Core Viewpoint - The approval of the first injectable recombinant collagen type I medical device by Juzi Biotech marks a significant breakthrough in the aesthetic medicine sector, indicating the start of a second growth curve for the company in this field [1][4]. Product Approval - On October 23, 2025, Juzi Biotech announced that its self-developed "Recombinant Type I α1 Collagen Lyophilized Fiber" received the Class III medical device registration certificate from the National Medical Products Administration (NMPA), with registration number 国械注准20253132049 [1][2]. - This product is the first approved drug-device combination in Juzi Biotech's Class III medical device pipeline, extending its business from functional skincare and Class II medical devices to the high-barrier Class III aesthetic injection devices [1][2]. Product Specifications and Efficacy - The product is a white or off-white sponge-like solid composed of recombinant Type I α1 collagen, with a total of 753 amino acids [2]. - It is indicated for facial dermal tissue filling to correct dynamic wrinkles, including forehead lines, glabellar lines, and crow's feet, showing efficacy rates of 94.7% for forehead lines and 97.2% for crow's feet in clinical trials [2]. Market Potential - The domestic market currently has 12 approved Class III collagen medical devices, with only four related to recombinant collagen, making Juzi's product the first recombinant Type I collagen Class III medical device approved [2][3]. - The collagen injection market is projected to reach approximately 9.8 billion by 2025, indicating significant growth potential for Juzi's recombinant Type I collagen, which is not in direct competition with existing products [3]. Future Pipeline and Growth Strategy - Juzi Biotech has additional products in the pipeline, including a "Recombinant Collagen Implant" that is currently under review, which may expedite approval following the recent success [4]. - Despite short-term stock price pressures due to initial sales fluctuations during the Double 11 shopping festival, the company is expected to gain momentum in the latter half of the event [4][6]. Sales Performance and Brand Strategy - In Q3, Juzi Biotech achieved a GMV of approximately 726 million, with significant growth rates across platforms like Tmall and JD, indicating a recovery in brand performance [4]. - The company has engaged in strategic partnerships with influencers to enhance brand visibility and sales during the Double 11 event, ranking 16th in Tmall's beauty category during the promotional period [4]. Management Confidence - The company's major shareholder has been actively increasing its stake, purchasing approximately 4.23 million shares for about 200 million HKD, which signals strong confidence in the company's long-term prospects [6].
巨子生物(02367.HK)：械三证落地打开新增长曲线 管理层持续增持彰显长期信心