10月10日早盘，创新药概念异动拉升。长春高新涨超8%，星昊医药、万邦德涨超5%，西藏医药、荣昌 生物、信立泰、广生堂、诺诚健华等跟涨。 ...

Core Viewpoint - The stock of Shenzhen Xinlitai Pharmaceutical Co., Ltd. has experienced significant fluctuations, with a year-to-date increase of 94.35% and recent declines in the short term [1][2]. Company Overview - Shenzhen Xinlitai Pharmaceutical Co., Ltd. was established on November 3, 1998, and listed on September 10, 2009. The company is located in the Futian District of Shenzhen, Guangdong Province [1]. - The main business segments include pharmaceuticals and medical devices, with revenue composition as follows: formulations 81.69%, devices 8.54%, raw materials 7.17%, and others 2.59% [1]. Financial Performance - For the first half of 2025, Xinlitai achieved operating revenue of 2.131 billion yuan, representing a year-on-year growth of 4.32%. The net profit attributable to shareholders was 365 million yuan, with a growth of 6.10% [2]. - Since its A-share listing, the company has distributed a total of 7.204 billion yuan in dividends, with 1.649 billion yuan distributed over the past three years [3]. Shareholder Structure - As of June 30, 2025, the number of shareholders was 24,000, a decrease of 0.79% from the previous period. The average circulating shares per person increased by 0.80% to 46,403 shares [2]. - The top circulating shareholders include China Europe Medical Health Mixed A (holding 26.163 million shares), Hong Kong Central Clearing Limited (holding 15.307 million shares), and ICBC Frontier Medical Stock A (holding 15 million shares) [3].

信立泰 新力泰的创新药物可以分为三个维度：创新 1.0 主要集中在高血压管理，以阿 利沙坦酯为基础，从单方到复方，实现对不同程度高血压患者的覆盖。例如， 去年（2024 年）获批的 107 号产品和今年（2025 年）获批的 S086 和 108 号产品都体现了这一点。公司还引入了全固酮抑制剂和小核酸技术，这些产品 摘要 新力泰在高血压领域构建了全生命周期管理产品线，从轻中度到难治性 高血压，覆盖不同患者群体，并针对高血压并发症进行产品布局，巩固 了其在该领域的领导地位，预计相关收入未来将超过 100 亿元。 新力泰大幅增加研发投入，2024 年研发支出超 10 亿元，占营收比例达 25%，推动创新药收入占比提升，2025 年上半年已达 58%，预计全年 将超过 60%，业绩驱动模式转向创新药驱动。 JK07 项目是新力泰创新 2.0 的重点，二期临床入组已完成，预计 2026 年上半年公布顶线数据，仅心衰适应症市场销售峰值预计可达 200 亿美 元。 新力泰在降脂领域形成多种产品组合，包括已上市的大分子 PCSK9 单 抗，以及处于临床阶段的小核酸、基因编辑等，显示出在该领域的巨大 潜力。 新力泰在男性高血 ...

Group 1 - In the past five trading days, a total of 222 companies were investigated by institutions, with significant interest in companies like Siwei Technology, Borui Pharmaceutical, and Xinlitai [1][2] - Among the companies investigated, 41 received attention from more than 20 institutions, with Siwei Technology being the most popular, attracting 92 institutions [1][2] - The types of institutions involved in the investigations included 194 securities companies, 145 fund companies, and 74 private equity firms, indicating a strong interest from the securities sector [1] Group 2 - In terms of investigation frequency, two companies, Hu Dian Co. and Ice Wheel Environment, were investigated three times, indicating high interest [2] - Out of the stocks investigated by more than 20 institutions, 13 saw net inflows of funds, with Jucheng Co. receiving the highest net inflow of 297 million yuan [2] - Among the stocks investigated, 24 experienced price increases, with Jucheng Co. leading with a rise of 36.31%, while 17 saw declines, with Borui Pharmaceutical dropping by 27.33% [2][3] Group 3 - The investigation data included various companies across different sectors, with notable mentions such as Siwei Technology (92 institutions), Borui Pharmaceutical (80 institutions), and Xinlitai (78 institutions) [2][3] - The latest closing prices and percentage changes for these companies were also highlighted, showing significant volatility in the market [2][3] - The data provided a comprehensive overview of institutional interest and market performance, reflecting the dynamic nature of the investment landscape [2][3]

