Sirsram Medical announces NMPA approval for DAXXIFY®

Marking the introduction of the world’s first and only peptide-powered  botulinum toxin product to Mainland China

HONG KONG, Sept. 9, 2024 /PRNewswire/ — Sisram Medical (1696.HK), a global leading innovator and provider of holistic medical aesthetic solutions announced today that the National Medical Products Administration has accepted the Biologics License Application ("BLA") for the Company’s botulinum toxin, DAXXIFY® (Chinese trademark: 达希斐®), intended for the temporary improvement in the appearance of moderate to severe glabellar lines caused by movements associated with corrugator and/or procures muscle activity in adult patients. As the first innovation of its kind in over 20 years, DAXXIFY® brings together botulinum toxin and Revances’s proprietary Peptide Exchange Technology™ (PXT) to deliver outstanding efficacy.

Results from DAXXIFY® can be seen as early as day following treatment for some people, and typically within 2 days①. The treatment is also considered long-lasting and keeps frown lines smoother with the convenience of as few as 2 treatments a year②, and results slowly soften over a prolonged period of time③. Additionally, DAXXIFY® is known to result in a better look to skin texture after treatment④, smoothing even the deepest lines.

Alongside its outstanding clinically proven results, the high-end injectable botulinum toxin offers high safety. Free of human albumin or animal-based components, it has a lower probability of neutralizing antibodies or allergic reactions occurring during treatment sessions. DAXXIFY® also provides practitioners with more convenient and controllable storage management, aligning with clinic day operations. It can be kept at room temperature below 25°C, and after reconstitution, it can be stored in a refrigerator at 2°C-8°C, protected from light for 72 hours.

The registration of DAXXIFY® in Mainland China is a landmark milestone for Sisram’s injectable business block, which strengthens the Company’s comprehensive wellness ecosystem and represents a solid foundation for future commercialization in these strategic territories.

Alongside a license agreement granting exclusive rights to import, sell, and commercialize DAXXIFY® in Mainland China, Hong Kong SAR, and Macao SAR, the Company’s comprehensive injectables portfolio includes partnerships with IBSA for the dermal biostimulator Profhilo® in other APAC markets, and with Prollenium® for its renowned dermal filler collection, FDA & CE approved Revanesse®, in several key markets including Germany, Austria, Switzerland, Australia, New Zealand, and Japan, with potential expansion into other regions.

The market value of the injectable segment in China has significantly soared, reaching an estimated value of RMB33.3 billion in recent years. According to the Company, this pivotal achievement serves as a competitive advantage, creating a significant new driver for revenues and laying a new cornerstone for business development.

Mr. Liu Yi, Sisram Chairman and Executive Director, said, "China has always been a strategic market for Sisram, and the approval of DAXXIFY® serves as a key milestone for bringing Sisram’s high-end injectables portfolio to Mainland China."

"From a business perspective, this achievement enhances the competitiveness of the Company’s products, expanding its diversified offerings and delivering an innovative experience for beauty-seeking patients," he added.

"We are committed to building lasting Partner-Patient relationships by delivering clinical excellence and outstanding patient experiences. The recent approval of DAXXIFY® represents a significant advancement in our offerings, providing consumers with a longer-lasting and safer treatment option and aligning perfectly with practitioners’ needs for greater flexibility and convenience in their management practices," said Lior Dayan, CEO of Sisram and Alma.

He continued, "Sisram will continue to enhance our diversified product portfolio, reinforcing our mission to improve patients’ quality of life and prioritize the customer journey as a key driver of our long-term success."

Note:

①     Based on pooled patient diary data from SAKURA 1 and SAKURA 2②     At least 50% of patients in SAKURA 1 and SAKURA 2 had none or mild frown lines for 24 weeks (6 months) and 23.9 weeks (6 months) or longer, respectively, per both investigator’s and patient’s assessments.③     Median time to return to baseline wrinkle severity was 27.7 weeks in SAKURA 1 and 26 weeks in SAKURA 2④     64% of patients achieved an improvement in the appearance of skin texture at week 2 from a post hoc analysis of a phase 2 study with 60 patients

About Sisram Medical Ltd

Sisram Medical Ltd (1696.HK) is a global consumer wellness group, featuring a first-of-its-kind synergistic ecosystem of business building blocks and consumer-focused branding, ranging from Energy Based Devices, injectables, aesthetics and digital dentistry, personal care and more. The Company is majority-owned by Fosun Pharma, one of China’s leading healthcare groups. Sisram Medical went public on the Main Board of the Hong Kong Exchange in September 2017.

Sisram Medical – Enhancing Quality of Life

http://www.sisram-medical.com

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