Sisram's Profhilo clears China regulatory hurdle

Profhilo is a high-concentration sodium hyaluronate product made without BDDE, using what Sisram calls its patented NAHYCO technology. The injectable stimulates collagen and elastin by hydrating skin deeply, improving skin texture, firmness, and elasticity. Sisram holds exclusive distribution rights across Israel, India, and Thailand, where the product has already established a solid track record.

In Thailand specifically, Profhilo has grown steadily among leading medical aesthetics clinics. The company has begun pairing Profhilo with its Soprano series of energy-based devices, creating combination protocols that link its injectables and device businesses. This bundled approach is part of what Sisram plans to replicate in China.

The NMPA acceptance does not mean approval yet. The product still moves through the Chinese regulator's review process. But Sisram has already started groundwork that typically precedes a launch: positioning the market, developing channel strategy, educating medical professionals, engaging end users, and planning how it will operate. The company is drawing on its existing customer network in China's medical aesthetics market and the clinic support infrastructure it built while commercializing other premium injectables there.

Jiahong Li, Co-CEO and CFO of Sisram, framed the NMPA acceptance as proof that the company's strategy to expand selectively into significant markets using its global portfolio works. He said Sisram will progress Profhilo's regulatory review while preparing to commercialize in parallel, using its existing portfolio and distribution network to support the future launch. Li also signaled that closer work between the company's energy-based device and injectables units could generate further synergies across how they combine treatments, distribute them, and apply them clinically.

Sisram is majority-owned by Fosun Pharma and operates across more than 110 countries and regions. The company has over 25 years of experience in energy-based devices and now positions itself as offering a synergistic ecosystem spanning EBD technologies, injectables, diagnostics, and complementary solutions. It has been listed on the Main Board of the Hong Kong Stock Exchange since September 2017.

The company's strategy hinges on what it calls the differentiated technology and unique product attributes of Profhilo, which it says gives it a competitive edge in the medical aesthetics skin rejuvenation segment. Profhilo has been successfully commercialized in multiple international markets, establishing what Sisram describes as a solid track record of clinical applications and market recognition. The company's medical training, localized operations, and clinic support capabilities developed through commercializing premium injectables in China provide what it calls practical knowledge and a base for Profhilo's planned entry.

The acceptance by NMPA marks what Sisram calls an important milestone for its injectables business in China. The company plans to draw on its global expertise and local market knowledge to bring what it describes as high-quality products to China and broaden its offerings. The combination treatment protocols integrating Profhilo with the Soprano series have already proven successful in Thailand, providing a tested model for the Chinese market.

Business information, not medical or legal advice. Verify regulatory status at FDA.gov.