百济神州迎来新的人事调整。 公告显示，汪来自2021年4月起担任公司全球研发负责人。在此之前，自2011年加入公司以来，其担任过多个研发领导职务，职责逐渐扩大加入公司之 前，于2008年至2011年，汪来在位于美国得克萨斯州达拉斯的生物技术公司Joyant Pharmaceuticals担任研究主管。汪来于1996年获得复旦大学理学学士学 位，于2001年获得克萨斯大学圣安东尼奥健康科学中心博士学位。 12月18日晚间，百济神州公告称，公司董事会同意聘任其全球研发负责人汪来担任公司总裁，全球研发负责人。聘任生效后，汪来担任公司总裁，全球研 发负责人职务，负责管理公司研发、业务拓展以及业务联盟关系管理等职能。 在汪来被任命为总裁之前，百济神州总裁一职由吴晓滨担任。但百济神州并未在公告中官宣原任总裁吴晓滨的变动。由此，这一消息一度引发市场产 生"吴晓滨辞去百济神州总裁职务，由汪来接任"的猜想。 对此，百济神州官网12月19日发布消息称，吴晓滨的所有职务与职责保持不变。这也意味着，吴晓滨将继续担任百济神州总裁兼首席运营官，公司迎 来"双总裁"。 资料显示，吴晓滨2018年加入百济神州并担任中国区总经理兼公司总裁。吴 ...

炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 百济神州迎来新的人事调整。 12月18日晚间，百济神州公告称，公司董事会同意聘任其全球研发负责人汪来担任公司总裁，全球研发 负责人。聘任生效后，汪来担任公司总裁，全球研发负责人职务，负责管理公司研发、业务拓展以及业 务联盟关系管理等职能。 公告显示，汪来自2021年4月起担任公司全球研发负责人。在此之前，自2011年加入公司以来，其担任 过多个研发领导职务，职责逐渐扩大加入公司之前，于2008年至2011年，汪来在位于美国得克萨斯州达 拉斯的生物技术公司Joyant Pharmaceuticals担任研究主管。汪来于1996年获得复旦大学理学学士学位， 于2001年获得克萨斯大学圣安东尼奥健康科学中心博士学位。 在汪来被任命为总裁之前，百济神州总裁一职由吴晓滨担任。但百济神州并未在公告中官宣原任总裁吴 晓滨的变动。由此，这一消息一度引发市场产生"吴晓滨辞去百济神州总裁职务，由汪来接任"的猜想。 资料显示，吴晓滨2018年加入百济神州并担任中国区总经理兼公司总裁。吴晓滨于制药行业拥有超过25 年的经验，具有研发、战略、商业化及整体管理方面 ...

Core Insights - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have released the new National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory, set to be implemented nationwide from January 1, 2026 [1][2] Summary by Sections National Medical Insurance Directory - A total of 114 new drugs have been added to the National Medical Insurance Directory, with 111 of them being new products launched within the last five years, representing 97.3% of the new additions [2] - Among the new drugs, 50 are classified as Category 1 innovative drugs, with a success rate of 88%, an increase from 76% in 2024 [2] - The total number of drugs in the directory has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [2] Company Announcements - Several listed companies, including Heng Rui Medicine, Fosun Pharma, and Hai Si Ke, announced new drug inclusions or renewals in the updated National Medical Insurance Directory [3] - Heng Rui Medicine reported that 20 products/indications were included, with significant coverage across various diseases such as tumors and cardiovascular conditions [3][4] - Hai Si Ke's two Category 1 innovative drugs were included, with one being a new addition and the other a renewal [4] Commercial Health Insurance Innovative Drug Directory - The first Commercial Health Insurance Innovative Drug Directory includes 19 new drugs from 18 innovative pharmaceutical companies, with 9 being Category 1 innovative drugs [7] - Notably, five CAR-T products were included, representing over half of the CAR-T products available in China, which previously faced challenges in entering the insurance market due to high pricing [7][8] - The directory also includes treatments for rare diseases and high-profile conditions such as Alzheimer's disease, enhancing the complementarity with the basic medical insurance [7][10] Notable Drug Inclusions - The directory includes drugs for significant diseases such as triple-negative breast cancer and pancreatic cancer, as well as treatments for rare diseases like Gaucher disease [5][9] - In the diabetes sector, several domestic drugs were newly included, such as a long-acting GLP-1 receptor agonist [6] - Companies like Bei Hai Kang Cheng and Bai Ji Shen Zhou have also successfully included their innovative drugs in the Commercial Health Insurance Directory [9]

