Sisram Medical's DAXXIFY Clears Final Regulatory Hurdle for China Market Launch
Key Insights
Sisram Medical's long-acting botulinum toxin product DAXXIFY has successfully passed quality testing from China's National Institutes for Food and Drug Control (search), completing the final regulatory step before market launch.
DAXXIFY represents the world's first and only long-acting peptide-formulated neuromodulator featuring proprietary Peptide Exchange Technology, designed for treating moderate to severe glabellar lines (search).
The company has secured initial commercial orders with several core medical aesthetic institutions and established comprehensive commercialization infrastructure including partnerships with Fosun Wanbang (search) and Shanghai Pharmaceuticals (search).
Sisram Medical Ltd (search) announced that its long-acting botulinum toxin type A product, DAXXIFY, has passed quality testing from the National Institutes for Food and Drug Control (search) of the People's Republic of China (NIFDC). This milestone confirms that DAXXIFY meets China's rigorous national drug regulatory requirements for quality, safety, and efficacy, representing the final critical step toward market launch.
Revolutionary Neuromodulator Technology
DAXXIFY stands as the world's first and only long-acting peptide-formulated neuromodulator, containing the active pharmaceutical ingredient botulinum toxin type A (DaxibotulinumtoxinA). The product distinguishes itself as the first and only botulinum toxin type A approved in mainland China featuring proprietary Peptide Exchange Technology (PXT) and a stabilized peptide formulation.
The innovative formulation is designed to deliver both a long duration of effect and rapid onset of action, addressing the temporary improvement of moderate to severe glabellar lines (search) associated with corrugator and/or procerus muscle (search) activity in adult patients.
Market Readiness and Commercial Validation
Sisram has already secured initial commercial orders with several core medical aesthetic institutions, validating market expectations and recognition for this long-acting innovative product. This achievement marks DAXXIFY's transition from the preparation stage to the active sales phase.
The company has established a comprehensive professional team dedicated to market expansion, clinical support, and supply chain management. The experienced sales and marketing team continues to cultivate core medical networks while deepening strategic collaborations with medical aesthetics institutions.
Strategic Infrastructure Development
To support commercialization efforts, Sisram has developed a dedicated medical affairs team that empowers physicians through systematic training programs and clinical evidence generation. This approach ensures standardized and precise treatment delivery across the medical aesthetics community.
In operations and supply chain management, the company has partnered with industry leaders, including Fosun Wanbang (search) (Jiangsu) and Shanghai Pharmaceuticals (search), to establish an efficient, reliable, and fully traceable supply chain system. This collaborative framework ensures that all stages from production and logistics to final clinical delivery adhere to stringent quality and compliance standards.
Strategic Business Impact
As Sisram's first injectable product launched in mainland China, DAXXIFY represents a premium choice for consumers seeking higher quality standards and exceptional aesthetic experiences. The product is positioned to become a cornerstone of Sisram's injectable portfolio and a key driver of business growth.
The successful regulatory clearance supports Sisram's strategic expansion into injectables, creating what the company describes as a "second growth curve" and strengthening competitiveness through an integrated wellness ecosystem encompassing Energy-Based Device technologies, injectables, diagnostics, and complementary solutions.
Sisram Medical Ltd (search), listed on the Hong Kong Stock Exchange since September 2017 and majority-owned by Fosun Pharma, operates as a global leader in medical aesthetic solutions with over 25 years of expertise in Energy-Based Devices, serving customers in over 110 countries and regions.