近日，江苏省创新药械产品目录（第一批）发布，全省共收录149款创新药械产品，苏州共有60款 产品入选，占全省40%，数量位居全省第一。据悉，此次苏州入选产品全面覆盖1类创新药、2类改良型 新药和第三类创新医疗器械、第二类创新医疗器械等四大核心领域，形成了多维度、全链条的创新产品 矩阵，精准对接临床需求痛点。 另据了解，苏州市场监管部门推出的一系列服务举措，也为创新产品研发上市加速了进程。 聚焦创新项目顺利开展，市场监管部门组建市生物医药产业审评审批服务专班，建立重点企业、重 点项目清单，梳理企业诉求，跟踪服务保障；每月召开专班例会，协调解决重点项目在注册申报、研发 生产中遇到的难点堵点，助力一批创新产品上市提速。 聚焦医药企业发展提升，市场监管部门推动成立市医药产业服务中心，积极对接国家、省级部门， 探索建立人才交流与培训机制；选派业务骨干赴上级部门交流学习，邀请国家药监局医疗器械技术审评 检查长三角分中心、省药监局审评及核查中心等单位专家来苏开展专题培训和"面对面"服务，通过"请 进来"指导与"送出去"学习，提升产业服务能力和企业注册申报质效。 聚焦产业园区和基层服务升级，我市建成运行省药监局审评核查张家港 ...

本报讯(记者张敏)12月18日，记者从信达生物制药集团(以下简称"信达生物")获悉，信达生物自主开发 的全球首款胰高血糖素(GCG)/胰高血糖素样肽-1(GLP-1)双受体激动剂玛仕度肽注射液(以下简称"玛仕 度肽")，在中国2型糖尿病患者中开展的两项Ⅲ期临床研究(DREAMS-1、DREAMS-2)结果近日在国际知 名学术期刊《自然》(Nature)背靠背以"文章加速预览(Accelerated Article Preview)"形式同步在线发表。 糖尿病与肥胖密切相关，超重会加重胰岛素抵抗，是导致2型糖尿病发生、进展和并发症增加的主要因 素之一。相关并发症可累及血管、眼睛、肾脏、足部等多个器官。与欧美患者相比，我国糖尿病群体普 遍具有更高比例的胰岛素抵抗、脂肪肝和内脏脂肪积聚等代谢特征，常见临床表现为腹型肥胖，但临床 长期缺乏适配中国患者的用药方案。 DREAMS-1第一作者分别为南京大学医学院附属鼓楼医院朱大龙教授和山东第一医科大学附属省立医院 赵家军教授，信达生物制药集团钱镭博士与前述两位共同第一作者为文章共同通讯作者；DREAMS-2第 一作者分别为北京医院郭立新教授和中日友好医院张波教授，中日友好 ...

Economic Development - Suzhou's GDP reached 19,930.21 billion yuan in the first three quarters, with a year-on-year growth of 5.5% [1] - The total import and export volume was 20,244.4 billion yuan, increasing by 6.1% year-on-year [1] - Per capita disposable income for residents was 61,616 yuan, reflecting a 4.2% increase year-on-year [1] Technological Innovation - Suzhou is implementing eight major projects for technological innovation and has established a global influential industrial technology innovation center [2] - The city has made significant advancements in high-temperature superconducting materials and developed the world's first dual-target weight loss drug [2] - Suzhou's artificial intelligence industry generated 2,472 billion yuan in revenue from January to August, with an 18.7% growth rate [3] Foreign Trade and Investment - Suzhou organized 26 trade delegations, leading over 400 companies to engage in international trade activities [3] - The city achieved an intended transaction amount of 1.388 billion USD at the recent trade fair, accounting for 20.8% of the total in the province [4] - Suzhou has attracted over 170 billion USD in foreign investment, with 185 Fortune 500 companies involved in more than 500 projects [4] Business Environment - The "2025 Action Plan for Optimizing the Business Environment" was introduced, including measures to reduce costs and improve service centers for enterprises [4] - Suzhou has established 110 comprehensive service centers for businesses, achieving full coverage at city, district, and town levels [4] Social Welfare - Suzhou has built 2,188 community day care centers and 100 comprehensive elderly service centers to enhance elderly care services [6] - The city has expanded its educational offerings, with over 10,000 additional full-time enrollment slots in higher education institutions [7] - Medical services have been improved, providing free health screenings and vaccinations to thousands of residents [7] Cultural and Tourism Development - Suzhou has seen a 12.1% increase in domestic and international tourist numbers, with a 11.2% rise in tourism revenue [8] - The city hosted the 14th Suzhou Cultural and Creative Design Industry Expo, attracting nearly 500 exhibitors from over 40 countries [8] Housing and Urban Development - Suzhou is implementing 71 high-quality residential projects, with 42 already on the market [9] - The city has initiated urban renewal projects, including the renovation of 50 old residential communities [9] - A comprehensive digital governance system is being developed to enhance urban management [10] Environmental Protection - Suzhou has achieved a 100% rural sewage treatment rate and an 87.7% urban sewage treatment rate, leading the province [12] - The city is actively working on ecological restoration projects in Taihu Lake and improving water quality monitoring [12] Agricultural Development - Suzhou has been recognized for its rural revitalization efforts, ranking first in the province for five consecutive years [13] - The city has signed projects worth over 6 billion yuan at the 2025 Technology-Strong Agriculture Conference [13]

