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Nicorandil for Injection Approved by Shijiazhuang Sihua Pharmaceutical Group

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Honors Announcement

发布时间：2024-03-05

【概要描述】 Spring breezes bring good news, heralding innovation and a bright future. On March 1, the Class 3 chemical drug injection Nicorandil, submitted by Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration, receiving drug production registration approval and being deemed to have passed the consistency evaluation. This marks the group’s third lyophilized powder for injection to receive approval, as well as its 14th new product approved so far this year.

Nicorandil for Injection Approved by Shijiazhuang Sihua Pharmaceutical Group

The spring breeze brings good news, heralding innovation and a bright future. On March 1, the Class 3 chemical injectable nicorandil submitted by Shijiazhuang Sihua Pharmaceutical Group was approved by the National Medical Products Administration, receiving drug production registration approval and being deemed to have passed the consistency evaluation. This marks the group’s third lyophilized powder for injection to receive approval, as well as its 14th new product approved so far this year.

According to available information, nicorandil for injection is a potassium channel opener primarily used in clinical practice to treat unstable angina. Nicorandil dilates coronary vessels, sustainably increases coronary blood flow, and inhibits coronary spasm; it also exerts nitrate-like effects, with particularly potent vasodilatory action on larger coronary arteries, thereby further augmenting coronary blood flow.

In recent years, Shijiazhuang Sihua Pharmaceutical Group has aligned its strategies with national development priorities and cutting-edge market demands, leveraging innovation as the driving force to strategically develop an integrated API–finished-product value chain and vigorously promote synergistic growth between APIs and related formulations. Previously, nicorandil submitted by the Group’s Hebei Guolong Pharmaceutical Co., Ltd. was approved by the National Medical Products Administration and registered as an API used in marketed finished products. The recent approval of injectable nicorandil, which is deemed to have passed the consistency evaluation, will play a positive role in further enriching the product portfolio, enhancing the quality and efficiency of both formulation and API operations, and achieving win-win outcomes.

Analyzing market trends by starting with the initial momentum and viewing the entire year through the lens of the year’s opening quarter, Shijiazhuang Sihua Pharmaceutical Group has continuously increased its R&D investment, allowing its innovative achievements to accumulate steadily and then emerge in a concentrated burst. Since the beginning of this year, the company has secured approval for 14 new products, including a high-end, complex formulation—propofol medium- and long-chain fat emulsion for injection—marking an accelerated upgrade in its innovation capabilities. Meanwhile, the group has achieved remarkable results in its consistency evaluation efforts: to date, 76 drug varieties comprising 101 dosage forms have either passed or been deemed to have passed the consistency evaluation. This ongoing enhancement of the company’s innovation capacity has laid a solid foundation for achieving its annual innovation targets.

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