/£4.66bn/HK$46.61bn, or $34.26/ADS and 548p/HK$53.44 per share.
| Year-end: December 31 | 2023 | 2024 | 2025E | 2026E |
| Revenues ($m) | 838.0 | 630.2 | 533.1 | 581.0 |
| Adj. EBITDA ($m) | 73.9 | 15.1 | 3.0 | (7.9) |
| Adj. PBT ($m) | 58.3 | (1.1) | 20.7 | 40.1 |
| Net Income ($m) | 100.8 | 37.7 | 453.1 | 43.5 |
| Earnings per ADS ($) | 0.59 | 0.22 | 2.64 | 0.25 |
| Cash ($m) | 886.3 | 836.1 | 1,387.3 | 1,440.2 |
Update
15 December 2025
| Price (US ADS) (UK share)(SEHK share) | $13.42 204p HK$21.48 |
| Market Cap   | $2.34bn £1.78bn HK$18.74bn |
| Enterprise Value   | $1.07bn £0.76bn HK$8.82bn |
| Shares in issue (ADS) (shares) | 174.4m 872.2m |
| 12-month range   | $11.51-$19.50 185.5p-292.0p HK$18.36-30.75 |
| Free float | 61.9% |
| Primary exchange   | NASDAQ AIM SEHK |
| Sector | Healthcare |
| Company Code   | HCM HCM.L 00.13HK |
| Corporate client | Yes |
Company description
HUTCHMED is a Hong Kong headquartered biopharma focused on discovering, developing and commercialising innovative targeted therapeutics and immunotherapies to treat cancer and immunological diseases for the China and global markets.
Analysts
Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043
Franc Gregori
fgregori@trinitydelta.org
+44 (0) 20 3637 5041
Table of Contents
HUTCHMED has established a solid track record of delivery on its strategic objectives. Four products are now available in China, with the first HUTCHMED product launched in the US, Europe, and Japan by partner Takeda. Key pipeline programmes are progressing with multiple near-term clinical and regulatory catalysts for new indications, new markets, and new products. The oncology opportunities remain compelling globally and, while its first-in-class/best-in-class small molecule TKI (tyrosine kinase inhibitor) drugs gain market traction, HUTCHMED has diversified into biologics with its ATTC (antibody-targeted therapy conjugate) platform, with the first product set to enter the clinic this year. We continue to view HUTCHMED as a unique opportunity in biopharma, with a broad pipeline of differentiated assets, global ambitions supported by large pharma partners, proven commercial execution in China yielding a growing top line, all balanced with shrewd investment. Our HUTCHMED valuation is $5.98bn/£4.66bn/HK$46.61bn, or $34.26/ADS and 548p/HK$53.44 per share.
Pipeline progress, coupled to commercial execution, is the key valuation driver for HUTCHMED, with several important catalysts anticipated over the next 12 months. China catalysts include potential approval of fruquintinib in its third indication, renal cell carcinoma (RCC); regulatory submissions for savolitinib in 3L gastric cancer and fanregratinib in intrahepatic cholangiocarcinoma (IHCC), and potential resubmission of sovleplenib in 2L immune thrombocytopenia (ITP). The global pipeline is also progressing with the highly anticipated read out of the Phase III SAFFRON study of savolitinib plus Tagrisso in 2/3L Tagrisso-refractory NSCLC with MET aberration, expected in H126, as well as top line Phase III SAMETA data for savolitinib plus Imfinzi in MET-driven papillary RCC. Phase I start for first ATTC asset, HMPL-A251, by end-2025 opens up a large new opportunity for HUTCHMED.
HUTCHMED’s proprietary ATTC (antibody-targeted therapy conjugate) platform has been designed to overcome the challenges of existing antibody-drug conjugates (ADC). ADCs are a rapidly emerging class of therapeutic agents that combine the target specificity of a monoclonal antibody (mAb) with the lethality of cytotoxic cellular payloads. The main limitations of ADCs centre on their toxicity profile, with common side effects including haematologic toxicities (such as myelosuppression, cytopenia, neutropenia and anaemia) and liver/hepatotoxicity.
