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Tigermed-Jyton Supports Approval of First PCL Product for Temporal Region

Recently, Sinclair announced that its injectable polycaprolactone (PCL) microspheres facial filler, Ellansé® Type M, has officially obtained market approval from the National Medical Products Administration (NMPA) for the improvement of mild-to-moderate temporal hollowing in adults. Notably, this product is the first PCL product approved by the NMPA for the temporal region, and Tigermed-Jyton provided clinical research services that supported the successful market approval of this product.

(Image source: official website of the National Medical Products Administration)

Ellansé® Type M: Durable Activation of Ordered Collagen Regeneration for Safe and Effective Facial Contouring

Ellansé® consists of polycaprolactone (PCL) microspheres and a carboxymethyl cellulose (CMC)-based gel carrier. Its mechanism of action involves immediate contouring via rapid CMC-based volume restoration, followed by PCL-induced neocollagenesis, which rebuilds the collagen scaffold to achieve natural, safe, and long-lasting aesthetic improvement. Both PCL and CMC offer excellent biocompatibility, delivering reliable and natural outcomes. Ellansé® is currently registered or approved for marketing in over 60 countries and regions, with 16 years of global clinical use, and its clinical safety and efficacy have been widely recognized.

The approved Ellansé® Type M durably activates the ordered regeneration of endogenous collagen (particularly Type I collagen), providing enhanced deep structural support and achieving a lifting effect. This further meets the growing demand for refined, long-lasting natural results and offers an optimized solution for precise facial contouring. In China, a clinical trial titled "A Study to Evaluate the Safety and Efficacy of Injectable Polycaprolactone Microsphere Facial Filler in the Improvement of Temporal Hollowing" was conducted and completed, demonstrating favorable efficacy and safety of the product.

Tigermed-Jyton: Efficient Enrollment - Safe, Reliable, and Traceable Data Ensured

From clinical trial initiation to final approval, Tigermed-Jyton, as the clinical research organization (CRO), worked closely with the sponsor to overcome multiple challenges, ultimately achieving this success.

During project execution, the Tigermed-Jyton team demonstrated exceptional collaboration efficiency and professional expertise. Subject enrollment was significantly accelerated owing to the team's efficient efforts, which further secured valuable time for follow-up and regulatory submission. Throughout the clinical trial, Tigermed-Jyton actively assisted the sponsor in expert meetings organization, efficiently coordinated responses to regulatory queries, continuously monitored long-term subject safety, effectively managed the SMO team, maintained high subject compliance, and ensured that every piece of data was complete, authentic, and traceable. From the last subject's study completion to CSR stamping, the entire process was completed in a timeframe far shorter than the industry standard — reflected not only the team's execution efficiency but also its end-to-end project management capability.

After project completion, Tigermed-Jyton received a letter of appreciation from the sponsor’s clinical research team:

This letter represents the highest recognition and encouragement for the Tigermed-Jyton team.

The successful approval of Ellansé® Type M marks not only a significant milestone for Sinclair in the Chinese market but also another outstanding example of Tigermed-Jyton’s clinical research excellence in the aesthetic medicine field. Going forward, Tigermed-Jyton will continue to uphold its service philosophy of "Service Creates Value," helping more medical device products accelerate their market entry and contributing professional expertise to Healthy China.

About Sinclair

Sinclair, founded in the UK in 1971, has nearly 50 years of scientific expertise and continues to grow rapidly in the global market. Today, it has become a global innovative aesthetic medicine company integrating R&D, manufacturing, sales, and services. Sinclair has established a strong, differentiated, and complementary product portfolio across injectables, energy-based devices, and beauty spa (INJECTABLE, EBD & BEAUTY SPA). From regenerative injectable dermal fillers Ellansé® (Types S and M) and the innovative premium hyaluronic acid Mai series, to energy-based device brands Reaction and V20/30 series, and further to lifestyle beauty devices such as Coolifting (a non-invasive cooling beauty device) and the next-generation facial cleansing device Préime Derma Facial, the company is committed to providing "one-stop" solutions that deliver effective, long-lasting, high-quality, and natural-looking results for aesthetic seekers.

Since its inception, Sinclair has focused on the development of high-quality aesthetic medical products, with six innovation centers worldwide (Chester, UK; Almere, Netherlands; Lyon, France; Geneva, Switzerland; Barcelona, Spain; and Israel). Leveraging strong technological capabilities and access to cutting-edge industry insights, Sinclair enhances its product development advantages. Supported by a robust global operating platform, its commercial reach extends to over 80 countries and regions. Adhering to the brand philosophy of "putting the aesthetic seeker at the core," the company collaborates closely with global medical experts and continuously expands its product portfolio. In the future, Sinclair will continue to introduce more innovative products, offering richer and more diverse aesthetic experiences to an increasing number of Chinese consumers.