FUDANZHANGJIANG (01349): Powder for oral solution of amphotericin B butyrate hydrochloride in visualizing brain glioma surgery has obtained a drug market application acceptance letter.

FUDANZHANGJIANG (01349) announced that its subsidiary Taizhou FUDANZHANGJIANG Pharmaceutical Co., Ltd. (Taizhou FUDANZHANGJIANG) has received the "Acceptance Notice" issued by the National Medical Products Administration (NMPA) for the listing application of Amikacin Sulfate Pentanoic Acid Oral Solution Powder (the drug) for visualizing malignant tissues in adult patients with high-grade malignant glioma (CNS WHO grade III-IV) during surgery. Glioma refers to tumors originating from glial cells and is the most common primary intracranial tumor, accounting for about 80% of all malignant brain tumors. Gliomas typically have characteristics such as high disability rates, high recurrence rates, high mortality rates, and short survival periods. According to publicly available data, the five-year mortality rate of gliomas in China ranks only behind pancreatic cancer and lung cancer among all types of tumors. Surgical resection is the primary treatment for gliomas, and a patient's prognosis is related to the extent of tumor resection. Therefore, the basic principle of surgery is to completely remove the diseased tissue as much as possible without damaging nearby normal brain tissue. However, most high-grade gliomas grow invasively and have unclear boundaries with surrounding normal brain tissue, making conventional surgery challenging. The company plans to develop intraoperative fluorescence guidance technology to indicate the edges of gliomas, real-time positioning, and guide the extent of resection, assisting surgeons in maximizing tumor removal while preserving healthy tissue to reduce postoperative neurological deficits, improve postoperative quality of life, and extend patient survival. The subsidiary Taizhou FUDANZHANGJIANG received the drug clinical trial application acceptance notice in December 2023 and initiated confirmatory clinical studies in June 2024 to evaluate the efficacy and safety of Amikacin Sulfate Pentanoic Acid Oral Solution Powder for oral administration in adult patients with high-grade malignant gliomas (CNS WHO grade III-IV) undergoing tumor resection guided by fluorescence. The clinical trial of the drug has been completed, and its drug registration application has recently been accepted. If the drug is approved for market, it will further enrich the product line of the group and enhance the overall competitiveness of the company. According to the requirements of relevant laws and regulations on drug registration in China, after the drug's application for market approval is accepted by the NMPA, it still needs to undergo technical review, on-site verification of drug registration, administrative approval, and other processes. The timing and outcome of obtaining the drug's market registration approval are uncertain. The acceptance of the drug's market application will not have a significant impact on the company's recent performance.