上海证券指出，国内GLP-1赛道角逐激烈，多家药企积极布局，关注相关创新靶点/剂型、临床数据 及商业化推进情况。恒瑞医药的GLP-1/GIP双重受体激动剂HRS9531注射液III期临床试验达到优效性， 上市申请已获受理；众生药业的RAY1225注射液在II期临床试验中表现出积极疗效和优秀安全性，胃肠 道不良反应和低血糖风险低于替尔泊肽数据；华东医药的口服小分子GLP-1受体激动剂HDM1002已完 成体重管理适应症III期受试者入组，多项适应症临床进展顺利。信达生物的玛仕度肽注射液III期研究达 成主要终点，在不合并2型糖尿病的受试者中平均体重降幅达20.08%，肝脏脂肪含量显著改善。此外， GLP-1R/GIPR双靶点及三靶点激动剂等创新疗法持续推进，行业创新活力显著。 （责任编辑：张晓波 ） 【免责声明】本文仅代表作者本人观点，与和讯网无关。和讯网站对文中陈述、观点判断保持中立，不对所包含内容 的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。邮箱： news_center@staff.hexun.com 生物医药ETF（512290）跟踪的是CS生医指数（9307 ...

Core Viewpoint - Recently, Innovent Biologics announced that its high-dose 9mg injection of Ma Shidu Peptide has received acceptance for listing application from the National Medical Products Administration of China, aimed at long-term weight control for adults with moderate to severe obesity [1] Group 1: Clinical Research Results - The Phase III clinical study GLORY-2 demonstrated outstanding results for Ma Shidu Peptide in the Chinese population with moderate to severe obesity, showing an average weight reduction of 18.55% in the 9mg group at week 60, compared to only 3.02% in the placebo group [1] - In the 9mg group, 44.0% of participants achieved a weight reduction of 20% or more, while only 2.6% in the placebo group reached this threshold (P values less than 0.0001) [1] Group 2: Additional Health Benefits - The study also indicated a significant average percentage reduction of 71.9% in liver fat content for the 9mg group, along with notable improvements in key cardiovascular metabolic indicators such as blood pressure, blood lipids, and uric acid levels [1] - The safety profile of the drug was reported to be good, with no new safety signals identified [1]

Investment Rating - The industry investment rating is "Outperform the Market" [1][32]. Core Insights - Johnson & Johnson's first-in-class drug, Icotrokinra, has been submitted for market approval in China, targeting moderate to severe plaque psoriasis in adults and children aged 12 and above. This drug is expected to achieve peak annual sales of over $5 billion [3][14]. - Icotrokinra is the first and only IL-23R targeted drug submitted for approval globally, with previous submissions in the US and Europe earlier this year [3][14]. - Johnson & Johnson has initiated a head-to-head study (ICONIC-ASCEND) to demonstrate the superiority of Icotrokinra over the injectable biologic, ustekinumab [3][14]. Summary by Sections Industry Overview - The report highlights the approval of Johnson & Johnson's Icotrokinra for treating moderate to severe plaque psoriasis, which has been prioritized for review by the CDE [3][14]. - The drug was developed with an investment of nearly $1 billion from Protagonist and is positioned as a significant innovation in the market [3][14]. Investment Strategy - The report suggests focusing on innovative pharmaceutical companies with rich pipelines, such as Hengrui Medicine, BeiGene, and China National Pharmaceutical Group. It also highlights companies with high potential single products and leading technology platforms [5]. - The report emphasizes the increasing investment in pharmaceutical R&D and the potential for growth in emerging fields, recommending companies like WuXi AppTec and Kelun Pharmaceutical [5]. Market Performance - The pharmaceutical sector experienced a decline of 6.88% last week, ranking 23rd among 28 industries, while the Shanghai Composite Index fell by 3.77% [19][31]. - The report notes that the pharmaceutical sector's valuation stands at 29.49 times earnings, with a premium of 21.01% over the overall A-share market [25][31].

消息面上，11月21日，恒生指数系列季度检讨结果出炉，所有变动将于2025年12月8日起生效。其中， 信达生物将被纳入恒生指数成份股，成份股数目将由88只增加至89只。 信达生物(01801)一度涨近5%，截至发稿，涨3.9%，报90.65港元，成交额1.77亿港元。 值得一提的是，11月20日，信达生物宣布，玛仕度肽注射液(胰高血糖素[GCG]/胰高血糖素样肽-1[GLP- 1]双受体激动剂，研发代号：IBI362)在中国中重度肥胖人群中开展的III期临床研究(GLORY-2)达成主要 终点和所有关键次要终点，信达生物将于近期向监管机构递交玛仕度肽9mg用于成人体重控制的新药上 市申请。 ...

