Pashion Bio Files IPO Prospectus: A Pioneer in Collagen-Based Regenerative Medical Devices with Multiple NMPA-Certified Products

From reviewing others’ medical devices to launching his own venture in the sector, Dr. Zhang Ziqiang, founder of Pashion, has undergone a professional transition from “reading stories” to “writing them.”

“Pashion”—“Passion”: Founder Dr. Zhang Ziqiang and his team deliberated for a considerable period when naming the company, ultimately deciding to adopt a homophone of the English word “Passion” as the corporate name, symbolizing the team’s surging entrepreneurial passion. Pashion Group, fully known as Beijing Pashion Biotechnology Co., Ltd., is a medical device enterprise dedicated to the research and development, manufacturing, and sales of regenerative medical materials based on collagen.

When discussing the original intention behind his entrepreneurial venture, Zhang Ziqiang’s academic and professional experiences played a significant role. During his academic years, he majored in biology and received an offer as a visiting scholar at the Cancer Research Center of the University of Texas in the United States while pursuing his combined bachelor’s and master’s degrees. He declined the offer for personal reasons and continued his work and doctoral studies in China. Throughout his career, in addition to serving in medical device companies where he was responsible for production and R&D, Zhang also spent many years working for TÜV, a prestigious German certification agency, focusing on medical device certification. Many well-known products from leading Chinese medical device giants obtained the widely recognized EU CE marking only after being reviewed by Zhang, thereby enabling their export to Europe.

“Of course, it is a process of observing stories,” said Zhang Ziqiang modestly. “I provide services to medical device companies.” He added, “In the course of my work, besides well-known industry players, I have also served many startups. Some of them have undergone significant transformations over two or three years and achieved remarkable success.” Having reviewed hundreds of domestic medical device companies during his career, Zhang Ziqiang planted the seed of entrepreneurial ambition in his heart. Compared with the ease of “observing stories,” Zhang, now past the age of thirty, felt that participating in creating stories was the life he truly desired, even though he knew full well it would by no means be easy.

As a seasoned industry veteran, Zhang Ziqiang’s career has paralleled the development of China’s medical device sector, bearing witness to the evolution of its industry standards. “The certification standards for domestic product approvals are largely adopted from international counterparts. On the surface, the gap has narrowed significantly, with certain even exceeding those in Europe and the United States,” Zhang stated candidly. “However, some underlying concepts in China still lag behind those in Western countries.”

Repeated audit experiences have not only broadened Zhang Ziqiang’s international perspective but also deepened his understanding of the medical device sector, given his background in the research, development, and production of biomaterials. He recognizes that the quality of regenerative medicine products hinges on foundational materials, with scaffold materials playing a pivotal role in biological tissue repair. To pursue his aspirations with greater conviction, Zhang Ziqiang decisively resigned from his well-compensated position at a multinational corporation. Building on his extensive frontline experience in the R&D, manufacturing, and regulatory review of medical devices, he chose to further specialize in his master’s and undergraduate research focus by pursuing a Ph.D. in biomaterials.

During his doctoral studies, Zhang Ziqiang balanced scientific research with preparations for entrepreneurship. Many advised him to establish a medical project consulting firm, suggesting it would be a quicker path to profit without the burdens of physical manufacturing. Zhang did hesitate. Indeed, given his extensive experience in reviewing medical devices both domestically and internationally, launching a medical device consulting company would undoubtedly have been the “most comfortable” choice. With new medical device enterprises springing up like mushrooms after rain, the market demand for consulting services was high, and clients paid generously and promptly. However, he recalled his original aspiration: not to remain a mere “spectator,” but to immerse himself in creating something tangible. “Stay true to your original mission! Build products!” Zhang Ziqiang made up his mind.

After the establishment of Pashion, the company initially planned to launch its first product: a biomedical collagen hemostatic material for abdominal surgery, designed to manage severe internal bleeding. This area was characterized by high technical barriers, a market dominated by imports, and a scarcity of comparable domestic products. Although the necessary technological expertise had long been accumulated, Zhang Ziqiang carefully weighed various factors, including the lengthy clinical trial cycle for general surgical biomedical collagen hemostatic materials, the market environment, potential changes in future national medical insurance policies, and the company’s constrained initial capital—despite having invested his life savings. Leveraging his extensive experience in medical device regulatory review, Zhang decided to conduct a thorough and prudent selection process for Pashion’s inaugural product.

