World First! LivingPHOENIX Secures China's First Medical Device Registration Certificate for Biomimetic Collagen, Ushering in the Era of Third-Generation "Biomimetic Collagen ECM"

CHENGDU, China, Nov. 10, 2026 /PRNewswire/ -- On November 6, at the 2026 Golden Panda Global Innovation and Entrepreneurship Competition, LivingPHOENIX Regenerative Technology Development (Chengdu) Co., Ltd. ("LivingPHOENIX") achieved a historic milestone: its independently developed "Sterile Biomimetic Collagen Dressing" officially received a medical device registration certificate from the Sichuan Medical Products Administration. This is not only China's first-ever registration certificate for a triple-helix biomimetic collagen medical device but also marks a critical leap for the country in high-end regenerative medicine materials—from "catching up" to "leading." Concurrently, two core invention patents related to hydrogel extracellular matrix (ECM) technology were rapidly granted by the China National Intellectual Property Administration (CNIPA) via the green channel pre-examination process. The company emerged victorious among 2,119 innovative projects from countries including South Korea, the United States, Germany, and China, across leading technology sectors—including AI, electronic information, pharmaceuticals & health, new materials, new energy, and advanced manufacturing—winning the Third Prize at the 2026 Golden Panda Global Innovation and Entrepreneurship Competition. This trifecta of breakthroughs—"First Medical Device Certificate + Patent Authorization + Global Competition Honor"—signals that the collagen industry is accelerating into a "Biomimetic Era," defined by precise structural design and functional bio-mimicry.

Historical Leap: China's First Certificate Issued, Solving Industrialization Challenges
Extracellular Matrix (ECM) is often metaphorically described as the "urban infrastructure" maintaining human homeostasis, with cells acting as its "residents." Certified by Cell magazine as the "13th Hallmark of Aging," ECM consists primarily of collagen (~80%), supplemented by elastin (~3%) and hyaluronic acid (~1%). Collagen, dubbed the "scaffold of life," is the most abundant and widely distributed functional protein in the human body. Currently, precisely replicating the natural triple-helix structure while preserving biological function during large-scale production remains a recognized technical barrier in regenerative medicine. The recently approved "Sterile Biomimetic Collagen Dressing" relies on LivingPHOENIX's globally pioneered third-generation Triple-Helix Biomimetic Collagen-Based ECM technology. Unlike traditional products, this solution resolves the long-standing industry conflict between "sterilization processing," "structural integrity retention," and "biological functionality."

According to Dr. Qin Xingjiong, Founder of LivingPHOENIX, the technology utilizes green biomanufacturing to obtain amino acids, employs aqueous-phase chemical polycondensation to construct homologous triple-helix skeletons, and forms highly stable ECM networks through engineered assembly. Crucially, this biomimetic collagen withstands terminal wet heat sterilization at 121°C while retaining its triple-helix structure. This breakthrough means structural advantages from the lab can truly translate into scalable, medical products that meet sterility requirements, clearing process obstacles for the clinical conversion of high-value consumables such as Class II sterile products and Class III implants.

Technological Evolution Review: Limitations and Breakthroughs from Animal Extraction to Gene Recombination
To understand the value of "World First," one must review the three generations of collagen technology evolution.

First Generation: Animal-Derived Collagen
From the 1980s to the 1990s, bovine and porcine animal-derived collagen dominated the market. Examples include Zyderm and Zyplast, approved by the US FDA. While these products retained natural triple-helix structures, they had significant pain points: preparation relied entirely on low-temperature environments to prevent denaturation; there were potential risks of viral contamination and immunogenicity; and cumbersome skin allergy tests were required before use. With the rise of safer, longer-lasting hyaluronic acid (HA), traditional animal collagen's market share shrank due to short duration and complication issues, even facing withdrawal of medical device registrations by the US FDA.

Second Generation: Recombinant Collagen
To address safety concerns, the industry shifted to recombinant gene technology. Although raw materials became controllable and costs lower, limitations in folding capabilities of expression systems like E. coli and yeast meant most recombinant products could only form single chains or short peptides, lacking complete, stable natural triple-helix higher-order structures. This restricted their biological functions in mimicking human microenvironments, supporting cell growth, and constructing tissue scaffolds. It is understood that "the difficulty in directing proline hydroxylation" became a key technical bottleneck hindering stable triple-helix formation in recombinant collagen.

Third Generation: Triple-Helix Biomimetic Collagen
Facing the limitations of previous generations, LivingPHOENIX proposed a new logic: rather than relying solely on natural extraction or biological expression, actively "design" collagen at the molecular level. By precisely regulating amino acid sequences and self-assembly processes, triple-helix biomimetic collagen highly resembling natural collagen structures is constructed in vitro. This inherits the structural advantages of animal collagen while overcoming its safety risks; it possesses the controllability of recombinant collagen while breaking through its structural defects.

