翰森制药(03692)发布公告，集团创新药阿美乐(甲磺酸阿美替尼片)获中国国家药品监督管理局 ("NMPA")签发的药品注册证书，批准增加"阿美乐联合培美曲塞和铂类化疗药物适用于具有表皮生长因 子受体("EGFR")外显子19缺失或外显子21(L858R)置换突变的局部晚期或转移性非小细胞肺癌 ("NSCLC")成人患者的一线治疗"适应症。此为阿美乐获批的第五项适应症。 ...

智通财经APP讯，翰森制药(03692)发布公告，集团创新药阿美乐 (甲磺酸阿美替尼片)获中国国家药品监督管理局("NMPA")签发的药品注册证书， 批准增加"阿美乐联合培美曲塞和铂类化疗药物适用于具有表皮生长因子受体("EGFR")外显子19缺失或外显子 21(L858R)置换突变的局部晚期或转 移性非小细胞肺癌("NSCLC")成人患者的一线治疗"适应症。此为阿美乐获批的第五项适应症。 （原标题：翰森制药(03692)：阿美乐® (甲磺酸阿美替尼片)第五项适应症获国家药品监督管理局签发药品注册证书） ...

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份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 自願公告 阿美樂® （甲磺酸阿美替尼片）第五項適應症 獲國家藥品監督管理局簽發藥品註冊證書 翰森製藥集團有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董 事會」）欣然宣佈，本集團創新藥阿美樂® （甲磺酸阿美替尼片）獲中國國家藥品監 督管理局（「NMPA」）簽發的藥品註冊證書，批准增加「阿美樂®聯合培美曲塞和 鉑類化療藥物適用於具有表皮生長因子受體（「EGFR」）外顯子19缺失或外顯子 21(L858R)置換突變的局部晚期或轉移性非小細胞肺癌（「NSCLC」）成人患者的一 線治療」適應症。此為阿美樂®獲批的第五項適應症。 關於阿美樂® 阿美樂® （甲磺酸阿美替尼片）是中國首個原研三代EGFR-TKI創新藥，此前已於 中國獲批四項適應症，分別為：二零二零年獲批用於既往經EGFR-TKI治療進 展，且T790M突變陽性的局部晚期或轉移性NSCLC患者；二零二一年獲批用於 具有EGFR外顯子19 ...

Market Overview - The Hong Kong stock market experienced a decline, with the Hang Seng Index falling by 1.17% or 309.64 points, closing at 26,149.31 points, and a total trading volume of 268.275 billion HKD [1] - The Hang Seng Tech Index dropped by 1.05%, while the Hang Seng China Enterprises Index decreased by 1.09% [1] - Everbright Securities noted that domestic policy support and a weaker US dollar may lead to continued fluctuations and potential upward movement in the Hong Kong market, highlighting strong overall profitability and relatively low valuations [1] Blue-Chip Stocks Performance - New World Development (00016) led blue-chip stocks with a rise of 3.21%, closing at 102.8 HKD, contributing 7.39 points to the Hang Seng Index [2] - China Shenhua (01088) increased by 2.56%, while Hansoh Pharmaceutical (03692) rose by 1.75% [2] - Sands China (01928) fell by 4.49%, and Tingyi (00322) dropped by 4.18%, negatively impacting the index [2] Sector Highlights - Large tech stocks faced pressure, with Alibaba and Tencent both declining [3] - The commercial aerospace sector saw significant gains, with Asia Pacific Satellite rising over 20% [4] - Semiconductor stocks performed well, with Tian Shuo Zhi Xin (09903) increasing by 8.44% and Shanghai Fudan (01385) rising by 5.27% [3] - The brain-computer interface sector gained attention, with companies like Brainhole Technology (02203) and Micro-Innovation Brain Science (02172) seeing notable increases [4][5] New Listings and Market Movements - New listings included Zhipu AI (02513), which rose by 13.17% on its debut, becoming known as the "first stock of large models" [7] - COSCO Shipping Energy (01138) saw a strong performance, increasing by 7.09% amid rising demand for legal oil tankers due to geopolitical dynamics [8] - Xindong Company (02400) also performed well, rising by 6.46% following the global launch of its mobile game [9] HSBC Holdings Update - HSBC Holdings (00005) faced pressure, declining by 2.28% as it held a court meeting and shareholder meeting to vote on a privatization proposal valued at approximately 290.3 billion HKD [10] - The proposed buyout price is set at 155 HKD per share, representing a 30.3% premium over the previous closing price [10]

