Core Viewpoint - The company, Xinlitai (002294.SZ), has received an acceptance notice from the National Medical Products Administration for its clinical trial application of the innovative drug SAL0145 injection, which is intended for the treatment of MASH [1] Group 1 - The drug SAL0145 is a self-developed siRNA medication with independent intellectual property rights [1] - The clinical trial application submitted by the company is specifically for SAL0145's use in treating MASH [1]

证券代码：002294 证券简称：信立泰 编号：2026-001 申请事项：境内生产药品注册临床试验 受理号：CXHL2600021 深圳信立泰药业股份有限公司 关于 SAL0145 药品临床试验申请获得受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 近日，深圳信立泰药业股份有限公司（下称"公司"）收到国家药品监督管 理局核准签发的受理通知书，公司自主研发的创新药 SAL0145 注射液（项目代 码：SAL0145）临床试验申请获得受理。 现就相关信息公告如下： 一、药品基本情况 药品名称：SAL0145 注射液 董事会 受理说明：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 二〇二六年一月八日 自受理之日起 60 日内，未收到药审中心否定或质疑意见的，申请人可以按 照提交的方案开展临床试验。 SAL0145 是公司研发的具有自主知识产权的 siRNA 药物，公司本次提交的 申请为 SAL0145 用于治疗 MASH 的临床试验申请。 二、其他相关情况 代谢功能障碍相关脂肪性肝炎（MASH）是代谢功能障碍相关脂肪性肝病 ...

Core Viewpoint - The company has received acceptance for the clinical trial application of its innovative drug SAL0145 injection, which is developed with proprietary intellectual property and is intended for the treatment of MASH [1] Group 1 - The drug SAL0145 is a siRNA medication developed by the company [1] - The clinical trial application submitted is specifically for the treatment of MASH [1]

Group 1 - The core point of the article highlights that in December 2025, the worst-performing ordinary equity and mixed funds were both managed by Baoying Fund, specifically the Baoying Medical Health Hong Kong-Shenzhen Stock A and C, which reported returns of -13.20% and -13.26% respectively [1] - The Baoying Innovation Medical Mixed Initiation A and C funds also performed poorly, with returns of -14.14% and -14.19%, making them the worst in the mixed fund category [1] - All these funds are themed around the medical sector and are managed by the same fund manager, Yao Yi, who has a background in research and fund management [1] Group 2 - The latest quarterly report indicates that the top ten holdings of the Baoying Medical Health Hong Kong-Shenzhen Stock fund include major companies such as Innovent Biologics, Kelun Pharmaceutical, and others, while the Baoying Innovation Medical Mixed Initiation fund shares many of the same top holdings [1][2] - Notably, several of these top holdings experienced significant declines in December, with the largest holding, Innovent Biologics, dropping by 18.97%, and another major holding, 3SBio, declining by over 22% [2] - The performance metrics of the funds show that the Baoying Innovation Medical Mixed Initiation C has a cumulative net value of 0.8857 and a scale of 0.51 billion, while the A share has a cumulative net value of 0.8886 and a scale of 0.47 billion [3]

Group 1 - The core investment theme for the pharmaceutical industry in 2025 is the overseas expansion of innovative drugs, which is expected to yield excess returns compared to the broader pharmaceutical sector and the CSI 300 index [2][21] - The innovative drug index has shown a significant increase, outperforming the pharmaceutical biological index by 37.48 percentage points, with a year-to-date increase of 65.99% [21] - Major transactions in the ADC and dual antibody fields are anticipated to continue, while there is a need to avoid repetitive competition in areas like small nucleic acids and focus on unmet clinical needs [3][4] Group 2 - The report emphasizes the importance of overseas markets for both innovative drugs and medical devices, suggesting that companies should seek growth opportunities beyond domestic market saturation [4][5] - The Chinese pharmaceutical industry is gradually becoming a global innovation center, with significant advancements in dual antibodies and ADCs, while also making strides in emerging fields like small nucleic acids and inhalation formulations [5][6] - The report highlights that the overseas authorization revenue has become a crucial funding source for innovative drug development, with a total upfront payment of $4.551 billion in the first three quarters of 2025 [29][32] Group 3 - The medical device sector is experiencing a shift towards overseas expansion, with a focus on high-value consumables and IVD products, as Chinese companies enhance their market share [7][55] - The export growth of high-value consumables is significant, with a recorded increase of 10.75% in the first half of 2025, particularly in the North American and European markets [57][66] - The report notes that the certification and market establishment processes for high-value consumables are long-term investments, requiring compliance with stringent regulations in the EU and the US [60][61] Group 4 - The recovery of financing in the domestic innovative drug sector has been robust, with a total of 324 financing events amounting to $5.51 billion in the first three quarters of 2025, marking a 67.6% increase year-on-year [70][72] - The CXO industry is experiencing varied recovery rhythms across different segments, with some areas like CDMO seeing order growth due to overseas financing recovery [74]

证券之星消息，12月31日化学制药板块较上一交易日下跌0.31%，信立泰领跌。当日上证指数报收于 3968.84，上涨0.09%。深证成指报收于13525.02，下跌0.58%。化学制药板块个股涨跌见下表： | 代码 | 名称 | 主力净流入(元) | 主力净占比 游资净流入 (元) | | 游资净占比 散户净流入 (元) | | 散户净占比 | | --- | --- | --- | --- | --- | --- | --- | --- | | 300573 | 兴齐眼药 | 7439.59万 | 13.65% | -697.93万 | -1.28% | -6741.66万 | -12.37% | | 000963 | 华东医药 | 6823.36万 | 18.91% | -4988.17万 | -13.83% | -1835.19万 | -5.09% | | 300086 | 康芝药业 | 3651.55万 | 3.67% | 4453.79万 | 4.47% | -8105.34万 | -8.14% | | 301246 | 宏源药业 | 3493.05万 | 3.27% | -208.79万 | - ...

