TCE 或将下一个 BD 风口，建议关注泽璟制 药-U、康诺亚、德琪医药等 增持（维持） [Table_Tag] [Table_Summary] 投资要点 2026 年 03 月 29 日 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 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 行业走势 -8% -5% -2% 1% 4% 7% 10% 13% 16% 19% 22% 25% 2025/3/31 2025/7/29 2025/11/26 2026/3/26 医药生物 沪深300 相关研究 《BD 放量及再融资，创新药龙头现金 流充裕》 2026-03-22 《十五五"聚焦脑机接口、首款产品 获批，关注：微创脑科学、翔宇医疗、 爱朋医疗等》 2026-03-15 东吴证券研究所 1 / 30 请务必阅读正文之后的免责声明部分 ◼ 本周、年初至今 A 股医药指数涨跌幅分别为-1.26%、-1.38%，相对沪 深 300 的超额收益分别为 2.31%、1.37%；本周、年初至今恒生生物科 技指数涨跌幅分别为+4.03%、+2.52%，相对于恒生科技指 ...

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 TCE 或将下一个 BD 风口，建议关注泽璟制 药-U、康诺亚、德琪医药等 增持（维持） [Table_Tag] [Table_Summary] 投资要点 2026 年 03 月 29 日 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 行业走势 -8% -5% -2% 1% 4% 7% 10% 13% 16% 19% 22% 25% 2025/3/31 2025/7/29 2025/11/26 2026/3/26 医药生物 沪深300 相关研究 | 1. 本周及年初至今各医药股收益情况 | 4 | | --- | --- | | 2. TCE：冉冉升起的肿瘤及自免治疗新星 7 | | | 3. 研发进展与企业动态 | 13 | | 3.1. 创新药/改良药研发进展（获批上市/申报上市/获批临床） 13 | | | 3.2. 仿制药及生物类似物上市、临床申报情况 18 | | | 3.3. 重要研发管线一览 24 | | | 4. 行业洞察与监管洞察 | 25 | | 5. 行情回顾 | 25 | | ...

证券研究报告 康诺亚-B (2162 HK) 港股通 销售放量在即，国际化兑现路径清晰 2026 年 3 月 28 日│中国香港 生物医药 3 月 26 日，康诺亚披露 2025 年度业绩，营收 7.16 亿元（+67.3%yoy）， 净亏损和和经调整净亏损分别为 5.23/4.95 亿元，收入/净亏损优于我们预期 的 5.71/6.79 亿元，主因出海品种推进顺利确认多笔里程碑。司普奇拜单抗 25 年销售额 3.15 亿元，考虑其三大适应症纳入医保、价格良好，入院快速 推进，看好 26 年销售额跨越式增长。同时公司全球价值兑现路径进一步明 晰：1）CMG901 2L 胃癌 III 期预计年内报 BLA，阿斯利康已启动全球 1L 胃癌 III 期；2）吉利德收购 Ouro，CM336 全球价值兑现有望加速；3）CM512、 CM518D1 有望 26 年读出多项数据，看好全球竞争力。维持"买入"。 司普奇拜单抗有望迎来 2026 年放量期 我们看好司普奇拜单抗 26 年销售达 7.5 亿元：1）AD、CRSwNP、SAR 三 大适应症均纳入医保，单价 1039 元降幅缓和；其中 AD 较达必妥价格竞争 力强， ...

业绩简评 3 月 26 日公司发布年报，实现收入 7.16 亿元（+67%），其中产品 销售收入（司普奇拜单抗）3.15 亿元，合作收入 4.02 亿元；年内 亏损 5.23 亿元，经调整年内亏损 4.95 亿元；研发投入 7.2 亿元， 截至 25/12/31 在手现金储备 19.6 亿元。 经营分析 司普奇拜单抗于 26 年纳入医保目录，销售放量在即。司普奇拜单 抗目前已经获批的三大适应症（AD、慢性鼻窦炎伴鼻息肉、季节过 敏性鼻炎）均已于 2026 年初正式纳入医保目录，预计在医保身份 +价格优势+独家适应症加持下，26 年有望实现快速增长。其他适 应症持续拓展：青少年 AD 适应症于 26M1 递交 NDA，PN 预计 26H1 递交 NDA，儿童 AD Ⅲ期入组中。 2026 年多管线有望迎来关键催化节点。①CMG901(CLDN18.2 ADC， 已于 23 年对外授权阿斯利康)：预计 26H1 读出Ⅲ期 2L 胃癌数据， 26 年内递交该适应症 NDA，产品上市后有望获得低双位数净销售 额分成；1L 胃癌Ⅲ期、Ⅱ期围手术期胃癌、Ⅱ期胰腺癌等持续拓 展中，1L 胃癌Ⅲ期临床首例患者入组 4500 ...

