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].

智通财经APP讯，荣昌生物(09995)发布公告，公司原研的新型双特异性抗体RC148被中国国家药品监督 管理局药品审评中心(CDE)正式纳入突破性治疗药物品种，针对适应症为：RC148联合多西他赛治疗经 PD-1/PD-L1抑制剂和含铂化疗(联合或序贯)治疗失败的驱动基因阴性局部晚期或转移性非小细胞肺癌 (NSCLC)。 此次被CDE纳入突破性治疗药物品种，基于RC148一项在中国开展的多中心、开放性I/II期临床研究 (RC148-C001)。该临床研究包括探索RC148联合多西他赛治疗既往经PD-1/PD-L1抑制剂和含铂化疗(联 合或续贯)治疗失败的NSCLC的疗效和安全性，主要终点为客观缓解率(ORR)等。研究结果显示，在经 PD-1/PD-L1抑制剂和含铂化疗(联合或续贯)治疗失败的晚期NSCLC患者中，RC148联合多西他赛展现出 相比同类药物或者标准治疗更加优异的疗效，且联合治疗安全性可控，耐受良好，有望为该人群提供新 的治疗选择。 突破性治疗药物是指用于防治严重危及生命或者严重影响生存质量的疾病，且尚无有效防治手段，或者 与现有治疗手段相比有足够证据表明具有明显临床优势的创新药或改良型药物。 ...

突破性治疗药物是指用于防治严重危及生命或者严重影响生存质量的疾病，且尚无有效防治手段，或者 与现有治疗手段相比有足够证据表明具有明显临床优势的创新药或改良型药物。对纳入突破性治疗药物 的创新药，CDE将优先配置资源，新药上市时间将大大缩短。本次被纳入突破性治疗品种认定，彰显了 RC148巨大的临床价值和开发潜力，将有助于加速RC148的临床开发进程，更快惠及广大患者。 荣昌生物(09995)发布公告，公司原研的新型双特异性抗体RC148被中国国家药品监督管理局药品审评中 心(CDE)正式纳入突破性治疗药物品种，针对适应症为：RC148联合多西他赛治疗经PD-1/PD-L1抑制剂 和含铂化疗(联合或序贯)治疗失败的驱动基因阴性局部晚期或转移性非小细胞肺癌(NSCLC)。 此次被CDE纳入突破性治疗药物品种，基于RC148一项在中国开展的多中心、开放性I/II期临床研究 (RC148-C001)。该临床研究包括探索RC148联合多西他赛治疗既往经PD-1/PD-L1抑制剂和含铂化疗(联 合或续贯)治疗失败的NSCLC的疗效和安全性，主要终点为客观缓解率(ORR)等。研究结果显示，在经 PD-1/PD-L1抑制剂和 ...

Core Viewpoint - Rongchang Biologics has announced a business development (BD) deal with Santen Pharmaceutical for the exclusive licensing of the ophthalmic innovative drug RC28-E in several Asian markets, marking its second BD announcement this year [1][2]. Group 1: Business Development and Financials - Rongchang Biologics will receive an upfront payment of 250 million yuan, with potential milestone payments totaling up to 520 million yuan for development and regulatory achievements, and up to 525 million yuan for sales milestones [1]. - The company will also 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 Details and Clinical Trials - RC28-E is a dual-target fusion protein drug aimed at treating neovascular eye diseases, specifically targeting VEGF and FGF pathways to inhibit new blood vessel formation [2]. - The drug is currently undergoing Phase III clinical trials for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), with an expected submission for market approval in China for DME in the second half of 2025 and for wAMD in mid-2026 [3][5]. Group 3: Market Context and Competition - The domestic ophthalmic drug market is transitioning from generics to innovative products, with increasing competition as patents for existing drugs expire [6][9]. - Other companies, such as Qilu Pharmaceutical and Innovent Biologics, are also advancing in the development of biosimilars and innovative drugs in the ophthalmic space, indicating a shift towards more competitive innovation in the sector [9].

根据协议，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；荣昌生物将取得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5.2亿元人民币的近 期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。 经济观察网据荣昌生物8月19日公告，荣昌生物宣布，与参天制药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。 ...

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 ...

每经AI快讯，截至8月19日收盘，98只个股连续上涨5个交易日及以上。中粮糖业连续上涨12个交易 日，力生制药、君亭酒店、荣昌生物、昀冢科技连续上涨8个交易日。从累计涨幅来看，海能技术连涨 期间累计涨幅达90.23%，戈碧迦连涨期间累计涨幅达87.60%。 （文章来源：每日经济新闻） ...

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。 ...

Market Overview - On August 19, the innovative drug sector experienced a significant surge, with multiple companies including Shenyuan Biological and Xintian Pharmaceutical hitting the daily limit increase [1] Key Events - On August 19, Rongchang Biopharmaceutical announced a licensing agreement for its RC28-E injection with Santen China, receiving an upfront payment of 250 million RMB and potential milestone payments totaling up to 12.45 billion RMB [4] - On August 7, Buchang Pharmaceutical's subsidiary signed an exclusive supply agreement with GOODFELLOW for the registration and sales of Efparepoetinalfa in the Philippines [4] - On July 28, Hengrui Medicine announced a deal with GSK for global exclusive rights to the HRS-9821 project, with an upfront payment of 500 million USD and potential total payments of approximately 12 billion USD [4] - Prior to these announcements, companies like CSPC Pharmaceutical, 3SBio, and China National Pharmaceutical Group also secured significant overseas contracts [5] Institutional Insights - According to data from Toubao, the U.S. pharmaceutical market was valued at 600.3 billion USD in 2022, with innovative drugs accounting for over 70%, approximately 420 billion USD. In contrast, China's pharmaceutical market was valued at 250.8 billion USD, with innovative drugs making up less than 20%, around 50 billion USD [6] - The trend of Chinese pharmaceutical companies collaborating with international giants is increasing, with record-high upfront payments and total transaction amounts. The potential market for domestic innovative drugs could rise from 50 billion USD domestically to over 420 billion USD in the U.S. market alone [6] - Recent catalysts in the innovative drug sector are emerging, with upcoming industry conferences expected to showcase promising data from companies like Diligent Pharma and Fuhong Hanlin [6] - The domestic innovative drug industry is transitioning from a capital-driven model to a profit-driven model, with expectations for performance and valuation recovery opportunities in the sector by 2025 [7]