创新药已经突围成功。 "十五五"规划开局之年，医药行业在2026年将呈现创新药爆发、CXO回暖、中药转型、药店收缩、医院 洗牌、并购潮涌的总体格局，行业分化加剧，强者恒强。 创新药：20款重磅新药有望获批 在2025年，共有76个创新药物成功获批上市，数量较上年增长58%。与此同时，创新药对外授权交易活 跃，交易数量突破150起，累计交易总额更是高达1300亿美元以上，彰显了我国创新药产业的强劲发展 势头。 西部证券指出，2026年创新药行情将从"BD为王"转向"数据为王"，全球多中心临床试验数据读出将成 为核心催化。 随着临床数据和上市审批的加速，2026年，中国创新药出海会迎来爆发期。业内预测，2026年将有约20 款重磅新药有望在中国获批上市，涵盖肿瘤、感染性疾病、罕见病、自身免疫性疾病、神经系统疾病等 多个治疗领域。比如，BL-B01D1是百利天恒自主研发的全球首创EGFR×HER3双抗ADC，用于治疗复 发性或转移性食管鳞癌。作为全球首个被纳入优先审评的EGFR×HER3双抗ADC，它填补了PD-1/PD-L1 联合化疗失败患者的治疗空白。此外，BL-B01D1的鼻咽癌适应症也已获优先审评，预计20 ...

Core Viewpoint - The approval of the BCL-2 inhibitor Sotorakra by BeiGene marks a significant advancement in the treatment of hematologic malignancies, with potential implications for the competitive landscape of BCL-2 inhibitors in the market [1][3]. Company Developments - BeiGene's Sotorakra has received approval for two indications: treatment of adult patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL) [1]. - The approval came just eight months after the new drug application was accepted by the NMPA, indicating a rapid development timeline [1]. - Sotorakra is positioned as a next-generation BCL-2 inhibitor, designed to block the BCL-2 protein that aids tumor cell survival, and has shown strong efficacy and specificity in clinical trials [1][2]. Clinical Trial Results - Early clinical trials of Sotorakra combined with Zebutini have demonstrated unprecedented rates of undetectable minimal residual disease in treatment-naive CLL patients [2]. - Recent data from five clinical studies indicate significant clinical benefits for Sotorakra, suggesting its potential as a cornerstone therapy for various B-cell malignancies [2]. Market Landscape - The global BCL-2 inhibitor market is projected to reach $5.2 billion by 2028, with the Chinese market expected to reach 1.4 billion yuan [5]. - The approval of Sotorakra follows the approval of another BCL-2 inhibitor, Lisatoclax, from Ascentage Pharma, indicating a growing presence of Chinese companies in the BCL-2 space [3][5]. - The competitive landscape is intensifying as multiple Chinese pharmaceutical companies, including Innovent Biologics and Zai Lab, are developing BCL-2 inhibitors [3][4]. Financial Performance - BeiGene's Zebutini has become a significant revenue driver, with global sales reaching $1.3 billion in 2023, marking a 129% year-over-year increase [6]. - In the first half of 2025, BeiGene reported a revenue of 17.52 billion yuan, a 46% increase year-over-year, largely driven by Zebutini sales [6][7]. - The company is under pressure to identify the next blockbuster product as Zebutini's growth may slow down in the future [7].

12月18日晚间，百济神州有限公司（688235.SH、06160.HK）发布《关于聘任公司高级管理人员的公 告》，引发市场猜想。 根据公告，12月17日，经百济神州有限公司董事会审议通过，公司董事会同意聘任公司全球研发负责人 汪来担任公司总裁、全球研发负责人，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。 公开资料显示，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。百济神州并未在公告中官 宣原任总裁吴晓滨的变动。此前数年，吴晓滨一直是百济神州的核心人物，2025年6月以前，其同时担 任公司总裁、首席运营官兼中国区总经理。 12月19日，智通财经从百济神州获悉，吴晓滨职务并未发生变化，依旧任公司总裁兼首席运营官。 据百济神州11月12日晚间发布的2025年三季报，第三季度实现营收为100.77亿元，同比增长41.1%；净 利润为6.89亿元，同比扭亏为盈。前三季度营收为275.95亿元，同比增长44.2%；净利润为11.39亿元， 同比扭亏为盈。 具体来看，2025年第三季度，百济神州的拳头产品泽布替尼全球销售额为74.23亿元，营收规模在全球 同类BTK抑制剂中排名第一，其中美国市场销售额为 ...

