Over a Dozen US and European Biotechs Set Their Sights on China's IITs, While a US Rare-Disease Company Prepares for Collaboration

"A well-known US rare-disease company is preparing to advance an siRNA IIT study with a Chinese drugmaker, hoping that China's IIT data can accelerate FDA approval in the US and save part of the early clinical costs." A senior industry insider recently told VCBeat.

This is not an isolated case. Sheng Da, founder of Beacon Capital, also told VCBeat that in 2026, multiple overseas companies have directly emailed to ask: what resources can be connected for those wanting to run IITs in China?

Sheng Da focuses on cross-border innovative drug licensing deals and frequently exchanges views with US and European life sciences funds and biotechs. He has found that the number of overseas companies wanting to run IITs in China has been growing over the past six months.

"Sometimes at conferences abroad, when chatting offline, US and European VCs would mention that they have invested in several portfolios covering small nucleic acids, gene therapy, and other fields, and they all want to bring them to China for IITs. They ask very detailed questions — which hospital to approach, what the processes are, what the specific requirements are, and so on. I help connect them with domestic CROs, CDMOs, and core clinical institutions, and we sit down and talk."

"Although the new Regulation No. 818 has just taken effect and brought some uncertainty to IITs, cases like EsoBiotec and YolTech using IITs to drive M&A and capital market moves still attract global biotechs," Sheng Da told VCBeat.

According to VCBeat's statistics, as of press time, the China National Center for Biotechnology Development has published six batches of project lists for the recordation of clinical research on new biomedical technologies, covering 93 projects.

Overseas companies' interest in Chinese IITs has grown markedly of late. They come with pipelines, budgets, and even well-defined indication targets, trying to find a "fast track" to the US FDA within China's vast patient population and efficient clinical system.

These sharp-eyed overseas biotechs have their eyes on an increasingly clear path: using Chinese IIT data to obtain FDA IND approval, or even directly waiving US Phase I clinical trials, substantially compressing time and capital costs.

Moreover, the YolTech case in 2026 has further validated the feasibility of this path, giving the industry the most direct confidence — after obtaining FDA approval for Phase II/III clinical studies with IIT data, the company listed on Nasdaq through a reverse merger, completing the full channel for Chinese early clinical data to reach the US capital market.

But whether this "fast track" can be replicated on a large scale, the industry's view remains sober.

Sheng Da currently focuses on the RNA field. He told VCBeat that in this segment, more than ten US and European companies have already expressed clear intent to run IIT clinical studies in China. "There will be even more in gene therapy, and not just for rare-disease indications — even major diseases like Alzheimer's have companies thinking about running IITs in China."

These intentions are quickly turning into action. For example, Umoja Biopharma, a star in vivo CAR-T company, has chosen China for its first clinical trial, and Gilead has reached a strategic collaboration with Pregene.

On July 21, 2026, US biotech Tempest Therapeutics and Hebei Senlang Biotechnology reached a strategic collaboration to jointly advance TPST-4003, a next-generation in vivo CAR-T candidate, in IIT studies in China.

The CEO of another US biotech, Stylus Medicine, has also said the company is considering China as the site for its first clinical trial, noting that the Chinese model can substantially accelerate clinical validation — critical for startups — and that this opportunity should not be overlooked.

The warming overseas interest in Chinese IITs did not come out of nowhere. Reviewing recent cases, Chinese IIT data appears to be upgrading into an important basis for FDA review.

According to VCBeat's incomplete statistics, at least ten innovative drug companies have obtained FDA IND approval or completed BD deals with the help of IIT research, including:

YolTech Therapeutics, meanwhile, has made overseas companies realize the "premium potential" of Chinese IIT data through concrete actions.

In March 2026, YOLT-202 (overseas code SERP-01), an in vivo gene-editing drug independently developed by YolTech, obtained FDA approval to enter Phase II/III clinical studies directly. This means the IIT data generated in China were accepted by the FDA, exempting the drug from a US Phase I clinical trial.

This will save companies substantial time and money. Research shows that the cost of a US cancer Phase I clinical trial is about USD 19.2 million, taking one to three years.

Beyond clinical approvals, YOLT-202's capital-market maneuvers are even more striking.

In June 2026, YolTech licensed the global rights to YOLT-202 outside Greater China to Serapha Bio. Serapha subsequently reached an all-stock merger with Nasdaq-listed Boundless Bio in a reverse-merger listing, with the combined company expected to trade under the ticker "AATD".

Through its stake in Serapha, YolTech has indirectly become a shareholder of a Nasdaq-listed company.

In Sheng Da's view, YolTech is one of the rare cases where Chinese IIT data have been directly recognized by the US capital market.

