GIL 2026 | Reimagining the Paradigm of Regenerative Medicine: Insights from Phoenix Qin Xingjiong on the Technological Breakthroughs and Industrial Layout of Third-Generation Bionic Collagen ECM

In your view, has the “era” of first-generation (animal-derived) and second-generation (gene-recombinant) collagen ended? What is the core characteristic of third-generation collagen?

Phoenix’s technical philosophy is “structure determines function”. Our core breakthrough lies in “aqueous phase polymerization induced self-assembly” technology.

Compared with traditionalenzymatic catalysisor solid-phase synthesis, aqueous phase polymerization offers significant advantages such as high reaction efficiency, fewer by-products, and easy scaling. This technology uses renewable biomass (such as corn starch or glucose fermentation products) as raw materials. By precisely controlling reaction conditions, bio-derived amino acids are arranged in a natural Gly-X-Y sequence and connected, successfully folding into a highly stable natural homologous three-helix conformation. This process not only avoids the use of toxic cross-linking agents (such as glutaraldehyde) and achieves true green manufacturing but also provides excellent thermodynamic stability—our products can withstand 121°C terminal wet-heat sterilization while maintaining the three-helix structure, which is a recognized challenge in the industry.

Regarding platform-based construction, Phoenix does not limit itself to individual proteins but focuses on the engineering construction of ECM using collagen as the framework, with emphasis oncollagen, elastin, and hyaluronic acid.

• Collagen-based ECM gel system:By adjusting pH value, ionic strength, and temperature field, peptide chains are driven to self-assemble into a three-dimensional interconnected microgel system, simulating the microenvironment of natural ECM.

• Multi-component collaboration:We are developing composite systems including bionic elastin. For example, collagen works together with multiple components to jointly regulate the TGF-β/Smad2/3 pathway, promoting the expression of ECM in fibroblasts.

• Engineered customization:Through different self-assembly strategies (such as ACL, ADL-type self-assembly, AFL-type self-assembly, etc.), self-crosslinking, multi-dimensional crosslinking, and engineered composite strategies, we can customize materials with different mechanical properties and degradation rates, corresponding to different clinical scenarios such as skin repair, bone regeneration, or cartilage repair, thus forming an open and scalable biomaterial platform.

If we must rank them, the research and development and registration of Class III medical devices are undoubtedly the most challenging first level, but they are also crucial for building long-term competitive barriers for the company.

The “three-step jump” from Class II to Class III is essentially a dimensional transition from “surface care” to “deep regeneration”. In the field of Class II devices, Phoenix precisely focuses on the essential market of “physical skin barrier repair”. Given the huge demand for immediate repair in sensitive skin care and cosmetic surgery markets, we have developed China’s first full-formulation bionic collagen dressing matrix. Through a flexible ODM model, we have not only quickly penetrated the consumer market with technology but also deeply empowered the industrial chain, meeting the commercial needs of “medical device and cosmetic integration”, and providing stable cash flow support for the research and development of high-end Class III implants. Class III implant medical devices directly involve deep tissue repair inside the body and belong to a high-risk, high-barrier “deep water area”. They require materials with extreme biological safety and effectiveness, and also need to prove their long-term retention ability and regenerative induction function through strict clinical data. This is the core challenge that Phoenix aims to overcome and the critical turning point determining whether the company can enter the high-end regenerative medicine market.

The biggest challenges lie in “classification definition”, “standard establishment”, and “completeness of clinical data”.

First, regulatory science is evolving. China’s NMPA Class III registration certificate clearly distinguishes between those with and without a three-helix structure. Second, the challenge in clinical trials is to prove “long-lasting effect” and “regenerative ability”. For example, our injectable bionic collagen freeze-dried fiber has already undergone systematic pre-clinical verification. It is worth noting thatClassification definition of products is the foundation of compliance and commercialization. Currently, bionic collagen has been clearly classified by the National Medical Products Administration (NMPA) as Class II and Class III medical devices. At the same time, with the iteration of technology and the deepening of application scenarios, some protein products in the industry are gradually breaking out of the traditional device category and being included in “medicinal device combinations” or even regulated and evaluated as “innovative drugs”, indicating the refinement and upgrading of bi.material regulatory science. Traditional naturally extracted extracellular matrix (ECM) has long been restricted by scarcity of sources(limited supply of human and animal tissues), ethical controversies, and technical bottlenecks in maintaining activity and removing immunogenicity during decellularization, resulting in large differences between product batches and high safety risks, making it difficult to meet large-scale clinical needs. Against this background, Phoenix’s globally first three-helix bionic collagen-based ECM was introduced, effectively solving both regulatory and clinical challenges. It retains the complex biological functions of natural ECM while achieving controlled structure and standardized green synthesis through bionic technology, thus ensuring “zero endotoxin” and “no immunogenicity” while overcoming the regulatory gap of traditional animal-derived materials.

