There is less than a month left until May 1st, 2026.
On this day, the "Regulations on the Administration of Clinical Research and Clinical Translational Application of Biomedical New Technologies" (State Council Decree No. 818) will officially come into effect. This is the first time in China that a full chain regulatory framework has been established in the form of administrative regulations for cutting-edge technologies such as stem cell therapy, gene editing, CAR-T, from laboratory to clinical practice. Order No. 818 was approved by the State Council in September 2025 and officially released in just 28 days, demonstrating the firm determination to promote it.
For a while, there was a lot of talk about "industry winter approaching" and "80% of enterprises facing elimination". But is this really a 'cold winter'?
Careful analysis of policy intentions reveals that the core logic of Order 818 is not "comprehensive tightening", but "precise clearance".
1、 Re examination of policy implications: not 'comprehensive tightening', but 'precise clearance'
After the issuance of Order No. 818, the industry's response showed a strong polarization. There has been a wave of enterprise "exodus" and asset transfer - experimental equipment, clinical approvals, company equity, almost all assets that can be monetized have been put on the shelves, and sellers only want to leave as soon as possible. Many people interpret this phenomenon as an industry "approaching winter".
However, the Science and Education Department of the National Health Commission issued a special statement in February 2026, which made a rare strategic deployment for the implementation of the regulations. Careful analysis reveals that the core logic of the regulations is not "comprehensive tightening", but "precise clearance". Specifically, three types of behaviors are listed as the focus of cleanup:
Firstly, relying on beauty institutions and health management centers to carry out fee based business through the "research on behalf of business" model.
Article 11 of the Regulation clearly requires that clinical research institutions must be tertiary Grade A medical institutions, and clinical research is prohibited from charging fees to subjects. It also sets a high fine of up to 20 times the illegal gains. The model of charging high fees to patients under the banner of "clinical research" will completely lose its living space under Order 818.
Secondly, speculators who rely on vague regulatory space and engage in non-standard operations under the banner of "cell therapy".
The regulation has established a dual control system of "clinical research filing+conversion application approval". Enterprises that have never conducted standardized non clinical research and lack data support will lose their foothold.
Thirdly, the act of using raw materials with unclear ingredients and sources for research and production.
As a supporting implementation regulation of Order No. 818, the "Guidelines for Clinical Research Filing of New Technologies for Cell Components and Derivatives Therapy (Draft for Comments)" for the first time explicitly states in mandatory terms that the harvest culture medium used for preparing cell components and derivative preparations must be free of serum and substitutes, and the components must be fully defined. This provision completely prohibits the routine use of fetal bovine serum, platelet lysate, and serum substitutes in clinical research of cell derivatives such as exosomes from a regulatory perspective.
Since the announcement of the regulations, there has been a strong polarization in the industry's response. For institutions engaged in high-quality research and suppliers providing compliant raw materials for enterprises, the purification of regulatory environment means the reconstruction of competitive order, which is a tangible strategic benefit.
2、 The fundamental transformation of upstream raw material value: from "laboratory consumables" to "compliance cornerstone"
The deepest impact brought by Order No. 818 to upstream raw material suppliers is not the increase or decrease in the number of customers, but the fundamental change in the value positioning of raw materials in the industrial chain.
The first transformation: the compliance of raw materials has changed from a "bonus item" to a "mandatory question".
The "Filing Guidelines" clearly require that the harvested culture medium must have a complete traceability system and compliant quality control documents. For GMP production capacity, quality system certification, raw material traceability, and batch stability, downstream customers in the past may only "hope" that suppliers have these capabilities; Now, regulatory agencies directly require that raw material suppliers without these capabilities will not be able to enter the supply chain of compliant customers.
Under the pressure of significantly increasing compliance costs in the industry, downstream customers are more in need of stable and verifiable raw material suppliers than ever before to reduce the time and capital costs caused by repeated verification.
Second transformation: The value of non clinical research data is highlighted, and the stability of raw materials affects research and development results.
Article 9 of the Regulations clearly requires that before conducting clinical research, non clinical research such as laboratory research and animal experiments must be completed in accordance with the law, and can only enter the clinical stage after being proven safe and effective. This means that before cell projects enter clinical practice, they must be fully validated at the laboratory and animal levels. The inter batch stability of the raw materials directly affects the reliability of these data - if the raw materials fluctuate, the entire non clinical research data may become invalid.
The third transformation: a drastic change in customer structure and a significant increase in the threshold for cooperation.
Clinical research is limited to tertiary hospitals. Cell companies that have cooperated with beauty institutions and health management centers in the past will lose their survival foundation. As of December 2025, 33 tertiary hospitals in China have established cell therapy and regenerative medicine centers, taking over the leading role in clinical translation. For upstream raw material suppliers, the number of downstream customers will be significantly reduced, but retained customers - compliant pharmaceutical companies, CDMO institutions, and tertiary hospitals - will undergo unprecedented scrutiny of the supply chain. GMP production capacity, quality system certification, raw material traceability, and inter batch stability are transforming from "bonus points" to "entry tickets".
