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Tigermed-Jyton Supports China NMPA Approval of Aqualuna® ECM Filler

On August 31, Bloomage Biotech's Cross-linked Sodium Hyaluronate Gel for Injection (Aqualuna® ECM injectable) was officially granted marketing authorization by the National Medical Products Administration (NMPA). This product is the first China produced composite nutritional filler specifically designed for extracellular matrix (ECM) homeostatic repair. It is indicated for injection into the mid-to-deep dermal layers of the perioral region to improve moderate-to-severe static perioral wrinkles in adults. Tigermed-Jyton provided end-to-end clinical trial services for this product.

(Image source: National Medical Products Administration)

As Cell identifies ECM alteration as a hallmark of aging, and Biomaterials underscores the critical importance of ECM homeostasis, Bloomage Biotechnology leverages its robust fundamental research and industrial‑scale manufacturing capabilities to launch the Aqualuna® ECM injectable.

Positioned centrally around "ECM homeostasis restoration," this product breaks through the homogenization of traditional anti‑aging pathway targets, delivering a comprehensive upgrade in both anti‑aging concepts and scientific technology.

Built upon rigorous synthetic biology research—not as a mere addition or subtraction of ingredients, but through a specific scaffold architecture identified from tens of thousands of anti‑aging gene sequences (RNA‑seq transcriptomics)—the Aqualuna® ECM injectable features a native biomimetic scaffold that closely mimics natural ECM. By restoring ECM architecture via this native ECM scaffold structure, it activates the collagen synthesis switch and establishes a fully closed‑loop system for ECM homeostasis restoration that integrates structural, signaling, and nutritional dimensions. Concurrently, stringent R&D provenance ensures utmost product safety, with no immunogenicity risk, pathogen contamination, or other safety concerns.

The core composition—ultra‑low cross‑linked hyaluronic acid (HA), a multi‑amino acid complex, and lidocaine—delivers sustained efficacy for up to 3 months, ensuring reliable outcome delivery. The lidocaine component provides anesthetic comfort and rapid recovery, while the product exhibits excellent injectability (smooth push‑force) and high tissue compatibility, minimizing adverse reactions such as wheals or papules.

When combined with a hydrodynamic delivery system, the Aqualuna® ECM injectable achieves holistic skin improvement across multiple dimensions: tactile (smoother texture), optical (brighter and whiter appearance), and mechanical (tighter firmness upon palpation). It concurrently addresses volumetric filling support and dermal matrix microenvironment enhancement, thereby disrupting the conventional single‑approach paradigm of volumetric filling that has long dominated the domestic anti‑aging market.

In the full-service clinical trial process for Aqualuna® ECM injectable, the Tigermed-Jyton team successfully overcame three core challenges, owning to deep expertise in the medical aesthetics field and outstanding project management capabilities.

First, given the practical difficulty that the target enrollment population for perioral wrinkles tended to be older in age, whereas Chinese subjects generally present with relatively mild perioral wrinkles, the team rapidly formulated and executed a precise, integrated online+offline recruitment strategy. Through multi‑channel promotion and in‑depth collaboration with multiple investigational sites and investigators nationwide, they ensured that both enrollment timelines and subject quality met the required standards under stringent screening criteria.

Second, the critical execution phase of the project coincided with the COVID‑19 pandemic, which imposed substantial constraints on on‑site monitoring, participant follow‑up, and multi‑center coordination. Leveraging mature standard operating procedures (SOPs) and a flexible remote management framework, the team efficiently coordinated resources across regions while strictly adhering to GCP standards, thereby ensuring that all trial data throughout the entire process remained authentic, complete, and traceable.

More crucially, as the first China maded compound nutritional product targeting perioral ECM homeostasis restoration, this product’s clinical trial had no established precedents to follow—from injection technique control and endpoint determination to overall study design. The Tigermed‑Jyton team engaged in intensive and iterative discussions with the sponsor, conducting scientific reasoning from the ground up to establish a unified multi‑center operational standard and trial framework. Through multiple rounds of testing and rigorous quality control, they ultimately generated high‑quality, high‑credibility clinical data, providing solid support for the product’s successful regulatory approval and market launch.

In the future, Tigermed-Jyton will continue to uphold its core philosophy of “Service Creates Value,” accelerating the market approval and launch of more products, while consistently delivering professional expertise to contribute to the world healthcare.

About Bloomage Biotech

Founded in 2000, Bloomage Biotech is a world-leading biotech and biomanufacturer enterprise. We were the first company, worldwide to achieve industrial-scale production of hyaluronic acid (HA), a core anti-aging ingredient, and have maintained a leading global market position for years. Building on our strengths in HA R&D, we conduct advanced research in glycobiology and cell biology. Leveraging the world’s largest synthetic biomanufacturing platform, Bloomage Biotech is committed to translating life science research into practical applications in aging intervention, tissue regeneration, and related fields. We have developed an integrated solution spanning from raw materials to finished products, covering pharmaceuticals, medical aesthetics, nutrition science, and skin science. Our brand portfolio includes BIOHYALUX, QUADHA, MedRepair, Bio-MESO, and Bloomage Health. Guided by our mission to “Make every life vibrant,” we continuously advance the health and beauty industries.

References:

1.      Aqualuna 's official WeChat account 2026/9/1 《Aqualuna® ECM injectable has received regulatory approval, marking Bloomage Biotechnology's successful implementation of compliant productization practices for ECM-based aging intervention.》https://mp.weixin.qq.com/s