SSY GROUP (02005.HK): Four Products Obtain NMPA Manufacturing Registration Approvals, All Deemed to Have Passed Consistency Evaluation
NewTimeSpace News: SSY Group Limited (02005.HK) announced that four pharmaceutical products of the Group have secured manufacturing approvals issued by NMPA. Classified as Category 4 chemical drugs, all are deemed to have passed generic consistency evaluation. The portfolio comprises Sodium Citrate Hemofiltration Replacement Fluid (5000ml), Benidipine Hydrochloride Tablets (4mg), 1.4% Polyvinyl Alcohol Eye Drops (0.4ml:5.6mg), and Fat Emulsion, Amino Acids (17) and Glucose (19%) Injection (1540ml & 1026ml). The approvals further enrich the Group’s product portfolio covering blood purification, hypertension, ophthalmology and parenteral nutrition.
NewTimeSpace News: On 23 July 2026, SSY Group Limited (02005.HK) released a voluntary announcement regarding the approval of four new products.
Sodium Citrate Hemofiltration Replacement Fluid (5000ml) serves as replacement fluid for continuous renal replacement therapy (CRRT) with regional citrate anticoagulation. It is indicated for patients unsuitable for systemic heparin anticoagulation such as those with elevated bleeding risks, demonstrating notable advantages over mainstream split citrate regimens. The Group is actively expanding its pipeline of large-volume parenteral formulations including hemofiltration replacement fluids and peritoneal dialysis solutions.
Benidipine Hydrochloride Tablets (4mg) are indicated for primary hypertension and angina pectoris. Approval of the 4mg strength meets clinical demands for low-dose initial hypertension treatment and completes a full dosage regimen featuring 4mg for initiation and titration plus 8mg for maintenance therapy. The Group has established a comprehensive hypertension product matrix.
1.4% Polyvinyl Alcohol Eye Drops (0.4ml:5.6mg) are preservative-free single-dose lubricants for the prevention and relief of eye dryness, foreign body sensation, eye strain and other ocular irritations. Strategically focusing on preservative-free single-dose ophthalmic formulations, the Group develops both hospital prescription medicines and retail OTC eye care products.
Fat Emulsion, Amino Acids (17) and Glucose (19%) Injection (1540ml & 1026ml) is a technically complex three-chamber bag parenteral nutrition formulation with high manufacturing barriers. It provides intravenous nutritional support for adult patients after surgery, cancer patients and ICU patients. The two specifications accommodate personalised clinical requirements for patients with varying body weight and energy demands.
NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.
Tags:
- SSY GROUP (02005.HK): Gadobutrol API Approved for Registration by NMPA, a New-Generation Macrocyclic MRI Contrast Agent
- SSY GROUP (02005.HK): Choline Fenofibrate Sustained-release Capsule Obtains Drug Production Registration Approval
- SSY GROUP (02005.HK): Baloxavir Marboxil API Approved for Registration, Becoming the Third Domestic Enterprise with Such Approval
- SSY GROUP (02005.HK): Propylthiouracil Tablets and Calcium Gluconate and Sodium Chloride Injection Obtain Drug Registration Approvals, Deemed to Have Passed Consistency Evaluation
- SSY GROUP (02005.HK): 95 Varieties Included in National Essential Medicines List (2026 Edition)