生物医药ETF（512290）连续3日迎净流入，制药行业表现较好。 中信建投指出，制药行业表现较好，恒瑞医药艾速达（JAK1）提交了新的适应症上市申请；信达生物 首个中国原研IL-23p19单抗获批上市；百济神州索托克拉上市申请已获美国FDA受理并授予优先审评资 格；康方生物卡度尼利方案一线治疗晚期宫颈癌被作为全人群治疗的"首选方案"写入NCCN指南中国版 推荐；诺和诺德Amycretin糖尿病二期临床数据公布，司美格鲁肽阿尔茨海默症三期临床失败；美国第 二轮IRA谈判结果出炉；BioNTech更新PD-L1/VEGFTNBC临床数据。 生物医药ETF（512290）跟踪的是CS生医指数（930726），该指数从沪深市场中选取涉及生物技术、制 药、医疗设备等业务的上市公司证券作为指数样本，以反映生物科技与医药健康相关上市公司证券的整 体表现。该指数成分股具有较高的成长性和创新性，侧重于展示生物医药行业的综合发展水平。 （文章来源：每日经济新闻） ...

Investment Rating - The report recommends an "Outperform" rating for leading pharmaceutical and biotech companies with robust pipelines, as well as high-quality CXOs and internet healthcare firms [1]. Core Insights - The report highlights the strong performance of innovative drug leaders such as BeiGene and Innovent Biologics, which have shown significant revenue growth in Q3 2025, with BeiGene achieving USD 1.41 billion in revenue (up 41% year-on-year) and Innovent exceeding CNY 3.3 billion (up 40% year-on-year) [39][40]. - The CXO sector experienced a pullback in November, with notable declines in stocks like WuXi AppTec and Tigermed, attributed to profit-taking after strong performance in the first three quarters of 2025 and concerns over geopolitical risks [42]. - The report emphasizes the importance of upcoming clinical data readouts from major conferences such as ESMO Asia and ASH, which could serve as catalysts for stock performance [10]. Summary by Sections Top Picks - The report lists top picks including Hansoh Pharma, 3SBio, Kelun-Biotech, Innovent, Akeso, JD Health, and WuXi AppTec, all rated as "Outperform" [1][4][35]. Performance Overview - The Hong Kong stock picks portfolio gained an average of 5.2% in November 2025, outperforming the Hang Seng Healthcare Index, which declined by 0.1% [5][36]. - The top three performers in the portfolio were Hansoh Pharma (+12.9%), BeiGene (+10.2%), and Innovent (+10.0%) [5][36]. Market Trends - The innovative drug sector has shown resilience, benefiting from previous corrections and strong earnings catalysts from leading companies [39]. - The report notes that the recent implementation of key industry policies, including the 11th National Centralized Drug Procurement, has led to significant price reductions for selected products, impacting market dynamics [38]. Clinical Developments - Significant clinical progress is noted for companies like 3SBio, which is advancing its SSGJ707 (PD-1/VEGF) with Pfizer, planning to initiate multiple clinical trials [41]. - The report also highlights the potential of innovative therapies in oncology, with companies like BeiGene and Innovent expanding their product pipelines and market presence [32][40].

Macro and Strategy Research - The report highlights a divergence in the Federal Reserve's stance on interest rate cuts, with a 70% market expectation for a cut in December, although the actual impact may be similar whether it occurs in December or January [3][4] - In the U.S., retail sales showed a slowdown, particularly in the automotive sector, while investment in AI-related fields continues to support economic growth [3] - Domestic industrial profits have declined, with a notable drop in profits for mid and downstream industries, while upstream sectors benefited from stable raw material prices [4] Fixed Income Research - The report indicates a downward trend in the average issuance guidance rates for credit bonds in 2025, with a decrease of 151 basis points to 39 basis points compared to 2024 [5][7] - Credit bond issuance in 2025 decreased compared to the previous year, but net financing increased, indicating a shift in market dynamics [7] - The report emphasizes the importance of liquidity in the bond market, with a focus on the "debt and development" narrative, suggesting that credit risk is perceived to be low [7][8] Industry Research - The report discusses the State Council's initiative to promote provincial-level coordination of basic medical insurance, enhancing the system's security capabilities [13][17] - Recent FDA approvals for innovative treatments, such as BeiGene's Sotigalimab for lymphoma, highlight the ongoing advancements in the biopharmaceutical sector [14][15] - The report notes a decline in the SW pharmaceutical index, with a current P/E ratio of 51.78, indicating a significant premium over the CSI 300 index [16] - The report recommends focusing on investment opportunities in the innovative drug sector, particularly in diagnostics, vaccines, and related pharmaceutical companies [16]

