Group 1 - The biotechnology sector in Hong Kong has seen a significant rally, with notable stock price increases for several companies [1] - WuXi AppTec (02126.HK) experienced an 11.7% increase in its stock price [1] - WuXi Biologics (02269.HK) and Junshi Biosciences (01877.HK) also saw substantial gains, with increases of 6.85% and nearly 6% respectively [1] - WuXi AppTec's subsidiary, WuXi Biologics (02268.HK), rose by 7.34% [1]

Group 1 - The core viewpoint of the articles highlights the significant presence of Chinese innovative drugs on the international stage, with a record number of original research results presented at the 2025 ASCO annual meeting [1][2] - The Hong Kong stock market saw active trading in the pharmaceutical and biotechnology sector, with the Hong Kong Innovative Drug ETF (159567) experiencing a high opening but a subsequent decline of 0.77% [1] - Notable performance among component stocks included Junshi Biosciences rising over 2%, while major stocks like Innovent Biologics and WuXi Biologics faced declines [1] Group 2 - Citic Securities indicated that the concentration of innovative drug results signifies that Chinese pharmaceutical companies are rapidly advancing in international innovative research and development [2] - Some innovative drugs are targeting previously underserved indications, while others are challenging current standard treatment protocols (SOC) to reach broader markets [2] - The innovative drug industry is maintained at a rating of outperforming the broader market [2]

Core Viewpoint - Junshi Biosciences has received approval from the National Medical Products Administration (NMPA) for two supplemental new drug applications for ongericimab, marking it as China's first domestic PCSK9-targeted drug approved for statin-intolerant patients [1][10]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of novel therapies [13]. - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas, including cancer, autoimmune, metabolic, neurological, and infectious diseases [13]. - Junshi Biosciences has received approvals for five products in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [13]. Product Details - Ongericimab is a recombinant humanized anti-PCSK9 monoclonal antibody injection, approved for three indications in China: 1) adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia; 2) adult patients with heterozygous familial hypercholesterolemia (HeFH); 3) statin-intolerant patients with non-familial hypercholesterolemia and mixed dyslipidemia [11]. - The approved specifications for ongericimab are 150 mg (1 ml) in a single dose, available in pre-filled syringes and autosyringes [11]. Clinical Trials - The approval of ongericimab is based on two registered clinical trials: JS002-005 and JS002-007 [6]. - JS002-005 involved 135 patients with HeFH and demonstrated significant LDL-C reductions of 69.4% and 80.6% compared to placebo [8]. - JS002-007 is focused on statin-intolerant patients with primary hypercholesterolemia and mixed dyslipidemia, with results to be published soon [9]. Market Context - Cardiovascular disease is the leading cause of death in China, with atherosclerotic cardiovascular disease (ASCVD) being the predominant subtype [2]. - Lowering LDL-C levels is crucial for reducing the incidence of ASCVD and associated mortality [2]. - Approximately 9.1% of patients exhibit statin intolerance, which is more prevalent in Asian populations, leading to suboptimal LDL-C levels and increased cardiovascular risk [4].

