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之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因倚 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） 自願公告 中國國家藥品監督管理局藥品審評中心(CDE)授予RC148突破性治療 藥物認定用於治療非小細胞肺癌(NSCLC) 本公告由榮昌生物製藥（煙台）股份有限公司（「本公司」）自願作出。 本公司董事會（「董事會」）欣然宣佈，本公司原研的新型雙特異性抗體RC148被中 國國家藥品監督管理局藥品審評中心(CDE)正式納入突破性治療藥物品種，針對 適應症為：RC148聯合多西他賽治療經PD-1/PD-L1抑制劑和含鉑化療（聯合或序 貫）治療失敗的驅動基因陰性局部晚期或轉移性非小細胞肺癌(NSCLC)。 此次被CDE納入突破性治療藥物品種，基於RC148一項在中國開展的多中心、開 放性I/II期臨床研究(RC148-C001)。該臨床研究包括探索 ...

根据协议，荣昌生物将从参天中国取得2.5亿元的不可退还且不可抵扣的首付款，以及最高可达5.2亿元 的开发及监管里程碑付款和最高可达5.25亿元的销售里程碑付款。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。 北京商报讯（记者 丁宁）8月19日早间，荣昌生物（688331）发布公告称，公司与日本参天制药株式会 社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。 ...

消息面上，荣昌生物公告，公司与日本参天制药株式会社全资子公司参天中国达成协议，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。据悉，RC28-E注射液 是由荣昌生物自主研发的针对眼部新生血管性疾病的VEGF/FGF双靶标融合蛋白药物。 智通财经APP获悉，荣昌生物(09995)高开逾4%，截至发稿，涨4.42%，报83.95港元，成交额936.04万港 元。 ...

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。据悉，RC28-E注射液 是由荣昌生物自主研发的针对眼部新生血管性疾病的VEGF/FGF双靶标融合蛋白药物。 荣昌生物(09995)高开逾4%，截至发稿，涨4.42%，报83.95港元，成交额936.04万港元。 消息面上，荣昌生物公告，公司与日本参天制药株式会社全资子公司参天中国达成协议，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。 ...

Core Viewpoint - Rongchang Biopharmaceutical (09995) has made significant strides in its stock performance and strategic partnerships, indicating strong growth potential and market interest [1] Group 1: Stock Performance - As of August 18, 2023, shareholders transferred shares worth HKD 784 million from the Hong Kong Stock Connect (Shanghai) to HSBC Hong Kong, representing 4.87% of the company's market value [1] - The company's stock price has surged over 458% year-to-date [1] Group 2: Strategic Partnership - On August 19, 2023, Rongchang Biopharmaceutical announced an agreement with Santen Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Santen (China) Co., Ltd., to license its proprietary RC28-E injection [1] - Santen China will gain 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 retains global exclusive rights outside these regions [1] Group 3: Financial Terms of the Agreement - Rongchang Biopharmaceutical will receive a non-refundable and non-offsettable upfront payment of RMB 250 million from Santen China, along with potential milestone payments of up to RMB 520 million for development and regulatory achievements, and up to RMB 525 million for sales milestones [1] - Additionally, Rongchang will earn a tiered sales royalty ranging from high single-digit to double-digit percentages based on product sales in the licensed regions [1]

Core Viewpoint - Rongchang Biopharmaceutical (09995) has made significant strides in its stock performance and strategic partnerships, indicating strong growth potential and market interest [1] Group 1: Stock Performance - As of August 18, 2023, shareholders transferred shares worth HKD 784 million from the Hong Kong Stock Connect (Shanghai) to HSBC Hong Kong, representing 4.87% of the company's market value [1] - The company's stock price has surged over 458% year-to-date [1] Group 2: Strategic Partnership - On August 19, 2023, Rongchang Biopharmaceutical announced an agreement with Santen Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Santen (China) Co., Ltd., to license its proprietary RC28-E injection [1] - Santen China will gain 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 retains global exclusive rights outside these regions [1] Group 3: Financial Terms of the Agreement - Rongchang Biopharmaceutical will receive a non-refundable and non-offsettable upfront payment of RMB 250 million from Santen China, along with potential milestone payments of up to RMB 520 million for development and regulatory achievements, and up to RMB 525 million for sales milestones [1] - Additionally, Rongchang will earn a tiered sales royalty ranging from high single-digit to double-digit percentages based on product sales in the licensed regions [1]

