Hengyu Biopharma Advances with Full-Chain Self-Developed Marine-Derived PDRN Class III Medical Device Entering Clinical Trials

Yesterday, Hengyu Biopharmaceuticals (Shandong) Co., Ltd. and its subsidiary Zhengyu Biotechnology (Hainan) Co., Ltd.（hereinafter referred to as“Hengyu Biopharmaceuticals”“Hainan Zhengyu Biotechnology”）officially announced its independently developed marine-derivedPDRN (Polydeoxyribonucleotide) No.ⅢThe Class [X] medical device product has successfully passed the national multi-center ethical review and has fully entered the clinical trial phase.

This progress not onlyRichdomestically producedPDRNⅢClassMedical DeviceThe competitive landscape of the sector has further propelled the industry to take a critical step toward the goals of technological self-reliance and domestic substitution.

PDRN, as a core segment in the field of novel marine-based medical materials, is ushering in a historic opportunity for development. Authoritative market research data indicates that the global market size for PDRN-related products is projected to exceed RMB 10 billion in 2025, with medical-grade products accounting for over 40% of the total. This highlights a vast market landscape and significant growth potential.

The market is exhibiting a robust momentum driven by the dual engines of “consumer demand” and “medical applications.” On the consumer front, international premium brands such as Lancôme and L’Oréal, along with numerous best-selling domestic brands, have actively launched PDRN-based flagship products, underscoring strong market acceptance and significant demand potential. On the medical front, Hainan Zhengyu Biotechnology is accelerating clinical trials for its independently developed domestic products, while simultaneously facilitating the expedited introduction of foreign PDRN pharmaceuticals through the Boao Lecheng International Medical Tourism Pilot Zone. These efforts are establishing a medical product ecosystem for China’s Class III PDRN medical devices that integrates local innovation with a global perspective.

Currently, the “first tier” of domestic Class III medical device registration applications for PDRN has formed a concerted force to tackle key challenges. In addition to Hengyu Biopharmaceutical and Hainan Zhengyu Biotechnology, Lepu Medical and Jiangsu Wuzhong are also actively advancing the registration of related products, with all having entered the critical phase for certificate approval.

The breakthrough path of Hengyu Biopharmaceuticals and Hainan Zhengyu Biotechnology serves as a microcosm of the industrialization of domestically produced PDRN. From achieving breakthroughs in raw material technology to the rise of industrial clusters, and from isolated advancements to leadership across the entire value chain, these companies have gradually established a comprehensive, independent R&D system encompassing core source material technologies, formulation development, and efficacy validation, thereby achieving full control over all critical links.

Currently, Hengyu Biopharmaceutical and Hainan Zhengyu Biotechnology have three PDRN Class III medical device products in the application process (Acceptance Numbers: YX20240108, YX20240081, N20221031), demonstrating strong momentum with simultaneous progress across all three devices.

In terms of technological layout, Hengyu Biopharmaceuticals and Hainan Zhengyu Biology have completed a patent matrix spanning from raw material extraction to Class III medical device formulations. The master file registration for device raw materials has been successfully approved, and related technical achievements have repeatedly won gold awards at international technology innovation competitions, establishing a distinctive path for technological innovation and industrial development. At the capital level, the company received joint investment from two major state-owned capital entities at the provincial and municipal levels in late 2024. This not only reflects high recognition from the capital market of its technical strength and industrial prospects but also provides solid support for its subsequent R&D and clinical trials.

As clinical trials advance comprehensively, whether the fully in-house R&D model will take the lead and which company will ultimately secure the first Class III medical device approval for domestically produced PDRN have become focal points of sustained industry attention. In any case, China’s PDRN industry is writing a new chapter in domestic substitution, using independent innovation as its pen and industrial collaboration as its ink. In the future, the market launch of more domestically produced Class III PDRN medical devices will reshape the global market landscape, achieve domestic substitution, extend the benefits of marine biotechnology to a broader population, and open up new blue-ocean opportunities in niche fields such as cellular repair, thereby driving the marine industry toward autonomous, high-end development.