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ShanghaiMay 25, 2026 /PRNewswire/ — D3 Bio (“the Company”), a global clinical-stage biotechnology company dedicated to developing innovative oncology therapeutics, announced on May 20, 2025, that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to the Company’s investigational product, Elisrasib (D3S-001). The proposed indication is for the first-line treatment of advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations. This marks the first drug in China to receive Breakthrough Therapy Designation for first-line monotherapy in treating advanced NSCLC with KRAS G12C mutations.
According to information published by the NMPA, Elisrasib has been reviewed and found to comply with the relevant requirements of the “Drug Registration Regulation” and the “Announcement of the National Medical Products Administration on Issuing Three Documents, including the ‘Breakthrough Therapy Drug Review Work Procedures (Trial)'” (2020 No. 82), and has been approved for inclusion in the Breakthrough Therapy Drug Program.
Elisrasib is a next-generation KRAS G12C inhibitor designed to achieve rapid, complete, and selective target binding. The drug covalently binds to KRAS G12C in its GDP-bound state (OFF state), thereby blocking nucleotide cycling and inhibiting oncogenic signaling. Preclinical studies have shown that D3S-001 exhibits potent activity, the potential for sufficient KRAS G12C target engagement at clinically relevant exposure levels, and central nervous system (CNS) penetration capability. Currently, Elisrasib is undergoing global Phase II monotherapy and combination therapy studies targeting KRAS G12C-mutant solid tumors, covering various tumor types including NSCLC, colorectal cancer, and pancreatic cancer.
“The inclusion of Elisrasib in the Breakthrough Therapy Drug Program is a significant recognition of its clinical potential in the first-line treatment of KRAS G12C-mutant non-small cell lung cancer,” said Dr. Zhiqiang Chen, Founder, Chairman, and CEO of D3 Bio. “Notably, Elisrasib has previously received Breakthrough Therapy Designation from the U.S. FDA (for second-line treatment of NSCLC). This latest designation from the CDE reflects recognition from both Chinese and U.S. regulatory authorities and demonstrates its development potential across different treatment stages. There remains a significant unmet clinical need for patients with advanced NSCLC harboring KRAS G12C mutations. We look forward to maintaining close communication with regulatory authorities to accelerate the clinical development of Elisrasib and strive to bring new treatment options to Chinese patients as soon as possible.”
Non-small cell lung cancer accounts for approximately 80% to 85% of all lung cancers and is one of the leading causes of cancer-related deaths worldwide. Despite significant advances in targeted therapy and immunotherapy in recent years, patients with advanced NSCLC harboring driver mutations such as KRAS G12C still face substantial unmet clinical needs in the first-line treatment setting. Currently, targeted therapies for KRAS G12C mutations have made progress in later-line treatments, but no approved targeted therapy options exist in the first-line treatment field.
The Breakthrough Therapy Drug Program aims to accelerate the development and review process of drugs intended for the prevention and treatment of serious, life-threatening diseases, where preliminary clinical evidence suggests a significant improvement over existing therapies.