SSY GROUP (02005.HK): Four Products Receive NMPA Drug Manufacturing Registration Approvals, Deepening Infusion Therapy and Ophthalmology Portfolio

NewTimeSpace News: SSY GROUP announced that four products received NMPA drug manufacturing registration approvals, all deemed to have passed the consistency evaluation; the Potassium Chloride Injection (II) represents the second domestic enterprise approval, further strengthening the therapeutic infusion layout in the ICU field; both Sodium Hyaluronate Eye Drops feature single-dose preservative-free packaging, forming a stratified dry eye treatment portfolio together with previously approved products; the approval of Metoclopramide Tablets marks the realization of API-to-formulation vertical integration.

NewTimeSpace News: SSY Group Limited (stock code: 02005) announced that the board of directors is pleased to announce that the Group has obtained drug manufacturing registration approvals from the National Medical Products Administration (NMPA) for four products, all of which are deemed to have passed the consistency evaluation.

Potassium Chloride Injection (II) (100ml:1.5g), classified as a Category 3 chemical drug, is primarily indicated for the treatment of hypokalemia when oral potassium supplementation is not feasible. The Group is the second domestic enterprise to receive approval for this product. The announcement disclosed that this product further enriches the Group's therapeutic infusion product portfolio and strengthens its product layout and specialized clinical supply capabilities in the intensive care unit (ICU) field.

In addition, two Sodium Hyaluronate Eye Drops received approval simultaneously—0.3% (0.4ml:1.2mg) and 0.1% (0.4ml:0.4mg), both classified as Category 4 chemical drugs. The 0.3% specification is primarily indicated for the treatment of keratoconjunctival epithelial damage associated with endogenous conditions such as Sjögren's syndrome, Stevens-Johnson syndrome, and dry eye syndrome, as well as exogenous conditions including post-surgery, drug-induced, traumatic, and contact lens wear-related disorders. The 0.1% specification is primarily indicated for dry eye disease and relief of dry eye symptoms. Both eye drop products feature single-dose preservative-free packaging, and together with the previously approved Polyvinyl Alcohol Eye Drops, they form a product portfolio covering different severity levels of dry eye disease, offering patients stratified treatment options. In terms of strategic layout, the Group has entered the ophthalmic drug segment with its single-dose preservative-free formulation strategy, having established a product matrix covering anti-infectives, anti-allergics, intraocular pressure-lowering agents, artificial tears, and ocular anti-inflammatories, forming a dual-channel layout of hospital prescription drugs and retail OTC.

As for the fourth product, Metoclopramide Tablets (5mg), classified as a Category 3 chemical drug, is primarily indicated for the symptomatic treatment of nausea and vomiting of various etiologies, short-term treatment of symptomatic gastroesophageal reflux that is unresponsive to conventional therapy, and relief of symptoms of acute and recurrent diabetic gastroparesis. The Group had previously announced on 27 February 2026 that its Metoclopramide API had been approved and registered by the NMPA for use as an active pharmaceutical ingredient in marketed formulations.

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