Investment Rating - The report maintains a rating of "Buy" for the pharmaceutical and biotechnology industry [1]. Core Insights - The overseas small nucleic acid market is entering a harvest period, with a focus on domestic companies such as Yuyuan, Frontier, and Fuyuan [1][16]. - The A-share pharmaceutical index has increased by 2.67% this week and 16.72% year-to-date, outperforming the CSI 300 by 1.03% and 1.68% respectively [4][9]. - The report highlights significant advancements in small nucleic acid drug technologies, expanding their application beyond rare diseases to chronic conditions such as cardiovascular diseases and metabolic disorders [16][18]. Summary by Sections Industry Trends - The report notes that various pharmaceutical sectors, including raw materials (+4.27%), chemical pharmaceuticals (+4.19%), and medical devices (+2.30%), have seen stock price increases [4][9]. - Key companies with notable stock performance include Haiwang Biological (+38.2%) and Guangdong Wannianqing (+36.2%) [4][9]. Research and Development Progress - Significant drug approvals include the self-immune new drug "Pikangqibai" by Innovent Biologics and the BCL2 inhibitor "Sotokura" by BeiGene, both of which have received regulatory approval [4]. - The report emphasizes the importance of delivery systems in the development of small nucleic acid drugs, with a focus on companies like Yuyuan Pharmaceutical and Frontier Biotech [16][18]. Market Insights and Regulatory Dynamics - The report ranks promising sub-industries as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10][12]. - Specific stock recommendations include Yuyuan Pharmaceutical, Frontier Biotech, and Heng Rui Medicine among others, based on their innovative drug pipelines and market potential [12][18].

Core Viewpoint - The article discusses the blood purification device industry, highlighting the increasing prevalence of End-Stage Renal Disease (ESRD) and the growth potential of blood purification technologies in response to this global health challenge [18][21]. Market Overview - The global ESRD patient population is projected to grow from 91.33 million in 2019 to 148.51 million by 2030, with a CAGR of 4.2% [18][19]. - In China, the ESRD patient population is expected to increase from 3.025 million in 2019 to 6.132 million by 2030, with a CAGR of 5.8% [20][18]. Treatment Methods - Blood purification is the most widely used treatment for ESRD, offering higher survival rates compared to kidney transplantation and conservative treatment [21]. - The number of patients receiving blood purification treatment in China rose from 736,000 in 2019 to 1.069 million in 2023, with a CAGR of 9.8%, and is expected to reach 3.791 million by 2030, with a CAGR of 19.8% [21][23]. Blood Purification Technologies - The main blood purification methods include hemodialysis, peritoneal dialysis, blood perfusion, and blood filtration, with hemodialysis being the most mature and widely applied [29]. - Hemodialysis effectively removes harmful substances and excess fluid from the blood, making it suitable for patients at various disease stages [29]. Market Size and Growth - The Chinese blood dialysis device market is projected to grow from CNY 11.63 billion in 2019 to CNY 51.52 billion by 2030, with a CAGR of 19.9% from 2023 to 2030 [30][28]. - The market share of blood dialysis devices in China is expected to see significant growth, with specific segments like blood dialysis machines and consumables also experiencing robust growth rates [30]. Competitive Landscape - Domestic companies are rapidly catching up with international competitors in the blood purification consumables sector, achieving nearly 50% market share in dialysis filters [31]. - The competitive landscape for blood dialysis machines is evolving, with domestic manufacturers improving their technology and performance to match imported products [37][33]. Policy and Market Dynamics - The article notes that the Chinese government has been implementing centralized procurement policies, leading to significant price reductions and accelerating the domestic replacement process in the blood purification market [36][35].

