舒泰神（北京）生物制药股份有限公司 证券代码：300204 证券简称:舒泰神 投资者关系活动记录表 编号：2025-002 | 投资者关系活动 | ■特定对象调研□分析师会议 | | | | | | --- | --- | --- | --- | --- | --- | | 类别 | □媒体采访□业绩说明会 | | | | | | | □新闻发布会□路演活动 | | | | | | | □现场参观 | | | | | | | □其他 | | | | | | 参与单位名称 | 国泰海通等 | | | | | | 时间 | 日 2025 11:30-12:30 | 年 | 05 | 月 | 23 | | 地点 | 公司会议室 | | | | | | 上市公司接待人 | 董事长周志文先生 | | | | | | 员姓名 | 董事会秘书、副总经理于茂荣先生 | | | | | | | 证券事务代表蔡晗先生 | | | | | | 投资者关系活动 | 投资者互动问答 | | | | | | 主要内容介绍 | | | | | | | 附件清单 | 调研纪要 | | | | | | 日期 | 2025 日 | 年 | 05 ...

舒泰神（北京）生物制药股份有限公司接待投资者调研纪要 形式：线下调研 参会单位:国泰海通等 接待人：董事长周志文先生 董事会秘书、副总经理于茂荣先生 证券事务代表蔡晗先生 舒泰神调研纪要 时间：2025 年 05 月 23 日 11:30-12:30 舒泰神（北京）生物制药股份有限公司接待投资者调研纪要 生产许可证是取得了 B 证，项目进度在尽快推进，此前子公司贝捷泰的融资有 助于公司的长期经营发展。 3、请问公司 STSA-1002 注射液项目目前研发进展情况？ 回答：STSA-1002 注射液项目在急性呼吸窘迫综合征适应症的 II 期临床试 验正在推进，已处于收尾阶段，希望可以取得预期的临床进展。STSA-1002 注射 液由公司自主研发，已在国内和国际申请发明专利，有全球权益。 一、投资者互动问答 1、请问公司 STSP-0601 项目目前研发及注册进展情况？ 回答：注射用 STSP-0601（"波米泰酶α "）用于伴抑制物血友病 A 或 B 患者出血按需治疗已取得 IIb 期临床研究总结报告，2025 年 01 月已公告 的 IIb 结果已达到主要有效性终点。目前正在开展 III 期临床研究，已完成 ...

一、股票交易异常波动的情况介绍 舒泰神（北京）生物制药股份有限公司（以下简称"舒泰神"或"公司"） 股票（股票简称：舒泰神，股票代码：300204）连续三个交易日（2025年05月20 日、2025年05月21日、2025年05月22日）收盘价格涨幅偏离值累计超过30%，根 据《深圳证券交易所交易规则》等相关规定，属于股票交易异常波动的情况。 二、公司关注并核实情况的说明 公司董事会已对公司、控股股东及实际控制人就近期公司股票交易发生异常 波动问题进行了核实，现将有关情况说明如下： 证券代码：300204 证券简称：舒泰神 公告编号：2025-033 舒泰神（北京）生物制药股份有限公司 关于股票交易异常波动的公告 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。 重要内容提示： 1、舒泰神（北京）生物制药股份有限公司股票交易连续三个交易日（2025 年05月20日、2025年05月21日、2025年05月22日）收盘价格涨幅偏离值累计超过 30%，根据《深圳证券交易所交易规则》等相关规定，属于股票交易异常波动的 情况。 2、经公司董事会核实，截至本公告披露日，公 ...

舒泰神（300204）今日涨停，成交额5.07亿元，换手率8.01%，盘后龙虎榜数据显示，四机构专用席位 净买入6495.59万元。 ...

智通财经5月21日电，舒泰神20CM涨停，此前三生国健3连板，赛升药业、海创药业、海辰药业、诺思 格、君实生物等跟涨。消息面上，港股创新药企三生制药公告称，其与辉瑞公司就前者自主研发的PD- 1/VEGF双特异性抗体SSGJ-707签订了独家许可协议。本次协议中12.5亿美元的首付款再次刷新了国产 创新药出海首付款金额纪录。 创新药概念延续强势 舒泰神20CM涨停 ...