HUTCHMED’s ATTCs are a novel class of therapeutic, which incorporate a dual mechanism of action by combining an antibody with a proprietary small molecule targeted therapeutic that specifically targets proteins required for cancer growth (vs ADCs which typically employ a cell killing payload that targets rapidly dividing cells). Importantly, the combination of the antibody and targeted therapeutic is expected to have a synergistic effect. Additionally, ATTCs could potentially be combined with immunotherapy- or chemotherapy-based frontline standards of care (which is a challenge for ADCs due to their toxicity profiles) and also have the potential for long-term dosing.
HUTCHMED’s first ATTC candidate, HMPL-A251, comprises a novel PI3K/PIKK inhibitor payload linked to a humanised anti-HER2 IgG1 antibody, via a cleavable linker. The IND has been filed in China, and approved in the US, with plans to commence a Phase I trial this year. Two further programmes, A580 and A830, on which we have limited details, are set to enter the clinic during 2026.
HMPL-A251 is a PAM-HER2 ATTC (Exhibit 4) which targets the PI3K/AKT/mTOR (PAM) signalling pathway, a key intracellular pathway that drives cell growth, cell survival, and cell division. The payload in HMPL-A251 is HM5041609 (“609”), a proprietary small molecule that is highly selective for two structurally related protein kinases, PI3K (phosphoinositide 3-kinase) and PIKK (phosphoinositide 3-kinase-related protein kinases), and has limited off-target activity. In vitro models have shown that “609” has a potent and dose-dependent inhibition of both the PAM and the PIKK pathways, and robust anti-tumour activity against a broad panel of tumour cell lines. The targeting antibody is a biosimilar of trastuzumab, which inhibits the activity of HER2 (human epidermal growth factor receptor 2) tyrosine kinase. HER2 is an established tumour-associated antigen that promotes cell growth and is overexpressed in multiple solid tumours. Trastuzumab was first approved in 1998 as Herceptin (Roche/Genentech) for the treatment of HER2-positive breast cancer, with subsequent approvals in HER2-positive stomach and gastro-oesophageal cancers.
The goal of ATTCs is to block oncogenic driver mutations via a dual mechanism of action through the inhibitory activity of the mAb and small molecule payloads, while reducing toxicities and potentially enhancing clinical efficacy through synergies. HMPL-A251 specifically seeks to address the PAM and HER2 pathways by coupling the PAM inhibitor (PAMi) “609” with an anti-HER2 antibody. Patients with genomic alterations in either of these pathways tend to have a poor prognosis. The PAM signalling pathway is an attractive target as PAM alterations (eg loss of function or gain of function mutations) are present in c 50% of solid tumours, and at a higher frequency in indications such as endometrial, breast, and prostate cancers, as well as often being associated with treatment resistance including to trastuzumab-based therapy.
Clinical development of PAM targeting drugs has had a chequered history, with first- and second-generation pan-PI3K/mTOR and pan-PI3K inhibitors being discontinued or having failed due to a narrow therapeutic window and severe on-target toxicities that restricted dosing. Once the development focus shifted towards single target PAM inhibitors, there was more success with the approval of everolimus (mTOR1 inhibitor Afinitor), alpelisib (P13Kα inhibitor Piqray), and capivasertib (AKT inhibitor Truqap); however, while these drugs demonstrated tolerable safety profiles, their efficacy was limited with no significant overall survival benefit, likely due to feedback/feedforward loops that enable pathway reactivation. More recently, the positive read out of the Phase III VIKTORIA-1 trial of dual pan-PI3K/mTOR inhibitor gedatolisib (Celcuity) in 2L HR+/HER2- advanced breast cancer suggests that historic challenges can be overcome and has also strengthened the rationale for targeting the PAM pathway in breast cancer.
HUTCHMED’s strategy with HMPL-A251 is to target tumour-specific delivery of PAMi, to both maximise the therapeutic benefit and limit systemic exposure. We note that the PAM pathway is one of the main downstream signalling pathways of HER2, with aberrations conferring resistance to trastuzumab-based therapy. The combination of a PAMi with an anti-HER2 mAb should have a synergistic anti-tumour effect as well as being less toxic by the targeted delivery of “609” into HER2-positive tumour cells.
