| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2026-014 | | --- | --- | --- | | 港股代码：09995 | 港股简称：榮昌生物 | | 荣昌生物制药（烟台）股份有限公司 2025年度募集资金存放、管理与实际使用情况的专项报告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 根据中国证券监督管理委员会（以下简称"中国证监会"）《上市公司募集 资金监管规则》和《上海证券交易所科创板上市公司自律监管指引第 1 号——规 范运作》等相关规定，荣昌生物制药（烟台）股份有限公司（以下简称"公司"） 将 2025 年度募集资金存放与使用情况报告如下： 一、募集资金基本情况 （一）实际募集资金金额及资金到账情况 经中国证券监督管理委员会《关于同意荣昌生物制药（烟台）股份有限公司 首次公开发行股票注册的批复》（证监许可[2022]62 号）核准，公司首次公开 发行人民币普通股（A 股）股票 5,442.6301 万股，发行价格为每股 48 元。截至 2022 年 3 月 28 日，公司实际募 ...

截至2025年12月31日止年度 年度業績公告 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 RemeGen Co., Ltd.* 榮 昌 生 物 製 藥（ 煙 台 ）股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：9995） 董事會欣然宣佈本公司截至2025年12月31日止年度的綜合業績，連同截至2024年 12月31日止年度的比較數字。 業務摘要 過去一年，本公司於推進商業化、產品管線及業務運營方面取得重大進展： 商業化 － 本集團截至2025年12月31日止年度的產品銷售收益約為人民幣2,307.4百萬 元，較去年同期的人民幣1,699.1百萬元增長35.8%，主要由本公司自身免 疫類商業化產品泰它西普（RC18，商品名：泰愛®）及抗腫瘤類商業化產品 維迪西妥單抗（RC48，商品名：愛地希®）的強勁銷售增長帶動。 1 產品管線 泰它西普（RC18，商品名：泰愛®） 2 － 2025年4月，泰它西普用於治療全身型 ...

Group 1 - The core point of the news is that Rongchang Biopharmaceuticals announced the approval of its self-developed injection drug, Vidisicimab (brand name: Aidiqi), for a new indication in the treatment of specific populations with breast cancer, marking the fourth approved indication for this drug in China [1] - The expansion of indications for Vidisicimab, one of the core products of the company, will further enrich the product matrix and enhance the core competitiveness of the company [1] - The drug has successfully entered the Category B directory through national medical insurance negotiations in 2024, significantly reducing the patient co-payment ratio, which is expected to drive a substantial increase in terminal prescription volume and lay a foundation for market promotion of the new indication [1] Group 2 - Rongchang Biopharmaceuticals' stock price increased by over 4%, with a current price of 90.6 HKD and a trading volume of 67.64 million HKD [2] - The stock performance reflects a rise of 3.82% at the time of reporting, indicating positive market sentiment towards the company's recent developments [2]

Group 1 - The core point of the article is that Rongchang Biologics (09995.HK) experienced a significant stock price increase, rising over 4% at one point and closing with a gain of 3.82% at HKD 90.6 [1] - The trading volume for Rongchang Biologics reached HKD 67.6447 million, indicating active market participation [1]

Core Viewpoint - Rongchang Biologics (09995) has seen its stock price increase by over 4%, currently trading at 90.6 HKD, following the announcement of a new indication approval for its self-developed drug, Vidisizumab (brand name: Aidiqi), for the treatment of specific breast cancer populations [1] Group 1: Product Development - The National Medical Products Administration has approved a new indication for Vidisizumab, marking the fourth approved indication for this drug in China [1] - The expansion of indications for Vidisizumab will enhance the company's product matrix and strengthen its core competitiveness [1] Group 2: Market Impact - The drug was successfully included in the Category B directory through the national medical insurance negotiation in 2024, significantly reducing the patient out-of-pocket expenses [1] - This reduction in costs is expected to drive a substantial increase in terminal prescription volumes, laying a solid foundation for the market promotion of the new indication [1]

Core Viewpoint - Rongchang Biopharmaceutical (688331) has received approval from the National Medical Products Administration for the new indication of Vedisizumab (brand name: Aidiqi) to treat HER2 low-expressing breast cancer with liver metastasis, marking the fourth approved indication for this drug in China [1] Group 1 - The approval of the new indication enhances the market competitiveness of Vedisizumab [1]

