Veristat Discovers a Goldmine of Opportunities in China

Veristat Discovers a Goldmine of Opportunities in China

By Deborah Borfitz

April 16, 2026 | Following an eye-opening experience at China’s largest biotechnology and life sciences event, Veristat is positioning itself as a first mover in accommodating the regulatory needs of multiple Chinese companies eager to enter European and North American markets. “They are no longer just developing for the Chinese market,” according to Daphne Smyth, who heads up global regulatory programs for the contract research organization (CRO) and consultancy. The shift comes in response to government policy reforms over the past decade, with purpose-built R&D cities and science parks in more recent years acting as physical accelerators.

The pivotal moment for Veristat came at Bio China 2026, held at the Suzhou International Expo Center in March with more than 30,000 attendees and over 4,000 exhibitors. Veristat had an all-English exhibition booth in the small international section where it was the only global CRO to be found.

“We were literally bombarded with people wanting to know what we do, how we get drugs approved, and what kind of services we can offer,” says Smyth. “There was a certain curiosity factor, since there weren’t many European or U.S. companies there, but still the level of interest was absolutely incredible.”

Veristat plans to open an office in China this year and is now in search of bilingual regulatory, medical writing, and sales staff, Smyth reports. “Our Chinese clients speak very good English, but we speak no Chinese,” making the language gap a key barrier to overcome—especially when it comes to explaining the layered and complex European regulatory system for drug approvals, she adds.

Transparent Market

Despite the linguistic divide, Veristat has had a string of recent successes for its China-based customers in securing drug approvals in the U.S. via the Food and Drug Administration (FDA), European Union via the European Medicines Agency (EMA), and U.K. via the Medicines and Healthcare products Regulatory Agency (MHRA). Between 2020 and 2025, the CRO reports that it submitted 68 initial investigational new drug (IND) applications and drug master files, 10 initial FDA marketing applications, and eight initial marketing applications to the EMA, MHRA, and Swissmedic (Switzerland’s regulatory agency).

Originating in Boston in 1994, Veristat has established several offices in Europe since 2019, including Basel (Switzerland), Barcelona (Spain) and Fréjus (France). These locations provide “the local regulatory expertise to translate a Chinese dossier into a European market authorization and to have the Chinese companies get their drugs either approved or clinical trials started up outside of China,” says Smyth.

Veristat currently serves six large Chinese pharma companies, including Hansoh Pharma and CStone Pharmaceuticals. “The Chinese market is very transparent, so once we got the [first] CStone approval, we were contacted by many other companies and all our existing clients recommended us,” Smyth says.

The EU and U.K. are especially attractive market destinations for Chinese sponsor companies, she adds. In the U.S., the FDA is relatively stringent about the number of U.S. patients that need to be included in phase 3 trials to apply for a new drug application (NDA) or biologics license application. “The European agencies care more about the relevance of a treatment for the population.”

While rare, Veristat succeeded in getting an NDA approval based on mainly Chinese data, she says. This required “ongoing studies and justifications based on comparability to the class approval.”

The soon-to-open location in Shanghai, China, will serve more of a sales than a consulting function, says Smyth. It will likely initially employ a few staff who are familiar with both in-country and ex-China regulatory systems and will speak to Chinese companies, encouraging them to use services in Veristat’s established offices elsewhere.

‘Mind-blowing’ Scale

Smyth is an industry veteran, specifically on regulatory matters, with decades of perspectives on China.

She formerly worked for big pharma and headed up regulatory functions in the Asia-Pacific region, where countries like Japan and South Korea were increasingly being integrated into international development programs.

Not China, where the aim was invariably in-country commercialization until about 2015. The trials were enormous in size, thanks to the huge availability of patients, and would complete quickly, she says, “but always inside of China.”

