By Fineline Cube 
China-based biopharma leader Innovent Biologics Inc. (HKG: 1801) has announced a significant regulatory milestone with the approval of Dabote (fulzerasib), its novel KRAS G12C inhibitor, by Macau’s health authorities. This marks the first time a China-originated KRAS G12C inhibitor has been approved in the region, underscoring Innovent’s leadership in innovative oncology treatments.
Mechanism of Action and Clinical Efficacy
Fulzerasib works by irreversibly modifying the cysteine residues of the KRAS G12C protein mutant through covalent modification. This action inhibits the GTP/GDP exchange mediated by the protein, downregulates KRAS activation levels, and disrupts downstream signaling pathways. The result is the induction of tumor cell apoptosis and cell cycle arrest, delivering potent anti-tumor effects.
In a Phase II clinical trial involving Chinese patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), fulzerasib demonstrated:
- 49.1% Objective Response Rate (ORR): A robust efficacy profile in targeting KRAS G12C mutations.
- 9.7 Months Median Progression-Free Survival (mPFS): Highlighting the drug’s ability to delay disease progression.
- 54.4% 12-Month Overall Survival (OS) Rate: Reflecting its potential to improve patient outcomes.
The therapy also exhibited a favorable tolerability profile, further enhancing its clinical utility.
Regulatory and Development Milestones
Fulzerasib received approval from China’s National Medical Products Administration (NMPA) in April 2022 for the treatment of adult patients with KRAS G12C-mutated NSCLC. This Macau approval expands the drug’s reach within Greater China, reinforcing Innovent’s commitment to advancing innovative cancer therapies.
Innovent’s Vision and Impact
As a pioneer in China’s biopharmaceutical industry, Innovent Biologics continues to demonstrate its ability to develop cutting-edge treatments that address unmet medical needs. The approval of Dabote in Macau is a testament to the company’s innovative prowess and its dedication to improving patient care across the region.-Fineline Info & Tech