第三张Ⅲ类械证落地 医美注射新品上市 巨子也要卷ECM？

This article centers on leading Chinese medical aesthetics and skincare company Giant Biotech obtaining its third Class III medical device registration certificate, marking its official entry into the injectable extracellular matrix (ECM) anti-aging segment. Key takeaways are as follows:

1. The company’s expansion follows a clear timeline: its three Class III certificates were approved in October 2025, January 2026, and June 2026 respectively, with products targeting static wrinkle filling, cheek texture improvement, and correction of moderate-to-severe horizontal neck wrinkles. Its first injectable product, Canlia CoreGen 753 Collagen Filler, has already launched commercially.

2. Giant Biotech’s move into the new segment is driven by growth headwinds in its core business: the company posted year-over-year declines in total revenue and net profit in 2025. Its core medical dressing category is already mired in price competition, and new healthcare insurance regulations bar non-compliant Class III-marketed products from insurance reimbursement, forcing the company to pursue new growth curves.

3. ECM has been officially recognized as the 13th aging biomarker by international academic journals, with multiple leading domestic and international brands already entering the space, making ECM anti-aging the next high-potential trend in the global anti-aging market.

This article provides key insights on category positioning and product development for medical aesthetics and skincare brands, detailed as follows:

1. Consumer trends and segment opportunities: The ECM anti-aging segment has become a key focus for leading global and domestic brands, including domestic players like Bloomage Biotech and Marubi, and global giants Shiseido and Estée Lauder. With ECM formally classified as an aging biomarker, consumer anti-aging demand is shifting from surface filling to improving skin microenvironment, creating significant new demand growth.

2. Product development direction: Injectable recombinant collagen products with compliant Class III medical device certification represent a largely untapped blue ocean. Adopting physical cross-linking technology eliminates the risk of residual chemical cross-linking agents, which better aligns with consumer demand for safety. The existing Class II medical dressing market is already locked in price wars, so compliant strictly clinical products represent the key new growth driver.

3. Brand operations and risk mitigation: When core brands face stagnant growth, companies can reallocate resources to high-growth sub-brands to house new business lines, as Giant Biotech did by placing its new collagen filler with its only growing brand Canlia. Brands should also adjust their product portfolios in line with new healthcare insurance regulations, removing non-compliant mislabeled device products to avoid policy risks.

This article offers key insights on policy interpretation and opportunity spotting for sellers in the medical aesthetics and skincare space, detailed as follows:

1. Policy interpretation and risk alerts: Regulators require local authorities to establish a whitelist system for retail pharmacy healthcare insurance personal account payments by the end of September. Non-compliant "masked" device products, such as face masks and care pads labeled with improper device registrations, will be barred from insurance reimbursement. Sellers should remove non-compliant products promptly to avoid regulatory penalties.

2. Growth market and opportunities: The existing Class II medical dressing category has become a major battleground for price wars, with profit margins continuously compressed. Compliant Class III injectable medical aesthetics and ECM anti-aging related products represent a new high-growth segment. With leading domestic and international brands already entering the space, consumer acceptance is rising steadily.

3. Shifting demand alerts: Consumer anti-aging demand has upgraded, shifting from single wrinkle filling to improving the skin’s ECM microenvironment, and from general skincare to strictly clinical medical aesthetic anti-aging. Sellers can get ahead of the curve by stocking relevant product categories to capture new traffic and sales growth, offsetting revenue declines from stagnant legacy categories.

This article provides insights on shifting demand and new business opportunities for manufacturers in the medical aesthetics and skincare industry, detailed as follows:

1. Shifting product design and manufacturing demand: Downstream brands are rushing to develop ECM-related anti-aging products, with a key focus on compliant Class III injectable recombinant collagen products, which creates higher requirements for production technology. Physical cross-linking processing, which eliminates residual chemical cross-linking agents, better matches market demand. Factories can upgrade related production processes in advance to meet downstream brands’ R&D needs.

