丨 2025年8月1日星期五丨 NO.1 2025年版基孔肯雅热诊疗方案发布 据央视新闻7月31日报道，为进一步指导各级各类医疗机构做好基孔肯雅热医疗救治工作，提高规范 化、同质化诊疗水平，在2008年发布的基孔肯雅热诊断和治疗方案基础上，国家卫健委和国家中医药管 理局发布了基孔肯雅热诊疗方案（2025年版）。 点评：新版基孔肯雅热诊疗方案的发布，体现出我国公共卫生体系对境外输入性疫情的高度警觉。当前 我国尚无针对该病毒的疫苗，防控仍依赖传统手段以降低蚊媒密度，这也提醒公众应提高防控意识和自 我保护能力。 点评：相较于单抗，HB0043具有更强的抑制细胞因子诱导的炎症和纤维化反应，通过IL-17A和IL-36R 的双重阻断，在多种动物疾病模型如特应性皮炎（AD）、特发性肺纤维化（IPF）、糖尿病肾病 （DN）、中性粒细胞哮喘中证明了强于单抗的药效。 NO.4 微芯生物：CS231295片临床试验申请获得FDA批准 7月31日，微芯生物公告称，公司全资子公司微芯生物科技（美国）有限公司收到FDA签发的关于 CS231295开展治疗晚期实体瘤的I期临床试验的通知。CS231295是一种透脑AuroraB选择性抑制 ...

舒泰神（300204）(300204.SZ)公告，公司取得关于BDB-001注射液(ANCA相关性血管炎适应症，AAV) 的I/II期临床研究总结报告。本品已完成的I/II期临床试验中显示出较好的控制疾病缓解的效果，且安全 耐受性良好。公司将积极推进Ⅲ期临床试验，进一步验证其治疗AAV患者的临床获益。 ...

格隆汇7月31日丨舒泰神(300204.SZ)公布，近日，舒泰神(北京)生物制药股份有限公司取得关于BDB- 001注射液(ANCA相关性血管炎适应症，AAV)的I/II期临床研究总结报告。本品已完成的I/II期临床试验 中显示出较好的控制疾病缓解的效果，且安全耐受性良好。 研究证实BDB-001注射液在实现激素减量方面具有显著临床优势，特别是在完全缓解率指标上观察到明 显改善。基于当前数据，公司将积极推进Ⅲ期临床试验，进一步验证其治疗AAV患者的临床获益。 ...

舒泰神(300204.SZ)公告称，公司取得BDB-001注射液（ANCA相关性血管炎适应症）的I/II期临床研究 总结报告。主要结论包括：该注射液在实现激素减量方面具有显著临床优势，特别是在完全缓解率指标 上观察到明显改善。公司将积极推进Ⅲ期临床试验，进一步验证其治疗AA V患者的临床获益。但需注 意，创新生物医药具有高科技、高风险、高附加值的特点，存在研发失败、审批不及预期等风险。 ...

证券代码：300204 证券简称：舒泰神 公告编号：2025-044 舒泰神（北京）生物制药股份有限公司 1、药品名称：BDB-001 注射液 2、试验题目：多中心、随机、开放、平行对照研究 BDB-001 注射液替代糖 皮质激素治疗 ANCA 相关性血管炎患者的有效性和安全性 I/II 期临床试验 3、适应症：抗中性粒细胞胞质抗体（ANCA）相关性血管炎 4、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 本品已完成的 I/II 期临床试验中显示出较好的控制疾病缓解的效果，且安全 耐受性良好。主要结果总结如下： 关于 BDB-001 注射液（ANCA 相关性血管炎适应症） 获得 I/II 期临床研究总结报告的公告 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，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"）取得关于 BDB-001 注射液（ANCA 相关性血管炎适应症，AAV）的 I/II 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 抗中性粒细胞胞质抗体相关性血管炎是由 ANCA 介导的以寡免疫 ...

Core Viewpoint - The stock of Shutaishen Biotechnology Co., Ltd. experienced a significant increase of 6.21% on July 31, reaching a price of 49.95 yuan per share, with a trading volume of 449 million yuan and a turnover rate of 1.96%, resulting in a total market capitalization of 23.865 billion yuan [1] Company Overview - Shutaishen Biotechnology Co., Ltd. is located in Beijing Economic and Technological Development Zone and primarily engages in the research, production, and marketing of innovative drugs with independent intellectual property rights, focusing on biopharmaceuticals [1] - The company's main products include protein-based drugs and chemical drugs, targeting treatment areas such as infectious diseases, autoimmune diseases, and neurological disorders [1] - Key products developed by the company include the national class I new drug "Sutai Sheng" (injection of mouse nerve growth factor) and the constipation treatment "Sutai Qing" (polyethylene glycol electrolyte powder), both recognized as "National Torch Program Products" and "Beijing High-tech Achievement Transformation Projects" [1] Financial Performance - For the period from January to March 2025, Shutaishen reported an operating income of 63.214 million yuan, representing a year-on-year decrease of 33.45% [1] - The net profit attributable to shareholders was -2.335 million yuan, showing a year-on-year increase of 38.05% [1] - As of March 31, the number of shareholders of Shutaishen was 24,500, with an average of 19,300 circulating shares per person [1]

