Home PuJu Bio Submits IPO Prospectus Highlighting Differentiated Anti-Aging Solutions and Proprietary CaHA-Based Regenerative Filler Rejuve

PuJu Bio Submits IPO Prospectus Highlighting Differentiated Anti-Aging Solutions and Proprietary CaHA-Based Regenerative Filler Rejuve

Oct 08, 2024 09:58 CST Updated 09:58

The medical aesthetics industry in China has witnessed rapid market growth. The midlife crises experienced by the post-1980s and post-1990s generations, coupled with the consumption awakening of the post-2000s generation, have jointly driven the booming development of the sector. According to the "2023 Annual Insight Report on China's Medical Aesthetics Industry," the domestic market size for medical aesthetics exceeded RMB 200 billion in 2023.


As the medical aesthetics industry flourishes, differentiated anti-aging demands and product positioning have also emerged amid intensifying competition: Human skin generally begins to age gradually after the age of 25, with more noticeable signs of aging appearing around age 35, and accelerated aging occurring after age 45. Therefore, treatment protocols vary according to different age groups.


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Image source: Puju Bio


Therefore, varying degrees of aging correspond to differentiated clinical efficacy requirements. At the initial stage of product design and research and development in medical aesthetics, it is necessary to precisely design and regulate various performance attributes—such as degradation control, regeneration induction, supportiveness, functionality and longevity, biocompatibility and safety, ease of implantation and storage, as well as immediate effects and tactile properties—according to the positioning of different products. Underpinning this “performance” design are stringent requirements for material selection, combination strategies, and processing techniques.


Driven by strong market demand and industry opportunities, Puju Bio was established. Puju Bio focuses on building an engineering process platform for bioactive filler materials, dedicated to continuously launching globally leading high-end regenerative medicine products to benefit a wide range of aesthetic seekers, and providing new material solutions for medical aesthetic anti-aging across all age groups.


Regenerative Materials Emerge as a New Blue Ocean Market: Transitioning from the “Filler Era” to the “Regenerative Era”


Prior to 2023, injectable collagen dominated the global market for medical aesthetic dermal fillers. For the subsequent two decades, hyaluronic acid largely supplanted collagen as the market leader, owing to its rapid and long-lasting lifting effects, enhanced safety profile, and simple injection technique. However, following the approval of products such as Ellansé (“Girl’s Needle”) and Sculptra (“Youthful Face Needle”) by China’s National Medical Products Administration (NMPA) in 2021, the Chinese injectable aesthetics industry has entered a new era of “regenerative repair.”


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Data Source: Global Dermal Facial Fillers Market OutlookImage courtesy of Puju Bio


Among regenerative materials, calcium hydroxylapatite (CaHA)-based products are highly favored by aesthetic patients due to their potent immediate filling effect and ability to induce tissue regeneration. Furthermore, the release of calcium ions during degradation promotes the restoration of elasticity in surrounding dermal tissues, resulting in more natural and youthful-looking outcomes. Consequently, sales of Radiesse, manufactured by Germany’s MERZ Aesthetics, have grown year over year, with annual sales exceeding one million units.


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Image source: Puju Bio


The True and False Monkey King


The immense market potential has attracted a flood of “gold rushers” into the industry, while the lack of regulation has resulted in a chaotic landscape with mixed quality. Currently, the annual number of CaHA-based medical aesthetic injections in China is conservatively estimated to exceed 100,000 units. However, as of now, there is not a single compliant Class III medical device registration certificate nationwide that has been approved specifically for injectable dermal fillers used in medical aesthetics.


Admittedly, hydroxyapatite is a well-established material that has been widely used in the field of synthetic bone grafts. However, while the wording of the scope of application or intended use varies slightly among the registration certificates for approved hydroxyapatite-based synthetic bone products, they all explicitly state “filling of bone defects.” Clearly, aesthetic medical filling does not fall within this category.


Traditional hydroxyapatite artificial bone products feature a loose, porous structure with pore sizes of 40–200 μm and porosity of 60–70%. This structure exerts biological effects that induce the differentiation of autologous mesenchymal stem cells into osteoblasts in vivo (osteoinduction), thereby achieving autologous bone regeneration and healing at sites of bone defects. However, applying such products for medical aesthetic filling can lead to severe subcutaneous bony nodules that are difficult to remove, resulting in serious medical adverse events.


Furthermore, traditional hydroxyapatite artificial bone products mostly feature non-spherical, irregular structures. On one hand, these structures are not readily phagocytosed by autologous macrophages, resulting in prolonged degradation times and poor collagen-inducing capacity. On the other hand, such structures are difficult to disperse uniformly within compounded gels, leading to poor homogeneity of components injected into the face and low cytocompatibility and histocompatibility, thereby impairing regenerative induction capability and increasing the potential risks associated with injection.


Based on this, Puju Bio has established a multi-form inorganic material preparation technology platform capable of meeting the diverse morphological requirements of various products. Notably, the company’s platform, centered on nano-scale calcium phosphate salts, enables precise control over microsphere structures and particle size distribution while effectively removing pyrogens and other impurities. Consequently, key performance indicators of Rejuve, the company’s CaHA-based medical aesthetic injectable filler—such as microsphere uniformity and viscoelastic properties—are either superior to or highly consistent with those of Radiesse.


Currently, nearly 200 subjects have been fully enrolled in the registrational clinical trials for the company’s Rejuve product, with follow-up data exceeding six months. The results to date consistently demonstrate the product’s robust immediate filling effect, regenerative induction capacity, and long-term safety.

 

Dedicated to Becoming a Provider of New Material Solutions for Anti-Aging Medical Aesthetics Across All Age Groups


In addition to Rejuve, a hydroxyapatite-based facial filler, the company has developed a portfolio of surgical and injectable products tailored to the treatment needs of patients at different stages of aging. These products have all completed preliminary R&D and finalization, and are scheduled to enter clinical trials sequentially over the coming year.


The company’s core founding management team comprises seasoned veterans of the medical device industry, each with over 20 years of experience in the traditional medical device sector. Mr. Yue Shurong, the founder, previously served for ten years as General Manager of a leading R&D and manufacturing enterprise in the biomaterials field. During his tenure, he led or participated in multiple National Key R&D Programs and biomedical innovation R&D projects funded by the Shanghai Municipal Science and Technology Commission.


In early 2024, the company completed a Series A financing round worth tens of millions of yuan, invested by Mifang Health Fund, with Tunan Capital serving as the exclusive financial advisor. Following the financing, the company fulfilled its commitments by completing patient enrollment and follow-up for the registered clinical trials on schedule.


Zhou Yujian, Managing Partner of Mifang Health FundStatement: In the current era, where anti-aging awareness is awakening among middle-aged and young adults, Mifang Health Fund remains firmly optimistic about the development potential of the medical aesthetics industry and the competitive advantages of regenerative filler materials. The Puju Bio team’s over 20 years of industry expertise and its proprietary technological platform have laid a solid foundation for the company’s rapid growth. Excellent clinical trial data have instilled in us full confidence in Puju Bio’s future, and we look forward to the company providing safer and more effective anti-aging solutions to a broad base of beauty-seeking consumers in the near future.


Yue Shurong, Chairman of Puju BioStatement: Puju Bio expresses its gratitude to Mifang Health Fund and the company’s other shareholders for their support and companionship. Guided by its mission of “Shaping Better Lives Through Technology,” Puju Bio is committed to continuously launching globally leading, high-end regenerative medicine material products to benefit a broad base of aesthetic seekers.


Puju Bio plans to initiate a new round of financing in the near future to support the commercial promotion of Rejuve products and the regulatory registration of other pipeline products.