在获批新药的治疗领域方面，肿瘤是占比最大的治疗领域，涵盖了多种实体瘤和血液瘤；其他治疗领域 也涉及到呼吸系统、内分泌与代谢、心血管等领域。其中，多达34 款新药的审评审批涉及特殊审评。 国外MNC 大型药企获批新药领先，国内药企同样有新药获批 事件 2025 年，FDA 药品评价与研究中心（CDER）共批准了46 款新药，虽然获批数量相较于2024 年及2023 年均有所下降，但是获批新药的类型丰富且创新性较高。 2025 年FDA 批准新药的类型丰富且创新性较高 2025 年FDA 共批准了46 款新药，获批新药的创新性较高，"first-in-class"疗法占比过半；获批新药类型 丰富，以小分子化药为主，其他包括单克隆抗体、ADC、siRNA、ASO、融合蛋白和双特异性T 细胞接 合器等。 2025 年FDA 批准新药的治疗领域以肿瘤治疗为主 智通财经APP获悉，万联证券发布研报称，2025 年FDA 批准新药的创新"质量"提升和技术平台多元 化，国内药企崭露头角。建议聚焦前沿技术平台，重点关注拥有ADC、siRNA、细胞基因治疗（CGT） 等前沿技术平台的公司；建议布局具有"出海"潜力的中国创新，重点 ...

市 场 研 究 [Table_MeetReportDate] 2026 年 01 月 08 日 星期四 [Table_Summary] 概览 核心观点 3028 【市场回顾】 周三 A 股震荡上涨，上证指数收涨 0.05%报 4085.77 点，深证成指涨 0.06%，创业板指涨 0.31%；沪深两市成交额 2.85 万亿元。申万行业 方面，煤炭、电子、通信等领涨；石油石化、非银、美容护理等领跌。 概念板块方面，光刻胶、科创次新股、存储芯片等上涨，DRG、互联 网保险、脑机接口等下跌。港股方面，恒生指数收跌 0.94%报 26458.95 点；恒生科技指数跌 1.49%；美国三大股指收盘涨跌不一，道指跌 0.94%报 48996.08 点，标普 500 指数跌 0.34%报 6920.93 点，纳指涨 0.16%报 23584.27 点；欧洲三大股指收盘涨跌不一，亚太主要股指收 盘涨跌互现。 【重要新闻】 [Table_Title] 万联晨会 【工信部等八部门印发《"人工智能+制造"专项行动实施意见》】工 信部等八部门印发《"人工智能+制造"专项行动实施意见》，目标是 到 2027 年，我国人工智能关键核心技 ...

12.5亿美元首付款，60亿美元总交易额，三生制药与辉瑞的一纸协议，在今年5月点燃了资本市场的热 情，也映照出中国创新药的"DeepSeek时刻"。在本轮行情中，百济神州、百利天恒、诺诚健华等一批企 业凭借技术实力和出海策略脱颖而出，它们可以作为观察行业趋势的典型样本。它们是当下的典型，未 来却绝不是"全部"。 资本市场敏锐地嗅到了变化。今年以来，二级市场上创新药板块成为明星。港股创新药指数一度飙升逾 100%，A股创新药板块亦亮点频现。水涨船高之下，A股和港股千亿市值创新药企已达8家。 与此同时，港交所迎来药企扎堆申报，仅11月就有近10家创新药企递表，其中不乏多轮融资但仍未盈利 的创新药企。资本的热浪席卷着二级市场，而在这背后，中国创新药企正用实实在在的临床数据和商业 价值实现价值重估。 /二级市场狂欢/ 资本市场总是先知先觉。经历近四年的深度调整后，创新药在2025年迎来强势反弹。 东方财富显示，自4月9日阶段性探底后，港股创新药板块发起猛攻，截至11月19日收盘，港股创新药指 数累计涨幅达到110.75%，期间一度涨超100%。A股创新药板块同样大涨。4月9日至11月19日，A股创 新药板块累计上涨4 ...