HUTCHMED presented first in vitro and in vivo preclinical data on HMPL-A251 at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. These data included in vitro confirmation of HMPL-A251’s:
Importantly, in vivo studies have provided preclinical proof of concept for the potential synergy of HMPL-A251’s dual mechanism of action, with improved anti-tumour efficacy and tolerability vs the separate administration of the naked trastuzumab antibody and “609” payload.
These data showed that a single dose of HMPL-A251 resulted in 14 days of sustained tumour suppression and a greater reduction in tumour volume when compared with trastuzumab and “609” dosed separately and simultaneously in an HER2-amplified breast cancer xenograft model (Exhibit 5). Additionally, HMPL-A251 was better tolerated than the combined dosing of trastuzumab and “609”, with the latter resulting in weight loss and increased blood glucose levels (Exhibit 6). PK/PD studies indicate that HMPL-A251 has a superior tumour-to-plasma ratio vs systemic administration of “609”, suggesting it could circumvent such safety concerns and reduce payload-mediated systemic toxicity through targeted payload delivery to the tumour.
Additionally, in preclinical models of both HER2-low and HER2-overexpression, a single dose of HMPL-A251 demonstrated a comparable or superior tumour response to an equivalent Enhertu (trastuzumab deruxtecan) dose.
HUTCHMED’s clinical development strategy for HMPL-A251 has been informed by these encouraging preclinical data, particularly with respect to activity in both HER2+ and HER2-low models, with or without PAM alterations. A Phase Ia/Ib trial is planned to start in Q425; the US IND for HMPL-A251 has been cleared and the China NDA is currently under review. HUTCHMED intends to pursue a data driven development strategy, with initial studies evaluating HMPL-A251 across several tumour types with varied HER2 and PAM alteration status.
The Phase Ia/Ib trial design (Exhibit 7) will initially recruit cancer patients with HER2+ or HER2-low status (retrospectively determining PAM status) into the Phase Ia dose finding portion where the safety and tolerability of HMPL-A251 monotherapy will be evaluated. Once the appropriate HMPL-A251 monotherapy dose has been determined, this will be taken into a Phase Ib dose expansion that will explore early efficacy signals in various indications and define a potential biomarker strategy to guide patient selection. The data from these expansion cohorts will then guide future development plans. Given the relatively high frequency of aberrations in the PI3K/AKT/mTOR signalling transduction pathway across solid tumours, there are multiple tumour types in which a PI3K/PIKK inhibitor such as “609” should have broad applicability and significant market potential (Exhibit 8).
Potential indications for future development will be determined by clinical data but could include breast, prostate, gastric and ovarian cancers. Current plans are for selected tumour types (three HER2+ and PAM+/-, one HER2-low with PAM+) to be taken into a proof-of-concept study, in which HMPL-A251’s safety and efficacy will be evaluated as monotherapy in ≥2L patients, and potentially in the 1L setting in combination with standard of care chemotherapy in HER2+ tumours. The expectation is that there will be activity in the late stage pre-treated patients; however, moving into the front line setting in combination with chemotherapy would significantly expand the potential HMPL-A251 opportunity.
Clinical data for HMPL-A251 will be a key step in defining the potential market opportunity for this asset, with the demonstration of clinical proof of concept also being important in de-risking the ATTC platform as a whole.
The ATTC platform leverages HUTCHMED’s small molecule inhibitor expertise and extensive knowledge of oncogenic drivers of disease, developed over the past two decades. The pipeline beyond HMLP-A251 includes two programmes, HMPL-A580 and HMPL-A830, that are on track to enter Phase I studies in H126 and H226, respectively. While the targeting antibodies and payloads are undisclosed, we understand that there is no overlap with HMPL-A251 or each other; they incorporate two different antibodies and two different payloads.
