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Last update 12 Aug 2026
Olevaprubart
Last update 12 Aug 2026
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms IMG 007, IMG-007, IMG007 |
Target |
Action inhibitors |
Mechanism OX40 inhibitors(Tumor necrosis factor receptor superfamily member 4 inhibitors) |
Active Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhasePhase 2 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Sequence Code 1142967200L
Source: *****
Sequence Code 1142967218H
Source: *****
Related
6
Clinical Trials associated with OlevaprubartNCT07734415
A Long-term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous IMG-007 in Participants of a Previous IMG-007 Moderate-To-Severe Atopic Dermatitis Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis (AD)
Start Date05 Jun 2026 |
Sponsor / Collaborator |
NCT07037901
A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
Start Date17 Jun 2025 |
Sponsor / Collaborator |
NCT06304740
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of a Single Subcutaneous Dose of IMG-007 in Healthy Participants
This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.
Start Date06 Mar 2024 |
Sponsor / Collaborator |
100 Clinical Results associated with Olevaprubart
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100 Translational Medicine associated with Olevaprubart
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100 Patents (Medical) associated with Olevaprubart
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2
Literatures (Medical) associated with Olevaprubart01 Mar 2026·BIODRUGS
The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis
Review
Author: Alvarenga, José Miguel ; Torres, Tiago ; Mohamed, Adam ; Oliveira Dos Santos, David ; Mohamed, Amir
Atopic dermatitis is a chronic inflammatory skin disease affecting approximately 15-20% of children and 2-10% of adults worldwide. Epidermal barrier dysfunction and immune dysregulation are central to its pathogenesis, creating a self-perpetuating cycle in which barrier disruption exacerbates inflammation, which in turn further impairs skin barrier integrity. The OX40/OX40L axis, involving the co-stimulatory receptor OX40 expressed on T cells and its ligand OX40L on antigen-presenting cells, plays a critical role in sustaining T cell-driven inflammatory responses in AD. Despite recent therapeutic advances, many patients remain inadequately controlled, and key unmet needs persist. Inhibitors of the OX40/OX40L pathway represent a novel therapeutic approach by modulating multiple effector and memory T-cell subsets implicated in disease pathogenesis. Amlitelimab, an anti-OX40L monoclonal antibody, has demonstrated sustained efficacy and a favorable safety profile in phase IIa and IIb trials. Rocatinlimab, targeting OX40, has also shown promising results in a phase IIb study and has progressed into multiple phase III trials, with supportive top-line data. In contrast, telazorlimab has shown more modest efficacy and has not advanced to later-stage development. Next-generation agents, including IMG-007, STAR-0310, APG990, and APG279, have been engineered with extended half-lives and attenuated antibody-dependent cellular cytotoxicity to support longer dosing intervals and improve tolerability. While these findings are encouraging, direct comparative studies among agents and versus established therapies are lacking, and long-term efficacy and safety data are still needed. This narrative review explores the role of the OX40/OX40L axis in atopic dermatitis pathogenesis and critically evaluates emerging therapies targeting this pathway, aiming to inform their future integration into clinical practice.
01 Sep 2024·Dermatology and Therapy
Extended Half-life Antibodies: A Narrative Review of a New Approach in the Management of Atopic Dermatitis
Review
Author: Yilmaz, Orhan ; Torres, Tiago
Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense pruritus and eczematous lesions, significantly impacting physical health and quality of life. The pathogenesis of AD involves genetic predisposition, immune dysregulation, and environmental factors, with a defective skin barrier playing a crucial role. Treatment options for AD include both topical and systemic therapies, with advanced treatments like Janus kinase inhibitors and biologics offering significant improvements but facing limitations in safety and dosing frequency. Extended half-life antibodies represent a promising advancement for the management of immune-mediated inflammatory diseases, including AD. These antibodies, engineered for prolonged circulation and reduced dosing frequency, target key cytokines and immune pathways known to be involved in the pathogenesis of AD, offering potential for less frequent administration while maintaining efficacy. Currently, two such agents are in phase 2 trials. APG777, targeting interleukin-13 (IL-13), and IMG-007, targeting OX40 receptor, have shown promising preclinical and early clinical results. They demonstrated prolonged half-lives and the potential for less frequent dosage regimen, along with significant improvements in AD symptoms. These therapies could enhance patient adherence and reduce healthcare burdens by decreasing injection frequencies and clinic visits. As research continues, extended half-life antibodies could significantly improve AD management and patient quality of life. Further studies will determine the long-term safety and efficacy of extended half-life antibodies, with ongoing innovations in antibody engineering likely to broaden their applications and benefits.
49
News (Medical) associated with Olevaprubart07 Aug 2026
SAN DIEGO, Aug. 05, 2026 (GLOBE NEWSWIRE) -- ImageneBio, Inc. (Nasdaq: IMA) ("Imagene" or the "Company") today reported financial results for the quarter ended June 30, 2026, and provided a company update.
Company Highlights
Olevaprubart, also known as IMG-007, the potential first-in-class therapeutic targeting the OX40 pathway, is a non-T cell-depleting, ADCC-silenced, anti-OX40 receptor antagonist with an extended half-life.
The Phase 2b ADAPTIVE trial of olevaprubart in moderate-to-severe atopic dermatitis continues to progress as planned under the amended protocol.
A long-term extension (LTE) study has been opened for patients enrolled in ADAPTIVE and sites are actively enrolling patients into the extension protocol.
A Phase 2 clinical trial of olevaprubart in alopecia areata is planned to initiate in 2026.
The company will present two posters on olevaprubart at the 2026 European Academy of Dermatology and Venereology (EADV) Congress.
