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Acetylcysteine Injection (25 ml: 5 g) by Shijiazhuang Sihua Pharmaceutical Group Approved

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Honors Announcement

发布时间：2025-12-11

【概要描述】 With the year drawing to a close and the final sprint to meet annual targets well underway, Shijiazhuang Sihua Pharmaceutical Group has once again delivered encouraging news in its pursuit of scientific research and innovation: on December 11, the Group’s Class 3 chemical drug—acetylcysteine injection (25 ml: 5 g)—received production registration approval from the National Medical Products Administration, which is deemed equivalent to passing the consistency evaluation. This makes Sihua the third company nationwide to obtain such approval, underscoring the Group’s robust capabilities in generic drug R&D. So far this year, the Group has secured approval for a total of 91 new products, surpassing its full-year total for 2024.

Acetylcysteine Injection (25 ml: 5 g) by Shijiazhuang Sihua Pharmaceutical Group Approved

With the year drawing to a close and the final sprint to achieve the annual targets well underway, Shijiazhuang Sihua Pharmaceutical Group has once again delivered encouraging news in its pursuit of scientific research and innovation: on December 11, the Group’s application for marketing authorization of Class 3 chemical drug acetylcysteine injection (25 mL: 5 g) was approved by the National Medical Products Administration, with the approval deemed to signify compliance with the bioequivalence evaluation. This makes Sihua the third company nationwide to receive such approval, underscoring the Group’s robust capabilities in generic drug R&D. So far this year, the Group has secured approval for a total of 91 new products, surpassing its full-year performance in 2024.

According to available information, acetylcysteine injection is indicated for the antidotal treatment of acute acetaminophen poisoning and for the prevention or mitigation of liver injury caused by overdose.

According to data from MeneNet, sales of acetylcysteine injection in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 560 million in 2024, with sales in the first half of 2025 reaching about RMB 130 million.

In recent years, guided by innovation-driven development and the pursuit of high-quality growth, the Group has continuously enhanced its innovation capabilities, consistently met market demands, and effectively accelerated the emergence of innovative achievements. To date, 164 drug varieties comprising 215 dosage forms have either passed or been deemed to have passed the consistency evaluation, providing strong momentum for the Company to capture untapped market opportunities and unlock new growth prospects. Looking ahead, the Group will remain committed to leveraging innovation as the primary driver to advance the research, development, and commercialization of more high-quality generic and innovative medicines, thereby expanding access to affordable therapeutic options for patients and contributing to the Healthy China initiative.

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Good News Abounds! Shijiazhuang Sihua Pharmaceutical Group’s Compound Sodium Acetate Ringer’s Injection (500 ml) Has Been Approved

Good News! Shijiazhuang No.4 Pharmaceutical Group’s Levofloxacin Ophthalmic Solution 0.488% (5 ml: 24.4 mg) and Compound Potassium Sulfate Granules Have Been Approved