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Supplementary Application for the Addition of Three New Dosage Forms of Class I New Drug NP-01 Tablets by Shijiazhuang Sihua Pharmaceutical Group Approved
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发布时间：2023-10-25
【概要描述】
On October 23, Shijiazhuang Sihua Pharmaceutical Group’s supplemental application for adding three dosage strengths (175 mg, 200 mg, and 275 mg) to the clinical trial of its Class I new drug NP-01 tablet was approved by the National Medical Products Administration.
On October 23, the National Medical Products Administration approved Shijiazhuang Sihua Pharmaceutical Group’s supplemental application to add three dosage strengths (175 mg, 200 mg, and 275 mg) to the clinical trial of its Class I new drug, NP-01 tablets.
According to reports, NP-01 tablets are an oral multi-target kinase inhibitor targeting KDR, Met, and Axl, classified as a Class 1 new chemical entity. Shijiazhuang Sihua Pharmaceutical obtained approval from the National Medical Products Administration for clinical trials in November 2020 and has since initiated Phase I clinical trials for advanced solid tumors, including gastric cancer, lung cancer, and liver cancer. Currently, the company is conducting a Phase I clinical study of NP-01 tablets, which has demonstrated good safety and tolerability, with preliminary evidence of clinical efficacy in some patients. The company plans to rapidly advance to Phase II clinical trials.
In recent years, Shijiazhuang Sihua Pharmaceutical has steadfastly pursued an innovation-driven development strategy, concentrating its strengths on tackling key scientific and technological challenges in the areas of innovative drugs, shortage medications, and treatments for rare diseases. The company has continuously accelerated its strategic planning and deployment in complex formulations, improved new drugs, and truly innovative medicines, marking a transition in its R&D efforts from generic drug development to a new phase of original, breakthrough research.
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