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的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對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。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） Sherwin博士已與本公司訂立委任函，自2025年8月26日起為期三年，其後繼續有 效，直至任何一方發出至少3個月書面通知終止為止。Sherwin博士須根據本公司 組織章程大綱及細則及香港聯合交易所有限公司證券上市規則（「上市規則」）附錄 C1所載之企業管治守則於應屆股東週年大會輪值告退及重選連任。根據委任函， Sherwin博士有權收取董事袍金每年人民幣400,000元，有關金額乃由董事會根據 本公司薪酬委員會之建議，經參考其經驗及於本公司的職責以及現行市況釐定。 除上文所披露者外，於本公告日期，(i) Sherwin博士並無於本公司或其附屬公司 擔任任何其他職位；(ii) Sherwin博士於過往三年內並無在其證券在香港或海外任 何證券市場上市的任何其他公眾公司擔任任何其他董事 ...

Group 1 - On August 26, 2025, the top three companies by trading volume in the Southbound Stock Connect were Yingfu Fund (02800) with a trading volume of 5.01 billion, SMIC (00981) with 3.86 billion, and Alibaba-W (09988) with 3.29 billion [1] - In the Southbound Stock Connect for Shenzhen-Hong Kong, the top three companies were Alibaba-W (09988) with a trading volume of 2.19 billion, SMIC (00981) with 1.95 billion, and Tencent Holdings (00700) with 1.81 billion [1] Group 2 - The top active companies in the Southbound Stock Connect (Hong Kong) included Yingfu Fund (02800) with a net buy of 4.997 billion, Alibaba-W (09988) with a net buy of 448 million, and Tencent Holdings (00700) with a net buy of 911 million [2] - In the Southbound Stock Connect (Shenzhen), Alibaba-W (09988) had a net buy of 897 million, while SMIC (00981) and Tencent Holdings (00700) had net sells of 275 million and 240 million respectively [2]

智通财经APP获悉，8月26日港股市场，北水成交净买入165.73亿港元，其中港股通(沪)成交净买入96.05亿港元，港股通 (深)成交净买入69.67亿港元。 北水净买入最多的个股是盈富基金(02800)、恒生中国企业(02800)、阿里巴巴-W(09988)。北水净卖出最多的个股是中芯 国际(00981)、东方甄选(01797)、小米集团-W(01810)。 | 股票名称 | 买入额 | 卖出额 | 买卖总额 | | --- | --- | --- | --- | | | | | 净流入 | | 盈富县金 | 50.04亿 | 621.48万 | 50.10亿 | | HK 02800 | | | +49.9716 | | 中芯国际 | 15.76 乙 | 22.84 Z | 38.61亿 | | HK 00981 | | | -7.08 Z- | | 阿里巴巴-W | 18.69 亿 | 14.20亿 | 32.89 亿 | | HK 09988 | | | +4.48亿 | | 腾讯控股 | 18.04 Z | 8.93 Z | 26.97 亿 | | HK 00700 | | | +9.11 亿 | ...

美联储主席鲍威尔周五在杰克逊霍尔全球央行年会上表示，美国就业市场面临的下行风险上升，风险的 平衡转变可能使得美联储调整政策立场成为恰当之举。这是鲍威尔迄今为止发出的最强烈的信号，暗示 美联储最早将于9月降息。华鑫证券指，美联储仍处于降息周期，鲍威尔发言为贵金属市场注入强心 剂，看好黄金价格进一步上涨。另值得关注的是，特朗普在社交媒体高调宣布，解除美联储理事丽莎· 库克（Lisa Cook）职务"立即生效"，此举引发对联储独立性的担忧。 港股未能延续昨日强劲走势，三大指数集体调整，恒指及国指午后跌幅均扩大逾1%。截止收盘，恒生 指数跌1.18%或304.99点，报25524.92点，全日成交额为3178.71亿港元；恒生国企指数跌1.07%，报 9148.66点；恒生科技指数跌0.74%，报5782.24点。 方正证券指出，港股近两月的行情则略逊于A股，无论是恒指还是恒科，涨幅均低于全A。该行认为， 港股后市行情值得期待，原因有如下几点：一是港股在估值上具备充分的吸引力；二是外资有望回流； 三是南向资金有望持续流入；四是港股具有一定的代表性和稀缺性。 蓝筹股表现 石药集团(01093)领跌蓝筹。截至收盘，跌4. ...

大摩此前发布研报称，对外授权合作(BD)交易付款征收关税的可能性较低。目前，美国关税主要针对 有形商品，聚焦生产回流，而服务相关收入(包括知识产权转让)较少受关注，特别是美国对中国保持服 务贸易顺差情况下。此外，大多数BD交易协议包含向全球授权方授予开发及制造权，部分授权方表 示，计划在美国获批后，于当地生产这些获批的授权药品。 消息上，美国总统特朗普称，将把药品价格削减至目前价格的1/1400到1/1500，将迅速对药品征收关 税。有分析指出，如果付诸实施，可能会对全球医药行业产生震荡。对于中国生物医药股而言，这意味 着机遇与挑战并存。 智通财经APP获悉，创新药概念股午后跌幅扩大，截至发稿，信达生物(01801)跌5.3%，报94.65港元； 诺诚健华(09969)跌3.72%，报17.35港元；联邦制药(03933)跌3.03%，报16.31港元；和黄医药(00013)跌 1.98%，报24.74港元。 ...

