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Yabao Pharmaceutical: Scopolamine Transdermal Patch Obtains Clinical Trial Approval

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Yabao Pharmaceutical announced that it has recently received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration for scopolamine transdermal patch. The indication of this drug is for the prevention of postoperative nausea and vomiting associated with anesthesia and/or opioid analgesia and surgical recovery. The original drug TRANSDERM SCOP, jointly developed by ALZA and Ciba-Geigy, was approved by the FDA for marketing in the United States in 1979. In 2024, its sales in the U.S. amounted to approximately $8.31M. It is currently not marketed in China. The domestic scopolamine patch already on the market is indicated for the prevention of nausea and vomiting associated with motion sickness, which is significantly different from the indication of this clinically approved product. The company has invested approximately RMB 30.1739 million in research and development expenses. The drug must undergo bioequivalence studies and Phase III clinical trials, and be reviewed and approved by the National Medical Products Administration before it can be produced and marketed.
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