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Last update 12 Aug 2026
Batoclimab
Last update 12 Aug 2026
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms Batoclimab (USAN/INN), Immunoglobulin g1(238-alanine, 239-alanine), anti-(human fcrn receptor) (human monoclonal hl161bkn .gamma.1-chain), disulfide with human monoclonal hl161bkn .lambda.-chain, dimer, HBM-9161 + [6] |
Target |
Action antagonists, modulators |
Mechanism FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationOrphan Drug (Japan), Breakthrough Therapy (China) |
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Structure/Sequence
Sequence Code 524289076H
Source: *****
Sequence Code 524289077L
Source: *****
Related
30
Clinical Trials associated with BatoclimabNCT07188844
An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This is an open-label extension (OLE) study designed to evaluate the long-term safety and tolerability of batoclimab in participants with CIDP who have completed Study IMVT-1401-2401 (NCT05581199). In this study, participants will receive 340 mg of batoclimab subcutaneously (SC) once weekly (QW) for up to 52 weeks. Upon completion of the Week 52 or early termination (ET) Visit, participants will transition into the 4-week Follow-up Period, which concludes with a Follow-up Visit approximately 28 (± 7) days after the Week 52 or ET Visit.
Start Date28 Aug 2025 |
Sponsor / Collaborator |
NCT05907668
IMVT-1401-2501: A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)
The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs).
Start Date15 May 2023 |
Sponsor / Collaborator |
NCT05524571
A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)
To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.
Start Date05 Jan 2023 |
Sponsor / Collaborator |
100 Clinical Results associated with Batoclimab
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100 Translational Medicine associated with Batoclimab
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100 Patents (Medical) associated with Batoclimab
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21
Literatures (Medical) associated with Batoclimab01 Apr 2026·JOURNAL OF NEUROLOGY
Efficacy and safety of complement inhibitors and FcRn blockers in generalized AChR antibody-positive myasthenia gravis: a meta-analysis
Review
Author: Di Giovanni, Simone ; Filippakopoulou, Eugenia ; Arnaoutoglou, Marianthi ; Kimiskidis, Vasilios ; Gavriilaki, Maria
BACKGROUND:
Antibody status is increasingly used to inform treatment strategies in generalized myasthenia gravis (gMG). We evaluated the efficacy and safety of complement inhibitors and neonatal Fc receptor (FcRn) blockers versus placebo or standard care in adults with acetylcholine receptor antibody-positive (AChR-Ab⁺) gMG.
METHODS:
We systematically searched MEDLINE, EMBASE, Cochrane Central Register Controlled Trials, and ClinicalTrials.gov through November 2024. Eligible randomized controlled trials (RCTs) informed short-term analyses while long-term outcomes were extracted from open-label extension (OLE) studies. Pooled mean difference (MD) and odds ratio (OR) were calculated using random-effects model.
RESULTS:
Six RCTs (n = 739) and four OLEs (n = 588) evaluating eculizumab, ravulizumab, zilucoplan, efgartigimod, rozanolixizumab, and batoclimab were included. Both drug classes significantly improved mean changes from baseline versus placebo in Myasthenia Gravis Activities of Daily Living [MD 1.7, 95% confidence interval (CI) 1.1-2.3], Quantitative Myasthenia Gravis [MD 2.7, 95%(CI)1.8-3.5], Myasthenia Gravis Composite [MD 6.3, 95%(CI) 5-7.6], MGQoL15r [MD 3.4, 95%(CI)1.2-5.6], and Neuro-QoL [MD 4.5, 95%(CI)1.2-7.7]. Odds of achieving clinically meaningful MG-ADL and QMG improvements were more than doubled (ORs 2.7 and 3.5). Risks of clinical worsening and rescue therapy use were reduced by 72% and 48%, respectively. Complement inhibitors OLEs showed durable benefit up to 156 weeks; 30% of patients reduced corticosteroid doses. Rates of serious adverse events, discontinuation, and mortality were comparable to placebo.
CONCLUSION:
In AChR-Ab⁺ gMG, complement inhibitors and FcRn blockers yield clinically meaningful improvements with favourable safety profiles. Complement inhibition additionally confers sustained benefits and corticosteroid-sparing effects in this population over long-term.