Core Viewpoint - The sales of Zepzelca in the U.S. have surpassed those of Acala and Ibru, establishing it as the leading product in the BTK inhibitor market, prompting the company to raise its annual revenue guidance [1][4][7]. Sales Performance - In Q2, Zepzelca's sales in the U.S. reached $684 million, while Acala and Ibru generated $583 million and $543 million, respectively, marking year-on-year growth of 43%, 5%, and -9% [1]. - Zepzelca's quarterly sales in the U.S. converted to approximately 5 billion RMB, making it a standout among domestic innovative drugs [1]. - For the first half of the year, Zepzelca's global sales totaled 12.527 billion RMB, with U.S. sales accounting for 8.958 billion RMB, reflecting a year-on-year increase of 56.2% and 51.7%, respectively [9][11]. Revenue Guidance Adjustment - The company has adjusted its revenue guidance for the year from a range of 35.2 billion to 38.1 billion RMB to a new range of 35.8 billion to 38.1 billion RMB, increasing the lower limit by 600 million RMB [4][7]. Profitability - The company achieved its first quarterly profit under GAAP in Q1, with a total revenue of 17.518 billion RMB, a 46% year-on-year increase, and a net profit of 450 million RMB [9]. - The company has shown a significant turnaround in profitability, with a notable increase in sales across various markets [9][10]. Market Expansion - Zepzelca has seen substantial growth in Europe, with sales reaching 1.918 billion RMB, a year-on-year increase of 81.4%, driven by market share gains in major European markets [10]. - The company is also focusing on expanding its product portfolio beyond Zepzelca, with ongoing development of new products such as the BCL2 inhibitor [15][18]. Management Changes - A new regional manager, Sean Shan, is set to join the company, which may influence future domestic and international strategies [16]. Cost Management and Profit Margins - The company has raised its expected gross profit margin to a range of 80% to 90%, indicating anticipated growth in product sales and improved cost control measures [18][19].

Core Insights - Baiyue Shenzhou's bispecific HER2 inhibitor, Zhenidamab (百赫安), received conditional approval from the National Medical Products Administration (NMPA) for treating HER2-positive advanced or metastatic biliary tract cancer (BTC) patients who have previously undergone systemic therapy [1][2] - This approval marks Zhenidamab as the first and only bispecific antibody approved in China for targeted therapy of HER2-positive biliary cancer, providing a new treatment option for patients [1][2] - The incidence of biliary tract cancer is on the rise, with approximately 15% to 30% of BTC patients exhibiting HER2 abnormalities, making HER2 a key target for BTC treatment [1] Clinical Data - The conditional approval is based on the results of the global multicenter clinical study HERIZON-BTC-01, which showed an objective response rate (ORR) of 51.6% in previously treated, unresectable HER2-positive advanced or metastatic BTC patients [2] - The median duration of response (mDoR) was 14.9 months, and the median overall survival (mOS) was 18.1 months, indicating a significant improvement in survival compared to previous second-line chemotherapy options [2] - The safety profile of Zhenidamab was reported to be favorable, demonstrating good overall safety [2] Mechanism of Action - Zhenidamab utilizes a dual-targeting mechanism by binding to two different non-overlapping epitopes of the HER2 protein, enhancing its binding and inhibitory capabilities, which may lead to a synergistic effect in tumor suppression [2] - This innovative mechanism allows for dual signal blockade and the formation of larger receptor clusters, potentially improving therapeutic efficacy [2] Strategic Collaboration - Zhenidamab was developed by Zymeworks, with Baiyue Shenzhou entering a strategic partnership for its development and commercialization in Asia (excluding Japan), Australia, and New Zealand [3] - The drug is also set to be available in the United States, having received FDA approval for the same indication in November 2024 [3] - The President and COO of Baiyue Shenzhou expressed confidence that this innovative drug will significantly benefit the survival of BTC patients in China [3]