Imagene strengthened its leadership team with the appointments of Yanina Grant-Huerta as Chief Financial Officer and Matt Robbins as General Counsel.
$136.2 million in cash, cash equivalents and marketable securities as of June 30, 2026, providing anticipated funding for planned operations into the first quarter of 2028.
"Imagene’s olevaprubart is now primed to emerge as the leading OX40 signal blockade program. With our continued progress in advanced clinical development, our conviction remains strong," said Kristin Yarema, Ph.D., chief executive officer of Imagene. "Olevaprubart was engineered to be a genuinely differentiated medicine with the potential for strong, competitive efficacy and a favorable safety profile. This is what our Phase 2b ADAPTIVE study is designed to evaluate and we are very pleased with our progress. Atopic dermatitis and alopecia areata remain areas of significant unmet need, and, as we are following every new development in the field closely, none of it changes what we believe: that direct, T cell-targeted yet non-T cell depleting approaches like ours have the potential to provide durable, safe and strong benefit for patients. Our programs remain on track and we continue to advance as planned, including welcoming patients who have completed a year of treatment into our long-term extension study."
Recent Corporate Updates
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ezstandalone.showAds(131);
});
In April 2026, Imagene closed a $30 million private placement with participation from both new and current investors.
In July 2026, Imagene appointed Yanina Grant-Huerta as Chief Financial Officer.
Grant brings 20 years of financial and accounting leadership experience in the biopharma industry.
She most recently served as Chief Accounting Officer at Atara Biotherapeutics and previously spent 14 years at Amgen Inc. in progressively senior finance and business analysis roles.
Imagene also appointed Matt Robbins as General Counsel, bringing more than 15 years of corporate, securities, and transactional experience advising public and private life sciences companies.
Dr. Ben Porter-Brown transitioned to a consulting role at the end of July 2026, continuing to support the Company as a consulting clinical development expert and strategic advisor.
Olevaprubart Program Updates
Atopic Dermatitis:
The previously announced protocol amendment to the ADAPTIVE trial has been implemented, and the study continues to progress under the amended protocol.
The amended protocol introduces a robust design intended to further evaluate the potential of olevaprubart in moderate-to-severe atopic dermatitis.
Topline data from the study is anticipated in the fourth quarter of 2027.
A long-term extension study has been opened for those who have completed one year in the ADAPTIVE study (
NCT07734415
) and patients are actively moving into the LTE.
The Independent Data Monitoring Committee (IDMC) for the ADAPTIVE study recommended the study proceed with no changes to the protocol or monitoring on July 23, 2026.
As of July 31, 2026 no cases of Kaposi sarcoma have been observed across the olevaprubart program, including in ongoing studies.
Alopecia Areata
: Imagene remains on track to initiate a Phase 2 study of olevaprubart in alopecia areata in 2026.
Initial data expected in 2028, leveraging the clinical operations and investigator network the Company has developed through its atopic dermatitis program.
Upcoming Scientific Presentations:
Imagene will present two posters at the 2026 European Academy of Dermatology and Venereology (EADV) Congress:
Title:
IMG-007, a non-depleting OX40 antagonist: Optimizing Peak Loading Concentration and Exposure Range to Unlock the Full Potential of OX40-OX40L Pathway Targeting in Immune Mediated Diseases
Poster Number:
P1683
Abstract ID:
AS-4099
Title:
IMG-007, a non-depleting OX40 mAb, produces durable shift in TCR repertoire and T cell function: Early biomarker insights from a Phase 1b/2a trial in immune-mediated alopecias
Poster Number:
P2203
Abstract ID:
AS-3275
Second Quarter 2026 Financial Highlights
Cash Position:
Following a $30 million PIPE financing completed in April 2026, the Company ended June 30, 2026 with $136.2 million in cash, cash equivalents and marketable securities. The Company expects that such resources will be sufficient to fund planned operations into the first quarter of 2028.
Research and Development (R&D) Expenses:
R&D expenses were $6.7 million for the three months ended June 30, 2026, compared to $5.7 million for the same period in 2025. The Company continues to invest in clinical trial and personnel-related expenses associated with its primary development program.
General and Administrative (G&A) Expenses:
G&A expenses were $5.1 million for the three months ended June 30, 2026, compared to $1.7 million for the same period in 2025.
Net Loss:
Net loss was $10.2 million, or $0.63 loss per share, for the three months ended June 30, 2026, compared to a net loss of $10.7 million, or $4.46 per share, for the same period in 2025.
About Olevaprubart (formerly IMG-007)
Olevaprubart (formerly IMG-007) is an investigational, non-T cell-depleting monoclonal antibody targeting OX40, a receptor protein primarily found on activated human T cells. When OX40 binds its ligand OX40L in human tissue, the signal generated plays a key role in the activation, expansion, and survival of many subtypes of T cells. Targeted inhibition of OX40 is being studied in the clinic across a range of autoimmune, inflammatory and immunological conditions where aberrant signaling of one or more T cell subtypes is believed to drive disease. Olevaprubart has been engineered to include a silenced antibody-dependent cell-mediated cytotoxicity function demonstrated to avoid T cell depletion or killing and intended to minimize safety risk. This technology also resulted in an approximately 5-week half-life, prolonging therapeutic activity with the aim of maximizing time between doses for a patient.
About ImageneBio, Inc.