PROTOCOL REGISTRATION:
PROSPERO ID: CRD42024513406.
01 Mar 2026·THYROID
Euthyroidism and Long-Term Remission of Graves’ Hyperthyroidism Following Treatment With an FcRn Blocker: A Case Report
Article
Author: Macias, William ; Wolf, Jan ; Luffy, Maximilian ; Kahaly, George J. ; Albert, Katherine
Background::
Neonatal fragment crystallizable receptor (FcRn) blockers selectively inhibit FcRn-mediated IgG recycling, resulting in degradation of IgG autoantibodies, including thyrotropin receptor autoantibodies (TSH-R-Ab).
Methods::
We describe a case involving a 55-year-old woman with a 17-month history of Graves’ disease (GD) who was hyperthyroid despite 15 months on methimazole (MMI) 15–25 mg/day. She received the investigational FcRn blocker batoclimab in a clinical study and was subsequently followed in clinic.
Results::
Within 1 week of starting weekly subcutaneous batoclimab, serum free triiodothyronine (FT3) and thyroxine (FT4) were normalized. Thyrotropin (TSH) was normal within 4 weeks. MMI was discontinued by study week 6. Twenty-three months after stopping batoclimab, the patient remained off MMI, with normal FT3, FT4, and TSH. Total IgG returned to approximate baseline levels 18 months post discontinuation of batoclimab, whereas TSH-R-Ab, which was elevated at baseline, remained below the upper limit of normal 23 months post batoclimab discontinuation.
Conclusions::
FcRn blockade may be an effective and potentially disease-modifying treatment for GD.
01 Sep 2025·DRUG SAFETY
Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants
Article
Author: Liang, Su ; Hardy, Thomas ; Tedeschi, Philip ; Davidson, Michael H ; Brinton, Eliot A ; Lin, E
INTRODUCTION:
Batoclimab is an anti-neonatal fragment crystallizable receptor monoclonal antibody in clinical development for the treatment of autoimmune diseases. In phase II trials, batoclimab resulted in dose-dependent reductions in pathogenic immunoglobulin G autoantibodies; however, dose-related increases in low-density lipoprotein cholesterol and other lipids were observed.
OBJECTIVE:
This study examined the relationship between batoclimab treatment and lipid levels, and whether increases in low-density lipoprotein cholesterol could be mitigated by coadministration with atorvastatin, a widely used cholesterol-lowering agent.
METHODS:
In this phase I, randomized, fixed-sequence, single-blind trial, 70 healthy participants received subcutaneous injections of batoclimab at various doses or placebo for 6 weeks. Open-label oral atorvastatin was coadministered in a subset of participants receiving batoclimab 340 mg or 680 mg weekly, starting 14 days before the first dose of the study drug, and continuing through the 6-week treatment period and 8-week safety follow-up. Key endpoints included changes in lipid parameters and atorvastatin pharmacokinetics.
RESULTS:
Dose-dependent increases in total cholesterol and low-density lipoprotein cholesterol were observed with batoclimab doses ≥ 255 mg weekly, comparable to previous observations, whereas coadministration of atorvastatin 10 mg or 40 mg daily mitigated these changes. Batoclimab had little effect on atorvastatin pharmacokinetics. Dose-dependent decreases in serum albumin up to 37% were observed with batoclimab doses ≥ 255 mg weekly, returning to near-baseline levels 4 weeks after stopping batoclimab. As expected, coadministration of atorvastatin did not meaningfully impact the albumin level. The majority of adverse events were mild in severity.
CONCLUSIONS:
Atorvastatin can mitigate clinically significant increases in low-density lipoprotein cholesterol that may occur with batoclimab treatment.
192
News (Medical) associated with Batoclimab06 Aug 2026
All IMVT-1402 clinical development timelines remain on track, including ongoing studies in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA), Sjögren’s disease (SjD) and cutaneous lupus erythematosus (CLE)
Current cash balance provides runway to the potential launch of IMVT-1402 in GD
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026
DURHAM, N.C., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its first fiscal quarter ended June 30, 2026.
