Giant Biogene Receives NMPA Approval for First Recombinant Type I Collagen Injectable Device
核心洞察
Giant Biogene (搜索)'s recombinant Type I α1 subtype collagen (搜索) lyophilized fiber injection received NMPA approval as a Class III medical device on October 21, 2025, marking the company's first drug-device combination product.
The approved product uses a humanized sequence with 753 amino acids and is indicated for facial dermal tissue filling to correct dynamic wrinkles (搜索) including glabellar lines (搜索), forehead lines (搜索), and crow's feet (搜索).
The approval represents a significant regulatory breakthrough that elevates Giant Biogene (搜索) from Class II auxiliary materials to Class III injectables, with analysts forecasting EPS growth to RMB 2.35/2.83/3.38 for 2025-2027.
Giant Biogene (搜索) (02367) achieved a major regulatory milestone with the National Medical Products Administration (NMPA) approval of its recombinant Type I α1 subtype collagen (搜索) lyophilized fiber injection as a Class III medical device on October 21, 2025. The product received registration number Guo Xie Zhu Zhun 20253132049, marking the company's entry into the premium injectable medical aesthetics market.
Breakthrough in Regulatory Approval
The approved solid lyophilized fiber formulation represents the first drug-device combination product in Giant Biogene (搜索)'s Class III medical device pipeline, achieving a significant breakthrough in overcoming regulatory approval barriers. The product utilizes a humanized sequence, specifically selecting 753 amino acids from positions 305-1057 of the single-chain human natural Type I α1 amino acid sequence, offering excellent biocompatibility and safety profiles.
The injectable device is indicated for facial dermal tissue filling to correct dynamic wrinkles (搜索) in the forehead area, including glabellar lines (搜索), forehead lines (搜索), and crow's feet (搜索). This approval fills a market gap in injectable applications of Type I collagen (搜索), creating clear differentiation from existing Type III collagen (搜索) products currently available.
Comprehensive Technology Platform
Giant Biogene (搜索) has established a robust technology platform with a library of over 50 recombinant collagen molecules, achieving extensive research and development coverage across multiple categories including full-length chains, selected fragments, and repeated chains. The company is advancing development of Type IV and Type XVII collagen (搜索) for applications in thermal damage repair and hair regeneration, demonstrating comprehensive technical expertise across multiple indications.
The company has planned subsequent formulations including liquid, gel, and cross-linked gel variants, continuously enriching its product matrix and consolidating its competitive position in the recombinant collagen field.
Commercial Impact and Market Positioning
The Class III medical device approval will drive Giant Biogene (搜索)'s medical device business from Class II auxiliary materials to Class III injectables, significantly boosting segment revenue potential. Future injectable products are expected to command premium pricing compared to existing Class II devices, driving margin expansion.
The company's current Class II product, KeyGene Starlight Bottle (搜索), commands an average retail price of RMB 2,000 per 4ml, demonstrating strong market willingness to pay and established brand recognition for recombinant collagen products. Leveraging its established channel foundation and market awareness, the company's injectable products are positioned for rapid scaling under high market acceptance.
Financial Outlook
Securities analysts have maintained 'Buy' ratings for Giant Biogene (搜索) based on the breakthrough in medical aesthetics business, steady growth in medical dressings and functional skincare products, and gradual dissipation of short-term negative sentiment. The approval of the Class III medical device is expected to significantly raise the company's long-term growth potential ceiling, with analysts forecasting EPS for 2025-2027 at RMB 2.35/2.83/3.38, leading to upward revisions in both earnings projections and valuation.