The Chinese pharmaceutical market continues to grow steadily, but drug developers in China face similar challenges as their global counterparts: Development times are increasing and success rates are declining. Xiaoning Guo, PhD, PMP, clinical development program director of our Asia Pacific services, recently discussed potential strategies to improve investment returns and accelerate global development.
An evolving landscape
“Regulations in China have changed a lot with new policies and guidelines as the China Food and Drug Administration (CFDA) is strongly promoting innovation,” said Guo. “Domestic pharma companies in China can benefit from revised IND review timelines and approval processes to get their clinical trials in Phases I through III approved simultaneously.”
New drugs in China, defined as drugs not marketed anywhere in the world, may qualify for accelerated review with China’s Center for Drug Evaluation (CDE), depending on the type of therapy. Innovative drugs meeting urgent clinical needs can be placed in a separate CDE queue, cutting down the typical 12- to 18-month review and approval cycle to as little as 6 months.
Chinese pharmaceuticals also are encouraged to run parallel regional clinical trials with global trials in a dual-development model. This strategy shortens the overall development time and mitigates investment risk with earlier proof of concept results.
Understanding the challenges
Reaping the advantages of dual development requires addressing a few associated challenges. Proactive communication must be incorporated into the process to meet regulatory needs, not only with the CFDA but also with the other regulatory agencies, like the FDA and EMA. From the financial side, earlier-stage investment may be necessary to run the trials locally and globally.
Overall, the program design can require more effort to accommodate multiple trials. However, if development is successful, this strategy promises to maximize the patent protection period and deliver earlier investment returns to fund late-stage development.
Supporting a strategy
“Chinese pharmaceuticals should consider several key points in their dual development strategy,” said Guo. “Preclinical data packages should be able to support IND dual filing in multiple countries. A strong early-phase strategy should also look at a gap analysis and plan for pre-IND meetings.”
Proactive planning is key to well-designed and executed clinical studies in the crucial space between first in human and proof of concept milestones. Here, biomarkers can help segment patient populations to support faster patient recruitment at sites identified as high performing for the targeted therapeutic area. Early commercial planning also helps identify potential global partners for late-stage development to build interest for the project and gain visibility among competitors.
The future outlook
The CFDA continues to make efforts to shorten the IND/CTA review cycle and promote accelerated timelines. Making the most of the quickly shifting standards isn’t always straightforward, but the outlook is promising. “As with any development strategy,” said Guo, “one size does not fit all, particularly in China. Each sponsor needs custom-made solutions to take advantage of the new regulatory paradigm and enable its global development success.”
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