Shanghai Pharmaceuticals Holding (02607): Pregabalin Capsules Obtain Singapore Drug Registration Certificate.
Shanghai Pharmaceuticals (02607) announced that recently, Prabalin Capsules produced by Changzhou Pharmaceutical Factory Co., Ltd. (hereinafter referred to as "Changzhou Pharmaceutical Factory"), a subsidiary of Shanghai Pharmaceuticals Group Co., Ltd. (hereinafter referred to as "Shanghai Pharmaceuticals" or "the Company"), has received a drug registration certificate issued by the Health Sciences Authority (HSA) of Singapore, and the drug has been approved for listing.
Shanghai Pharmaceuticals Holding (02607) announced that recently, Prufalin capsules (hereinafter referred to as "the drug") produced by Changzhou Pharmaceutical Co., Ltd., a subsidiary of Shanghai Pharmaceuticals Holding Group Co., Ltd. (hereinafter referred to as "Shanghai Pharmaceuticals Holding" or the "Company"), have received a drug registration certificate issued by the Health Sciences Authority (HSA) of Singapore, and the drug has been approved for listing.
Prufalin capsules are mainly used for the treatment of post-herpetic neuralgia, peripheral neuropathic pain in diabetes, fibromyalgia, neuropathic pain caused by spinal cord injuries, and as an adjuvant therapy for epilepsy.
In October 2019, Changzhou Pharmaceutical Co., Ltd. completed the research and development work of Prufalin capsules; in July 2021, the drug obtained an approval number from the Food and Drug Administration (FDA) of the United States (see Company announcement No. 2021-065); in June 2025, the drug obtained approval for listing from the Food and Drug Administration of Thailand. As of the date of this announcement, the Company has invested approximately RMB 2.19 million in research and development expenses for the listing of the drug in the Southeast Asian market (including Thailand, Singapore, Malaysia, and the Philippines).
The three specifications of Prufalin capsules (50mg, 75mg, 150mg) have obtained drug registration approval from the Health Sciences Authority of Singapore, indicating that the Company is qualified to sell the drug in the Singapore market. This will have a positive impact on the Company's expansion into overseas markets and will accumulate valuable experience.
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