Vivoryon Biologics' Next-Generation TRK Inhibitor Yilatini Receives Market Approval in China

NTRK gene fusions are oncogenic drivers in adult and pediatric patients with pan-solid tumors. Over 229 fusion partner genes have been identified, resulting in 358 unique fusion–tumor pairs. In patients with advanced solid tumors who have not received targeted therapy, the median overall survival ranges from 10.2 to 12.7 months, with a high risk of brain metastasis; treatment relies on small-molecule TRK inhibitors.

NTRK fusions are characterized by rare mutations and a broad spectrum of tumor types. They exhibit a high incidence in certain rare malignancies, while the absolute number of positive cases is substantial in common cancers. Patients with four types of cancer, including non-small cell lung cancer (NSCLC), account for nearly 50% of affected cases. The prevalence is high in East Asian populations, with an overall incidence rate of approximately 0.4% among Chinese patients, resulting in over 15,000 newly diagnosed cases annually.

On June 4, Vico Pharmaceuticals’ Class 1 new drug, elatinib, was approved for marketing in China, indicated for adult and adolescent patients with advanced solid tumors harboring NTRK gene fusions.

Clinical trials of elatinib demonstrated an objective response rate (ORR) of 68.5% and a disease control rate (DCR) of 85.2%. In patients with more than 6 months of follow-up, the ORR reached 89.7%, the DCR was 100%, and the median overall survival (mOS) was 40.7 months. The 2-year progression-free survival (PFS) rate was 75.7%, and the 2-year duration of response (DOR) rate was 85.5%. Among patients with baseline brain metastases, the ORR was 87.5%, while in patients previously treated with TRK-TKIs, the ORR was 47.4%.

Ilatenib features a cyclic molecular structure and possesses mechanisms to combat drug resistance.

Vico Pharmaceuticals, established in 2010, is a commercial-stage innovative biopharmaceutical company. With over 900 employees, more than 84% are technical professionals. The company boasts a full-chain innovation system, and its innovative drug pipeline covers a wide range of diseases. In addition to Elatinib, Shumeige Capsules are in the pivotal confirmatory clinical trial phase, and VC005 is in Phase III clinical trials. Over the past five years, the company has secured cumulative financing exceeding RMB 1.2 billion, and it will continue to promote innovation and expand its market presence in the future.

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