社会信用代码：91320206MAE6KA557W 证券代码：300204 证券简称：舒泰神 公告编号：2025-032 舒泰神（北京）生物制药股份有限公司 关于子公司贝捷泰取得药品生产许可证的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 舒泰神（北京）生物制药股份有限公司（以下简称"公司"）子公司江苏贝 捷泰生物科技有限公司（以下简称"贝捷泰"）于近期取得了江苏省药品监督管 理局（以下简称"江苏省药监局"）下发的药品生产许可证。《药品生产许可证》 具体内容如下： 一、《药品生产许可证》主要情况 企业名称：江苏贝捷泰生物科技有限公司 注册地址：无锡市惠山区玉祁街道唐平路 66 号 1 号楼 4-1 法定代表人：王超 企业负责人：海岗 质量负责人：王红卫 许可证编号：苏 20250008 委托生产：治疗用生物制品（注射用 STSP-0601)***（仅限注册申报使用） 委托或受托情况： | 类型： | 委托 | | --- | --- | | 企业名称： | 舒泰神（北京）生物制药股份有限公司 | | 生产/注册地址： | 北京市北京经济技术开发区经海二 ...

创新药概念股拉升，舒泰神（300204）涨超10%，海创药业涨超6%，热景生物、恒瑞医药 （600276）、通化金马（000766）拉升。 暗盘资金正涌入这些股票，点击速看>>> ...

舒泰神（300204）公告，近日取得STSP-902注射液用于治疗少弱精子症的Ia期临床研究总结报告。研究 显示，在健康受试者中，STSP-902注射液单次皮下注射安全性和耐受性良好，基本呈线性药代动力学 特征，未报告ADA阳性，提示免疫原性风险较低。本试验结果支持STSP-902注射液开展进一步的临床 研究。公司于2024年4月向国家药品监督管理局提交STSP-0902注射液临床试验申请，于2024年06月取 得临床试验批准。2024年8月，完成Ia期临床试验的首例受试者给药。 ...

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，舒泰神（北京）生物制药股份有限公司（以下简称"舒泰神"或"公 司"）取得 STSP-0902 注射液用于治疗少弱精子症的 Ia 期临床研究总结报告， 现将主要情况公告如下： 一、药品的基本情况 1、药品名称：STSP-0902 注射液 2、剂型：注射剂 证券代码：300204 证券简称：舒泰神 公告编号：2025-031 舒泰神（北京）生物制药股份有限公司 关于 STSP-0902 注射液（用于治疗少弱精子症） 取得 Ia 期临床研究总结报告的公告 3、适应症：用于治疗少弱精子症 4、研究题目：随机、双盲、安慰剂对照、单剂量递增评价 STSP-0902 注射 液在健康受试者中的安全性、耐受性、药代动力学特征及免疫原性的 Ia 期临床 研究 5、临床研究单位：北京大学第三医院 6、申办方：舒泰神（北京）生物制药股份有限公司 二、主要研究结论 在健康受试者中，在方案设计的剂量范围内，STSP-0902 注射液单次皮下注 射安全性和耐受性良好，基本呈线性药代动力学特征，未报告 ADA 阳性，提示 免疫原性风险较低 ...

