Beijing, November 22,2020 – Congratulations to InnoCare Pharma Limited (hereinafter as ” InnoCare”) for its BTK inhibitor Orelabrutinib has been officially approved by NMPA for commercial! The potential indications of Orelabrutinib are mainly for the treatment of :(1) adult mantle cell lymphoma (MCL) patients who have received at least one previous treatment;(2) Adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one previous treatment.


Sundia participated in the preclinical Formulation R&D of Orelabrutinib, and congratulates to Innocare’s achievements! We also look forward to the success of Innocare on bringing more innovative and quality drug to global patients!

Orelabrutinib is Innocare’s first innovative drugs approved for commercial marketing, which is a highly selective new Bruton tyrosine kinase (BTK) inhibitor. This is the second domestically-made BTK inhibitor independently developed in China. Currently, only 4 BTK inhibitors have been approved commercial globally, namely Ibrutinib from Johnson & Johnson/AbbVie, Cartinib from AstraZeneca/Acerta Pharma, Gilead/Ono’s Tirabrutinib and BeiGene’s Zebutinib.

BTK is a non-receptor tyrosine kinase that plays a key role in the signal transmission of the B cell antigen receptor (BCR). The BCR signaling pathway is critical for the proliferation and survival of leukemia cells in lymphoma. BTK inhibitors selectively block BTK kinase activity and interfere with B cell development by regulating signal pathways, thereby controlling the oncogenic progression of various B cell malignant tumors.

BTK Signal Pathway   Image:Reference 1

Orelabrutinib shows obvious therapeutic advantages in clinical trails. According to the latest clinical data released by Innocare at the 2020 American Society of Hematology (ASH) annual meeting, the overall objective response rate (ORR) of CLL/SLL patients treated with Orelabrutinib was as high as 91.3%. In an open, multi-center phase II clinical study of long-term safety in patients with relapsed/refractory intumescent cell lymphoma treated with Orelabrutinib monotherapy, 87 (87.9%) patients achieved ORR and 93.9% achieved disease control.

(Orelabrutinib Clinical Trials  Image: Innocare Website)

In addition, Innocare is also exploring the efficacy of Orelabrutinib on symptoms including relapsed and refractory marginal zone lymphoma, diffuse large B-cell lymphoma, Waldenstrom’s macroglobulinemia, and systemic lupus erythematosus, ect. which means that Orelabrutinib will benefit more patients!


[1] Updated Results for BTK Inhibitor Ibrutinib (PCI-32765) Shows Prolonged Progression Free Survival in High Risk, Advanced CLL/SLL and MCL Patients

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