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 ...

Core Viewpoint - Rongchang Biopharmaceutical has signed an agreement with Santen Pharmaceutical for the exclusive development, production, and commercialization rights of its innovative drug RC28-E in several Asian markets, marking a significant step in China's ophthalmic drug innovation [1][3][4]. Group 1: Agreement Details - The agreement grants Santen exclusive rights in Greater China, South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia for the drug RC28-E, which targets ocular neovascular diseases [1]. - Rongchang will receive an upfront payment of 250 million RMB, with potential milestone payments totaling up to 5.2 billion RMB for development and regulatory achievements, and up to 5.25 billion RMB for sales milestones [1]. - Additionally, Rongchang 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 Information - RC28-E is a dual-target fusion protein drug that addresses VEGF/FGF pathways, currently in Phase III clinical trials for treating major ocular diseases such as Diabetic Macular Edema (DME) and Wet Age-related Macular Degeneration (wAMD) [4]. - The company plans to submit a marketing application for DME in the second half of 2025 and for wAMD by mid-2026 in China [4]. Group 3: Strategic Implications - The collaboration with Santen, which has over 130 years of expertise in ophthalmology and a strong sales network across more than 60 countries, is expected to maximize the potential of RC28-E and provide innovative solutions for retinal disease treatment [3][4]. - This partnership signifies a shift in China's pharmaceutical landscape, moving from a "follower" to a "leader" in the global value chain of ophthalmic drugs [1][7]. Group 4: Recent Achievements - Rongchang has previously made significant strides in international collaborations, including granting global rights for its ADC drug to Seagen, with potential revenues reaching 2.6 billion USD, and a recent deal with Vor Biopharma for another innovative product, totaling 4.23 billion USD [5][7]. - These milestones highlight the rapid innovation and industrial strength of Chinese pharmaceuticals on the global stage [7].

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 ...

Core Viewpoint - Rongchang Biopharma has entered into an agreement with Santen China to license its proprietary 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 these regions [1][4]. Group 1: Financial Aspects - Rongchang Biopharma will receive a non-refundable upfront payment of 250 million RMB (approximately 35.5 million USD), with potential milestone payments totaling up to 520 million RMB (approximately 73.5 million USD) for development and regulatory achievements, and up to 525 million RMB (approximately 74.5 million USD) for sales milestones [1]. - The total value of the collaboration is estimated at 1.295 billion RMB (approximately 183.5 million USD), resulting in an investment return rate of 355.76% based on the company's initial investment of 364 million RMB (approximately 51.5 million USD) [5][4]. - As of Q1 2025, Rongchang Biopharma reported cash reserves of 721 million RMB (approximately 102.5 million USD) and a negative operating cash flow of 188 million RMB (approximately 26.6 million USD) [9]. Group 2: Strategic Considerations - The licensing agreement allows Rongchang Biopharma to focus on the more lucrative markets in Europe and the U.S. while transferring the risks and costs associated with the Asian market to Santen China [4][6]. - The RC28-E injection targets eye-related neovascular diseases and is positioned against the leading ophthalmic drug, Eylea, which has a global sales figure of 9.554 billion USD, with a significant portion coming from the U.S. and Europe [6]. - The decision to license rather than build a commercial team in China reflects the company's strategy to mitigate risks associated with high costs and uncertainties in drug commercialization [7]. Group 3: Market Context - Compared to global standards, Chinese biotech assets are generally undervalued, with upfront payments typically 60% to 70% lower and overall transaction sizes 40% to 50% smaller than their global counterparts [2][4]. - The competitive landscape in China is intensifying, with both innovative and biosimilar drugs entering the market, posing challenges for new entrants like Rongchang Biopharma [7].

Group 1 - The core point of the news is that Rongchang Biologics' new bispecific antibody RC148 has been officially included in the list of breakthrough therapy drugs by the CDE, targeting locally advanced or metastatic non-small cell lung cancer (NSCLC) that has failed previous treatments [1][2] - The inclusion is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China, which evaluates the efficacy and safety of RC148 in combination with docetaxel for NSCLC patients who have failed PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The study results indicate that RC148 combined with docetaxel shows superior efficacy compared to similar drugs or standard treatments, with manageable safety and good tolerability, potentially providing a new treatment option for this patient population [1] Group 2 - Breakthrough therapy drugs are defined as innovative or modified drugs used to treat serious life-threatening diseases with no effective treatment options or those that demonstrate significant clinical advantages over existing therapies [2] - The inclusion of RC148 as a breakthrough therapy highlights its substantial clinical value and development potential, which will help accelerate its clinical development process and benefit a larger patient population more quickly [2]

Core Viewpoint - Rongchang Biopharma's innovative bispecific antibody RC148 has been officially included by the China National Medical Products Administration (NMPA) as a breakthrough therapy for specific indications in non-small cell lung cancer (NSCLC) [1] Group 1 - The indication for RC148 is for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has failed PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - RC148 is to be used in combination with docetaxel for the specified patient population [1]

Core Viewpoint - Rongchang Biopharma has entered into a business development agreement with Santen Pharmaceutical's subsidiary, granting exclusive rights for the RC28-E injection in several Asian markets, which reflects the company's strategy to expand its market presence and secure funding through licensing deals [2][6]. Group 1: Business Development Transactions - The agreement with Santen China includes an upfront payment of 250 million yuan, potential milestone payments totaling up to 5.2 billion yuan for development and regulatory achievements, and up to 5.25 billion yuan in sales milestone payments, along with a sales royalty based on product sales in the licensed regions [2][8]. - This is the second business development deal for Rongchang Biopharma in 2023, following a previous agreement with Vor Biopharma, which involved a total potential value of 4.23 billion USD, including an upfront payment of 125 million USD [7][8]. Group 2: Product and Market Potential - RC28-E injection is designed to treat ocular neovascular diseases and is currently undergoing Phase III clinical trials for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), with expected submission dates for market approval in China set for mid-2025 and mid-2026, respectively [3][4]. - The potential market for RC28-E is significant, with approximately 1.4 billion diabetes patients in China, including 5.7 million with clinically significant DME and 3.81 million with wAMD [4]. Group 3: Competitive Landscape - The DME and wAMD treatment markets are becoming increasingly competitive, with new clinical trials and product approvals from other companies, such as Boehringer Ingelheim and Regeneron, indicating a challenging environment for RC28-E [5][6]. - Santen Pharmaceutical's expertise in ophthalmology and its established market presence are expected to facilitate the rapid market entry and patient access for RC28-E [5]. Group 4: Financial Implications - Rongchang Biopharma's financial performance shows a significant revenue increase of 59.17% year-on-year in Q1 2025, but it also faces substantial net losses and high short-term debt, highlighting the need for cash flow relief through business development deals [8][9]. - The recent licensing agreements are seen as a necessary strategy for innovative pharmaceutical companies to manage research and development risks, especially in a tightening financing environment [9].