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Major New Launch: Shijiazhuang Sihua Pharmaceutical Group Receives Concurrent Approval for Three New Pharmaceutical Products—Procaterol Hydrochloride Inhalation Solution, Aminophylline Tablets, and Ademetionine Disulfonate for Injection

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Honors Announcement

发布时间：2025-11-24

【概要描述】 On November 24, Shijiazhuang Sihua Pharmaceutical Group’s applications for Class 3 chemical drugs—Procaterol Hydrochloride Inhalation Solution (0.5 ml: 50 μg) and Aminophylline Tablets (100 mg)—as well as its application for a Class 4 chemical drug—Ademetionine Disulfonate for Injection (0.5 g)—were granted manufacturing registration approval by the National Medical Products Administration, and are deemed to have passed the evaluation of generic drug quality and therapeutic equivalence. Notably, the Aminophylline Tablets represent the third domestically approved product of this type. To date this year, the Group has secured approval for a total of 83 new products, bringing the cumulative number of varieties that have either passed or are deemed to have passed the consistency evaluation to 160, encompassing 211 dosage forms.

Major New Launch: Shijiazhuang Sihua Pharmaceutical Group Receives Concurrent Approval for Three New Pharmaceutical Products—Procaterol Hydrochloride Inhalation Solution, Aminophylline Tablets, and Ademetionine Disulfonate for Injection

On November 24, Shijiazhuang Sihua Pharmaceutical Group’s applications for Class 3 chemical drugs—Procaterol Hydrochloride Inhalation Solution (0.5 ml: 50 μg) and Aminophylline Tablets (100 mg)—as well as its Class 4 chemical drug—Ademetionine Disulfonate for Injection (0.5 g)—were granted manufacturing registration approval by the National Medical Products Administration, and are deemed to have passed the evaluation of generic drug quality and therapeutic equivalence. Notably, the Aminophylline Tablets represent the third domestically approved product of this type. To date this year, the Group has secured approval for a total of 83 new products, bringing the cumulative number of varieties that have either passed or are deemed to have passed the consistency evaluation to 160, encompassing 211 dosage forms.

According to available information, procaterol hydrochloride inhalation solution is primarily used to relieve various symptoms associated with airflow limitation in conditions such as bronchial asthma, chronic bronchitis, and emphysema. Ademetionine disulfonate for injection is indicated for intrahepatic cholestasis caused by pre–cirrhotic liver disease and cirrhosis, as well as for intrahepatic cholestasis during pregnancy. Aminophylline tablets are indicated for the relief of wheezing symptoms in bronchial asthma, asthmatic bronchitis, obstructive emphysema, and other conditions; they may also be used for asthma secondary to cardiogenic pulmonary edema.

According to data from MeneNet, in 2024 the sales of procaterol hydrochloride inhalation solution across China’s three major end-user markets—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 130 million, with first-half 2025 sales reaching about RMB 190 million. For aminophylline tablets, sales in the same three markets amounted to roughly RMB 14.77 million in 2024, rising to approximately RMB 8.94 million in the first half of 2025.

In recent years, the Group has been guided by the need to meet demand in key segments of the pharmaceutical market, vigorously accelerating innovation-driven development. A steady stream of innovative achievements has propelled a rapid shift in the injectable dosage-form landscape—from a market dominated by large-volume parenterals to a more diversified portfolio encompassing aqueous injections, lyophilized powder for injection, emulsions, and inhalation formulations. Notably, significant progress has been made in the respiratory therapeutic area, with the Company securing approvals for multiple products, including terbutaline sulfate solution for nebulization, ipratropium bromide solution for inhalation, formoterol fumarate inhalation solution, and levalbuterol hydrochloride solution for nebulization. This diversified product pipeline provides greater choice for both the pharmaceutical market and patients.

Notably, the Group boasts a flagship product—aminophylline API. Previously, in 2023, the Group received approval for two specifications of aminophylline injection: 10 mL at 0.25 g and 20 mL at 0.5 g. The recent approval of aminophylline tablets (100 mg), which is deemed to have passed the consistency evaluation, further underscores the Group’s integrated “API-plus-formulation” development model and will positively contribute to enriching the product portfolio and boosting the production, sales, and distribution of both formulations and APIs.

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