On April 16, InnoCare Pharma Co., Ltd. (hereinafter referred to as "InnoCare"; SSE Code: 688428; HKEX: 09969) announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China (NMPA) has accepted a New Drug Application (NDA) for the treatment of adult and adolescent patients (aged 12 years ≤ aged < 18 years) with advanced solid tumors harboring NTRK fusion genes.

In a pivotal registrational clinical trial in adult and adolescent patients with advanced solid tumors who are positive for NTRK fusion genes, zurletrectinib demonstrated superior efficacy and safety while overcoming resistance to first-generation TRK inhibitors. The registrational clinical trial of zurletrectinib in pediatric patients (2 years ≤ age < 12 years) is ongoing, and the company is accelerating the clinical study in hopes of benefiting pediatric patients as soon as possible.

Dr. Jisong Cui, Co-Founder, Chairman and CEO of InnoCare, said, "Zurletrectinib has demonstrated outstanding efficacy and safety in adult, adolescent and pediatric patients with positive NTRK fusion genes, bringing better treatment options to patients with solid tumors. Through the combination of targeted therapies, immuno-oncology approaches and cutting-edge ADC technology, InnoCare continues to expand the depth and breadth of its solid tumor pipeline and looks forward to addressing the unmet needs of solid tumor patients as soon as possible. ”

NTRK fusion genes can be seen in various types of adult and pediatric tumors, and the incidence of some rare tumors, such as salivary gland cancer, secretory breast cancer, infantile fibrosarcoma, etc., exceeds 90%. The estimated number of new tumors carrying NTRK fusion genes in China is estimated to be 6,500 per year, and there is a lack of effective treatment methods and unmet clinical needs.