Investment Rating - The industry rating is maintained at "Outperform" [3] Core Insights - Breakthrough therapies (BTD) are defined as drugs that demonstrate significant and reliable clinical significance, aimed at accelerating the treatment of severe diseases or conditions that critically affect survival quality [4][6] - As of June 4, 2025, a total of 126 domestic innovative drugs have been approved for BTD by CDE, with a trend of expanding from traditional targets like PD-1 and HER2 to emerging targets such as PD-1/IL-2 and BCL2 [4][13] - The potential for overseas expansion of BTD drugs is notable, with 25% of domestic BTD molecules having achieved international market entry, compared to only 1% of all domestic molecules [28][29] Summary by Sections Breakthrough Therapy Overview - Breakthrough therapies were introduced in China in 2020 to expedite the development of innovative drugs for severe diseases [4] - The dynamic shift in breakthrough therapies shows a diversification of targets and companies involved, with emerging biotech firms gaining traction alongside established pharmaceutical companies [4][5] Market Dynamics - The CDE has approved 171 BTD products, with a significant portion being domestic innovations, indicating a robust pipeline for future drug development [13] - The distribution of BTD approvals shows that traditional chemical drugs and monoclonal antibodies dominate, while new molecular types like ADCs are gaining prominence [14][17] Company Performance - Leading companies in BTD approvals include Heng Rui Medicine with 17 approvals, followed by Innovent with 10 and CSPC with 8 [17] - Emerging biotech firms such as Shuyou and Legend Biotech are also highlighted for their potential in the BTD landscape [17] Clinical Progress and Global Expansion - Domestic innovative drugs are progressing steadily in clinical trials, with 13 products approved overseas and 60 in clinical stages as of June 4, 2025 [13] - The report identifies several domestic drugs with high potential for international expansion based on their clinical progress and BTD certification [31][32]

Group 1 - The A-share market's innovative drug concept stocks have shown strong performance, with the innovative drug sector index reaching a historical high [1] - Notable individual stock performances include Xinghao Pharmaceutical rising over 25%, RuiZhi Pharmaceutical hitting a 20% limit up, and Changshan Pharmaceutical reaching a historical high [1][2] - The overall pharmaceutical sector has experienced a prolonged adjustment period, resulting in low valuations and underweight public holdings, indicating potential for recovery and structural opportunities [2] Group 2 - Specific stock performances include: - Xinghao Pharmaceutical: 25.82% increase, market cap of 3.045 billion [2] - RuiZhi Pharmaceutical: 19.98% increase, market cap of 5.801 billion [2] - Changshan Pharmaceutical: 19.97% increase, market cap of 47.9 billion [2] - Shutaishen: 12.12% increase, market cap of 15.6 billion [2] - The report from China Galaxy Securities suggests that the pharmaceutical market is expected to see continuous recovery and that innovative drug companies will benefit from policy support and improved payment conditions by 2025 [2]

Core Viewpoint - Shuyou Shen's subsidiary, Beijitai, has received priority review status from the National Medical Products Administration (NMPA) for its product STSP-0601, which is intended for the treatment of bleeding in adult patients with hemophilia A or B with inhibitors, marking a significant advancement in the drug's approval process [2][3]. Company Developments - Shuyou Shen's stock price surged nearly 190% over a 10-day period, reaching a peak of 34.49 yuan per share, the highest since 2016, following the announcement of the priority review [4]. - The company has 13 major R&D projects in clinical research stages, focusing on unmet therapeutic needs, including monoclonal antibodies and protein drugs [4]. - The capitalized R&D expenditure for STSP-0601 (with inhibitors) is reported at 85.16 million yuan, while for STSP-0601 (without inhibitors) it stands at 10.89 million yuan [3]. Industry Context - The NMPA has also granted priority review status to other companies, including He Yu and Ke Ji Pharmaceuticals, indicating a broader trend in the industry towards expedited drug approvals [5][6]. - He Yu's drug ABSK021 has received multiple recognitions, including breakthrough therapy designation from the NMPA and FDA, and has seen a significant revenue increase due to licensing agreements [6][7]. - Ke Ji's product, a CAR-T cell therapy candidate, has also been recognized by the NMPA and FDA, highlighting the growing focus on innovative cancer treatments within the industry [7].