Recent Highlights and Upcoming Milestones:
Immunovant’s development plans for IMVT-1402 remain on track across all six announced indications. The Company expects to provide further updates on its potentially registrational IMVT-1402 D2T RA program and report topline data from the proof-of-concept trial of IMVT-1402 in CLE in the second half of calendar year 2026. In calendar year 2027, topline data are anticipated for the potentially registrational trials evaluating IMVT-1402 in GD and MG. Topline data are expected to follow in calendar year 2028 for the potentially registrational trials of IMVT-1402 in CIDP and SjD.
Financial Highlights for Fiscal First
Quarter Ended June 30, 2026:
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Cash Position:
As of June 30, 2026, Immunovant’s cash and cash equivalents totaled $797.8 million, providing runway to the potential commercial launch of IMVT-1402 in GD, based on our current operating plan.
Research and Development Expenses:
Research and development (R&D) expenses were $142.6 million for the three months ended June 30, 2026, compared to $101.2 million for the three months ended June 30, 2025. The increase was primarily due to activities related to our clinical trials of IMVT-1402, including contract manufacturing costs, partially offset by lower overall costs as we wind-down our batoclimab clinical trials.
Non-GAAP R&D expenses were $135.4 million for the three months ended June 30, 2026, compared to $93.3 million for the three months ended June 30, 2025.
General and Administrative Expenses:
General and administrative (G&A) expenses were $17.7 million for the three months ended June 30, 2026, compared to $26.0 million for the three months ended June 30, 2025. The decrease was primarily due to lower personnel-related expenses, professional fees, market research costs and information technology costs.
Non-GAAP G&A expenses were $11.2 million for the three months ended June 30, 2026, compared to $15.4 million for the three months ended June 30, 2025.
Net Loss:
Net loss was $153.2 million ($0.75 per common share) for the three months ended June 30, 2026, compared to $120.6 million ($0.71 per common share) for the three months ended June 30, 2025. Net loss for the three months ended June 30, 2026 and June 30, 2025 included $13.8 million and $18.5 million, respectively, related to non-cash stock-based compensation expense. Non-GAAP net loss was $139.4 million for the three months ended June 30, 2026, compared to $102.1 million for the three months ended June 30, 2025.
Common Stock:
As of June 30, 2026, there were 206,264,878 shares of common stock issued and outstanding.
Non-GAAP Financial Measures:
In addition to reporting the financial results in accordance with accounting principles generally accepted in the United States of America (GAAP), Immunovant reports certain financial results that differ from what is reported under GAAP. Immunovant believes these non-GAAP financial measures are useful to investors and others because they allow for additional information with respect to financial measures used by management in its financial and operational decision-making and they may be used by institutional investors and the analyst community to help them analyze the health of Immunovant’s business. However, there are a number of limitations related to the use of non-GAAP financial measures, and these non-GAAP measures should be considered in addition to, not as a substitute for or in isolation from, Immunovant’s financial results prepared in accordance with GAAP. Other companies, including companies in Immunovant’s industry, may calculate these non-GAAP financial measures differently or not at all, which reduces their usefulness as comparative measures.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com.
Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026.
