Group 1 - The core viewpoint of the article highlights significant financial projections and strategic developments within the biopharmaceutical industry, particularly focusing on companies like Shengnuo Bio, Shanghai Laishi, and Beijing Saiseng Pharmaceutical [1] Group 2 - Shengnuo Bio anticipates a substantial increase in net profit for the first half of 2025, projecting between 77.03 million to 94.14 million yuan, representing a year-on-year increase of 253.54% to 332.10% [1] - Shanghai Laishi has announced a 4.2 billion yuan acquisition of 100% equity in Nanyue Bio, with potential additional payments based on the company's plasma collection volume, indicating a strategic move to enhance its "plasma" strategy [1] - Beijing Saiseng Pharmaceutical signed a technology transfer contract with its affiliate, Beijing BGI Protein Research Center, for the NeoAB33 new drug project, which may optimize asset structure and support further R&D funding [1] Group 3 - The CDE has accepted the application for the new indication of Eli Lilly's Pirtobrutinib tablets, which is expected to strengthen its market position in the treatment of B-cell malignancies [1] - Innovent Biologics' CLDN-18.2 ADC product IBI343 is proposed to be included as a breakthrough therapy for advanced or metastatic pancreatic cancer, marking a significant advancement in treatment options for this indication [1]

｜2025年6月20日 星期五｜ NO.1 圣诺生物上半年归母净利润预增253.54%至332.10% 6月19日晚间，圣诺生物发布公告称，经财务部门初步测算，预计2025年半年度实现归属于母公司所有 者的净利润7702.75万元至9414.48万元，与上年同期相比，增加5523.99万元至7235.71万元，同比增加 253.54%至332.10%。 每经记者｜陈星 每经编辑｜张益铭 北京赛升药业股份有限公司与参股公司北京华大蛋白质研发中心有限公司签署《新药技术转让合同》， 华大蛋白将其拥有的NeoAB33新药项目相关技术转让给公司，交易总额为2000万元。 点评：华大蛋白2024年亏损830万元，此次转让或优化其资产结构。而赛升药业2025年一季度净利润达 3997万元，具备资金实力推进研发。 NO.4 礼来可逆BTK抑制剂新适应证国内申报上市 CDE官网显示，礼来匹妥布替尼片新适应证上市申请获受理。根据临床试验进展，Insight数据库推测该 药物用于治疗既往接受过BTK抑制剂（布鲁顿氏酪氨酸激酶）治疗的慢性淋巴细胞白血病/小淋巴细胞 淋巴瘤。 点评：匹妥布替尼是全球首个非共价BTK抑制剂，为共价BTK ...

南昌大学第一附属医院血液病诊治中心主任医师李菲教授对第一财经记者表示，中国慢淋白血病患者发 病的中位年龄为65岁，中国老年人口基数扩大将直接推高患病率，与欧美国家相比，中国慢淋白血病发 病率较低但增速更快，预计未来10年患者总数将以年均10%以上的速度在增长。 慢淋白血病是一种具有特定免疫表型特征的成熟B淋巴细胞克隆增殖性肿瘤，以淋巴细胞在外周血、骨 髓、脾脏和淋巴结聚集为特征。 在李菲看来，慢淋白血病诊疗目前面临多重挑战，包括优质医疗资源集中于大城市，基层诊疗能力薄 弱，诊疗缺乏标准化；老年患者合并症多，缺乏长期的疾病管理和更安全的治疗药物。 大多数慢淋白血病患者年龄较高，化疗对于这类患者的身体状况是一大考验。 慢性淋巴细胞白血病（CLL，下称"慢淋白血病"）是老年人常见的血液肿瘤之一，随着中国人口老龄化 进程加快，这类患者数量在增长，传统的治疗方案涉及化疗，副作用大且易复发。 今年以来，有两款小分子靶向药，即BTK抑制剂相继获批用于慢淋白血病一线治疗，其中一款是近期刚 刚获批的，即诺诚健华的奥布替尼。 截至目前，国内已有5款BTK抑制剂获批上市，包括三款进口药物，即礼来的匹妥布替尼、阿斯利康的 阿可替尼、 ...

Core Insights - The approval of multiple BTK inhibitors in China is transforming the treatment landscape for Chronic Lymphocytic Leukemia (CLL) and B-cell lymphomas, with a notable shift towards second-generation BTK inhibitors [1][3][4] Group 1: Market Overview - As of now, five BTK inhibitors have been approved in China, including three imported drugs and two domestic drugs, with the first-generation inhibitor ibrutinib and three second-generation inhibitors [3] - The global incidence of CLL is significant, with 191,000 new cases and 61,000 deaths annually, primarily affecting elderly patients with a median age of 65 in China [2] Group 2: Treatment Efficacy and Safety - The five-year survival rate for CLL patients is high, ranging from 80% to 90%, with low-risk patients having a median survival of nearly 20 years [2] - Newer BTK inhibitors demonstrate improved safety profiles compared to first-generation inhibitors, which have seen a decline in global recommendation levels due to safety concerns [3][4] Group 3: Future Directions - The development of BCL2 inhibitors is underway, with ongoing clinical trials combining these with BTK inhibitors, indicating a potential new direction for CLL treatment [5] - The increasing elderly population in China presents challenges for long-term management of CLL patients, necessitating systematic approaches to address treatment adherence and adverse effects [5]

