On June 9, Huadong Medicine (000963.SZ) announced that its application for a new indication for Ellansé® S - type , an imported Class III medical device injectable polycaprolactone microsphere facial filler , for subcutaneous or suprapeophyte implantation in the forehead to improve moderate to severe forehead contour defects, has been formally accepted by the National Medical Products Administration (NMPA). This application is expected to expand its scope from nasolabial folds to the forehead contour area, strengthening the company's multi-indication competitive advantage in the PCL regeneration field and enriching its supply of refined facial anti-aging solutions, further releasing the product's clinical value.

Ellansé® is one of the core products of Huadong Medicine Aesthetics , and is known as the " Youthful Needle" due to its outstanding triple effect of "immediate filling + long-lasting maintenance + natural metabolism". As the first approved imported PCL high-end facial filler in China, the application for a change of indication for Ellansé® S -type has been accepted. By expanding to the delicate area of the forehead, it synergizes with existing indications and strengthens the multi-indication layout competitiveness of the regenerative filling matrix, which is expected to bring a more comprehensive and precise forehead rejuvenation solution to domestic beauty seekers.

01 The regenerative medicine field welcomes a major new member, which is expected to lead a new trend in forehead filling.

The announcement states that Ellansé® is composed of polycaprolactone (PCL) microspheres and carboxymethyl cellulose (CMC) gel carrier. PCL and CMC have good biocompatibility, resulting in natural, safe , and reliable effects. Its mechanism of action involves rapid filling and immediate shaping via CMC, followed by stimulation of collagen regeneration at the injection site via PCL microspheres, reshaping the collagen scaffold and delivering natural, safe, and lasting aesthetic improvements.

Ellansé® S - type is the first imported high-end PCL facial filler in China to obtain NMPA Class III medical device certification, and it was officially launched in China in August 2021. The addition of forehead filling as an indication is strongly supported by a prospective, multicenter, randomized, uncontrolled, assessor-blinded, superiority clinical trial conducted and completed in China to evaluate the efficacy and safety of injectable polycaprolactone microsphere facial fillers for improving forehead contour. Data shows that the product has good efficacy and safety in improving forehead contour.

According to the "Blue Book on the Development Status and Future Trends of the Medical Aesthetic Injectable Products Industry" published by Frost & Sullivan, non-surgical medical aesthetic procedures, represented by injectable and phototherapy products, are more widely accepted by consumers due to their low invasiveness and quick recovery. Among them, injectable procedures have advantages such as strong shaping ability and visible results, making them widely favored by the market . According to reports from research institutions such as Deloitte and China Research & Consulting, the Chinese medical aesthetic market reached 289.4 billion yuan in 2024, with a long-term compound annual growth rate of over 15%. The industry is expected to shift to a new stage of "deepening quality and efficiency" in 2025, and is projected to exceed one trillion yuan by 2030.

It is reported that Ellansé® has established a differentiated product matrix in China, capable of meeting personalized anti-aging needs for different areas, layers, and durations of effect. The annual report shows that as of December 2025, the company's second -generation Ellansé® products—Zhenyan® , Jingyan® , and Zhizhen® — have entered nearly 500 medical aesthetic institutions, enjoying excellent market reputation and continuing to lead the PCL regeneration market. To meet the differentiated needs of channels and enhance market penetration, Xinkeli Aesthetics launched the Ellansé® Classic Edition , the first imported high-end PCL facial filler in China to receive Class III medical device certification. It has already successfully gained access to several key public hospitals nationwide and is developing customized new products with strategic partners. As of April 2026, Ellansé® has achieved market access in dozens of large public hospitals across nine provinces in China .

The approval of the new indication for forehead filler for the Yiyanshi® S-type filler marks another significant milestone for Huadong Medicine in its continued deep cultivation of the high-end medical aesthetics field. It also synergizes with the previously approved Yiyanshi® M - type filler, hyaluronic acid, and botulinum toxin products, further enriching the company's high-end injectable product portfolio. This not only provides domestic beauty seekers with more diverse facial filler options but also significantly strengthens Huadong Medicine's competitive advantage in the regenerative medicine sector through the expansion of its indications.

02 The medical aesthetics strategy has been fully implemented, consolidating its leading position in the high-end medical aesthetics industry.

