FDA Announces Phased Elimination of Animal Testing Requirements for Monoclonal Antibodies and Other Drugs | Organoid and Organ-on-a-Chip Technologies Ushered into Historic Opportunities

Jiyan Biotech interprets the new FDA policy and helps promote innovation in pharmaceutical research and development.

I. Core of the FDA's New Policy: Animal Testing Phases Out, and Human Substitute Technologies Take the Lead

On April 10, 2025, the U.S. Food and Drug Administration (FDA) made a significant announcement: it will gradually eliminate the mandatory requirement for animal testing in the development of monoclonal antibodies and other drugs and instead promote a new evaluation system based on human biology. This policy aims to enhance drug safety, accelerate the evaluation process, reduce animal experiments, lower research and development costs, and ultimately, reduce drug prices. It marks the official entry of the global pharmaceutical R&D into the "animal-free" era, with organoid and organ-on-a-chip technologies emerging as the biggest beneficiaries.

Three Core Directions of the New Policy

1. AI-based Computational Models: 

Encourage the use of artificial intelligence to predict drug behavior, such as simulating the distribution of monoclonal antibodies in the human body and their side effects, greatly reducing the need for animal testing.

2. Human Laboratory Models: 

Promote the use of laboratory - grown human "organoids" and "organ-on-a-chip" systems (such as liver, heart, and immune organ models) to directly reveal toxic reactions that may be overlooked in animal tests.

3. Regulatory Incentives: 

Update guidelines to recognize non-animal test data. Companies that submit high-quality safety data can enjoy expedited approval, driving the industry to invest in modern testing platforms.

Key Advantages of Animal Testing Alternatives for Monoclonal Antibody Safety Evaluation

More Accurate Human Response Simulation: 

Organoids and organ-on-a-chip technologies directly reflect human cellular and organ-level drug responses, overcoming species-specific limitations of animal testing.

• Faster Drug Development:

• AI modeling and human-based testing can shorten the drug development lifecycle, accelerating patient access to innovative therapies.

• Global Leadership in Regulatory Science:

• The FDA solidifies its position as a pioneer in modern regulatory science, advocating for humane and innovative testing methods.

•  II.Jiyan Biotech Layout: Meeting the Demands of the New Policy

• As a leading enterprise in the field of organoids and organonachip technologies, Jiyan Bio has developed a fullchain solution covering the core scenarios required by the new policy.

• Suzhou Jiyan Biotech Co., Ltd. focuses on the field of tumor precision medicine services. It is dedicated to the construction of tumor organoid models and the development of organonachip technology platforms for drug sensitivity testing, drug evaluation, potential target research, and tumor disease mechanism research. It provides personalized precision treatment strategies for patients and offers a new in vitro evaluation model for new drug discovery and development. Jiyan Bio has successively been recognized as a National Science and Technology Small and Mediumsized Enterprise, a Private Science and Technology Enterprise in Jiangsu Province, and a National Hightech Enterprise.

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• Currently, the company has independently developed more than 50 types of organoid models and has formed a series of "onestop" organoid construction kit products, organoid identification and embedding series products, and matrixfree organoid preparation and highthroughput drug screening series products. It has applied for 36 national patents, with 16 patents already authorized.

• III. The FDA's Implementation Roadmap and Future Plans

Immediate Implementation: 

Encourage the submission of nonanimal test data (such as organoid and organonachip results) in Investigational New Drug (IND) applications.

Pilot Program:

In 2025, launch a pilot for monoclonal antibody developers, allowing them to adopt a mainly nonanimalbased testing strategy. Through crossagency cooperation (such as with the NIH and NTP), accelerate the verification of new technologies.

Public Participation:

Hold public seminars within the year to solicit opinions from stakeholders and promote the phased implementation of the policy.

"A WinWin for Public Health and Ethics"

FDA Commissioner Martin A. Makary pointed out: "For a long time, pharmaceutical manufacturers have conducted additional animal tests on drugs with extensive international human data. This plan marks a paradigm shift in drug evaluation, which is expected to accelerate the development of cure plans and reduce animal use. Through AI computational modeling, human organ model testing, and realworld data, we can provide safer therapies to patients more quickly and reliably, while also reducing R&D costs and drug prices."

 IV. Industry Outlook

With the FDA's recognition of nonanimal testing methods, organoid and organonachip technologies have become core tools in drug development. Jiyan Bio will continue to delve into cuttingedge technologies to help customers achieve efficient R&D within the compliance framework.

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