Latest Data of InnoCare's Zurletrectinib Orally Presented at SIOP 2025

BEIJING, Oct. 29, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the latest data of its next generation pan-TRK inhibitor zurletrectinib (ICP-723) for the treatment of pediatric and adolescent patients with advanced solid tumors. The data from the phase I/II clinical trial has been released at the Congress of International Society of Paediatric Oncology (SIOP) 2025 as an oral presentation.

Oral Presentation

Professor Yizhuo Zhang, from the Department of Pediatric Oncology at the Sun Yat-sen University Cancer Center, is the leading PI of the study. Professor Juan Wang, representing the multicenter investigators team, delivered an oral presentation at the Congress entitled “Safety, pharmacokinetics, and efficacy of zurletrectinib, a next-generation pan-TRK inhibitor, in pediatric and adolescent patients with advanced solid tumor: a Phase I/II trial”.

In this study, zurletrectinib demonstrated favorable/well-tolerated safety and promising antitumor activity in pediatric/adolescent patients with NTRK/ROS1-altered solid tumors, The results/data highlight zurletrectinib’s strong potential as a next-generation therapy for NTRK/ROS1-driven malignancies, with the ability to overcoming resistance to first-generation TRK inhibitors.

The predominant tumor types included NTRK-rearranged spindle cell tumors and primary central nervous system tumors. The Recommended Phase 2 Dose (RP2D) was determined to be 7.2 mg/m² for pediatric patients and 8 mg for adolescents. Pharmacokinetic (PK) profiles at the RP2D showed comparable exposer levels between pediatric/adolescent and adult patients.

As of July 31, 2025, the objective response rate (ORR) was 90% in NTRK fusion patients, as assessed by the Independent Review Committee (IRC). Among the patients who completed full efficacy evaluations, all of those who were resistant to first-generation TRK inhibitors achieved partial responses.

No dose-limiting toxicities were observed. Treatment related adverse events (TRAEs) were predominantly grade 1~2, indicating a favorable safety profile.

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.

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