NOCIONS's next-generation TRK inhibitor, zurletrectinib, for the treatment of pediatric solid tumors, has been granted priority review

NOCIONS (HKEX stock code: 09969) announced today that its self-developed next-generation TRK inhibitor, zurletrectinib (zurletrectinib, ICP-723) orally disintegrating tablets have been granted priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of pediatric solid tumor patients (ages 2 to 12) carrying the NTRK fusion gene. Priority review is one of the key policies introduced by the CDE to accelerate drug approval and market entry.

Previously, zurletrectinib was also included in the CDE’s 'Pilot Program to Encourage the Development of Pediatric Anticancer Drugs (Starlight Plan),' which aims to improve the efficiency of developing anticancer drugs for children and bring them to market earlier to meet patient needs.

In December 2025, zurletrectinib was approved for the treatment of adult and adolescent solid tumor patients (above 12 years old) carrying the NTRK fusion gene, marking the first domestically developed next-generation TRK inhibitor approved for marketing in China. In pivotal registration clinical trials targeting NTRK fusion-positive solid tumor patients, zurletrectinib demonstrated outstanding efficacy and safety as a broad-spectrum anticancer drug regardless of tumor type. The registration clinical study showed an overall response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, a 24-month progression-free survival (PFS) rate of 77.4%, and a 24-month overall survival (OS) rate of 90.8%.

In October 2025, the results of a Phase I/II study of zurletrectinib for treating pediatric and adolescent patients with advanced solid tumors were selected for oral presentation at the 2025 International Society of Paediatric Oncology (SIOP) Annual Meeting. The findings showed that zurletrectinib exhibited good safety and significant antitumor activity in pediatric/adolescent patients with NTRK gene fusion-positive solid tumors, suggesting it as a potential therapy for NTRK-driven malignancies, particularly in overcoming resistance to first-generation TRK inhibitors, demonstrating better efficacy.

NTRK fusion genes are present in various types of tumors in both adults and children. In some rare cancers, such as salivary gland carcinoma, secretory breast carcinoma, and infantile fibrosarcoma, the incidence exceeds 90% [1]. It is estimated that there are 6,500 new cases annually in China of tumors carrying NTRK fusion genes. Currently, there is a lack of effective treatment options, indicating unmet clinical needs.

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

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