To access the conference call by phone, please register online using this
Registrational link
. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Immunovant website at The archived webcast will be available on Immunovant’s website after the conference call.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant’s progress towards developing IMVT-1402 across a broad range of indications; Immunovant’s expectations regarding the availability of results of clinical trials of IMVT-1402 and whether those results may be adequate to support registration; and the Company’s beliefs regarding the potential sufficiency of its cash runway. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, regulatory strategy, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402; Immunovant is at various stages of clinical development for IMVT-1402; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Annual Report on Form 10-K filed with the SEC on May 20, 2026, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
IMMUNOVANT, INC.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
Three Months Ended
June 30,
2026
2025
Operating expenses:
Research and development
$
142,631
$
101,200
General and administrative
17,692
26,024
Total operating expenses
160,323
127,224
Interest income, net
(7,095
)
(6,337
)
Other income, net
(4
)
(1,187
)
Loss before provision for income taxes
(153,224
)
(119,700
)
Provision for income taxes
—
913
Net loss
$
(153,224
)
$
(120,613
)
Net loss per common share – basic and diluted
$
(0.75
)
$
(0.71
)
Weighted-average common shares outstanding – basic and diluted
205,545,373
170,872,994
IMMUNOVANT, INC.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands, except share and per share data)
June 30, 2026
March 31, 2026
Assets
Current assets:
Cash and cash equivalents
$
797,798
$
902,110
Accounts receivable
697
1,133
Prepaid expenses and other current assets
52,683
45,576
Total current assets
851,178
948,819
Property and equipment, net
351
443
Other assets
961
7,752
Total assets
$
852,490
$
957,014
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
10,138
$
7,541
Accrued expenses and other current liabilities
106,964
96,881
Total current liabilities
117,102
104,422
Total liabilities
117,102
104,422
Commitments and contingencies
Stockholders’ equity:
Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at June 30, 2026 and March 31, 2026
—
—
Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2026 and March 31, 2026
—
—
Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 206,264,878 shares issued and outstanding at June 30, 2026 and 500,000,000 shares authorized, 203,940,353 shares issued and outstanding at March 31, 2026
20
20
Additional paid-in capital
2,632,996
2,596,971
Accumulated other comprehensive income
725
730
Accumulated deficit
(1,898,353
)
(1,745,129
)
Total stockholders’ equity
735,388
852,592
Total liabilities and stockholders’ equity
$
852,490
$
957,014
IMMUNOVANT, INC.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited, in thousands)
Three months ended June 30,
Note
2026
2025
Net loss:
$
(153,224
)
$
(120,613
)
Adjustments
Research and development:
Stock-based compensation
(1
)
7,254
7,865
General and administrative:
Stock-based compensation
(1
)
6,520
10,645
Estimated income tax impact from adjustments
—
42
Adjusted net loss (Non-GAAP)
$
(139,450
)
$
(102,061
)
Three months ended June 30,
Note
2026
2025
Research and Development Expenses
$
142,631
$
101,200
Adjustments:
Stock-based compensation
(1
)
7,254
7,865
Adjusted research and development expenses (Non-GAAP)
$
135,377
$
93,335
Three months ended June 30,
Note
2026
2025
General and Administrative Expenses
$
17,692
$
26,024
Adjustments:
Stock-based compensation
(1
)
6,520
10,645
Adjusted general and administrative expenses (Non-GAAP)
$
11,172
$
15,379
(1) Represents non-cash stock-based compensation expense
Contacts:
Investors
Keyur Parekh
keyur.parekh@roivant.com
Media
Stephanie Lee
stephanie.lee@roivant.com
24 Jul 2026
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, July 23, 2026 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, today announced a positive profit alert for the six months ended June 30, 2026 (the "Reporting Period").
Based on a preliminary review of the Company's unaudited management accounts for the Reporting Period, the revenue is expected to range between US$120 million (equivalent to approximately HK$941 million) and US$125 million (equivalent to approximately HK$980 million), representing an increase of approximately 19% to 24% compared with approximately US$101 million for the corresponding period in 2025. The profit for the Reporting Period is expected to range between US$62 million (equivalent to approximately HK$486 million) and US$67 million (equivalent to approximately HK$525 million). Total adjusted profit [1] is expected to range between US$70 million (equivalent to approximately HK$549 million) and US$75 million (equivalent to approximately HK$588 million).
The expected revenue growth and scaled profitability are primarily attributable to:
Continued strategic collaborations with global multinational pharmaceutical companies, including the potential 10-year long-term strategic collaboration with AstraZeneca and the global strategic collaboration with Bristol Myers Squibb.
Newly secured out-licensing and collaboration agreements for innovative products, such as the licensing agreement with Solstice Oncology, as well as milestone payments triggered by the advancement of previously out-licensed programs.
Strong business growth of Nona Biosciences, including revenue generated from antibody transactions and antibody discovery, such as the platform collaboration with Lonza in central nervous system.
With seven consecutive profitable half-years, Harbour BioMed has officially entered a phase of "normalized profitability," further validating the sustainability and replicability of the business model underpinning this platform-based biopharmaceutical group.
Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented: "Our expected profitability in the first half of 2026 marks an important milestone in Harbour BioMed's development and strongly validates our differentiated business model. The value of our proprietary technology platforms is gaining recognition through a growing number of deep strategic partnerships with multinational pharmaceutical companies and leading global biotechnology companies. More importantly, these partnerships are not one-off transactions—they are evolving into a sustainable financial foundation that enables us to continuously discover and develop innovative biotherapeutics for patients worldwide. Looking ahead, we will build on this momentum through continued innovation and high-impact collaborations to deliver sustainable long-term growth."
Global Strategic Collaborations Fuel Continued Strong Revenue Growth
The Company's strong earnings growth was primarily driven by the continued execution and expansion of high-value strategic collaborations with global partners. Harbour BioMed has successfully transformed its proprietary technology platforms and licensing business into a robust and recurring revenue engine.
During the Reporting Period, several major strategic collaborations made significant contributions to revenue. In December 2025, the Company entered into a long-term global strategic collaboration with Bristol Myers Squibb (BMS) to jointly discover and develop next-generation multi-specific antibodies. Under the terms of the agreement, Harbour BioMed could receive payments totaling $90 million, as well as development and commercial milestones of up to $1.035 billion. The Company also expanded its strategic collaboration with AstraZeneca to include antibody-drug conjugates (ADCs) and T-cell engager (TCE) therapeutics. In addition, previously announced licensing partnerships with AstraZeneca, Otsuka, Pfizer, Windward Bio and other global pharmaceutical companies continued to generate meaningful revenue. To date, Harbour BioMed's proprietary technology platforms have been applied across more than 380 drug discovery programs spanning multiple therapeutic areas, with more than 20 molecules having advanced into IND-enabling studies or clinical development, reinforcing the Company's leadership in next-generation biologics innovation.
Beyond licensing collaboration, Nona Biosciences has entered a period of rapid growth. Revenue generated from its platform-based technology licensing and discovery services, together with milestone payments from existing collaborations, has become another important pillar of the Company's business. These collaborations not only reflect the strong recognition of the Harbour Mice® platform by multinational pharmaceutical companies, innovative biotechnology companies and leading academic institutions worldwide, but also underscore Harbour BioMed's successful transformation into a sustainable cash-generating business with enhanced financial resilience and a significantly strengthened risk profile.
Technology Platforms and AI Innovation Strengthen the Value Foundation
Harbour BioMed has embraced artificial intelligence (AI) as a core strategic priority, integrating AI technologies throughout the entire drug discovery and development process. In October 2025, the Company launched the first fully human AI-powered heavy-chain-only antibody (HCAb) generation and screening model enabled by its proprietary Hu-mAtrIx™ AI platform, establishing a closed-loop workflow encompassing AI-driven design, intelligent screening and experimental validation. The model has already demonstrated strong performance, achieving a target hit rate of 78.5%, significantly improving both discovery efficiency and developability.
During the same month, Harbour BioMed initiated the AI + Biopharmaceutical Ecosystem Alliance, bringing together organizations including Insilico Medicine, Molecule Mind and more to systematically transform the drug discovery process through AI-enabled innovation.
In May 2026, the Company reported encouraging preclinical data for LET003, its first next-generation ACVR2A/2B-targeting monoclonal antibody developed using the Hu-mAtrIx™ AI platform. In June 2026, Harbour BioMed further strengthened its AI strategy by entering into a comprehensive long-term strategic partnership with BioMap, a global leader in foundation AI models for life sciences. Together, the two companies established MegaStream TechBio, a joint venture dedicated to developing innovative AI-enabled drug pipelines for the global market. By integrating proprietary datasets, domain-specific foundation models and a broad portfolio of innovative programs, MegaStream TechBio aims to build a next-generation AI drug discovery engine centered on intelligent wet-lab/dry-lab integration and personalized, multimodal, multi-attribute generative AI models.
Clinical Pipeline Continues to Unlock Long-Term Value
Harbour BioMed continues to make meaningful progress across its differentiated pipeline. The Company now has nearly 30 innovative product candidates spanning immunology, oncology, obesity and metabolic diseases, and central nervous system (CNS) disorders—therapeutic areas with significant unmet medical needs. Multiple programs have advanced into clinical development.