HUTCHMED’s aim is to expand the ATTC pipeline, potentially to five or six candidates over the next 18 months, and to develop the ATTC platform for both China and global markets. An area of development focus, driven by the science, has been on optimising the ATTC linker and small molecule payloads to address targets where both the likelihood of success is high and the potential market opportunity is attractive. There is significant scope to explore a broad range of synergistic antibody and small molecule payload combinations that target specific mutations (Exhibit 9), potentially including difficult to drug targets, with the goal of overcoming drug resistance mechanisms and improving selectivity and tolerability of the payload, allowing prolonged treatment and potential combinations with other targeted therapies, chemotherapy, and immunotherapy.
Successful development of multiple ATTC candidates, supported by clinical proof of concept for HMPL-A251, should lead to future collaborations and licensing opportunities. Business development will be central to HUTCHMED’s plans for ATTCs, particularly with respect to addressing international ex-China markets with development and/or commercialisation partners, but also covering one or more aspects of each ATTC molecule (novel antibodies, linkers, payloads), or broader development and manufacturing.
HUTCHMED has four products launched in China (Elunate, Orpathys, Sulanda and Tazverik), and one globally (Fruzaqla), and the launch of new products and new indications for existing assets are ongoing and/or on the horizon. Successful launches will be key for near- and mid-term revenue growth in China, which together with a continued focus on costs, should help to drive operating leverage. There have been a number of recent approvals, with multiple potential upcoming launches across the portfolio over the next 12-24 months.
Orpathys was approved in June 2025 in China in combination with AstraZeneca’s Tagrisso for EGFRm MET amplified 2L NSCLC (non-small cell lung cancer) after disease progression on first-line EGFR TKI therapy. This second indication for Orpathys represents a much broader patient group than the first approved indication (MET exon 14 skipping NSCLC) with around 30-40% of NSCLC patients in China with EGFRm vs 2-3% with METex14. Beyond NSCLC, patient enrolment has completed in a registrational trial in 3L MET-amplified gastric/ gastroesophageal cancers, with a potential China NDA submission by end-2025.
Elunate was approved in 3L colorectal cancer (CRC) in 2018, and in 2L endometrial cancer (EMC) at end 2024, with kidney cancer (renal cell carcinoma, RCC) representing the third potential indication in China. The incidence of kidney cancer in China is estimated at c 74k, of which around 90% are RCC. Regulatory review in 2L RCC is ongoing, with a potential approval decision expected in 2026. Phase III FRUSICA-2 data in 2L RCC are detailed later in this report.
Tazverik received conditional approval in 3L follicular lymphoma (FL) in mainland China in March 2025 and was launched commercially in July 2025. Until this date, Tazverik had been available on a limited basis in Hainan and Hong Kong Macau Special Administrative Region. Thus, the NMPA conditional approval should significantly broaden access for patients. The global Phase III SYMPHONY-1 trial is ongoing in 2L FL with partner Ipsen.
Sulanda was launched in China in NETs (neuroendocrine tumours) in early 2021 and has captured a 27% market share. It is also in development in a second indication: pancreatic ductal adenocarcinoma (PDAC), an aggressive tumour which represents >90% of pancreatic cancers and has a <13% five-year survival rate. Clinical trial successes in pancreatic cancer are rare, hence, positive top-line Phase II data in 1L PDAC has somewhat de-risked the Phase III part of this trial. Given the significant unmet need, the commercial potential of surufatinib in 1L PDAC could be sizeable.
This Phase II data in 62 patients (randomised 1:1), presented at ESMO Asia showed that surufatinib in combination with an anti-PD-1 antibody and chemotherapy (paclitaxel and gemcitabine) vs chemotherapy alone showed significant and consistent benefits across several efficacy endpoints, with a manageable safety profile. The tetrad regimen significantly improved median progression free survival (7.2 months vs 5.52 months, HR=0.499) with improvements seen in other efficacy measures: overall response rate (67.7% vs 41.9%, p<0.05) and disease control rate (93.5% vs 71.0%, p =0.015), with median overall survival not yet reached (vs 8.48 months).
