证券代码：688520 证券简称：神州细胞 公告编号：2025-037 北京神州细胞生物技术集团股份公司 自愿披露关于控股子公司产品 SCT640C 获得 药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 二、产品其他相关情况 3. 申请事项：药物临床试验 4. 申请人：神州细胞工程有限公司 类风湿关节炎（Rheumatoid Arthritis，RA）是一种系统性自身免疫性疾病， 以慢性侵蚀性关节炎为主要临床表现，是一种高致残性疾病，可并发肺部疾病、 心脑血管疾病、骨质疏松、恶性肿瘤等。RA 的全球发病率约为 0.5％~1％，我 国大陆地区发病率约为 0.4~2％，据此估计目前我国 RA 患者超过 500 万人。 近日，北京神州细胞生物技术集团股份公司控股子公司神州细胞工程有限公 司（以下简称"公司"）收到国家药品监督管理局（以下简称"国家药监局"）核 准签发的《药物临床试验批准通知书》，同意公司自主研发的产品 SCT640C 注射 液开展成人类风湿关节炎适应症的临床试验。由于 ...

Core Viewpoint - Shenzhou Cell's subsidiary has received approval for clinical trials of SCT640C injection for adult rheumatoid arthritis, indicating progress in the development of treatments for autoimmune diseases [1] Group 1 - Shenzhou Cell announced that its subsidiary, Shenzhou Cell Engineering Co., Ltd., has received the Drug Clinical Trial Approval Notice from the National Medical Products Administration [1] - SCT640C is a monoclonal antibody injection independently developed by the company for the treatment of autoimmune diseases [1]

Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [1]. Core Insights - The company has successfully turned a profit, with a promising clinical pipeline [4][5]. - Revenue for 2024 is projected at 25.13 billion yuan, a year-on-year increase of 33.13%, while Q1 2025 revenue is expected to be 5.20 billion yuan, reflecting a decline of 15.15% [4]. - The core product, Recombinant Factor VIII, achieved sales of 18.9 billion yuan in 2024, a growth of 6.18% year-on-year [4]. - The antibody product line saw significant growth, with 2024 revenue reaching 6.2 billion yuan, a remarkable increase of 499.80% [4]. - The company is advancing its clinical research, with several products in various stages of development, including SCTB14 and SCTB41 [5]. Financial Summary - The company is expected to achieve revenues of 28.27 billion yuan, 32 billion yuan, and 37.07 billion yuan for the years 2025, 2026, and 2027 respectively [6]. - Projected net profits for the same years are 2.23 billion yuan, 3.36 billion yuan, and 5.78 billion yuan [6]. - The company’s EBITDA for 2025 is estimated at 503.97 million yuan, with a growth rate of 12.50% [8]. - The earnings per share (EPS) is projected to increase from 0.25 yuan in 2024 to 1.30 yuan by 2027 [8].

Core Insights - The reactivation of the fifth listing standard on the Sci-Tech Innovation Board (STAR Market) aims to support high-growth technology companies, particularly in the biopharmaceutical sector, by allowing companies without profits to list based on expected market capitalization and R&D achievements [1][19] - The biopharmaceutical industry, especially innovative drug companies, faces longer investment periods and higher uncertainty due to strict regulatory requirements for product approval, making them highly reliant on capital [1][19] - Since the reactivation in June 2025, companies like He Yuan Bio and Bei Xin Life have made significant progress, signaling a positive outlook for other biopharmaceutical firms still in clinical stages [2] Market Performance - The innovative drug sector has seen a remarkable stock performance in 2025, driven by favorable policy changes, relaxed procurement policies, and the growth of commercial health insurance, which enhances market expectations for innovative drugs [3] - The 20 companies that successfully listed under the fifth standard have achieved a total market capitalization of 364.12 billion, with an average increase of 79.10% since the beginning of 2025 [3][7] Financial Performance - In 2024, the 20 companies reported a combined revenue exceeding 14.3 billion, a year-on-year growth of 45%, with 16 companies generating over 1 billion in revenue [12][16] - The total R&D expenses for these companies accounted for 67% of their total revenue, indicating a high dependency on external financing for continued innovation [16][18] R&D and Innovation - The 20 companies listed under the fifth standard have collectively developed 45 drug varieties, with 22 classified as first-class new drugs or innovative biological products, covering various advanced therapeutic areas [8][10] - The number of candidate products in the R&D pipeline for these companies has exceeded 200, showcasing their commitment to innovation and market expansion [8] Regulatory Environment - The reactivation of the fifth standard reflects a shift in regulatory focus towards recognizing the inherent risks and long timelines associated with technology innovation, moving away from traditional financial metrics [19][20] - The introduction of a "Sci-Tech Growth Tier" aims to enhance information disclosure and regulatory oversight for companies listed under the fifth standard, ensuring a balance between support and supervision [22]