2. New business opportunities: The existing Class II medical dressing market is stuck in homogenized price competition, and downstream brands are increasingly shifting to strictly clinical and injectable medical aesthetic segments. Factories can adjust their partnership focus, co-develop Class III collagen-related products with brands, open up new growth avenues, and escape the trap of low-margin price competition.

3. Transformation takeaways: The entire medical aesthetics and beauty industry is shifting toward higher-value compliant products. Factories need to upgrade their compliant R&D and manufacturing capabilities, instead of sticking to low-cost production of Class II dressings. Building production capacity for high-end compliant products in advance allows manufacturers to capture the dividends of industry upgrade.

This article shares insights on industry trends and client demand for service providers in the medical aesthetics and skincare industry, detailed as follows:

1. Industry development trends: The entire medical aesthetics and beauty industry is upgrading from general functional skincare and Class II medical dressings to strictly clinical medical aesthetics and compliant Class III anti-aging products. ECM anti-aging has emerged as a new high-profile segment, with leading domestic and international brands already completing initial layout, and the industry upgrade trend is clear.

2. Core pain points of current brand clients: Most brands face stagnant growth in their core categories and intensifying price wars that compress profit margins. At the same time, non-compliant mislabeled device products face policy risk of being barred from insurance coverage, so brands urgently need to identify new growth drivers and complete business structure upgrades.

3. New business directions for service providers: Service providers can develop supporting services tailored to the new ECM segment, including compliance application consulting for brands, consumer education content around the ECM concept, go-to-market marketing support for new products, and supply chain connection services. This allows providers to capture growing service demand during brand upgrade and expand their own business growth.

This article provides insights on category adjustment, merchant recruitment and operations for medical aesthetics and beauty platform operators, detailed as follows:

1. Core demands from brands on platforms: A large number of brands are currently expanding into the new ECM anti-aging and Class III injectable medical aesthetics categories, and require platforms to provide compliant category access and traffic support to help new products reach target consumers and gain market traction.

2. Operational management and risk mitigation: Platforms need to align with new healthcare insurance regulations, promptly remove non-compliant mislabeled device products, adjust platform rules to bar non-compliant products from using insurance payment channels, and mitigate the platform’s own compliance risks.

3. Merchant recruitment and category adjustment directions: Platforms can prioritize introducing new products from leading brands that hold compliant Class III certificates and have positioned themselves in the ECM segment. These new products are the industry’s current growth hotspot and can bring new traffic and revenue growth for platforms. At the same time, platforms should adjust their category mix to reduce the share of low-cost, homogenized Class II medical dressings, and mitigate the risk of declining platform profits from widespread price competition.

This article provides research materials on new industry dynamics and corporate transformation for researchers focused on the medical aesthetics and skincare industry, detailed as follows:

1. New industry development dynamics: Leading Chinese collagen-based skincare company Giant Biotech has completed its layout of three Class III medical device certificates, entered the injectable medical aesthetics segment, and officially positioned itself in the ECM anti-aging space. Currently, leading global and domestic beauty and medical aesthetics companies have completed initial layout of the ECM segment, and the entire industry is upgrading from mass-market functional skincare to strictly clinical anti-aging services and products.

2. New challenges facing the industry: The existing Class II medical dressing segment is already locked in homogenized price competition, and legacy business growth for leading players has stagnated. New healthcare insurance regulations are further accelerating the exit of non-compliant mislabeled products, putting the industry under pressure for overall structural upgrading and speeding up market consolidation.

3. A new transformation path for enterprises: Leveraging their existing technological accumulation in the collagen field, leading local Chinese companies are expanding from skincare products to compliant injectable medical aesthetic products, housing new business lines in high-growth sub-brands to enrich product portfolios and offset revenue gaps. This represents a new business model for local Chinese beauty companies’ transformation and carries high research value.