Choutu Tech Bridges China and Singapore to Disrupt the NASH Drug Development Black Hole with AI-Powered Digital Pathology

Non-alcoholic steatohepatitis (NASH) is one of the leading causes of liver cirrhosis, with a 15%–25% incidence rate of cirrhosis among NASH patients within 10 to 15 years. According to data from the Global Liver Institute, it is estimated that by 2030, 357 million people worldwide will be affected by NASH. Data from Frost & Sullivan indicates that the global market size for NASH therapeutics will reach $10.7 billion in 2025 and is projected to grow to $32.2 billion by 2030, representing compound annual growth rates (CAGRs) of 41.8% and 24.6%, respectively.

Despite affecting hundreds of millions of patients and representing a multi-billion-dollar market, non-alcoholic steatohepatitis (NASH) remains one of the few common diseases without any standard therapy. Its pathogenesis is complex, involving multiple aspects such as glucose metabolism and lipid metabolism. In the development of new drugs for NASH, most pharmaceutical companies currently base their approaches on the pathological interpretation of the "two-hit" hypothesis, targeting four key aspects: steatosis, inflammation, ballooning degeneration, and fibrosis.

Despite this $10 billion blue-ocean market, there is currently no FDA-approved novel drug for NASH on the market. For years, pharmaceutical giants such as Pfizer, Novartis, and Gilead have fallen into the R&D black hole of NASH therapeutics. To date, only one PPARα agonist, saroglitazar, has been approved in India.

The primary reason lies in the limitations of traditional pathological assessment methods for NASH, which are susceptible to staining artifacts and human interference. This raises concerns about the reliability of manual pathological slide interpretation and results in a lack of precise, reproducible quantitative analysis for evaluating NASH Activity Score (NAS) and fibrosis staging. To address the critical challenges in diagnosing fibrosis and cancer-related diseases such as NASH, as well as in drug development, ChouTu Technology may offer effective solutions.

Founded in 2014, ChouTu Technology is a subsidiary of HistoIndex, a Singapore-based medical technology company spun off from the Institute of Bioengineering and Nanotechnology (IBN) at the Agency for Science, Technology and Research (A*STAR). Headquartered in Singapore, the global hub of innovation, the Group has established branches or collaborative laboratories in China, the United States, and Europe. Its collaborations with global pharmaceutical companies, contract research organizations (CROs), and key opinion leaders (KOLs) have not only provided its domestic team with access to cutting-edge international insights and concepts but also secured numerous global orders for ChouTu Technology.

Currently, ChouTu Technology and its parent company boast a team with extensive research backgrounds, ranging from the founders to the heads of technology, data analysis, and even business development.

Take Dr. Teng Xiao, COO of Choutu Technology and Group CTO, as an example. Dr. Teng completed his undergraduate studies at Zhejiang University, where he had the privilege of being mentored by leading figures in China’s computer science field, including Professor Song Mingli, Professor Bu Jiajun, and Academician Chen Chun. After earning his bachelor’s degree, Dr. Teng received a full scholarship to pursue his Ph.D. at Nanyang Technological University (NTU) in Singapore, studying under Professor Cham Tat-Jen, Director of the Multimedia and Network Laboratory. Professor Cham is not only a distinguished alumnus of the University of Cambridge but also a top expert in the field of computer vision. His father is Professor Cham Tao Soon, the first President of NTU.

After graduation, Dr. Teng Xiao received job offers almost simultaneously from a major international corporation and HistoIndex, which was then a startup. After careful consideration, Dr. Teng chose the latter, stating, “Because in a startup, I can face more challenges and opportunities for growth, allowing my skills to be utilized to their fullest potential. Additionally, as the group was planning to establish a branch in China at that time, I also hoped that my expertise could better serve my home country.”

Driven by this passion, Dr. Teng Xiao returned to the starting point of his scientific research—Hangzhou. The core team, comprising Dr. Teng and HistoIndex’s two co-founders, Dr. Dean Tai and Dr. Gideon Ho, secured funding under the government’s program for overseas returnees and embarked on their entrepreneurial journey in China. Starting in 2019, due to both corporate restructuring and business adjustments, as well as pandemic-related lockdowns that prevented Singapore-based colleagues from frequently traveling to China for work exchanges, Dr. Teng Xiao was authorized by the Board of Directors to take full charge of the daily operations of the company’s Chinese entity, Choutu Technology. “It was quite challenging at the time, as the company had just adjusted its development direction, followed immediately by the pandemic lockdowns.”

However, over the past three years, ChouTu Technology has diverged from traditional industries; its R&D progress and sales performance have not faced significant challenges. Instead, the company’s global sales have witnessed substantial growth in recent years.

Dr. Teng Xiao recalled, “During that period, the group actually secured several major project orders,”Disclosable information includes the Phase III clinical trial of Madrigal-3196, a promising NASH drug poised to become the first FDA-approved therapy under accelerated approval, as well as preclinical collaborations with international pharmaceutical giants such as Merck & Co. and Takeda, and leading global CROs like LabCorp and WuXi AppTec.“Looking back, it was precisely during that period of rapid adjustment and development that Choutu Technology, through efficient collaboration with its parent company over the past few years, managed to turn losses into profits.”