Imagene is a clinical-stage biotechnology company dedicated to developing therapeutics for patients with immunological, autoimmune and inflammatory diseases with differentiated clinical pro The Company's program, olevaprubart (formerly IMG-007), is a receptor targeting, nondepleting anti-OX40 monoclonal antibody with multiple differentiating features. Imagene has completed Phase 1b/2a clinical trials of olevaprubart in both atopic dermatitis and alopecia areata and is currently conducting a Phase 2b clinical trial of olevaprubart in patients with moderate-to-severe atopic dermatitis. For more information, please visit
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the expected timing, progress and results of the Company's ongoing Phase 2b ADAPTIVE trial; the anticipated benefits and potential impact of the amended ADAPTIVE trial protocol; the expected timing of initiation of the Company's Phase 2 alopecia areata trial and the timing of initial clinical data; the therapeutic potential, safety pro clinical differentiation of olevaprubart; the Company's plans to advance the development of olevaprubart across multiple inflammatory and autoimmune indications; the Company's planned scientific presentations and anticipated dissemination of clinical data; the Company's expected cash resources, capital requirements and financing plans; and other statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future. Words such as "will," "can," "expect," "may," "plan," "potential," "goal," or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: risks associated with the nonclinical and clinical development and regulatory approval of olevaprubart, including potential delays in the completion of clinical trials and potential safety and other complications thereof; the timing of the availability of data from the Company's clinical trials; the risk that competitor data may materially and adversely impact the Company, its business, and its future prospects; the clinical utility, potential differentiation and/or benefits and market acceptance of olevaprubart; the requirement for additional capital to continue to advance the olevaprubart program, which may not be available on favorable terms or at all; the Company's ability to attract, hire, and retain skilled executive officers and employees; the Company's ability to protect its intellectual property and proprietary technologies; the Company's reliance on third parties, contract manufacturers, and contract research organizations; the possibility that the Company may be adversely affected by other economic, political, business, or competitive factors; and risks associated with changes in applicable laws or regulations or government resources and policies. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in the Company's filings with the Securities and Exchange Commission (the SEC), including the risks set forth under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, and our subsequent Quarterly Reports on Form 10-Q, filed with the SEC, and in our other filings with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
IMAGENEBIO, INC
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except share and per share amounts)
June 30,
December 31,
2026
2025
Assets
Current assets:
Cash and cash equivalents
$
94,677
$
94,532
Marketable securities
41,476
40,817
Prepaid expenses and other current assets
4,959
4,939
Total current assets
141,112
140,288
Operating lease right-of-use assets, net
521
790
Deposits and other non-current assets
7,852
4,878
Promissory note receivable from related party
2,560
7,020
Total assets
$
152,045
$
152,976
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
977
$
1,439
Accrued expenses and other current liabilities
3,684
7,533
Operating lease liabilities, current
1,912
2,262
Total current liabilities
6,573
11,234
Operating lease liabilities, non-current
—
713
Other non-current liabilities
838
870
CVR liability due to related party
2,560
7,020
Total liabilities
9,971
19,837
Commitments and contingencies (Note 10)
Stockholders’ equity:
Preferred Stock, $0.001 par value, 10,000,000 shares authorized; no shares issued
and outstanding as of June 30, 2026 and December 31, 2025
—
—
Voting Common Stock, $0.001 par value, 142,000,000 shares authorized; 11,279,130
and 10,650,925 shares issued and outstanding as of June 30, 2026
and December 31, 2025, respectively
11
11
Non-Voting Common Stock, $0.001 par value, 8,000,000 shares authorized;
no shares issued and outstanding as of June 30, 2026 and 530,714 shares
issued and outstanding as of December 31, 2025
—
—
Additional paid-in capital
392,964
363,094
Accumulated other comprehensive income (loss)
(51
)
87
Accumulated deficit
(250,850
)
(230,053
)
Total stockholders’ equity
142,074
133,139
Total liabilities and stockholders’ equity
$
152,045
$
152,976
IMAGENEBIO, INC
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
License revenue
$
—
$
—
$
—
$
800
Operating expenses:
Research and development
6,669
5,653
12,630
9,693
General and administrative
5,115
1,705
11,233
4,460
Total operating expenses
11,784
7,358
23,863
14,153
Loss from operations
(11,784
)
(7,358
)
(23,863
)
(13,353
)
Other income (expense):
Interest income (expense)
1,248
(236
)
2,377
(313
)
Other income, net
374
9
715
4
Total other income (expense), net
1,622
(227
)
3,092
(309
)
Loss before income taxes
(10,162
)
(7,585
)
(20,771
)
(13,662
)
Income tax expense
(16
)
—
(26
)
—
Net loss
(10,178
)
(7,585
)
(20,797
)
(13,662
)
Accretion of redeemable convertible preferred shares
—
(3,149
)
—
(6,200
)
Net loss attributable to common stockholders
$
(10,178
)
$
(10,734
)
$
(20,797
)
$
(19,862
)
Net loss per common share, basic and diluted
$
(0.63
)
$
(4.46
)
$
(1.52
)
$
(8.26
)
Weighted-average common shares outstanding,
basic and diluted
16,161,721
2,406,516
13,700,170
