InnoCare Announces NMPA Approval of China's First Self-Developed New Generation TRK Inhibitor, Zoleretinib (ICP-723), for NTRK Fusion-Positive Solid Tumors
December 11, 2024 – InnoCare Pharma (stock code: 09969.HK, 688428.SH) announced late evening on December 11 that the National Medical Products Administration (NMPA) has approved its self-developed, new-generation TRK inhibitor, Ichinoclax (Zoleretinib, ICP-723). The drug is indicated for the treatment of adult and adolescent patients aged 12 years and older with locally advanced or metastatic solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. This marks Zoleretinib as the first self-developed new-generation TRK inhibitor in China [1].
NTRK gene fusions are found in a variety of tumor types, having been identified in over 26 different solid tumors to date. In China, an estimated 6,500 new cases of NTRK fusion-positive tumors occur annually. These patients typically face short survival periods, rapid disease progression, and high disability rates. Due to the low penetration rate of next-generation sequencing (NGS), which is the current gold standard detection method, diagnoses are often delayed, indicating a significant unmet clinical need [1].
In pivotal registration clinical trials targeting NTRK fusion-positive solid tumor patients, Zoleretinib, acting as a tumor-agnostic (site-agnostic), broad-spectrum anti-cancer drug, demonstrated exceptional efficacy and safety. The results of 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% [1].
Professor Yizhuo Zhang from the Sun Yat-sen University Cancer Center commented: "NTRK fusion-positive tumors often progress rapidly, with limited treatment options. Zoleretinib has demonstrated remarkable efficacy, especially achieving a 100% ORR in adolescent patients. Clinically, Zoleretinib exhibits a significantly faster onset of action compared to traditional chemotherapy; many patients show obvious tumor shrinkage within one to two treatment cycles, securing a crucial treatment window for critically ill patients. Furthermore, the duration of response for Zoleretinib is exceptionally long; the longest response we have observed clinically has exceeded 36 months, offering hope for longer survival for patients with solid tumors."
Zoleretinib has been included in the "Pediatric Antitumor Drug Development Encouragement Pilot Program (Starlight Program)" by the NMPA. InnoCare stated that it expects to submit a New Drug Application (NDA) for the treatment of pediatric patients (aged 2 to 12 years) with Zoleretinib in the near future.

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