Harbour BioMed's Batoclimab (HBM9161) Receives China CDE Breakthrough Therapy Designation for Treatment of Adult Patients with Myasthenia Gravis

Harbour BioMed (HBM), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG).

Myasthenia Gravis is a severely debilitating condition that manifests itself in the form of skeletal muscle contraction and weakness limiting movement and could even result in fatal respiratory failure. In China, an estimated 250,000 patients suffer from this condition. Current therapies are limited due to inadequate efficacy, safety issues or limited availability.

Batoclimab (HBM9161), a fully human anti-FcRn mAb, blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies and leads to the treatment of pathogenic IgG-mediated autoimmune diseases. Earlier studies demonstrated that Batoclimab is well tolerated and can rapidly reduce total IgG. These findings make Batoclimab the first anti-FcRn to demonstrate a sustained IgG reduction in both Chinese and Caucasian populations when administered via subcutaneous (SC) injection.

According to CDE guidelines, Breakthrough Therapy designations are reserved for drugs that treat serious and/or life-threatening diseases or conditions, while demonstrating a substantial improvement over existing therapies on one or more clinically significant endpoints based on preliminary clinical evidence. The designation also indicates that the development and review of Batoclimab (HBM 9161) in adults with MG will be expedited in order to address patients' unmet needs quicker.

"This is the first Breakthrough Therapy designation granted to HBM, highlighting the unmet needs and the potential opportunity for our expanding immunology portfolio." said Dr. Jingsong Wang, Founder, Chairman, and CEO of HBM. "In China, large numbers of patients suffer IgG-mediated autoimmune diseases including MG, ITP, NMOSD, among others. This Breakthrough Therapy designation will enable the accelerated development of Batoclimab for MG thereby bringing this life-changing innovative drugs to patients in China sooner." he added.

About Harbour BioMed

Harbour BioMed (HKEX: 02142.HK) is a global, clinical development stage, biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and immunologic diseases. The company is building its proprietary pipeline through internal R&D programs, collaborations with co-discovery and co-development partners and select acquisitions.

The company's internal discovery programs are centered around its two patented transgenic mouse platforms (Harbour Mice®) for generating both fully human monoclonal antibodies, heavy chain only antibodies (HCAb) and HBICE™ immune cell engager technology for developing bispecific antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions. 

The company has operations in Cambridge, Massachusetts; Rotterdam, the Netherlands; and Suzhou & Shanghai, China.