HANALL BIOPHARMA announced on the 18th that it has notified Harbor BioMed of the termination of the license agreement for the autoimmune disease treatment 'batoclimab (HL161).'
HANALL BIOPHARMA entered into a contract with Harbor BioMed in 2017, granting exclusive development and business rights for batoclimab in the Greater China region, including Taiwan, Hong Kong, and Macau.
Batoclimab is an antibody new drug developed by HANALL BIOPHARMA for the treatment of autoimmune diseases. Because it targets several autoimmune diseases, various clinical trials need to be conducted.
Harbor BioMed has completed phase 3 clinical trials for myasthenia gravis and is in the process of obtaining product approval. However, it is not conducting follow-up clinical trials after phase 2 for other major target diseases, including thyroid eye disease, optic neuritis, and immune thrombocytopenia.
HANALL BIOPHARMA determined that delays in clinical trials negatively impact the competitiveness of batoclimab in the Greater China market. It concluded that Harbor BioMed did not fulfill its contractual obligation of 'commercially reasonable efforts' and notified Harbor BioMed of the contract termination on January 26.
Mediation through the International Chamber of Commerce (ICC) in New York has begun according to the contract termination procedures.
A representative of HANALL BIOPHARMA said, "If an agreement is not reached during the mediation process, we will reclaim the business rights for batoclimab through an arbitration ruling and accelerate development and commercialization in the Greater China region with a new partner," adding, "Regardless of the arbitration, the new drug approval review for myasthenia gravis in China will proceed as scheduled, and we will also continue the clinical research being conducted in the United States and Japan."