Core Insights - The 2025 International Cooperation and Exchange Conference on Industrial and Supply Chains was held in Wuxi, focusing on the theme "Gathering New Quality Productive Forces, Open Cooperation for a Win-Win Future" [1] - The establishment of the Jiangsu Province Biopharmaceutical Full Industry Chain Open Innovation Alliance and the signing of several foreign-funded R&D center projects mark a significant acceleration for Wuxi's life and health industry [1] Industry Growth - Wuxi's biopharmaceutical industry has shown robust growth, reaching a total scale of 200 billion yuan by the end of 2023, with an average growth rate exceeding 13% over the past five years [2] - The Wuxi High-tech Zone (Xinwu District) accounts for over 1 billion yuan of this growth, representing a significant portion of the city's biopharmaceutical industry [2] - GE Healthcare's Wuxi base has evolved from an ultrasound equipment assembly plant to the largest global production base for ultrasound and life care devices, serving over 100 countries [2] Innovation in Medical Devices - GE Healthcare's Carevance patient monitor, developed in Wuxi, features a "mobile brain" design that simplifies clinical operations and ensures continuous monitoring of vital signs [4] - Wuxi has released a list of innovative biopharmaceutical products, including advanced ultrasound diagnostic systems, showcasing the city's strong innovation capabilities [6] Breakthroughs in Pharmaceuticals - Local pharmaceutical company Nuoyu Pharmaceutical has made significant progress with its cancer diagnostic radiopharmaceuticals, with plans to submit for market approval next year [5] - The approval of two innovative drugs by Dize Pharmaceutical marks a breakthrough for original drug approvals in Wuxi [5] Supportive Ecosystem - The Jiangsu provincial government has implemented policies to optimize the regulatory environment for the biopharmaceutical industry, facilitating its development [9] - Financial support measures have been introduced to enhance investment in the biopharmaceutical sector, creating a collaborative ecosystem [11] - Wuxi has established a matrix of life and health industry carriers, focusing on various sectors such as synthetic biology and gene therapy [11] Future Prospects - The establishment of the Jiangsu Province Biopharmaceutical Full Industry Chain Open Innovation Alliance positions Wuxi as a new hub for innovation in the life and health industry [12]

Group 1 - The report emphasizes the rapid development of China's innovative pharmaceuticals, highlighting that the number of clinical trials has reached a global leading position, with a significant increase in new drug approvals [3][5][7] - Chinese pharmaceutical companies are transitioning from a "fast follower" to an "innovation leader" model, actively engaging in cutting-edge fields such as ADC, bispecific antibodies, and mRNA vaccines, with a notable increase in the number of products in late-stage development [8][11][18] - The report identifies two main investment directions: the transformation of biotech companies into biopharma and the revaluation of traditional pharmaceutical companies during their innovation transition, suggesting specific companies to watch in both categories [3][4] Group 2 - China's integration into the global innovative drug value chain is deepening, with a growing number of global multi-center clinical trials led by Chinese companies, indicating a shift in the global drug development landscape [3][24] - The report notes that the contribution of Chinese companies to global clinical trials has significantly increased, with a projection of 1,903 innovative drug clinical trials registered in China by 2024 [7][24] - The report highlights the increasing competitiveness of Chinese companies in high-potential therapeutic areas, particularly in oncology, metabolic diseases, and autoimmune diseases, with substantial market shares in these segments [18][19] Group 3 - The report discusses the rising trend of BD (business development) transactions involving Chinese assets, with a notable increase in transaction amounts and numbers, indicating China's growing influence in the global pharmaceutical innovation landscape [33][44] - It highlights that the majority of license-out projects are now in early stages, reflecting the international interest in early-stage Chinese innovations, particularly in oncology and metabolic therapies [39][44] - The report points out that major multinational corporations (MNCs) are increasingly seeking next-generation blockbuster products from China to fill revenue gaps due to impending patent expirations [62][66]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected stock price increase of over 20% relative to the benchmark index within the next six months [2][14]. Core Insights - The company reported a revenue of 3.73 billion yuan for the first three quarters of 2025, representing a year-on-year growth of 47.3%. The net profit attributable to shareholders was 1.62 billion yuan, up 52.0% year-on-year, with a stable performance in Q3 [5][6]. - The company's product, Vomeletin, shows a steady increase in market share due to its "high efficiency and low toxicity" advantages, with a gross margin of 96.8% for the first three quarters of 2025 [6][8]. - The NDA for Vomeletin for the treatment of NSCLC has been accepted for priority review, with competitive efficacy and safety data compared to other treatments in the market [7][8]. Financial Performance - For 2025, the company is projected to achieve revenues of 4.82 billion yuan, a 35.3% increase year-on-year, and a net profit of 1.99 billion yuan, reflecting a growth of 38.8% [8][10]. - The gross margin is expected to remain high, with estimates of 96.3% for 2025 and 96.4% for 2026 and 2027 [10][13]. - The company’s debt-to-asset ratio is low at 10.7%, indicating strong financial stability [4][13]. Earnings Forecast - The earnings per share (EPS) is projected to be 4.41 yuan in 2025, increasing to 6.23 yuan by 2027, with corresponding price-to-earnings (P/E) ratios of 23.89 and 16.92 respectively [10][13]. - The company is expected to continue its growth trajectory with revenue forecasts of 5.87 billion yuan in 2026 and 7.07 billion yuan in 2027, maintaining a strong growth rate [10][11].