Sovleplenib is in development for ITP (idiopathic thrombocytopenic purpura) and wAIHA (warm antibody autoimmune haemolytic anaemia). A China NDA was submitted in January 2024 following the successful ESLIM-01 ITP registrational trial. However, an impurity issue has delayed the review; bioequivalence and stability studies are being finalised with a new formulation and ITP resubmission is targeted in H126. Longer-term ESLIM-01 data, demonstrating clinically meaningful and sustained platelet responses in adult ITP patients and a tolerable safety profile, were presented at ASH 2025. In addition, this new formulation should also satisfy global regulators, and HUTCHMED will seek to restart global development and partnering discussions in ITP. The ESLIM-02 registrational trial in the smaller indication of wAIHA completed enrolment in June 2025 and a China NDA submission is targeted for Q226.
Patient enrolment is complete for fanregratinib (a FGFR1/2/3 inhibitor) in 2L intrahepatic cholangiocarcinoma (IHCC with FGFR fusion/rearrangement) with a potential China NDA submission in H126. China accounts for almost half of all hepatic carcinomas and IHCC is the second most common primary hepatic malignancy (representing 10%-20% of new diagnoses), with c 10%-15% of these harbouring a FGFR fusion.
Detailed data from the Phase III part of FRUSICA-2, the China registration study of fruquintinib in combination with sintilimab (Tyvyt, a PD-1 inhibitor) as second-line (2L) treatment for locally advanced or metastatic renal cell carcinoma (RCC) were recently presented at ESMO 2025. FRUSICA-2 is an open-label, active-controlled study that recruited 234 patients comparing fruquintinib and sintilimab vs investigator choice of axitinib or everolimus monotherapy in advanced 2L clear-cell RCC (Exhibit 10). This indication is currently under NMPA review with a potential approval decision expected in 2026.
Median PFS (progression free survival), as centrally assessed, for the fruquintinib combination was 22.2 months compared to 6.9 months for axitinib/everolimus, with a hazard ratio of 0.373 (p<0.0001) ie the risk of progression reduced by 63% for patients treated with the fruquintinib combination (left of Exhibit 11). The ORR (objective response rate), shown on the right of Exhibit 11, more than doubled with 60.5% for the fruquintinib combination vs 24.3% for the control arm (odds ratio 4.622, p<0.0001) and the median DoR (duration of response) was 23.7 months vs 11.3 months, respectively. Similar outcomes were observed by investigator assessment. Overall survival data continue to mature. The combination was tolerable, and the safety profile was consistent with each individual treatment.
Outside China, a key event will be top-line data from partner AstraZeneca’s Phase III SAFFRON global study of savolitinib + Tagrisso in patients with 2/3L Tagrisso refractory NSCLC with MET aberration (amplified or overexpressed), which are expected in H126. The SAFFRON trial completed recruitment in November 2025. The recent approval of the combination in China for 2L EGFRm MET-amp NSCLC was based on a positive outcome in the SACHI study, which included a predefined subset of patients that had received prior Tagrisso treatment (ie a population similar to that in the SAFFRON study) and significant PFS benefits were observed, helping to de-risk the SAFFRON study outcome. If this indication is successfully approved ex-China, this could be the second global launch of a HUTCHMED product (with HUTCHMED eligible for milestones and royalties from savolitinib partner AstraZeneca).
Meanwhile, partner Takeda continues to roll-out Fruzaqla (fruquintinib) in colorectal cancer. New geographical launches have helped to drive +22% CER growth for the six-months ended 30 September 2025, albeit US sales declined by 14% (on a reported basis) owing to the Medicare Part D redesign. Takeda has lowered Fruzaqla revenue guidance to >10% annual growth (to the year ended March 2026), from the prior >20% aim set in May 2025.
We value HUTCHMED using a sum-of-the-parts (SOTP) valuation methodology, with a risk-adjusted net present value (rNPV) model for the Oncology/ Immunology portfolio, an earnings-based multiple for the established Other Ventures commercial platforms, and net cash. Our valuation reflects latest updates to our financial model, which has incorporated interim H125 results (discussed below) plus latest Q3 partner updates, and has been rolled forward in time. We have made no major changes to any key underlying valuation assumptions. Overall, these result in a minor c 2% change to our valuation, with our updated HUTCHMED valuation now $5.98bn (from $5.86bn), equivalent to $34.26 per ADS; £4.66bn (548p per share), and HK$46.61bn (HK$53.44 per share). A summary of our valuation is shown in Exhibit 12, with the contributions of the various Oncology/Immunology assets presented in Exhibit 13. More detail on our valuation methodology can be found in our May 2025 Outlook.