3、 Jinyuankang Biotechnology: From Upstream Raw Material Suppliers to Compliance Supply Chain Partners
Faced with this profound transformation, Jinyuankang Biotechnology has accumulated existing capabilities in the upstream raw material field of cell culture that are highly aligned with policy directions. These capabilities were not temporarily built to respond to Order 818, but rather core assets that have gradually accumulated over the past two decades of development.
Advantage 1: Large scale GMP production capacity, ensuring customer compliance and stable supply chain.
Jinyuankang has a globally leading GMP grade serum and culture medium production base, with an annual production capacity exceeding 1.5 billion ml and a daily production capacity of 4 million ml. The fully intelligent GMP production line adopts a full chain unmanned intelligent manufacturing system, with intelligent monitoring and automated operation from raw material collection to finished product filling, effectively ensuring batch stability.
In the context of the GMP requirements for the preparation of cell therapy products in Order No. 818, large-scale and high standard GMP production capacity is a hardware foundation that is difficult for small and medium-sized competitors to replicate in the short term, and can meet the strict requirements of compliant customers for supply chain stability and batch consistency.
Advantage 2: Authoritative quality system certification, providing downstream customers with directly trustworthy compliance basis.
Jinyuankang is the first serum production enterprise in China to pass both the "New Cow Serum Production Quality Standard Enterprise Certification" and the "Cell Culture Medium Production Quality Standard Enterprise" dual standard certification, and has obtained seven management system certifications including ISO 9001 and ISO 14001.
The Regulation sets out complete data requirements for clinical research filing, including basic information of the initiating institution, non clinical research reports, risk prevention and control measures, etc. Among them, the traceability and compliance of raw materials are easily overlooked but crucial links in the filing materials. Jinyuankang's existing authoritative certification system provides downstream customers with a directly credible compliance basis, which can help customers shorten the supplier audit cycle and reduce verification costs in supply chain compliance.
Advantage 3: Self built cell bank with raw material verification capability, helping customers reduce trial and error costs during compliance window period.
Jinyuankang has built its own cell bank, with over 50 industrial cell lines and over 500 scientific research cell lines. The company not only produces raw materials, but also has the ability to verify the effectiveness of cell culture.
The Regulation requires non clinical research to prove the safety and effectiveness of the technology before conducting clinical research. Under this logic, the quality of raw materials directly determines the reliability of non clinical research data. If customers frequently change raw material suppliers, each change means revalidating the cultivation system and accumulating data again - this is an unbearable trial and error cost for downstream enterprises that are currently in the compliance window period.
Jinyuankang's integrated service of "serum screening+cell validation+application scenario customization" can provide sufficient data support before customers purchase raw materials, helping customers reduce validation costs and R&D risks caused by changing raw materials.
Advantage 4: With 26 years of technological accumulation, we ensure the traceability and continuous compliance of raw materials.
Jinyuankang has a 26 year history of serum and culture medium research and development, and has applied for a total of 28 patents (including 5 invention patents). It is a national high-tech enterprise, a national intellectual property advantage enterprise, a national level green factory, and an autonomous region specialized and innovative small and medium-sized enterprise.
From a deeper logical perspective, the requirement of "traceability of raw materials" in the Regulations is essentially a test of the supplier's ability to control the quality throughout the entire process. This means that downstream customers are not just choosing a batch of raw materials, but a supply chain partner that can continuously meet compliance requirements.
Jinyuankang's 26 year stable operation record and technological accumulation ensure the full chain quality control capability from raw material source to finished product, and can continuously meet the dynamic requirements of regulatory compliance for raw materials.
Advantage 5: Layout serum-free culture media and expand service boundaries in line with policy trends.
The supporting regulations of Order No. 818 explicitly require in the field of cell derivatives that they do not contain serum or substitutes. This means that serum-free culture medium is no longer just a technical option, but a compliance threshold for specific application scenarios. While consolidating its serum business, Jinyuankang is actively developing and producing serum-free culture media. This measure is not following the trend, but based on the existing GMP production capacity, quality system, and cell validation capabilities, extending the service scope from "serum containing" to "serum-free", providing customers with a more complete selection of compliant raw materials. For downstream enterprises that are adapting to the new regulations, being able to obtain high-quality serum and serum-free culture media from the same supplier at the same time also means lower supplier management costs and more controllable supply chain risks.
4、 Be a trustworthy upstream partner in the new compliance landscape
The implementation of Order 818 is pushing cell therapy and related industries from the "gray zone" to the "sunshine avenue".
For upstream raw material suppliers, the core of this change lies not in the increase or decrease of customer numbers, but in the transformation of the role of raw materials from "laboratory consumables" to "compliance cornerstone". GMP production capacity, quality system certification, raw material validation capability, and technological accumulation are becoming key factors determining whether customers can pass regulatory reviews.
Jinyuankang Biotechnology has a solid foundation in the above dimensions. In the process of industry reshuffle, these existing advantages will be transformed into core competitiveness in serving compliant customers, providing the market with more stable and verifiable upstream raw material guarantees.
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