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].

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 ...