​​ In the field of stem cell therapy, a harsh reality is:

Technological leadership doesn’t equal clinical priority.

Many innovative teams spend years completing their research and development, only to hit a roadblock during the IND submission phase—facing requests for additional data, encountering rigorous scrutiny, and undergoing repeated revisions—sometimes even missing the critical clinical window altogether.

Especially for stem cell therapies, which Living attributes, manufacturing complexity, and quality heterogeneity These characteristics make regulatory review standards even more cautious. A single unprofessional submission not only wastes resources but could also put previously cutting-edge technologies at a disadvantage.

How to make excellent stem cell therapies, From "laboratory breakthrough" to successful "clinical validation" ？

The answer is: Choose someone who truly understands stem cells, regulations, and review processes. Our professional partners 。

Jiuzhitang's MakerCQDMO platform is dedicated to accelerating stem cell therapy products. End-to-end empowerment from R&D to market launch Leveraging mature stem cell production processes, a robust quality management system, and extensive clinical registration experience, we are establishing a reliable pathway for stem cell IND applications.
 

Pain points are the battlefield.

The Five Major "Hurdles" in Stem Cell Applications
 

During in-depth discussions with several innovative companies, we identified the five most common challenges in stem cell IND applications:

1. "Technical Language" Difficult to Convert into "Registered Language"

The R&D team has deep expertise in stem cell mechanisms, but struggles to translate the technical rationale into a clear, standardized narrative that adheres to CTD formatting and meets regulatory review requirements—resulting in "great technology being poorly communicated."

2. Vague boundaries for process changes

Stem cell process optimization is frequent, but which changes qualify as "major"? Are additional non-clinical studies required? Without forward-thinking judgment, it’s easy for the CDE to question whether "quality remains uncontrollable."

3. Insufficient Identification of Critical Quality Attributes (CQAs)

The quality control strategies in the submitted documentation are fragmented and fail to establish a closed-loop evidence chain centered around CQAs, making it difficult to convince the review experts that the "product is stable and reliable."

4. Pre-IND preparations were rushed, leading to low communication efficiency.

The meeting materials lacked logical structure, and the defense preparation was insufficient, resulting in a missed opportunity to build valuable trust with the CDE.

5. Unclear reporting process leads to passive responses to feedback

Without a comprehensive strategic plan, the team has fallen into a vicious cycle of "issue—patch—repeat," severely slowing down R&D progress.

At the heart of these issues lies Skill proficiency gap : R&D is disconnected from registration, and there’s a mismatch between technology and regulation.

The Way to Break the Impasse
 

Jiuzhitang Maker Systemic Solutions

We don’t do “paper writing services”—we provide A full-cycle, systematic IND submission service—from strategy to implementation With pharmaceutical-grade expertise, we're bridging the "last mile" of regulatory submissions.

Front-end strategy: IND submission, initiated in the early stages of R&D

We advocate for "pre-submission engagement," stepping in early in the project phase:

Assist customers in organizing Product Features and Risk Points ；

Assist customers in optimizing processes when necessary, enhancing process robustness and scalability.

Assist in developing registration strategies, scientifically map out pathways for process changes, and mitigate risks associated with late-stage submissions.

Provide the "IND Submission Roadmap," outlining key milestones and a checklist for document preparation.

Let reporting no longer be a "last-minute push," but instead become a systematic engineering process that runs throughout the R&D journey.

Professional Translation: Turning "cellular language" into "regulatory language"

The Jiuzhitang Maker registration team has an average of 10 years of registration experience and all members hold clinical backgrounds. Well-versed in CDE review logic We excel at:

Transforming the complex cell preparation process into A CTD narrative with clear logic and a closed-loop of evidence ；

Precisely highlight the product's unique advantages, emphasizing its key "scalability" feature.

Proactively filter out redundant information to ensure accurate data. Concise, focused, and efficient 。

We don’t do “translation”—we do Architect of Registration Logic 。

Review Perspective: Structuring Documentation from CDE's "First-Person View"

We always think from the perspective of regulatory review experts:

Which data are the "must-see items"?

Which risks must be addressed?

Which control strategies are the most compelling?

Based on this, we have built " Must-see, Highly Recommended, Easy to Approve "the data structure, proactively anticipate issues, and actively provide evidence," Minimize replenishment risks to the greatest extent possible 。

End-to-end services: Comprehensive support from start to finish, seamless collaboration
 

We offer professional services covering the entire lifecycle of IND submissions:

Declaration Strategy Consulting and Path Planning

Complete Set of Materials for CTD Modules 1–5: Writing and Review

Clinical Trial Protocol Design and Optimization

Pre-IND Meeting Documentation Preparation and Presentation Support

CDE Communication, Coordination, and Issue Response

One-stop delivery—let your team focus on R&D; we’ll handle the "clearance" process.

Strength speaks for itself
 

Verified Successful Submission Path

​

As of now, Jiuzhitang Maker has successfully advanced Three groundbreaking stem cell projects Having entered the National Medical Products Administration's clinical implicit approval stage, the program covers indications such as the nervous and respiratory systems, and has accumulated extensive experience in communicating with the CDE.

The first stem-cell-based new drug clinical trial (Acceptance No.: JXSL1900126) has now entered Phase IIa and is being conducted simultaneously at Beijing Tiantan Hospital, Peking University Third Hospital, and Beijing Tongren Hospital.

The second stem-cell new drug clinical trial (Acceptance No.: CXSL2300202) is being jointly conducted with the First Affiliated Hospital of Guangzhou Medical University. Currently, the project is in Phase IIa.

The third stem-cell new drug clinical trial (Application No.: CXSL2400859) is being conducted jointly with Beijing Anding Hospital, and the project has now entered Phase I.

We deeply understand that every successful application is A Victory of Expertise, Experience, and Collaboration 。

Choose Jiuzhitang Maker
 

It's about choosing a "certainty fast track."
 

On the track of stem cell therapy, Speed is life; certainty is competitiveness.

We don’t promise a "guaranteed pass," but we do promise:

Minimize reporting risks to the lowest possible level through professionalism.

Use experience to shorten the approved path to its shortest possible length;

Use collaboration to ensure that technological value isn't overlooked.

We deeply understand that every successful application is a victory built on expertise, experience, and collaboration.

Don't let the promising stem cell therapy get stuck any longer in the maze of regulatory approvals.

Jiuzhitang MakerCQDMO Platform – the stem cell IND application project, helping you take the first step and get ahead in the race.

Consult now

Let's make the next submission,

From "reactive response" to "proactive control."