Group 1: Market Overview - US stock markets collectively declined, with the Dow Jones down 0.25%, Nasdaq down 0.83%, and S&P 500 down 0.53% [1] - Tesla shares fell by 14.27%, while Nvidia dropped 1.36%, Apple decreased by 1.08%, and Meta Platforms fell by 0.48% [1] - Circle's IPO in the US saw a significant increase of 168% on its first day [1] - Broadcom's Q2 revenue exceeded expectations with a 20% increase, but AI revenue guidance was underwhelming, leading to a post-market drop of over 5% [1] - The Baltic Dry Index rose by 9.2%, marking its seventh consecutive day of increase [1] Group 2: Economic Indicators - The US trade deficit narrowed significantly, with imports dropping by 16.3% [1] - First-time unemployment claims in the US reached 247,000, the highest level since October 2024 [1] Group 3: Domestic Developments - China's Ministry of Commerce announced that it will approve export license applications for rare earths that meet regulations [2] - The Chinese government plans to establish 10 national data factor comprehensive pilot zones to enhance the integration of the digital economy with the real economy [6] Group 4: Industry Insights - The data factor market is projected to grow significantly, with the scale of data assets entering balance sheets expected to increase from 48.7 billion yuan in 2024 to 827.8 billion yuan by 2030, a growth of over 16 times [7] - The Chinese automotive industry is facing increased regulatory scrutiny to maintain fair competition and promote healthy development [8] - The pharmaceutical sector is seeing a shift in the perception of Metformin, which is now being recognized for its potential anti-aging properties, with studies indicating a 30% higher chance of living to 90 for women taking it compared to those on sulfonylureas [8] Group 5: Corporate Announcements - Guokai Microelectronics plans to acquire 94.37% of the shares of Zhongxin Integrated Circuit (Ningbo) [10] - Maipu Medical intends to purchase 100% of Yijie Medical, which will enhance its capabilities in the field of interventional biomaterials [10] - HT Development is planning to acquire a controlling stake in Zhixueyun, which is expected to constitute a major asset restructuring [11]

Group 1 - Haitai Development plans to acquire controlling stake in Zhixueyun through cash, which may constitute a major asset restructuring [3] - Shutaishen's product STSP-0601 has been included in the priority review list by the National Medical Products Administration, entering the expedited approval process [4] - Yuyin Co. confirmed no undisclosed significant matters despite stock price fluctuations exceeding 20% over three trading days [5] Group 2 - ST Four Seasons announced the resignation of three vice presidents due to personal reasons [6] - Wanda Film is set to launch a shareholder reward program, offering discounted movie vouchers and exclusive purchase options for shareholders [7] - Huamai Technology reported normal business operations focused on communication infrastructure, with no undisclosed significant information [8] Group 3 - Cuiwei Co. is currently experiencing losses in its main business due to market conditions and operational changes [9] - Dongfang Yuhong has received government subsidies totaling 11.3344 million yuan, accounting for 10.48% of the audited net profit for 2024 [10] Group 4 - Wen's Co. reported a 14.23% year-on-year increase in pig sales revenue for May, with total sales of 3.1554 million pigs generating 5.323 billion yuan [12] - Wentaike plans to reduce its stake by up to 3% through block trades and centralized bidding, amounting to 37.3374 million shares [14] - Debang Technology has reduced its shareholding by 1% through block trades, now holding 16.83% of the company [15] Group 5 - Lanjian Intelligent plans to repurchase shares worth 10 to 20 million yuan at a maximum price of 41.88 yuan per share [17] - Chengdi Xiangjiang's subsidiary has won a bid for a 440 million yuan project with China Mobile for data center power system construction [19]