Core Viewpoint - Rongchang Biopharmaceutical has received approval from the National Medical Products Administration for the new indication of Vidixtumab (brand name: Aidiqi®) for the treatment of HER2 low-expressing breast cancer with liver metastasis, marking the fourth approved indication for this drug in China [1] Group 1 - The new indication is applicable to adult patients with unresectable or metastatic HER2 low-expressing breast cancer who have previously received at least one systemic treatment during the metastatic disease stage, or who have relapsed within 12 months after adjuvant chemotherapy [1] - Vidixtumab is the first original antibody-drug conjugate (ADC) developed independently by the company, targeting the HER2 protein on tumor surfaces, and has shown leading clinical data in trials for gastric and breast cancers [1] - The approval of this new indication is expected to further enhance the market competitiveness of Vidixtumab [1]

Core Viewpoint - Rongchang Biopharmaceutical (09995) has received approval from the National Medical Products Administration of China for the drug registration certificate of Vedisituzumab (RC48), which is now approved for a new indication in treating HER2 low-expressing breast cancer with liver metastasis [1][2] Group 1: Drug Approval Details - The new indication is for adult breast cancer patients with unresectable or metastatic HER2 low-expressing (IHC 1+ or IHC 2+/ISH-) who have previously received at least one systemic treatment during the metastatic disease stage or have relapsed within 12 months after completing adjuvant chemotherapy [1] - This approval is based on data from a randomized, open-label, parallel-controlled, multi-center Phase III clinical trial (RC48-C012) conducted in China, which demonstrated good efficacy and safety for Vedisituzumab in this specific patient population [1] Group 2: Product Background - Vedisituzumab is the first original ADC independently developed in China, targeting the HER2 protein on tumor cells, and has achieved world-leading clinical data in trials for gastric cancer, urothelial carcinoma, and breast cancer [2] - With this latest approval, Vedisituzumab is now approved for four indications in China: HER2 overexpressing locally advanced or metastatic gastric cancer; HER2 overexpressing locally advanced or metastatic urothelial carcinoma; HER2 positive with liver metastasis in advanced breast cancer; and HER2 low-expressing with liver metastasis in breast cancer [2]

Core Viewpoint - Rongchang Biopharmaceutical (09995) has received approval from the National Medical Products Administration of China for the drug registration certificate of Vidixtimab (RC48), which is now approved for a new indication in treating HER2 low-expressing breast cancer with liver metastasis [1][2] Group 1 - The new indication is for adult breast cancer patients with unresectable or metastatic HER2 low-expressing (IHC 1+ or IHC 2+/ISH-) tumors who have previously received at least one systemic treatment during the metastatic disease stage or have relapsed within 12 months after adjuvant chemotherapy [1] - This approval is based on data from a randomized, open-label, parallel-controlled, multi-center Phase III clinical trial (RC48-C012) conducted in China, which demonstrated good efficacy and safety for Vidixtimab in this specific patient population [1] Group 2 - Vidixtimab is the first original ADC independently developed in China, targeting the HER2 protein on tumor cells, and has achieved world-leading clinical data in trials for gastric cancer, urothelial carcinoma, and breast cancer [2] - With this latest approval, Vidixtimab is now approved for four indications in China: HER2 overexpressing locally advanced or metastatic gastric cancer; HER2 overexpressing locally advanced or metastatic urothelial carcinoma; HER2 positive with liver metastasis in advanced breast cancer; and HER2 low-expressing with liver metastasis in breast cancer [2]

Core Viewpoint - Rongchang Biopharmaceutical (09995.HK) has received approval from the National Medical Products Administration of China for the drug registration certificate of Vidisichan (RC48), marking the fourth indication approved for this drug in the domestic market [1] Group 1 - The new indication is for the treatment of adult breast cancer patients with low HER2 expression (IHC1+ or IHC2+/ISH-) and liver metastasis, who have previously received at least one systemic treatment during the metastatic disease stage or have relapsed within 12 months after adjuvant chemotherapy [1] - The approval is based on data from a randomized, open-label, parallel-controlled, multi-center Phase III clinical trial (RC48-C012) conducted in China, which demonstrated good efficacy and safety of Vidisichan for this specific patient population [1]