The Regulatory Constraints in Making Your LDT/CDx Partnership Choices in China

Our previous blog discussed the emerging trends for the companion diagnostics (CDx) regulations in China. There have been several developments since then, including the introduction of Laboratory-Developed Tests (LDTs) in China through pilot programs after China updated its medical device regulations in 2021.

However, when it comes to choosing a LDT partner in genetic testing, the choice is fairly limited for the international oncology drug manufacturers, as foreign investment into genetic testing and gene therapies is prohibited by Chinese laws and regulations.

As advanced diagnostics and Precision Medicine are key business areas for Veranex, we took an interest and selected three examples to provide a snapshot of the development of CDx in China and the regulatory-led choice of LDT partners in genetic testing.

CASE STUDY 1: IRESSA

Iressa, a targeted lung cancer drug manufactured by AstraZeneca, was launched in China in 2005, when there was no recognition of CDx in the regulatory pathway. The first EGFR biomarker (the biomarker associated with Iressa) test kit was only approved in China in 2010, this kit was manufactured by AmoyDx, an early pioneer in personalized medicine  in the Chinese diagnostic industry.

Table 1: Comparison of CDx Approved in the US and China for Iressa

CASE STUDY 2: PD-1/ PD-L1 INHIBITORS

There are both locally manufactured and imported PD-1/PD-L1 inhibitors in China. Compared to the early days of personalized medicine in China where there was a significant lag between drug approval and CDx approval, in the case of PD-1/PD-L1 inhibitorrs, the foreign diagnostic players were able to navigate the Chinese regulatory system more quickly to get the test registered closer to the time the drugs were approved and ahead of their Chinese competitors. Ventana, the Roche Diagnostics China team, even took a creative step and developed a CDx for a Chinese PD-1 player, Beigene.

Table 2: Comparison of CDx Approved in the US and China for Select PD-1/PD-L1 Inhibitors

CASE STUDY 3: NGS-BASED MINIMUM RESIDUAL DISEASE MONITORING

Next Generation Sequencing (NGS) is another fast-growing area in terms of technology and partnerships between pharma and diagnostic players. However, due to the legal restrictions on foreign involvement in Chinese genetic resources, Chinese players are clearly at an advantage in offering the LDT services.

Table 3: Bayer’s CDx/LDT Partners in the US and China for Its Orphan Drug, Larotrectinib

Advanced diagnostics and Precision Medicine are key business areas for Veranex. We also have a deep understanding of the evolving healthcare landscape in China. Our in-market experts closely monitor the policy and market trends in the strategic markets like China to help clients stay on top of industry trends and develop strategies and action plans to tap into the opportunities or tackle the issues.