Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that we have entered into an exclusive, worldwide licensing agreement with Harbour BioMed for the development and commercialization of HBM7020, a BCMAxCD3 bispecific T-cell engager under development by Harbour BioMed. The license covers all territories worldwide except for Greater China (Mainland China, Hong Kong, Taiwan and Macau).

HBM7020 has been confirmed in preclinical studies to activate T cells, which are part of the immune system, and bring them into close proximity with antibody producing B cells and plasma cells to induce cell destruction. Since many autoimmune diseases involve B cells and plasma cells that produce autoantibodies, HBM7020 is expected to have broad efficacy against these diseases. Otsuka Pharmaceutical plans to advance the development of HBM7020 as a therapeutic agent for autoimmune diseases.

Under the terms of the agreement, Otsuka will pay Harbour BioMed a total of U.S. $47 million in upfront and near-term milestones. Other payments are contingent on the achievement of specified development and commercial milestones. Otsuka will exclusively conduct development and commercialization worldwide, excluding Greater China, and will pay Harbour BioMed tiered royalties based on sales. Otsuka will fund all future development.

Makoto Inoue, president and representative director of Otsuka Pharmaceutical, noted, "Otsuka is expanding our development pipeline in the autoimmune disease field by leveraging the antibody drug platform of our subsidiary Visterra, and the small molecule drug discovery platform of our subsidiary Jnana. HBM7020 is expected to demonstrate efficacy in a broad range of autoimmune diseases in which B cells play a major role in disease pathogenesis, and we hope to contribute further to the field of specialized autoimmune diseases and thereby benefit patients."

Dr. Jingsong Wang, founder, chairman, and CEO of Harbour BioMed commented, "We are delighted to collaborate with Otsuka, a global healthcare leader renowned for its innovative approach to addressing unmet medical needs. This collaboration underscores the strength of Harbour BioMed's proprietary Harbour Mice^® and HBICE^® technology platforms, which enable the rapid development of fully human bispecific antibodies with optimized safety and efficacy profiles. By leveraging our unique capabilities, we are well-positioned to advance next-generation biotherapeutics that can make a meaningful difference in patients' lives worldwide."

About HBM7020

HBM7020 is a BCMAxCD3 bispecific antibody generated using Harbour BioMed's fully human HBICE ^®bispecific technology and Harbour Mice^® platform. It is designed to crosslink target cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and targeted cell elimination. By incorporating dual anti-BCMA binding sites for enhanced cell targeting and monovalent-optimized CD3 activity to minimize cytokine release syndrome (CRS), HBM7020 has demonstrated potent cytotoxicity with broad therapeutic potential in both immunological and oncological diseases. In August 2023, HBM7020 obtained IND clearance from the National Medical Products Administration (NMPA) to commence a Phase I trial for cancer in China.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide.

For further information, please visit www.otsuka.co.jp/en/

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions.

Harbour BioMed's 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. Additionally, the HCAb-based bispecific immune cell antagonist (HBICA^TM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice^®, HBICE^®, and HBICA^TM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com.