Cullinan Therapeutics (CGEM) has started submitting its new drug application to the US Food and Drug Administration for zipalertinib plus platinum-based chemotherapy in previously untreated non-small cell lung cancer, the company said late Thursday.

The filing is being reviewed under the FDA's Real-Time Oncology Review program, which allows regulators to assess clinical data ahead of a full application.

The submission is supported by results from a phase 3 trial showing a significant progression-free survival benefit over chemotherapy alone, the company said.

Cullinan expects to complete the regulatory submission by year-end 2026.

The company is eligible for milestone payments of $30 million and $100 million tied to potential second-line and first-line approvals, respectively, it said.

Cullinan said Zipalertinib remains an investigational drug and has not been approved by any health authority.