2,405,680
Comprehensive loss:
Net loss
$
(10,178
)
$
(7,585
)
$
(20,797
)
$
(13,662
)
Other comprehensive loss:
Unrealized loss on marketable securities
(34
)
—
(138
)
—
Foreign currency translation adjustment
—
(17
)
—
(26
)
Total comprehensive loss
$
(10,212
)
$
(7,602
)
$
(20,935
)
$
(13,688
)
Contacts
Investor Contact:
Rebecca Cohen
rcohen@imagenebio.com
Media Contact:
Jason Braco, PhD
Valence Communications
jason@valencecomms.com
Phase 2Executive ChangeFinancial Statement
30 Jul 2026
— China product sales recovery continues led by ELUNATE® and SULANDA® with over 40% growth each — — FRUZAQLA® ex-US sales driving growth – now approved or launched in 41 countries — — Strong progress in ATTCs, a source of novel drug candidates with broad therapeutic potential — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 30, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for the six months ended June 30, 2026 and provides updates on key clinical and commercial developments. All amounts are expressed in US dollars unless otherwise stated. A glossary of abbreviations is on page 25. Global sales growth driven by China rebound and FRUZAQLA® geographical expansion In-market sales from key China commercial products up over 40% compared to the first half of 2025. ELUNATE® (fruquintinib in China) up 41% to $60.8 million as it expanded reimbursement coverage for endometrial cancer and was approved for kidney cancer. SULANDA® up 45% to $18.4 million, boosted by upgraded recommendation in Chinese Society of Clinical Oncology guidelines for neuroendocrine tumors.In-market sales of FRUZAQLA® (fruquintinib ex-China) ex-US up ~70% to $68.9 million during first half of 2026, alongside steady US sales, driven by the need for novel non-chemo treatment options in mCRC and ongoing positive experiences of oncologists in third line setting.Profitability maintained amid higher R&D investment, with net income attributable to HUTCHMED at $15.9 million (H1-25: $455.0m including $416.3m gain on divestment of 45% of Shanghai Hutchison Pharmaceuticals Limited (SHPL)), which allowed the Company to maintain a strong cash balance of $1.37 billion. Multiple first-in-class Antibody-Targeted Therapy Conjugate (ATTC) candidates in clinical trials Initiated clinical trial of HMPL-A251 (PI3K/PIKK-HER2) in December 2025 and of HMPL-A580 (PI3K/PIKK-EGFR) in March 2026 and presented preclinical data at American Association for Cancer Research Annual Meeting. Both ATTCs are progressing through dose escalation as planned.HMPL-A830 clinical trial application approved in July 2026, based on a different ATTC payload platform. Regulatory and clinical achievements across late-stage clinical portfolio New Drug Application (NDA) approval of ELUNATE® with sintilimab for second-line kidney cancer in China in May 2026, supported by FRUSICA-2 Phase III data showing median progression-free survival (PFS) of 22.2 months vs. 6.9 months in control group.NDA acceptance of sovleplenib for warm autoimmune hemolytic anemia (wAIHA) in China in April 2026, supported by ESLIM-02 Phase III data presented at European Hematology Association Congress with durable response rate of 66.0%, along with NDA acceptance for immune thrombocytopenia (ITP) in China in February 2026; both wAIHA and ITP indications received priority review status.Positive SACHI Phase III data of ORPATHYS® in combination with TAGRISSO® (osimertinib) sub-group analysis published in The Lancet in January 2026 with median overall survival (OS) of 22.9 months vs. 7.9 months with chemotherapy. NDA approval for third-line MET-amplified gastric cancer in China in June 2026, supported by Phase II data presented at American Society of Clinical Oncology Annual Meeting with objective response rate of 32.3%.Positive pivotal Phase II data of fanregratinib (FGFR inhibitor) in intrahepatic cholangiocarcinoma presented at European Society for Medical Oncology Gastrointestinal Cancers Congress.Initiated Phase III trial of HMPL-760 (BTK inhibitor) in combination with rituximab and chemotherapy for second-line diffuse large B-cell lymphoma in March 2026. HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English on Thursday, July 30, 2026, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, July 31, 2026. After registration, investors may access the live webcast at www.hutch-med.com/event. Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, “HUTCHMED has a clear strategic focus: to build a globally competitive oncology portfolio anchored by differentiated innovation. This future is shaped by our global first-in-class Antibody-Targeted Therapy Conjugate (ATTC) novel payload platforms and other emerging large-molecule modalities. These give us multiple opportunities to pursue first-in-class or best-in-class assets, with potential to be used in combination with standard-of-care or newer medicines, in turn conferring front-line treatment prospects. As these programs advance, multinational partnerships – some presently under discussion – can provide important external validation, broaden development reach and accelerate access to major international markets. We will continue to invest in our world-class R&D organization and deploy our resources in areas where HUTCHMED can create significant impact on the lives of patients globally, harnessing the most advanced scientific modalities, while creating commercial and shareholder value.” Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said, “Strong in-market sales growth from ELUNATE® and SULANDA® in the first half reflects the impact of last year’s streamlining of our salesforce, enhancing productivity with more focused marketing strategies, as we structured our commercial organization to meet the changing China market regulatory guidelines for a sustainable future. We are accelerating ATTC development and strengthening discovery operations through expanding talent and AI capabilities. We are also pursuing business development discussions with multinational partners to expedite global development and commercialization of our most promising programs.” Dr Weiguo Su, Chief Executive Officer (currently on leave of absence) and Chief Scientific Officer of HUTCHMED, said, “The acceptance by the NMPA of the NDA filings for sovleplenib in ITP and wAIHA during the first half of 2026 reflects the strength of the clinical data package, supporting its potential for regulatory and commercial success. Sovleplenib once again attests to the importance of target selectivity, differentiating efficacy and toxicity profiles of our assets. Our ATTC drug candidates are guided by the same principles, designed to navigate our proprietary potent small-molecule targeted therapy payloads to tumor cells while sparing healthy tissues and decreasing side-effects. Pre-clinical data has shown encouraging tumor shrinkage as compared to standard-of-care treatments and emerging therapies recently launched or in development. With three highly novel molecules from two ATTC payload platforms progressing through or about to start first-in-human clinical development, and additional candidates advancing behind them, we are building a science-driven pipeline designed to translate differentiated biology into meaningful clinical benefit.” 2026 INTERIM RESULTS & BUSINESS UPDATES I. COMMERCIAL OPERATIONS There was a strong rebound in China in-market sales, achieving $94.4 million in H1 2026, up 32% vs H1 2025 ($71.6 million) as our sales team continues to improve productivity. This contributed to total in-market sales for oncology products of $279.8 million in H1 2026 (H1-25: $234.4 million). ELUNATE® in-market sales were up 41% to $60.8 million, successfully expanded NRDL coverage to include 2L EMC with pMMR in combination with sintilimab. It also renewed coverage in metastatic CRC for patients who have been previously treated with chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF or anti-EGFR (RAS wild-type). SULANDA® in-market sales were up 45% to $18.4 million, driven by an update to Chinese Society of Clinical Oncology guidelines upgrading the usage for SULANDA® in neuroendocrine tumors to the highest Level I recommendation standard over competing SSA products. It also benefited from shifting marketing strategies to focus on key hospitals. FRUZAQLA® in-market sales growth was primarily driven by sales outside the US, which had growth of ~70%, contributed by approvals or launches in 41 countries to date, including securing reimbursement in France in Q1 2026 and late 2025 launches in Portugal, Belgium, South Korea and Mexico. This helped boost global in-market sales to $185.4 million. Total consolidated revenue for oncology products increased 23% to $121.4 million as compared to H1 2025, primarily due to strong in-market sales growth in ELUNATE® and SULANDA®. Other Oncology/Immunology revenue, consisting of upfront, regulatory milestones, R&D services and licensing revenue was $40.9 million, including an $18.1 million milestone payment from Eli Lilly, triggered by China approval for 2L RCC. Other Ventures revenue, mainly from prescription drug distribution was $116.0 million, leading to total consolidated revenue of $278.3 million. ($ in millions)In-market Sales*Consolidated Revenue** H1 2026H1 2025% Change(CER)H1 2026H1 2025% Change (CER)FRUZAQLA®$185.4$162.8+14%(+14%)$43.1$43.1— —ELUNATE®$60.8$43.0+41%(+33%)$47.1$33.6+40%(+32%)SULANDA®$18.4$12.7+45%(+37%)$18.4$12.7+45%(+37%)ORPATHYS®$15.7$15.2+3%(-3%)$13.3$9.0+48%(+39%)TAZVERIK®***$(0.5)$0.7— —$(0.5)$0.7— —Oncology Products$279.8$234.4+19%(+17%)$121.4$99.1+23%(+18%)Takeda upfront, regulatory milestones and R&D services$20.7$29.5-30%(-30%)Other revenue (R&D services and licensing)$20.2$14.9+35%(+35%)Total Oncology/Immunology$162.3$143.5+13%(+10%)Other Ventures$116.0$134.2-14%(-19%)Total Revenue$278.3$277.7— (-4%) * FRUZAQLA®, ELUNATE® and ORPATHYS® mainly represent total sales to third parties as provided by Takeda, Eli Lilly and AstraZeneca, respectively. ** FRUZAQLA® represents manufacturing revenue and royalties paid by Takeda to HUTCHMED; ELUNATE® represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Eli Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS® represents manufacturing revenue and royalties paid by AstraZeneca to HUTCHMED and sales to other third parties invoiced by HUTCHMED; SULANDA® and TAZVERIK® represent HUTCHMED’s sales of the products to third parties.*** Ipsen is the Marketing Authorization Holder for TAZVERIK®, for which HUTCHMED acts as domestic agent/licensee. In March 2026 Ipsen voluntarily withdrew TAZVERIK® from all Ipsen markets, effective immediately, following emerging safety data from the ongoing SYMPHONY‑1 trial. II. 2026 REGULATORY UPDATES Savolitinib sNDA approved by NMPA in 3L MET-amplified GC in June 2026.Savolitinib MAA approved (temporary authorization) by Swissmedic in combination with TAGRISSO® for 2L EGFRm NSCLC with MET amplification and/or overexpression in February 2026.Fruquintinib sNDA approved by NMPA in combination with sintilimab for 2L RCC in May 2026.Sovleplenib NDA accepted by NMPA for 2L wAIHA in April 2026.Sovleplenib NDA resubmission accepted by NMPA for 2L ITP in February 2026.Tazemetostat voluntary withdrawal by Ipsen in China in March 2026. III. 2026 LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET Expecting topline results in H2 2026 for SAFFRON and SANOVO, following full enrollment in H2 2025:
SAFFRON global Phase III study for 2L/3L EGFRm NSCLC patients with MET amplification and/or overexpression could support global filings (NCT05261399).SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression could support China filing (NCT05009836).
