4月22日晚间，冠昊生物（300238）(300238.SZ)披露2024年年度报告及2025年一季报。在行业变革等因 素影响下，2024年公司收入利润同比小幅下滑，营业收入实现3.77亿元，归母净利润2741.69万元。至 2025年一季度，公司收入利润恢复正增长，营业收入同比增长3.67%，实现9479.71万元，归母净利润同 比增长3.30%，实现1486.61万元，经营状况有所改善。 更值得一提的是公司在干细胞领域的布局。近年来，细胞行业在全球范围内持续蓬勃发展，展现出巨大 的潜力与活力。国内方面，尤其在2024年，国家药监局药审中心相继发布多项文件，如《免疫细胞治疗 产品临床试验技术指导原则(试行)》《人源干细胞产品药学研究与评价技术指导原则(试行)》等，从监 管政策层面为细胞治疗产业化明晰方向，规范细胞产品的药学研发与临床试验流程。政策环境的优化， 为细胞创新技术和产品的转化落地创造了有利条件。 此外，年报披露，公司在研的生物人工肝项目，目前正推进细胞药物的药学研究和体外支持装置等第三 类医疗器械性能研究工作，公司正积极与相关医院等多方合作申请开展临床前研究。若相关研发后续顺 利实现商业化，或将为 ...

Core Viewpoint - The article highlights the ongoing issues and risks associated with unapproved cancer treatments, particularly the use of NKT immune cells in hospitals, which have not received regulatory approval in China [1][7]. Group 1: Current Situation in the Industry - Recently, multiple departments of Tianqiao People's Hospital in Jinan, Shandong, were reported to provide NKT immune cell therapy for cancer patients, charging over 100,000 yuan per treatment, despite the product not being approved by the National Medical Products Administration [1]. - The Jinan Health Commission has mandated the hospital to cease these unauthorized treatment activities [1]. - A South China stem cell industry insider noted that prior to the "Wei Zexi incident," many tertiary hospitals offered stem cell and immune cell therapies at prices ranging from 20,000 to 30,000 yuan, but only a few private hospitals continue to do so now [1][2]. Group 2: Market Potential and Risks - The immune cell therapy market, particularly TCR-T cell therapy, shows significant potential in treating various cancers, with a global total of 6,448 clinical trials registered as of August 2024, of which China accounts for 2,687 trials, representing 41.7% [5]. - The Chinese cell immune therapy market reached 10 billion yuan in 2019 and is expected to exceed 30 billion yuan by 2025, indicating rapid growth [5]. - The cost of stem cell preparation is under 3,000 yuan, while market prices can exceed 100,000 yuan, leading to substantial profit margins [5]. Group 3: Compliance and Regulatory Challenges - Despite the potential of NKT therapy, no products have received formal approval in China, and the industry faces significant compliance challenges, including technical standardization and product quality concerns [7][8]. - The dual-track regulatory system complicates the standardization of cell and gene therapies, as the health commission oversees clinical research while the drug administration manages drug registration [8]. - Industry insiders advocate for improved legal frameworks and expedited processes from laboratory to clinical application to foster industry growth [8][9].

Investment Rating - The report maintains a "Buy" rating for the company [4] Core Insights - The company reported a revenue of $594 million for 2024, reflecting a year-over-year increase of 6.1%, and a significant net profit of approximately $2.96 billion, primarily due to the deconsolidation of its cell therapy business, which contributed $3.2 billion in gains [1][4] - The life sciences segment achieved a revenue of $455 million in 2024, up 10.2% year-over-year, with an adjusted operating profit of $90 million, marking a 15.5% increase [2] - The CDMO business saw a revenue decline of 13.2% to $95 million in 2024, with an adjusted operating loss of $43 million, attributed to unfavorable market conditions and increased competition [3] - The synthetic biology segment experienced a revenue growth of 24.6% to $54 million, with a stable adjusted operating profit of $2.1 million [3] - The company expects a revenue growth of 15%-20% in the CDMO business for 2025, driven by new project acquisitions and anticipated upfront payments from partners [3] Financial Forecasts and Valuation - The updated net profit forecasts for 2025 and 2026 are $248 million and $235 million, respectively, with a new estimate for 2027 at $505 million, reflecting the expected ramp-up in production capacity [4] - The earnings per share (EPS) estimates for 2025, 2026, and 2027 are $0.12, $0.11, and $0.23, respectively, with corresponding price-to-earnings (PE) ratios of 14, 15, and 7 [4][5]

[Table_Chart] 行业指数与沪深 300 走势比较 30% -25% -14% -3% 8% 19% 3/24 6/24 9/24 12/24 3/25 基础化工 沪深300 [Table_Author] 分析师：王强峰 D [Table_IndNameRptType] 基础化工 行业周报 合成生物学周报：上海召开合成生物学赋能高质量发 展研讨会，常州发布合成生物学技术需求项目 [Table_IndRank] 行业评级：增持 报告日期： 2025-03-04 执业证书号：S0010522110002 电话：13621792701 邮箱：wangqf@hazq.com 分析师：刘天其 执业证书号：S0010524080003 电话：17321190296 邮箱：liutq@hazq.com 主要观点： [Table_Summary] 华安证券化工团队发表的《合成生物学周报》是一份面向一级市场、 二级市场，汇总国内外合成生物学相关领域企业信息的行业周报。 目前生命科学基础前沿研究持续活跃，生物技术革命浪潮席卷全球并 加速融入经济社会发展，为人类应对生命健康、气候变化、资源能源 安全、粮食安全等重大挑战提 ...