信诺维科创板IPO已受理 注射用亚胺西福预计明年实现国内获批上市

Core Viewpoint - Suzhou Xinnoway Pharmaceutical Technology Co., Ltd. has submitted its IPO application to the Shanghai Stock Exchange's Sci-Tech Innovation Board, aiming to raise 2.94 billion yuan for its innovative drug development focused on unmet clinical needs globally [1][2]. Group 1: Company Overview - Xinnoway is dedicated to transforming innovation into clinical value, providing the best therapeutic drugs in disease areas with significant unmet needs [1]. - The company has established an innovative drug pipeline consisting of "1 (NDA) + 3 (Phase III) + N," focusing on major diseases such as oncology and infections [1][2]. - Xinnoway is developing 10 key innovative drugs, with three in the oncology field (XNW5004, XNW27011, and XNW28012) currently in Phase III or critical clinical research stages, all showing excellent clinical efficacy [1][2]. Group 2: Drug Development and Pipeline - The drug XNW4107, a combination of a new β-lactamase inhibitor and other components, has received acceptance for its marketing application, expected to be approved by 2026, addressing antibiotic resistance in Gram-negative bacteria [2]. - The company has achieved breakthrough therapy designation from the National Medical Products Administration for its oncology drugs and has received fast track designation from the FDA for XNW27011 and XNW28012 [1][2]. Group 3: Financial Overview - Xinnoway has entered into four external authorization collaborations, with total agreement amounts exceeding 2 billion USD, including an irrevocable upfront payment of 130 million USD received in 2025 [3]. - The company has not yet generated revenue from drug sales and has reported continuous losses, with net profits of -463 million yuan, -427 million yuan, -386 million yuan, and -374 million yuan for the years 2022, 2023, 2024, and the first half of 2025, respectively [4][5]. - The total assets as of June 30, 2025, are 1.12 billion yuan, with a debt ratio of 63.19% for the parent company [5]. Group 4: Fundraising and Investment Plans - The net proceeds from the IPO, after deducting issuance costs, will be invested in new drug research and development projects totaling 2.35 billion yuan and in supplementary working capital of 600 million yuan [3].