Core Viewpoint - Shanghai Raist (002252.SZ) has received approval from the National Medical Products Administration (NMPA) for the clinical trial of SR604 injection, aimed at preventing bleeding episodes in patients with von Willebrand disease [1] Group 1: Drug Information - Drug Name: SR604 Injection [1] - Drug Registration Category: Class 1 therapeutic biological product [1] - Indication: Prevention of bleeding episodes in patients with von Willebrand disease [1] - Application: Clinical trial for domestic production of the drug [1] - Applicant: Shanghai Raist Blood Products Co., Ltd. [1] - Approval Conclusion: The clinical trial application for SR604 injection meets the requirements for drug registration and is approved to proceed [1] Group 2: Existing Clinical Trials - Currently conducted clinical trials for indications include: prevention of bleeding episodes in patients with Hemophilia A/B and congenital factor VII deficiency [2]

Investment Rating - The report maintains a "Buy" rating for the pharmaceutical and biotechnology sector [4][5]. Core Viewpoints - The proportion of public fund holdings in the pharmaceutical sector has decreased quarter-on-quarter, but the market is expected to experience a rebound [2][23]. - The investment focus should increasingly emphasize the clinical value of pharmaceuticals, driven by domestic and international policy changes [3][34]. - The report highlights the potential for continuous valuation recovery and upward movement in the pharmaceutical sector due to the opening of the US interest rate cut cycle and advancements in domestic innovative drugs [2][35]. Summary by Sections Market Review - Last week, the pharmaceutical and biotechnology index rose by 1.31%, outperforming the CSI 300 index by 1.74 percentage points [1][17]. - The Hong Kong Hang Seng Medical Health Index fell by 0.11%, but still outperformed the Hang Seng Index by 1.97 percentage points [1][17]. Company Updates - Notable clinical application approvals include Shanghai Lai Shi's SR604 injection and YKYY013 injection from Yuekang Pharmaceutical [39]. - Ongoing clinical trials include HRS-8080 from Heng Rui Pharmaceutical and ICP-332 from Nuo Cheng Jian Hua, both in Phase III [39]. Investment Strategy - The report emphasizes a three-stage clinical value investment strategy: "0 to 1" for technological breakthroughs, "1 to 10" for clinical validation, and "10 to 100" for efficiency in the Chinese market [34][35]. - Key recommended companies include Innovent Biologics (H), Eifang Biologics-U, Tian Shi Li, WuXi AppTec (A+H), and Mindray Medical [36]. Fund Holdings - As of Q3 2025, the market value of public funds heavily invested in pharmaceuticals is 11.93%, down by 0.32 percentage points from the previous quarter [2][24]. - The top 20 stocks by market value show significant upward movement for companies like Rongchang Biologics and BeiGene (H) [2][30]. Financial Performance - The pharmaceutical manufacturing industry reported a revenue decline of 2.0% year-on-year for the first nine months of 2025, totaling 182.11 billion yuan [59]. - The report indicates a positive trend in the valuation of the pharmaceutical sector, with a steady recovery in PE ratios since Q1 2025 [34].

Company Overview - Shanghai Raist Blood Products Co., Ltd. was established in 1988 and listed on the Shenzhen Stock Exchange in 2008. In December 2023, Haier Group signed a strategic cooperation and share purchase agreement with Kilibof, acquiring 20% of the company’s shares through its subsidiary, Haiyingkang. The transaction was completed in June 2024, resulting in a change of controlling shareholder to Haiyingkang and actual controller to Haier Group [2][3]. Industry Situation - The blood products industry is a sub-sector of the biopharmaceutical industry, characterized by high technical barriers and strict regulatory requirements. Since 2001, no new blood product manufacturing enterprises have been approved in China, with fewer than 30 companies currently operating [3]. - In 2024, there were over 300 plasma collection stations in China, with a total plasma collection exceeding 13,000 tons, showing significant growth compared to 2023, although there remains a gap between supply and actual demand [3]. - Human albumin is the most significant product in terms of domestic sales, with a high proportion of imports. Imported human albumin is currently the only permitted human-derived blood product in China [3]. Company Goodwill - The company's goodwill primarily arises from the acquisition of other stable and well-performing enterprises in the same industry. The company conducts annual impairment testing of goodwill in compliance with regulatory requirements [4]. Sales and Market Dynamics - Domestic sales of human albumin have slightly slowed due to medical insurance policies and supply-demand dynamics. However, there remains a rigid demand for human albumin, which is used in various medical conditions [5]. - The blood products industry currently has some inventory among companies and distributors, with production and inspection cycles being relatively long [6]. - Prices of blood products have been affected by policy factors and supply-demand relationships, leading to some price reductions since the second half of last year [7]. Innovation and R&D - The company is advancing its "plasma expansion" and "plasma reduction" strategies, focusing on safety, quality, and efficiency, while increasing investment in basic research, clinical translation, and industrial upgrades [8]. - The company is conducting clinical research on SR604 injection, which is in Phase IIb trials. This product aims to prevent and treat hemophilia A and B, as well as factor VII deficiency [8][9]. Conclusion - The report highlights the strategic developments, market conditions, and innovation efforts of Shanghai Raist Blood Products Co., Ltd., emphasizing the company's position in a highly regulated and competitive industry.