BEIJING, March 01, 2026 — InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical firm focused on cancer and autoimmune disease treatments, announced today that its next-generation TRK inhibitor zurletrectinib (ICP-723) has been awarded priority review status by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This review is for the treatment of pediatric patients (ages 2 to 12) with solid tumors containing NTRK gene fusions. Priority review is a key CDE policy designed to speed up drug approvals.
Zurletrectinib has also been included in the CDE’s “SPARK Program,” a pilot initiative aimed at encouraging the development of pediatric anti-cancer medications.
In December 2025, zurletrectinib was approved in China for treating adult and adolescent patients (12 years and older) with solid tumors harboring NTRK gene fusions. In the registrational clinical trial for NTRK fusion-positive solid tumor patients, zurletrectinib showed exceptional efficacy and a favorable safety profile. Study results revealed an 89.1% objective response rate (ORR), 96.4% disease control rate (DCR), and 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8%, respectively.
In October 2025, data from the Phase I/II clinical trial of zurletrectinib for pediatric and adolescent patients with advanced solid tumors was presented orally at the 2025 Congress of the International Society of Pediatric Oncology (SIOP). Zurletrectinib demonstrated a well-tolerated safety profile and promising anti-tumor activity in pediatric/adolescent patients with NTRK/ROS1-altered solid tumors. The findings underscore zurletrectinib’s strong potential as a next-generation therapy for NTRK/ROS1-driven cancers, with the ability to overcome resistance to first-generation TRK inhibitors.
NTRK fusion genes are present in various adult and pediatric tumor types. In certain rare cancers—such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma—the incidence of NTRK gene fusion exceeds 90%1. It is estimated that around 6,500 new cases of NTRK fusion-positive solid tumors are diagnosed in China each year. A significant unmet clinical need exists in this area due to the lack of effective treatment options.
About InnoCare
InnoCare is a commercial-stage biopharmaceutical company dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for cancers and autoimmune diseases with unmet medical needs in China and globally. The company has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
InnoCare Forward-looking Statements
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1 Cocco, E., Scaltriti, M., and Drilon, A. (2018). NTRK fusion-positive cancers and TRK inhibitor therapy. Nature Reviews Clinical Oncology 15, 731-747.
