| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2025-039 | | --- | --- | --- | | 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 第二届董事会第二十八次会议决议公告 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。 一、董事会会议召开情况 本议案已经公司第二届董事会审核委员会第十三次会议审议通过。 经与会董事表决，同意票：9 票，反对票：0 票，弃权票：0 票。同意票占 出席董事的 100％。 （二）审议通过《关于听取公司 2025 年中期股息派发计划的议案》 经考虑公司的整体财务状况、资本需求等多个因素，公司不建议宣派截至 2025 年 6 月 30 日止六个月的中期股息。 1 经与会董事表决，同意票：9 票，反对票：0 票，弃权票：0 票。同意票占 出席董事的 100％。 （三）审议通过《关于公司 2025 年半年度报告及其摘要的议案》 公司 2025 年半年度报告的编制和审议程序符合法律、法规和《公司章程》 等各项规定，内容与格式 ...

荣昌生物制药（烟台）股份有限公司2025 年半年度报告 二、 重大风险提示 公司致力于创新疗法的发现、开发和商业化。公司积极布局覆盖多项疾病治疗领域的在研产 品管线，未来仍将维持相应规模的研发投入用于在研产品进行临床前研究、全球范围内的临床试 验以及新药上市前准备等药物开发工作。同时，公司新药上市申请等注册工作、上市后的市场推 广等方面亦将带来高额费用，均可能导致短期内公司亏损进一步扩大，从而对公司日常经营、财 务状况等方面造成不利影响。报告期内，公司的主营业务、核心竞争力未发生重大不利变化。公 司已在本报告详细阐述在生产经营过程中可能面临的各种风险因素，敬请参阅"第三节管理层讨 论与分析"之"四、风险因素"相关内容。 三、 公司全体董事出席董事会会议。 四、 本半年度报告未经审计。 五、 公司负责人王威东、主管会计工作负责人童少靖及会计机构负责人（会计主管人员）魏建 良声明：保证半年度报告中财务报告的真实、准确、完整。 公司代码：688331 公司简称：荣昌生物 荣昌生物制药（烟台）股份有限公司 2025 年半年度报告 1 / 183 荣昌生物制药（烟台）股份有限公司2025 年半年度报告 重要提示 一、 ...

荣昌生物公告，2025年上半年营业收入10.98亿元，同比增长48.02%。归属于上市公司股东的净亏损4.5 亿元，上年同期净亏损7.8亿元。研发投入占营业收入的比例58.95%，减少49.74个百分点。 ...

Group 1 - The core viewpoint of the news is that Rongchang Biopharmaceutical has received a breakthrough therapy designation from the China National Medical Products Administration (NMPA) for its innovative bispecific antibody RC148, aimed at treating non-small cell lung cancer (NSCLC) [1][2] - RC148 is specifically indicated for use in combination with docetaxel for patients with locally advanced or metastatic NSCLC who have failed prior treatment with PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The designation is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China, which demonstrated superior efficacy and manageable safety of RC148 combined with docetaxel compared to similar drugs or standard treatments in patients with advanced NSCLC [1] Group 2 - Breakthrough therapy drugs are defined as innovative or modified drugs that are used to treat serious life-threatening diseases with no effective treatment options or those that show significant clinical advantages over existing therapies [2] - The inclusion of RC148 in the breakthrough therapy category highlights its substantial clinical value and development potential, which will facilitate faster clinical development and quicker access for patients [2]

Core Viewpoint - Rongchang Biopharmaceutical has received a breakthrough therapy designation from the China National Medical Products Administration (NMPA) for its innovative bispecific antibody RC148, aimed at treating non-small cell lung cancer (NSCLC) [1][2]. Group 1: Breakthrough Therapy Designation - The bispecific antibody RC148 has been officially included in the list of breakthrough therapies by the NMPA, targeting the indication of RC148 in combination with docetaxel for patients who have previously failed PD-1/PD-L1 inhibitors [2]. - The designation is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China, which demonstrated superior efficacy of RC148 combined with docetaxel compared to similar drugs or standard treatments in advanced NSCLC patients who failed prior treatments [2]. Group 2: Clinical Value and Development Potential - The breakthrough therapy designation signifies the significant clinical value and development potential of RC148, which will facilitate accelerated clinical development and resource allocation by the NMPA [2]. - Breakthrough therapies are defined as innovative drugs or modified drugs that provide substantial clinical advantages over existing treatment methods for serious or life-threatening diseases, where no effective treatment options are available [2].

Core Viewpoint - Rongchang Biopharmaceuticals has signed a licensing agreement with Santen Pharmaceutical's subsidiary, which is expected to generate over 1.2 billion yuan in milestone payments and sales revenue sharing, alleviating the company's financial losses [2][3][4]. Financial Impact - The agreement includes a non-refundable upfront payment of 250 million yuan, potential milestone payments of up to 520 million yuan for development and regulatory achievements, and up to 525 million yuan for sales milestones [3]. - Rongchang Biopharmaceuticals has reported cumulative net losses of approximately 3.95 billion yuan from 2022 to 2024, but showed a revenue increase of 59.17% year-on-year in Q1 2025, reaching 526 million yuan [5]. Product Development - The RC28-E injection is a dual-target fusion protein drug developed by Rongchang Biopharmaceuticals for treating ocular neovascular diseases, with promising results in clinical trials for diabetic macular edema [3][4]. - The company has initiated Phase III clinical trials for RC28-E targeting wet age-related macular degeneration and diabetic macular edema in 2023 [3]. Company Background - Rongchang Biopharmaceuticals focuses on innovative biopharmaceuticals, particularly in antibody-drug conjugates and therapeutic antibodies, with key products including Tai'aisip and Vidisizumab [4]. - The company went public in Hong Kong in 2020 and achieved profitability only in 2021, with a revenue of 1.426 billion yuan and a net profit of 276 million yuan [4]. Challenges and Costs - Sales and management expenses have been rising, with total sales expenses reaching 2.441 billion yuan from 2022 to 2024, contributing to cash flow pressure [6]. - The company faces significant challenges in drug approval processes, market competition, and commercialization capabilities, which could impact future revenue growth [5][6].

