On March 10th, 2023， Beijing InnoCare announced that its independently developed BCL2 inhibitor ICP-248 completed the first subject administration in China.
ICP-248 is a new oral highly selective BCL2 inhibitor independently developed by InnoCare. It is intended for the treatment of malignant hematological tumors such as non-Hodgkin’s lymphoma (NHL) and acute lymphoblastic leukemia (ALL) as a monotherapy or in combination with other drugs such as BTK inhibitors.
ICP-248 is currently being investigated for B-cell malignancies, malignant hematologic tumors, and hematologic tumors.
BCL2 is an oncogene with a significant role in inhibiting cell apoptosis, especially in lymphocytes. According to drug intelligence data, InnoCare/GeneTech’s BCL2 inhibitor Venetoclax has been marketed and is also being investigated for hematological tumors.
Venetoclax is the first approved BCL2 inhibitor in China, and it was included in priority review by the Center for Drug Evaluation (CDE). Drug intelligence data show that Venetoclax tablets were approved by the CDE for sale in December 2020. Venetoclax tablets have now been included in medical insurance and are indicated for the treatment of newly diagnosed adult acute myeloid leukemia (AML) patients aged 75 years and older who are not suitable for strong induction chemotherapy due to concurrent illnesses in combination with Azacitidine, Decitabine or low-dose Cytarabine.
Statistics show that there are currently more than 30 BCL2 inhibitors in development, with most of them in Phase II clinical trials. In relative terms, the progress of ICP-248 is not fast.
However, InnoCare still has its “ace card.” As InnoCare’s first commercial product, Ibrutinib has supported its main performance. As a new irreversible covalently binding BTK inhibitor, Ibrutinib has an excellent chemical structure, which gives it high selectivity, reduces off-target effects, and has better efficacy and safety. At present, BTK inhibitors are very popular, and products such as Imbruvica, Calquence, and Zanubrutinib have been approved and marketed by Johnson & Johnson/AbbVie, AstraZeneca, and BeiGene. Although the BTK market is already very large, Ibrutinib still has some competitiveness, and even it was included in the national medical insurance in December 2021.
In the current popular BTK market, drug combination therapy may be a good method for winning a unique victory. According to InnoCare, ICP-248 is intended to be used alone or in combination with BTK inhibitors or other drugs to produce a synergistic effect when used in conjunction with other hematological tumor products. Therefore, it is believed that ICP-248 may be combined with Ibrutinib in the future.
In recent years, China’s pharmaceutical industry has seen many emerging enterprises, many of which have performed well. Many leading enterprises have now developed their representative drugs, such as Hengrui’s Apratastat tablets, BeiGene’s Zanubrutinib, Tirzepatide, and Junshi Biosciences’ Tislelizumab. It can be learn that to move towards the future, we need to enhance our research and development capabilities instead of being restricted by the present.