The senior industry insider quoted above also analyzed to VCBeat that the value of this chain of moves lies not only in how much the pipeline itself sold for, but in completing a full closed loop: from Chinese IIT data to FDA clinical approval, to listing on Nasdaq through a reverse merger — with YolTech itself also holding shares.

Underpinning this series of cases is the fundamental advantage of China's clinical efficiency.

According to McKinsey research, patient enrollment in Chinese oncology clinical trials is three to five times faster than in the US and Europe, at one-third to one-quarter of the cost.

A population base of 1.4 billion, 4.2 million new cancer patients per year, and patients' habit of seeking care at centralized medical centers make large tertiary hospitals a natural breeding ground for clinical trials. In 2025, the number of newly initiated clinical trials in China surpassed the US for the first time, ranking first globally, with cell and gene therapy leading the pack.

"IIT is an opportunity for China's biomedicine to overtake on the curve," the above-mentioned senior insider analyzed to VCBeat. IIT clinical research helps boost the total output value of the biomedical industry and provides a cash-flow channel that gives hospitals and researchers the incentive to keep investing, making it a "living source" for industrial development.

This collaboration model also benefits hospitals and patients: combining foreign technology with domestic clinical resources gives patients access to the latest therapies, hospitals the ability to improve clinical research capabilities, and the industry the chance to approach international standards through technological exchange and cooperation.

"Company-led IITs also help improve clinical research quality. Many drug company founders have received rigorous training abroad or have years of experience at multinational companies; their teams possess rigorous scientific spirit and engineering qualities. Moreover, when companies participate as stakeholders, it adds a safety valve — they are also signatories and will hold the trial process to stricter standards, improving the safety of IITs," the senior insider noted.

Although the prospects for Chinese IITs are widely viewed positively, the replicability of the path validated by YolTech remains to be tested.

"The past success cases are groundbreaking, but many unseen attempts have not worked out. The outcome ultimately depends on the company, the PI, the health commission, and how communication with the FDA is handled," Sheng Da told VCBeat.

In Sheng Da's view, FDA acceptance of IIT data is not a universal standard; companies need to be sufficiently professional in study design, data quality, and pre-communication with regulators. "YolTech may have done very well here — its communication with the FDA was thorough, and the standards were aligned in advance."

The background of Wu Yuxuan, PhD, founder of YolTech, may offer part of the explanation: he participated in the foundational R&D of Casgevy, the world's first approved CRISPR gene-editing drug, which may help him deeply understand the standards, processes, and communication style of FDA drug approval.

Such compound talent — familiar with China's clinical resources and versed in US regulatory logic — is extremely scarce in China.

Sheng Da pointed out to VCBeat that China still has clear gaps in its innovative drug talent structure. First, there is a shortage of biologists able to discover new targets; second, there is a shortage of talent able to explain Chinese clinical data to the FDA, including how to argue that Chinese data can be used directly for US submissions. "If communication fails, you have to redo everything in the US, and all the time and money saved is wasted."

It is understood that communicating with the FDA using Chinese IIT data may face three difficulties: first, data compliance and quality are hard to align — the FDA requires complete GCP standards and auditable records, and some domestic IITs may have weaknesses in these areas; second, the FDA's review logic and communication style differ from China's, and domestic companies are unfamiliar with its rules of engagement; third, there may be a systemic gap between Chinese data and "FDA-ready evidence," requiring a full-chain evidence package.

Beyond the talent threshold, indication selection is also a key variable.

YOLT-202 targets AATD, which affects about 100,000 patients in the US and falls within the rare disease category. Sheng Da believes the most viable path for Chinese IIT data today remains rare diseases or innovative therapies. "For major diseases, the competitive landscape is complex, the FDA's review standards are higher, and the risks are greater."

The senior insider further stated that domestic drugmakers should strive to become shareholders of their overseas partners amid the IIT opportunity wave, noting that a mutual-shareholding model would be more sustainable.

"Domestic companies only talk about cash upfront payments in BD deals and are reluctant to ask for equity, fearing buyers won't agree. But the US capital market prices high-quality biomedical assets fairly rationally — the stock value of a good pipeline far exceeds cash. Only when both sides hold shares in each other can interests be bound for the long term: Chinese companies hold equity in foreign companies, and foreign companies hold equity in Chinese companies, so no matter which one lists, everyone can benefit. A one-off product sale is a short-term move, while mutual shareholding allows both sides to share the long-term value after the product is launched," the senior insider noted.

The window of opportunity for Chinese IITs is opening, but the road is not a smooth expressway. It tests companies' scientific rigor, regulatory communication capabilities, talent depth, and precision in indication selection. Whether individual cases can be converted into a systemic industry opportunity still awaits more practice to verify.