Press Release: Harbour BioMed Reports 2026 Interim Results: Three Integrated Growth Engines Accelerate Execution of Its Platform-Based Strategy

Dow Jones
Aug 27

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, Aug. 27, 2026 /PRNewswire/ -- Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, today announced its interim results for the six months ended June 30, 2026.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "In the first half of 2026, Harbour BioMed continued to advance our Phase 3.0 strategy, with meaningful progress across all three integrated growth engines. We continued to advance the global value of our mid- to late-stage innovative assets, further strengthened our technology platform capabilities, particularly in AI-driven next-generation antibody discovery capability, and continued to deepen long-term strategic partnerships with leading global pharmaceutical companies. The three growth engines are mutually reinforcing, creating stronger connections among our technology platforms, innovative pipeline and global partnership network, and continuously translating these capabilities into long-term value.

We also achieved a landmark milestone in intellectual property protection. Our historic and decisive victory in the U.S. patent litigation not only reaffirmed the validity of the intellectual property underlying our core antibody discovery platforms, but also demonstrated our firm commitment to protecting our core innovations and building global competitive advantages.

In terms of talent and organizational development, we have further streamlined our global management and scientific teams over the past six months. We have appointed experienced industry leaders, experts across multiple therapeutic areas, and world-renowned scientific advisors, who provide enhanced support for R&D innovation, portfolio strategy, and global collaboration.

Looking ahead, we will continue to drive strategic execution across our three integrated growth engines, accelerate the advancement of high-potential innovative assets into mid- to late-stage clinical development, unlock the global value of our technology platforms and pipeline, and further expand high-quality global partnerships. We are steadily advancing toward our 2028 vision of becoming a globally leading platform-based biopharmaceutical group."

2026 Interim Financial Highlights: Strong Revenue Growth and Sustained Profitability for Seven Consecutive Half-Years

   -- Total revenue reached US$122.5 million, representing a 20.9% 
      year-over-year increase, primarily driven by continued strategic 
      collaborations with global multinational pharmaceutical companies, newly 
      established out-licensing agreements for innovative products, and strong 
      business growth of Nona Biosciences; 
 
   -- Profit for the period reached US$64.9 million, and adjusted net profit 
      for the period[1] was approximately US$71.6 million, marking seven 
      consecutive profitable half-years and confirming that 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; 
 
   -- Cash and cash equivalents stood at approximately US$359.2 million as of 
      June 30, 2026. The Company maintains strong financial resources and 
      flexibility to support its strategic execution. 

[1] Adjusted items of profit are mainly from share-based compensation expenses and other one-time expenses.

Multiple Milestones Achieved, Unlocking the Global Value of Mid- to Late-Stage Innovative Assets

Harbour BioMed continued to advance a differentiated portfolio across immunology, oncology, obesity and metabolic diseases, and central nervous system (CNS) disorders, with multiple high-potential programs progressing toward key clinical development milestones.

Key programs in mid- to late-stage clinical development

Batoclimab (HBM9161) is the first anti-FcRn monoclonal antibody to have completed Phase I to pivotal trials in China. The Biologics License Application (BLA) for the treatment of generalized myasthenia gravis (gMG) was accepted by China's National Medical Products Administration (NMPA) in July 2024 and is currently under review. Batoclimab has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases.

HBM9378 is an ultra-long-acting fully human monoclonal antibody against TSLP generated from the H2L2 Harbour Mice(R) platform, engineered to achieve an extended half-life and effector silencing with subcutaneous administration. In March 2026, the Company published first-in-human Phase I trial results in the peer-reviewed journal Drug Design, Development and Therapy, demonstrating favorable safety and an extended half-life (mean T1/2: 55.0--65.8 days).

In January 2025, it was announced that the Company and Kelun-Biotech entered into an exclusive license agreement with Windward Bio, under which Windward Bio was granted an exclusive license for the research, development, manufacturing and commercialization of HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). In July 2025, our partner Windward Bio launched the Phase II/III POLARIS clinical study in asthma, with initial data expected in the second half of 2026 and the first Phase III study of HBM9378 in asthma is expected to begin in the fourth quarter of 2026. In June 2026, Windward Bio dosed the first patients in the Phase II SIRIUS study in COPD.

Note: HBM9378 is known as SKB378 in Kelun-Biotech's pipeline and WIN378 in Windward Bio's pipeline.

Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice(R) platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. In October 2025, the Company published positive Phase II data in combination with tislelizumab for the treatment of microsatellite stable $(MSS)$ metastatic colorectal cancer (mCRC). Of the 23 evaluable patients, the objective response rate $(ORR)$ is 34.8%, disease control rate (DCR) is 60.9%, and 12-month overall survival (OS) Rate is 84%. In February 2026, the Company entered a license agreement and equity partnership with Solstice Oncology, a clinical stage biotechnology company established by a syndicate of major venture capital investors, for the exclusive development and commercialization of HBM4003 outside Greater China. Following this agreement, HBM4003 made meaningful global development progress during the reporting period.

HBM7575 is an ultra-long-acting bispecific antibody targeting TSLP and an undisclosed antigen, with a dual mechanism of action. On one hand, by blocking the interaction between TSLP and its receptor, it inhibits TSLP-mediated signaling pathways and the activation of Th2 immune cells. On the other hand, binding to and blocking the undisclosed target generates a synergistic effect, with the potential to achieve broader control of inflammation compared to single-target approaches. HBM7575 has been engineered to allow for longer dosing intervals and a convenient subcutaneous route of administration. Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy.

In March 2026, an IND application for HBM7575 for the treatment of atopic dermatitis was approved by the NMPA, and the first participant has been dosed in a Phase 1 clinical study. In July 2026, an IND application for HBM7575 for the treatment of asthma was approved by the NMPA.

Note: HBM7575 is known as SKB575 in Kelun-Biotech's pipeline. According to the collaboration agreement between Harbour BioMed and Kelun-Biotech, HBM7575 is led by Kelun-Biotech in its design, global development and commercialization, with Harbour BioMed participating in the investment and development of this asset and sharing the benefits as agreed.

Key products in the next-generation innovation portfolio include:

HBM2001 is a potent TL1A×IL-23p19 bispecific antibody generated using the proprietary HBICA(R) bispecific technology and Harbour Mice(R) platform, offering a differentiated mechanism to address both inflammatory and fibrotic pathways in inflammatory bowel disease. In April 2026, HBM2001 obtained FDA IND clearance to commence a Phase I trial in the United States. In July 2026, HBM2001 obtained NMPA IND clearance to commence a Phase I trial in China.

HBM7020 is a BCMA×CD3 bispecific antibody generated using the HBICE(R) technology and Harbour Mice(R) platform. Following the global strategic collaboration with Otsuka Pharmaceutical established in June 2025, HBM7020 continued to advance product development as planned during the reporting period, with the Phase I clinical trial expected to initiate overseas in the second half of the year.

HBM7004 is a novel B7H4×CD3 bispecific antibody demonstrating strong anti-tumor efficacy and favorable safety in preclinical studies. In May 2026, the FDA cleared the IND application for HBM7004, enabling the initiation of a first-in-human Phase I clinical trial in the United States. In August 2026, the NMPA approved the IND application for HBM7004 for the treatment of advanced solid tumors.

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