-
ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
-
INNOVATIONSSY Group Limited has built a relatively perfect scientific research and innovation system with the development mode of “production, learning, research, and application” of multi-disciplinary integration and multi-directional combination.
-
RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
-
SUBSIDIARIESThe company has a diversified business development pattern of R&D, production and export of new drugs, generic drugs, characteristic APIs, advanced finished pharmaceutical products, biological preparations and pharmaceutical packaging materials.
-
CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Shijiazhuang Sihua Pharmaceutical Group Receives Concurrent Approval for Two New Products: Gabexate Mesylate Injection and Dronedarone Hydrochloride Tablets
Category:
发布时间：2025-05-21
【概要描述】
On May 21, Shijiazhuang Sihua Pharmaceutical Group’s two new products—the Class 3 chemical drug Gabexate Mesylate for Injection and the Class 4 chemical drug Dronedarone Hydrochloride Tablets—both received drug production registration approvals from the National Medical Products Administration on the same day and are deemed to have passed the consistency evaluation. To date this year, the Group has secured approval for 22 new dosage-form products, bringing its total number of approved and evaluated products to 170 specifications across 126 varieties.
On May 21, Shijiazhuang Sihua Pharmaceutical Group’s two new products—the Class 3 chemical drug Gabexate Mesylate Injection and the Class 4 chemical drug Dronedarone Hydrochloride Tablets—were simultaneously granted drug production registration approvals by the National Medical Products Administration, and are deemed to have passed the consistency evaluation. To date this year, the Group has received approval for 22 new dosage-form products, bringing its total number of approved and evaluated products to 170 specifications across 126 varieties.
According to available information, Gabexate Mesylate for Injection is a protease inhibitor primarily used in the treatment of acute mild (edematous) pancreatitis and as an adjunctive therapy for acute hemorrhagic necrotizing pancreatitis; it is widely employed in clinical practice for the emergency management of acute pancreatitis. Dronedarone Hydrochloride Tablets are a novel antiarrhythmic agent indicated mainly for patients with sinus rhythm who have a history of paroxysmal or persistent atrial fibrillation, aimed at reducing the risk of hospitalization due to atrial fibrillation (AF).
According to data from MeneNet, sales of gabexate mesylate for injection in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 170 million in 2022, about RMB 190 million in 2023, and roughly RMB 180 million in 2024, underscoring its broad market demand. For dronedarone hydrochloride tablets, sales in the same three channels reached RMB 23.96 million in 2022, RMB 30.77 million in 2023, and RMB 35.41 million in 2024.
Over the past two years, the Group has continuously deepened its integrated “API + Formulation” development strategy, steadily increasing R&D investment and market development efforts for specialty oral formulations and high-end injectables, with the aim of providing end-users with higher-quality, more accessible pharmaceutical options.
Keywords:
Recommended News
Share to
SERVICE HOTLINE
Address: Shimen Building, No. 8 Xingye Street, Shijiazhuang Economic and Technological Development Zone
Tel.: +86-311-67167130
Email: office@sjzsiyao.com
Mobile site
E code
Non-Commercial (Filing) – 2025-0091