Group 1 - The core viewpoint of the article is that China Galaxy has given a "recommended" rating to Dize Pharmaceutical (688192.SH) based on significant developments in its product pipeline [1] - Shuwotini has received overseas approval for market launch, and multiple achievements have been selected for the 2025 WCLC [1] - The dual-target BTK has received fast track designation and is set to be showcased at the 2025 ASH [1]

Core Viewpoint - DIZHE Pharmaceuticals, established in 2017 and listed in 2021, focuses on innovative therapies for malignant tumors and has a competitive product pipeline with two products already on the market [1] Business Performance - For Q3 2025, DIZHE Pharmaceuticals reported revenue of 586 million yuan, ranking 73rd in the industry, while the industry leader, Huadong Medicine, reported revenue of 32.664 billion yuan [2] - The net profit for the same period was -583 million yuan, placing the company 109th in the industry, with the top performer, Heng Rui Medicine, achieving a net profit of 5.76 billion yuan [2] Financial Ratios - As of Q3 2025, the company's debt-to-asset ratio was 51.15%, higher than the industry average of 35.26%, but down from 73.38% year-on-year, indicating reduced debt pressure [3] - The gross profit margin stood at 95.68%, significantly above the industry average of 57.17%, despite a slight decrease from 97.73% in the previous year, reflecting strong profitability [3] Executive Compensation - Chairman and CEO Xiaolin Zhang's compensation for 2024 was 6.0572 million yuan, a decrease of 3.4776 million yuan from 2023 [4] Shareholder Information - As of September 30, 2025, the number of A-share shareholders increased by 5.01% to 8,806, with an average holding of 46,500 shares, up 108.97% from the previous period [5] Revenue and Profit Forecast - According to Huatai Securities, DIZHE Pharmaceuticals is expected to achieve nearly 800 million yuan in revenue from its product Shuwotini in 2025, with a domestic peak potential of over 2 billion yuan [6] - Donghai Securities highlighted the company's strong R&D and commercialization capabilities, predicting revenues of 700 million, 1.225 billion, and 2.314 billion yuan for 2025 to 2027 [7]

