InnoCare Announces Clearance of Clinical Trial of BCL2 Inhibitor ICP-248 by U.S. FDA


Beijing, Jan. 16, 2024 – InnoCare Pharma (HKEX: 09969; SSE: 688428), a commercial-stage biotech company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Company's B-cell lymphoma-2 (BCL2) inhibitor, ICP-248. This is InnoCare’s fifth innovative drug to enter the clinical stage in the U.S.

This is a Phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of ICP-248 in hematologic malignancy patients.

ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies. The Phase I dose escalation trial of ICP-248 is ongoing in China, and the preliminary results demonstrated good efficacy and safety profiles.

BCL2 is an important regulatory protein of the apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 exhibits its anti-tumor effects by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare said, “ICP-248 would become an important asset for the Company’s globalization after orelabrutinib. The current study results will support ICP-248 to treat hematologic malignancies as a monotherapy or in combination with other therapies. Meanwhile, InnoCare is dedicated to building a leading franchise in hemato-oncology, and we have developed multiple drugs that cover a variety of important hemato-oncology targets such as BTK, CD19, CD20xCD3, BCL2 and E-3 ligase to address unmet medical needs.”

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.