Zolastrictinib: China's First Domestically Developed TRK Inhibitor Approved for NTRK Fusion-Positive Solid Tumors

The latest cancer data report released by the National Cancer Center shows that: China has more than 3.5 million new cancer cases each year, accounting for about 20% of the global new cases, and over 2 million deaths.

NTRK fusion genes can be found in various types of tumors in both adults and children, and have become one of the hottest anti-cancer targets globally, known in the industry as a "diamond" target. Drugs targeting this gene have the characteristic of being "tumor-agnostic." Therefore, in addition to InnoCare, more than 10 NTRK-targeted drugs from companies such as Vcare Pharma, CT Tianqing, Betta Pharmaceuticals, Pfizer, and AstraZeneca are currently in clinical research stages.

On December 11, InnoCare announced that the company's self-developed next-generation TRK inhibitor, Zolotrectinib, received marketing approval from the National Medical Products Administration (NMPA) for the treatment of adult and adolescent patients aged 12 years and above with solid tumors harboring NTRK fusion genes. This is China’s first self-developed next-generation TRK inhibitor.

Zolitacitinib has been included in the "Pilot Program for Encouraging the Development of Pediatric Anticancer Drugs (Starlight Plan)" by the National Medical Products Administration. InnoCare expects to submit a new drug application for zolitacitinib to treat pediatric patients (ages 2 to 12) in the near future.