English
Back
Open Account
INNOCARE
wrote a column · May 28 16:29

InnoCare Pharma's new drug application for orelabrutinib to treat primary immune thrombocytopenia has been accepted in China

InnoCare Pharma (SSE: 688428; HKEX: 09969) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for orelabrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with primary immune thrombocytopenia (ITP). This marks the first acceptance of an NDA for orelabrutinib in an autoimmune disease indication.
InnoCare Pharma (SSE: 688428; HKEX: 09969) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for orelabrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with primary immune thrombocytopenia (ITP). This marks the first acceptance of an NDA for orelabrutinib in an autoimmune disease indication. ITP is the first autoimmune disease indication orelabrutinib has entered following its initial development in hematologic malignancies. With its high target selectivity and favorable safety profile, orelabrutinib is poised to become a preferred BTK inhibitor for ITP treatment. Currently, no BTK inhibitors have been approved in China for ITP. Dr. Jasmine Cui, Co-founder, Chairperson, and CEO of InnoCare Pharma, said, 'The acceptance of the NDA for orelabrutinib in ITP represents a significant milestone and breakthrough for InnoCare in the field of autoimmune diseases. We believe this innovative therapy will effectively address the unmet medical need in ITP treatment and offer new hope to patients suffering from ITP and other autoimmune conditions who have long faced limited therapeutic options.' ITP is an acquired autoimmune bleeding disorder. Data show that over 200,000 new ITP cases are diagnosed globally each year, with approximately 60,000 new cases annually in China, reflecting a substantial unmet medical need. Orelabrutinib has already demonstrated promising efficacy and...
ITP is the first autoimmune disease indication orelabrutinib has entered following its initial development in hematologic malignancies. With its high target selectivity and favorable safety profile, orelabrutinib is poised to become a preferred BTK inhibitor for ITP treatment. Currently, no BTK inhibitors have been approved in China for ITP.
Dr. Jasmine Cui, Co-founder, Chairperson, and CEO of InnoCare Pharma, said, 'The acceptance of the NDA for orelabrutinib in ITP represents a significant milestone and breakthrough for InnoCare in the field of autoimmune diseases. We believe this innovative therapy will effectively address the unmet medical need in ITP treatment and offer new hope to patients suffering from ITP and other autoimmune conditions who have long faced limited therapeutic options.'
Immune thrombocytopenia (ITP) is an acquired autoimmune bleeding disorder. Data show that over 200,000 new ITP cases are diagnosed globally each year, with approximately 60,000 new cases annually in China, indicating a significant unmet medical need.
Orelabrutinib has demonstrated favorable efficacy and safety in treating autoimmune diseases such as ITP. Beyond ITP, pivotal Phase III clinical trials of orelabrutinib for systemic lupus erythematosus (SLE), primary progressive multiple sclerosis (PPMS), and secondary progressive multiple sclerosis (SPMS) are currently underway in China and globally.
Risk Disclaimer: The above content only represents the author's view. It does not represent any position or investment advice of Futu. Futu makes no representation or warranty.Read more
19K Views
Report
Comments (2)
Write a Comment...
2