Sihuan Pharmaceutical (00460) announced that six new specifications of the self-developed polylactic acid facial filler (commonly known as the "Youth Needle") from its subsidiary, Mei Yan Space Biotechnology (Jilin) Co., Ltd., have been formally approved by the National Medical Products Administration (NMPA) of China. This represents another significant milestone following the product's initial approval, further enhancing the company's market positioning within the regenerative aesthetic medicine product sector. As the sole domestic enterprise simultaneously holding compliant versions of both major regenerative filler products—the "Maiden Needle" and the "Youth Needle"—alongside other heavyweight Class III medical device aesthetic products such as botulinum toxin, hydro-booster shots, and golden microneedling, Sihuan's Youth Needle utilizes poly-L-lactic acid (PLLA) microspheres as its core component to achieve the dual effects of "immediate filling + long-term regeneration." Its unique patented technology ensures regular microsphere morphology and uniform particle size, demonstrating excellent safety and clinical efficacy, with the majority of patients maintaining effective results for up to one year post-injection. Prior to this specification expansion, the product was already approved in three specifications: 45mg/vial, 75mg/vial, and 150mg/vial, catering to different needs such as preventative management, combination therapy, and comprehensive rejuvenation. The newly approved six specifications—60mg/vial, 80mg/vial, 100mg/vial, 110mg/vial, 120mg/vial, and 130mg/vial—will further enrich the product selection spectrum. The value and significance of this product specification increase are as follows: 1. Precise Matching of Diverse Anti-Aging Needs: The new specifications fill the dosage gaps between the original ones, enabling full-scenario coverage from mild initial aging to moderate-severe aging. Whether for subtle improvement in delicate areas or moderate volumizing needs for facial contours, personalized treatment can be achieved through precise dosage selection, meeting the segmented needs of different age groups and varying degrees of aging. 2. Optimizing Clinical Operational Flexibility: Leveraging the product's characteristic of rapid reconstitution within one minute, the multiple specifications allow doctors to flexibly adjust dilution concentration and injection dosage based on the injection site and treatment layer, reducing the complexity of combination therapies and enhancing treatment efficiency and safety. 3. Strengthening Market Competition Barriers: Against the backdrop of continuous growth in the global Youth Needle market and intensifying domestic competition, the multi-specification layout further consolidates Sihuan Pharmaceutical's differentiated advantage in the regenerative aesthetics track, creating synergistic effects with its other products like the "Maiden Needle" and "Dual-Wave Radiofrequency," thereby completing its comprehensive portfolio of light aesthetic products. 4. Promoting Refined Development in the Industry: This specification expansion responds to the aesthetic industry's trend from "standardized treatment" towards "personalized solutions." By refining dosages, it guides the industry to focus on individual patient differences, provides an industry reference for the specification design of regenerative aesthetic products, and assists the industry's upgrade towards higher quality and refinement. Sihuan Pharmaceutical will leverage its extensive distribution network covering over 7,000 medical institutions to rapidly promote the market launch of the new specifications. The company will continue to empower aesthetic product innovation with its pharmaceutical R&D heritage, providing consumers with safer, more precise, and diverse anti-aging solutions, thereby propelling its aesthetic business segment into a new phase of scaled growth.
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