Shijiazhuang Fourth Pharmaceutical Group Achieves Another Breakthrough in R&D Innovation! Two New Products—Ornidazole Injection and Lipoic Acid Injection—Have Been Approved.


Time:2023-02-03

On February 2, the chemical drug products—Oxazolidine Injection (3 ml: 0.5 g and 6 ml: 1 g) and Lipoic Acid Injection (24 ml: 600 mg)—submitted by Shijiazhuang Fourth Pharmaceutical Group received drug production registration approvals from the National Medical Products Administration on the same day, effectively being deemed as having passed the consistency evaluation. This marks another significant achievement for the group, following its receipt of approvals for five new products in the first month of this year, bringing the total number of innovative products approved to two new varieties across three specifications. The group has thus gotten off to an excellent start in R&D innovation.
On February 2, the chemical drug products—Oxazolidine Injection (3 ml: 0.5 g and 6 ml: 1 g) and Lipoic Acid Injection (24 ml: 600 mg)—submitted by Shijiazhuang Fourth Pharmaceutical Group simultaneously received drug production registration approvals from the National Medical Products Administration, which are deemed equivalent to passing the consistency evaluation. This marks another significant achievement for the group, following its receipt of approvals for five new products in the first month of this year, bringing the total number of innovative products approved to two new varieties across three specifications. The group has thus gotten off to an excellent start in R&D innovation.
It is reported that Ornidazole Injection is primarily indicated for the treatment of severe amebiasis affecting the intestines and liver, as well as for the treatment of postoperative infections caused by anaerobic bacteria sensitive to ornidazole and for the prevention of infections caused by such sensitive anaerobic bacteria following surgical procedures. Lipoic Acid Injection is primarily indicated for the treatment of sensory abnormalities resulting from diabetic peripheral neuropathy.
The head of the R&D center at Shijiazhuang Sihua Pharmaceutical Group stated that, as of now, the group has achieved consistency in 37 drug varieties and 49 specifications, giving it a head start and creating room for optimizing its product portfolio, gaining access to national centralized procurement, and enhancing its products’ market competitiveness.
Over the past two years, Shijiazhuang Four Pharmaceutical has taken innovation-driven development as its guiding principle and actively implemented a “API + Formulation” growth strategy. Focusing on industrial chain layout to support innovation chains, the company has coordinated and promoted research and development of high-end, complex generic drugs, innovative drugs, specialty APIs, pharmaceutical packaging materials, and products that have undergone consistency evaluations. It has also accelerated its strategic deployment in therapeutic areas including antiviral, antibacterial, cough-relief and expectorant, anti-tumor, nervous system, cardiovascular, digestive, and anesthetic therapies.
In the recently concluded year of 2022, Shijiazhuang No.4 Pharmaceutical leveraged a comprehensive package of supportive policies from the national, provincial, and municipal governments to continuously increase its R&D investment. By adopting an innovative mechanism that integrates industry, academia, research, and application, the company has established an innovation consortium led by the enterprise itself, supported by universities and research institutes, and characterized by synergistic collaboration among various innovation players. This has enabled the company to steadily forge ahead on new growth tracks, build new competitive advantages, create new development patterns, generate new driving forces, and unlock fresh opportunities. Continuous innovation has allowed Shijiazhuang No.4 Pharmaceutical to accumulate substantial R&D achievements that are now beginning to yield remarkable results. Currently, the company has nearly 200 projects under development and over 100 new products awaiting approval, ushering in a new phase of product iteration characterized by "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 rank among the top in the domestic industry. The increasingly abundant innovation outcomes have provided the company with a stronger foundation and a powerful engine for high-quality development.

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