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Shijiazhuang Sihua Pharmaceutical Group’s two new products—Tranexamic Acid Sodium Chloride Injection and Levocarnitine Oral Solution—were approved on the same day.

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Honors Announcement

发布时间：2025-06-12

【概要描述】 Continuous innovation has yielded a steady stream of achievements. On June 12, Shijiazhuang Sihua Pharmaceutical Group’s two newly developed products—the Class 3 chemical drug tranexamic acid sodium chloride injection (100 mL: tranexamic acid 1.0 g and sodium chloride 0.7 g) and the Class 4 chemical drug levocarnitine oral solution (10 mL: 1 g)—both received approval for drug production registration from the National Medical Products Administration on the same day and are deemed to have passed the bioequivalence evaluation for generic drugs.

Shijiazhuang Sihua Pharmaceutical Group’s two new products—Tranexamic Acid Sodium Chloride Injection and Levocarnitine Oral Solution—were approved on the same day.

Continuous innovation has yielded a steady stream of achievements. On June 12, Shijiazhuang Sihua Pharmaceutical Group’s two new products—the Class 3 chemical drug tranexamic acid sodium chloride injection (100 mL: tranexamic acid 1.0 g and sodium chloride 0.7 g) and the Class 4 chemical drug levocarnitine oral solution (10 mL: 1 g)—both received drug production registration approvals from the National Medical Products Administration on the same day and are deemed to have passed the bioequivalence evaluation for generic drugs.

To date, the Group has received approval for 29 new formulation products this year, bringing the total number of approved and evaluated products to 177 specifications across 132 varieties.

According to available information, tranexamic acid sodium chloride injection is primarily indicated for various types of bleeding caused by acute or chronic, localized or systemic primary hyperfibrinolysis. Levocarnitine oral solution is used to treat primary systemic carnitine deficiency as well as secondary carnitine deficiency resulting from congenital metabolic disorders.

Previously, the Group obtained marketing authorization for tranexamic acid tablets in February 2025; the recent approval of the injectable formulation further expands the company’s product portfolio for this indication, creating new opportunities to better meet the differentiated needs of various markets. According to data from MeneNet, sales of tranexamic acid sodium chloride injection in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 147 million in 2024.

Currently, levocarnitine is available in China primarily as an oral solution and an injectable formulation, with the oral solution market demonstrating particularly strong performance in recent years. In 2024, sales revenue for this product reached approximately RMB 252 million.

In recent years, the Group has proactively adapted to market changes by adopting an R&D innovation strategy that integrates generic and innovative drug development, emphasizes distinctive product features, and focuses on key areas, while systematically advancing the development of oral dosage forms. Since the beginning of this year, the Group has secured approval for 14 new oral dosage forms, accounting for half of all approved formulations. This increasingly robust portfolio of oral products and the ongoing optimization of the product mix have provided strong support for accelerating the Company’s transformation and development.

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