Published sub-group analysis of SACHI China Phase III study for 2L EGFRm NSCLC patients with MET amplification in The Lancet in January 2026, showing mOS of 22.9 months vs 7.9 months with chemotherapy (HR 0.32) when excluding control group patients who received subsequent MET inhibitor.Presented and published positive China Phase II pivotal study data in 3L MET-amplified GC at ASCO 2026 and in Nature Medicine in June 2026, respectively, with IRC-assessed ORR of 32.3%, mPFS of 4.0 months and mOS of 6.9 months (NCT04923932). Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk Presented positive ESLIM-02 China Phase III study data in 2L wAIHA at EHA 2026 Congress in June 2026, having met its primary endpoint of durable response rate of 66.0%, showing median time to response of 3.1 weeks and median cumulative duration of response of 16.1 weeks. Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3 Presented positive China Phase II pivotal study data in 2L FGFR2 fusion/rearrangement ICC at ESMO Gastrointestinal Cancers Congress in July 2026, having met its primary endpoint of IRC-assessed ORR of 42.5%, as well as showing mPFS of 6.9 months and mOS of 16.6 months. An NDA for 2L ICC was accepted by NMPA with priority review status in December 2025 (NCT04353375). HMPL-760, a non-covalent, third generation BTK inhibitor, targeting wild-type and C481S-mutated BTK Initiated China Phase III study in combination with R-GemOx (rituximab, gemcitabine and oxaliplatin) in patients with 2L relapsed/refractory DLBCL versus placebo in combination with R-GemOx in March 2026 (NCT07409428). Primary endpoints are investigator-assessed PFS and OS. 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 Progressing a dose-escalation and expansion trial for unresectable, advanced or metastatic HER2-expressing solid tumors with first patient dosed in December 2025 (NCT07228247).Preclinical data showed anti-tumor activity in DXd-resistant cell line and good efficacy and safety when in combination with chemotherapy via a differentiated mechanism of action. HMPL-A580, a first-in-class PI3K/PIKK-EGFR ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to an anti-EGFR IgG1 antibody, via a cleavable linker Progressing a dose-escalation and expansion trial for solid tumors, including NSCLC, CRC, HNSCC and ESCC with first patient dosed in March 2026 (NCT07396584).Preclinical data presented at AACR 2026 showing tumor shrinkage in osimertinib-resistant EGFRm NSCLC cell line and good efficacy and safety when used in combination with osimertinib in EGFRm PAM non-altered NSCLC cell line. HMPL-A830 China/US INDs cleared Plans for global clinical trial initiation in H2 2026. Preclinical data showed superior potency and safety profiles to antibodies or small molecules with the same target, with data to be presented at a scientific conference. V. COLLABORATION UPDATES ImageneBio is developing IMG-007, a non-T cell depleting, antibody-dependent cell-mediated cytotoxicity -silenced OX40 antagonist discovered by HUTCHMED Phase IIb trial (NCT07037901) in patients with moderate-to-severe atopic dermatitis progressing, with an amended protocol and topline data anticipated in the fourth quarter of 2027.Phase II trial initiation in patients with alopecia areata expected in 2026, with initial data expected in 2028. VI. OTHER VENTURES Other Ventures consolidated revenue decreased to $116.0 million for the six months ended June 30, 2026 (H1-25: $134.2 million) which has minimal impact on profitability as the segment is predominantly low-margin prescription drug distribution business in China and HUTCHMED continues to optimize working capital management.Consolidated net income attributable to HUTCHMED from Other Ventures decreased to $3.8 million (H1-25: $24.0m), primarily due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025. VII. SUSTAINABILITY The 2025 Sustainability Report was published in April 2026 alongside the 2025 Annual Report. We have initiated a new target-setting cycle. A list of potential focus initiatives has been identified under our five sustainability pillars: Innovation, Climate Action, Human Capital, Access to Healthcare, and Ethics and Transparency. In 2026, we will develop this into a final list, including a roadmap for achievement and monitoring. In 2026, our sustainability initiatives have continued to receive strong recognition. Most recently, our commitment was reflected in an upgraded AA rating by MSCI, recognizing HUTCHMED as a Leader, and placing us among the top 19% of pharmaceutical companies. For its second consecutive year, HUTCHMED was recognized as Most Honored Company and ranked 1st place in ESG in its sector by Extel, formerly Institutional Investor Research, in its 16th Asia Executive Team Survey. It achieved top rankings across several areas – leading CEO, CFO, Investor Relations, ESG and Corporate Governance – earning the Most Honored Company designation. HUTCHMED was the only company to earn these designations in 2026 in All Asia (ex-Mainland China) Biopharmaceuticals. FINANCIAL HIGHLIGHTS Revenue for the six months ended June 30, 2026 was $278.3 million compared to $277.7 million for the six months ended June 30, 2025. Oncology/Immunology consolidated revenue amounted to $162.3 million (H1-25: $143.5m):
ELUNATE® revenue was $47.1 million, up 40% (H1-25: $33.6m), comprising manufacturing revenue, promotion and marketing services revenue and royalties, supported by ongoing label expansions.SULANDA® revenue was $18.4 million, up 45% (H1-25: $12.7m), driven by marketing strategies focusing on key hospitals and supported by recent oncology clinical guideline upgrades.ORPATHYS® revenue was $13.3 million, up 48% (H1-25: $9.0m), driven by higher manufacturing sales to AstraZeneca in preparation for the 3L MET-amplified GC launch.FRUZAQLA® revenue was $43.1 million (H1-25: $43.1m), reflecting continued growth in royalties, offset by reduced manufacturing revenue compared to the prior period, driven by strong in-market sales growth following approvals/launches in 41 countries to date.Takeda upfront, regulatory milestones and R&D services revenue were $20.7 million (H1-25: $29.5m), due to less R&D and regulatory support services to Takeda.Other revenue of $20.2 million (H1-25: $14.9m), includes an $18.1 million milestone payment from Eli Lilly triggered by China approval of ELUNATE® in combination with sintilimab for 2L RCC (H1-25: $11.1 million regulatory milestone from AstraZeneca following China NDA approval for SACHI).