消息上，美国总统特朗普称，将把药品价格削减至目前价格的1/1400到1/1500，将迅速对药品征收关 税。有分析指出，如果付诸实施，可能会对全球医药行业产生震荡。对于中国生物医药股而言，这意味 着机遇与挑战并存。 大摩此前发布研报称，对外授权合作(BD)交易付款征收关税的可能性较低。目前，美国关税主要针对 有形商品，聚焦生产回流，而服务相关收入(包括知识产权转让)较少受关注，特别是美国对中国保持服 务贸易顺差情况下。此外，大多数BD交易协议包含向全球授权方授予开发及制造权，部分授权方表 示，计划在美国获批后，于当地生产这些获批的授权药品。 创新药概念股午后跌幅扩大，截至发稿，信达生物(01801)跌5.3%，报94.65港元；诺诚健华(09969)跌 3.72%，报17.35港元；联邦制药(03933)跌3.03%，报16.31港元；和黄医药(00013)跌1.98%，报24.74港 元。 ...

Core Viewpoint - The Chinese innovative drug industry is rapidly developing under policy support and globalization, with leading companies like BeiGene and HengRui Medicine making significant advancements through high R&D investments and dense pipelines [2][3]. Policy and Market Dynamics - The National Healthcare Security Administration initiated the 2025 medical insurance directory adjustment, emphasizing support for innovative drugs, which has boosted industry confidence [3]. - In the first half of 2025, the transaction amount for Chinese innovative drug BD reached $48.448 billion, highlighting accelerated globalization and international cooperation [3]. Company Performance Overview - **BeiGene**: Achieved revenue of 17.518 billion yuan, a 46% increase year-on-year, with a net profit of 450 million yuan, marking its first profitable half-year since listing. Its core product, Tislelizumab, generated sales of 2.643 billion yuan, up 20.6% [7]. - **HengRui Medicine**: Reported innovative drug sales and licensing income of 9.561 billion yuan, accounting for 60.66% of total revenue, with core innovative drug sales driving growth [8]. - **Hansoh Pharmaceutical**: Revenue reached 7.434 billion yuan, a 14.3% increase, with innovative drug sales contributing 82.7% [8]. - **Innovent Biologics**: Generated over 5.2 billion yuan in product revenue, a growth of over 35%, and completed a significant financing project [8]. - **China National Pharmaceutical Group**: Revenue of 17.57 billion yuan, with a net profit of 3.39 billion yuan, a 140.2% increase year-on-year [8]. - **East China Pharmaceutical**: Achieved revenue of 7.317 billion yuan, a 9.24% increase, with R&D investment rising significantly [9]. R&D Pipeline and Trends - The innovative drug sector is experiencing a concentrated R&D phase, with leading companies accelerating their pipeline development [10]. - **HengRui Medicine**: Six first-class innovative drugs were approved during the reporting period, with a robust pipeline including multiple drugs in various clinical stages [13]. - **BeiGene**: Continues to advance in ADC and bispecific antibodies, enhancing its international competitiveness [13]. - **Innovent Biologics**: Has 52 drugs in clinical stages, focusing on various innovative targets [13]. Role of Scientific Instrumentation - Scientific instrument manufacturers are transitioning from supporters to key enablers in the innovative drug sector, providing comprehensive technical support throughout the drug development process [3][14]. - **Waters Corporation**: Reported an 11% growth in pharmaceutical business, with a 70% increase in GLP-1 related income [15]. - **Agilent Technologies**: Increased revenue in life sciences and diagnostics, establishing strategic partnerships to enhance drug development capabilities [16]. - **Thermo Fisher Scientific**: Achieved $6 billion in laboratory product sales, exceeding market expectations, and providing comprehensive services for drug development [16]. Industry Outlook - The rapid development of new molecular types like antibodies and ADCs is creating significant challenges in quality management, fostering a deep coupling between innovative drug companies and scientific instrument manufacturers [18].

