Formerly regarded as a “me-too” producer, China has continued to expand its innovation capabilities within the last 10 years, whilst gaining traction as a major competitor within the international pharmaceutical landscape, according to GlobalData, a leading data and analytics company.
Over the last decade, the Chinese government has incorporated numerous regulatory initiatives, such as China’s 2015 “Opinions on Deepening the Reform of the Review and Approval Processes to Encourage Innovation of Drugs and Medical Devices,” which was the catalyst of change to implement several regulatory frameworks to encourage domestic innovation, expedite drug approvals, and enhance China’s presence on the global pharmaceutical stage.
GlobalData’s latest report, “China’s Evolution in Global Drug Development and Clinical Trials,” reveals that changes like these have advanced the development of novel targeted therapies, clinical trial optimisation, and increased international collaboration. Furthermore, China’s 2020 “Provisions for Drug Registration” regulation that aims to enhance accelerated approvals and priority review pathways has enabled significant scalability when conducting clinical trials, especially in early-stages.
China has been able to advance across therapy areas and modalities, including bi-specifics, monoclonal antibodies and antibody-drug conjugates. As a result, China has developed into an increasingly desirable hub for innovative therapeutics for big pharma.
Gaffar Aga, Strategic Intelligence Analyst at GlobalData, comments: “This represents years of regulatory initiatives demonstrated by China, which enabled it to continue to advance into a key source of credible innovation within the global pharmaceutical landscape.”
Looking at the development of drugs across phases, China-based companies now represent 20% of drugs in development, globally, compared to 40% for the US and 11% for the 5EU, according to GlobalData’s Drug Database.
China has also accelerated its first-in-class (FIC) capabilities, highlighting its successful transition into a global hub for innovation. As a result, global biopharma organizations are more incentivised to partner with China-based organizations for innovative therapies.
George El-Helou, Strategic Intelligence Analyst at GlobalData, comments: “China continues to transition from ‘me-too’ to a global innovator, redefining the global drug development landscape. Other markets must continue to monitor China’s pipeline assets to maintain global market share.”
The US continues to dominate drug development across therapy areas. However, China’s advancement is moving beyond oncology, with an increasing focus on immunology and metabolic disorders. Additionally, the US continues to lead the market share across modalities, but China has outpaced 5EU in some areas such as monoclonal antibodies, bispecifics and antibody drug conjugates.
Hannah Hans, Head of Pharma Strategic Intelligence at GlobalData, says: “The US continues to dominate FIC drug development across all therapy areas. Meanwhile, China’s biopharma sector has advanced at remarkable speed, surpassing the 5EU in several therapy areas and modalities, as well as delivering globally competitive FIC innovation.
“Importantly, Global Pharmaceutical companies remain highly engaged in partnerships, investments and co-development programs with Chinese companies advancing differentiated FIC assets. As China’s biopharma pipeline matures, assets may not only complement Global Pharma’s portfolio, but in some cases, directly compete with them in the future.”
*5EU includes UK, France, Germany, Spain, Italy.