Group 1 - Guangdian Electric's wholly-owned subsidiary plans to sell 5.91% stake in Shanghai Winshun Electric Technology Co., Ltd. to Yapp Automotive Parts Co., Ltd. for 62.63 million yuan, aiming to optimize asset structure [1] - Anhui Natural Gas received approval for the registration of 500 million yuan short-term financing bonds and 600 million yuan medium-term notes, valid for two years [1] - Kirin Security received government subsidies totaling 6.48 million yuan, which are related to revenue [2] Group 2 - Junshi Biosciences received approval for two new indications for its self-developed drug, Oncorhynchus monoclonal antibody injection, targeting adult patients with heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia [3] - China Resources Double Crane's subsidiary passed GMP compliance inspection for small and large volume injection production lines [4] - Nanjing Public Utilities' board approved the absorption and merger of its wholly-owned subsidiary, Nanjing Jinguang Industry Co., Ltd. [7] Group 3 - Boya Bio received drug registration certificate for human immunoglobulin (pH4) in the Dominican Republic, valid until August 12, 2029 [8] - Jizhi Co. announced that its controlling shareholder and actual controller committed not to reduce their shareholdings until December 31, 2025 [9] - Yuhua Tian won a bid for the integrated urban management project in Lanzhou City, with a total service subsidy of 353 million yuan [10] Group 4 - Anke Rui obtained five invention patent certificates related to various energy management and control technologies [11] - Kebo Da's wholly-owned subsidiary plans to acquire 100% of Czech IMI Company for approximately 9.43 million euros to enhance global production layout [13] - Yantian Port announced a cash dividend of 1.30 yuan per 10 shares, totaling 676 million yuan [14] Group 5 - Huawang Technology plans to distribute a cash dividend of 0.45 yuan per share and a capital reserve increase of 0.20 shares per share [15] - Kabe Yi established a wholly-owned subsidiary in Japan to enhance its business layout [16] - Dongcheng Pharmaceutical's subsidiary received approval for the marketing of sodium fluoride injection, a PET radiopharmaceutical [18] Group 6 - Huaxin New Materials' subsidiary received two utility model patent certificates for innovative devices [19] - Lingang Steel's new 2290 cubic meter blast furnace has been successfully put into operation [21] - Xinlitai received drug registration certificate for Sacubitril/Valsartan tablets, the first of its kind in China [23] Group 7 - Aike Co.'s subsidiary received project designation notices from multiple clients for electric drive platform components [25] - Tonghe Pharmaceutical received drug registration certificate for Apixaban in South Korea [26] - Junting Hotel signed a cooperation agreement with Choice Hotels for exclusive brand usage in mainland China [28] Group 8 - Guangdong Hongtu plans to establish a wholly-owned subsidiary in Zhengzhou to enhance market layout [30] - Yuheng Pharmaceutical signed a joint promotion agreement for Pemafibrate tablets with Xinghe Pharmaceutical [31] - Chongqing Steel terminated the absorption and merger of its wholly-owned subsidiary, citing strategic advantages of independent operation [33] Group 9 - Jihong Co. announced the listing of its H-shares on the Hong Kong Stock Exchange [34] - Deshi Co. announced plans for shareholders to reduce their holdings by up to 0.3% [36] - Xinhai Medical's subsidiary received medical device registration for a dialysis fluid filter [42]

证券代码：688180 证券简称：君实生物 公告编号：临 2025-028 上海君实生物医药科技股份有限公司 自愿披露关于昂戈瑞西单抗注射液 新适应症上市申请获得批准的公告 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、准确性和完整性依法承担法律责任。 近日，上海君实生物医药科技股份有限公司（以下简称"公司"）收到国家 药品监督管理局（以下简称"国家药监局"）核准签发的《药品注册证书》，昂 戈瑞西单抗注射液（重组人源化抗 PCSK9 单克隆抗体注射液，商品名：君适达®） 用于：1）杂合子型家族性高胆固醇血症（以下简称"HeFH"）的成人患者；2） 在他汀类药物不耐受或禁忌使用的患者中，单独或与依折麦布联合用药用于非家 族性高胆固醇血症和混合型血脂异常的成人患者的两项新适应症上市申请获得 批准。昂戈瑞西单抗成为首个获批用于他汀不耐受人群的国产 PCSK9 靶点药物。 由于药品获得上市批准后的商业化容易受到一些不确定性因素的影响，敬请广大 投资者谨慎决策，注意防范投资风险。现将相关情况公告如下： 一、药品基本情况 药品名称：昂戈瑞西单抗注射液 申请事项：药品 ...

君实生物：昂戈瑞西单抗注射液新适应症上市申请获得批准 智通财经5月27日电，君实生物(688180.SH)公告称，公司收到国家药监局核准签发的《药品注册证 书》，昂戈瑞西单抗注射液（商品名：君适达®）用于杂合子型家族性高胆固醇血症（HeFH）的成人 患者以及他汀类药物不耐受或禁忌使用的患者中，单独或与依折麦布联合用药用于非家族性高胆固醇血 症和混合型血脂异常的成人患者的新适应症上市申请获得批准。昂戈瑞西单抗成为首个获批用于他汀不 耐受人群的国产PCSK9靶点药物。 ...