Core Insights - The article highlights the significant transformation occurring in China's biotechnology sector, driven by international investor interest and the competitive advantages of Chinese biotech companies [2][5]. Group 1: Investment Trends - Morgan Stanley has sponsored notable IPOs in the Hong Kong market, including projects from companies like Heng Rui Medicine and Ying En Biology, and has facilitated multiple refinancing projects totaling billions [1][3]. - The Hong Kong Stock Exchange has emerged as the world's second-largest biotechnology financing center, with 12 healthcare companies raising a total of $2.5 billion in the first half of 2025 [3]. - New listings have shown strong market performance, with an average first-day increase of 23.1% for the 12 healthcare companies [3]. Group 2: Financing Activities - Morgan Stanley has assisted Chinese issuers in raising over $5 billion in financing by the end of July, with notable projects including WuXi AppTec's $980 million share placement [4]. - The financing activities reflect a growing demand for biotech stocks, with significant oversubscription and reduced discount rates for recent offerings [4]. Group 3: Global Expansion of Chinese Biotech - Chinese biotech companies are increasingly pursuing international clinical registrations and market entries, with a notable rise in "License-out" agreements [5][6]. - The gap in innovation capabilities between Chinese and U.S. biotech firms has narrowed, with Chinese companies demonstrating significant advancements in drug development efficiency and cost [5][6]. - The total value of transactions related to antibody-drug conjugates (ADCs) has reached approximately $44 billion, indicating robust international collaboration [6]. Group 4: Strategic Collaborations - Chinese biotech firms are forming strategic partnerships with international giants, exemplified by Heng Rui Medicine's $12.5 billion deal with GlaxoSmithKline [6][7]. - The collaboration models are evolving from simple licensing to joint development and new company formations, showcasing increased confidence in Chinese biotech capabilities [6][7]. Group 5: Future Outlook and Challenges - The article emphasizes the need for Chinese biotech companies to overcome regulatory complexities and market entry barriers to enhance their global presence [8][9]. - Recommendations include building international talent teams, improving communication with regulatory bodies, and optimizing government support for innovation [9].

整理 | GLP1减重宝典内容团队 中国国家药监局药品审评中心（CDE）官网近日公示，信达生物申报的1类新药IBI3032获得临床试验默示许可，拟用于成人超重或肥胖患者 的长期体重控制。公开资料显示，这是信达生物研发的创新口服小分子GLP-1R激动剂，已经于今年8月初在美国获批IND。IBI3032的1期临床 试验将在中美同步推进，将于2025年下半年开始在健康受试者及超重或肥胖人群中给药。 | 2 | CXHL2500702 | IBI3032 | 信达生物科技有限公 | 本品拟用于成人招車或肥胖患 | | --- | --- | --- | --- | --- | | | | | 글 | 者的长期体重控制 | | 3 | CXHL2500701 | IBI3032 | 信达生物科技有限公 | 本品拟用于成人超重或肥胖患 | | | | | 글 | 者的长期体重控制 | | प | CXHL2500700 | IBI3032 | 信达生物科技有限公 | 本品拟用于成人超重或肥胖患 | | | | | 글 | 者的长期体重控制 | | 5 | CXHL2500699 | IBI3032 | 信达生物科技有限公 ...

Core Viewpoint - Innovent Biologics has received FDA clearance for the IND application to initiate a global Phase 3 clinical trial of IBI363, a novel PD-1/IL-2α-bias bispecific antibody fusion protein, targeting immunotherapy-resistant squamous non-small cell lung cancer (NSCLC) [1][2][10] Group 1: Clinical Trial Details - The Phase 3 trial, named MarsLight-11, will enroll approximately 600 patients globally, including regions such as China, the U.S., Canada, the EU, the UK, and Japan [3] - The study will compare the efficacy and safety of IBI363 at a dosage of 3 mg/kg as monotherapy against docetaxel in patients with unresectable, locally advanced or metastatic squamous NSCLC who have shown disease progression after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy [3] - The primary endpoint of the trial is overall survival [3] Group 2: Regulatory Approvals and Designations - The IND clearance follows positive feedback from the FDA during the End-of-Phase 2 meeting, with major alignments reached on dose selection and study design [2] - IBI363 has received Fast Track Designation (FTD) from the FDA and Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) for this indication [2] Group 3: Mechanism and Efficacy - IBI363 operates by simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway, targeting tumor-specific T cells [9] - Preliminary trials have shown that IBI363 induces tumor remission in some patients and achieves disease stability in the majority, indicating durable anti-tumor activity [8] - Compared to traditional chemotherapy, IBI363 is expected to offer advantages in objective response rate (ORR) and progression-free survival (PFS) [8] Group 4: Broader Development Strategy - Innovent is advancing IBI363 into registrational studies, with ongoing pivotal trials in melanoma and plans for colorectal cancer [5][6] - Multiple Phase 1b/2 trials are evaluating IBI363 as both monotherapy and in combination therapies across various cancer types, including first-line NSCLC and platinum-resistant ovarian cancer [6] - The comprehensive development strategy aims to maximize the value of IBI363 and expand its potential in large global oncology markets [6] Group 5: Company Vision and Pipeline - Innovent's mission is to empower patients worldwide with affordable, high-quality biopharmaceuticals, and it aims to build a global premier biopharmaceutical leader [11] - The company has launched 16 products and has 2 new drug applications under regulatory review, alongside 4 assets in Phase III or pivotal clinical trials [12]