每经记者｜金喆 每经编辑｜魏官红 如果一个靶点历经三十年才有一款药物成功上市，其成药难度之高，不言而喻。 "研究这样的靶点如同攀登珠穆朗玛峰。"亚盛医药董事长、CEO（首席执行官）杨大俊在接受《每日经济新闻》记者采访时说。他和搭档王少萌从1995年 开始研究Bcl-2靶点，在2004年筛选出化合物进入临床研究后，一做就是21年。今年7月，亚盛医药的利沙托克拉（利生妥）获得国家药品监督管理局附条 件批准上市，成为国产原研首家、全球第2款Bcl-2抑制剂，打破了艾伯维在这一领域长达9年的垄断。 Bcl-2靶点早在上世纪80年代就被发现，直到2025年，杨大俊的团队终于针对该靶点获得成功，而亚盛医药另一款产品奥雷巴替尼片（商品名：耐立 克），研发历程也长达13年。 杨大俊觉得，做药就是这样，找最难的靶点、做最好的临床设计、让药物效果发挥到极致，才能在同类药物竞争中胜出。 "me-too也好、快速跟进也好、生物类似药也好，我一直说我们不做这类创新。这些在研发阶段的风险比较小，但上市后的商业化风险更大，那时候（失 败的）成本更高。"杨大俊认为，在信息发达的今天已经很难有"唯一、独一、缺一不可"的品种，不管在什么样的阶段 ...

2025 年 7 月 21 日 证券研究报告 行业周报 行业评级： | 报告期：2025.7.7-2025.7.20 | | | --- | --- | | 投资评级 | 看好 | | 评级变动 | 维持评级 | 行业走势： 分析师： huchenxi@gwgsc.com 执业证书编号：S0200518090001 联系电话：010-68085205 分析师 魏钰琪 weiyuqi@gwgsc.com 执业证书编号：S0200525060001 联系电话：010-68099389 2 号院 1 号楼中国长城资产大厦 16 层 医药生物行业双周报 2025 年第 15 期总第 138 期 《2024 年全国医疗保障事业发展统计公报》发布 第十一批集采规则优化 行业回顾 本报告期医药生物行业指数涨幅为 5.89%，在申万 31 个一级行业中 位居第 3，跑赢沪深 300 指数（1.92%）。从子行业来看，医疗研发 外包、化学制剂涨幅居前，涨幅分别为 13.94%、8.43%；线下药店跌 幅居前，跌幅为 3.91%。 估值方面，截至 2025 年 7 月 18 日，医药生物行业 PE（TTM 整体法， 剔除负值）为 ...

Core Insights - A Chinese original drug, APG-2575 (brand name: Lisatoclax), has broken the nearly decade-long monopoly of multinational pharmaceutical companies in the global anti-cancer drug market, marking a significant shift in the competitive landscape [2][9] - The drug has received conditional approval from the National Medical Products Administration (NMPA) in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have undergone at least one systemic treatment including a BTK inhibitor [2][5] Drug Development Challenges - The Bcl-2 target, discovered in 1985, has only two approved drugs: AbbVie's venetoclax and APG-2575, due to the high difficulty of drug development associated with protein-protein interactions and the need for drugs to penetrate cell membranes and mitochondrial membranes [3][4] - Major pharmaceutical companies have attempted to develop Bcl-2 inhibitors over the past 20 years without success, highlighting the complexity of this target [4] Market Potential - The global targeted apoptosis therapy market is projected to grow at a compound annual growth rate (CAGR) of 24% from 2023 to 2030, reaching a market size of $22 billion by 2030 [6] - The approval of Lisatoclax is expected to change treatment paradigms and expand the market for Bcl-2 inhibitors, especially in combination therapies [6] Commercialization Strategy - The company plans to independently drive the commercialization of Lisatoclax in China, aiming to explore additional indications beyond CLL/SLL [7][8] - The CEO emphasizes the importance of generating profits from product sales to support ongoing research and development, aiming for the company to achieve overall profitability by 2027 [8] Industry Trends - Following the success of APG-2575, other Chinese companies like BeiGene and Innovent Biologics are also developing Bcl-2 inhibitors, indicating a shift towards a new ecosystem of anti-cancer drugs led by Chinese enterprises [9]

腾盛博药-B(02137)再涨超6%，近期向健康元集团授予新药BRII-693大中华区独家许可。 智通财经APP获悉，港股恒生指数涨0.07%，涨17点，报24534点；恒生科技指数涨0.29%。港股早盘成 交1287亿港元。 创新药概念再度走强，政策利好及BD预期双轮驱动，机构称板块当前估值仍具吸引力。恒生生物科技 指数继续大涨4.41%。成份股中，乐普生物-B（02157）涨超13%；康方生物（09926）涨10.16%；康若 亚-B（02162）涨12.4%；三生制药（01530）涨8.94%。 复旦张江(01349)涨23.9%，ADC平台研发进展顺利，光动力平台项目加速进行。 金斯瑞生物科技(01548)涨超6%，第二季CARVYKTI销售额同比增长约1.36倍。 亚盛医药-B(06855)再涨4.87%，近期配股净筹超14.9亿港元，利沙托克拉新药上市申请获批。 大麦娱乐(01060)再涨7.27%，公司成为苏超球赛官方渠道，关注体育票务增量。 哔哩哔哩-W(09626)涨超4%，游戏及广告业务增量体现，美银上调公司目标价。 粉笔(02469)再涨超14%，AI刷题班3.0发布，机构指其渗透率提升 ...

