GenFleet Therapeutics and Innovent Biologics have secured approval from China’s National Medical Products Administration (NMPA) for Dupert (fulzerasib), the country’s first KRAS G12C inhibitor for advanced non-small cell lung cancer (NSCLC) in adults who have undergone prior systemic therapy. This breakthrough therapy addresses a challenging mutation, offering a critical new treatment option for patients with limited alternatives, says GlobalData.
Innovent and GenFleet Therapeutics entered into an exclusive licence agreement in September 2021 for the development and commercialization of fulzerasib in China, with option-in rights for markets outside the country. Fulzerasib, in combination with cetuximab, is currently in Phase II trials for NSCLC in Europe in collaboration with Merck KGaA. Fulzerasib is also in clinical development for colorectal cancer (CRC). It is in Phase III trials in China and the US for CRC.
Chilamula Srija, Pharma Analyst at GlobalData, states, “The approval of Dupert underscores the advancement of China’s oncology landscape towards more effective cancer treatments, aiming at difficult-to-treat targets like KRAS G12C mutations and addressing a significant unmet need of patients.”
According to GlobalData’s Pharmaceutical Intelligence Center, the incident cases of NSCLC with KRAS G12C in China are expected to increase at an annual growth rate (AGR) of 5.42 per cent from 12,757 cases in 2023 to 17,535 by 2030, which is the highest among the major markets*. With the growing disease burden, Dupert stands as a crucial treatment option. Dupert is anticipated to generate sales of $3 million in 2024 and grow to $282 million globally for all indications by 2030, at a CAGR of 113.2 per cent.
Dupert enters a highly competitive KRAS G12C inhibitor market. Amgen’s Lumakras (sotorasib) is approved in the US, Europe, Japan, and other regions, while Bristol-Myers Squibb’s Krazati (adagrasib) is approved in the US and Europe as a second-line therapy. In China, Chia Tai Tianqing Pharmaceutical Group’s garsorasib and Jacobio Pharmaceuticals’ glecirasib are in pre-registration for this mutation as second-line therapies, and Zai Lab’s adagrasib is in Phase III trials.
Chilamula adds, “Dupert, as the first approved KRAS G12C inhibitor in China, is positioned to impact the treatment landscape for both NSCLC and CRC upon successful clinical trials and regulatory approvals. While competition is expected to increase with upcoming drug launches, Dupert’s first-mover advantage and the growing KRAS G12C mutation burden in China highlight its strong potential in cancer treatment.”
*Major markets: Australia, Brazil, Canada, France, Germany, India, Italy, Japan, Mexico, the UK, the US, Urban China, Spain, South Korea, South Africa, Russia.