공고 • 22h
SSY Group Limited Announces Update on Drug Approvals Enhancing Diversified Pharmaceutical Product Portfolio The board of directors of SSY Group Limited announced that the Group has obtained the approvals for drug production and registration for the following four products from National Medical Products Administration of China, all being under type 4 chemical drug and regarded as passing the consistency evaluation. Hemofiltration Replacement Fluid of Sodium Citrate (5000ml): This product is mainly used as a replacement fluid in continuous renal replacement therapy (CRRT) with local citrate anticoagulation, and is particularly suitable for patients such as those with an increased risk of bleeding who are not advised for systemic anticoagulation with heparin. Compared to clinical mainstream split citrate formula (bicarbonate replacement fluid combined with a separate sodium citrate anticoagulant), this product has significant clinical advantages and a promising market prospect. The Group is actively developing large-volume injections such as hemofiltration replacement solutions and peritoneal dialysis solutions, further improving its product portfolio. Benidipine Hydrochloride Tablets (4mg): This product is mainly used for the treatment of primary hypertension and angina pectoris. The Group has established a comprehensive hypertension product portfolio, covering 2nd and 3rd generation calcium channel blockers, ACE inhibitors, -receptor blockers, and multiple single- tablet compound preparations, along with intravenous emergency antihypertensive drugs used in intensive care unit (ICU). Among which, the Group's Benidipine Hydrochloride Tablets in 8mg specification has been approved for market and selected in the tender result of the eleventh batch of the National Centralised Medicines Procurement. With the approval of its 4mg specification, the initial low-dose treatment needs for hypertension can be fully met, forming a complete dose gradient of "initial titration 4mg + maintenance therapy 8mg". Polyvinyl Alcohol Eye Drops 1.4% (0.4ml: 5.6mg): This product is mainly used as a lubricant for prevention or treatment of irritation symptoms such as dry eyes, foreign matter sensation and eye fatigue, or for improvement of eye dryness symptoms. Polyvinyl Alcohol Eye Drop is in single-dose packaging, preservative-free, and is an OTC product for office workers experiencing eye strain, people spending long time at screens or with sensitive ocular surfaces for their immediate relief of dry eyes. The Group has a strategic layout in ophthalmic drug segment with single-dose and preservative-free formulations, and has built a product portfolio including anti-infectives, anti-allergens, intraocular pressure lowering, artificial tears and ocular anti-inflammatory, forming a dual-channel layout of in-hospital prescription drugs and retail OTC. Fat Emulsion, Amino Acids (17) and Glucose (19%) Injection (1540ml and 1026ml): This product is mainly used for adult patients who are unable, with impaired function or not advised for receiving nutrition orally or enterally. This product is a complex three-chamber bag preparation for parenteral nutrition with high technological barriers. It is mainly used for intravenous nutritional support in adult patients after surgery, those with tumors or in ICU. The newly approved 1540ml and 1026ml specifications can meet the individualised clinical needs of patients with different weights and energy requirements. The Group is systematically developing a parenteral nutrition product platform covering premixed three-chamber bag all-in-one preparations, nutrients, vitamins, trace elements and electrolyte supplements. This approval further enhances the Group's high-end intravenous nutrition product portfolio, creating synergy with its basic infusion, amino acid and fat emulsion series, and will bring a positive effect on its expansion into the perioperative and critical care nutrition markets. 공고 • Jul 21
SSY Group Limited Obtains Approval For Registration Of Gadobutrol As Bulk Drug For Market Preparations SSY Group Limited has announced that the Group’s Gadobutrol has obtained the approval for registration from the National Medical Products Administration of China to become a bulk drug for the preparations on the market. Gadobutrol is a magnetic resonance imaging contrast agent used for adults and children of all ages (including full-term newborns), and 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. Gadobutrol, as a new generation of magnetic resonance imaging contrast agent with macrocyclic structure, is more stable and safer than Gadopentetate Dimeglumine with linear structure, offering advantage for clinical substitution. Gadolinium is a rare-earth metal, and the Group is actively developing an integrated business of bulk drugs and injection preparations under Gadolinium category. 공고 • Jul 18
Ssy Group Limited Obtains Approval for Drug Production and Registration of Choline Fenofibrate Sustained-Release Capsules SSY Group Limited has obtained the approval for drug production and registration for Choline Fenofibrate Sustained-release Capsules (135mg) from National Medical Products Administration of China, being under type 4 chemical drug and regarded as passing the consistency evaluation. Choline Fenofibrate Sustained-release Capsule is mainly used in adults with controlled diets for lowering triglyceride levels in patients with severe hypertriglyceridemia, and for treatment of patients with primary hypercholesterolemia or mixed dyslipidemia. As compared to traditional fenofibrate, choline fenofibrate has a direct effect, a lower liver and kidney burden, can be taken without dietary restrictions and safely combined with statins drug, making it a high-end triglyceride-lowering product of next generation with clinical necessity. 공고 • Jul 13
SSY Group Limited Obtains Approval for Registration of Baloxavir Marboxil as Bulk Drug in China SSY Group Limited announced that the Group’s Baloxavir Marboxil has obtained the approval for registration from the National Medical Products Administration of China to become a bulk drug for the preparations on the market, being the third of such approvals for the PRC entities. Baloxavir Marboxil is mainly used for the treatment of influenza A and influenza B. 공고 • Jun 24
SSY Group Limited Obtains Approval for Drug Production and Registration for Safinamide Mesylate Tablets and Procaterol Hydrochloride Inhalation Solution SSY Group Limited has obtained the approval for drug production and registration for Safinamide Mesylate Tablets (100mg and 50mg) from National Medical Products Administration of China (the NMPA), being under type 4 chemical drug, regarded as passing the consistency evaluation and the third of such approvals for the PRC entities. Safinamide Mesylate Tablet is mainly used in combination therapy for adult patients with primary Parkinson’s disease and symptoms fluctuation, in combination with other drugs for Parkinson’s disease such as levodopa. As stated in the Company’s announcement dated 26 May 2026, the Group’s Safinamide Mesylate bulk drug has obtained the approval for registration from the NMPA to become a bulk drug for the preparations on the market. The Group has obtained the approval for drug production and registration for Procaterol Hydrochloride Inhalation Solution (0.3ml: 30µg) from the NMPA, being under type 3 chemical drug and regarded as passing the consistency evaluation. Procaterol Hydrochloride Inhalation Solution is mainly used in the relief of various symptoms based on airflow limitation in bronchial asthma, chronic bronchitis and emphysema. 