智通财经APP获悉，信达生物(01801)一度涨近5%，截至发稿，涨3.9%，报90.65港元，成交额1.77亿港 元。 消息面上，11月21日，恒生指数系列季度检讨结果出炉，所有变动将于2025年12月8日起生效。其中， 信达生物将被纳入恒生指数成份股，成份股数目将由 88 只增加至 89 只。 值得一提的是，11月20日，信达生物宣布，玛仕度肽注射液（胰高血糖素[GCG] /胰高血糖素样 肽-1[GLP-1] 双受体激动剂，研发代号：IBI362）在中国中重度肥胖人群中开展的III期临床研究 （GLORY-2）达成主要终点和所有关键次要终点，信达生物将于近期向监管机构递交玛仕度肽9mg用于 成人体重控制的新药上市申请。 ...

Investment Rating - The report maintains an investment rating of "Outperform" with a rating of A [7] Core Insights - The report highlights significant advancements in small nucleic acid drugs for the treatment of hepatitis B, particularly the promising data from the drug AHB-137 presented at the AASLD 2025 conference, indicating its potential as the best small nucleic acid drug for hepatitis B [3][22] Summary by Sections Weekly New Drug Market Review - From November 17 to November 23, 2025, the top five gainers in the new drug sector were: - LaiKai Pharmaceutical (+13.34%) - Beihai Kangcheng (+2.67%) - Jiahe Biotech (+2.19%) - Yongtai Biotech (+1.94%) - Youzhi You (+1.14%) - The top five losers were: - WuXi AppTec (-15.75%) - Adi Pharma (-14.56%) - Mengke Pharma (-14.34%) - Yiming Oncology (-13.40%) - Kain Technology (-13.04%) [1][16] Weekly Focused Investment Targets - The report suggests focusing on several promising targets due to upcoming catalysts, including: 1. Products with high certainty for overseas expansion certified by MNCs: Sanofi, Federated Pharmaceuticals, and Kelun-Botai 2. Products with overseas data catalysts: Betta Pharmaceuticals, Hutchison China MediTech, and Yiming Biotech 3. Potential blockbuster products for overseas licensing by MNCs: Fuhong Hanlin, CSPC Pharmaceutical Group, and Yifang Biotech 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat reduction and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][20] Weekly New Drug Industry Analysis - The report emphasizes the breakthrough data for small nucleic acid drugs in treating hepatitis B, particularly the two-phase follow-up data for AHB-137, which shows a high potential for becoming the leading small nucleic acid drug in this field [3][22] Weekly New Drug Approval & Acceptance Status - No new drug or new indication approvals were reported this week, but six new drug or new indication applications were accepted [4][24] Weekly New Drug Clinical Application Approval & Acceptance Status - This week, 42 new drug clinical applications were approved, and 44 new drug clinical applications were accepted [5][26] Domestic Market Key Events TOP3 - Key events included: 1. Zean Biopharma's strategic collaboration with GSK to develop up to four "first-in-class" candidates in oncology [11] 2. Innovent Biologics announcing successful Phase III clinical study results for a drug in moderate to severe obesity [11] 3. Fuhong Hanlin's FDA approval for a biosimilar product [11] Overseas Market Key Events TOP3 - Key events included: 1. Merck's presentation of key Phase III trial results at the AHA Scientific Sessions [12] 2. Johnson & Johnson's acquisition of Halda Therapeutics for $3.05 billion [12] 3. The EMA's recommendation for the approval of a gene therapy product [12]

2025 年 11 月 21 日 星期五 ➢ 每日大市点评 11 月 20 日，港股缺乏向上推动力。除美国 12 月减息的不确定性外，中日关系紧张亦增加市场风险情绪，加上近期迎来 多达 28 只股份将陆续解禁，为港股带来调整压力。周四恒生指数最终收报 25,835 点，微涨 4 点（0.02%）；恒生科技指 数下跌 32 点（0.6%），收报 5,574 点；全天大市成交额稍稍扩大至 2,451 亿元。港股通净流入增长至接近 160 亿元，是 近一个月以来单日净流入金额最高。盘面上，市场传闻政府将推出新一轮房地产刺激措施，消息导致内房股周四造好， 碧桂园（2007 HK）涨 3.1%；万科（2202 HK）涨 3.7%；中海外（688 HK）涨 2.5%。11 月 19 日宁德时代（3750 HK）有 7,000 多万股 H 股解禁，周四股价下挫 5.7%。除了宁德时代，年底前还有曹操出行（2643 HK）、英诺赛科（2577 HK） 和药捷安康（2617 HK）等较大规模股份解禁。投资者警惕基金在假期前减持股份。 美股方面，英伟达季度业绩强劲，令市场对人工智能前景重启乐观情绪；加上延迟发布的美国 9 月非农 ...