Policy Developments - Shanghai has introduced 18 measures to promote the high-quality development of commercial health insurance, focusing on expanding coverage to include new medical technologies, drugs, and devices [1] Drug and Device Approvals - Heng Rui Medicine's injection of Rukang Qutuo Zhun Tan has received orphan drug designation from the FDA for use in gastric cancer, which had 968,400 new cases globally in 2022 [3] - DIZHE Pharmaceutical's DZD8586, a dual-target inhibitor, has received Fast Track Designation from the FDA for treating relapsed chronic lymphocytic leukemia [4] - Sainuo Medical's subsidiary has received breakthrough device designation from the FDA for its self-expanding intracranial drug-coated stent system, marking a first for domestic neuro-interventional devices [7] Financial Reports - BeiGene reported a net profit of 450 million yuan for the first half of 2025, reversing losses from the previous year, with product revenue increasing by 45.8% to 17.36 billion yuan [8] - Tiantan Biological's net profit for the first half of 2025 decreased by 12.88% to 633 million yuan, attributed to declining product prices and reduced interest income [9] Capital Market Activities - Pianzaihuang plans to invest 200 million yuan in the Gao Xin Run Xin Fund, which aims to raise 1 billion yuan, representing 20% of the fund's target size [10] Industry Developments - Jingtai Technology has entered a 47 billion HKD collaboration with DoveTree for AI drug development, setting a new record in the AI pharmaceutical sector [11] Shareholder Actions - Qianhong Pharmaceutical's shareholder plans to reduce holdings by up to 20.9 million shares, representing 1.63% of the total share capital [11] - Shuyupingmin's controlling shareholder intends to reduce holdings by up to 804,730 shares, accounting for 2% of the total share capital [12]

审批结论：根据美国《联邦食品、药品和化妆品法案》第526条,授予注射用瑞康曲妥珠单抗联合阿得贝 利单抗注射液和化疗用于胃癌或胃食管结合部腺癌适应症的孤儿药资格。 一、药品的基本情况 药品名称：注射用瑞康曲妥珠单抗 适应症：联合阿得贝利单抗注射液和化疗用于胃癌或胃食管结合部腺癌 申请编号：DRU-2025-10850 申请人：江苏恒瑞医药股份有限公司 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、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）产品注射用瑞康曲妥珠单抗联合阿得贝利单抗注 射液和化疗用于胃癌或胃食管结合部腺癌适应症获得美国食品药品监督管理局（以下简称"美国FDA"） 授予的孤儿药资格认定。孤儿药又称罕见病药，是指用于预防、治疗、诊断罕见病的药品。本次公司获 得美国FDA孤儿药资格认定，将有机会在产品研发、注册及商业化等方面享受美国的政策支持。现将相 关情况公告如下： 2025年8月6日 二、药品的其他情况 [1]．Freddie Bray et al. Global cancer statistics 2022 ...

Group 1 - In the first seven months of this year, Jiangsu approved 14 innovative drugs for market, surpassing the total of 13 from the previous year, accounting for nearly 30% of the 49 innovative drugs approved nationwide [1] - The approved innovative drugs target diseases such as tumors, spondyloarthritis, and influenza, with notable products including Suweisituzumab, the first anti-angiogenesis drug for "platinum-resistant" ovarian cancer in China [1] - Heng Rui Medicine has increased its innovation efforts, with R&D investment accounting for 29.4% of sales revenue last year, totaling 46 billion yuan, and over 90 self-innovative products currently in clinical development [1] Group 2 - Jiangsu is promoting industrial R&D innovation while optimizing drug review and approval processes, exemplified by the approval of the first segmented production model antibody-drug conjugate in the country [2] - The segmented production model allows for specialized production management and quality control at different sites, enhancing resource allocation and collaboration within the industry [2] - Jiangsu has established seven national key laboratories in the biopharmaceutical field and has been approved to build the first national technology innovation center in this area, leading to a robust innovation ecosystem [2]

