今年以来，智飞生物多个自主研发项目取得重要进展，创新成果迎来密集收获期。预防领域成果丰硕： 四价流感病毒裂解疫苗等两款疫苗今年上市并完成多省准入；冻干人用狂犬病疫苗（人二倍体细胞）、 ACYW135群脑膜炎球菌多糖结合疫苗、15价肺炎球菌结合疫苗已进入上市审评阶段；四价重组诺如病 毒疫苗、福氏宋内氏痢疾双价结合疫苗已进入Ⅲ期临床；26价肺炎结合疫苗在澳及国内开展临床试验。 目前，智飞生物在预防领域布局34项自主研发项目，24项处于申报、临床或上市申报阶段。 此次上榜是对智飞生物研发投入、技术积累与创新成果的权威认可。企业相关负责人表示，未来将强化 创新主体地位，聚焦科技前沿与民生需求，攻关核心技术，助力生物医药产业高质量发展与健康中国建 设。 治疗领域多点突破：共布局8项自主研发项目，7项处于临床或注册阶段。控股子公司宸安生物的利拉鲁 肽注射液待上市申报；德谷胰岛素注射液、降糖用司美格鲁肽注射液完成Ⅲ期临床；减重用司美格鲁肽 注射液处于Ⅲ期临床。 关键词阅读：智飞生物 责任编辑：山上 12月26日，重庆市工商联主办的重庆市民营经济创新发展大会成功举行，会上正式发布《2025重庆民营 企业科技创新指数100强榜 ...

在预防领域，智飞生物自主研发的四价流感病毒裂解疫苗、流感病毒裂解疫苗已于今年上市，并在多个省份完成准入；冻干人用狂犬病疫苗（人二倍体细 胞）、ACYW135群脑膜炎球菌多糖结合疫苗、15价肺炎球菌结合疫苗已进入上市审评阶段；四价重组诺如病毒疫苗（毕赤酵母）、福氏宋内氏痢疾双价结 合疫苗等已进入Ⅲ期临床试验阶段；26价肺炎结合疫苗已于澳大利亚及国内开展临床试验。 12月26日，由重庆市工商联主办的重庆市民营经济创新发展大会成功举行，会上正式发布《2025重庆民营企业科技创新指数100强榜单》。智飞生物凭借在 科技创新领域的突出表现，荣登"2025重庆民营企业科技创新指数100强榜单"第3位、"2025重庆民营企业研发投入50家榜单"第4位。智飞生物总裁蒋凌峰出 席会议并代表企业获颁奖牌。 来源：重庆市民营经济创新发展大会主办方 生物医药产业是关系国计民生和国家安全的战略性新兴产业，科技创新是其可持续发展的核心动力。智飞生物自成立以来，始终坚持"自主研发为主、合作 研发为辅、投资孵化为补"的创新策略，持续加大研发投入，深化管线布局，近三年智飞体系累计研发投入超60亿元，自主创新能力得到持续夯实与提升。 今年以来， ...

