Immune checkpoint inhibitors (ICIs) and their introduction into the treatment paradigm of multiple oncology indications has arguably been the largest transformative force in the treatment of cancer in the last decade. The generation of Chinese domestic ICI brands are now poised for approvals across multiple oncology indications in China and international markets, according to GlobalData.
Adam Pearson, Senior Oncology Analyst at GlobalData, says, “The Chinese market has historically been a target for a third wave of revenue generation for Western brands after gaining market access in the US and Europe. However, in the last decade a mixture of local R&D investment, regulatory reform, and international partnerships have accelerated Chinese capabilities for drug commercialisation and the development of domestic brands.”
Domestic products are promoted in China by inclusion on the National Reimbursement Drug List (NRDL) and are subsequentially heavily discounted compared to international brands, creating a significant commercial advantage. For example, several domestic checkpoint inhibitors approved since 2018 have been placed on the NRDL and are subject to significant discounts (up to 75%) compared to their international counterparts.
Dr Pearson adds, “International ICI brands seeking market access in China are now required to balance diminishing drug prices with the opportunity to target an enormous patient pool or identify underserved markets, where local brands are not available and pricing pressures are less restrictive.”
Currently, Tuoyi, Tyvyt, tislelizumab and camrelizumab are the frontrunners, boasting the broadest clinical development programs spanning multiple oncology indications. Due to a fierce competitive landscape, established physician familiarity with international brands and severe pricing pressures, the commercial potential for domestic ICIs may be limited, however international market access may provide additional revenue streams.
Dr Pearson continues, “There has been a significant increase in deals where Chinese companies will develop and commercialise innovative drug candidates developed by Western companies and where multinational companies will commercialise Chinese drugs outside of China.”