After drawing on past experience and conducting extensive market research, Pashion has gradually zeroed in on the oral care sector—a field that has garnered increasing attention and willingness to spend as living standards improve. Specifically, Pashion is targeting several niche segments of collagen products for oral surgical procedures. These segments are just beginning to see significant volume growth, are currently dominated by foreign brands with relatively high prices, and thus offer substantial potential for import substitution. Furthermore, the robust development of both public and private medical institutions in the oral care sector helps mitigate risks associated with reliance on a single type of public hospital. This presents a prime opportunity for Pashion, which specializes in collagen-based materials.

Collagen is widely distributed in the human skin, oral cavity, and gastrointestinal tract, with different collagen structures corresponding to distinct functions. Pashion’s telopeptide-free collagen is extracted from animal sources and subsequently processed to remove telopeptides, yielding telopeptide-free collagen. Leveraging this as a platform, structurally designed medical products with diverse functions and indications are developed to meet clinical application needs. This constitutes the core technology of Pashion, representing the culmination of Zhang Ziqiang’s extensive hands-on experience in the research and development, manufacturing, and regulatory review of medical devices, as well as his academic research achievements accumulated throughout his bachelor’s, master’s, and doctoral studies.

“Telopeptide-Free Collagen” produced by Pashion using its core technologies exhibits excellent immunogenicity properties. To meet the industry’s highest standards for immunological risk, Pashion Group invested nearly one million yuan solely on a single immunogenicity risk assessment. The test results showed no detectable immunogenicity risk in Pashion’s collagen products—the most favorable outcome possible—marking that this technology has reached a leading level within China.

In 2015, the company focused its R&D efforts on oral soft tissue filler products and oral tissue barrier membrane products. The oral soft tissue filler series includes various forms of porous materials, such as collagen plugs, collagen sheets, collagen blocks, collagen matrix covers, and collagen matrix flaps, which can be applied in multiple oral scenarios including post-extraction care, alveolar ridge reconstruction, and socket preservation.

Oral Soft Tissue Filler Products and Oral Tissue Barrier Membrane Products

Notably, the products in this series obtained Class III medical device certification from the National Medical Products Administration (NMPA) in April 2019 and are now commercially available.

Pashion’s other oral collagen product, a “guided bone regeneration membrane,” is positioned as the company’s future blockbuster. When used over bone graft material during dental implant procedures, this membrane helps stimulate bone regeneration. The product has completed clinical trials and is expected to receive regulatory approval around late 2019.

Zhang Ziqiang candidly stated that for startups, innovation is necessary, but survival is even more critical. The certification process for Class III medical devices takes several years. How could Pashion secure a reliable source of funding, in addition to external capital, during this extended period? Pashion’s approach was to explore multiple options and make careful selections, ultimately choosing a product line capable of rapid commercialization.

The telopeptide-free collagen produced using the company’s core technology serves as a “platform” with the capacity to develop a variety of downstream products. In addition to researching and developing oral care products, Pashion has leveraged its collagen technology to establish two new product lines: facial skin repair and veterinary healthcare. Given the vast size of the beauty market, collagen offers numerous applications in this sector. Pashion has already launched several products, which have not only generated favorable returns for the company but also helped spread various costs across multiple offerings. Furthermore, this strategy has strengthened the organization’s capabilities in multi-project management and multi-product marketing across all departments and teams. In summary, this decision has provided strong support for the company’s early-stage survival and growth.

Zhang Ziqiang stated that the company will further strengthen its product portfolio in dental medical care over the coming period. He explained that collagen products for oral surgery have been gradually launched, with more blockbuster products to follow. As a startup, Pashion needs to maintain focus and concentrate on developing its core products during the early stages of growth. Therefore, Pashion initially aims to become a benchmark enterprise for collagen-based products in the field of oral surgery. When the time is right in the future, it will expand into other areas, such as hemostasis in major surgeries and bone repair in orthopedics.

Pashion is committed to becoming a top-tier player in China’s collagen regenerative medicine sector. To date, the company has filed more than 20 national invention patents and has earned certifications and honors including National High-Tech Enterprise, Zhongguancun Golden Seed Enterprise, Zhongguancun Life Science Park High-Tech Enterprise, and Zhongguancun High-End Medical Device R&D and Registration Platform.

It is reported that Pashion has completed its angel and Series A funding rounds and has launched a new round of financing. The proceeds from this new round are planned to be used for new product development, marketing, and production expansion.