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received orphan drug designation from the U.S. FDA for its product, injection of Rukang Trastuzumab combined with Atezolizumab injection and chemotherapy for the treatment of gastric cancer or gastroesophageal junction adenocarcinoma, which will provide opportunities for policy support in product development, registration, and commercialization [1][4]. Group 1: Drug Information - Drug Name: Injection of Rukang Trastuzumab - Indication: Combined with Atezolizumab injection and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma - Application Number: DRU-2025-10850 - Approval Conclusion: Granted orphan drug designation under Section 526 of the U.S. Federal Food, Drug, and Cosmetic Act [1]. Group 2: Market Context - In 2022, gastric cancer ranked 5th in global cancer incidence and mortality, with 968,400 new cases and 659,900 deaths worldwide. In China, there were 358,700 new cases and 260,400 deaths, ranking 5th in incidence and 3rd in mortality [2]. - Current first-line treatment standards have shown some clinical effectiveness, but unmet clinical needs remain due to short survival periods and poor prognosis [2]. Group 3: Competitive Landscape - Injection of Rukang Trastuzumab binds to HER2-expressing tumor cells, inducing apoptosis. It was approved in China in May 2025 for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with HER2 mutations [3]. - Competing products include Ado-trastuzumab emtansine (Kadcyla) and Fam-trastuzumab deruxtecan (Enhertu), with combined global sales projected at approximately $6.557 billion in 2024 [3]. Group 4: Impact of Orphan Drug Designation - The orphan drug designation will expedite clinical trials and registration processes. The company will benefit from policy support, including tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [4].

Group 1: Company Performance - BeiGene reported a net profit of 450 million yuan for the first half of 2025, marking a turnaround from losses in the previous year, with product revenue increasing by 45.8% to 17.36 billion yuan and total revenue rising by 46.0% to 17.52 billion yuan [1] - CITIC Securities announced that Huaxia Fund achieved an operating income of 4.258 billion yuan and a net profit of 1.123 billion yuan in the first half of 2025, with total comprehensive income of 1.106 billion yuan [3] - Shanghai Pudong Development Bank's net profit for the first half of 2025 was 29.737 billion yuan, reflecting a year-on-year growth of 10.19%, with total operating income of 90.559 billion yuan, up 2.62% [6] - Xianhe Co. plans to invest approximately 11 billion yuan in a new integrated high-performance paper-based material project, with an expected annual output value of about 5.15 billion yuan from the first phase [7] - Shengmei Shanghai reported a net profit of 696 million yuan for the first half of 2025, representing a year-on-year increase of 56.99% [14] Group 2: Regulatory and Corporate Actions - Sino Medical's subsidiary received breakthrough medical device designation from the FDA for its intracranial atherosclerosis treatment product, marking it as the first of its kind globally [2] - *ST Dongtong's actual controller and chairman is under investigation by the China Securities Regulatory Commission for suspected violations of information disclosure laws [8] - Tianyang Technology is planning to purchase equity in Tonglian Financial Services, with key transaction details still under negotiation [10] - Dongfang Guoxin's major shareholder reduced their stake by 2.68 million shares, decreasing their total shareholding from 27.06% to 26.82% [5] - Filinger's president reduced his holdings by 8,600 shares during a period of stock price volatility, while other executives did not sell shares [4]

Group 1: Company Performance - BeiGene reported a net profit of 450 million yuan for the first half of 2025, marking a turnaround from losses in the previous year, with product revenue increasing by 45.8% to 17.36 billion yuan and total revenue rising by 46.0% to 17.52 billion yuan [1] - CITIC Securities announced that Huaxia Fund achieved a net profit of 1.123 billion yuan in the first half of 2025, with total operating income of 4.258 billion yuan and total comprehensive income of 1.106 billion yuan [1] - Shanghai Pudong Development Bank reported a net profit of 29.737 billion yuan for the first half of 2025, reflecting a year-on-year growth of 10.19%, with total operating income of 90.559 billion yuan, up 2.62% [4] - Xianhe Co., Ltd. plans to invest approximately 11 billion yuan in a new integrated high-performance paper-based material project, with an expected annual output value of about 5.15 billion yuan from the first phase [5] - Shunbo Alloy reported a net profit growth of 110.56% year-on-year for the first half of 2025 [12] Group 2: Regulatory and Corporate Actions - Sino Medical announced that its subsidiary received breakthrough medical device designation from the FDA for a new intracranial atherosclerosis treatment product, marking a significant milestone as the first of its kind globally [1] - *ST Dongtong's actual controller and chairman is under investigation by the China Securities Regulatory Commission for suspected violations of information disclosure laws [6][7] - Tianyang Technology is planning to purchase equity in Tonglian Jinfu and related companies, with key transaction details still under negotiation [8] - Filinger reported stock price fluctuations, with the president reducing his holdings by 8,600 shares during a period of abnormal trading activity [2] - Dongfang Guoxin's controlling shareholder reduced their stake by 2.68 million shares, decreasing their total shareholding from 27.06% to 26.82% [3]