Other Ventures consolidated revenue of $116.0 million (H1-25: $134.2m), primarily due to scaling down low-margin logistics distribution sales after considering working capital. Net Expenses for the six months ended June 30, 2026 were $262.4 million compared to $239.0 million for the six months ended June 30, 2025. Cost of Revenue was $152.2 million (H1-25: $167.6m), predominantly due to a lower cost of sales related to the prescription drug distribution business. Cost of revenue as a percentage of oncology product revenue improved to 33% (H1-25: 39%) driven by enhanced productivity and efficiency.R&D Expenses were $78.8 million (H1-25: $72.0m) as we initiated early-stage global clinical programs for our ATTC assets and we maintain ongoing investment in discovery to deliver sustained innovation.S&A Expenses were $46.5 million (H1-25: $41.6m), driven by strong performance of our Oncology/Immunology commercial operations and enhanced productivity.Other Items generated net income of $15.1 million (H1-25: $42.2m), which mainly includes interest income and expense, foreign exchange, equity in earnings of SHPL and taxes. The decrease was mainly due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025. Net Income attributable to HUTCHMED for the six months ended June 30, 2026 was $15.9 million compared to $455.0 million for the six months ended June 30, 2025. $0.02 basic earnings per ordinary share / $0.09 basic earnings per ADS in the first half of 2026 (H1-25: $0.53 basic earnings per ordinary share / $2.65 basic earnings per ADS). Cash, Cash Equivalents and Short-Term Investments were $1,374.8 million as of June 30, 2026 compared to $1,367.3 million as of December 31, 2025. Adjusted Group (non-GAAP) net cash inflow excluding financing activities in the first half of 2026 was $10.5 million mainly due to net income of $16.2 million less $5.6 million in capital expenditures (H1-25: net cash inflow of $519.1m mainly due to the $549.0m net proceeds from the partial divestment of SHPL less a $10.0m regulatory approval milestone payment and $9.2m in capital expenditures).Net cash used in financing activities in the first half of 2026 totaled $2.9 million mainly due to net repayments of bank borrowings (H1-25: net cash inflow of $9.3m mainly due to proceeds from bank borrowings of $8.2m). Foreign exchange impact: The RMB appreciated against the US dollar on average by approximately 5% during the first half of 2026, 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 GUIDANCE HUTCHMED reiterates full year 2026 guidance for Oncology/Immunology consolidated revenue in the range of $330 million to $450 million. HUTCHMED will leverage its strong cash resources to accelerate ATTC global development and explore investment opportunities. Shareholders and investors should note that: 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; andThe 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 June 30, 2026 As of December 31, 2025Assets(Unaudited) Cash and cash equivalents and short-term investments1,374,817 1,367,275Accounts receivable117,556 126,750Other current assets61,036 73,317Property, plant and equipment93,788 94,623Investment in equity investees11,020 10,865Other non-current assets78,210 80,267Total assets1,736,427 1,753,097Liabilities and shareholders’ equityAccounts payable33,646 45,533Other payables and accruals197,627 208,892Bank borrowings94,508 93,160Deferred revenue27,630 51,547Other liabilities108,048 102,703Total liabilities461,459 501,835Company’s shareholders’ equity1,260,776 1,237,926Non-controlling interests14,192 13,336Total liabilities and shareholders’ equity1,736,427 1,753,097 Condensed Consolidated Statements of Operations Data (Unaudited, in $’000, except share and per share data)Six months ended June 30, 2026 2025Revenue:Oncology/Immunology – Marketed Products121,434 99,039 Oncology/Immunology – R&D40,887 44,408 Oncology/Immunology Consolidated Revenue162,321 143,447 Other Ventures115,966 134,230 Total revenue278,287 277,677 Operating expenses:Cost of revenue(152,158) (167,577)Research and development expenses(78,783) (71,990)Selling and administrative expenses(46,477) (41,624)Total operating expenses(277,418) (281,191) Gain on divestment of an equity investee— 477,456 Other income, net12,784 21,650 Income before income taxes and equity in earnings of equity investees13,653 495,592 Income tax expense(1,209) (2,029)Income tax expense – Divestment of an equity investee— (61,133)Equity in earnings of equity investees, net of tax3,798 23,125 Net income16,242 455,555 Less: Net income attributable to non-controlling interests(314) (601)Net income attributable to HUTCHMED15,928 454,954 Earnings per share attributable to HUTCHMED (US$ per share)– basic 0.02 0.53 – diluted0.02 0.52 Number of shares used in per share calculation– basic865,770,498 857,038,725 – diluted872,869,494 872,564,513 Earnings per ADS attributable to HUTCHMED (US$ per ADS)– basic 0.09 2.65 – diluted0.09 2.61 Number of ADSs used in per ADS calculation– basic173,154,100 171,407,745 – diluted174,573,899 174,512,903 About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, and the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Contacts Investor Enquiries+852 2121 8200 /ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 /HUTCHMED@fticonsulting.comBen Atwell / Tim Stamper+44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) /HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerDuncan Monteith / Ramin Naji+44 20 7545 8000 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 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 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; 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 delay or inability of a drug candidate to meet the primary or secondary endpoint of a study; the delay or 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, including various third party services, 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 to obtain additional funding when needed; the ability to obtain and maintain protection of intellectual property for HUTCHMED’s Products and drug candidates; 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, uncertainties in global interest rates, and geopolitical relations, sanctions and tariffs. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, on AIM and on HKEX. 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 (EU) No 596/2014 (as it forms part of retained EU 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/031c06fc-010c-45d1-8c53-ed93a7275b6c
Phase 2Clinical ResultPhase 3Drug ApprovalPhase 1
24 Jul 2026
Sanofi is discontinuing amlitelimab’s development in AD, but the Phase II study in celiac disease will continue. Credit: Kwangmoozaa / Shutterstock.com.