Dr. Zhou Boyu, Inventor and R&D Director of LivingPHOENIX, stated that the company pioneered a fusion innovation route of "Bio-based Raw Materials + Green Chemical Manufacturing," successfully tackling long-term bottlenecks in clinical applications of collagen materials. At the starting material end, biomimetic collagen ECM uses renewable biomass substrates like corn starch and glucose, extracting amino acids such as proline and hydroxyproline via microbial fermentation—typical products of green biomanufacturing. At the polymerization end, liquid-phase chemical polycondensation is used to synthesize, accurately replicating the homologous triple-helix structure of natural collagen. Addressing traditional pain points where protein gel preparation relied on exogenous crosslinkers or physical induction—causing complex processes, high energy consumption, cytotoxic residues, and conformational damage—and specifically resolving the contradiction between "sterilization treatment" and "material structure retention" that has long constrained clinical application, LivingPHOENIX innovatively developed "Triple-Helix Biomimetic Collagen Self-Crosslinking Hydrogel ECM Technology." This requires no exogenous crosslinkers and creatively achieves compatibility between wet heat/radiation sterilization processes and self-crosslinking mechanisms. The technology effectively solves common industry problems of protein denaturation and fiber network collapse during traditional sterilization. The product features stable, uniform pore structures and excellent elastic mechanical properties, with core amino acid sequences fully homologous to human collagen, demonstrating superior biocompatibility.

Intellectual Property Moat: Dual Patents Seizing Global High Ground
While securing the medical device registration certificate, LivingPHOENIX reached another milestone in protecting core technologies. Recently, two invention patents—"A Triple-Helix Biomimetic Collagen Self-Crosslinking Hydrogel, Extracellular Matrix Based on Wet Heat Sterilization Process, Preparation Method, and Use" and "A Similar Material Patent Based on Radiation Sterilization Process"—were granted by the CNIPA at super-high speeds of 37 and 39 working days, respectively. According to Dr. Sun Yunmou, Inventor and Deputy Chief Physician of Plastic Surgery at Peking University Third Hospital, the triple-helix structure of collagen drives tissue evolution as a key feature of ECM. This characteristic makes it an ideal hydrogel substrate for simulating human microenvironments, supporting cell growth, and building healthy tissues in regenerative medicine and tissue engineering. Animal model experimental data confirmed: triple-helix biomimetic collagen hydrogel materials showed no obvious inflammatory reactions, and their effect on promoting collagen deposition and regeneration was significantly superior to existing marketed animal-derived and recombinant collagen hydrogel products, providing solid data support for clinical translation of Class III medical devices.

CNIPA patent examiners visited LivingPHOENIX for technical practice on October 12 and June 8; Chengdu Intellectual Property Protection Center patent pre-examiners also conducted a technical practice visit.

These two invention patents are the world's only core patents for third-generation triple-helix biomimetic collagen hydrogels following animal extraction and gene recombination. They conquered the global challenge of "Sterilization vs. Structure Retention," achieving self-crosslinking through wet heat/radiation sterilization without adding exogenous crosslinkers. This efficient authorization process not only secured valuable time windows for the enterprise but also provided solid legal protection for seizing the global high ground in third-generation biomimetic collagen ECM regenerative materials. Currently, the company has filed 8 Chinese invention patents and 6 PCT international patents, with its innovation value recognized twice through specialized surveys by the CNIPA.

Full-Range Product Portfolio: Broad Prospects from Barrier Repair to Brain-Computer Interfaces
Relying on its proprietary third-generation Triple-Helix Biomimetic Collagen-Based ECM platform, LivingPHOENIX has built a tiered product matrix covering Class II medical devices, functional cosmetics, Class III aesthetic medical devices, and implantable Class III devices. This matrix aligns precisely with the high-end "Device-Cosmetics Fusion" system of international leading enterprises in terms of dosage form richness and application scenarios, forming a full-scenario regenerative medicine ecosystem from consumer healthcare to clinical treatment.

1. Solutions & Lyophilized Fibers: Deepening Aesthetic Skincare, Establishing the "Third-Generation Benchmark"
This pipeline focuses on skin barrier repair and anti-aging management, building a "Barrier Native" full-range dressing portfolio.

