China is emerging as a key player in developing novel oncology therapies, particularly in treating non-small cell lung cancer (NSCLC). Kirsten rat sarcoma homolog (KRAS) G12C inhibitors have gained significant attention for their efficacy in targeting KRAS G12C mutations, prevalent in NSCLC. China’s robust pipeline of in-house developed therapies targeting these mutations promises future affordability and accessibility for patients, reinforcing its position in the field of innovative treatment options, says GlobalData, a leading data and analytics company.

According to GlobalData’s Pharmaceutical Intelligence Center, China witnesses the highest number of incident as well as diagnosed prevalent cases of NSCLC among the 16 major markets (16MM*). The incident and diagnosed prevalent cases of NSCLC in the country are expected to increase at compound annual growth rates (CAGR) of approximately 4.1% and 4.3% from 362,653 to 444,159 and 426,565 to 527,634 from 2023 to 2028, respectively.

Neha Myneni, Pharma Analyst at GlobalData, comments: “Access to targeted cancer therapies in developing markets like China was historically limited due to regulatory obstacles and delayed launch strategies by multinational companies. However, the landscape is shifting as domestic companies conduct their own research and development, supported by China’s drug regulatory reform and national price negotiation policies. These initiatives, implemented since 2015, have paved the way for increased availability of innovative anticancer drugs, benefiting patients in the region.”

Currently, there are no marketed therapies approved for the treatment of KRAS G12C positive NSCLC in China. Six domestic companies are developing these targeted therapies in Phase II and above for various cancers, primarily NSCLC and colorectal cancer. Of these, Innovent Biologics’ GFH-925 is being studied in Phase III, while Jacobio Pharmaceuticals plans to initiate a Phase III study towards the end of 2023.

Overall, only two KRAS G12C inhibitors are currently approved for NSCLC (Amgen’s sotorasib and Mirati Therapeutics’ adagrasib) in selected global markets. Moreover, only Genentech’s (divarasib), and Novartis’s (JDQ-443) drugs are being developed for KRAS G12C positive NSCLC globally in Phase III.

Myneni concludes: “There exists a substantial room for growth and market success for the drugs developed by local companies in China. However, competition from potential late-stage molecules from foreign players like Mirati Therapeutics (adagrasib is being developed in Phase III in China in collaboration with Zai Lab) is inevitable. To offset this competition, domestic companies could parallelly invest in the development of a companion diagnostic solution to support the market uptake of their drugs at affordable prices once approved.”

*16MM: Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Russia, South Africa, South Korea, Spain, the UK, and the US.