Registration certificates are indeed a threshold to enter the market, but the real moat lies in how we solve industry pain points at the root through innovative technical routes. Phoenix’s core competitiveness is reflected in thorough breakthroughs in three dimensions:

First, fully green and controllable origin, reshaping the safety foundation.

We abandon reliance on animal tissues and use bio-based amino acids as raw materials, combined with our unique “aqueous phase polymerization induced self-assembly” technology. This not only eliminates ethical controversies and virus transmission risks from the source but also ensures absolute purity and control at the raw material level.

Second, uniform and stable structure, establishing quality benchmarks.

Through advanced ECM engineering preparation technology, we achieve high-purity preparation of collagen-based extracellular matrix and precise regulation of molecular structure. This significantly improves batch consistency and thermodynamic stability of materials, solving the industry’s persistent problem of performance variability and ensuring predictable clinical efficacy.

Third, breaking through production barriers, strengthening industrial foundations.

We have established a green manufacturing process that can be scaled up and replicated, successfully overcoming the bottleneck of difficult industrialization of third-generation bionic collagen-based ECM. This means high-quality materials are no longer limited to the laboratory but have industrial potential for large-scale clinical use.

Looking forward: Building a “gene-cell-material” data closed loop to drive intelligent upgrading of regenerative medicine

In the future, Phoenix will evolve from simply “material manufacturing” to “intelligent design and precise regulation”, redefining the research and development paradigm of ECM regeneration materials by integrating cutting-edge multi-disciplinary technologies such as biocatalysis and green chemistry:

• High-throughput screening and multi-omics analysis:

Using high-throughput experimental platforms, combined with multi-omics analysis such as transcriptomics and proteomics, we deeply analyze the regulatory mechanisms of bionic ECM with different structural features on cell behavior (mobility, adhesion, differentiation, proliferation), revealing the internal logic between “material structure-microenvironment-cell fate”.

• Building a globally leading “gene-cell-material” database:

Integrating upstream gene sequences, midstream cell response data, and downstream physical and chemical parameters of materials, we establish a multi-dimensional big data base for regenerative materials, providing solid data support for algorithm training.

• AI-driven reverse design:

Introducing machine learning and deep learning algorithms to uncover hidden patterns in massive data, constructing a high-dimensional mapping model between “material structure-biological function”. We will shift from traditional “trial-and-error research and development” to a “rational computational design” paradigm, using AI to predict optimal molecular design and assembly parameters.

Ultimate mission:

Our ultimate goal is to rapidly develop personalized and customized regenerative materials for specific tissue defects (such as bone, cartilage, nerves, etc.). We aim to bring regenerative medicine into an intelligent era of “customized repair on demand”, which is not only a technological iteration but also reflects Phoenix’s mission to benefit patients.

These three approaches are not simple linear replacements but a hierarchical evolution based on application scenarios.

• Animal-derived extraction:It has lower costs, but poses immunogenicity and virus risks, and can only retain a limited market in low-risk areas. It has also faced significant challenges in the mainstream European and American markets.

• Gene-recombinant:It solves safety and scalability issues and is currently the main force in the cosmetic and skincare markets. However, it generally lacks a stable three-helix structure and has limited biological activity, so it is mainly used for superficial repair.

• Bionic synthesis (Phoenix’s approach):It combines safety, stability, and high biological function. It overcomes the world-wide challenges of difficult folding and unstable structure of recombinant collagen.

I believe thatin the fields of high-end implants and tissue regeneration, bionic synthesis has great potential.Because with the increasing aging population, the demand for “safe, long-lasting, and regenerative guidance” is growing explosively. Animal-derived materials cannot meet safety requirements, and ordinary recombinant collagen cannot meet long-term regenerative needs. Phoenix’s bionic collagen has no immunogenicity, a stable three-helix structure, and affordable cost—this is the ultimate solution to current problems. But it requires time. Currently, we adopt a “complementary + upgrade” strategy, establishing a dominant position in high-barrier areas such as Class III medical devices, while empowering the biomaterial industry and the “medical-cosmetic integration” market through exclusive raw materials via ODM and BD models.

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