Major Events - CSPC Pharmaceutical Group (01093) received clinical trial approval for Dupilumab injection in China [1] - Rongchang Biopharmaceutical (09995) was granted breakthrough therapy designation for RC148 for non-small cell lung cancer by the National Medical Products Administration [1] - China Biologic Products (01177) included LM-302 "CLDN18.2 ADC" in the breakthrough therapy program [1] - Sunshine Oilsands (02012) plans to acquire 51% stake in Noble Technology Limited for HKD 50.91945 million [1] - Galenica Pharmaceutical-B (01672) plans to issue shares at a discount of approximately 9.9%, raising HKD 468 million [1] Financial Performance - Xiaomi Group-W (01810) reported record high revenue and profit for Q2, with attributable profit of HKD 11.904 billion, up 133.51% year-on-year [1] - Pop Mart (09992) announced a mid-term profit of HKD 4.574 billion, a year-on-year increase of 396.5% [1] - Fuyao Glass (03606) reported a half-year net profit of approximately HKD 4.805 billion, up 37.33% year-on-year [1] - China Resources Beer (00291) announced a mid-term profit of HKD 5.789 billion, an increase of 23.04% year-on-year [1] - Kunlun Energy (00135) reported a mid-term profit of HKD 3.161 billion, down 4.36% year-on-year, with a dividend of HKD 0.166 per share [1] - WuXi Biologics (02269) reported a mid-term profit of approximately HKD 2.339 billion, up 56% year-on-year [1] - Sunny Optical Technology (02382) announced a mid-term profit of HKD 1.646 billion, an increase of 52.56% year-on-year [1] - Yixin Group (02858) reported an adjusted net profit of HKD 648 million, up 28% year-on-year [1] - Kangchen Pharmaceutical (01681) reported a mid-term profit of HKD 498 million, up 24.6% year-on-year, maintaining market leadership with its flagship product [1] - Ping An Good Doctor (01833) reported a mid-term profit of HKD 134 million, a year-on-year increase of 136.84% [1] - China Communication Services (02342) reported a mid-term profit of HKD 61.781 million, returning to profitability [1] - XPeng Motors-W (09868) achieved record levels in core business and financial metrics for Q2, with a net loss of HKD 480 million, narrowing by 62.8% year-on-year [1] - Guochuang Tongqiao (02190) reported a mid-term profit of HKD 121 million, up 76% year-on-year [1] - Yanda Pharmaceutical (00512) reported record revenue of HKD 6.107 billion [1] - Jinli Permanent Magnet (06680) reported a mid-term profit of approximately HKD 305 million, up 154.81% year-on-year [1] - Zhaogang Group-W (06676) issued a profit warning, expecting a mid-term profit of approximately HKD 140 million to HKD 180 million, returning to profitability [1] - Longyuan Power (00916) reported a mid-term profit of HKD 3.519 billion, down 14.4% year-on-year [1] - Yancoal Australia (03668) reported a mid-term profit of AUD 16.3 million, down 61.19% year-on-year [1] - SF Holding (06936) reported total revenue of HKD 24.847 billion for July in logistics, supply chain, and international business, up 9.95% year-on-year [1] - Chow Sang Sang (00116) expects a mid-term profit from continuing operations of approximately HKD 900 million to HKD 920 million [1]

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].

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].