D [Table_IndNameRptType] 基础化工 行业周报 合成生物学周报：工信部征集非粮生物基材料案例， 常德市出台全国首部合成生物制造法规 | | | 报告日期： 2025-07-03 [Table_Chart] 行业指数与沪深 300 走势比较 22% 33% -21% -10% 1% 11% 7/24 10/24 1/25 4/25 7/25 基础化工 沪深300 [Table_Author] 分析师：王强峰 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供了崭新的解决方案。国家发改委印发 《"十 ...

Investment Rating - The industry is rated as "Positive" for the next 12 months, indicating an expected increase in performance relative to the CSI 300 index [58][70]. Core Insights - The report highlights the approval of measures by the National Medical Products Administration (NMPA) to support the innovation of high-end medical devices, which is expected to enhance the industry’s growth [16][17]. - The report notes that from January to May 2025, there were 167 million instances of employee medical insurance personal account mutual aid, amounting to 22.026 billion yuan [4][16]. - Dupilumab has received FDA approval for the treatment of bullous pemphigoid, marking a significant advancement in targeted therapies [18]. Industry News - The NMPA has approved measures to optimize the lifecycle regulation supporting high-end medical device innovation, which includes ten specific actions aimed at enhancing the development of innovative medical technologies [16][17]. - The report mentions the upcoming ADA conference, where numerous pharmaceutical companies will showcase their innovative drug research, suggesting potential investment opportunities in related sectors [8][57]. - The report emphasizes the ongoing optimization of centralized procurement policies, which is expected to mitigate negative impacts on the industry and improve performance in related sectors [8][57]. Market Performance - The report indicates that during the week of June 20-26, 2025, the Shanghai Composite Index rose by 2.57%, while the pharmaceutical and biological sector increased by 1.34%, with all sub-sectors showing positive growth [6][47]. - As of June 26, 2025, the price-to-earnings ratio (TTM) for the pharmaceutical and biological industry was 27.45, with a valuation premium of 138% compared to the CSI 300 index [51][58]. Company Announcements - Kintor Pharmaceutical announced that the NMPA has accepted the new drug application for Shurike Aolun's injection for the treatment of advanced gastric/esophageal junction adenocarcinoma [27]. - HBM7020, developed by Hengrui Medicine, has entered a global strategic cooperation agreement with Otsuka Pharmaceutical for the treatment of autoimmune diseases [28][32]. - The report also highlights various collaborations and licensing agreements among companies, indicating a trend towards strategic partnerships in the industry [33][34][35].

6 月 25 日，港股创新药企科济药业（ 02171.HK ）宣布，已正式向中国国家药品监督管理局药品审评 中心提交舒瑞基奥仑赛注射液的新药上市申请（ NDA ）。 6 月 26 日，药品审评中心网站公示受理了该 产品的 NDA 。 这意味着，这家中国的创新药企业，在全球范围内实现了一项引领性的突破 ——将 CAR-T 细胞疗法从 血液肿瘤，拓展到了实体肿瘤领域。 事实上，从去年三季度以来， CAR-T 疗法领头企业科济药业的股价已经一路狂飙，从最低谷的 2.48 元 飙升了近 10 倍，涨到了当下的 25 元附近。 值得一提的是，这样的上涨并非由眼下大热的 BD 逻辑带动，而是真正由研发驱动带来的价值回升。舒瑞 基奥仑赛的成功，意味着这款 CAR-T 将成为全球范围内的独家产品。在这款产品的推动下，科济药业将 迈向 Biopharma 的进阶之路。 全球首款 CAR-T 细胞疗法在实体肿瘤领域实现突破 "死磕"实体瘤领域多年，科济药业终于在 2025 年上半年快要收尾之际迎来曙光。 6 月 25 日，科济药业宣布，旗下 CAR-T 细胞产品舒瑞基奥仑赛注射液（ CT041 ）的新药上市申请（ NDA ）已正 ...

证 券 研 究 报 告 行业周报 重估延续，趋势分化 分析师：胡博新 SAC编号：S1050522120002 分析师：吴景欢 SAC编号：S1050523070004 医 药 行 业 观 点 1. 重磅交易落地持续推升创新价值，未来将逐步分化 创新出海是本轮创新药价值重估的重要推动因素，其价值的锚点在于BD估值水平的变化，尤其是EGFR/PD-1为代表的双抗。 从康方生物与SUMMIT THERAPEUTICS 的合作开始到6月2日，BMS与BioNTech达成一项超90亿美元的交易，海外MNC 对EGFR/PD-1的价值认知和交易金额的快速提高。国内BD单个项目金额也显著提升，多个重磅交易落地，根据医药魔方数 据，2025年Q1，中国医药交易数量同比增加34%，而交易总金额同比增加222%。创新价值重估的过程也从biotech公司延 伸至三生制药、石药集团等Pharm一类公司，以及更多的转型创新公司。中国创新药的研发效率优势，以及不断更新的研 发管线，海外MNC面临的专利悬崖问题，我们认为未来创新药出海的趋势将持续强化，并支撑创新药的整体估值。从细分 方向上看，除肿瘤和自免等MNC聚焦的治疗领域之外，国内 ...

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].