Core Viewpoint - The pharmaceutical sector, particularly innovative drugs, is experiencing a significant surge, driven by upcoming events and favorable policies [2][5][9] Group 1: Innovative Drug Market Performance - Innovative drugs have seen substantial gains, with companies like Junshi Bioscience rising over 16% and the Hong Kong market's innovative drug sector increasing nearly 4% [2][4] - The upcoming ASCO conference in Chicago, scheduled for May 30 to June 3, 2025, is expected to further ignite interest in innovative drugs, with numerous Chinese pharmaceutical companies showcasing their research [5][9] Group 2: Clinical Advancements - Junshi Bioscience's JS015 and other drugs are leading in clinical trials, with promising early data indicating a 100% objective response rate (ORR) in certain treatment groups [4] - The 2025 ASCO conference will present updated data, which may enhance the visibility and credibility of Chinese innovative drugs on the global stage [5][9] Group 3: Policy and Market Dynamics - Recent policies, such as the draft action plan for Traditional Chinese Medicine (TCM) in Shanghai, aim to enhance the development and integration of TCM, indicating a supportive environment for the pharmaceutical sector [5] - Long-term investment strategies are focusing on two main areas: international expansion of innovative drugs and recovery of domestic demand, particularly in TCM and consumer healthcare [8][9]

Group 1 - The core viewpoint is that the innovative drug sector is experiencing a significant recovery in stock prices, attracting attention from brokers for research and investment opportunities [2] - The Tianhong Innovative Drug ETF (517380) has seen a net inflow of 3.6 million yuan, with a current scale of 389 million yuan as of May 26 [1] - The Tianhong ETF is the only product that comprehensively covers the innovative drug sector across A-shares and Hong Kong stocks, with a focus on the "Hengsheng Huasheng Hong Kong Innovative Drug Selected 50" index [1] Group 2 - The innovative drug industry is entering a new cycle of value reassessment due to a combination of policy, industry, and performance factors [2] - Longjiang Securities suggests that the previous valuation methods used during the bear market may no longer be applicable, indicating a need for a re-evaluation of the valuation system for innovative drug companies [2] - There has been significant interest from brokers, with nearly 60 companies in the pharmaceutical and biotechnology sector being researched this month, highlighting the sector's attractiveness [2]

金融界5月27日消息，港股周二集体低开，盘面上，创新药走高，截至11：30，港股创新药50ETF （513780）涨1.89%，盘中最高涨超3%。 截至5月27日，中证港股通创新药指数前十大成分股累计权重71.6%，包含信达生物、石药集团等A股稀 缺优质标的。指数的50只成分股业务均涉及创新药研发以及为制药企业提供药物研究、开发和生产等服 务。 当前国内创新药板块正站在新的历史起点上：国内企业凭借自身竞争力的提升，出海空间不断拓展；行 业营业收入快速增长，正逐步迈向盈利驱动的新周期；与此同时，政策层面的大力支持，为产业发展保 驾护航。想要把握这一机遇可以关注港股创新药50ETF及其联接基金（A类：023597，C类： 023598）。 本文源自：金融界 作者：E播报 消息面上，2025年ASCO年会将于美国芝加哥当地时间5月30日~6月3日举行。据了解，美国临床肿瘤学 会(ASCO)年会是世界上规模最大、学术水平最高、最具权威的临床肿瘤学会议之一。大会摘要数据于5 月22日正式公布，多家国内创新药企业展示了优异的临床数据，其中中国专家的发言数量再创新高，共 有71项原创性研究成果入选口头发言环节。 光大证券指 ...

智通财经5月27日电，截至发稿，君实生物(01877.HK)涨16.14%、石药集团(01093.HK)涨7.82%、先声药 业(02096.HK)涨6.69%、绿叶制药(02186.HK)涨6.54%。 港股医药股多数上涨 君实生物涨超16% ...