风险提示：股市有风险，投资需谨慎。 舒泰神属于生物医药行业，专注于研发、生产和销售临床需求未被满足的治疗性药物。公司主要产品包 括蛋白类药物和化学药物，重点布局感染性疾病、自身免疫系统疾病及神经系统疾病治疗药物领域。 2022年至2024年，公司营业收入分别为5.49亿元、3.64亿元和3.25亿元。 7月30日主力资金净流出3283.32万元，占流通市值的0.15%。当日股价波动区间为45.51元至50.18元，振 幅达到9.55%。 截至2025年7月30日收盘，舒泰神股价报47.03元，较前一交易日下跌1.85元，跌幅3.78%。当日成交量 为19.6万手，成交金额达9.42亿元。 ...

Core Viewpoint - The Chinese innovative pharmaceutical sector is experiencing a significant rebound, with numerous stocks doubling in value and a strong performance from innovative drug companies, indicating a potential for continued growth and investment opportunities [1][2][3]. Group 1: Market Performance - As of July 29, 2023, the pharmaceutical sector has seen 42 stocks double in value this year, with Shuyatain leading at a 560% increase [1]. - Eight stocks, including Saifen Technology and Yipin Hong, have risen over 200%, while over 30 stocks have increased by more than 100% [1]. Group 2: Fund Performance - The surge in the pharmaceutical sector has led to significant gains in several pharmaceutical-themed funds, with many achieving over 100% returns in the past year [2]. - Fund managers believe that innovative drugs are likely to gain traction due to high demand and the upcoming product launches from various A-share and H-share companies [2]. Group 3: Industry Insights - Analysts highlight that the innovative drug sector is entering a golden development phase, supported by short-term performance from research outcomes and long-term benefits from aging populations and health demand upgrades [2]. - The innovative drug sector is seen as the most promising sub-industry within pharmaceuticals, with a clear growth trajectory and investment potential [3]. Group 4: Future Outlook - The innovative drug sector is expected to benefit from a combination of policy support and fundamental growth, leading to a revaluation of the sector [3]. - Analysts recommend continued investment in specific segments such as CRO & CDMO, GLP-1, and unique raw materials, which are anticipated to show strong performance [3].

Core Insights - The report maintains a positive outlook on small molecule drug conjugates (SMDCs) and related companies, highlighting their potential in cancer treatment due to their ability to enhance efficacy while reducing toxicity [1][5][17] - The report emphasizes the clinical advantages of SMDCs, including better tumor penetration, reduced toxicity to normal cells, and easier control over synthesis and costs compared to antibody-drug conjugates (ADCs) [5][11][12] - The report identifies domestic biopharmaceutical companies, particularly Affinivax, as leaders in the SMDC space, showcasing significant advancements in innovative cancer drug development [5][12][17] Industry Overview - The pharmaceutical and biotechnology sector has shown a relative price-to-earnings (P/E) ratio of 51.14 as of July 25, 2025, which is significantly higher than its historical low of 24.38, indicating a premium valuation compared to the broader market [19] - The report notes that the healthcare sector's valuation is 279% higher than the Shanghai Composite Index, reflecting strong investor interest and confidence in the industry [19] - Recent market performance indicates a 1.90% increase in the pharmaceutical and biotechnology sector from July 21 to July 25, 2025, ranking it 16th among 27 sub-industries [26][29] Company Focus - The report suggests monitoring companies involved in the SMDC space, including Affinivax, and those collaborating with them, such as Innovent Biologics and others, which are expected to benefit from the growing interest in innovative cancer therapies [5][17][18] - Specific companies highlighted for their innovative drug development capabilities include Innovent Biologics, Shunyi Pharmaceutical, and others, which are positioned to capitalize on the advancements in SMDC technology [5][18]

Core Insights - The stock of Aowei New Materials has become the first 10x stock in A-shares for 2025, with a peak increase of over 17% and a closing rise of 13.12% on the day of the report [1] - Aowei New Materials has achieved 10 limit-up trading days since July, setting a record for A-shares [1] - The company is a major supplier of environmentally friendly corrosion-resistant resins and is seeking control through a combination of share transfer and tender offer by Zhiyuan Robotics [1] Company Performance - Aowei New Materials was listed on the Sci-Tech Innovation Board in September 2020 and primarily focuses on industrial robots, with its thermosetting resins not widely applied in humanoid robots [1] - Other notable stocks include Shoutai Shen, which has seen a 5x increase due to a rich pipeline of products entering critical clinical trials [1] - ST Yushun has experienced over a 4x increase in stock price, recovering from previous performance declines through management optimization and asset restructuring [1] - United Chemical has also seen over a 4x increase, benefiting from industry prosperity and strong demand growth, leading to improved product pricing and market expansion [1] Market Trends - Since the beginning of 2025, the Shanghai Composite Index has surpassed 3600 points, with 21 stocks increasing by over 2x, entering the "star stock" category [1] - The four highlighted stocks represent different industries but share a common theme of proactive change and continuous innovation driving their growth [1]