InnoCare Announces the Acceptance of New Drug Application for Orelabrutinib in Primary Immune Thrombocytopenia in China

BEIJING, May 28, 2026 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with primary immune thrombocytopenia (ITP) in China. This marks the first NDA acceptance for orelabrutinib in the field of autoimmune diseases.

ITP represents an important expansion of orelabrutinib beyond hematologic malignancies into autoimmune diseases. With its high target selectivity and a favorable safety profile, orelabrutinib is well positioned to become a preferred BTK inhibitor for the treatment of ITP. Currently, no BTK inhibitors have been approved in China for ITP.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, said, “The NDA acceptance of orelabrutinib for the treatment of ITP marks a significant milestone for InnoCare in autoimmune diseases. We believe this innovative therapy will effectively address the huge unmet medical need in ITP and bring new hope to patients with limited treatment options.”

ITP is an acquired immune mediated disorder characterized by a decrease in peripheral blood platelet counts, resulting in an increased risk of bruising and bleeding. With over 200,000 new cases globally each year, including 60,000 in China, ITP represents a significant unmet medical need. 

Orelabrutinib has demonstrated favorable efficacy and safety in the field of autoimmune diseases. In addition to ITP, Phase III registrational clinical trials for orelabrutinib in systemic lupus erythematosus (SLE), primary progressive multiple sclerosis (PPMS), and secondary progressive multiple sclerosis (SPMS) are currently underway in China and globally.

About InnoCare Pharma

InnoCare (HKEX: 9969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.

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