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New Year, New Products, New Momentum: Shijiazhuang No.4 Pharmaceutical Group Secures Consecutive Approvals for New Products

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Honors Announcement

发布时间：2023-01-06

【概要描述】 At the start of the new year, Shijiazhuang Sihua Pharmaceutical Group has been receiving one piece of good news after another in its research and development efforts. Following the recent approval by the National Medical Products Administration for the production of 200 mL ciprofloxacin lactate and sodium chloride injection, just one day later the company simultaneously secured drug production registration approvals for two additional new products: felodipine sustained-release tablets (5 mg) and lacosamide injection (20 mL: 0.2 g).

New Year, New Products, New Momentum: Shijiazhuang No.4 Pharmaceutical Group Secures Consecutive Approvals for New Products

At the start of the new year, Shijiazhuang Sihua Pharmaceutical Group has been receiving one piece of good news after another in its research and development efforts. Following the recent approval by the National Medical Products Administration for the production of 200 mL ciprofloxacin lactate and sodium chloride injection, just one day later the company simultaneously secured drug production registration approvals for two additional new products: felodipine sustained-release tablets (5 mg) and lacosamide injection (20 mL: 0.2 g).

According to available information, the two newly approved products both fall under Category 4 of chemical drugs and are deemed to have passed the consistency evaluation. Specifically, felodipine extended-release tablets are primarily indicated for the treatment of hypertension and stable angina pectoris, while lacosamide injection is mainly used as adjunctive therapy for partial seizures in patients with epilepsy.

Previously, Shijiazhuang Sihua Pharmaceutical submitted applications for two strengths of lacosamide tablets—50 mg and 100 mg—and in October 2021 received drug registration certificates from the National Medical Products Administration, which were deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs. In May 2022, the lacosamide API produced by Guangxiang Pharmaceutical, a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the national authorities, enabling its official use in marketed dosage forms. The recent approval of the 20 mL lacosamide injection will further expand the product portfolio, making the product line more comprehensive and well-rounded.

To date, Siyao has achieved bioequivalence for 34 drug varieties encompassing 45 dosage forms and strengths, laying a solid foundation for optimizing its product portfolio and enhancing its competitiveness in the market.

Over the past two years, Shijiazhuang Sihua Pharmaceutical Group has been driven by innovation, actively implementing a “API-plus-formulation” development strategy. The company has aligned its innovation chain with the industrial value chain, comprehensively advancing the R&D of generic drugs, innovative medicines, specialty APIs, pharmaceutical packaging materials, and products undergoing bioequivalence evaluation. It has also accelerated its strategic positioning in key therapeutic areas such as antivirals, antibacterials, cough suppressants and expectorants, anticancer agents, neurological disorders, cardiovascular diseases, gastrointestinal conditions, and anesthesia. In 2022, benefiting from a comprehensive package of national, provincial, and municipal policies designed to support enterprises, Sihua continued to increase its R&D investment. Leveraging an innovation mechanism that integrates industry, academia, research, and application, the company has established an innovation consortium led by the enterprise, supported by universities and research institutes, and characterized by close collaboration among all relevant innovation players. This collaborative framework continuously provides new momentum and creates fresh opportunities for the company to enter emerging markets, build new competitive advantages, and shape a new development landscape.

Continuous innovation has enabled Shijiazhuang Sihua Pharmaceutical to accumulate a robust pipeline of R&D achievements that are now yielding significant results. Currently, the company has nearly 200 projects in development and more than 100 new products awaiting approval, establishing a new paradigm of product iteration characterized by “developing a batch, stockpiling a batch, and commercializing a batch.” In 2022, the company secured a total of 37 product approvals across various categories, with its R&D efficiency for specialty generic drugs and the number of applications submitted ranking among the top in the domestic industry. This ever-expanding portfolio of innovative achievements provides a stronger foundation and a powerful growth engine for the company’s high-quality development.

Keywords:

Guangxiang Pharmaceutical of Shijiazhuang Sihua Pharmaceutical Group Recognized as a Provincial Model Enterprise for Technological Innovation

Guolong Pharmaceutical of the Group Recognized as a Provincial Benchmark for Quality in Industrial Enterprises

Guangxiang Pharmaceutical of Shijiazhuang Sihua Pharmaceutical Group Recognized as a Provincial Model Enterprise for Technological Innovation

Guolong Pharmaceutical of the Group Recognized as a Provincial Benchmark for Quality in Industrial Enterprises