Agreement signed to advance therapy for autoimmune disease

shutterstock autoimmune disease 2

HanAll Biopharma’s licensed partner, Harbour BioMed, has signed an exclusive sublicense agreement with CSPC NBP Pharmaceutical Co., Ltd for an advanced inhibitor.

The agreement is for HanAll’s neonatal Fc receptor (FcRn) inhibitor batoclimab which is one of the most advanced being developed in Greater China. The companies say it has the potential to become a ‘first-in-class’ therapy to treat autoimmune diseases.

The neonatal Fc receptor (FcRn) has an important function in preventing IgG degradation; in vascular endothelial cells, receptor-mediated internalization and recycling of IgG occur via FcRn, which is responsible for maintaining IgG levels. Among many other functions, FcRn is also essential for the transfer of humoral immunity to the fetus.

Exclusive rights

FcRn is the primary protein responsible for preventing the degradation of IgG antibodies and albumin, the most abundant protein found in the blood. FcRn’s role is to bind to the IgG antibodies in the endosome, and transport them to the cell surface, where they are released back into circulation.

Inhibitor batoclimab is a human monoclonal antibody targeting FcRn and has the potential to address a number of autoimmune diseases by injection.

The deal grants NBP Pharma the exclusive rights to develop and commercialize batoclimab in Greater China including mainland of China, Hong Kong, Macau, and Taiwan. Under the agreement Harbour BioMed will receive a total of more than RMB 1 billion ($139.5 million), including the RMB 150 million ($21 million) worth upfront payment along with the potential milestone payments.

Benefit for patients in China

“We are pleased to have reached this agreement with Harbour BioMed,” said Cuilong Zhang, CEO of CSPC.

“Batoclimab is a promising innovative drug, and we hope to accelerate its clinical development, manufacturing, registration and commercialization in China, so as to benefit the patients in China better and earlier,” he added.

“HanAll welcomes CSPC to join our journey to develop innovative medicines for patients in China.  With its strong track records of R&D and commercialization, CSPC is expected to even further accelerate and expand the clinical development of batoclimab to contribute to autoimmune patients in China,” said Sean Jeong, CEO of HanAll Biopharma.

Rare autoimmune disorders

HanAll has also expanded its focus to ophthalmology, immunology, oncology and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Batoclimab is in phase 3 and phase 2 trials across the world for the treatment of rare autoimmune disorders including myasthenia gravis, thyroid eye disease, warm autoimmune hemolytic anemia, neuromyelitis optica, and immune thrombocytopenia.

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