Core Viewpoint - Sinopharm's subsidiary Salubris Biotherapeutics has made significant progress with its innovative biologics JK07 and JK06, which are currently undergoing clinical trials for heart failure and solid tumors respectively [1][2][3] Group 1: JK07 Development - JK07 is in a Phase II clinical trial (RENEU-HF) for patients with HFrEF and HFpEF, with all patient enrollments for HFrEF completed and results expected in the first half of 2026 [1] - The trial is randomized, double-blind, placebo-controlled, and aims to assess the safety and efficacy of JK07, with a total of 215 HFrEF patients enrolled [1] - The primary endpoint for the HFrEF cohort is the change in left ventricular ejection fraction after 26 weeks of follow-up [1] Group 2: JK07 in Pulmonary Hypertension - JK07 has received FDA approval for a clinical trial (RENEU-PH) targeting pulmonary hypertension caused by left heart disease, with a Phase IIa study now initiated [2] - The study is an open-label, dose-escalation trial aimed at evaluating the safety, efficacy, and tolerability of JK07 in patients with cpcPH, planning to enroll up to 30 patients [2] - Epidemiological studies indicate that up to 50% of HFrEF or HFpEF patients exhibit varying degrees of pulmonary hypertension, which significantly worsens prognosis [2] Group 3: JK06 Development - JK06 is a selective 5T4-targeting antibody-drug conjugate (ADC) currently undergoing Phase I clinical trials in Europe, with plans for dose expansion studies by the end of the year [3] - Initial data from the Phase I trial is expected to be presented at the ESMO conference in October 2025 [3] - The trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 in patients with solid tumors expressing the 5T4 protein, with a maximum enrollment of 155 patients [3]

Core Viewpoint - Sinopharm's subsidiary Salubris Biotherapeutics has made significant progress with its innovative biologics JK07 and JK06, which are currently undergoing clinical trials for heart failure and solid tumors respectively [1][2][3] Group 1: JK07 Development - JK07 is in a Phase II clinical trial (RENEU-HF) for patients with HFrEF and HFpEF, with all patient enrollments for HFrEF completed and results expected in the first half of 2026 [1] - The trial is randomized, double-blind, placebo-controlled, and aims to assess the safety and efficacy of JK07, with a total of 215 HFrEF patients enrolled [1] - The primary endpoint for the HFrEF cohort is the change in left ventricular ejection fraction after 26 weeks of follow-up [1] Group 2: JK07 in Pulmonary Hypertension - JK07 has received FDA approval for a clinical trial (RENEU-PH) targeting pulmonary hypertension caused by left heart disease, with a Phase IIa study now initiated [2] - This open-label, dose-escalation study will evaluate the safety, efficacy, and tolerability of JK07 in patients with cpcPH, aiming to enroll up to 30 patients [2] - The study duration is 6 months, with patients receiving four doses of JK07 over 13 weeks, followed by a 12-week follow-up [2] Group 3: JK06 Development - JK06 is a selective 5T4-targeting antibody-drug conjugate (ADC) currently in a Phase I clinical trial in Europe, with plans for dose expansion later this year [3] - Initial data from the Phase I trial is expected to be presented at the ESMO conference in October 2025 [3] - The trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 in patients with solid tumors expressing the 5T4 protein, with a maximum enrollment of 155 patients [3]

证券代码：002294 证券简称：信立泰 编号：2025-051 深圳信立泰药业股份有限公司 关于 JK07、JK06 境外临床试验进展的公告 基于 JK07 具有同时靶向心肌功能障碍和肺血管系统的潜力，JK07 在左心疾 病所致的肺动脉高压的临床方案（RENEU-PH）已获得 FDA 批准，并启动 IIa 期临床研究。 JK07 的 IIa 期临床试验（RENEU-PH）为开放标签、剂量递增研究，旨在评 估 JK07 在左心疾病所致的毛细血管前和毛细血管后肺动脉高压（cpcPH）患者 中的安全性、有效性和耐受性。试验为期 6 个月，计划入组不超过 30 名患者。 这些患者将在 13 周内接受四次、每四周一次（QW4）的 JK07 给药，随后进行 12 周随访。 由左心疾病引起的肺动脉高压是心衰患者的一个重要并发症，目前尚无获批 的治疗方案。流行病学研究显示，高达 50%的 HFrEF 或 HFpEF 患者表现出不同 程度的肺动脉高压，而 cpcPH 会导致预后显著恶化，如增加患者住院率、死亡 率等。 3、JK07（重组人神经调节蛋白 1（NRG-1）-抗 HER3 抗体融合蛋白注射液） 是公司自主研发、具有 ...