Sanofi has chosen not to file for approval or continue the development of its immunology therapy, amlitelimab, in atopic dermatitis (AD) – dealing a blow to the company’s efforts to secure a successor for blockbuster drug Dupixent’s (dupilumab) as the drug’s patent expiry looms.
After a strategic review, the French pharma giant put a stop to the OX40 ligand blocker’s development programme in AD due to its belief that the drug would not offer “meaningful improvements” over the standard of care (SoC). While amlitelimab did display efficacy across its Phase III programme, the drug failed to meet its co-primary endpoint in the
COAST 2 study
(NCT06181435) – leading some analysts to doubt the ability of the wider OX40 drug class to penetrate the first-line market in AD.
This
AD
discontinuation marks another setback for amlitelimab’s market prospects, which was once touted as a potential successor to Sanofi’s best-selling immunology asset, Dupixent. Previously, Sanofi previously canned development programmes for the drug focused on asthma, alopecia and hidradenitis suppurativa (HS).
According to Tanuj Sircar, associate director of Competitive Intelligence at GlobalData, Sanofi’s decision to discontinue amlitelimab at the pre-registration stage is surprising, though it’s likely attributed to competitor dynamics within the space and adjacent indications. GlobalData is the parent company of
Pharmaceutical Technology
.
However, there could still be hope for the drug’s market prospects, as Sanofi is currently forging on with its Phase II study on amlitelimab in celiac disease, which the company expects to read out in the second half of 2026.
OX40 class takes another hit
Amlitelimab’s discontinuation in AD comes as challenges continue for the OX40 drug class. Kyowa Kirin has terminated its development programme for its OX40 receptor blocker, rocatinlimab, after some patients given the drug developed rare blood vessel cancer, Kaposi sarcoma.
These malignancies, Sircar says, likely cast scrutiny on amlitelimab’s safety profile – potentially eroding the drug’s value and franchise potential. Previously, two patients treated with amlitelimab have developed Kaposi’s sarcoma, according to a paper published in
Frontiers
.
“Amlitelimab’s discontinuation draws parallels to its peer, rocatinlimab, and the discontinuation of both assets prior to filing will likely damage stakeholder perception of the class,” Sircar commented.
“Industry momentum for OX40s will likely wind down, though Inmagene’s non-depleting anti-OX40-R, IMG-007, is in Phase IIb development and it remains to be seen if AbbVie will continue development of Apogee’s OX40L, APG990,” he added.
Moving forward, Sircar theorises that Sanofi will redirect its investments towards Dupixent, as well as in oral modalities such as its Kymera Therapeutics co-developed IRAK4 degrader, KT-485 and its Nurix-acquired STAT6 degrader, NX-3911, in AD.
Phase 2AcquisitionPhase 3
100 Deals associated with Olevaprubart
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Dermatitis, Atopic | Phase 2 | United States | 17 Jun 2025 | |
| Dermatitis, Atopic | Phase 2 | Australia | 17 Jun 2025 | |
| Dermatitis, Atopic | Phase 2 | Canada | 17 Jun 2025 | |
| Dermatitis, Atopic | Phase 2 | New Zealand | 17 Jun 2025 | |
| Eczema | Phase 2 | United States | 17 Jun 2025 | |
| Eczema | Phase 2 | Australia | 17 Jun 2025 | |
| Eczema | Phase 2 | Canada | 17 Jun 2025 | |
| Eczema | Phase 2 | New Zealand | 17 Jun 2025 | |
| Alopecia Areata | Phase 2 | United States | 25 Sep 2023 | |
| Alopecia Areata | Phase 2 | Canada | 25 Sep 2023 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 1/2 | 29 | (IMG-007 300 mg) | ybxbbcefyk = nbaucoersa nnkzdkquhw (imxguvupwp, kulbljpltn - awlwzmrgvn) View more | - | 09 Feb 2026 | ||
(IMG-007 600 mg) | ybxbbcefyk = ubslurzmwz nnkzdkquhw (imxguvupwp, beufcvrrgz - xutsgldgqf) View more | ||||||
Phase 1/2 | 13 | fvsuwdmugh = wvmfqauigy kaupmuphyy (advwlnnofc, skcqxjbzul - yuqycwyevz) View more | - | 06 Nov 2025 | |||
NCT06060977 (NEWS) Manual  | Phase 2 | 29 | vglbbzzznw(gukyachgnv) = rcwxmmgcwh isombqjjef (hfpkadyhre ) | Positive | 25 Apr 2025 | ||
vglbbzzznw(gukyachgnv) = ibgnmyhdii isombqjjef (hfpkadyhre ) View more | |||||||
NCT06304740 (NEWS) Manual | Phase 1 | 16 | egexkyiksy(onalrntvaf) = xxskxdxgmy tmtnqoxjoe (kdydffywhk ) View more | Positive | 10 Jan 2025 | ||
Placebo | wptkdgnvum(hmwndthjqt) = tkgdenxhfr xwqhivsruv (vxrtbuwzvq ) | ||||||
Phase 2 | 13 | IMG-007 300 mg | gotuiwqufi(dykbcsoasy) = jgquhcehnu zopbniujnt (btwczwbhkh ) View more | Positive | 06 May 2024 | ||
NCT05353972 (NEWS) Manual | Phase 1 | 44 | ksohuihwwk(vnkrnxuntn) = IMG-007组未见比安慰剂组更高比例的特别不良事件（除了无剂量相关性的一些孤立 COVID-19病例），没有受试者报告任何与治疗相关的不良事件。重要的是，未报告发热或寒战事件。 udipylfdzg (esvpoggowo ) | Positive | 21 Aug 2023 | ||
placebo |
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