Financial Performance - The company's revenue for Q1 2025 was ¥63,214,002.99, a decrease of 33.45% compared to ¥94,983,395.63 in the same period last year[3] - The net loss attributable to shareholders was ¥2,335,039.14, an improvement of 38.05% from a loss of ¥3,769,395.63 in the previous year[3] - The net cash flow from operating activities was -¥15,273,176.15, which is a 10.33% improvement compared to -¥17,031,862.23 last year[3] - The total operating revenue for the current period is ¥63,214,002.99, a decrease of approximately 33.6% compared to ¥94,983,395.63 in the previous period[33] - The company reported a net loss of ¥411,117,990.66, slightly increasing from a loss of ¥408,785,633.30 in the previous period[31] - The company reported a net loss of CNY 4,407,104.91, compared to a net loss of CNY 3,769,395.63 in the previous period, indicating a deterioration in performance[34] - Operating profit was recorded at CNY -4,387,963.90, worsening from CNY -3,268,100.38 year-over-year[34] - Total comprehensive income amounted to CNY -34,065,021.00, significantly lower than CNY 8,418,612.81 in the prior period[34] Cash Flow and Assets - The company's cash and cash equivalents increased by ¥35,525,295.04, a rise of 65.90% due to an increase in bank deposits[7] - The cash and cash equivalents increased to ¥89,436,475.08 from ¥53,911,180.04, representing a growth of approximately 65.9%[29] - The total assets increased by 1.10% to ¥1,162,255,527.06 from ¥1,149,607,757.17 at the end of the previous year[4] - The total liabilities decreased to ¥219,559,206.21 from ¥232,846,415.32, reflecting a reduction of approximately 5.7%[30] - The ending cash and cash equivalents balance increased to CNY 89,436,475.08 from CNY 62,981,635.34 in the previous period[36] Shareholder Information - The total number of common shareholders at the end of the reporting period is 24,509[11] - The largest shareholder, Yizhao (Beijing) Pharmaceutical Technology Co., Ltd., holds 31.01% of shares, totaling 148,165,963 shares[11] - The second-largest shareholder, Xiangtang Group Co., Ltd., holds 7.68% of shares, totaling 36,695,008 shares, with 32,550,000 shares pledged[11] - The total number of restricted shares at the end of the period is 24,108,054, with significant increases in restricted shares for key executives[14] - The company has no major changes in the participation of top shareholders in margin trading activities[12] Research and Development - Research and development expenses decreased by 46.54% to ¥16,426,000.00, reflecting reduced investment in R&D projects[7] - Research and development expenses decreased to ¥16,408,159.79 from ¥30,691,001.31, indicating a reduction of approximately 46.4%[33] - The company reported a significant clinical trial result for STSP-0601, achieving a 12-hour effective hemostasis rate of 81.94% in hemophilia A or B patients[15] - The average number of doses required for effective hemostasis in the trial was 1.9, with 77.12% of visits requiring only 1-2 doses[15] - The safety profile of STSP-0601 was good, with 36.00% of participants reporting mild adverse events, and no serious adverse events reported[16] - The company has made progress in clinical projects, including the STSP-0601 injection for hemophilia A or B patients, which has completed the IIb phase and is now entering the III phase of clinical research[26] - The BDB-001 study for ANCA-associated vasculitis has completed all subject follow-ups and is preparing for the III phase clinical research[27] - The company plans to submit a conditional marketing application for STSP-0601 based on the positive IIb phase clinical data[26] Financing and Investments - The company raised ¥40,000,000.00 from minority shareholders during the quarter, indicating successful capital raising efforts[9] - The company received a total of RMB 60 million in initial investment from Wuxi Jinyi Yuanli Equity Investment Partnership, with RMB 40 million as capital increase and RMB 20 million as share transfer payment[21] - The company plans to apply for a loan of RMB 50 million from Beijing Rural Commercial Bank for operational turnover, with a term of 12 months[24] - The company will provide collateral for the loan using its own real estate and land use rights, with a guarantee amount of RMB 65 million[24] - The company raised CNY 80,000,000.00 through financing activities, with a net cash inflow of CNY 49,936,200.00 after outflows[36] Management Changes - The company appointed several senior management personnel on March 23, 2025, including a new deputy general manager and heads of various departments[25] - The company completed the transfer of shares from its controlling shareholder, Yizhao Technology, to Mr. Zhou Zhiwen, with the registration completed on February 25, 2025[18] - The subsidiary, Jiangsu Beijitai Biotechnology Co., Ltd., completed its business registration change and received a new business license on February 10, 2025[18] - The subsidiary, Beijing Sannuo Jiayi Biotechnology Co., Ltd., was recognized as a national high-tech enterprise on February 13, 2025[19] Other Financial Metrics - The company generated CNY 60,332,701.69 in cash from sales, down from CNY 90,313,155.91 in the prior period[35] - Cash flow from investing activities yielded a net inflow of CNY 863,486.76, compared to a net outflow of CNY -4,955,311.49 last year[36] - Basic and diluted earnings per share remained at CNY 0.00, unchanged from the previous period[35] - The company experienced a significant increase in credit impairment losses, totaling CNY -16,586.06, compared to CNY 51,282.21 previously[34]