SSY GROUP (02005.HK): Gadobutrol injection and indocyanine green for injection approved, enhancing imaging and critical care product portfolio

NewTimeSpace News: On 27 August 2026, SSY Group Limited (stock code: 02005) voluntarily announced that the Group has obtained from the National Medical Products Administration (NMPA) the production registration approval for gadobutrol injection (7.5ml: 4.5354g), classified as Category 4 chemical drug and deemed to have passed consistency evaluation.

According to the announcement, gadobutrol injection is mainly used for diagnostic purposes and is for intravenous administration only, applicable to adults and pediatric patients of all ages (including full-term neonates), primarily for contrast-enhanced magnetic resonance imaging (CE-MRI) of lesions in various parts of the body (including the brain and spinal cord), and contrast-enhanced magnetic resonance angiography (CE-MRA) of various parts of the body. The Group's gadobutrol API was approved by the NMPA for registration as an API used in marketed preparations on 21 July 2026; as a new-generation macrocyclic MRI contrast agent, the approval of the injection completes the Group's integrated layout of gadolinium-based API and injection preparations, supporting the expansion of the clinical medical imaging market.

The Group has also obtained from the NMPA the approval for indocyanine green for injection (25mg), classified as Category 3 chemical drug and deemed to have passed consistency evaluation. Indocyanine green for injection is mainly used for the diagnosis of various liver diseases including liver cirrhosis, liver fibrosis, chronic hepatitis and occupational and drug-induced toxic liver diseases, to assess the extent of liver damage and reserve function, and can also be used for choroidal angiography to identify the location of choroidal lesions. The Group's indocyanine green API was approved for registration on 9 September 2025; the approval of the powder for injection further improves the Group's product layout for perioperative and ICU critical care departments, leveraging the integrated advantage of API and preparations to support expansion into the tertiary hospital surgery and critical care markets.

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