SSY GROUP (HKEX: 02005) has announced that the group has obtained drug production registration approvals from China's National Medical Products Administration (NMPA) for the following four products. All are classified as chemical drug category 4 and are considered to have passed consistency evaluations.
The first product is Sodium Citrate Hemofiltration Replacement Solution (5000ml). This product is primarily used as a replacement fluid for Continuous Renal Replacement Therapy (CRRT) employing regional citrate anticoagulation, particularly suitable for patients with contraindications to systemic heparin anticoagulation, such as those with an increased bleeding risk. Compared to the mainstream clinical split citrate regimen (bicarbonate replacement solution paired with an independent sodium citrate anticoagulant), this product offers significant clinical advantages and has broad market prospects. The group is actively expanding its portfolio of large-volume injectables, including hemofiltration replacement solutions and peritoneal dialysis solutions, further enhancing its product offerings.
The second product is Benidipine Hydrochloride Tablets (4mg). This product is primarily used to treat essential hypertension and angina pectoris. The group has established a comprehensive hypertension product matrix, covering second and third-generation calcium channel blockers, ACE inhibitors, α-blockers, and several single-pill combination formulations, supported by intravenous emergency antihypertensive drugs for use in Intensive Care Units (ICU). Among these, the group's Benidipine Hydrochloride Tablets in the 8mg specification have already received market approval and were selected in the 11th national centralized drug procurement. With the approval of the 4mg specification, the product can fully meet the need for initial low-dose hypertension treatment, creating a complete dosage gradient of "starting titration at 4mg + maintenance therapy at 8mg."
The third product is Polyvinyl Alcohol Eye Drops 1.4% (0.4ml: 5.6mg). This product primarily acts as a lubricant to prevent or treat ocular irritation symptoms such as dryness, foreign body sensation, and eye fatigue, or to improve symptoms of ocular dryness. These single-dose, preservative-free eye drops serve as an over-the-counter (OTC) product for immediate relief of dry eyes among office workers experiencing visual fatigue, prolonged screen time, and individuals with sensitive ocular surfaces. With a strategic focus on the ophthalmology segment using single-dose, preservative-free formulations, the group has built a product matrix including anti-infectives, anti-allergics, intraocular pressure reducers, artificial tears, and ocular anti-inflammatories, establishing a dual-channel approach for hospital-prescribed drugs and retail OTC products.
The fourth product is Fat Emulsion, Amino Acids (17) and Glucose (19%) Injection (1540ml and 1026ml). This product is mainly intended for adult patients who cannot, have insufficient, or are contraindicated from receiving oral/enteral nutrition. As a complex three-chamber bag formulation for parenteral nutrition with high technical barriers, it is primarily used for intravenous nutritional support in adult patients post-surgery, with cancer, or in the ICU. The approval of the 1540ml and 1026ml specifications meets the personalized clinical needs of patients with different body weights and varying energy requirements. The group has systematically developed a parenteral nutrition product platform, covering premixed three-chamber all-in-one formulations, nutrients, vitamins, trace elements, and electrolyte supplements. This latest approval further enhances the group's high-end intravenous nutrition product matrix, creating synergies with its foundational infusions, amino acids, and fat emulsion series, which is expected to positively impact the expansion of the hospital perioperative and critical care nutrition markets.
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