For respiratory and immunological diseases, batoclimab, the Company's anti-FcRn monoclonal antibody, is the first drug in China to have completed the full clinical development pathway from Phase 1 through pivotal clinical trials. The biologics license application (BLA) has been submitted, and the therapy has the potential to become an important treatment option across multiple autoimmune diseases. Phase 1 data for the Company's ultra-long-acting anti-TSLP antibody HBM9378 demonstrated a substantially extended half-life, supporting the potential for twice-yearly dosing and reinforcing its best-in-class potential. Initial Phase 2 data in asthma are expected in the second half of 2026, while the Phase 2 SIRIUS study in chronic obstructive pulmonary disease (COPD) has already dosed its first patients. Meanwhile, another ultra-long-acting, TSLP-targeting bispecific antibody, HBM7575, has dosed the first subject in its Phase 1 study for atopic dermatitis and recently received IND clearance for the treatment of asthma.
For immuno-oncology, HBM4003, the Company's anti-CTLA-4 heavy-chain-only antibody, has demonstrated best-in-class potential. In a Phase 2 study in microsatellite stable (MSS) metastatic colorectal cancer (mCRC), HBM4003 in combination with tislelizumab achieved an objective response rate (ORR) of 34.8% and a median progression-free survival (mPFS) of 4.2 months. Based on these encouraging results, the Company entered into a licensing agreement and equity partnership with Solstice Oncology in February 2026, receiving upfront consideration valued at over $105 million and being eligible for milestone payments of up to approximately US$1.1 billion.
In addition, the Company's HBM7004, a bispecific antibody for solid tumors, has received IND clearance from the U.S. Food and Drug Administration (FDA), while its IND application has been accepted by China's National Medical Products Administration (NMPA).
From its foundational proprietary technology platforms and AI-driven innovation to the advancement of a differentiated clinical pipeline and the execution of high-value global partnerships, Harbour BioMed has built a self-reinforcing innovation ecosystem. The Company's sustained profitability over multiple years demonstrates the successful execution of its unique business model, creating a virtuous cycle that converts technology innovation into long-term commercial value.
Looking ahead, supported by an expanding global partner network, a deeply integrated AI- and automation-enabled R&D platform, and a steadily advancing differentiated pipeline, Harbour BioMed is well positioned to continue delivering sustainable growth. With a strong financial foundation and industry-leading technological capabilities, the Company is evolving from a technology adopter to a technology leader, bringing more innovative antibody therapeutics to patients worldwide.
About Harbour BioMed
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas. The Company is building a robust portfolio and differentiated pipeline through internal R&D capability, strategic global collaborations in co-discovery and co-development, and selective acquisitions.
Our proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. The HCAb-based Antibody Plus technology (HCAb PLUSTM) provides comprehensive modality solutions for the development of innovative multi-specific medicines in different disease areas. Additionally, building upon the Harbour Mice® platform, Harbour BioMed launched its first fully human Generative AI HCAb Model powered by its Hu-mAtrIxTM AI platform, accelerating the development of innovative therapies.
By integrating Harbour Mice®, HBICE®, HCAb PLUSTM, a single B-cell cloning platform and AI technologies, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit .
Statement
The information contained in this press release is only a preliminary assessment by the Board based on the unaudited management accounts of the Company and its subsidiaries for the six months ended June 30, 2026 currently available to the Company, and is not based on any figures or information which have been reviewed or confirmed by the audit committee of the Board, or reviewed or audited by the auditors of the Company. The actual results for the six months ended June 30, 2026 may differ from those disclosed in this press release. As such, the above figures are strictly for information only and not for any other purposes.
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Phase 1License out/inClinical ResultPhase 2
21 May 2026
Immunovant reported preliminary Week 16 data for its FcRn inhibitor IMVT-1402 in heavily pretreated rheumatoid arthritis patients, with ACR20, ACR50, and ACR70 response rates of 72.7%, 54.5%, and 35.8%, respectively, according to results disclosed alongside the company’s fiscal year 2026 financial results.