Under the leadership of its core team and with the support of its parent company, HistoIndex, Choutu Technology adheres to source innovation across three key dimensions: environment, talent, and academia. In particular, regarding talent development, the company has invested substantial time and effort in enhancing employees’ professional knowledge and providing industry-specific skills training. Furthermore, it actively encourages its R&D team to submit papers to top-tier international conferences and journals, and to file for various patents and software copyrights.

With the team's efforts,The Group has achieved end-to-end independent research, development, and manufacturing of hardware for pathological imaging equipment and image analysis software.

ChouTu Technology adoptsGenesis: The World’s First Label-Free Imaging System Based on Second Harmonic Generation (SHG)/Two-Photon Excitation Fluorescence (TPE) Technology^®, scanning and acquiring images of unstained pathological tissue samples (white sections) using purely physical principles.Currently, the device has been iterated to Genesis.^®200，Genesis^®200 By leveraging the intrinsic optical properties of tissues, this method enables direct scanning and imaging without the need for staining. Two-photon laser excitation of biological tissues generates nonlinear effects and autofluorescence. Consequently, unlike traditional chemical staining techniques, this approach does not damage biological samples and is free from human-induced variables such as operational techniques and dosage during the staining process.

Based on the hardware,Choutu Technology, in conjunction with its self-developed AI image analysis application HistoHepa, automatically identifying tissue structures and key features through AI, and training on a large number of samples, particularly clinical trial sample data,Thereby establishing a series of methods for the continuous, quantitative, and objective evaluation of pathological features. Dr. Teng Xiao told VCBeat, “On one hand, this can be correlated with traditional pathology scoring; on the other hand, it can capture subtle changes that are not recorded by traditional pathology scores.””

Leveraging the aforementioned technologies and equipment, Chitu Technology currently provides pathological sample scanning and analysis services for preclinical trials, clinical trials, and research projects. These services specifically include assistance with trial protocol design, slide scanning, algorithmic image processing, statistical data analysis, and report writing.

By addressing pain points that traditional technologies cannot resolve, ChouTu Technology’s products naturally meet market demand. On the market front, ChouTu Technology initially targets the hundred-billion-dollar blue ocean of NASH (non-alcoholic steatohepatitis), helping new drug developers overcome the limitations of traditional pathological evaluation and providing a novel solution to the issue that the pathological “gold standard” for NASH may not be truly “golden.”

According to incomplete statistics, the Group currently has more than 100 collaborative partners worldwide, including biotech companies such as Madrigal, Intercept, Sagimet, and Terns; international pharmaceutical giants such as Merck & Co., Gilead Sciences, Novartis, Takeda Pharmaceutical, Regeneron Pharmaceuticals, Bristol Myers Squibb, and Boehringer Ingelheim; CRO firms such as ICON, Labcorp, and WuXi AppTec; and research institutions and hospitals such as Baylor College of Medicine, Massachusetts General Hospital, Memorial Sloan Kettering Cancer Center, University of Cambridge, University of Oxford, Peking University People’s Hospital, Beijing Friendship Hospital, and Shanghai Shuguang Hospital.

In preclinical NASH research, ChouTu Technology conducted animal studies with over 50 partners, validating more than 20 large and small animal models of NASH, including Gubra, Diamond, HFD+CCL4, and CDHFD.

Among publicly disclosed Phase II/III clinical trials for NASH, nearly half have utilized the Group’s proprietary stain-free digital pathology platform as a primary, secondary, or exploratory endpoint, or for retrospective analyses.

As indicated on the FDA website, Regeneron’s Phase II clinical trial for NASH employed SHG technology as the sole primary endpoint. Meanwhile, certain domestic partners, such as the R&D team at Xiamen Ganbaoli Biotechnology, have submitted quantitative analytical data reports generated by the SHG/TPE label-free digital pathology platform as part of their Investigational New Drug (IND) application materials to the Center for Drug Evaluation (CDE). This approach provided a more objective and accurate characterization of the specific pharmacodynamic effects of their investigational drug, and the project has since received approval for clinical trials.

Of course, the multi-billion-dollar NASH blue ocean is merely a starting point for Choutu Technology’s exploration of fibrosis and cancer. Through collaborations with numerous clients, Choutu Technology is also actively exploring other disease areas,“Many international clients are already using our technology platform for exploration in multiple other organs and diseases, such as scleroderma, myelofibrosis, renal fibrosis, pulmonary fibrosis, and triple-negative breast cancer.”

Regarding future development, Dr. Teng Xiao stated, “Tensquare Technology and the entire group aim to provide researchers and clinicians in fibrosis and cancer with novel tissue imaging and analysis systems through continuous exploration, thereby facilitating more effective disease diagnosis and drug development.” We look forward to Tensquare Technology rapidly establishing new standards for stain-free pathological evaluation and diagnosis.

Note: This article was jointly published by VCBeat and FT Bio. We thank FT Bio for its support of this report.