Group 1: Market Performance - Hong Kong's innovative drug ETF (159570) surged by 3%, with a trading volume exceeding 1.5 billion yuan, following a net inflow of over 62 million yuan today after a previous inflow of 430 million yuan [1][3] - As of January 6, the latest scale of the Hong Kong innovative drug ETF reached over 23.3 billion yuan, leading its peers in the same category [1] Group 2: Economic Signals - Federal Reserve Governor Milan indicated that upcoming economic data may support further interest rate cuts, with expectations of a reduction exceeding 100 basis points this year [3] - Wall Street analysts suggest that if the U.S. unemployment rate rises to 4.7% by December 2025, the Fed may cut rates by 25 basis points this month [3] Group 3: Company Developments - Brain-computer interface "unicorn" Strong Brain Technology completed a financing round of 2 billion yuan, second only to Musk's Neuralink [3] - AI pharmaceutical company Insilico Medicine announced a long-term collaboration with Siveya for anti-tumor drug development, with a total deal value of 888 million USD [3] Group 4: New Drug Approvals - On January 6, BeiGene announced that its self-developed BCL2 inhibitor, Baiyueda® (sotucumab), received conditional approval from the National Medical Products Administration [3] - Shiyao's SYS6017 has initiated Phase II clinical trials for the prevention of shingles [3] Group 5: Investment Insights - Zhongtai Securities predicts that the pharmaceutical sector's opportunities in 2025 will focus on innovation and industry upgrades, with investment strategies continuing into 2026 [5] - The report emphasizes the importance of "innovative drugs and industry chains, demand recovery, and AI" as key investment dimensions [5] Group 6: J.P. Morgan Healthcare Conference - The 44th J.P. Morgan Healthcare Conference is set to take place from January 12 to 15, 2026, in San Francisco, attracting over 8,000 global participants [6] - The conference will feature over 500 listed companies and thousands of startups, focusing on "capital + strategy" discussions [6] Group 7: Industry Trends - Three major trends are highlighted for 2026: the continued rise of gene and cell therapies, deep integration of AI in pharmaceuticals, and the emergence of new market forces [7] - The report notes that over 20 gene editing companies will showcase breakthroughs in CAR-T and base editing at the conference [7] Group 8: MNC Engagement - Multinational corporations (MNCs) are willing to pay higher prices for innovative drugs from China, with the average total package for drugs purchased from China being 2.76 billion USD, compared to 1.29 billion USD for those from overseas [8] - The willingness of MNCs to pay a premium for Chinese innovations is driven by the need to fill significant pipeline gaps due to impending patent expirations [8] Group 9: Investment Focus - Investment strategies should focus on companies with strong clinical development capabilities and those in popular therapeutic areas such as ADCs, GLP-1, and dual antibodies [11] - Companies that can produce high-quality late-stage clinical assets are likely to attract MNC interest [11] Group 10: Key Therapeutic Areas - The report identifies key therapeutic areas for investment, including ADCs, GLP-1, dual antibodies, and neuroscience, emphasizing the need for innovative platforms and clinical data superiority [12]

Core Viewpoint - The Hong Kong Innovative Drug ETF (159567) has shown a positive performance since its inception, with a slight increase in scale and significant trading activity in the early days of 2024 [1][2] Group 1: Fund Performance - The Hong Kong Innovative Drug ETF (159567) closed at a 0.38% increase on January 6, with a trading volume of 1.163 billion yuan [1] - As of January 5, the fund's latest share count was 10.479 billion shares, with a total scale of 8.331 billion yuan, reflecting a 5.50% increase in scale since December 31, 2025 [1] - The fund's management fee is set at 0.50% annually, and the custody fee is 0.10% annually [1] Group 2: Trading Activity - Over the past 20 trading days, the cumulative trading amount for the ETF reached 16.464 billion yuan, with an average daily trading amount of 0.823 billion yuan [1] - In the first two trading days of 2024, the ETF recorded a cumulative trading amount of 2.789 billion yuan, averaging 1.394 billion yuan per day [1] Group 3: Fund Holdings - The top holdings of the Hong Kong Innovative Drug ETF include companies such as BeiGene, CanSino Biologics, and Innovent Biologics, with significant percentages of the fund's total assets allocated to these stocks [2] - The largest holding is BeiGene, accounting for 10.62% of the portfolio, followed closely by CanSino Biologics at 10.55% and Innovent Biologics at 10.21% [2] - Other notable holdings include China National Pharmaceutical Group and Stone Group, with respective allocations of 9.62% and 7.56% [2]

Core Insights - The report from China Merchants Securities International indicates that the pharmaceutical industry will experience differentiated growth by 2026, with chronic diseases remaining the largest driver for the future of the pharmaceutical sector [1] - The report emphasizes that upgrades on the supply side and improvements in the operational quality of representative companies are key strategies for bottom-up stock selection [1] - It highlights that the US and China will engage in more competition and collaboration in the innovative drug sector, with policy disruptions causing fluctuations but not altering the long-term development direction of the industry [1] Industry Focus - The report expresses a positive outlook on the biopharmaceutical sector, identifying key companies such as Novartis, Innovent Biologics, Aileron Therapeutics, Hansoh Pharmaceutical, and CanSino Biologics as industry favorites [1] - Additional recommendations include companies like Healer, China Resources Pharmaceutical, Thermo Fisher Scientific, and Eli Lilly [1]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 翰森製藥集團有限公司 呈交日期: 2026年1月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 03692 | 說明 | - | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 20,000,000,000 | HKD | | 0.00001 | HKD | | 200,000 | | 增加 / 減少 (-) | | | | | | | HKD | | | | 本月底結存 | | | 20,000,000,000 | HKD | | 0.00001 | HKD | | 200,000 | 本月底法定 ...