医 药 行 业 观 点 证 券 研 究 报 告 行业周报 创新价值重估，重视转型类公司 医药行业周报 | 投资评级： | 推荐 （ 维持 | ） | | --- | --- | --- | | 报告日期： | 2025年06月03日 | | 分析师：胡博新 SAC编号：S1050522120002 分析师：吴景欢 SAC编号：S1050523070004 美国东部时间5月30日~6月3日，2025 年美国临床肿瘤学会（ASCO）年会在芝加哥隆重召开，数据显示，有34项中国研 究入选口头报告，32项中国研究入选快速口头报告，8项中国研究入选临床科学研讨会。不仅海外MNC、中国的制药企业 均将ADC、双抗和三抗作为报告的主要重点。三抗方面，泽景制药发布ZG006（CD3/DLL3/DLL3 三抗）单药治疗晚期小细 胞肺癌的 II 期剂量扩展研究，根据公布结果，ORR 为 66.7%，DCR 为 88.9%。10 mg 组的 ORR 为 62.5%，DCR 为 70.8%；30 mg 组的 ORR 为 58.3%，DCR 为 66.7%。会上，中国生物制药公布了贝莫苏拜单抗联合安罗替尼对比帕博利 珠单抗用于PD-L ...

Core Viewpoint - The company Kogei Pharmaceutical-B (02171.HK) announced that its CAR-T cell therapy candidate, Shurijiaolun Sai Injection (CT041), has been prioritized for review by the National Medical Products Administration for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma patients who have failed at least two lines of treatment [1][2]. Group 1 - Shurijiaolun Sai Injection is a potentially first-in-class CAR-T cell therapy targeting Claudin18.2 protein, primarily for advanced gastric/esophagogastric junction adenocarcinoma and pancreatic cancer [2]. - Ongoing clinical trials include a researcher-initiated trial in China (CT041-CG4006, NCT03874897), a confirmatory Phase II trial for advanced gastric/esophagogastric junction adenocarcinoma (CT041-ST-01, NCT04581473), a Phase Ib trial for pancreatic cancer (CT041-ST-05, NCT05911217), and a post-operative consolidation therapy trial (CT041-CG4010, NCT06857786) [2]. - In March 2025, the injection received breakthrough therapy designation from the National Medical Products Administration in China for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma after at least two lines of treatment failure [2]. Group 2 - In January 2022, the injection was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in the United States for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma [2]. - In September 2020, the injection received Orphan Drug designation from the FDA for treating gastric/esophagogastric junction adenocarcinoma [2].

Core Viewpoint - The announcement by Kintor Pharmaceutical regarding the clinical trial results of Shu Rui Ji Ao Lun Sai injection (CT041) for advanced gastric and gastroesophageal junction adenocarcinoma has been accepted for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] Group 1: Product Overview - Shu Rui Ji Ao Lun Sai injection is a potential first-in-class autologous CAR-T cell therapy targeting Claudin18.2 protein, primarily for treating Claudin18.2 positive solid tumors, including gastric and gastroesophageal junction adenocarcinoma, as well as pancreatic cancer [2] - The ongoing trials include multiple studies in China, such as a confirmatory Phase II trial for advanced gastric/gastroesophageal junction adenocarcinoma (CT041-ST-01) and a Phase I trial for pancreatic cancer (CT041-ST-05) [2] Group 2: Regulatory Designations - In February 2025, Shu Rui Ji Ao Lun Sai injection received breakthrough therapy designation from the National Medical Products Administration of China for advanced gastric/gastroesophageal junction adenocarcinoma that has failed at least two lines of prior treatment [2] - In January 2022, the product was granted "Regenerative Medicine Advanced Therapy" designation by the FDA for treating advanced gastric/gastroesophageal junction adenocarcinoma [2] - In 2020, it was designated as an "orphan drug" by the FDA for the same indications [2]

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [2]. Core Views - The report highlights that the Chinese innovative drug sector is expected to experience new growth logic due to internal and external policy catalysts, suggesting a focus on undervalued small-cap pharmaceutical stocks [5][6]. Summary by Sections 1. Innovative Drugs and Industry Chain - **Sangfor Pharmaceutical**: Core products show steady growth, with innovative pipelines gradually yielding results. The PD-1/VEGF dual antibody AK112 has become the first to defeat K drug in head-to-head Phase III trials, enhancing the development heat for PD(L)-1/VEGF dual antibodies [10][11]. - **Kojin Pharmaceutical**: The CAR-T therapy shows significant potential, with its first product, CT053, approved for multiple myeloma treatment. Another product, CT041, is expected to submit NDA in mid-2025 [12][13]. - **Hotgen Biotech**: The SGC001 drug for acute myocardial infarction is progressing through clinical trials, with promising preclinical data indicating significant therapeutic effects [20][21]. - **Kangfang Biotech**: The company is advancing its IO+ADC strategy, with two dual antibodies already approved. It is collaborating with Pfizer to explore combination therapies for various solid tumors [30][34]. - **Kolin Biotech**: The company is expanding its international clinical trials with Merck, focusing on multiple cancer types [36][40]. 2. Market Performance Review - The pharmaceutical sector index fell by 2.7% from February 24 to February 28, 2025, underperforming the CSI 300 index by 0.5%. However, year-to-date, the sector has risen by 1.1%, outperforming the CSI 300 by 2.3% [43][44]. 3. Investment Strategy and Focus - The report suggests focusing on four main investment lines: 1) Oversold blue-chip stocks and Hong Kong stocks, 2) Companies with positive short-term changes and low price-to-book ratios, 3) Firms with solid fundamentals, and 4) Companies expected to show high growth in H2 2024 [7][8]. - Recommended stocks include Kangfang Biotech, Zai Lab, Kolin Biotech, and others [7]. 4. Industry Outlook - The report anticipates a recovery in the demand for innovative drugs, driven by supportive government policies and increased investment in the biotech sector. This recovery is expected to benefit upstream companies and CRO services [42].