Some useful background for understanding the significance of having China on board:
China a growing international leader in clinical trials HiRO - Harvest Integrated Research Organization
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July 26, 2023
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China's pharmaceutical market has witnessed significant growth and expansion. 1. Why is China a growing destination for global biotech and pharmaceutical companies?
Access to a large patient population:
China has a population of over 1.4 billion people, providing access to a large diverse pool of potential study participants.
By 2030, China will have one of the largest middle class populations in the world and is expected to make up as 70% of its projected population. ¹
China will soon have one of the oldest (80+ years) populations in the world and has an estimated growth of 1 million people aged 80+ years each year until 2025.²
As China’s population increases, so will its burden of lifestyle and chronic related disease; with disease incidence equalling and even outstripping that of Western nations. ³
China currently has one of the largest treatment-naive populations in the world – together with its growing middle class and aging population, it will also have one of the largest pool of patients in the world.²
Large hospitals in China are attractive for studies that require large patient pools from one site, specifically large Phase 3 clinical trials.
2. Rapid patient recruitment:
Due to its large population, China offers the advantage of faster patient recruitment for clinical trials, especially in therapeutic areas with high prevalence rates. This can significantly reduce the time and cost required to complete a study. With patients concentrated around top urban medical centres this can support a patient recruitment effort that is 2-3 times faster. ⁶ 3. Market potential, an emerging market for pharmaceuticals:
China is one of the largest pharmaceutical markets in the world. Conducting clinical trials in China can help pharmaceutical companies gain early access to this market and better understand the specific needs and preferences of Chinese patients. It also allows them to generate data that can support regulatory approvals and commercialization in China.
Generally domestic clinical trials are required for all drugs to be sold in China. ²
However recent Chinese reforms allow Real World Data (RWD/RWE) to support applications and speed up the commericalisation process for medicines that have already received regulatory approvals from other international regulatory agencies and are deemed to be essential.
4. Cost-effectiveness:
Clinical trials in China can be cost-effective compared to some Western countries. The lower costs of labour, infrastructure, and study procedures can help reduce overall trial costs, which is particularly appealing for companies aiming to optimize their research and development budgets.
Conducting trials in China often proves more cost-effective compared to other regions and direct costs are considered 30% lower than in the US. ⁶
Competitive pricing for services, lower infrastructure costs, and a favourable exchange rate contribute to cost savings without compromising on quality.
As an example, DIA looks at the area of immune-oncology where there are 234,000 newly diagnosed patients in the U.S. versus 780,000 in China. The direct Phase 3 cost per patient in the U.S. is approximately $69,000 compared to just $25,000 in China.⁶
5. Regulatory environment:
The Chinese government has made efforts to streamline and improve its regulatory environment for clinical trials. In recent years, there have been regulatory reforms aimed at accelerating the approval process and reducing administrative burden, making it more attractive for global pharmaceutical companies to conduct trials in China.
Shortened IND approval timelines
July 2018, the NMPA issued the "Announcement on Adjusting the Review and Approval of Drug Clinical Trials," and the clinical trial approval system was replaced, significantly shortening the IND approval timeline to three months. ⁴
The time period for a regulatory approval has also been substantially shortened from 265 days to 65 days. ⁶
Currently the China regulatory process can be completed in around 6 months, which is comparable to the US. The EU process is longer around 12 months, and the AU NZ region offers a streamlined regulatory timeframe with no pre-IND requirements and regulatory approvals as rapidly as 35 days. Regulatory focus on quality
Since 2018, China has been a member country of the International Conference on Harmonization (ICH) to help harmonise and streamline global clinical trial conduct and help increase trial quality and efficiency. China has changed and applied guidelines by sharing announcements and published a Chinese version of the original ICH guidelines.⁴
Since 2019 with the Regulation on Human Genetic Resources, multinational pharma and medical device companies are required to file notifications prior to electronic data capture (EDC). This means sharing of clinical trial data even for adverse-event reporting to foreign parties of interest, including the US FDA and other regulatory agencies.⁴
6. Government support:
The Chinese government is targeting the biotech industry as a key area of growth. Certain biotechnology and pharma subsectors will benefit from provisions outlined within the Chinese government’s latest Five-Year Plan.³ 7. Increasing expertise and infrastructure:
China has been investing heavily in its healthcare infrastructure and clinical research capabilities. Many hospitals and research institutions have advanced facilities and experienced investigators, ensuring high-quality trial conduct and data collection. Collaborating with these institutions provides access to scientific expertise and can enhance the quality of clinical trial conduct and data collection. 8. Faster trial timelines:
Due to the large patient population and streamlined regulatory processes, clinical trials in China can often have shorter timelines compared to other countries. This can help accelerate the drug development process and bring new treatments to market more quickly. 9. Global development strategy:
Global pharmaceutical companies often have a strategic interest in conducting clinical trials in multiple regions, including China. By conducting trials in China, they can gather data on the efficacy and safety of their drugs in different ethnic populations, which can be important for global regulatory submissions and market approvals.
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