5、纳入优先审评品种名单日期：2025 年 06 月 05 日； 证券代码：300204 证券简称：舒泰神 公告编号：2025-040 舒泰神（北京）生物制药股份有限公司 关于注射用 STSP-0601 纳入优先审评程序的公告 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。 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"） 子公司江苏贝捷泰生物科技有限公司（以下简称"贝捷泰"）的产品注射用 STSP-0601 于 2025 年 05 月 26 日被国家药品监督管理局药品审评中心纳入拟优 先审评品种公示名单；公示期满后，根据国家药品监督管理局药品审评中心网站 信息公开显示，于 2025 年 06 月 05 日纳入优先审评品种名单，正式进入药品上 市许可优先审评审批程序。现将相关情况公告如下： 一、药品基本情况 1、药品名称：注射用 STSP-0601； 2、申请人：江苏贝捷泰生物科技有限公司； 3、申请日期：2025 年 05 月 23 日； 4、公示日期：2025 年 05 月 26 日； 6、受理号：CXSS2500057 7、优先审评理由 ...

Core Viewpoint - The innovative drug sector has become a focal point in the A-share market, with Shuyou Shen (300204.SZ) emerging as a standout performer, experiencing significant stock price increases despite ongoing operational challenges [1][5]. Stock Performance - On June 4, Shuyou Shen opened high but closed at 30.79 CNY per share, down 3.18% from the previous day. The stock price surged from 11.04 CNY to 31.80 CNY between May 20 and June 3, marking a 188.04% increase over 10 trading days. From a low of 5.90 CNY on April 9, the stock has risen by 438.98% [2][11]. - The company's market capitalization increased by approximately 12.4 billion CNY due to the stock price surge [15]. - Institutional investors played a significant role in the stock's rise, with substantial buying activity noted on multiple trading days [13][14]. Financial Performance - Despite the stock price increase, Shuyou Shen's operational performance remains under pressure, with a 33.45% year-on-year decline in revenue for Q1. The net profit attributable to shareholders was -2.34 million CNY, although this represented a 38.05% reduction in losses compared to the previous year [2][19]. - The company has reported cumulative losses exceeding 1 billion CNY over five consecutive years from 2020 to 2024 [3][19]. - In 2024, the company’s revenue from its main products, Shutaqing and Sutai Sheng, declined, with sales of Shutaqing at 1.79 billion CNY (down 8.20%) and Sutai Sheng at 1.34 billion CNY (down 17.30%) [19]. Research and Development - Shuyou Shen's R&D investment dropped significantly to 162 million CNY in 2024, a decrease of 63.84% year-on-year [4][20]. - The company has reduced its R&D personnel by 14.75%, with R&D staff now comprising 21.14% of the total workforce [20]. - Despite the decline in R&D spending, the company has multiple I-class innovative biological drugs in clinical trials and is focused on advancing projects in areas such as neurological diseases and infectious diseases [20].