Core Viewpoint - Rongchang Biologics (09995) has entered into a licensing agreement with Santen Pharmaceutical (China) Co., Ltd. for the RC28-E injection, granting Santen exclusive rights for development, production, and commercialization in Greater China and several Southeast Asian countries, while retaining global rights outside this region [1][2] Group 1: Licensing Agreement Details - The licensing agreement will commence on August 18, 2025, and will remain effective unless terminated early according to its terms [1] - Rongchang will receive a non-refundable upfront payment of 250 million RMB, up to 520 million RMB in development and regulatory milestone payments, and up to 525 million RMB in sales milestone payments [1] - Additionally, the company will earn a tiered sales royalty based on product sales in the licensed territories, ranging from high single-digit to double-digit percentages [1] Group 2: Product Information and Clinical Trials - RC28-E injection is a self-developed drug targeting VEGF/FGF dual pathways for treating ocular neovascular diseases [2] - The Phase II clinical trial results for RC28-E in treating diabetic macular edema (DME) were presented at the ARVO 2025 conference, showing significant improvements in best-corrected visual acuity (BCVA), reduction in central subfield thickness (CST), and effective alleviation of macular edema [2] - In 2023, the company initiated Phase III clinical trials for RC28-E in treating wet age-related macular degeneration (wAMD) and diabetic macular edema [2]

Core Viewpoint - Rongchang Biologics (688331.SH) has entered into an agreement with Santen Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Santen (China) Co., Ltd., 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 [1][2]. Group 1: Agreement Details - Rongchang Biologics will receive a non-refundable and non-offsettable upfront payment of 250 million RMB from Santen China [1]. - The agreement includes potential milestone payments of up to 520 million RMB for development and regulatory achievements, and up to 525 million RMB for sales milestones [1]. - Additionally, Rongchang Biologics will earn a tiered sales royalty based on product sales in the authorized regions, ranging from high single-digit to double-digit percentages [1]. Group 2: Product and Market Impact - RC28-E injection is a dual-target fusion protein drug developed by Rongchang Biologics for treating ocular neovascular diseases [2]. - The collaboration is expected to accelerate market access and patient coverage for RC28-E, significantly shortening the commercialization cycle [2]. - This partnership aims to provide innovative and efficient solutions for the treatment of retinal diseases [2].

| 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 一、 许可产品信息 三、 许可协议主要内容 许可人：荣昌生物制药（烟台）股份有限公司 被许可人：参天制药（中国）有限公司 1、 许可范围 荣昌生物将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。 RC28-E 注射液是由荣昌生物自主研发的针对眼部新生血管性疾病的 VEGF/FGF 双靶 标融合蛋白药物。2025 年 5 月 7 日，RC28-E 治疗糖尿病性黄斑水肿（DME）的Ⅱ期临床 试验结果在 2025 年美国眼科 ...

Group 1 - The core point of the news is that Rongchang Biologics has entered into a licensing agreement with Santen Pharmaceutical (China) Co., Ltd. for the RC28-E injection, granting Santen exclusive rights for development, production, and commercialization in several regions, while retaining global rights outside these areas [1][2] - The agreement includes a non-refundable upfront payment of 250 million RMB, milestone payments that could total up to 520 million RMB for development and regulatory achievements, and up to 525 million RMB for sales milestones [1] - The licensing agreement is set to take effect on August 18, 2025, and will remain valid unless terminated early according to its terms [1] Group 2 - The signing of the licensing agreement is expected to accelerate market access and patient coverage for RC28-E, significantly shortening the commercialization cycle and providing innovative solutions for the treatment of retinal diseases [2] - Santen Pharmaceutical, a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd., has over 130 years of history in the ophthalmic field and is a leader in the global ophthalmic market, focusing on the development, production, and sale of ophthalmic drugs and medical devices [2]