Core Viewpoint - The company has received a summary report on the I/II phase clinical study of BDB-001 injection for ANCA-associated vasculitis (AAV), indicating promising disease control and good safety tolerance [1] Group 1 - The I/II phase clinical trial of BDB-001 has shown good efficacy in controlling disease remission [1] - The safety and tolerability of BDB-001 have been reported as favorable [1] - The company plans to actively advance to the III phase clinical trial to further validate the clinical benefits for AAV patients [1]

智通财经APP讯，舒泰神(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。 ...

Core Viewpoint - The company Shutaishen (300204.SZ) has announced the successful completion of a summary report for the I/II phase clinical study of BDB-001 injection, which targets ANCA-associated vasculitis (AAV), demonstrating significant clinical advantages in hormone reduction and improved complete remission rates [1] Group 1: Clinical Research Findings - The clinical study confirms that BDB-001 injection shows significant clinical advantages in achieving hormone reduction, particularly in the complete remission rate [1] - The company plans to actively advance to phase III clinical trials to further validate the clinical benefits of BDB-001 for AAV patients based on current data [1] Group 2: Industry Characteristics - The innovative biopharmaceutical industry is characterized by high technology, high risk, and high added value, with long development cycles and multiple stages from research and clinical trials to approval and production [1] - The industry is susceptible to various factors including technology, regulatory approvals, and policy changes [1]

Core Viewpoint - Shuyou Shen (300204.SZ) has announced positive results from the I/II phase clinical trial of BDB-001 injection for ANCA-associated vasculitis (AAV), demonstrating good disease control and safety [1] Group 1: Clinical Trial Results - The I/II phase clinical trial of BDB-001 injection has shown effective disease remission control [1] - The product exhibits good safety and tolerability [1] - Significant clinical advantages in hormone reduction have been confirmed, particularly in the complete remission rate [1] Group 2: Future Plans - Based on current data, the company plans to actively advance to the III phase clinical trial to further validate the clinical benefits for AAV patients [1]

人民财讯7月31日电，舒泰神（300204）7月31日晚间公告，近日，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。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。 ...

Core Viewpoint - The company has announced the results of the I/II clinical study for BDB-001 injection, indicating significant clinical advantages in hormone reduction, particularly in the complete remission rate [1] Group 1: Clinical Study Results - The BDB-001 injection shows notable improvement in the complete remission rate for patients with ANCA-associated vasculitis [1] - The company plans to actively advance to the Phase III clinical trial to further validate the clinical benefits for AAV patients [1] Group 2: Industry Characteristics - The innovative biopharmaceutical sector is characterized by high technology, high risk, and high added value [1] - There are inherent risks in research and development, including potential failures and delays in approval processes [1]

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]

Core Viewpoint - The stock price of Shutaishen as of July 30, 2025, closed at 47.03 yuan, reflecting a decline of 1.85 yuan or 3.78% from the previous trading day [1] Company Overview - Shutaishen operates in the biopharmaceutical industry, focusing on the research, development, production, and sales of therapeutic drugs that address unmet clinical needs [1] - The company's main products include protein-based drugs and chemical drugs, with a focus on treatments for infectious diseases, autoimmune diseases, and neurological disorders [1] Financial Performance - The company's revenue for the years 2022 to 2024 is reported as follows: 549 million yuan in 2022, 364 million yuan in 2023, and 325 million yuan in 2024 [1] - On July 30, 2025, the net outflow of main funds was 32.83 million yuan, accounting for 0.15% of the circulating market value [1] Market Activity - The trading volume on July 30, 2025, was 196,000 hands, with a total transaction amount of 942 million yuan [1] - The stock price fluctuated between 45.51 yuan and 50.18 yuan on the same day, resulting in a volatility of 9.55% [1]

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].