经济观察网基于最新公开信息，诺诚健华-U(688428)在2026年有以下值得关注的事件进展，主要涉及临 床研发、合作推进和产品商业化等方面。 临床研发进展 ICP-488(高选择性TYK2抑制剂)：2026年2月2日，公司宣布其治疗银屑病的III期临床试验已完成患者入 组，共入组383例患者，标志该药取得关键临床节点。 Soficitinib(TYK2抑制剂)：2026年年初，治疗中重度特应性皮炎的III期注册临床试验已完成患者入组； 该药治疗白癜风、结节性痒疹等适应症的临床试验也在加速推进。 奥布替尼(BTK抑制剂)： 可持续盈利基础：公司2025年首次实现扭亏为盈(营收约23.7亿元，归母净利润约6.3亿元)，管理层表示 将从2025年起进入可持续盈利阶段，重点通过全球化布局和管线多元化巩固业绩。 以上内容基于公开资料整理，不构成投资建议。 治疗特发性血小板减少性紫癜(ITP)的III期临床研究已完成，预计2026年上半年提交新药上市申请 (NDA)。 治疗系统性红斑狼疮(SLE)的IIb期研究已达到主要终点，III期注册临床试验即将启动。 BCL2抑制剂(Mesutoclax/ICP-248)：目前正 ...

2025年，中国创新药BD交易总额历史性突破千亿美元，并出现百亿美元级订单，跨国药企支付的首付 款站在12.5亿美元的新台阶。 如果要挑选2025年的股市关键词，创新药一定是其中之一。2025年1月至9月，多只创新药企股票实现翻 倍上涨，而支撑行业在二级市场受热捧的，并非传统意义上的已上市药品带来的业绩增长，而是在研创 新药通过BD交易出海带来的想象空间。 年度标志性交易刷新多项纪录： 1月，启光德健与美国Biohaven、韩国AimedBio达成的超130亿美元合作，涵盖同类首创FGFR3靶点 ADC药物GQ1011的全球权益授权，同时涉及21个ADC靶点的联合开发平台，是中国ADC底层技术能力 获得国际背书的里程碑。 2025年初，迪哲医药（688192.SH）研发的肺癌靶向药向美国FDA递交新药上市申请并获得优先审评资 格，7月该药正式获批，成为中国首款独立研发在美获批的全球首创新药。7月，凯思凯迪研发的1类新 药CS0159口服片剂获FDA突破性疗法认定。8月，禾元生物（688765.SH）研发的重组人白蛋白注射液 获FDA批准开展三期临床试验。12月，康宁杰瑞（09966.HK）研发的HER2双抗A ...

科创综指日K线图 郭晨凯 制图 ◎记者 何昕怡 自2025年1月20日正式发布以来，上证科创板综合指数（简称"科创综指"）已平稳运行一年。作为刻画 科创板"全景图"的指数，科创综指在表征市场整体表现与引导长期资金配置方面的作用日益凸显。 数据显示，截至2月10日，科创综指样本数量达580只，市值覆盖度超过90%，总市值高于100亿元的科 创综指成分股权重占比较发布时提升15.1%，成长效应显著。 业内人士认为，科创综指已成为与上证指数、深证成指、创业板指并列的A股四大核心宽基指数，为境 内外投资者观测和分享中国新质生产力发展红利提供了重要工具。 2月10日，宇航电源"国家队"电科蓝天正式挂牌上市，成为科创板第603家上市公司。当前，作为"硬科 技"企业的聚集地，科创板的板块产业图谱与现代化产业体系建设同向而行，尤其是在新一代信息技 术、生物医药、高端装备制造等战略性新兴产业，已形成"链主引领、上下协同"的发展格局。 科创板公司坚持创新驱动发展，持续加大创新要素投入力度，创新成果积极涌现。2025年前三季度，科 创板公司研发投入总额达1328.64亿元，是板块净利润的2.7倍；研发投入占营业收入比例中位数为 1 ...