Group 1 - HuLuWa's chairman Liu Jingping is under investigation by the China Securities Regulatory Commission (CSRC) for suspected violations of information disclosure laws [1] - The company assures that all production and operational activities are proceeding normally and will cooperate with the CSRC during the investigation [1] Group 2 - HengRui Medicine has signed an exclusive licensing agreement with Hansoh Pharmaceutical for the SHR6508 project, with an initial payment of 30 million RMB [2] - SHR6508 is a new calcium-sensing receptor modulator intended for treating secondary hyperparathyroidism in chronic kidney disease patients undergoing dialysis, currently in phase III clinical trials [2] - HengRui is eligible for milestone payments up to 190 million RMB and a sales commission of up to 9% based on quarterly net sales [2] Group 3 - YueKang Pharmaceutical has submitted an application for H-share issuance and listing on the Hong Kong Stock Exchange [3] - The application materials are subject to updates and revisions as per regulatory requirements [3] Group 4 - Novo Nordisk announced a favorable ruling from the Supreme People's Court of China regarding the patent for semaglutide, a key component in its obesity and diabetes medications [4] - The company anticipates a low single-digit negative impact on global sales growth in 2026 due to the expiration of the patent in some markets [4] Group 5 - Sinovac Biotech has secured an exclusive contract to supply over 8 million doses of flu vaccine to the Chilean government for the 2026 flu season [5][6] - The first batch of vaccines is expected to arrive in Chile by the end of January 2026, continuing Sinovac's role as the sole supplier for the second consecutive year [6] Group 6 - Carestream Health has completed a strategic restructuring, splitting into two independent companies, with its international business unit acquired by Midea Group [7] - The specific transaction amount for the asset sale has not been disclosed [7] Group 7 - Haiwang Bio plans to sell its pharmaceutical distribution subsidiary for 248.08 million RMB to focus on high-margin sectors like medical devices [8] - The divestment aims to optimize the company's asset and business structure, reduce operational costs, and enhance long-term strategic focus [8]

Core Insights - The year 2025 marks a significant milestone for China's innovative pharmaceutical industry, characterized by intense interactions between capital and industry, with BD transaction totals exceeding $130 billion, setting a historical record and surpassing 50% of the global market share [1][5] - The market has experienced a rollercoaster ride, with a resurgence in the first half of the year followed by a collective pullback in the third quarter, highlighting the importance of distinguishing between companies driven by solid fundamentals versus those reliant on market sentiment [3][10] - The industry is transitioning from "scale expansion" to "value realization," indicating a shift towards more sustainable growth and resilience in the face of external uncertainties [1][12] BD Transactions - In 2025, China saw explosive growth in license-out transactions, with over 100 deals totaling more than $110 billion, including 15 transactions with upfront payments exceeding $100 million [5][6] - Notable milestone BD transactions include a $12.5 billion deal between 3SBio and Pfizer, and a $114 billion strategic partnership between Innovent Biologics and Takeda, marking a shift in traditional licensing models [5][6] - The total value of license-out transactions reached $130 billion, a year-on-year increase of over 150%, underscoring China's emergence as a key player in global pharmaceutical innovation [5][6] Market Dynamics - The traditional pharmaceutical companies are adapting and showing resilience, with firms like Hengrui Medicine and 3SBio successfully navigating the transition from generics to innovative drugs [4][10] - The industry is expected to continue its upward trajectory, supported by increased R&D investments, a growing number of clinical trials, and a dual payment system that enhances patient access to innovative therapies [10][11] - The anticipated "data validation year" in 2026 will see more Chinese innovative pipelines entering global clinical development, influencing market expectations for Chinese innovation [10][11] Future Outlook - The innovative pharmaceutical sector is poised for a more solid and resilient future, with a focus on delivering effective treatment solutions for patients and contributing to the global pharmaceutical landscape [12][13] - The ongoing demand for innovative assets from multinational corporations (MNCs) is expected to rise, driven by patent expirations and declining R&D efficiency, leading to a strategic focus on "in China for global" initiatives [6][7] - The industry is entering a new era characterized by value-driven growth, where the emphasis will be on the contribution of products to revenue rather than mere availability [7][9]