<p>Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd. announced that its subsidiary, Taizhou Fudan-Zhangjiang Pharmaceutical Co., Ltd., has received an Acceptance Notice from the National Medical Products Administration (NMPA) of China for the Abbreviated New Drug Application (ANDA) of aminolevulinic acid hydrochloride powder for oral solution. The drug is indicated for intraoperative visualisation of malignant tissue in adults with malignant glioma (CNS WHO grade III to IV). The application has entered the regulatory review process, which includes technical review, on-site inspection, and administrative approval. The timeline and outcome for final approval remain uncertain at this stage. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260129-12004740), on January 29, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)</p>

Shanghai Fudan-Zhangjiang Receives NMPA Acceptance for Aminolevulinic Acid ANDA