医药 本周医药板块上涨 1.27%，百济 BTK PROTAC 启动头对头 3 期临 床 证券研究报告 | 行业周报 2025 年 05 月 19 日 | 股票 | 股票 | 投资 | EPS （元） | | PE | | | --- | --- | --- | --- | --- | --- | --- | | 代码 | 名称 | 评级 | 2025E | 2026E | 2025E | 2026E | | 002755.SZ | 奥赛康 | 买入 | 0.2 | 0.28 | 87.7 | 62.64 | | 01952.HK | 云顶新耀 | 买入 | -0.94 | 0.58 | - | - | | 600079.SH | 人福医药 | 增持 | 1.59 | 1.86 | 12.83 | 10.97 | | 688192.SH | 迪哲医药 | 增持 | -1.33 | -0.08 | - | - | | 688315.SH | 诺禾致源 | 买入 | 0.53 | 0.62 | 26.51 | 22.66 | | 688321.SH | 微芯生物 | 增持 | 0.05 | 0.23 | 349. ...

证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 2025 年 05 月 18 日 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 三抗药物研发进入快车道，建议关注泽璟制 药、三生制药等 增持（维持） [Table_Tag] [Table_Summary] 投资要点 ◼ 全球首个:艾伯维 c-Met ADC 获批上市；百济神州启动 BGB-16673 vs Pirtobrutinib 头对头 I 期研究：5 月 14 日，艾伯维宣布 FDA 已批准 c- Met 靶向 ADC 药物 telisotuzumab vedotin（Teliso-V，ABBV-399）的生 物制品许可申请（BLA），用于治疗既往接受过治疗的 c-Met 蛋白过表 达、表皮生长因子受体（EGFR）野生型晚期/转移性非鳞状非小细胞肺 癌（NSCLC）成人患者。该药物是 c-Met 赛道首款获批上市的 ADC 产 品，也是艾伯维首款自研 ADC 产品。5 月 15 日，全球临床试验收录网 站 显 示 ， 百 济 神 州 启 动 了 BGB-16673 （ catadegbrutin ...

作为百济神州收入最高的自研产品，BTK抑制剂百悦泽2024年以26亿美元的销售额，位居全球抗肿瘤药 物销售排名第20位，跻身"全球大药"之一。2025年第一季度，这款产品全球销售额达到56.92亿元，同 比增长63.7%。美国市场方面，百悦泽一季度的销售额达40.41亿元，同比增长61.9%。财报显示，百悦 泽在本季度首次位居美国BTK抑制剂领域市场份额首位。 作为公司收入第二高的自研产品，PD-1单抗百泽安（替雷利珠单抗）销售额为12.45亿元，同比增长 19.3%，主要得益于在中国获批新适应证纳入医保所带来的新增患者需求以及药品进院数量的增加。目 前，百泽安在中国获批14项适应证，其中有13项适应证已纳入国家医保目录。 百济神表示，公司维持2025年财务指引不变，2025年全年营业收入预计将介于人民币352亿元至381亿元 之间，同时，公司重申预计经营利润为正且经营活动产生现金流为正。 美股财报显示，在美国通用会计准则（GAAP）下，百济神州首次实现季度盈利，GAAP净利润为127万 美元。 今年以来，百济神州（ONC.NS、06160.HK、688235.SH）美股、港股、A股三地的股价累计涨幅均超 过 ...

Group 1 - The National Internet Information Office and six other departments have jointly issued the "Regulations on the Management of Direct Satellite Services for Terminal Equipment," effective from June 1, 2025, which governs the provision and use of direct satellite services within China [1] - China's low-orbit satellite constellation, Qianfan, has successfully completed five batches of satellite launches, with over 600 satellites ordered, amounting to approximately 4.5 billion RMB, and plans to deliver over 200 satellites by 2025 [1] Group 2 - MGM China reported total revenue of 7.994 billion HKD for Q1 2025, a decrease of 3.2% year-on-year, with adjusted EBITDA of 2.368 billion HKD, down 5.46% [6] - China Hongqiao reported a net profit of 6.357 billion RMB for Q1 2025, representing a year-on-year increase of 46.46%, with total revenue of 40.173 billion RMB, up 15.56% [10] Group 3 - NIO delivered 23,900 vehicles in April, a year-on-year increase of 53%, while Li Auto delivered 33,939 vehicles, up 31.6% [7] - BYD's total sales of new energy vehicles reached approximately 1.3809 million units in the first four months of 2025, reflecting a year-on-year growth of 46.98% [7] Group 4 - Xinda Biopharmaceuticals reported total product revenue exceeding 2.4 billion RMB in Q1 2025, maintaining a strong year-on-year growth of over 40%, with four new drugs launched during the quarter [9] - Hansoh Pharmaceutical's HS-20089 has been approved as a breakthrough therapy for platinum-resistant recurrent epithelial ovarian cancer by the National Medical Products Administration [8]