Core Insights - Rongchang Biopharma's novel bispecific antibody RC148 has been officially included in the list of breakthrough therapy drugs by the Center for Drug Evaluation (CDE) in China, 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) demonstrating superior efficacy and manageable safety of RC148 combined with docetaxel compared to standard treatments in patients with treatment-resistant NSCLC [1] Group 1: Breakthrough Therapy Designation - Breakthrough therapy drugs are defined as innovative or modified drugs used to treat serious or life-threatening diseases with no effective treatment options or those showing significant clinical advantages over existing therapies [2] - The CDE will prioritize resources for drugs designated as breakthrough therapies, significantly shortening the time to market for new drugs [2] Group 2: Clinical Study Results - The primary endpoint of the clinical study was the objective response rate (ORR), which indicated that RC148 combined with docetaxel showed better efficacy than similar drugs or standard treatments in patients who had previously failed PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The safety profile of the combination treatment was reported to be controllable and well-tolerated, suggesting a new treatment option for this patient population [1]

Core Insights - Rongchang Biopharma's novel bispecific antibody RC148 has been officially included in the list of breakthrough therapy drugs by the China National Medical Products Administration (NMPA) [1][2] - The indication for RC148 is for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has failed prior PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The inclusion is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) demonstrating superior efficacy and manageable safety compared to similar drugs or standard treatments [1] Group 1 - RC148's inclusion as a breakthrough therapy highlights its significant clinical value and development potential [2] - The drug aims to provide a new treatment option for patients with advanced NSCLC who have limited alternatives [1][2] - The NMPA's designation will expedite the clinical development process and potentially shorten the time to market for RC148 [2] Group 2 - Breakthrough therapy drugs are defined as innovative or modified drugs that address serious or life-threatening diseases with no effective treatment options or demonstrate significant clinical advantages over existing therapies [2] - The NMPA will prioritize resource allocation for drugs recognized as breakthrough therapies, facilitating faster access for patients [2]

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 ...

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]