BEIJING — May 28, 2026
InnoCare Pharma announced that China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for orelabrutinib for the treatment of primary immune thrombocytopenia (ITP). The regulatory milestone marks the first NDA acceptance for orelabrutinib in autoimmune diseases, significantly expanding the drug’s clinical positioning beyond hematologic cancers into immunology and autoimmune disorders.
Orelabrutinib Expands Beyond Blood Cancer Into Autoimmune Disease
Primary immune thrombocytopenia is a serious immune-mediated blood disorder characterized by low platelet counts that increase the risk of bruising, bleeding, and severe hemorrhagic complications. According to the company, more than 200,000 new ITP cases are reported globally each year, including approximately 60,000 cases in China, highlighting a substantial unmet medical need for safer and more effective long-term therapies.
Orelabrutinib is a highly selective Bruton’s tyrosine kinase (BTK) inhibitor designed to suppress abnormal immune signaling while minimizing off-target toxicities commonly associated with earlier-generation BTK therapies. InnoCare stated that the molecule has demonstrated a favorable efficacy and safety profile in autoimmune disease studies and could potentially become a preferred BTK inhibitor for ITP treatment in China. Notably, no BTK inhibitor has yet been approved in China for ITP, positioning orelabrutinib as a potential first-in-class treatment option in the country.
Dr. Jasmine Cui, Co-founder, Chairwoman, and Chief Executive Officer of InnoCare, described the NDA acceptance as a major milestone for the company’s autoimmune disease strategy. She noted that the therapy could help address significant unmet needs for patients with limited treatment options while strengthening InnoCare’s expanding immunology portfolio.
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Clinical Development Pipeline Continues to Advance
The NDA filing for ITP represents a strategic diversification effort for InnoCare as the company broadens the commercial and clinical applications of orelabrutinib beyond oncology. The drug is already established in hematologic malignancies, and the company is now aggressively pursuing autoimmune disease indications across multiple therapeutic areas.
In addition to ITP, Phase III registrational clinical trials evaluating orelabrutinib are currently underway for several major autoimmune and neuroinflammatory disorders, including systemic lupus erythematosus (SLE), primary progressive multiple sclerosis (PPMS), and secondary progressive multiple sclerosis (SPMS) in China and international markets. These programs position orelabrutinib as a potentially important next-generation BTK inhibitor within the rapidly growing autoimmune therapeutics market.
The expansion into autoimmune diseases also reflects broader industry momentum around BTK inhibitors as pharmaceutical companies increasingly investigate the mechanism’s role beyond cancer treatment. Analysts view selective BTK inhibition as a promising strategy for chronic inflammatory diseases because of its ability to modulate B-cell and immune signaling pathways linked to autoimmune pathology.
InnoCare Strengthens Position in China’s Biopharma Sector
InnoCare Pharma has continued to strengthen its position as one of China’s leading innovative biopharmaceutical companies focused on oncology and autoimmune diseases. The company currently markets three approved products — orelabrutinib, tafasitamab, and zurletrectinib — while advancing more than ten additional clinical-stage candidates and multiple preclinical programs.
With the acceptance of the orelabrutinib NDA in ITP, InnoCare gains another important regulatory catalyst that could support future commercialization growth and reinforce its long-term strategy in immune-mediated diseases. If approved, orelabrutinib could become one of the first highly selective BTK inhibitors available for autoimmune disease treatment in China, potentially opening a major new commercial opportunity in the rapidly expanding immunology market.
Source: InnoCare Pharma press release