证券日报网讯 8月6日晚间，恒瑞医药发布公告称，近日，公司产品注射用瑞康曲妥珠单抗联合阿得贝 利单抗注射液和化疗用于胃癌或胃食管结合部腺癌适应症获得美国食品药品监督管理局（简称"美国 FDA"）授予的孤儿药资格认定。孤儿药又称罕见病药，是指用于预防、治疗、诊断罕见病的药品。本 次公司获得美国FDA孤儿药资格认定，将有机会在产品研发、注册及商业化等方面享受美国的政策支 持。 （编辑 任世碧） ...

Core Viewpoint - The CSI Technology Leaders Index has shown significant growth, reflecting the strong performance of leading companies in the technology sector [1][2] Group 1: Index Performance - The CSI Technology Leaders Index opened lower but closed higher, increasing by 0.45% to 4001.15 points, with a trading volume of 85.612 billion yuan [1] - Over the past month, the index has risen by 11.14%, by 19.59% over the last three months, and by 14.83% year-to-date [1] Group 2: Index Composition - The index comprises 50 listed companies selected from sectors such as electronics, computers, communications, and biotechnology, focusing on those with large market capitalization, high market share, strong growth potential, and significant R&D investment [1] - The top ten weighted companies in the index are: - Heng Rui Medicine (7.46%) - WuXi AppTec (6.35%) - Zhongji Xuchuang (5.07%) - Xinyi Technology (5.02%) - SMIC (4.89%) - BOE Technology Group (4.04%) - Northern Huachuang (3.89%) - Mindray Medical (3.75%) - Haiguang Information (3.46%) - Shenghong Technology (3.24%) [1] Group 3: Market Distribution - The index's holdings are distributed with 52.50% from the Shenzhen Stock Exchange and 47.50% from the Shanghai Stock Exchange [1] Group 4: Sector Allocation - The sector allocation of the index shows that Information Technology accounts for 66.70%, Healthcare for 18.47%, Communication Services for 14.03%, and Consumer Discretionary for 0.80% [2] Group 5: Index Adjustment Mechanism - The index samples are adjusted semi-annually, with adjustments implemented on the next trading day following the second Friday of June and December each year [2] - Weight factors are generally fixed until the next scheduled adjustment, with special circumstances allowing for temporary adjustments [2]

据了解，恒瑞医药本次注射用瑞康曲妥珠单抗联合阿得贝利单抗注射液和化疗用于胃癌或胃食管结合部 腺癌适应症获得孤儿药资格认定后，能够加快推进临床试验及上市注册的进度。同时，可享受一定的政 策支持，包括但不限于临床试验费用的税收抵免、免除新药申请费、产品获批后将享受7年的市场独占 权。 目前，国内外指南推荐一线治疗标准方案在临床取得一定效果，但仍存在生存期较短、预后不佳等未被 满足临床需求。 公告显示，注射用瑞康曲妥珠单抗可通过与HER2表达的肿瘤细胞结合并内吞，在肿瘤细胞溶酶体内通 过蛋白酶剪切释放毒素，诱导细胞周期阻滞从而诱导肿瘤细胞凋亡。公司注射用瑞康曲妥珠单抗已于 2025年5月在国内获批上市，适用于治疗存在HER2(ERBB2)激活突变且既往接受过至少一种系统治疗的 不可切除的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者。经查询，目前国外已上市的同类产品有 Ado-trastuzumab emtansine(商品名Kadcyla)和Fam-trastuzumab deruxtecan(商品名Enhertu)。 Kadcyla由罗氏公司开发，2019年国内已进口上市；Enhertu由阿斯利康和第一三共 ...

北京商报讯（记者 王寅浩 实习记者 宋雨盈）8月6日，恒瑞医药发布公告称，公司注射用瑞康曲妥珠单 抗获得美国食品药品监督管理局（简称"美国FDA"）授予的孤儿药资格认定。孤儿药又称罕见病药，是 指用于预防、治疗、诊断罕见病的药品。 ...