Core Viewpoint - The article highlights a significant surge in the innovative drug sector, driven by new policies from the National Healthcare Security Administration aimed at supporting the development of innovative drugs and optimizing procurement processes [1][2]. Summary by Sections Innovative Drug Market Surge - On July 17, there was a notable increase in the stock prices of innovative drug companies, with companies like ShenZhou Cell rising over 15% and KangnuoYa increasing over 14% [1]. - The article mentions that the 11th batch of national drug centralized procurement has been initiated, emphasizing that new drugs will not be included in centralized procurement to protect industry innovation [1]. Policy Support for Innovative Drugs - The "Measures" issued on June 30 by the National Healthcare Security Administration and the National Health Commission aim to support the entire chain of innovative drug development from laboratory to bedside [1]. - The measures include dynamic adjustments to the medical insurance catalog, allowing eligible innovative drugs to be included, and establishing more scientifically reasonable payment standards [1]. Establishment of Commercial Health Insurance Directory - A groundbreaking proposal to establish a "Commercial Health Insurance Innovative Drug Directory" is introduced, which will include innovative drugs with significant clinical value that exceed basic medical insurance coverage [2]. - Drugs in this directory will enjoy special treatment, such as confidential price negotiations and exemption from centralized procurement monitoring, creating new payment channels for high-priced breakthrough therapies [2]. Investment Opportunities - Analysts from Bohai Securities suggest that the introduction of innovative drug policies and the potential establishment of the commercial health insurance directory present investment opportunities in related innovative drug companies and their supply chains [2]. - Xiangcai Securities predicts that by 2025, the domestic innovative drug industry may experience a turning point, shifting from capital-driven to profit-driven trends, leading to dual recovery in performance and valuation [2].

Group 1 - The innovative drug concept index rose by 2.68%, ranking 9th among concept sectors, with 197 stocks increasing in value [1] - Notable gainers included Chengdu Xian Dao, Weikang Pharmaceutical, and Maiwei Biotech, each reaching a 20% limit up, while Seli Medical, Lisheng Pharmaceutical, and Xinlitai also hit the limit up [1] - The top gainers in percentage terms were Meidi Xi, Shouyao Holdings, and Shenzhou Cell, with increases of 19.00%, 15.54%, and 15.40% respectively [1] Group 2 - The innovative drug sector saw a net inflow of 1.07 billion yuan, with 104 stocks receiving net inflows, and 8 stocks exceeding 100 million yuan in net inflow [2] - Seli Medical led the net inflow with 222 million yuan, followed by Shenzhou Cell, WuXi AppTec, and Xinlitai with net inflows of 217 million yuan, 203 million yuan, and 147 million yuan respectively [2] - The top stocks by net inflow ratio included Han Shang Group, Weikang Pharmaceutical, and Seli Medical, with net inflow ratios of 56.11%, 17.61%, and 17.43% respectively [3] Group 3 - The innovative drug sector's performance was contrasted by the decline of ST Unimed, *ST Suwu, and Guangsheng Tang, which fell by 5.01%, 4.81%, and 4.41% respectively [1][2] - The overall market sentiment reflected a mixed performance across various sectors, with some sectors like military restructuring and AI-related concepts showing positive trends while others like housing inspection and cement concepts experienced slight declines [2]

Market Performance - The recombinant protein concept increased by 2.92%, ranking 7th among concept sectors, with 43 stocks rising, including Chengdu Xian Dao and Mai Wei Bio reaching a 20% limit up [1] - Leading gainers included Shen Zhou Cell, Hai Te Bio, and Ke Xing Pharmaceutical, with increases of 15.40%, 11.93%, and 10.14% respectively [1] - Decliners included ST Wei Ming, *ST Su Wu, and Lizu Group, with decreases of 5.01%, 4.81%, and 0.49% respectively [1] Capital Flow - The recombinant protein sector saw a net inflow of 188 million yuan, with 17 stocks receiving net inflows, and 5 stocks exceeding 30 million yuan in net inflow [1] - Shen Zhou Cell led with a net inflow of 217 million yuan, followed by Chengdu Xian Dao, Mai Wei Bio, and Hui Yu Pharmaceutical with net inflows of 126 million yuan, 96.87 million yuan, and 45.41 million yuan respectively [1] Capital Inflow Ratios - Leading stocks in capital inflow ratios included Shen Zhou Cell, Chengdu Xian Dao, and Cheng Da Bio, with net inflow ratios of 16.25%, 12.33%, and 10.79% respectively [2] - The top stocks in the recombinant protein concept based on capital flow included Shen Zhou Cell, Chengdu Xian Dao, and Mai Wei Bio, with respective daily turnover rates of 3.70%, 12.33%, and 17.80% [2]