Market Overview - A-shares experienced narrow fluctuations, with the Sci-Tech Innovation Board showing strong performance, particularly in AI applications and computing chips [1] - The Hong Kong stock market saw a significant rebound in the pharmaceutical sector, with the Hong Kong Innovation Drug ETF (520880) reaching a peak increase of 3.86% and closing up 2.9% [3][5] ETF Performance - The Hong Kong Innovation Drug ETF (520880) recorded a trading volume of 5.9 billion, while the Hong Kong Medical ETF (159137) rose by 2.1%, marking its sixth consecutive day of gains [2][3] - The Sci-Tech Artificial Intelligence ETF (589520) increased by 1.81%, with a peak rise of over 2.4% during the trading session [8] Industry Insights - The Chinese innovative drug sector is experiencing a dual breakthrough in internationalization and commercialization, with over 70% of innovative drug companies reporting positive revenue growth [6][7] - Significant collaborations in the innovative drug space include a strategic partnership between Innovent Biologics and Eli Lilly, valued at up to $8.85 billion, and a $18.5 billion collaboration between CSPC Pharmaceutical and AstraZeneca [6] AI and Technology Developments - ByteDance's recent launches, including the Seedance 2.0 video generation model and Seedream 5.0 image generation model, have generated significant interest in the AI sector [11] - The Sci-Tech Artificial Intelligence ETF (589520) has a substantial exposure to ByteDance, with a weight of 29.42% in its index [11][13] Semiconductor and Chip Industry - The semiconductor equipment industry is experiencing an upward trend, with projected sales growth of 26% in 2026, reaching $791.7 billion [17] - The Sci-Tech Chip ETF (589190) is positioned to benefit from the ongoing "super cycle" in the semiconductor industry, with a focus on domestic production and expansion [15][17] Investment Strategy - Analysts suggest that the current market conditions present a favorable opportunity for investment in innovative drugs and AI sectors, with a recommendation to focus on ETFs that track these industries [7][19] - The Sci-Tech Chip ETF has shown a strong annualized return of 17.93%, outperforming other semiconductor indices [19][20]

科创创新药ETF汇添富（589120）标的指数成分股多数冲高，荣昌生物、百利天恒涨超5%，百济神州涨超4%，泽璟制药、博瑞医药等涨幅居前， 特宝生物、益方生物等小幅回调。 【科创创新药ETF汇添富（589120）标的指数前十大成分股】 | 序号 | 代码 | 名称 | 申万一级行业 | 涨跌幅 | 估算权重 | | --- | --- | --- | --- | --- | --- | | 1 | 688235 | J-Z**KD | 医药生物 | 4.04% | 10.43% | | 2 | 688578 | 艾力斯 | 医药生物 | 0.82% | 9.10% | | 3 | 688506 | 百利天恒 | 医药生物 | 5.10% | 7.89% | | র্ব | 688180 | 君实生物-U | 医药生物 | 1.10% | 6.70% | | 5 | 688331 | 荣昌生物 | 医药生物 | 5.51% | 6.35% | | 6 | 688266 | 泽昌制药-U | 医药生物 | 3.74% | 6.07% | | 7 | 688166 | 博瑞医药 | 医药生物 | 2.27% | 4 ...

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry, indicating a positive outlook for investment opportunities in this sector [3]. Core Insights - The commercialization of Antibody-Drug Conjugates (ADC) is accelerating, with 20 ADC drugs approved globally, and 6 of them consistently generating over $1 billion in revenue for two consecutive years. The competition in the ADC market is entering a new phase, with approximately 60 ADC drugs currently in clinical phase 3 or awaiting market approval [6][30]. - Domestic innovative pharmaceutical companies are adopting various strategies for ADC capacity layout, with companies like Rongchang Biopharma transitioning from outsourcing to in-house production, while others like Kelong Biotechnology are building their own production bases [6][31]. - The recent revision of the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" supports segmented contract manufacturing and commercial-scale drug sales, providing a foundation for ADC commercialization partnerships [6][32]. Market Performance - The pharmaceutical index rose by 0.14% this week, outperforming the CSI 300 index by 1.47 percentage points, ranking 15th in industry performance [10]. - Since the beginning of 2026, the pharmaceutical index has increased by 3.28%, again outperforming the CSI 300 index by 2.99 percentage points, ranking 23rd [10]. - The best-performing sub-sector this week was Traditional Chinese Medicine, which increased by 2.56%, while Chemical Pharmaceuticals and Biological Products saw declines of 0.62% and 1.82%, respectively [15][17]. Stock Performance - Among A-share pharmaceutical stocks, the top five performers this week were Guangshengtang (+29.83%), Haixiang Pharmaceutical (+18.64%), and Meidixi (+18.04%) [20]. - In the Hong Kong market, the top performers included Yiteng Jiahe (+14%) and Kedi-B (+9.96%), with 38 out of 116 pharmaceutical stocks rising, representing 32.76% [24][25]. Industry News and Policies - The inclusion of implantable brain-machine interfaces in the category of Class III medical devices marks a significant regulatory development, indicating a focus on innovative medical technologies [27]. - Novartis has submitted an application for the marketing of Ianalumab in China, a drug targeting various autoimmune diseases, which has shown promising results in clinical trials [27]. - Johnson & Johnson announced the approval of Daratumumab injection for a new combination therapy in China, providing a new treatment option for multiple myeloma patients [28].