Huadong Medicine has completed its comprehensive strategic layout in the medical aesthetics field, successfully building a complete product matrix driven by "medical aesthetic injections + photoelectric energy sources," achieving full coverage of high-end products in all core non-surgical medical aesthetic tracks. Based on its forward-looking industrial layout, the company has created a comprehensive and differentiated medical aesthetics product cluster, with both the number of products and the areas covered ranking among the top in the industry.

Currently, the company has over 50 international high-end medical aesthetic products that combine non-invasive and minimally invasive techniques, of which 33 have been launched both domestically and internationally, forming a relatively complete product matrix. The product portfolio comprehensively covers mainstream non-surgical medical aesthetic fields such as facial filling, facial cleansing, thread lifting, skin management, body sculpting, hair removal, and intimate area repair, and its international influence continues to grow.

In the field of injectable aesthetic medicine, the company has established a comprehensive and differentiated pipeline across its three core product categories, building a competitive barrier. Huadong Medicine has achieved full coverage of the three core product categories: regenerative fillers, hyaluronic acid, and botulinum toxin. Its blockbuster products, such as the regenerative filler Ellansé® S and M types, the high-end long-acting hyaluronic acid MaiLi Extreme , and the world's first recombinant type A botulinum toxin Retoxin® , have all been launched in the domestic market. Moreover, each product category has two or more differentiated pipelines, providing solid support for accurately matching the diversified needs of the market and building a strong core competitive barrier.

In March of this year, the company's exclusively distributed recombinant botulinum toxin type A, Retoxin® , was officially approved for marketing. It is suitable for the temporary improvement of moderate to severe frown lines caused by the activity of the corrugator supercilii/depressor supercilii muscles in adults aged 65 and under. The product will soon begin official commercial sales. As the world's first recombinant botulinum toxin type A, it has the same biological functions and pharmacological effects as natural botulinum toxin, filling the market gap in the field of recombinant botulinum toxin.

Extreme® (trade name: MeiLi® Shuoying® ) , a novel high-end lidocaine-containing sodium hyaluronate filler, has established partnerships with over 100 companies since its official commercialization in May 2025. Originating in Switzerland, this product utilizes the world's first OxiFree® " oxygen-free" cross-linking technology. With its "small dosage, high efficacy, and dynamic shaping" characteristics and effects, its market acceptance is steadily increasing. The annual report shows that MeiLi® Shuoying® has completed the listing and price adjustment processes in 23 provinces. Xinkeli Aesthetics , in conjunction with the Huadong Medicine Pharmaceutical Service team, has conducted over 20 doctor training sessions, covering nearly 500 doctors from public medical institutions. This has not only improved the professional skills of clinicians but also laid a solid foundation for high-quality medical aesthetic services and increased patient satisfaction. MaiLi Precise, as the product with the lowest sodium hyaluronate concentration in the series, had its Chinese registration application accepted by the National Medical Products Administration (NMPA) in October 2025.

In the field of regenerative fillers, the clinical trials of the company's poly-L-lactic acid collagen stimulant Lanluma® are progressing steadily. As the world's first approved regenerative product for filling the buttocks and thighs, Lanluma® comes in two main sizes: V-shape and X-shape. The V-shape is suitable for filling small areas such as the face, upper arms, and neck, while the X-shape is specifically designed for shaping larger areas such as the buttocks. Its core ingredient, poly-L-lactic acid (PLLA), is also a core ingredient in domestic "baby face injection" products, indicating a broad market potential.

In the field of optoelectronic energy source equipment, Huadong Medicine has consolidated its leading position through a comprehensive medical device matrix. The company has achieved full coverage of the high-end market. As of the end of 2025, over 400 institutions have adopted its Glacial® spa cryotherapy product , Reaction® radiofrequency anti-aging product , and the new generation "Youth Light" pulsed light radiofrequency therapy device Renotion. Institutional coverage has doubled compared to 2024, further consolidating the advantages of its EBD pipeline. The successful launch of the Préime DermaFacial beauty device continues to strengthen the product portfolio and support channel business expansion. The registration application for the all-around skin aesthetic device V30 was accepted in 2025, and its future launch will further solidify the company's leading position in the field of non-surgical aesthetic medical devices.

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