□ 本报记者 杨 彦 2025年，江苏在生物医药产业与医疗器械领域捷报频传。苏州、无锡、南京等地企业研发的多个"全球 首个""国内首创"产品相继获批上市，为重大疾病治疗提供新的解决方案与选择。创新药械上市"加速 度"的背后，是江苏各级药品监管部门着力打造"政策高地""质量高地""发展高地"，以精准帮扶不断提 升创新药械产业的整体实力，朝着打造医药产业高地的目标稳步迈进的"久久为功"。 □ 本报记者 杨 彦 从"国内首个"到"全球首创"，江苏捷报频传 2024年，全省共获批上市药品352个，创新药13个、占全国总数27.08%，第三类医疗器械490个，批准 第二类医疗器械1921个，进入创新医疗（002173）器械特别审查通道产品19个，均居全国第一。 新一年，创新药械上市的速度还在被刷新。 5月29日，国家药监局官宣发布批准11款创新药上市，其中江苏获批5款创新药，4款与肿瘤相关。 在同一天5款药品获批后，7月份好消息接踵而至。苏州亚盛药业有限公司自主研发的利沙托克拉片与苏 州旺山旺水生物医药股份有限公司自主研发的盐酸司美那非片，获得国家药监局批准上市。前者是国内 首个获批的BCL-2抑制剂，填补了慢性淋巴细 ...

Core Insights - The approval of innovative drugs is a significant indicator of the new productive forces in the biopharmaceutical industry, with Suzhou Industrial Park accounting for approximately 20% of the new innovative drugs approved in China this year [1][3]. Group 1: Drug Approvals - As of July 10, 2023, Ascentage Pharma's new Bcl-2 selective inhibitor, Lisatoclax, received approval for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have undergone prior systemic therapy [1]. - On July 8, 2023, Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. and the Shanghai Institute of Materia Medica collaborated to launch a new drug, Semaglutide, for the treatment of erectile dysfunction [1]. - On June 27, 2023, Innovent Biologics' injection, Ma Shidu, was approved for long-term weight management in adults with obesity or overweight, being the first dual receptor agonist for weight loss globally [1]. - On May 29, 2023, the injection of Trastuzumab deruxtecan was approved for treating adult patients with HER2-mutant non-small cell lung cancer who have received prior systemic therapy, marking it as the first antibody-drug conjugate for this indication in China [2]. - On the same day, BeiGene's bispecific antibody, Zhenidamab, was approved for patients with HER2-positive advanced biliary tract cancer, providing a new treatment option [2]. - On January 10, 2023, the approval of the long-acting PCSK9 monoclonal antibody, Rucaparib, was granted for treating high cholesterol levels [2]. Group 2: Industry Development - Since 2006, Suzhou Industrial Park has focused on the biopharmaceutical and health industry, attracting over 2,000 related enterprises, with a projected output value of 165.5 billion yuan by 2024 [3]. - The park has implemented a targeted investment strategy, introducing approximately 300 biopharmaceutical and health projects annually over the past three years [3]. - In May 2023, Suzhou Industrial Park announced an action plan to accelerate the growth of the biopharmaceutical and health industry, aiming to develop over five leading enterprises with international competitiveness and achieve significant sales milestones by 2027 [3].

编辑人 崔健 022-28451618 SAC NO：S1150511010016 cuijian@bhzq.com 渤海证券研究所晨会纪要（2025.07.14） 宏观及策略研究 外部"反关税"，内部"反内卷"——宏观经济周报 固定收益研究 晨会纪要（2025/07/14） 半年报预告密集披露，关注业绩表现——医药生物行业周报 证 券 研 究 报 告 晨 会 纪 要 请务必阅读正文之后的声明 渤海证券股份有限公司具备证券投资咨询业务资格 1 of 6 晨会纪要（2025/07/14） 宏观及策略研究 外部"反关税"，内部"反内卷"——宏观经济周报 利率小幅上行，曲线整体走平——利率债周报 行业研究 周 喜（证券分析师，SAC NO：S1150511010017） 宋亦威（证券分析师，SAC NO：S1150514080001） 严佩佩（证券分析师，SAC NO：S1150520110001） 靳沛芃（研究助理，SAC NO：S1150124030005） 1、外围环境而言 美国方面，截至 7 月 4 日的周度初请失业金人数意外降至 6 月份以来最低水平，暗示美国就业市场整体仍 具韧性。另外，在"对等关税"暂 ...

