InnoCare’s next-generation TRKi Zurletrectinib Receives Priority Review for the Treatment of Pediatric Patients with Solid Tumors in China

BEIJING, March 01, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced today that its next generation TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), for the treatment of pediatric patients (aged 2 to 12) with solid tumors harboring NTRK gene fusions. Priority review is one of the key policies introduced by the CDE to accelerate drug approval.

Zurletrectinib has also been included in the “SPARK Program” by the CDE, a pilot initiative to encourage the development of pediatric anti-tumor drugs.

In December 2025, zurletrectinib received approval for the treatment of adult and adolescent patients (aged 12 years and older) with solid tumors harboring NTRK gene fusions in China. In the registrational clinical trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy and a favorable safety profile. The study results showed an objective response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, and 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8% respectively.

In October 2025, the data from the Phase I/II clinical trial of zurletrectinib for the treatment of pediatric and adolescent patients with advanced solid tumors were released at the Congress of International Society of Pediatric Oncology (SIOP) 2025 as an oral presentation. Zurletrectinib demonstrated a well-tolerated safety profile and promising antitumor activity in pediatric/adolescent patients with NTRK/ROS1-altered solid tumors. The results highlight zurletrectinib's strong potential as a next-generation therapy for NTRK/ROS1-driven malignancies, with the ability to overcome resistance to first-generation TRK inhibitors.

NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%¹. It is estimated that there are about 6,500 new cases of NTRK fusion-positive solid tumors diagnosed in China each year. There are significant unmet clinical needs in this area due to the lack of effective treatment options.

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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¹ Cocco, E., Scaltriti, M., and Drilon, A. (2018). NTRK fusion-positive cancers and TRK inhibitor therapy. Nature Reviews Clinical Oncology 15, 731-747.