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ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
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INNOVATIONSSY Group Limited has built a relatively perfect scientific research and innovation system with the development mode of “production, learning, research, and application” of multi-disciplinary integration and multi-directional combination.
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RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
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SUBSIDIARIESThe company has a diversified business development pattern of R&D, production and export of new drugs, generic drugs, characteristic APIs, advanced finished pharmaceutical products, biological preparations and pharmaceutical packaging materials.
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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Shijiazhuang Sihua Pharmaceutical Approved to Initiate Clinical Trials for a Class 1 New Drug
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发布时间：2020-11-11
On November 6, Shijiazhuang Sihua Pharmaceutical Co., Ltd. received from the National Medical Products Administration an approval notice for the clinical trial of the NP-01 tablet, authorizing the conduct of clinical trials in advanced solid tumors, including gastric cancer, lung cancer, and liver cancer. This milestone signifies that Shijiazhuang Sihua Pharmaceutical now possesses comprehensive capabilities in innovative drug research.
According to reports, NP-01 is a novel small-molecule compound jointly developed by Shijiazhuang Sihua Pharmaceutical and domestic research institutions, possessing independent intellectual property rights. Its patent has been granted in China, the United States, and Europe, classifying it as a Class 1 new chemical entity. Studies have demonstrated that NP-01 exhibits outstanding antitumor activity in various tumor animal models, including gastric cancer, hepatocellular carcinoma, lung cancer, and prostate cancer.
Shijiazhuang Sihua Pharmaceutical, a national high-tech enterprise and one of China’s top 100 pharmaceutical companies, is firmly committed to fostering both domestic and international business loops. Guided by the new development philosophy, the company has deepened supply-side structural reform, aligned its strategy with an internationalization-oriented development vision, and vigorously implemented an innovation-driven growth strategy. Focusing on the cutting edge of research and development in innovative chemical drugs, Sihua adopts an integrated “industry–academia–research–application” model that emphasizes multidisciplinary integration and multi-stakeholder collaboration as its development paradigm. This approach has enabled the company to establish a relatively comprehensive R&D and innovation system among domestic pharmaceutical firms. To date, Sihua has jointly established innovation centers with leading universities and research institutes, including Zhejiang University, Zhengzhou University, Tianjin University, and the Chinese Academy of Medical Sciences, and has set up two provincial-level research centers (engineering laboratories), a National Enterprise Technology Center, a National Postdoctoral Research Station, a National–Local Joint Engineering Laboratory, an Academician Workstation, and other high-caliber innovation platforms. These initiatives have brought together an innovation team of more than 400 members led by top-tier talent, which has undertaken numerous major national and provincial projects in scientific and technological innovation and industrialization, thereby earning Sihua a place among the nation’s model innovative enterprises.
In recent years, Shijiazhuang Sihua Pharmaceutical has adhered to a development strategy that integrates generic and innovative drug R&D. While maintaining its leading position in China’s large-volume parenteral solutions market, the company has also prioritized the R&D of new oral solid dosage forms, active pharmaceutical ingredients, and pharmaceutical packaging materials. It has continuously accelerated the consolidation of its competitive advantages in key therapeutic areas—including anti-tumor, antibacterial, cardiovascular and cerebrovascular, respiratory, and psychiatric medications—as well as in the discovery and development of novel chemical entities, thereby building up robust innovation-driven momentum to propel the company toward becoming a enterprise with annual revenues exceeding RMB 10 billion.
“After years of painstaking accumulation, Shijiazhuang Sihua Pharmaceutical has built up the comprehensive capabilities needed to advance into innovative drug research. We are currently accelerating the development of our pipeline in chemical small-molecule drugs, novel drug-delivery systems, and generic pharmaceutical products, while also making significant progress in disruptive innovation, breakthrough therapeutic agents, and the discovery of landmark new targets for major diseases. Our Class 1 new drug, NP-01 tablets, has now received clinical trial approval from the National Medical Products Administration, marking a new era in Sihua’s innovative drug research and representing a truly milestone achievement,” said Su Xuejun, Chairman of Shijiazhuang Sihua Pharmaceutical.
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