One of the reasons for the more recent push outside the Chinese market is the increasingly competitive drug reimbursement environment in the country, continues Smyth. While China offers massive volume potential, profit margins are severely compressed by heavily government-controlled negotiations often requiring deep price cuts for innovative drugs and a procurement program forcing significant price drops for generic and off-patent drugs. But since Chinese companies enjoy massive economies of scale, lower labor and energy costs, and significant government support, they remain commercially viable despite the low price points.

In addition to tangibly supporting the biopharmaceutical industry, the Chinese government has also instituted a series of regulatory reforms expediting the approval process and reducing time-to-market for innovative therapies, she says. China has reportedly halved if not quartered clinical trial startup times by changes to its review policies, the adoption of parallel workflows for ethics submissions and IND applications, and a strong local CRO ecosystem.

The Chinese government is also encouraging foreign investment, further enabling sponsors to realize their global ambitions, adds Smyth. Some of the larger China-based biopharma companies already have out-licensing and co-development agreements with their global industry brethren.

When Smyth joined Veristat in January 2025, the company had only one or two Chinese clients, she notes. It was only after acting on their recommendation to attend the Bio China conference and exhibition that the CRO was struck by the enormity of the opportunity to help in-country drugmakers comply with destination country regulations.

The event focused on the latest technologies being developed by Chinese-based companies, and the focal point was an enormous exhibition hall with representatives from every stage of the pharmaceutical industry and most especially those providing manufacturing and machinery, says Smyth. The tiny international section featured the consultancies and ex-China companies and is expected to occupy more of the overall exhibition space in 2027.

“The pure scale of what’s going on there is mind-blowing,” says Smyth, referring to the high-tech metropolis of Suzhou. Situated about 60 miles west of Shanghai, the city was purpose-built as a biotech hub over the past three decades with hospitals, universities, R&D campuses, scale-up facilities, full-fledged pharma companies, and distribution centers. Nearly 13 million people now call it home, and “everything is electrified [including cars and scooters] due to the huge pollution problems in China.”

This is in stark contrast to conventional perceptions of China that likely persist among people whose only reference point are cheaply manufactured products that quickly fall apart. “That has changed,” she stresses, and this extends to the drug products coming out of China that are “no longer a copy of somebody else’s.” Rather, they are first-class drugs and technology, backed by robust science, which is why regulatory agencies around the world are approving them.

High-value Products

By any measure, China has a colossal pharmaceutical industry. It ranks as the second-largest drug market globally due both to the country’s’ massive population and the fact that it is a major supplier of pharmaceuticals to the entire Asia-Pacific region. China’s share of industry-sponsored trials has also reportedly been doubling since 2018, now surpassing those being conducted in the U.S.

Regulatory guidance from Veristat is being tapped for high-value products, including first-in-class drugs for treating cancer such as PD-L1 inhibitors and antibody-drug conjugates, says Smyth, who expects to see more of the same moving forward. “As a CRO we’re dependent on what our clients want to develop, but we do have the broad expertise” that extends also to rare diseases and neurological conditions as well as cell and gene therapies.

There is plenty of room for expanding global CRO capacity, she says. Many of the thousands of domestic pharmaceutical manufacturers are focused on global expansion and need the regulatory support, as ultimately might hundreds of the small CROs in China.

Despite having impressive, well-resourced development programs, large pharma companies in China tend to most need guidance in navigating the European regulatory system, which involves an interdependent network of organizations, agencies, and committees, says Smyth. “It’s something that needs very careful description, explanation, training, and awareness with these clients ... and with the language barrier a lot has to be done in writing.”

The one somewhat common barrier to getting a Chinese-made drug into foreign markets is that the European or U.S. population has not been “sufficiently considered,” she adds. “Once that is covered in the form of bridging studies or rationale, or some kind of in vitro comparisons, the products are approvable by normal standards.” While clinical trials are being conducted outside China, “the majority of the data in our experience is coming from China.”

The outlook is unquestionably positive for companies looking to support the ambitions of China’s sizable biopharma industry, as well as regulatory professionals who speak both Chinese and English, says Smyth. “I also think we will be seeing more early-phase studies conducted outside of China,” she adds.