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Shijiazhuang Sihua Pharmaceutical Group’s three new products—diprophylline injection, furosemide tablets, and formoterol fumarate inhalation solution—were approved on the same day.

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Honors Announcement

发布时间：2025-06-30

【概要描述】 Accelerating efforts to achieve “more than half” in both quantity and quality, while further speeding up innovation. On June 30, Shijiazhuang Sihua Pharmaceutical Group’s three newly developed products—the Class 3 chemical drug dihydroxypropyltheophylline injection (2 ml: 0.3 g), furosemide tablets, and the Class 4 chemical drug formoterol fumarate inhalation solution (2 ml: 20 μg)—each received approval for drug production registration from the National Medical Products Administration on the same day, which is deemed equivalent to passing the bioequivalence evaluation for generic drugs. To date, the Group has a total of 135 drug varieties comprising 180 dosage forms that have either passed or are deemed to have passed the bioequivalence evaluation.

Shijiazhuang Sihua Pharmaceutical Group’s three new products—diprophylline injection, furosemide tablets, and formoterol fumarate inhalation solution—were approved on the same day.

Accelerating efforts to achieve “more than half” in both quantity and quality, with innovation gaining further momentum. On June 30, Shijiazhuang Sihua Pharmaceutical Group received approval from the National Medical Products Administration for the production registration of three new products: Class 3 chemical drug Dihydroxypropyltheophylline Injection (2 mL: 0.3 g), Furosemide Tablets, and Class 4 chemical drug Formoterol Fumarate Inhalation Solution (2 mL: 20 μg)—all of which are deemed to have passed the bioequivalence evaluation for generic drugs. To date, the Group has a total of 135 drug varieties comprising 180 dosage forms that have either passed or are deemed to have passed the bioequivalence evaluation.

According to reports, theophylline dihydrate injection is indicated for relieving wheezing symptoms in conditions such as bronchial asthma, asthmatic bronchitis, and obstructive emphysema, and may also be used for wheezing caused by cardiogenic pulmonary edema. In April 2025, the group’s application for registration of theophylline dihydrate API was approved by the National Medical Products Administration, designating it as an API for use in marketed dosage forms. Data from MeneNet show that in 2023, sales of theophylline dihydrate injection across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 230 million, declining to about RMB 190 million in 2024.

Furosemide tablets, as a commonly used diuretic, are indicated for conditions such as edema, hypertension, hypercalcemia and hyperkalemia, dilutional hyponatremia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), acute drug or toxin poisoning, and the prevention of acute renal failure. Currently, the furosemide products developed by the Group are available in both injectable solution and tablet formulations. According to data from MeneNet, sales of furosemide tablets in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—amounted to approximately RMB 496 million in 2023 and about RMB 210 million in 2024.

Formoterol fumarate inhalation solution is indicated for the maintenance treatment of airway obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Previously, in May 2024, the group’s developed formoterol fumarate API was approved by the National Medical Products Administration for registration as an API used in marketed dosage forms. According to data from MeneNet, sales of formoterol fumarate inhalation solution in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—amounted to approximately RMB 72.76 million in 2023 and about RMB 310 million in 2024, with further room for growth at present.

Since the beginning of this year, the Group has focused on “newness,” committing itself to researching and developing more “Chinese medicines” that are tailored to the genetic heritage and physical characteristics of the Chinese population. The Group has steadily advanced integrated development of active pharmaceutical ingredients (APIs) and finished dosage forms, with a steady accumulation of innovative achievements and an ever-expanding pipeline of new products. The recent approval of three new products will further highlight the Group’s advantages in integrated API–formulation development and create favorable conditions for enhancing product accessibility.

To date this year, a total of 42 new formulations and active pharmaceutical ingredients have been approved, including 32 formulation specifications and 10 API varieties. This increasingly diversified product portfolio and continuously optimized product mix provide strong support for the company to accelerate its transformation and development while enhancing quality and efficiency.

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