Group 1 - The core investment theme for the pharmaceutical sector in 2026 is the innovation drug industry chain, with a clear trend towards international business development and accelerated commercialization of domestic products [2][3]. - The CXO sector is experiencing continuous improvement in performance and orders, supported by favorable financing conditions that benefit the industry's upward trajectory [3]. - The medical device sector is focusing on two main lines: international expansion and innovation [3]. Group 2 - The latest trends in medical insurance show a decline in total expenditure for the first ten months of 2025, amounting to 1,903.6 billion yuan, a year-on-year decrease of 1% [5][7]. - The total income of the medical insurance fund for the same period reached 2,352 billion yuan, with a year-on-year growth of 2%, indicating a slowdown in income growth [7][11]. - The number of medical insurance beneficiaries and hospitalization cases continues to grow, with 6.07 billion total beneficiaries in 2024, a year-on-year increase of 18% [11]. Group 3 - The average medical insurance cost per visit decreased in 2024, with the average cost for employees at 629 yuan (down 10%) and for residents at 351 yuan (down 12%) [15]. - The average hospitalization cost also saw a decline, with employees averaging 11,707 yuan (down 3.8%) and residents at 7,408 yuan (down 3.5%) [15]. Group 4 - The Chinese pharmaceutical industry is witnessing a significant increase in license-out transactions, with over 100 deals completed in 2025, totaling more than 110 billion USD [21][32]. - The number of license-out transactions involving upfront payments exceeding 100 million USD has also risen, indicating a growing interest from global pharmaceutical companies in Chinese innovations [21][32]. - The ADC (Antibody-Drug Conjugate) market is expanding rapidly, with a projected market size exceeding 16 billion USD in 2025, driven by several successful product launches [38]. Group 5 - The Chinese government is actively supporting the innovation drug sector through various policies aimed at enhancing accessibility and encouraging high-quality innovation [16][18]. - The proportion of medical insurance spending on innovative drugs is steadily increasing, with 149 innovative drugs included in the insurance coverage over the past seven years [90][94]. - The average price reduction for innovative drugs during negotiations with the national medical insurance has been around 60%, with some drugs seeing reductions as high as 94% [88][94].

Core Viewpoint - The company, Xinlitai, announced that it will hold its first extraordinary general meeting of shareholders on December 25, 2025, to review and approve several proposals, including amendments to certain governance systems [2] Group 1 - The extraordinary general meeting is scheduled for December 25, 2025 [2] - The agenda includes the review and approval of proposals related to the revision of the company's governance systems [2]

5. 公司本次股东大会股权登记日的股东名册； 6. 出席现场会议的股东的到会登记记录及凭证资料； 7. 深圳证券信息有限公司提供给公司的本次股东大会网络投票情况的统计结果； 北京市金杜（深圳）律师事务所 关于深圳信立泰药业股份有限公司 2025 年第一次临时股东大会 的法律意见书 致：深圳信立泰药业股份有限公司 北京市金杜（深圳）律师事务所（以下简称本所）接受深圳信立泰药业股份有限 公司（以下简称公司）的委托，根据《中华人民共和国证券法》（以下简称《证券 法》）、《中华人民共和国公司法》（以下简称《公司法》）、中国证券监督管理委 员会（以下简称中国证监会）《上市公司股东会规则》（以下简称《股东会规则》） 等中华人民共和国境内（以下简称中国境内，为本法律意见书之目的，不包括中国香 港特别行政区、中国澳门特别行政区和中国台湾省）现行有效的法律、行政法规、规 章和规范性文件及现行有效的公司章程有关规定，指派律师出席了公司于 2025 年 12 月 25 日召开的 2025 年第一次临时股东大会（以下简称本次股东大会），并就本次股 东大会相关事项出具本法律意见书。 为出具本法律意见书，本所律师审查了公司提供的以下文件 ...

证券代码：002294 证券简称：信立泰 编号：2025-069 深圳信立泰药业股份有限公司 2025 年第一次临时股东大会决议公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 特别提示： 1、本次股东大会无增加、变更、否决提案的情况。 2、本次股东大会不涉及变更以往股东大会已通过的决议。 3、本决议所称中小投资者是指单独或合计持有公司 5%以上股份的股东、公 司董事、监事、高级管理人员以外的其他股东。 一、会议召开情况 1、会议召集人：深圳信立泰药业股份有限公司第六届董事会 2、召开时间： 现场会议时间：2025 年 12 月 25 日下午 14:30 网络投票时间： 通过深圳证券交易所交易系统进行网络投票的时间为 2025 年 12 月 25 日上 午 9:15 – 9:25，9:30 – 11:30，下午 13:00 – 15:00；通过深圳证券交易所互联网 投票系统投票时间为 2025 年 12 月 25 日上午 9:15 至下午 15:00。 3、会议召开地点：深圳市福田区深南大道 6009 号车公庙绿景广场主楼（B 座）37 层公司会议室 4、 ...