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]

Core Viewpoint - Rongchang Biologics has entered into an agreement with Santen Pharmaceutical's 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 [1][2] Group 1: Agreement Details - Rongchang Biologics will receive a non-refundable 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 licensed 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]

Core Viewpoint - Rongchang Biopharmaceutical (688331) has entered into an agreement with Santen Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Santen (China) Co., Ltd., to license its proprietary RC28-E injection for a fee, granting Santen exclusive rights for development, production, and commercialization in Greater China and several Southeast Asian countries [1] Financial Summary - Rongchang Biopharmaceutical 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 will earn a tiered sales royalty based on product sales in the licensed regions, ranging from high single-digit to double-digit percentages [1] Product Information - RC28-E injection is a dual-target fusion protein drug developed by Rongchang Biopharmaceutical, aimed at treating ocular neovascular diseases [1]

Group 1 - The company Rongchang Biopharmaceutical (09995.HK) 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 [1][2] - The agreement includes a non-refundable upfront payment of 250 million RMB, potential milestone payments up to 520 million RMB for development and regulatory achievements, and up to 525 million RMB for sales milestones, along with a tiered sales royalty based on product sales in the licensed territories [1] - The licensing agreement is set to take effect on August 18, 2025, and will remain in force unless terminated early according to its terms [1] Group 2 - 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 experience 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]

Core Viewpoint - Rongchang Biopharma has entered into a licensing agreement with Santen China for the RC28-E injection, granting exclusive rights for development, production, and commercialization in Greater China and South Korea [1] Financial Terms - Rongchang Biopharma 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 Biopharma will earn a tiered sales royalty ranging from high single-digit to double-digit percentages based on product sales within the licensing scope [1]

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。 本公告由榮昌生物製藥（煙台）股份有限公司（「本公司」）根據香港聯合交易所有限 公司證券上市規則（「上市規則」）第13.09(2)條及證券及期貨條例（香港法例第571 章）第XIVA部項下的內幕消息條文（定義見上市規則）作出。 緒言 本公司董事（「董事」）會（「董事會」）欣然宣佈，於2025年8月18日（交易時段後）， 本公司及參天製藥（中國）有限公司（「參天中國」）訂立許可協議（「許可協議」）， 據此，本公司將具有自主知識產權的RC28-E注射液（「許可產品」）有償許可給參 天中國，參天中國將獲得在大中華區（即中國、香港、澳門及台灣）及韓國、泰 國、越南、新加坡、菲律賓、印度尼西亞及馬來西亞（「許可範圍」）的獨家開發、 生產和商業化權利，而本公司將保留RC28-E在上述許可範圍以外的全球獨家權 益。 許可協議的主要條款 根據許可協議及在其條款及條件的規限下，本公司將從參天中國取得(i)2.5億元人 民幣 ...

Core Viewpoint - CICC maintains the net loss forecast for Rongchang Biologics (09995) at RMB 915 million for 2025 and RMB 333 million for 2026, while raising the target price by 24.8% to HKD 95.34 due to positive clinical results of Taitasip and the approval of RC148 for Phase II trials in the U.S. [1] Group 1 - The positive results from the Phase III clinical trial of Taitasip for dry eye syndrome are expected to enhance its future value [1] - The approval of RC148 for Phase II clinical trials in the U.S. marks its entry into global clinical development, indicating its international clinical value and potential for overseas expansion [1] - The company plans to submit a marketing application for Taitasip to the National Medical Products Administration (NMPA) and will present detailed data at major international academic conferences [1]