Core Insights - The Chinese innovative pharmaceutical industry is experiencing significant transformation, marked by substantial licensing deals and a shift towards global leadership in quality over quantity [2][3][6] - The total amount of License-out upfront payments has surpassed that of the primary market for the first time, indicating a shift in funding dynamics within the industry [13][31] - Despite the growth, there are underlying challenges such as a lack of clinical development capabilities and the undervaluation of early-stage pipelines, leading to a phenomenon of "selling seedlings at a discount" [16][20][24] Group 1: Industry Growth and Transactions - In 2025, the total amount of License-out transactions in China is expected to exceed that of the U.S. by 3.2 times, reflecting a rapid acceleration in drug approvals and a surge in innovative drug development [3][6] - The total amount of BD transactions in the Chinese pharmaceutical sector has surpassed $100 billion, with a significant increase in both the number of deals and transaction values [8][11] - Major transactions include a $125 billion collaboration between Hengrui Medicine and GSK, a $114 billion partnership between Innovent Biologics and Takeda, and a $61.5 billion deal between 3SBio and Pfizer, positioning these deals among the largest in global innovative drug licensing [9][10] Group 2: Challenges and Market Dynamics - The industry faces a stark divide, with leading companies achieving profitability while smaller biotech firms struggle with funding and development risks, leading to a survival of the fittest scenario [28][31] - The proportion of License-out transactions for late-stage clinical projects has only slightly increased, indicating ongoing challenges in clinical development capabilities [16][20] - The gap in clinical trial design and execution between Chinese companies and multinational corporations (MNCs) remains significant, impacting the ability of domestic firms to retain control over late-stage assets [19][21][24] Group 3: Financial Performance and Market Reactions - Innovative drug companies in China reported a revenue increase of 22.1% year-on-year in the first three quarters of 2025, with a notable reduction in net losses [28][31] - The market is becoming more discerning, focusing on clinical value and commercialization potential rather than short-term trading excitement, leading to a more cautious approach to BD transactions [32][33] - The capital market's response to BD transactions has been mixed, with significant deals not necessarily translating into sustained stock price increases, highlighting the need for long-term value realization [32][33]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Views - The report emphasizes three core investment directions: 1) Breakthroughs in cutting-edge technologies (e.g., First-in-class drugs in oncology, weight loss, autoimmune fields, and innovative devices like brain-machine interfaces); 2) Clinical validation and commercialization potential (focus on the progress of domestic innovative drugs going abroad and the clinical development progress post-BD transactions); 3) Efficiency advantages in the industry chain (CXO leaders and high-value consumables' global layout) [8] Industry Review - The pharmaceutical and biotechnology industry index increased by 0.81%, ranking 21st among 31 primary industries, outperforming the CSI 300 index which decreased by 0.27% [5][16] - The sub-industries of pharmaceutical circulation and in vitro diagnostics saw significant gains of 7.61% and 5.32% respectively, while medical research outsourcing and medical devices experienced declines of 3.49% and 1.76% [5][16] - As of November 14, 2025, the industry PE (TTM overall method, excluding negative values) was 30.89x, up from 30.67x in the previous period, indicating an upward valuation trend that remains below the average [21] - The top three PE ratios among the sub-industries were for vaccines (50.42x), hospitals (43.67x), and medical devices (37.84x), while pharmaceutical circulation had the lowest valuation at 15.46x [21] Important Industry News - The National Health Commission and others issued implementation opinions to promote and regulate the application of "AI + healthcare" [7] - The NMPA released a new version of the "Medical Device Production Quality Management Specifications" [7] - Novartis received NMPA approval for its first radioligand therapy drug "Pluvicto®" for dual indications [7] - Sanofi's innovative targeted nano-antibody "Cablivi®" was approved by NMPA for treating immune-mediated thrombotic thrombocytopenic purpura [7] - The U.S. government reached a drug price control agreement with Eli Lilly and Novo Nordisk, leading to significant price reductions for GLP-1 drugs [7]

每经AI快讯，有投资者在投资者互动平台提问：请分析一下重庆精准生物最近新获批上市新药普利得 凯对本公司的影响？ 智飞生物（300122.SZ）11月14日在投资者互动平台表示，公司参股企业重庆智睿投资有限公司投资孵 化了重庆精准生物技术有限公司。近期，精准生物自主研发的国家1类生物新药普基奥仑赛注射液已获 批上市。相关情况请以该公司公开发布的信息为准。 （文章来源：每日经济新闻） ...

Core Insights - China's bio-economy is showing a positive trend, with significant advancements in CAR-T cell therapy, original drug production, and brain-machine interface medical devices, positioning the country as the second-largest biopharmaceutical market globally [1][2] Industry Overview - The global bio-manufacturing industry is receiving heightened attention from major economies, with increased funding for genetic and cell engineering research, biomass utilization, and bio-based product development [2] - The number of CAR-T clinical research centers worldwide has grown to 2069 in 2024, a 60% increase from 1297 in 2020, with China hosting 388 centers, ranking second globally [2] - China has achieved a record high in the proportion of self-developed new drugs, with 93 new drugs approved by the National Medical Products Administration in 2024, marking a five-year peak [2] Research and Development - In 2024, China published over 20,000 SCI papers in the medical equipment field, leading globally in research output [3] - The bio-economy in China is characterized by a robust industrial foundation, with significant growth in the pharmaceutical and chemical sectors driven by advancements in synthetic biology and high-throughput screening technologies [3] Industry Transformation - The bio-industry is transitioning from "quantitative accumulation" to "qualitative leap," focusing on core technology breakthroughs, product quality upgrades, and enhancing supply chain resilience [4] - Notable innovations include the approval of the world's first "rice-derived" human serum albumin injection and the launch of the world's first 5.0T whole-body MRI system [4] Future Prospects - Innovations in synthetic biology and gene editing are driving rapid growth in bio-manufacturing, outpacing GDP growth, and positioning the bio-economy as a crucial sector in the future global economy [5]

Group 1 - The 17th China Bioindustry Conference highlighted the theme "Biotechnology Empowering the Future, Biomanufacturing Reshaping the World," showcasing the latest achievements in China's biotechnology and biomanufacturing sectors [1] - Wuhan has developed a comprehensive biopharmaceutical industry cluster, with a scale exceeding 550 billion yuan, playing a significant role in both national and global biomanufacturing [1] - The "China Bioeconomy Development Report 2025" indicates that China ranks second globally in research centers and is a major player in the biopharmaceutical market, gradually participating in international competition [1][2] Group 2 - In 2024, China approved 93 new drugs, the highest in five years, and is now the second-largest biopharmaceutical market globally, with a growing number of research drugs [2] - China leads the world in medical device patent applications, with 91,513 applications, accounting for nearly 70% of the global total [2] - The Hubei Pathology Big Data Database is expected to exceed 5 million high-precision digital slices by the end of 2025, significantly enhancing medical institutions and driving innovation [2] Group 3 - China's bioeconomy is robust, with a steady growth trend, and the global bioeconomy is projected to grow from $40-50 trillion to $30 trillion by 2050, with a compound annual growth rate of 8.6% [3] - Advances in synthetic biology and high-throughput screening technologies have led to significant breakthroughs in the production of pharmaceutical chemicals using microbial cell factories [3] - In the field of agricultural biotechnology, China accounts for 23% of the global market share in biological breeding, which has effectively reduced production costs and pesticide usage [3]