The data arrive weeks after Immunovant discontinued development of batoclimab following failed Phase III thyroid eye disease studies, increasing investor focus on IMVT-1402 as the company’s lead FcRn inhibitor franchise.
The open-label study enrolled adults with difficult-to-treat rheumatoid arthritis who had failed at least two prior advanced therapies, including biologic and targeted synthetic DMARDs. Among 165 evaluable participants, response rates remained consistent in a subgroup previously treated with both JAK and anti-TNF inhibitors.
The IMVT-1402 rheumatoid arthritis study is a two-period trial enrolling heavily pretreated adults with difficult-to-treat rheumatoid arthritis who have failed at least two prior mechanisms of advanced therapy, including biologic and targeted synthetic DMARDs. Period 1 is an open-label, 16-week phase in which all 170 enrolled participants received IMVT-1402 600 mg weekly by subcutaneous injection. Of the 170 enrolled, 165 were evaluable at Week 16. The primary endpoint for the trial is the proportion of Period 1 ACR20 responders who maintain that response at Week 28.
At Week 16, the observed ACR20, ACR50, and ACR70 response rates across the 165 evaluable participants were 72.7%, 54.5%, and 35.8%, respectively, with participants who discontinued before Week 16 counted as non-responders. Within the subset of 107 participants who had failed at least one JAK inhibitor and at least one anti-TNF inhibitor — a group representing a particularly refractory population — the ACR20, ACR50, and ACR70 rates were 72.0%, 53.3%, and 37.4%, respectively, showing minimal attenuation compared to the overall cohort.
IMVT-1402 was described as safe and well-tolerated, with no new drug-related safety signals identified during Period 1.
These are preliminary, open-label data from a single-arm period, and the absence of a concurrent placebo arm limits direct causal interpretation. The randomized Period 2, with topline data expected in the H2 2026, will provide the controlled evidence needed to assess whether response is maintained and whether dose differentiation emerges between the 600 mg and 300 mg cohorts.
IMVT-1402 is an FcRn-targeting monoclonal antibody that blocks neonatal Fc receptor-mediated IgG recycling, accelerating lysosomal degradation of circulating IgG autoantibodies. The rationale in difficult-to-treat rheumatoid arthritis rests on the IgG-driven inflammatory pathology that persists in patients who have exhausted conventional biologic and targeted synthetic DMARD options.
The FcRn inhibitor class has established proof of concept in other IgG-mediated autoimmune diseases. argenx’s Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) and UCB’s Rystiggo (rozanolixizumab) are both approved in generalized myasthenia gravis, demonstrating meaningful IgG reduction and clinical benefit in antibody-driven disease. Neither has an approved indication in rheumatoid arthritis, and the application of FcRn inhibition to D2T RA remains investigational.
Immunovant clinical trial data from the D2T RA program are particularly relevant in the context of the company’s recent pipeline setback. In April 2026, Immunovant disclosed that two Phase III studies of batoclimab in active, moderate-to-severe thyroid eye disease failed to meet their primary endpoints, prompting discontinuation of batoclimab development across all indications. The company stated that clinical data, operational experience, and investigator relationships from the batoclimab program have been applied to inform IMVT-1402 development. IMVT-1402 is described as having a potentially improved albumin-sparing profile relative to batoclimab, a differentiation the company has cited as supporting broader chronic use across multiple autoimmune indications.
Beyond the D2T RA program, Immunovant reported that its proof-of-concept trial evaluating IMVT-1402 in cutaneous lupus erythematosus has completed enrollment, with topline data also expected in the second half of calendar year 2026. The IMVT-1402 cutaneous lupus study adds to a pipeline that now spans five active autoimmune indications, including potentially registrational trials in Graves’ disease, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjögren’s disease — all of which the company said remain on track.
The Immunovant financial results release noted that the company’s current cash position provides runway to the potential launch of IMVT-1402 in Graves’ disease, with topline data from the potentially registrational trials in Graves’ disease and myasthenia gravis expected in calendar year 2027.