The main catalysts over the next 12 to 24 months include: (1) expansion of Orpathys/savolitinib sales in China to the much larger indication of 2L EGFR refractory NSCLC with MET amplification (July 2025 Lighthouse) following the June 30 approval in combination with Tagrisso based on SACHI data; (2) the start of clinical trials for the first ATTC candidate HMPL-A251 by end-2025, and the start of Phase I trials for two further ATTC candidates during 2026; (3) surufatinib Phase II data in pancreatic ductal adenocarcinoma (PDAC), expected late-2025; (4) potential approval of Elunate/fruquintinib in China in 2L renal cell carcinoma (in combination with sintilimab), which is currently under regulatory review with a decision expected during 2026; and (5) data from the global Phase III SAFFRON study (from partner AstraZeneca) during H126. Note that we do not currently ascribe a value to the earlier stage pipeline (which includes fanregratinib and ranosidenib), nor to the ATTC platform, hence these represent upside.
During H125 Fruzaqla in-market sales grew +25% CER to $163m (H124: $131m) driven by global launches. However, the China commercial portfolio declined to $72m (H124: $113m), with Elunate (-29% CER), Sulanda (-50% CER) and Orpathys (-41% CER) impacted by increasing competition, in addition to more limited off-label use following broader anti-corruption activity and increasing compliance efforts in China. This resulted in Oncology/Immunology in-market H125 product sales of $234m (H124: $243m), and consolidated revenues of $144m (H124: $169m). Together with Other Ventures of $134m (H124: $137m), this led to total H125 revenues of $278m (H124: $306m).
Our updated forecasts reflect H125 and latest Q3 partner trends; on the latter, we note that Q3 Elunate sales in China grew +11% vs Q2, in-line with H125 management commentary that China in-market sales growth was already improving. Potential growth drivers for H225 and beyond are new indications, including: (1) Elunate launch in 2L EMC; (2) July Orpathys approval in combo with Tagrisso for EGFR refractory NSCLC with MET amplification, a much larger indication; and (3) mainland China July Tazverik launch in 3L follicular lymphoma. The main change to our FY25e revenue forecasts is the lowering of FY25e Sulanda sales to $26m (from $55m) based on H125 trends.
Our updated FY25e Oncology/Immunology in-market sales are $476m (from $539m), leading to Oncology/Immunology consolidated FY25e revenues of $278m (from $323m). This is within the reduced guidance range of $270m-$350m (from $350m-$450m), with the decrease largely due to milestone phasing, which we believe relates to Fruzaqla (August 2025 Lighthouse). We have increased Other Ventures to $253m (from $245m) based on H125 trends, hence our total group revenues for FY25e are correspondingly lower at $533m (from $568m) and are also slightly lower in FY26e at $581m (from $590m).
Operating Expenses were reduced across the board in H125: (1) R&D declined by 24% to $72m (H124: $95m) as registrational studies completed; (2) salesforce streamlining led to a 49% cut in S&M to $14m (H124: $27m); and (3) G&A was 9% lower at $28m (H124: $30m) with a continued focus on cost control. We have cut our Operating Expense forecasts based on the H125 trends, now forecasting FY25e R&D of $158m (from $216m), S&M of $31m (from $46m) and G&A of $55m (from $66m), with these trends continuing into FY26e. Our full updated forecasts are shown in Exhibit 15. The reduced Operating Expenses lead to higher Net Income in both FY25e and FY26e; the main changes to our forecasts are summarised in Exhibit 14. Recall that FY25e includes a post-tax gain of $416m from the SHPL divestment (with HUTCHMED’s share now 5%, from 50%, following divestment of a partial stake in April 2025).
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