• Compliance Landing: The newly certified "Sterile Biomimetic Collagen Dressing" is the first Class II medical device registration certificate. Seven other products—including liquid dressings, repair dressings, scar gels, and gynecological gels—are expected to complete certification by December, achieving a global first launch of 8 medical-grade dressings.
• Technical Efficacy: Utilizing triple-helix biomimetic collagen scaffolds to guide orderly cell regeneration, epidermal repair efficacy leaps multiple times, significantly shortening healing cycles and preventing scars and pigmentation.
• Market Validation: The functional skincare brand "SMARTENDER®" was officially launched at the 2025 Import Expo, validated by real-world data from 25,000 cases for safety and efficacy, establishing itself as a benchmark mega-product of the third generation following recombinant collagen. At the 19th Europe-China Business and Technology Cooperation Fair, the system received high praise from European customers, fully validating international market acceptance.

2. Hydrogel ECM: Deploying Implants & Brain-Computer Interfaces, Seizing Frontier Tech High Ground
Compared to topical products, hydrogel-form biomimetic collagen ECM possesses higher biological activity and structural support power, pointing toward more disruptive clinical applications.

• Class III Implant Industrialization: Experimental data from Peking University Third Hospital shows that self-crosslinking triple-helix biomimetic collagen gel demonstrates significantly superior collagen regeneration effects in the dermal papillary and reticular layers compared to existing marketed products. The enterprise plans to invest tens of millions of yuan to build production bases, accelerating Class III device registration and commercialization in gynecology, filling implants, and aesthetic skin booster injections.
• Brain-Computer Interfaces & Tissue Engineering: As a future strategic high ground, LivingPHOENIX's acellular human-derived scaffold offers triple safety guarantees: "Zero Animal Source, Zero Fermentation Residue, Zero Exogenous Crosslinker." By precisely matching brain tissue mechanical characteristics, the material effectively inhibits glial scar formation, providing an ideal solution for flexible BCI electrode coatings and composite conductive scaffolds. Currently, the company has jointly applied with universities for the National Natural Science Foundation of China's 2026 Major Research Plan, exploring innovative applications in diabetic wound repair.

Industry Outlook: The Arrival of the Biomimetic Collagen Era
As the main component of ECM, competition in the collagen industry has upgraded from initial "Source Battles" to today's "Comprehensive Structural and Functional Competition."
Data shows that Allergan strategically abandoned the recombinant collagen route Collplant, while Stuart Corp's biomimetic synthetic collagen performed excellently in clinical trials, securing exclusive licensing partnerships with multiple giants. LeadLeo Research Institute data indicates the biomimetic collagen sector's compound annual growth rate reaches 484%, with the Chinese market projected to reach ¥6.778 billion by 2030. This demonstrates that global capital and technology are converging toward biomimetic collagen with authentic triple-helix structures.
LivingPHOENIX's practice proves that when material R&D shifts from "Prepare then Verify" to "Define Needs then Reverse Design," regenerative medicine gains a new paradigm. In the future, whoever first connects the complete chain from molecular design, material engineering, clinical translation to standard establishment will hold the discourse power of the next-generation collagen industry.

One registration certificate, two core patents, one global competition award. The rise of LivingPHOENIX at Tianfu International Bio City in Chengdu is not just a victory for an enterprise, but a microcosm of China's original innovation in biomedicine. As biomimetic collagen formally enters the new stage of "Designed Collagen," we have reason to believe that this advanced technology originating from China will play a key role in reshaping the global regenerative medicine landscape.

About LivingPHOENIX | World First • China's First Certificate
LivingPHOENIX globally pioneers the third-generation Triple-Helix Biomimetic Collagen-Based Extracellular Matrix (ECM) following animal extraction and gene recombination. It has applied for 8 Chinese invention patents (6 granted) and 6 PCT international patents, recognized by the CNIPA through two consecutive surveys. The materials drive leaps in epidermal repair efficacy and doubling of dermal collagen deposition regeneration using "Stable Triple-Helix Structural Collagen" scaffold materials. Covering solutions, lyophilized fibers, and hydrogels, it supports terminal sterilization for sterile safety assurance. The project won accolades including Top 10 Pharma Health in Maker China, Champion in Startup Group and Runner-up in Growth Group at Sichuan Finals of China Innovation and Entrepreneurship Competition, and Third Prize at Golden Panda Innovation and Entrepreneurship Competition. It advanced to the national semi-finals of the Biomanufacturing Competition and Top 10 finals of the Golden Panda High-Value Patent Cultivation Competition. LeadLeo Research predicts the Chinese market size will reach ¥6.778 billion by 2030. LivingPHOENIX is accelerating the reshaping of the global regenerative medicine industrial landscape with its posture of "World First, China's First Certificate."

SOURCE LivingPHOENIX