The National Food And Drug Administration Of China Awarded Harbour BioMed FcRn Targeting Antibody Bartolizumab Breakthrough Drug Qualification!

- Feb 18, 2021-



Harbour BioMed recently announced that its product under development, bartolizumab (HBM9161), has recently been granted breakthrough therapy qualification by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).


The qualification of breakthrough therapeutic drugs is designed to accelerate the development of new drugs for serious diseases that have been shown to be significantly better than existing treatments in terms of efficacy or safety in pre-clinical trials. Obtaining a breakthrough therapeutic drug designation can enable the drug to receive CDE rapid review treatment, and it can communicate with CDE closely and obtain guidance, thereby speeding up the launch of new drugs and addressing the unmet clinical needs of Chinese patients earlier. Pharmaceutical companies such as Takeda and AstraZeneca were also approved during the same period.


Myasthenia gravis (MG) is a neuromuscular disease mediated by pathogenic IgG that seriously affects the quality of life. In China, there are approximately 250,000 patients suffering from myasthenia gravis. Existing treatments cannot effectively control the disease. New effective and safe treatments are urgently needed.



The neonatal Fc receptor (FcRn) is a cell receptor that binds IgG antibodies and guides the transport of these antibodies through cells. FcRn plays a key role in preventing the degradation of IgG antibodies. Therefore, FcRn inhibition (for example, through the use of FcRn targeting antibodies) has been shown to reduce the level of pathogenic IgG antibodies. Clinical trials of other anti-FcRn antibodies in IgG-mediated autoimmune diseases have achieved good clinical results, indicating that FcRn is an important drug target for the treatment of these related diseases.


Bartolizumab (HBM9161) is a new fully humanized monoclonal antibody (mAb) targeting FcRn, which can block the binding of FcRn-IgG to each other, accelerate the elimination of IgG in the body, and achieve effective treatment of pathogenic IgG Mediated effects of autoimmune diseases. The available evidence suggests that the reduction of IgG levels in patients with myasthenia gravis (MG) is associated with clinical benefit. Early studies have shown that bartolizumab is well tolerated and can rapidly reduce total IgG. Studies have also shown that bartolizumab is the first anti-FcRn target drug that has been proven to continuously reduce IgG after subcutaneous injection (SC) in Chinese and Caucasian populations.



Bartolizumab (HBM9161) was introduced under license from HanAll Biopharma by Harbour BioMed. Harbour BioMed has the right to develop, manufacture and commercialize the drug in Greater China (including Hong Kong, Macau and Taiwan). Based on this innovative mechanism and the unmet high medical needs in China, Harbour BioMed has initiated a number of clinical studies to evaluate HBM9161 in the treatment of various autoimmune diseases, including: immune thrombocytopenia, thyroid-related eye disease, and myasthenia gravis , Neuromyelitis optica spectrum diseases, autoimmune hemolytic anemia, chronic demyelinating polyneuropathy.


Dr. Wang Jinsong, the founder, chairman and CEO of Harbour BioMed, said: “Bartolizumab is the first product in Harbour’s history to be qualified as a breakthrough therapeutic drug for the first time. Immune diseases mediated by sexual IgG, including myasthenia gravis, immune thrombocytopenia and neuromyelitis optica spectrum diseases, etc. The qualification of breakthrough therapeutic drugs will further accelerate the development process of bartolizumab and accelerate the launch of drugs. We look forward to bringing innovative treatments to patients with myasthenia gravis soon."