Group 1 - Rongchang Biopharma (688331.SH) has entered into an agreement with Santen Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Santen China, to grant a paid license for its proprietary RC28-E injection [1] - Santen China will obtain exclusive rights for the development, production, and commercialization of RC28-E in Greater China, South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia, while Rongchang Biopharma retains global exclusive rights outside these regions [1] - Rongchang Biopharma will receive a non-refundable and non-offsettable upfront payment of 250 million RMB, with potential milestone payments of up to 520 million RMB for development and regulatory milestones, and up to 525 million RMB for sales milestones [1] Group 2 - Santen China is responsible for the business development of Santen Pharmaceutical in the Chinese market [2] - Santen Pharmaceutical, established over 130 years ago, specializes in ophthalmic pharmaceuticals and is a leader in the global ophthalmic market, focusing on prescription drugs, over-the-counter products, medical devices, and innovative service models [2] - The company's product range includes treatments for glaucoma, dry eye, myopia control, and retinal diseases [2]

从资金流向上来看，当日生物制品板块主力资金净流出8.57亿元，游资资金净流入2.95亿元，散户资金净 流入5.62亿元。生物制品板块个股资金流向见下表： 证券之星消息，8月20日生物制品板块较上一交易日下跌0.42%，荣昌生物领跌。当日上证指数报收于 3766.21，上涨1.04%。深证成指报收于11926.74，上涨0.89%。生物制品板块个股涨跌见下表： | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | --- | --- | --- | --- | --- | --- | | 688319 | 欧林生物 | 33.11 | 6.09% | 17.16万 | 5.59亿 | | 000534 | 万泽股份 | 17.55 | 4.84% | 34.99万 | 6.03亿 | | 000518 | *ST四环 | 2.30 | 2.68% | 18.92万 | 4320.70万 | | 300601 | 康泰生物 | 17.74 | 2.54% | 1 36.24万 | 6.38亿 | | 688443 | 智翔全泰 | 33.61 | 1.69% | 5.48万 | ...

Core Viewpoint - Rongchang Biopharmaceutical (Yantai) Co., Ltd. has signed a licensing agreement with Santen Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Santen China, granting exclusive rights for the development, production, and commercialization of the RC28-E injection in several Asian markets, while retaining global rights outside these regions [2][5]. Group 1: Licensing Agreement Details - The agreement allows Santen China to exclusively develop, produce, and commercialize the RC28-E injection in Greater China, South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia [2][5]. - Rongchang Biopharmaceutical will receive an upfront payment of 250 million RMB, along with potential milestone payments totaling up to 520 million RMB for development and regulatory achievements, and up to 525 million RMB for sales milestones [2][6]. - Additionally, the company will earn a tiered sales commission based on product sales in the licensed regions, ranging from high single-digit to double-digit percentages [6]. Group 2: Product Information - The RC28-E injection is a dual-target fusion protein drug developed by Rongchang Biopharmaceutical for treating ocular neovascular diseases [3]. - The drug has shown promising results in a Phase II clinical trial for diabetic macular edema (DME), demonstrating improvements in best-corrected visual acuity and reductions in central retinal thickness [3]. Group 3: Impact on the Company - This transaction is expected to accelerate market access and patient coverage for RC28-E, significantly shortening the commercialization cycle and providing innovative treatment solutions for retinal diseases [7]. - The agreement does not affect the company's operational independence and does not harm the interests of the company or its shareholders [7].

证券代码：688331 证券简称：荣昌生物 公告编号：2025-038 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 关于签署授权许可协议的公告 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、准确性和完整性承担法律责任。 ? 重要内容提示 日本参天制药株式会社（以下简称"参天制药"）全资子公司参天制药（中国） 有限公司（以下简称"参天中国"）达成协议，将公司具有自主知识产权的 RC28-E 注射液有偿许可给参天中国，参天中国将获得 RC28-E 在大中华区及韩国、泰 国、越南、新加坡、菲律宾、印度尼西亚及马来西亚的独家开发、生产和商业 化权利，而荣昌生物将保留 RC28-E 在上述区域以外的全球独家权益。根据协 议，荣昌生物将从参天中国取得 2.5 亿元人民币的不可退还且不可抵扣的首付 款，以及最高可达 5.2 亿元人民币的开发及监管里程碑付款和最高可达 5.25 亿元人民币的销售里程碑付款。此外，荣昌生物还将根据授权地区的产品销售 额收取高个位数至双位数百分比的梯度销售分成。 次交易事项已经董事会审议通过，无须提交股东会审 ...