FDA Policies Reshaping the Competitive Landscape of the CRO Industry: The Emergence of Structured Dividends

FDA Policies Reshaping the Competitive Landscape of the CRO Industry: The Emergence of Structured Dividends

The new drug R&D industry is currently facing a "cold winter," with a growing trend of cost reduction. Coupled with the impact of the Trump administration's policies, both traditional and new - type Contract Research Organization (CRO) companies are presented with complex opportunities and challenges. The limitations of traditional cell lines and animal models in drug development are becoming more and more prominent.

On April 10, the U.S. Food and Drug Administration (FDA) announced that it would gradually abandon the animal testing approach in the development of monoclonal antibodies and many other drugs and instead pursue "more effective human - relevant research methods." These include AI - based toxicity computational models, toxicity testing of cell lines and organoids in the laboratory, collectively referred to as "New Approach Methodologies" (NAMs). This initiative aims to improve drug safety and accelerate the evaluation process. This policy is not only based on ethical considerations but also aims to enhance the clinical prediction accuracy of drug R&D through human - sourced data and reduce the failure rate.

As a provider of organoid and organ - on - a - chip technology solutions in China, Jiyan Biotech is driven by the "stem - cell - derived organoids + organ - on - a - chip" dual - engine, building three technological moats. Currently, Jiyan Biotech has developed tumor organoid models, organoid models of the brain and myocardium derived from pluripotent stem cells, and normal organoid models derived from adult stem cells. It has also achieved the simulation of physiological and pathological microenvironments through a multi - organ linkage chip system. In the future, co - culture of tumor organoids and multiple normal organoids will be realized, enabling the simultaneous evaluation of drug efficacy and toxicity, and truly realizing an animal - alternative solution for in - vitro evaluation "lab - on - chips."

Jiyan Biotech's Full - Scene Model Matrix: Building an Innovative Organoid Drug Screening Platform

I. High - Fidelity Tumor Organoid Models

Jiyan Biotech has completed the development of more than 20 types of tumor organoid models and gene - edited mouse tumor organoid models. Single - cell sequencing shows that the proportion of immune cells in Jiyan Biotech's high - fidelity tumor organoid models is closer to that of tissues. In clinical translational application research projects, single - drug and combination - drug evaluations of multiple clinical treatment regimens have been carried out, and the results are highly consistent with clinical practice. At the same time, Jiyan Biotech has conducted drug efficacy and toxicity evaluations for many pharmaceutical companies, including antibody drugs, antibody - drug conjugates (ADCs), small - molecule drugs, anti - inflammatory drugs, and chimeric antigen receptor T - cell (CAR - T cell) therapies, which meet the expectations of pre - drug development.

Comparison of Colon Cancer Single - Cell Sequencing Evaluation Tissues and Different Culture Methods

Colon Cancer Clinical Drug Evaluation Cases

II. Brain and Myocardial Organoid Models Derived from Pluripotent Stem Cells and Normal Organoid Models Derived from Adult Stem Cells

Relying on the induced pluripotent stem cell (iPSC) technology platform, Jiyan Biotech has constructed three characteristic models: brain organoids, myocardial organoids, and mesenchymal stem cell (MSC) bone organoids. At the same time, more than ten types of normal tissue - derived organoids corresponding to adult stem cells have been developed, including those of the liver, bile duct, gallbladder, kidney, stomach, intestine, pancreas, breast, and placenta, which can be used for in - vitro toxicity and metabolism testing.

The CSwell 600 chamber can form 3D embryoid bodies in a high - throughput manner within 24 - 48 hours.

The myocardial organoid induction kit (product numbers iOCKs001, iOCK001) can induce in - situ differentiation into 3D myocardial organoids with beating functions within 7 - 20 days. To construct larger cardiac organoids, embryoid bodies are cultured in suspension and induced to differentiate into millimeter - sized myocardial organoids with beating functions within 14 days.

Morphological Characterization of Cardiac Organoids: Immunofluorescence results indicate that cardiac troponin T (cTnT) is positively expressed in cardiac organoids.

Testing of Anti - arrhythmic Drugs on Myocardial Organoids: It is shown that isoproterenol accelerates the beating frequency of organoids, and after removing the drug, the beating frequency returns to the level before drug treatment.

III. Organ - on - a - Chip Ecosystem: Patent Layout and Application Development

Jiyan Biotech has applied for 36 patents, with 16 already authorized. The newly authorized invention patents in 2024 include "A Multi - Organ Chip and Its Use Method" (Patent No.: CN111575187 B), "An Organoid Perfusion Culture Chip and Its Use Method," and "A Bionic Intestinal Organ Chip" (Authorization Announcement No.: CN221720838U).

In addition, Jiyan Biotech has innovatively laid out a matrix - free drug screening system. The authorized patent "A 3D Organoid Bioactivity Detection Culture Plate" (product number: GF996) can realize matrix - free drug screening, reducing uncertain factors in the drug screening process and improving reliability. Some organ - on - a - chip products have been used in the evaluation of Class II medical device license projects.

From the development of tumor organoid models, to the development of normal organoid models, and then to the construction of a multi - organ linkage chip system, Jiyan Biotech is gradually realizing innovative methods for more effective in - vivo - related research.

 Innovation - Driven Development of the Pharmaceutical Enterprise Ecosystem

The FDA's policy is not simply about phasing out animal experiments. Instead, it forces the CRO industry to upgrade through technology substitution and cost reconstruction. The ultimate winners are likely to be platform - type companies that can integrate the entire data chain of "animals - organoids - AI," and their data assets will become an irreplaceable necessity for pharmaceutical companies. However, for in - vitro models to prove the consistency between organoid data and human trial results, there are many challenges. For example, in the prediction of cardiac toxicity, tens of thousands of comparison data are required, resulting in huge upfront investment. Therefore, in - vitro models still have a long way to go. However, we firmly believe that as long as innovative biotechnology breaks through the most critical threshold of going from non - existence to existence, subsequent improvements in quality can be gradually achieved through time. Adhering to long - termism and bravely taking the path of innovation, although it is arduous, is the way to break the situation.

Portrait of Future Winners:

Future winners will be enterprises that possess human - sourced data assets (such as customized organoid libraries), have the ability to rapidly iterate technologies (with AI - driven drug discovery platforms), and have a say in regulation (participating in the formulation of FDA/Center for Drug Evaluation (CDE) standards).

Jiyan Biotech welcomes like - minded AI drug discovery platforms to jointly conduct dual - track explorations of "AI - driven + organoid empirical research" and clinical trial projects for personalized treatment, promoting the rapid development of precision medicine and new drug development, and establishing a Chinese pharmaceutical enterprise - biotechnology - medical ecosystem with Chinese characteristics and international competitiveness.

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