Harbour BioMed Advances Antibody Pipeline and AI Strategy

Cambridge, Massachusetts, USA; Rotterdam, Netherlands; Shanghai, China, Aug 27, 2026

Clinical Pipeline Advances Across Multiple Therapeutic Areas

Harbour BioMed continued to progress programs across immunology, oncology, obesity and metabolic diseases, and central nervous system disorders. Among its mid- to late-stage assets, batoclimab (HBM9161) remains under regulatory review in China following acceptance of its Biologics License Application by the National Medical Products Administration for generalized myasthenia gravis. The company is also advancing HBM9378, an ultra-long-acting anti-TSLP monoclonal antibody designed for extended dosing intervals. Its partner Windward Bio is conducting the Phase II/III POLARIS study in asthma, with initial data expected in the second half of 2026, while a Phase II study in chronic obstructive pulmonary disease is also underway. Porustobart (HBM4003), a next-generation anti-CTLA-4 antibody, has also progressed globally following a licensing and equity partnership with Solstice Oncology. Harbour BioMed previously reported Phase II data in microsatellite stable metastatic colorectal cancer, with the company continuing to advance the asset outside Greater China through its global partnership strategy. The pipeline also includes HBM7575, an ultra-long-acting bispecific antibody targeting TSLP and another undisclosed antigen. The program has entered Phase I development in atopic dermatitis following NMPA approval of its IND, while an additional IND for asthma was approved in July 2026. In earlier-stage development, HBM2001, a TL1A×IL-23p19 bispecific antibody, received IND clearances from both the U.S. FDA and China’s NMPA in 2026. HBM7020, a BCMA×CD3 bispecific antibody being advanced through collaboration with Otsuka Pharmaceutical, is also progressing toward overseas Phase I development. Meanwhile, HBM7004, a B7H4×CD3 bispecific antibody, received FDA IND clearance in May and NMPA IND approval in August 2026.

AI Platform Expands Next-Generation Antibody Discovery

A central component of Harbour BioMed’s strategy is the integration of artificial intelligence with antibody discovery and development. The company’s Hu-mAtrIx™ AI platform is being integrated with its Harbour Mice® antibody technology to improve capabilities including de novo antibody design, developability prediction, in silico screening, AI-guided engineering and sequence analysis. Harbour BioMed said the platform is increasingly being connected with wet-lab validation to create a more efficient drug discovery workflow.The company highlighted LET003, an ACVR2A/2B dual-target blocking antibody and the first next-generation candidate developed using the Hu-mAtrIx platform. Preclinical findings reported in May 2026 indicated favorable pharmacokinetic characteristics, while combination with semaglutide enhanced fat reduction and preserved lean mass in the company’s studies. LET003 has advanced to the IND-enabling stage, with an IND submission expected in the third quarter of 2026. Harbour BioMed is also expanding AI-enabled discovery through MegaStream TechBio, established with BioMap to develop complex biologics using large-scale datasets, purpose-built models and an intelligent dry-wet research platform.

Global Partnerships and Intellectual Property Strengthen Growth

Harbour BioMed continued expanding its global collaboration network through licensing, co-development and technology partnerships. During the first half of 2026, the company entered a license agreement and equity partnership with Solstice Oncology for HBM4003, receiving upfront consideration valued at more than US$105 million and becoming eligible for additional development, regulatory and commercial milestones of approximately US$1.1 billion, plus royalties on net sales outside Greater China. Its broader partnership portfolio includes collaborations with Bristol Myers Squibb, Windward Bio, Otsuka Pharmaceutical and Lonza, supporting antibody discovery, clinical development and technology expansion. The company also reported significant progress in intellectual property protection. As of June 30, 2026, Harbour BioMed had filed 706 patent applications, including 19 invention patents granted by China’s National Intellectual Property Administration. During the reporting period, a U.S. jury upheld the validity of a core Harbour BioMed patent and found infringement by Amgen to be willful, awarding US$20.20 million in damages. Harbour BioMed said it will continue advancing its three integrated growth engines while progressing high-potential candidates toward clinical milestones and strengthening its global partnership ecosystem as it works toward its 2028 vision of becoming a globally leading platform-based biopharmaceutical group.

Source: Harbour BioMed press relese