Investment Rating - The report indicates a positive outlook for the pharmaceutical and biotechnology sector, with a focus on innovative drug companies [2][3]. Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.82%, outperforming the CSI 300 index (0.82%) and the Wind All A index (1.71%). The market is currently focused on the expectations surrounding semi-annual reports and business development (BD) activities [8][9]. - The launch of the 2025 National Basic Medical Insurance and Commercial Health Insurance innovative drug directory is a significant development. This directory will include high-innovation drugs that provide substantial clinical value and patient benefits, which are not covered by basic medical insurance but recommended for commercial health insurance [3][13]. - The report highlights the importance of the commercial health insurance sector in the payment for innovative drugs, suggesting that the accessibility of high-priced innovative drugs is expected to improve, particularly in the areas of cell and gene therapy [3][13]. Market Weekly Review - The medical research outsourcing sector led the gains with a 9.29% increase, primarily driven by WuXi AppTec's positive semi-annual report announcement. Conversely, offline pharmacies and other biological products experienced declines of -1.29% and -1.55%, respectively [8][9]. - Notable stock performances included Frontier Biotech-U (41.4%), Mediso (38.9%), and Lianhuan Pharmaceutical (38.6%) leading the gains, while ST Unimed (-18.5%), Shenzhou Cell-U (-13.4%), and Shutai Shen (-11.6%) faced significant losses [11][12]. Industry News and Key Company Announcements - The report outlines several key industry events, including the approval of innovative drugs and strategic partnerships among major pharmaceutical companies, which are expected to enhance their market positions and product offerings [13][16][17]. - The report also mentions significant financial forecasts from various companies, indicating strong growth potential in the sector, with some companies projecting net profit increases of over 100% year-on-year [17][18].

Investment Rating - The report indicates a positive investment outlook for the hereditary angioedema (HAE) treatment sector, particularly following the approval of the first oral on-demand treatment, sebetralstat [14][21]. Core Insights - The report highlights the urgent need for effective HAE treatments due to the high risk of life-threatening episodes, with nearly half of HAE patients facing potential asphyxiation [10][16]. - Sebetralstat, approved by the FDA, is noted for its rapid onset of action, achieving near-complete inhibition of plasma kallikrein within 15 minutes of administration [21]. - The KONFIDENT trial results demonstrate that sebetralstat significantly reduces symptom relief time compared to placebo, with median relief times of 1.61 hours for the 300 mg dose and 1.79 hours for the 600 mg dose [20][21]. Summary by Sections Section 1: HAE Overview - HAE is characterized by recurrent episodes of angioedema without urticaria, with a prevalence of approximately 1.5 per 100,000 individuals [7]. - The disease can lead to severe complications, including laryngeal edema, which has a mortality rate of up to 40% among patients [7][10]. Section 2: Current Treatment Landscape - Existing treatments include long-term preventive therapies (LTP) and on-demand treatments for acute episodes [10][11]. - The global HAE drug market reached $2.9 billion in 2022, with $2 billion attributed to long-term prevention and $900 million to acute on-demand treatments [13]. Section 3: Sebetralstat Approval and Efficacy - Sebetralstat is the first oral on-demand treatment for HAE, approved on July 7, 2025, and is expected to address unmet needs in the treatment landscape [21]. - The KONFIDENT trial, involving 136 patients across 20 countries, confirmed the efficacy and safety of sebetralstat, showing significant improvements in symptom relief and severity reduction compared to placebo [21]. Section 4: Future Developments - Pharvaris is developing deucrictibant, a competitive oral antagonist for HAE, with promising Phase II trial results indicating effective management of HAE attacks [26]. - The report anticipates further advancements in HAE treatments, with ongoing clinical trials expected to yield additional data in the coming years [26].

Investment Rating - The report maintains a "Buy" rating for the pharmaceutical and biotechnology sector, specifically recommending stocks such as WuXi AppTec and AopuMai [1]. Core Insights - The CXO and research service sectors are experiencing a recovery in market sentiment, with significant performance improvements noted in companies like WuXi AppTec and BoTeng [1][4]. - The A-share pharmaceutical index has shown a year-to-date increase of 12%, outperforming the CSI 300 index by 10% [4][9]. - The report highlights a notable performance in the CXO and research service sectors, driven by a significant uptick in orders and positive earnings forecasts for Q2 [15][22]. Summary by Sections Industry Trends - The report indicates a positive trend in the investment climate for innovative drugs, with a notable increase in the number of new drug development pipelines in China, surpassing global averages [15][16]. - The easing of U.S. monetary policy is expected to enhance the financing environment for pharmaceutical investments, contributing to a recovery in the sector [15][16]. Performance Metrics - The report details that WuXi AppTec's order backlog grew by 47.1% year-on-year, indicating strong demand and operational stability [21]. - Other companies like KaiLong and BoTeng also reported significant increases in their order volumes, with KaiLong's new orders growing by over 20% [21][22]. Stock Recommendations - The report ranks sub-sectors in the following order of preference: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10]. - Specific stock recommendations include WuXi AppTec, AopuMai, and BaiPuSaiSi for their strong growth potential and market positioning [10][11].