On October 8, 2024, Newland Pharmaceutical Co., Ltd. (hereinafter referred to as "the Company") received the Approval Notice for the Marketing Application of the Chemical Active Pharmaceutical Ingredient for Ropivacaine Hydrochloride, approved and issued by the National Medical Products Administration (NMPA). The registration number is Y20220001314, and the notice number is 2024YS01021.

Drug Introduction

  Ropivacaine Hydrochloride is a long-acting amide-type local anesthetic with dual anesthetic and analgesic effects. Its pharmacological mechanism includes blocking nerve conduction and inhibiting the transmission of pain signals. It is widely used in surgical anesthesia, including epidural anesthesia (including for cesarean section), subarachnoid (spinal) anesthesia, and regional block. It is also indicated for acute pain management via continuous epidural infusion or intermittent single-dose administration, such as postoperative or vaginal delivery analgesia, and can provide analgesia through peripheral nerve block.

  The Company has obtained the Approval Notice for the Marketing Application of Chemical Active Pharmaceutical Ingredient for Ropivacaine Hydrochloride issued by the National Medical Products Administration (NMPA). The status of this API is shown as "A" on the CDE registration platform for APIs, excipients and packaging materials. 

Impact on the Company

  The Approval Notice for the Marketing Application of Chemical Active Pharmaceutical Ingredient for Ropivacaine Hydrochloride obtained by the Company confirms that the production of this API complies with the relevant Chinese drug review and technical standards, and that it has been approved for use in formulations marketed in China. The approval of this product will further enrich the Company's product portfolio.