Sisram Medical Clears Final Regulatory Step For DAXXIFY Market Entry In China

06 January 2026 | Tuesday | News


Long Acting Botulinum Toxin Secures National Quality Clearance, Strengthening Sisram’s Premium Aesthetics Strategy
Image Source : Public Domain

Image Source : Public Domain

 

 

Marking a Key Milestone Toward Market Launch and Strengthening Sisram's Premium Aesthetics Portfolio

Sisram Medical Ltd (the "Company" or "Sisram", 1696.HK; together with its subsidiaries collectively referred to as the "Group"), a global wellness group offering Energy-Based Devices (EBD), injectables, diagonostics, and other complementary solutions, announced that its long-acting botulinum toxin type A product, DAXXIFY (trademark in Chinese Mainland达希斐®), has passed the quality testing from National Institutes for Food and Drug Control of the People's Republic of China ("NIFDC"). This milestone confirms that DAXXIFY meets the rigorous requirements set by China's national drug regulatory system regarding quality, safety, and efficacy, successfully completing the final critical step towards market launch.

DAXXIFY is the world's first and only long-acting peptide-formulated neuromodulator, containing the active pharmaceutical ingredient botulinum toxin type A (DaxibotulinumtoxinA). It is also the first and only botulinum toxin type A product approved in mainland China featuring proprietary Peptide Exchange Technology (PXT) and a stabilized peptide formulation. Designed to deliver both a long duration of effect and a rapid onset of action, DAXXIFY addresses the temporary improvement of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. Currently, Sisram has reached initial commercial orders with several core medical aesthetic institutions, fully validating market expectations and recognition for this long-acting innovative product and marking its transition from the preparation stage to the sales phase.

To advance the commercialization of DAXXIFY, the Company has established a comprehensive professional team responsible for market expansion, clinical support, and supply chain management. The experienced sales and marketing team continues to cultivate core medical networks, deepening strategic collaborations with medical aesthetics institutions. A dedicated medical affairs team empowers physicians to provide standardized and precise treatments through systematic training programs and clinical evidence generation. In operations and supply chain management, the Company has partnered with industry leaders, including Fosun Wanbang (Jiangsu) and Shanghai Pharmaceuticals, to establish an efficient, reliable, and fully traceable supply chain system. This collaborative approach ensures that all stages, from production and logistics to final clinical delivery, adhere to stringent quality and compliance standards, supporting market readiness and reinforcing confidence across the medical aesthetics community. 

Leading a New Premium Choice in Medical Aesthetics and Powering the New Engine of Business Growth

As the first injectable product launched in mainland China, DAXXIFY offers a premium choice for consumers seeking higher standards of quality and exceptional aesthetic experiences. This successful testing signifies the final regulatory milestone before the market launch. Supported by a well-defined differentiation strategy, a structured value system, and a robust operational framework, the Company believes that DAXXIFY is set to become a cornerstone of Sisram's injectable portfolio and a key driver of business growth. Furthermore, the product is poised to support Sisram's strategic expansion into injectables, creating a "second growth curve" and strengthening the Company's competitiveness through an integrated wellness ecosystem encompassing EBD technologies, injectables, diagnostics, and complementary solutions. The team is fully dedicated to bringing DAXXIFY to market, with the product expected to be available for clinical application soon. Sisram looks forward to providing DAXXIFY to partner institutions across mainland China, enabling a wide range of consumers to experience the outstanding effects while reinforcing its commitment to delivering diverse and reliable wellness solutions to the market.

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