The market for clinical trials in China is currently experiencing significant growth, driven by increasing activity from both Chinese sponsors and overseas corporations. The country’s large patient population, evolving regulatory landscape, and improving infrastructure present a compelling opportunity for clinical research.

Recent regulatory updates by the Chinese State Council, allowing acceptance of overseas clinical data for drug registration, are facilitating greater participation from international sponsors. Meanwhile, since 2015, China’s innovative drug industry has grown into an important global force, with nearly 5,000 local innovative drug companies.

The rise of this industry has driven the rapid development of service industries. In 2022, Sharp and ClinsChain announced their partnership to offer clinical services support to help meet the needs of customers looking to run their trials in the Chinese market. Two years on, we examine the most recent data on the trends and expansion of clinical trials in China, as well as how this unique collaboration is progressing.

China has emerged as a critical player in global drug development, driven by an increasing focus on innovative therapies. This growth is bolstered by a supportive regulatory environment that encourages innovation and expedites drug approvals. As a result, the number of clinical trials conducted within China has risen significantly.  

While growth in the country’s trial activity is driven by local companies, Western firms are slowly creeping into China, from around 100 trials per year in 2010 to around 350 in 2021. Multi-country trials in China are more likely to involve foreign involvement than single-country studies, with half of international trials with sites in China including Western commercial sponsors between 2020-2022. However, multi-country trials represent just 9% of commercial trials in China, compared to 42% in South Korea and Japan. Nevertheless, overseas sponsors will continue to invest in China due to its large patient pool, investment in improving infrastructure, and access to local markets, which makes it an attractive clinical trial destination.

ClinsChain’s Paul Cao believes these trends reflect how the Chinese government and academic community are placing strong emphasis on fostering innovation and building research capacity. ClinsChain is based in Shanghai and Beijing and provides one-stop-shop clinical supply services.

“There are more research grants and funds available to support basic and translational research,” Cao explains. “China's pharmaceutical and biotechnology ecosystem is expanding rapidly. There is an increasing number of CROs and CDMOs emerging and maturing. These organizations offer a wide range of services from trial design, patient recruitment, data management to drug manufacturing and packaging. Their growth provides more comprehensive support for clinical trials, making it more convenient and efficient for sponsors to conduct trials [in China].”

Challenges to conducting clinical trials in China

Despite the Chinese National Medical Products Administration (NMPA) implementing regulations to expedite clinical trial approvals and accept overseas data during drug registration, enabling faster and more cost-effective clinical trials, there are still challenges. Cao tells us that while regulations are improving, they are often still being adjusted. For instance, a regulation was recently introduced to add new requirements for the procurement entities of comparators.

"There is also a trend of increasing difficulty in quality control at investigational sites,” notes Cao. “In China, clinical trials are mainly conducted in class III Grade A hospitals in big cities, where competition for clinical trial resources has been increasing as the number of clinical trials has increased in recent years. This poses challenges to the smooth implementation of clinical trials and the quality of clinical data.”

There are also challenges related to logistics and distribution. For example, when drugs are delivered to sites, they must be accompanied by copies of COAs, and some sites also require that the expiration date of drugs be no less than six months. In China, all packaging must comply with strict regulatory requirements as defined in GCP and GMP regulations. Labels must be in Chinese and follow strict NMPA guidelines, including detailed instructions for use, dosage, storage and safety information.

Challenges also lie in suitable storage, as not all trial sites in China have the infrastructure for proper Investigational Medicinal Product (IMP) storage, especially for drugs requiring ultra-low temperatures or specific environmental conditions. Thermometer calibration and transit temperature records are usually required.

One of the key challenges with running clinical trials in China revolves around having the correct documentation needed to receive greenlight approval. Further complications include how Chinese customs impose the same customs duties as commercial drugs.

Jayme Streff is a Logistics Specialist at Sharp Clinical, a leading contract pharmaceutical packaging, clinical trial services and small-scale sterile manufacturing organisation. Based at Sharp’s Bethlehem PA facility, Jayme acts as a key contact between Sharp and their client for all logistics-related functions.

“China does require more strict processes and documentation compared to other countries,” Streff says. “For instance, you need a CoA, SDS, Certificate of Origin, a MAWB that specifies the flight lane, Import License, which is only valid for 15 days, as well as photos of the physical product and label supplied. All these requirements are needed prior to greenlight approval.”

How Sharp and ClinsChain can help

This is where the unique collaboration between Sharp and ClinsChain can help sponsors, says Cao. “ClinsChain can provide GMP/GCP compliant storage and packaging services [as well as] all types of label translation, packaging design and production services to ensure regulatory compliance,” he says. “For distribution, ClinsChain has a comprehensive process able to cope with specific site requirements including provision of copies of COA, shelf-life control of IMP to be delivered, provision of temperature records during transit, etc.”

Since 2022, Sharp has partnered with ClinsChain to offer clinical services support to the Chinese market. ClinsChain offers comprehensive importation services, including IOR, import broker services, and license application, through various Chinese ports, ensuring optimal solutions for various business scenarios. 

“Sharp leverages our years of expertise to assist our US- and EU-based sponsors in expanding into new markets like China,” says Mike MacNeir, Vice President, Global Business Development, Sharp. “We provide comprehensive support for storage and distribution within China, while our partner, ClinsChain, enhances our capabilities with deep local knowledge and robust infrastructure—critical for strengthening the domestic supply chain. This collaboration continues to be a true win-win for our clients.”

“The business model established by our two companies has been widely recognized in the Chinese market,” says Cao. “This is due to the reputation and extensive customer base we have established in our respective markets.”

This support has been crucial when shipping and storing potentially dangerous goods (DG) products in China, explains Streff:

“Regulations need to be followed depending on the type of DG. This includes proper labelling identification on the outside of the shipper, as well as booking a specific flight to minimize risks during transit. For a recent DG shipment to China, Sharp was requested to place material into a zip lock bag with a label that specified the Country of Origin and total net weight within the bag.”

Ambitions for the future

Cao believes that the growing number of innovative Chinese pharmaceutical companies conducting clinical trials in Europe, America and other locations represents a significant opportunity. To capture this potential, Sharp and ClinsChain must continue to optimize their present solutions, particularly in terms of pricing, he says.

“Competition in this niche market is becoming increasingly fierce, not only from multinational service providers, but also from some Chinese service providers going global.”

ClinsChain is one of the largest and best-known Chinese enterprises to provide professional clinical supply services in China. Sharp can tap intp these capabilities, and the reputation established by ClinsChain, to help extend and strengthen its operational capabilities in China and the Asia-Pacific region and further develop its global market.

“I feel like this is the start of many more opportunities for both Sharp and ClinsChain,” says Streff. “We have established them as an approved Depot, which will leverage our customers' access to their facility, and ClinsChain also provides the capability for expiry updating. This will provide current and future customers access to the Chinese market.”