Tanja Obradovic: Global Shift in Oncology Drug Development

Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared an article on LinkedIn:

”Global implications upon Pharma, Biotech and CROs of rise in Asia-developed oncology assets ready for the clinical trials.

In the annual 2024 FDA’s Center for Drug Evaluation And Research (CDER) Report ‘Drug Trials Snapshots Summary‘  for 15 approved novel Oncology drugs percent of participating US patients was at 14% vs 86% of exUS. This reflects growing acceptance of data outside of US by FDA in light of still strong message from the Agency that results for novel cancer drugs need to reflect relevance to US population. Before pivotal trials, FDA is also increasingly accepting Phase I exUS data toward design of the late-stage development within US. Several global trends in drug development across Pharma and Biotech sponsors are driving this outcome and pulling along activity of Clinical Research Organizations (CROs).

ExUs Biotech companies and especially China based ones are increasingly engine of the clinical pipeline both in terms of collaborations/acquisitions/financing by Pharma as well as driving Asia-placed clinical trials. In 2023 and 2024, approximately 30% of molecules in-licensed by Big Pharma companies came from China while in 2024 the number of novel drugs entering development in China reached 1,250, just behind 1,440 in the U.S. According to recent study published in July. China experienced rapid growth in clinical trials, surpassing the US in total trials and randomized clinical trials (RCTs).

By 2023, China led with 16,612 total trials (7798 RCTs), while the US registered 9100 (4619 RCTs). Still important to note that China’s RCTs were predominantly domestic, while the United States maintained a much higher proportion of international trials. So, we are experiencing strong global rebalancing of drug development between US and Asia that are driven to coexisting increase due to needs for data across both geographies to support regulatory and market access needs. Paste of clinical trials execution, price and favorable regulatory stand in Asia is driving increase in local early trials and also driving more late stage trials.

China’s National Medical Products Administration proposed in June of this year to halve clinical trial reviews, bringing the waiting period down from 60 to 30 days. Recent Asia Biotech conference and report by Mercator Institute for China Studies show increasing trend in advancing strategy to utilize strength of availability of new drugs for clinical development and possibility for early clinical data generation prior to going outside of Asia to increase value and global success probability as well as value of new assets. Moves in business opportunities and approach to new drug pipeline strategic development by Pharma and Biotech are driving Clinical Research Organizations (CROs) activity.

Most of the forecasting reports predict that oncology will be dominant therapeutic area of development and in the next 5 years US and EU will see still high and increasing market share of new trials in oncology with Asia gaining even more.  US is especially critical in light of maturing Asia Biotech that is not only partnering with Big Pharma but also increasingly primary Sponsor of global or US-only Phase II and Phase III trials in order to bridge China/Asia data toward US regulatory approval and market. In light of these general trends, several emerging factors can add to future regional impact upon drug development and CROs.

Recent legislation this year by FDA initiated prohibition of shipping US patient living cells to China and other hostile countries for genetic engineering and subsequent infusion back into US patients (read) and debate around importance of US-based clinical trials as security issue has surfaced (read). These and other possible new updates to US policy and regulatory framework are already intensifying need for the strong US presence of CROs to foster acquisition of US-based data, deep US expertise and navigation of the US business development framework in order to support big surge of possible new cancer drugs sourced from Asia.”

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