Chinas First Approved Kras G12c Inhibitor Innovent Announces The Approval Of Dupert Fulzerasib By The National Medical Products Administration Of China

Innovent Announces Approval of China's First KRAS G12C Inhibitor, Dupert Fulzerasib

A Novel Treatment for Lung Cancer

Innovent Biologics, a leading biotechnology company in China, has announced the approval of Dupert Fulzerasib, the first KRAS G12C inhibitor approved in China. This approval marks a significant milestone in the treatment of lung cancer, as KRAS G12C mutations are found in approximately 13% of non-small cell lung cancers (NSCLC). Until now, there have been no targeted therapies available for patients with this type of mutation. Dupert Fulzerasib is an orally administered, potent and selective inhibitor of KRAS G12C mutations. It has been shown to be effective in shrinking tumors and improving survival in patients with KRAS G12C-mutated NSCLC.

Key Features of Dupert Fulzerasib

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Orally administered, once-daily tablet *

Potent and selective inhibitor of KRAS G12C mutations *

Shown to be effective in shrinking tumors and improving survival in patients with KRAS G12C-mutated NSCLC *

Well-tolerated, with the most common side effects being diarrhea, nausea, and fatigue

Approval Basis

The approval of Dupert Fulzerasib was based on the results of a single-arm, registrational Phase 2 clinical study conducted in China. The study enrolled 120 patients with KRAS G12C-mutated NSCLC who had previously received at least one line of systemic therapy. The study results showed that Dupert Fulzerasib had an overall response rate (ORR) of 44.2%, with a median duration of response (DOR) of 10.9 months. The median progression-free survival (PFS) was 6.9 months, and the median overall survival (OS) was 12.4 months. These results are comparable to those seen with other KRAS G12C inhibitors that have been approved in the United States and Europe.

Importance of This Approval

The approval of Dupert Fulzerasib is a major breakthrough for the treatment of lung cancer in China. It is the first targeted therapy available for patients with KRAS G12C-mutated NSCLC, and it has been shown to be effective in shrinking tumors and improving survival. This approval is also a significant milestone for Innovent Biologics. It is the company's eleventh product to be approved in China, and it further solidifies Innovent's position as a leading biotechnology company in China.

Conclusion

The approval of Dupert Fulzerasib is a major advance in the treatment of lung cancer in China. This new therapy provides hope for patients with KRAS G12C-mutated NSCLC, and it is a testament to the innovative research and development capabilities of Innovent Biologics.