Summary of the Conference Call for Shuyou Shen Company Overview - Shuyou Shen focuses on infectious diseases, respiratory and critical care, autoimmune diseases, and neurological disorders [2][6] - The company has faced revenue pressure due to declining sales of its main products, Sutai Sheng and Shuyou Qing, but has a rich pipeline of innovative products that present growth potential [2][6] Key Products and Market Potential - **Bomeipide Enzyme Alpha**: A new therapy for hemophilia, showing superior hemostatic efficiency, safety, and onset speed compared to existing therapies. It is expected to become a best-in-class option [2][7][9] - Clinical data indicates a hemostatic rate and onset speed better than existing treatments [2][9] - Anticipated peak sales could exceed 2 billion RMB, with its market application already accepted [2][9] - **C5A Pathway Drugs (001 and 1,002)**: Targeting ANCA-associated vasculitis (AAV) and acute respiratory distress syndrome (ARDS) [2][5][10] - 1,002 is an upgraded version of 001, with promising clinical trial progress [2][5] - The ARDS market is significant, with approximately 3 million new patients annually and high mortality rates [4][16] - The global market for ARDS treatments is largely unmet, presenting a blue ocean opportunity [4][16] Financial Performance and R&D Progress - The company has seen a decline in revenue since 2022 due to decreased sales of existing products and increased R&D expenses [6] - Despite financial pressures, the extensive R&D pipeline, including Bomeipide Enzyme Alpha and C5A pathway drugs, is expected to drive future growth [6][17] Competitive Landscape - The global hemophilia treatment market is approximately 30 billion RMB, with major competitors including recombinant factor VII, PCC, and emicizumab [3][8] - Bomeipide Enzyme Alpha is positioned as a first-in-class product with a unique mechanism, potentially capturing a significant market share due to its advantages over existing therapies [3][9][12] Commercialization Strategies - Bomeipide Enzyme Alpha's commercialization strategy may involve high pricing to target reimbursable patients or competitive pricing to expand market share [4][12] - The overseas market for hemophilia treatments is estimated at nearly 3 billion USD, with potential for market share capture through licensing [12][14] Clinical Trial Insights - The clinical trial data for 1,002 in ARDS has shown excellent results, indicating a strong potential for market entry [5][15] - The company is also exploring multiple indications for its products, enhancing its R&D pipeline diversity [17] Investor Concerns - Investors are particularly interested in the development of 1,002 and its potential patient population size, with expectations that it will serve a broader range of patients than initially thought [18][19] Conclusion - Shuyou Shen is positioned in a promising market with innovative products that address significant unmet medical needs. The company's strategic focus on R&D and potential market capture strategies could lead to substantial growth in the coming years [2][4][6]

Core Viewpoint - Aoke Co., Ltd. collaborates with Shutai Shen to provide pharmaceutical excipient polyethylene glycol products [1] Group 1 - Aoke Co., Ltd. stated on its interactive platform that Shutai Shen (Beijing) Biopharmaceutical Co., Ltd. is a downstream customer of its subsidiary Aoke Pharmaceutical [1] - Shutai Shen primarily purchases polyethylene glycol products from Aoke Pharmaceutical [1]

Core Viewpoint - The innovative drug sector in Hong Kong and A-shares has experienced significant growth, with companies like Shuyitai (300204.SZ) seeing stock price increases of over 188% from May 20 to June 3, before a subsequent correction on June 4 [1][2]. Group 1: Market Performance - The innovative drug sector has shown strong performance this year, with the Hong Kong biopharmaceutical B-class stock index rising over 80% and the innovative drug concept index increasing by over 40%. A-share innovative drug concepts have also risen by more than 20% [2]. - Recent favorable news, including multiple innovative drug approvals in May and a record $1.25 billion upfront payment for a licensing agreement between Sanofi (01530.HK) and Pfizer (PFE.US), has further stimulated the sector [2]. Group 2: Company-Specific Developments - Shuyitai has received a significant boost from its subsidiary Beijitai, which received a notice from the National Medical Products Administration regarding the conditional approval for the injection STSP-0601, aimed at treating bleeding in adult patients with hemophilia A or B [3]. - Preliminary results from the Ib/II clinical trial of STSA-1002 for acute respiratory distress syndrome (ARDS) indicate good safety and tolerability [3]. - Despite having several products on the market, Shuyitai's revenue has been declining, primarily due to decreasing sales of its main products, leading to continuous net losses [3]. Group 3: Investment Outlook - Analysts remain optimistic about the innovative drug sector, with firms like Zhongtai Securities highlighting the increasing global competitiveness of domestic innovative drugs and the potential for significant market revaluation [5]. - The upcoming national medical insurance negotiations are seen as a critical event, with successful drug approvals expected to accelerate market penetration [5]. - The Hong Kong innovative drug sector is noted for its higher elasticity in valuation compared to A-shares, benefiting from greater research and development expenditure and overseas revenue [6].