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry [3] Core Insights - The commercialization of ADC (Antibody-Drug Conjugates) is accelerating, with 20 ADC drugs approved globally, and 6 of them have been in the "billion-dollar club" for two consecutive years [30][31] - The report highlights the increasing competition in the ADC sector, with approximately 60 ADC drugs currently in clinical phase 3 and application stages [30] - Domestic innovative pharmaceutical companies are adopting various strategies for ADC capacity layout, with companies like Rongchang Biopharma transitioning from outsourcing to in-house production, while others like Kelong Biotechnology are building their own production bases [31][32] Summary by Sections Market Review - The pharmaceutical index rose by 0.14% this week, outperforming the CSI 300 index by 1.47 percentage points, ranking 15th in industry performance [10] - Year-to-date, the pharmaceutical index has increased by 3.28%, also outperforming the CSI 300 index by 2.99 percentage points, ranking 23rd [10] Individual Stock Performance - In the A-share market, 255 out of 479 pharmaceutical stocks rose, with the top five performers being Guangshengtang (+29.83%), Haixiang Pharmaceutical (+18.64%), and Meidixi (+18.04%) [20] - In the Hong Kong market, 38 out of 116 pharmaceutical stocks rose, with the top performers including Yiteng Jiahe (+14%) and Kedi-B (+9.96%) [24] Industry News and Policies - The newly revised "Regulations on the Implementation of the Drug Administration Law" supports segmented contract manufacturing and commercial-scale drug sales, providing a foundation for ADC commercialization cooperation [32] - Notable industry developments include Novartis's application for Ianalumab in China and Johnson & Johnson's approval of Daratumumab injection for multiple myeloma treatment [27][28] Weekly Insights - The ADC commercialization battle has begun, with a significant increase in demand for ADC production capacity, leading to a supply-demand imbalance [30] - Major CXO companies are expanding ADC production capacity, with companies like WuXi AppTec acquiring East Yao Pharmaceutical to meet rising orders [31]

Group 1 - The Hong Kong stock market showed a strong opening on February 9, with the Hang Seng Index rising by 1.59%, the State-owned Enterprises Index increasing by 1.54%, and the Technology Index up by 1.9% [1] - The Hang Seng Biotechnology Index, focusing on innovative drugs, performed robustly, with the largest ETF tracking this index (159892) rising nearly 2% [1] - The innovative drug sector is expected to enter a profit realization acceleration phase by 2025, with companies like Innovent Biologics and Rongchang Biopharmaceuticals turning losses into profits, while companies like 3SBio are significantly increasing their performance [1] Group 2 - The strong performance of the innovative drug sector validates the effectiveness of the domestic innovative drug business model, with core product volume growth supported by medical insurance becoming the foundation for performance growth [1] - External collaborations, such as business development (BD) partnerships, are becoming important drivers for enhancing performance in the innovative drug sector [1] - The Hang Seng Medical ETF (159892) focuses on innovative drugs, CXO, and related industries, benefiting from the advantages of the Hong Kong Stock Exchange's 18A system, covering numerous innovative targets like BeiGene and Innovent Biologics, and is expected to continue its valuation recovery trend under catalysts like overseas expansion of innovative drugs and commercial insurance directories [1]

Core Viewpoint - The company announced that its self-developed VAV1 molecular glue degrader ICP-538 has been approved by the National Medical Products Administration (NMPA) for clinical research, marking it as the first in China and the second globally to enter clinical trials [1] Group 1: Product Development - ICP-538 is a novel oral, highly efficient, and selectively targeted VAV1-specific molecular glue degrader [1] - VAV1 is a key protein downstream of T cell and B cell receptors, which is crucial for developing treatments for various difficult-to-treat autoimmune diseases [1] Group 2: Target Indications - The drug is aimed at treating multiple challenging autoimmune diseases, including inflammatory bowel disease (IBD), systemic lupus erythematosus (SLE), and multiple sclerosis (MS) [1]

2月9日，诺诚健华宣布，公司自主研发的VAV1分子胶降解剂ICP-538获国家药品监督管理局（NMPA） 药品审评中心（CDE）批准开展临床研究。据诺诚健华介绍，这是中国首款、全球第二款进入临床的 VAV1分子胶降解剂。ICP-538是新型口服高效、高选择性靶向VAV1的特异性分子胶降解剂，VAV1是T 细胞和B细胞受体下游的关键蛋白，用于开发治疗多种难治的自身免疫性疾病，比如炎症性肠病 （IBD）、系统性红斑狼疮（SLE）和多发性硬化（MS）。目前，全球尚无获批上市的VAV1靶向药 物。 ...