Group 1 - The core viewpoint of the news is that Sihuan Pharmaceutical has achieved a significant breakthrough in the regenerative medical aesthetics field with the approval of its self-developed polylactic acid facial filler, known as "童颜针" (Youthful Needle), by the National Medical Products Administration of China [1] - The "童颜针" is based on left-handed polylactic acid (PLLA) microspheres, which have stable biodegradation characteristics and can stimulate the regeneration of autologous collagen, providing both immediate filling and long-lasting regeneration effects [1] - The product has shown superior clinical efficacy compared to similar products on the market, with a high safety profile, as most patients maintain effectiveness for up to one year post-injection [1] Group 2 - According to a Pharmocean report, "童颜针" holds a 6.0% share of the global market, ranking third among similar products [2] - The global market size for "童颜针" is projected to reach approximately $1.488 billion in 2024, growing to $1.5445 billion in 2025, and expected to reach $2.0815 billion by 2033, with a compound annual growth rate (CAGR) of 3.8% from 2025 to 2033 [2] - In China, the market size for "童颜针" was approximately RMB 100 million in 2021, with estimates exceeding RMB 3 billion by 2024, and the regenerative injection market is expected to reach RMB 11.52 billion by 2027, with a CAGR of 54.73% from 2021 to 2025 [2] Group 3 - The approval of "童颜针" marks a dual breakthrough for Sihuan Pharmaceutical, as it has simultaneously obtained third-class medical device certifications for both "少女针" (Girl Needle) and "童颜针" within a month, making it the only company in China to hold compliant certifications for both products [3] - The dual product strategy is expected to create a differentiated competitive advantage and enhance the company's full-chain operational capabilities in research, registration, and commercialization [3] - The two products are anticipated to synergistically meet the needs of different age groups and consumption scenarios, paving the way for the company's growth in the medical aesthetics sector and establishing a strategic foundation for future product pipeline development and market education [3]
四环医药(00460.HK)：渼颜空间自主研发的童颜针获得国家药监局上市批准