INNOCARE Pharmaceuticals Limited (the "Company" or "INNOCARE") is currently in the clinical phase of registration of its innovative drug zurletrectinib (ICP-723). zurletrectinib (ICP-723) has shown favorable safety and efficacy in adult and adolescent (12 to 18 years old) patients. zurletrectinib (ICP-723) has demonstrated a favorable safety and efficacy profile in adults and adolescents (12 to 18 years of age), and has recently completed the first case of administration in a pediatric patient (2 to 12 years of age), initiating the first clinical study in a pediatric patient. The main information is announced as follows:

I. Introduction of ICP-723
Zurletrectinib (ICP-723) is INNOCARE's proprietary second-generation pan TRK small molecule inhibitor for the treatment of patients with advanced or metastatic solid tumors harboring NTRK fusion genes who have not received TRK inhibitor therapy and who are resistant to first-generation TRK inhibitors. Zurletrectinib (ICP-723) can effectively inhibit not only TRKA, TRKB, and TRKC in the TRK family, but also the drug-resistant mutations of TRKA, such as G595R and G667C, which can overcome the acquired resistance to first-generation TRK inhibitors. TRK plays an important role in maintaining normal nervous system function. Abnormal linkage of the segregating NTRK (neurotrophic tyrosine receptor kinase gene) gene or NTRK gene fusions can lead to the development of a number of different tumors, with up to a 90% prevalence of NTRK gene fusions in some rare tumor types, such as congenital infantile fibrosarcoma, etc. NTRK fusions have been linked to at least 19 tumor types in both adults and children, including cancers of the lung, colon, pancreas, and melanoma, NTRK gene fusions are associated with at least 19 tumor types in adults and children, including lung, colorectal, breast, pancreatic, and melanoma.

II. Progress of ICP-723 Clinical Trial
Zurletrectinib (ICP-723) has been initiated in a Phase II registrational clinical trial in mainland China for adult and adolescent (12 to 18 years old) patients with NTRK gene fusion-positive advanced solid tumors, and has demonstrated favorable safety and efficacy. （To date, the Company has observed an ORR of 80-90% in NTRK gene-fusion positive patients with different solid tumors. In response to the formulation and taste needs of children, the Company has developed orally disintegrating tablets that can significantly improve adherence in children, and the IND application for a new dosage form of zurletrectinib (ICP-723) for pediatric patients (2 weeks to 12 years of age) was approved in July 2023, with the first pediatric patient dosing recently completed in the Cancer Center of Sun Yat-sen University. The Company expects zurletrectinib (ICP-723) to benefit patients of all ages with NTRK gene fusion-positive solid tumors.

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