InnoCare Pharma Ltd, a Hong Kong-listed Chinese mainland biotech company, said on Thursday that its cancer drug Zurletrectinib has won approval from the National Medical Products Administration to treat adults and adolescents aged 12 and older with solid tumors carrying NTRK gene fusions.
The therapy, also known as ICP-723, is a next-generation TRK inhibitor designed to block abnormal TRK proteins that drive tumor growth. InnoCare said results from a registrational trial showed the drug produced an objective response rate of 89.1 percent and a disease control rate of 96.4 percent in patients with NTRK fusion-positive solid tumors. The 24-month progression-free survival and overall survival rates were 77.4 percent and 90.8 percent respectively.
The company said Zurletrectinib showed stronger efficacy than first-generation TRK inhibitors, delivered durable tumor shrinkage, demonstrated "strong" brain penetration and was able to overcome resistance that hindered the effectiveness of earlier drugs.
Zhang Yizhuo, a professor at Sun Yat-Sen University Cancer Center, said, "NTRK fusion-positive tumors often progress rapidly and have limited treatment options.
"Zurletrectinib has demonstrated remarkable efficacy, particularly in achieving an ORR of 100 percent in adolescent patients. Clinically, Zurletrectinib responds faster than traditional chemotherapy, with many patients showing substantial tumor shrinkage within one or two treatment cycles, providing a critical therapeutic window for patients in critical conditions.
"Moreover, Zurletrectinib demonstrated a long duration of response — the longest observed in our clinical practice has exceeded 36 months – offering hope of extended survival in patients with solid tumors," Zhang added.
Jasmine Cui, co-founder, chairwoman and CEO of InnoCare, said Zurletrectinib is the company's first solid-tumor drug to reach the market.
"It is of significant clinical importance for patients with NTRK fusion-positive solid tumors," Cui said, adding that regulatory support enabled patients to gain access earlier.
The drug has been included in the "SPARK Program" by the National Medical Products Administration, a pilot initiative to encourage the development of pediatric anti-tumor drugs.
InnoCare said it plans to submit a separate application for Zurletrectinib to treat children aged 2 to 12.
NTRK gene fusions occur across more than two dozen tumor types, with an estimated 6,500 new cases annually in China, according to InnoCare. The company said low rates of next-generation sequencing testing mean diagnosis is often delayed, leaving substantial unmet treatment needs.
