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].

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 Viewpoint - The innovative drug sector is expected to thrive in 2025, with significant capital inflow and a focus on products with overseas potential, leading to substantial stock price increases in this segment [1][3]. Group 1: Market Performance - From early 2025 to date, the innovative drug sector has seen an average increase of over 50%, with nearly 50 stocks rising more than 30% [1]. - The Hongtu Innovation Healthcare Fund has achieved a cumulative increase of nearly 64% since early 2025, outperforming the industry [1][5]. - Historical performance of the Hongtu Innovation Healthcare Fund shows a year-to-date return of 63.66%, ranking 92 out of 594 funds [2]. Group 2: Industry Trends - The long-term development trend of China's innovative drug sector remains strong, supported by national strategies and favorable capital market policies [3]. - The market for innovative drugs in China is projected to exceed 250 billion RMB in 2024, with expectations to grow to approximately 450 billion RMB by 2030 [3]. - The overall market size, including all aspects of the drug development chain, is expected to approach 5.5 trillion RMB by 2024 and surpass 20 trillion RMB by 2030 [3]. Group 3: Investment Strategy - The investment strategy of the Hongtu Innovation Healthcare Fund focuses on high-elasticity innovative drug companies, particularly those with significant clinical breakthroughs and potential for international market entry [7][11]. - Key investment targets include companies with promising clinical data and those that are expected to achieve commercial success through domestic market integration and overseas licensing [7][10]. - The fund manager has successfully captured structural opportunities in the pharmaceutical sector, leading to superior long-term performance compared to peers [12]. Group 4: Notable Stocks - Major holdings in the Hongtu Innovation Healthcare Fund include companies like Xinlitai, Shutaishen, and Yifang Biotechnology, which have shown significant price increases and promising clinical data [8][9]. - The fund emphasizes investments in companies with first-in-class (FIC) and best-in-class (BIC) potential, focusing on those that can disrupt current clinical supply [11][12]. Group 5: Future Outlook - The innovative drug sector is expected to continue its upward trajectory, driven by overseas licensing opportunities and supportive domestic policies [12]. - The ongoing global business development (BD) transactions and key clinical data releases are anticipated to catalyze further growth in high-value innovative drug companies [12].

Summary of Shuyou Pharmaceutical Conference Call Company Overview - Shuyou Pharmaceutical is focused on innovative biopharmaceuticals, with a history of approximately 20 years in the industry [3][4] - The company has multiple first-in-class (FIC) drugs in development, including 0,601 for hemophilia and 1,002 for ARDS [3][4] Key Products and Developments - **0,601**: A coagulation factor X activator for hemophilia patients, showing over 80% hemostatic efficiency, significantly better than existing treatments [2][7] - Submitted for conditional market approval, expected to launch by the end of this year or early next year [3][4] - **1,002**: Targeting C5A for ARDS, with phase II clinical trials showing a significant reduction in all-cause mortality [2][15] - Anticipated submission for phase III clinical trials in the second half of this year [3][15] - **0,902**: A fourth-generation product for various indications, currently in clinical development [2][17] - **1,301**: Targeting ITP, progressing to early clinical stages with potential for overseas collaboration [18] Financial Performance - Overall revenue is stable, ranging between 300 to 400 million RMB, with core products maintaining steady sales [6][19] - Sales of the core product Shuyouqing are close to 200 million RMB annually [2][17] - Previous peak sales of Suotaiseng reached 1 billion RMB, but recent performance has been affected by regulatory scrutiny [6][17] Market Insights - The hemophilia treatment market is characterized by high costs and low efficacy of existing therapies, with annual treatment costs around 600,000 RMB [7] - Shuyou's 0,601 offers a significant improvement in hemostatic efficiency, positioning it as a potential market leader [7][14] Competitive Advantages - Shuyou's core competencies include breakthrough therapies and a diverse pipeline across specialized fields [4][5] - The company has two drugs recognized as breakthrough therapies: 0,601 and BDB001 [4] Future Outlook - Plans to expand into international markets with key products 0,601, 1,002, and 1,301 [10][20] - Continued focus on innovation in specialized therapeutic areas to enhance business scale and profitability [10][20] - Positive revenue growth expected from existing products and new drug approvals by 2026 [19] Investment Rating - Given the potential approval of 0,601 and other catalysts, Shuyou Pharmaceutical is rated as a "Buy" [21]

Core Viewpoint - The stock price surge of Shuyou Shen (300204.SZ) is driven by the anticipated approval of the innovative drug STSP-0601, despite the company's ongoing financial struggles and reliance on aging products for revenue generation [1][5][8] Financial Performance - Shuyou Shen's stock price increased from 5.90 CNY to 43.15 CNY within two months, marking a cumulative rise of over 400% and a market capitalization exceeding 15 billion CNY [1] - The company reported a revenue of 325 million CNY in 2024, a year-on-year decline of 10.81%, and a net loss of 145 million CNY, although this represented a 63.69% reduction in losses compared to 2023 [1] - The core revenue sources, two long-standing drugs, contributed 96.37% of total revenue in 2024, with sales of Shutaqing at 179 million CNY and Sutai Sheng at 134 million CNY [1] Product Pipeline and R&D - The company is focusing on innovative drug development, with key candidates including STSP-0601 for hemophilia, STSA-1002 for ARDS, and STSG-0002 for hepatitis B [2] - STSP-0601 has shown promising results in IIb clinical trials, achieving a 12-hour hemostatic rate of 81.94%, surpassing competitors [2] - However, the small sample size of the IIb trial (36 participants) raises concerns about the generalizability of the results, and the company faces significant challenges in the competitive landscape of hemophilia treatments [3][7] Market Environment - The market for hemophilia drugs is highly competitive, with several established products already dominating the market, which may hinder STSP-0601's penetration [3][7] - The company’s financial health is strained by high R&D costs, with 2023 expenditures reaching 448 million CNY, which was 123.02% of its revenue [3] - Despite a reduction in R&D spending to 162 million CNY in 2024, the company has significantly cut its R&D workforce, raising concerns about the sustainability of its innovation pipeline [3][4] Governance and Compliance Issues - Shuyou Shen has faced governance challenges, including past compliance failures related to equity disclosures and tax violations, which have damaged investor confidence [4] - The disconnect between executive compensation and company performance has raised further concerns, as the company has reported significant losses while management continues to receive high salaries [4] Future Outlook - The success of STSP-0601's commercialization is critical for the company's future, with expectations of achieving 300-500 million CNY in first-year sales if approved [8] - The company must navigate cash flow challenges and explore partnerships to mitigate R&D risks while diversifying its product pipeline to reduce reliance on aging products [8]