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小分子药物 SAL0140 片（项 目代码：SAL0140）新适应症临床试验申请获得受理。 现就相关信息公告如下： 证券代码：002294 证券简称：信立泰 编号：2025-050 深圳信立泰药业股份有限公司 关于 SAL0140 药品临床试验申请获得受理的公告 一、药品基本情况 药品名称：SAL0140 片 申请事项：境内生产药品注册临床试验 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。 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。 公司本次提交的申请为 SAL0140 用于治疗原发性醛固酮增多症（PA，简称 "原醛症"）的临床试验申请。 二、其他相关情况 SAL0140 是公司具有自主知识产权的醛固酮合酶抑制剂，拟开发适应症包 括未控制高血压（包括难治性高血压）、慢性肾脏病（CKD）、原发性醛固酮增 多症等 ...

Group 1 - In the past five trading days, a total of 196 companies were investigated by institutions, with a significant focus on companies like Jingzhida, Xinlitai, and Enhua Pharmaceutical [1] - Among the companies investigated, 29 received attention from more than 20 institutions, with Jingzhida being the most popular, attracting 138 institutions [1] - The types of institutions involved in the investigations included 171 securities companies, 118 fund companies, and 57 private equity firms, indicating a strong interest from the securities sector [1] Group 2 - In terms of capital inflow, 8 out of the 29 companies that attracted more than 20 institutions saw net capital inflows, with Dangsheng Technology receiving the highest net inflow of 293 million yuan [1] - The performance of the investigated stocks showed that 12 companies experienced price increases, with Shen Gong Co., Jingzhida, and Xinlitai leading with gains of 31.80%, 17.68%, and 15.81% respectively [2] - Conversely, 17 companies saw declines, with Han Zhong Precision, Kexing Pharmaceutical, and Gao Weida experiencing the largest drops of 13.31%, 9.84%, and 9.25% respectively [2] Group 3 - The most frequently investigated company was Binglun Environment, which was surveyed 4 times, while Hu Dian Co. and Fule New Materials were investigated 3 and 2 times respectively [1] - The detailed list of companies investigated includes various sectors such as machinery, pharmaceuticals, and electronics, highlighting a diverse interest from institutions [2][3]

Market Performance - The market saw an increase last week, with the China Securities Xinhua National Brand Index rising by 1.10% to 2019.88 points [1] - The Shanghai Composite Index rose by 0.21%, the Shenzhen Component Index by 1.06%, the ChiNext Index by 1.96%, and the CSI 300 Index by 1.07% [1] Strong Performing Stocks - Notable strong performers included Hu Silicon Industry, which increased by 19.75%, and Anji Technology, which rose by 19.05% [1] - Other significant gainers included Xinlitai (up 15.81%), Yangguang Power, and Zhongwei Company (both over 14%) [1] Year-to-Date Performance - Since the beginning of the second half of the year, Zhongji Xuchuang has surged by 183.63%, leading the gains [2] - Yangguang Power and Kewo Si have also shown substantial increases of 132.40% and 82.81%, respectively [2] Market Outlook - Starstone Investment suggests that the market's trading sentiment has declined due to risk aversion ahead of the long holiday, but this may indicate that funds are waiting for clearer policy and fundamental information [2] - The overall market remains strong, with no systemic risks identified, and various sectors are expected to present opportunities [2] Sector Rotation - Source Le Sheng Asset notes a clear rotation pattern this year, with sectors such as new consumption, innovative pharmaceuticals, technology, and high-dividend stocks experiencing alternating rises [3] - The investment strategy has been adjusted to reduce the proportion of technology stocks while increasing exposure to the manufacturing sector, focusing on technology, non-ferrous metals, manufacturing, and innovative pharmaceuticals [3]