InnoCare Pharma Ltd (9969.HK), a commercial-stage biopharmaceutical company, announced that the Centre for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review for its zurletrectinib (ICP-723) to treat pediatric patients (aged 2 to 12) with solid tumours harbouring NTRK gene fusions.
NTRK fusion genes occur in various types of adult and pediatric tumours. NTRK gene fusion is associated with at least 19 tumour types in adults and children, including lung cancer, colorectal cancer, breast cancer, pancreatic cancer and melanoma. It is estimated that approximately 6,500 new cases of NTRK fusion-positive solid tumours are diagnosed in China each year.
Zurletrectinib is a pan-TRK inhibitor developed by InnoCare.In December 2025, zurletrectinib received approval in China for the treatment of adult and adolescent patients (aged 12 years and older) with solid tumours harbouring NTRK gene fusions.
Following that, it submitted a new drug application (NDA) for zurletrectinib to treat pediatric patients (aged 2 to 12).
In the registrational clinical trial for patients with NTRK fusion-positive solid tumours, Zurletrectinib demonstrated 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 tumours were released, and Zurletrectinib demonstrated a well-tolerated safety profile and promising antitumor activity in pediatric/adolescent patients with NTRK/ROS1-altered solid tumours.
In addition, Zurletrectinib has also been included in the "SPARK Program" by the CDE, an initiative to encourage the development of pediatric anti-tumour drugs.
9969.HK shares are down 4.71%, at HK$11.52 on the HKSE.
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