Core Viewpoint - China's biomanufacturing and biotechnology sectors are experiencing significant growth, with advancements in CAR-T cell therapy, biopharmaceuticals, and digital pathology, positioning the country as a global leader in these fields [3][5][10]. Group 1: Biopharmaceuticals - China ranks second globally in the number of CAR-T clinical research centers, with 388 centers as of 2024, reflecting a 60% increase from 2020 [7]. - The biopharmaceutical market in China has surpassed 1.1 trillion yuan, with the number of new drug approvals reaching a five-year high of 93 in 2024 [6][7]. - China is now the second-largest biopharmaceutical market globally, with a significant number of drugs in development, narrowing the gap with the United States [7]. Group 2: Biotechnology and Innovation - The report highlights that China leads globally in biotechnology patent applications and research personnel, with over 30% of new innovative drugs and research pipelines originating from the country [5][11]. - The establishment of 23 biomanufacturing bases across the country indicates a robust infrastructure supporting the growth of the biomanufacturing sector [5]. - The "National Innovative Drug Insight System" was launched to enhance the efficiency of drug development and address challenges in identifying quality projects and matching strategic resources [9]. Group 3: Digital Pathology and Medical Devices - The Hubei Pathology Big Data Database has become the second-largest globally, with 170,000 high-precision digital slices, expected to exceed 500,000 by the end of 2025 [8]. - China leads the world in medical device patent applications, accounting for nearly 70% of the global total, showcasing its strong research output in this field [8]. Group 4: Agricultural Biotechnology - The agricultural biotechnology market in China accounts for 23% of the global market, with significant advancements in genetically modified crops [12]. - The application of synthetic biology and gene editing is driving growth in biomanufacturing, with a focus on biopharmaceuticals, biomaterials, and bioenergy [12]. Group 5: Future Outlook - The global biomanufacturing market is projected to grow significantly, with estimates suggesting a rise from $4-5 trillion to $30 trillion by 2050, indicating a compound annual growth rate of 8.6% [11]. - The integration of artificial intelligence in life sciences is expected to enhance drug development efficiency and expand applications across various sectors, including healthcare and agriculture [12].

Group 1 - China ranks second globally in the number of CAR-T clinical research centers, with 388 centers, reflecting a 60% increase from 2020 [2] - The biopharmaceutical market in China has surpassed 1.1 trillion yuan, with over 30% of new drug approvals and research pipelines globally [1][3] - The number of in-development drugs in China is second globally, with a narrowing gap compared to the United States [3] Group 2 - The establishment of 23 biomanufacturing bases across China indicates a robust growth trajectory in the biomanufacturing sector [1] - The "National Innovation Drug Insight System" aims to enhance the efficiency of innovative drug development by integrating data across the R&D and approval chain [4] - The biomanufacturing industry is projected to grow significantly, with the global bio-based chemicals market expected to reach $125.23 billion by 2029 [5][6] Group 3 - China leads globally in the number of medical device patent applications, accounting for nearly 70% of the total [3] - The biomanufacturing sector is expected to become a key driver of economic growth, with significant advancements in synthetic biology and gene editing technologies [7] - The agricultural biotechnology market in China is projected to reduce production costs and pesticide usage, with transgenic crops entering the industrial demonstration phase [6]

Group 1: Overview of China's Biomanufacturing Industry - The value added by the biomanufacturing sector accounts for over 7% of China's GDP [4] - China ranks second globally in the number of CAR-T cell therapy research centers and the number of biopharmaceuticals under research [1][4] - The biopharmaceutical market in China has surpassed 1.1 trillion yuan, with a significant number of innovative drugs and research pipelines [5] Group 2: Innovations and Developments - The "National Innovation Drug Insight System" was launched to enhance the efficiency of innovative drug development and address industry challenges [7] - The Hubei Pathology Big Database has reached 170,000 high-precision digital slices, positioning it as the second largest globally [6] - The global CAR-T clinical research centers have increased by 60% from 2020 to 2024, with China contributing 388 centers [5] Group 3: Market Growth and Future Projections - The global biomanufacturing market is projected to grow significantly, with the biobased chemicals market expected to reach $125.23 billion by 2029 [8] - China's biomanufacturing sector is positioned as a new engine for economic growth, supported by national policies and strategic planning [8] - The biotechnological innovations in agriculture, such as genetically modified crops, are set to enter the industrialization demonstration phase in 2024 [9]