Investment Rating - The report does not explicitly provide an investment rating for the blood purification device industry Core Insights - The report highlights the increasing prevalence of End-Stage Renal Disease (ESRD) globally and in China, with the number of patients expected to rise significantly by 2030, indicating a growing market for blood purification devices [13][15] - Blood purification is identified as the most widely used treatment method for ESRD, with a higher survival rate compared to other treatments like kidney transplantation and conservative treatment [19] - The Chinese blood purification device market is projected to grow rapidly, driven by an increase in ESRD patients, improved reimbursement policies, and advancements in dialysis infrastructure [26] Market Overview - The global ESRD patient population increased from 9.13 million in 2019 to 11.14 million in 2023, with a CAGR of 5.1%, and is expected to reach 14.85 million by 2030 [13][14] - In China, the ESRD patient population grew from 3.03 million in 2019 to 4.13 million in 2023, with a CAGR of 8.1%, projected to reach 6.13 million by 2030 [15] - The number of patients receiving blood purification treatment in China rose from 736,000 in 2019 to 1.07 million in 2023, with a CAGR of 9.8%, expected to reach 3.79 million by 2030 [19][18] Treatment Methods - Blood purification methods include hemodialysis, peritoneal dialysis, blood perfusion, and blood filtration, with hemodialysis being the most common and effective method for ESRD patients [23] - Hemodialysis is noted for its effectiveness in removing toxins and excess fluid, while peritoneal dialysis is gaining traction due to its home treatment capabilities [21][23] Market Size and Growth - The Chinese blood purification device market size increased from 116.3 billion yuan in 2019 to 145.0 billion yuan in 2023, with a CAGR of 5.7%, and is expected to reach 515.2 billion yuan by 2030, with a projected CAGR of 19.9% from 2023 to 2030 [26] - The market for blood purification devices is segmented into blood purification machines, blood purification consumables, and other related equipment, with significant growth expected across all segments [26] Competitive Landscape - Domestic companies are rapidly catching up to international competitors in the blood purification consumables market, achieving nearly 50% market share in key areas [27] - The report indicates that the domestic market for blood purification machines still has room for growth, as these products have historically relied on imports due to high technical barriers [27][34] - The report emphasizes that domestic manufacturers are improving their technology and performance, positioning themselves to capture a larger market share [29][34]

Investment Rating - The investment rating for the company is "Buy" [5] Core Insights - The company reported a total revenue of approximately 27.595 billion yuan for the first three quarters of 2025, representing a year-on-year increase of 44.2%. The net profit attributable to shareholders was approximately 1.139 billion yuan, with a non-recurring net profit of about 969 million yuan. For Q3 2025, the total revenue was approximately 10.077 billion yuan, up 41.1% year-on-year, with a net profit of about 689 million yuan and a non-recurring net profit of approximately 708 million yuan. The company has raised its full-year revenue guidance for 2025, expecting total revenue to be between 36.2 billion yuan and 38.1 billion yuan [1][2][3]. Revenue Growth Drivers - The adjustment in expected revenue growth is primarily attributed to the leading position of Baiyueze® in the U.S. market and its ongoing expansion in Europe and other key global markets. The adjustments in R&D, sales, and management expenses are mainly due to prudent investments that promote revenue and pipeline growth, achieving significant operational efficiency [2]. Market Performance - In Q3, Baiyueze® generated global revenue totaling 1 billion USD, a year-on-year increase of 50.8%. In the U.S., revenue reached 738.7 million USD, up 46.6% from the previous year, driven by robust demand across all indications and moderate gains from net pricing. In Europe, revenue totaled 163.2 million USD, a 67.8% increase year-on-year, benefiting from market share growth in major European markets. In China, revenue was 92.4 million USD, up 36.2% year-on-year, while sales in other countries reached 46.4 million USD, a 116.6% increase [3]. Pipeline and Future Prospects - The company announced that nearly 50 abstracts from its hematology research projects will be presented at this year's ASH annual meeting, including 6 oral presentations. Sotokura is gradually becoming a potential best-in-class BCL2 inhibitor, offering better efficacy, higher safety, and greater convenience compared to the first-generation BCL2 inhibitor, venetoclax. The U.S. FDA has granted breakthrough therapy designation to Sotokura for the treatment of relapsed/refractory mantle cell lymphoma [4]. Financial Forecast - The company forecasts revenues for 2025-2027 to be 37.7 billion yuan, 48 billion yuan, and 55.1 billion yuan respectively, with year-on-year growth rates of 38%, 28%, and 15%. The net profit attributable to shareholders is expected to be 736 million yuan, 4.692 billion yuan, and 7.982 billion yuan for the same years, reflecting significant growth [8][10].