Group 1 - The Shanghai Stock Exchange Sci-Tech Innovation Board 100 Index rose by 0.46% as of July 17, 2025, with notable increases in constituent stocks such as Shengyi Electronics (up 13.37%) and Baiotai (up 6.51%) [1] - The Huaxia Sci-Tech 100 ETF (588800) also saw a rise of 0.50%, marking its fifth consecutive increase, with a latest price of 1 yuan and a trading volume of 27.1854 million yuan [1] - The latest scale of the Huaxia Sci-Tech 100 ETF reached 2.934 billion yuan [1] Group 2 - The adjustment of the national basic medical insurance and commercial health insurance innovative drug catalog officially started, with eligible applicants able to submit online applications from July 11 to 20 [1] - The domestic policy continues to favor innovative drugs, establishing a dynamic adjustment mechanism for new drug access to the medical insurance catalog [2] - The expenditure of employee medical insurance funds increased from 1.29 trillion yuan in 2020 to 1.91 trillion yuan in 2024, reflecting a growth of over 600 billion yuan in five years, indicating a rising demand for pharmaceuticals [2]

Group 1 - The article highlights the ongoing positive performance of the pharmaceutical sector, driven by favorable policies, with the drug ETF (562050) rising nearly 1% and aiming for a "seven consecutive rise" [1][3] - Significant gains were noted in leading pharmaceutical companies, with Xinlitai increasing over 6% and Shenzhou Cell rising more than 5% [1] - The drug ETF (562050) is the first domestic ETF tracking the CSI Pharmaceutical Index, focusing on innovative drugs while excluding medical and CXO sectors, thus accurately reflecting the performance of leading pharmaceutical companies [1][3] Group 2 - Recent policy developments, including the "dual-track system" of medical insurance and commercial insurance, aim to address the payment challenges for high-priced innovative drugs [3] - The 11th batch of centralized procurement proposed a policy that exempts innovative drugs from centralized procurement, providing pricing protection for these drugs [3] - Analysts suggest that the establishment of a "safety boundary" through procurement exemptions and commercial insurance directories could lead to a global revaluation of leading pharmaceutical companies, driven by overseas transactions and clinical data [3] Group 3 - The article expresses optimism for innovative drugs and traditional Chinese medicine, recommending the drug ETF (562050) as it encompasses three major pharmaceutical sectors: chemical drugs, biological drugs, and traditional Chinese medicine [3] - The ETF is expected to benefit from high growth driven by innovative drugs while traditional Chinese medicine helps to reduce index volatility [3] - Additionally, there is a focus on the largest medical ETF in A-shares (512170), which targets medical devices and services, with a strong correlation to AI healthcare [3]

Core Viewpoint - The innovative drug market is experiencing a surge in interest and investment, with significant inflows of capital and strong performance in related stocks [1][5]. Group 1: Market Performance - On July 15, the pharmaceutical ETF (562050) experienced a sharp increase during the opening auction, indicating heightened investor enthusiasm for innovative drugs [2][3]. - The ETF closed up 0.59% at 1.017 yuan per share, with a total trading volume of approximately 26.34 million yuan and a turnover rate of 22.94% [4]. - A-shares in innovative drugs have shown notable gains, with companies like ShenZhou Cell rising nearly 50% in the past month, and others like BoRui Medicine and Jilin AoDong increasing over 10% [5]. Group 2: Fund Performance and Strategy - The latest public fund reports reveal a significant shift towards innovative drugs, with the Changcheng Pharmaceutical Industry Selected Fund achieving over 90% returns, increasing its scale nearly 30 times in the second quarter [6][9]. - The fund manager of Yongying Medical Health Fund indicated a complete portfolio overhaul towards innovative drugs, with top holdings including ShuTaiShen and Rejing Biology, the latter seeing a staggering 443.59% increase this year [6][7]. - The Changcheng fund plans to continue focusing on innovative drugs in the third quarter, emphasizing clinical data, overseas licensing, and domestic sales growth [8]. Group 3: Policy and Market Trends - The innovative drug sector is benefiting from favorable policy developments, with the National Medical Insurance Bureau initiating adjustments to the drug catalog for 2025 [10]. - Data shows that the total amount for Chinese innovative drug licenses reached nearly 66 billion USD in the first half of 2025, surpassing the total for 2024, indicating a rapid rise in global competitiveness [11]. - The current market rally is primarily driven by clinical results and expectations for overseas licensing, with a focus on companies that have the potential for international expansion and those that have successfully transformed [11].