This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/
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Clinical ResultPhase 3Drug ApprovalFinancial StatementPhase 2
100 Deals associated with Batoclimab
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Myasthenia Gravis | NDA/BLA | China | 28 Jun 2023 | |
| Myasthenia Gravis | NDA/BLA | China | 28 Jun 2023 | |
| Myasthenia Gravis | NDA/BLA | China | 28 Jun 2023 | |
| Purpura, Thrombocytopenic, Idiopathic | Phase 3 | China | 23 Jun 2022 | |
| Graves Ophthalmopathy | Phase 3 | China | 22 Sep 2021 | |
| Thrombocytopenia | Phase 3 | - | - | |
| Thrombocytopenia | Phase 3 | - | - | |
| Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Phase 2 | United States | 15 Dec 2022 | |
| Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Phase 2 | Argentina | 15 Dec 2022 | |
| Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Phase 2 | Belgium | 15 Dec 2022 |
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 2 | 25 | abcosnttdd(rpzrnfndzm) = dgrlkyxrxa rnywmswcew (civezclrqx ) | Positive | 03 Sep 2025 | |||
Phase 2 | 25 | pqylqgcgpl(esnbmzljwr) = Adverse events were mild-to-moderate, with no new safety signals. eympqtuvpe (muoeanhsud ) | Positive | 12 Jul 2025 | |||
NCT05581199 (NEWS) Manual  | Phase 2 | 73 | hmcrsjucgk(zhtjwoffza) = upgcydwbim lewnliemgh (yzpynhqmyb ) View more | Positive | 19 Mar 2025 | ||
NCT05403541 (NEWS) Manual | Phase 3 | Myasthenia Gravis acetylcholine receptor antibody positive (AChR+) | - | xonadwtafj(mxqaavtctg) = tduqwtgrgt zkmfnnrpxr (lxraqzxugt ) Met View more | Positive | 19 Mar 2025 | |
xonadwtafj(mxqaavtctg) = mpqmttfear zkmfnnrpxr (lxraqzxugt ) Met View more | |||||||
Phase 2 | - | 12 weeks of high dose batoclimab, followed by 12 weeks of lower dose batoclimabbatoclimab, followed by 12 weeks of lower dose batoclimab | efcochmihz(hzrsfcuwin) = fwytgslexh gkcodfovlx (hkqeidxidb ) View more | Positive | 09 Sep 2024 | ||
12 weeks of high dose batoclimab | efcochmihz(hzrsfcuwin) = fhtarcsqsl gkcodfovlx (hkqeidxidb ) View more | ||||||
NCT05039190 (Literature) Manual | Phase 3 | 132 | hpeowvjzbe(rvhfgplawr) = ocrpvyprja hmfkxpcqfj (zknpgztiso ) View more | Positive | 04 Mar 2024 | ||
Placebo | hpeowvjzbe(rvhfgplawr) = cykzrmamym hmfkxpcqfj (zknpgztiso ) View more | ||||||
Phase 2 | - | krbxgzfjzv(wjlsqapgfk) = tuvrpwarxe swlzgqktox (heqxvqeewr ) View more | Positive | 20 Dec 2023 | |||
Phase 2 | 17 | RVT-1401+DB (Double-blind Treatment Period: Placebo) | cgdqblccqs = agptkhgmum gcxbrzmmjs (hdyykyolqz, euceovltcs - wadxtjsdax) View more | - | 20 Dec 2023 | ||
(Double-blind Treatment Period: RVT-1401 340 mg/Week) | cgdqblccqs = rkxpgneywq gcxbrzmmjs (hdyykyolqz, ajgbvrjesv - nkaxnqhgzv) View more | ||||||
Phase 2 | Graves Ophthalmopathy anti-TSHR-Ab positive | 7 | Batoclimab 680 mg for two weeks followed by 340 mg for four weeks | zzmmubskti(ykuoadtgfr) = n=2 for each mbmaqkkucd (rdhwunifpd ) View more | Positive | 01 Nov 2022 | |
Phase 2 | 65 | wtktcgijol(bdrtnzfosc) = jhaqzjemaf ejnzwryrjh (eazzdvqgwy ) View more | Positive | 01 Nov 2022 | |||
wtktcgijol(bdrtnzfosc) = rykjzwhkxk ejnzwryrjh (eazzdvqgwy ) View more |
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