Recently, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the NDA for Zurletrectinib (R&D code ICP-723), a Class 1 anti-tumor new drug independently developed by Innovent Biologics, has been accepted. The drug is a second-generation pan-TRK inhibitor, intended for the treatment of adult and adolescent patients (12 years old ≤ age < 18 years old) with advanced solid tumors carrying NTRK fusion genes, marking an important progress in China's "unlimited cancer" targeted therapy field.

Zolotinib is a new generation of pan-TRK inhibitor. Its core advantage lies in its ability to effectively solve the drug resistance problem of the first-generation TRK inhibitors (such as larotrectinib and entrectinib). According to the key registration Phase II clinical trial data disclosed in InnoCare Pharma's 2024 annual report, the drug showed excellent efficacy in patients with NTRK fusion-positive advanced solid tumors, with an overall response rate (ORR) of 85.5%, and the duration of remission in some patients exceeded 36 months.

In addition, the brain penetration and intracranial activity of Zoletinib are significantly better than those of similar drugs, and it has potential therapeutic value for patients with advanced solid tumors with brain metastases. Studies have shown that the drug exhibits a strong inhibitory effect on both wild-type TRK and drug-resistant mutant TRK (such as TRKA G595R and TRKA G667C), providing a new treatment option for drug-resistant patients.

In recent years, China's anti-tumor drug research and development has entered the fast lane. According to Yaozhi data, the scale of the domestic tumor market has approached 200 billion yuan. However, drugs targeting rare targets such as NTRK fusions still rely on imports. The launch of Zoletinib is expected to break this situation and boost the international competitiveness of China's innovative drugs in the field of precision treatment.

Currently, there are more than 70 CLDN18.2 target drugs under development worldwide (70% of which are developed by Chinese companies), and InnoCare Pharma's leading position in the TRK inhibitor track further confirms the innovative strength of Chinese pharmaceutical companies in the field of segmented targets.

The acceptance of the marketing application for Zoletinib is another milestone in the development of anti-tumor drugs in China. As tumor treatment develops towards "precision and combination", the combination of targeted drugs with immunotherapy and chemotherapy has become a trend. The clinical potential of Zoletinib is not limited to monotherapy. In the future, it may explore combined solutions such as PD-1 inhibitors to expand the beneficiary population.

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