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On the same day, two blockbuster products from Shijiazhuang Sihua Pharmaceutical Group—the levamlodipine besylate tablets (2.5 mg and 5 mg) and magnesium sulfate injection (5 mL: 2.5 mg)—received approval for expanded indications.

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Honors Announcement

发布时间：2025-10-17

【概要描述】 On October 17, Shijiazhuang Sihua Pharmaceutical Group received another major approval: its Class 4 chemical drug—levamlodipine besylate tablets (2.5 mg and 5 mg)—was granted a production registration certificate by the National Medical Products Administration, which is deemed equivalent to having passed the evaluation of generic drug quality and therapeutic equivalence. Concurrently, an expanded indication for magnesium sulfate injection (5 mL: 2.5 mg) also received approval on the same day and is likewise considered to have passed the equivalence assessment. Since the beginning of this year, the Group has secured approvals for a total of 57 new dosage-form products, bringing the cumulative number of products that have either passed or are deemed to have passed the equivalence assessment to 154 varieties encompassing 205 specifications.

On the same day, two blockbuster products from Shijiazhuang Sihua Pharmaceutical Group—the levamlodipine besylate tablets (2.5 mg and 5 mg) and magnesium sulfate injection (5 mL: 2.5 mg)—received approval for expanded indications.

On October 17, Shijiazhuang Sihua Pharmaceutical Group received another major approval: its Class 4 chemical drug—levamlodipine besylate tablets (2.5 mg and 5 mg)—was granted a production registration certificate by the National Medical Products Administration, which is deemed equivalent to having passed the evaluation of generic drug quality and therapeutic equivalence. Concurrently, an expanded indication for magnesium sulfate injection (5 mL: 2.5 mg) also received approval on the same day and is likewise considered to have passed the equivalence assessment. Since the beginning of this year, the Group has secured approvals for a total of 57 new dosage-form products, bringing the cumulative number of products that have either passed or are deemed to have passed the equivalence assessment to 154 varieties encompassing 205 specifications.

According to available information, levamlodipine besylate tablets are a dihydropyridine calcium channel blocker indicated for the treatment of hypertension and angina pectoris. Data from MeneNet show that in 2023, sales of levamlodipine besylate tablets across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 1.99 billion, while in 2024 sales declined to about RMB 1.35 billion, underscoring its significant clinical value. Magnesium sulfate injection is used as an anticonvulsant in the management of hypertensive disorders of pregnancy to lower blood pressure and treat gestational hypertension, pre-eclampsia, and eclampsia. MeneNet data indicate that in 2023, sales of magnesium sulfate injection across these same three channels amounted to roughly RMB 290 million, falling to about RMB 250 million in 2024.

The newly approved levamlodipine besylate tablets represent another blockbuster product developed by the Group in recent years in the cardiovascular therapeutic area. Together with existing products such as valsartan–amlodipine tablets (I), bisoprolol–amlodipine tablets, felodipine extended-release tablets, arginine perindopril tablets, urapidil extended-release capsules, benidipine hydrochloride tablets, and dronedarone hydrochloride tablets, this product helps to build a comprehensive portfolio of cardiovascular chronic-disease medications covering indications including hypertension, angina pectoris, and arrhythmias. This portfolio spans multiple tiers—ranging from monotherapy to combination therapy and from acute-phase management to long-term disease control—thereby providing clinicians with a broader range of therapeutic options and more diversified treatment strategies. It also provides strong support for further strengthening the Group’s market presence and development in the cardiovascular therapeutics segment.

Meanwhile, the newly approved magnesium sulfate injection (5 mL: 2.5 mg) expands the product portfolio, complementing the three previously approved formulations—magnesium sulfate injection (20 mL: 10 g, 10 mL: 5 g, and 2 mL: 1 g)—to create a more comprehensive line of dosage forms and offer the market a broader range of therapeutic options.

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