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Shijiazhuang Four Pharmaceutical has been approved to initiate clinical trials for a Class 1 new drug.

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Group Announcement

Time：2020-11-11

On November 6, Shijiazhuang Sihua Pharmaceutical Co., Ltd. received from the National Medical Products Administration a notice approving the clinical trial of NP-01 tablets, granting approval to conduct clinical trials for advanced solid tumors such as gastric cancer, lung cancer, and liver cancer.

On November 6, Shijiazhuang No.4 Pharmaceutical Co., Ltd. received from the National Medical Products Administration a notice approving the clinical trial of NP-01 tablets, granting approval to conduct clinical trials for advanced solid tumors such as gastric cancer, lung cancer, and liver cancer. This milestone signifies that Shijiazhuang No.4 Pharmaceutical now possesses comprehensive capabilities for innovative drug research.
It is reported that NP-01 is a novel small-molecule compound jointly developed by Shijiazhuang Four Pharmaceutical and a domestic research institution, possessing independent intellectual property rights. Its patent has been granted in China, the United States, and Europe, and it qualifies as a Class 1 new chemical entity drug. Studies have shown that NP-01 exhibits outstanding antitumor activity in various tumor animal models, including gastric cancer, liver cancer, lung cancer, and prostate cancer.
As a national high-tech enterprise and one of China’s top 100 pharmaceutical companies, Shijiazhuang Sihua Pharmaceutical Co., Ltd. is committed to fostering a dual-circulation strategy—both domestically and internationally—and is guided by a new development philosophy. The company is deepening supply-side structural reforms, focusing on an internationalized development strategy, and vigorously implementing an innovation-driven growth strategy. Targeting the cutting edge of chemical drug research and development, it adopts an integrated “industry-academia-research-application” model characterized by multidisciplinary integration and multi-faceted collaboration. This approach has enabled the company to establish a relatively comprehensive R&D and innovation system among domestic pharmaceutical enterprises. Sihua Pharmaceutical has successively joined forces with key universities and research institutes—including Zhejiang University, Zhengzhou University, Tianjin University, and the Chinese Academy of Medical Sciences—to set up innovation centers. It has also established two provincial-level research centers (engineering laboratories), a National Enterprise Technology Center, a National Postdoctoral Research Workstation, a National-Local Joint Engineering Laboratory, and an Academician Workstation—all high-level innovation platforms. The company has assembled an innovative team of over 400 members led by top-tier talent and is undertaking numerous major national and provincial science and technology innovation and industrialization projects, thereby earning its place among the nation’s exemplary innovation-driven enterprises.
In recent years, Shijiazhuang Fourth Pharmaceutical has adhered to a development strategy that combines generic drug development with innovative research and development. While maintaining its leading position in the domestic intravenous solution industry, the company has also focused on the R&D of new formulations for oral solid dosage forms, active pharmaceutical ingredients, and pharmaceutical packaging materials. It continues to accelerate the development of strengths in domestic markets for anti-tumor, antibacterial, cardiovascular and cerebrovascular, respiratory, and psychiatric drugs, as well as novel compounds, thereby accumulating innovative momentum for building a company with revenues exceeding 10 billion yuan.
"After years of painstaking efforts and solid accumulation, Shijiazhuang No.4 Pharmaceutical has developed comprehensive strengths that enable it to embark on the journey of innovative drug research. Currently, we are accelerating our efforts to build out our pipeline of small-molecule chemical drugs, novel drug delivery systems, and generic pharmaceutical products. We’re also making positive progress in groundbreaking innovation, revolutionary therapeutic drugs, and the exploration of landmark new targets for major diseases. The Class 1 new drug NP-01 tablets have received clinical approval from the National Medical Products Administration, marking a milestone and ushering in a new era for Shijiazhuang No.4 Pharmaceutical’s innovative drug research," said Su Xuejun, Chairman of Shijiazhuang No.4 Pharmaceutical.

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