石四藥集團获NMPA批准釓布醇注射液及注射用吲哚菁綠两个仿制药注册批件

Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no
responsibility for the contents of this announcement, make no representation as to its accuracy or
completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or
in reliance upon the whole or any part of the contents of this announcement.

VOLUNTARY ANNOUNCEMENT
UPDATE ON PRODUCT DEVELOPMENT
The board of directors (the “Board”) of SSY Group Limited (the “Company”, together with its
subsidiaries, the “Group”) is pleased to announce that the Group has obtained the approval for drug
production and registration for Gadobutrol Injection (7.5ml:4.5354g) from National Medical Products
Administration of China (the “NMPA”), being under type 4 chemical drug and regarded as passing the
consistency evaluation. Gadobutrol Injection is mainly used for diagnostic purposes and is for
intravenous administration only. It is for adults and children of all ages (including full-term newborns).
It is mainly used for contrast-enhanced magnetic resonance imaging (CE-MRI) examinations of lesions
in various parts of the body (including the brain and spinal cord), as well as contrast-enhanced magnetic
resonance angiography (CE-MRA) examinations of various parts of the body.
As stated in the Company’s announcement dated 21 July 2026, the Group’s Gadobutrol bulk drug has
obtained the approval for registration from the NMPA to become a bulk drug for the preparations on
the market. As a new generation of magnetic resonance imaging contrast agent with macrocyclic
structure, Gadobutrol further enriches the Group’s product portfolio of diagnostic treatment drugs.
Gadolinium is a rare-earth metal, and this approval of injection completes the integrated business layout
of bulk drugs and injection preparations under Gadolinium category, which helps expand the clinical
market for medical imaging and creates business synergies with the Group’s existing formulations.
The Board is also pleased to announce that the Group has obtained the approval for drug production
and registration for Indocyanine Green for Injection (25mg) from the NMPA, being under type 3
chemical drug and regarded as passing the consistency evaluation. Indocyanine Green for Injection is
mainly used to diagnose various liver diseases such as cirrhosis, liver fibrosis, chronic hepatitis,
occupational and drug-induced liver diseases, and to understand the extent of damage and reserve
function of liver. It can also be used for choroidal angiography to determine the location of choroidal
diseases.

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As stated in the Company’s announcement dated 9 September 2025, the Group’s Indocyanine Green
bulk drug has obtained the approval for registration from the NMPA to become a bulk drug for the
preparations on the market. This approval of powder form for injection further improves the product
portfolio for perioperative and ICU department. Leveraging the advantage of integration of bulk drugs
and preparations, it helps expand the surgical and critical care market in 3A hospitals, and creates
synergies with existing preparations for critical care.
This announcement is a voluntary announcement made by the Company to keep the shareholders and
potential investors informed of the latest business development of the Group.
By order of the Board
Chow Hing Yeung
Executive Director and Company Secretary
Hong Kong, 27 August 2026
As at the date of this announcement, the Board comprises Mr. Qu Jiguang, Mr. Su Xuejun, Mr. Meng
Guo, Mr. Chow Hing Yeung and Ms. Qu Wanrong as executive Directors, Mr. Liu Wenjun as
non-executive Director, and Mr. Wang Yibing, Mr. Chow Kwok Wai and Mr. Jiang Guangce as
independent non-executive Directors.

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香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確
性或完整性亦不發表任何聲明，並明確表示，概不會就因本公告全部或任何部份內容而產生
或因倚賴該等內容而引致之任何損失承擔任何責任。

自願公告
產品開發的最新進展
石四藥集團有限公司（「本公司」
，連同其附屬公司，
「本集團」）董事局（「董事局」）欣然公告，
本集團已取得中國國家藥品監督管理局（「國家藥監局」）有關釓布醇注射液(7.5ml：4.5354g)的
藥品生產註冊批件，屬於化學藥品第4類，視同通過一致性評價。釓布醇注射液主要用於診斷，
僅供靜脈內給藥，適用於成人及全年齡段兒童（包括足月新生兒）
，主要用於全身各部位（包括
顱腦和脊髓）病變的對比增強磁共振成像（CE-MRI）檢查，及全身各部位的對比增強磁共振血
管造影（CE-MRA）檢查。
誠如本公司日期為二零二六年七月二十一日之公告所載，本集團的釓布醇原料藥已獲國家藥監
局批准登記成為在上市製劑使用的原料藥。釓布醇作為新一代大環結構磁共振成像造影劑，進
一步豐富本集團診療用藥產品矩陣。釓是一種稀土金屬，此次注射液獲批落實釓類原料藥及注
射製劑一體化業務佈局，助力拓展醫學影像臨床市場，並與本集團現有製劑形成業務協同。
董事局亦欣然公告，本集團已取得國家藥監局有關注射用吲哚菁綠（25mg），屬於化學藥品第
3類，視同通過一致性評價。注射用吲哚菁綠主要用於診斷肝硬化、肝纖維化、韌性肝炎、職業
和藥物中毒性肝病等各種肝臟疾病，瞭解肝臟的損害程度及其儲備功能; 亦可用於脈絡膜血管
造影，確定脈絡膜疾患的位置。

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誠如本公司日期為二零二五年九月九日之公告所載，本集團的吲哚菁綠原料藥已獲國家藥監局
批准登記成為在上市製劑使用的原料藥。此次注射用粉劑獲批進一步完善圍手術期及 ICU 重
症科室產品佈局，依託原料藥及製劑一體化優勢，助力拓展三甲外科及重症醫療市場，與現有
重症製劑形成協同效應。
本公告為本公司自願發佈，目的是使股東及潛在投資者瞭解本集團最新業務發展情況。

承董事局命

執行董事兼公司秘書
周興揚
香港，二零二六年八月二十七日

於本公告日期，董事局成員包括執行董事曲繼廣先生、蘇學軍先生、孟國先生、周興揚先生及
曲婉蓉女士，非執行董事劉文軍先生，以及獨立非執行董事王亦兵先生、周國偉先生及姜廣策
先生。

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