New Year, New Products, New Momentum—Shijiazhuang Fourth Pharmaceutical Group’s New Products Approved One After Another
Category:
Time:2023-01-06
At the start of the new year, Shijiazhuang No.4 Pharmaceutical Group has been receiving one good news after another in its research and development efforts. Following the recent approval by the National Medical Products Administration for the 200ml ciprofloxacin lactate sodium injection, just one day later, two new products—felodipine sustained-release tablets (5mg) and lacosamide injection (20ml: 0.2g)—also simultaneously obtained drug production registration approvals.
At the start of the new year, Shijiazhuang Fourth Pharmaceutical Group has been receiving one good piece of news after another in its research and development efforts. Following the recent approval by the National Medical Products Administration for the 200ml ciprofloxacin lactate sodium injection, just one day later, two newly submitted products—felodipine sustained-release tablets (5mg) and lacosamide injection (20ml: 0.2g)—have simultaneously obtained drug production registration approvals.
It is understood that the two newly approved products both belong to Class 4 of chemical drugs and are deemed to have passed the consistency evaluation. Among them, felodipine extended-release tablets are primarily used for the treatment of hypertension and stable angina pectoris, while lacosamide injection is mainly indicated for the adjunctive treatment of partial-onset seizures in patients with epilepsy.
Previously, Shijiazhuang No.4 Pharmaceutical submitted applications for two specifications of lacosamide tablets—50 mg and 100 mg—and in October 2021, it received a drug registration certificate from the National Medical Products Administration, which is deemed equivalent to passing the evaluation of bioequivalence and therapeutic equivalence for generic drugs. In May 2022, the active pharmaceutical ingredient lacosamide produced by Guangxiang Pharmaceutical, a subsidiary of Shijiazhuang No.4 Pharmaceutical Group, was approved by the national authorities, enabling its official use in marketed formulations. The recent approval of the 20 ml lacosamide injection will help gradually expand the product line, making its structure more diverse and comprehensive.
As of now, Siyao has achieved consistency in 34 drug varieties across 45 specifications, laying a solid foundation for optimizing its product portfolio and participating in market competition.
Over the past two years, Shijiazhuang Fourth Pharmaceutical Group has been driven by innovation, actively implementing a “API + Finished Dosage Form” development strategy. Focusing on the industrial chain, the group has strategically arranged its innovation network, comprehensively promoting research and development across generic drugs, innovative drugs, specialty APIs, pharmaceutical packaging materials, and products undergoing consistency evaluations. It has also accelerated its efforts in key therapeutic areas such as antiviral, antibacterial, cough-relief and expectorant, anti-tumor, nervous system, cardiovascular, digestive, and anesthetic therapies. In the recently concluded year of 2022, benefiting from a comprehensive package of supportive policies at the national, provincial, and municipal levels, Fourth Pharmaceutical continued to increase its R&D investment. Leveraging an innovative mechanism integrating industry, academia, research, and application, the group has established an innovation consortium led by the company itself, supported by universities and research institutes, and featuring synergistic collaboration among various innovation players. This collaborative ecosystem continually provides new momentum and creates fresh opportunities for the company to explore new growth avenues, build new competitive advantages, and shape a new development landscape.
Continuous innovation has enabled Shijiazhuang Fourth Pharmaceutical to accumulate a wealth of R&D achievements that are now yielding remarkable results. Currently, the company has nearly 200 projects under development and over 100 new products awaiting approval, creating a new paradigm of product iteration—“developing a batch, reserving a batch, and commercializing a batch.” In 2022 alone, the company obtained a total of 37 product approvals across various categories. Its efficiency in developing specialty generic drugs and the number of applications submitted both rank among the top in the domestic industry. The increasingly abundant innovative achievements provide an even stronger foundation and a powerful engine for the company’s high-quality development.
Keywords:
Recommended News
SERVICE HOTLINE
Mobile site
E code
Business license