Core Insights - The Sci-Tech Innovation Board (STAR Market) has transformed from an experimental platform for institutional innovation to a hub for "hard tech" companies during the "14th Five-Year Plan" period, with significant growth in the number and market value of technology innovation companies [1][2]. Group 1: Market Growth and Financial Performance - As of October 26, 2025, the number of listed companies on the STAR Market reached 589, with total IPO fundraising of 925.7 billion yuan and refinancing of 186.7 billion yuan, exceeding 1.1 trillion yuan in total [2]. - The proportion of strategic emerging industries and new productivity development directions aligns closely with the STAR Market's focus, with over 80% of companies in new generation information technology, biomedicine, and high-end equipment manufacturing [2]. - R&D investment in the STAR Market companies increased from 640 billion yuan to 1.07 trillion yuan, a growth of 66%, accounting for nearly 40% of the national R&D investment [3]. Group 2: Institutional Innovations and Support - The STAR Market has introduced various institutional innovations during the "14th Five-Year Plan," enhancing inclusivity and providing tailored support for companies at different stages [4]. - A total of 376 new companies were listed on the STAR Market during this period, with 37 unprofitable companies achieving profitability post-listing, representing over 40% [5]. - The STAR Market has streamlined refinancing conditions and established a quick financing system, significantly improving financing convenience for companies [5]. Group 3: Talent and Investment Dynamics - The STAR Market has fostered a positive cycle of "technology-industry-capital," with over 60% of founding teams comprising scientists and engineers, and nearly 30% of actual controllers also serving as core technical personnel [7]. - Approximately 90% of STAR Market companies received venture capital investment before going public, indicating a strong trend towards early-stage investment in hard technology [7]. - The STAR Market has developed a comprehensive index system, with 29 indices and 161 products tracking these indices, totaling nearly 260 billion yuan in scale [7]. Group 4: Future Outlook - As the "14th Five-Year Plan" concludes, the capital market is expected to undergo deeper reforms, focusing on developing new productivity and addressing structural financing challenges for technology innovation enterprises [8]. - The upcoming "15th Five-Year Plan" will emphasize improving long-term capital arrangements and enhancing the investment patience of market-oriented institutions [8].

Core Insights - The Sci-Tech Innovation Board (STAR Market) has transformed from an experimental platform for institutional innovation to a hub for "hard tech" companies during the 14th Five-Year Plan period, with significant growth in the number and market capitalization of technology innovation companies [1][2] Group 1: Market Performance - As of October 26, 2025, the number of listed companies on the STAR Market reached 589, with total IPO fundraising of 925.7 billion yuan and refinancing of 186.7 billion yuan, exceeding 1.1 trillion yuan in total [2] - The proportion of technology innovation companies in the Shanghai market increased from 32% to 41%, and their market capitalization share rose from 27% to 32% [1] Group 2: Industry Focus - The STAR Market has seen over 80% of its companies in emerging industries such as new-generation information technology, biomedicine, and high-end equipment manufacturing [2] - Approximately 120 companies in the integrated circuit sector are listed on the STAR Market, covering all aspects of the industry chain, including design, manufacturing, and testing [2] Group 3: R&D Investment - R&D investment by companies in the Shanghai market increased from 640 billion yuan to 1.07 trillion yuan, a growth of 66%, accounting for nearly 40% of the national total [3] - STAR Market companies have accumulated 120,000 patents, with a median R&D intensity of 12.6%, leading all A-share sectors [3] Group 4: Institutional Innovation - The STAR Market has introduced various reforms, including the "STAR Market Eight" and "M&A Six," enhancing inclusivity and providing tailored support for companies at different stages [4][5] - The STAR Market has streamlined refinancing conditions and established a quick financing system, significantly improving financing convenience for companies [5] Group 5: Talent and Investment Dynamics - Over 60% of STAR Market companies have founding teams composed of scientists and engineers, with nearly 30% of actual controllers also serving as core technical personnel [7] - The STAR Market has fostered a culture of early, small, and hard-tech investments, with about 90% of companies receiving venture capital before listing [7] Group 6: Future Outlook - As the 14th Five-Year Plan concludes, the capital market is expected to undergo deeper reforms to enhance the development of new quality productivity [8] - Future initiatives will focus on improving long-term capital arrangements and facilitating the entry of medium to long-term funds into the market [8]