Batoclimab

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. SOURCE Harbour BioMed 21% more press release views with Request a Demo

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/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.