今日早参 2026 年 3 月 25 日 何康 策略首席研究员兼金融工程首席研究 员 座机：021-28972202 邮箱：hekang@htsc.com 王玮嘉 公用事业环保行业首席研究员 座机：021-28972079 邮箱：wangweijia@htsc.com 今日热点 策略：资金透视：配置型资金仓位转向防御 尽管外围风险此前已有演绎，但交易型资金在前期表现出较强的持仓惯性， 上周投资者对地缘政治定价提升，市场波动率放大，上周五融资资金单日净 流出超 150 亿标志着资金情绪出现回落，触发融资融券的去杠杆进程，担保 比例从 290%的历史高位迅速回落至 278%的年初水平，后续进一步出清需观 察融资去杠杆幅度；其次，存量资金的结构博弈正由"进攻"转向"防御避 险"。在不确定性升温的背景下，配置型资金的审美发生了显著转移：测算 数据显示，基金仓位出现向消费、金融等方向腾挪的倾向，资金开始在防御 性品种中寻找新的安全边际。此外，宽基 ETF 在净流出 9 周后转向小幅净流 入，上周宽基 ETF 净流入 95 亿元。 风险提示：1）估算持仓模型失效；2）数据统计口径有误。 闫萌 SAC:S057052512 ...

Investment Rating - The report indicates a positive investment outlook for the innovative drug sector, particularly focusing on the advancements in T-cell engagers (TCE) for multiple myeloma (MM) treatment [1]. Core Insights - Johnson & Johnson's teclistamab has shown significant efficacy in the treatment of relapsed or refractory multiple myeloma (r/r MM), with a 71% reduction in disease progression or death risk and a 40% reduction in mortality risk compared to standard treatments [14][15]. - The report highlights the unmet medical needs in the MM treatment landscape, emphasizing the potential of TCE therapies targeting BCMA and GPRC5D to improve patient outcomes [9][10]. - The ongoing clinical trials and approvals for various TCE therapies, including teclistamab and talquetamab, are expected to reshape the treatment paradigm for MM, particularly in patients who have undergone multiple lines of therapy [28][34]. Summary by Sections Innovative Drug Focus - The report reviews the recent developments in innovative drugs, particularly in the context of TCE therapies for blood cancers, with a focus on their expanding applications beyond hematological malignancies [5][7]. TCE Therapy Developments - TCE therapies have gained traction in the treatment of MM, with several candidates achieving FDA approval for patients who have received multiple prior therapies. The overall response rates (ORR) for these therapies range from 60% to 74% [9][10]. - The report details the clinical trial results for teclistamab, which has been shown to significantly improve progression-free survival (PFS) and overall survival (OS) in r/r MM patients [14][21]. Market Potential - The report estimates that the sales for teclistamab in China could reach approximately $5.49 billion by 2024, indicating a strong market potential for TCE therapies in the region [6]. - The ongoing research and development efforts in TCE therapies are expected to address the significant unmet needs in the MM treatment landscape, with a focus on improving patient outcomes and survival rates [9][10].

Core Insights - T cell engagers (TCEs) are gaining popularity among multinational corporations (MNCs) as a promising direction in immunotherapy, comparable to the previous surge in antibody-drug conjugates (ADCs) [1][4] - TCEs activate T cells to target tumor cells, offering advantages in convenience, accessibility, and production costs over personalized CAR-T therapies [1][4] - The TCE market is projected to grow significantly, from $400 million in 2020 to $30 billion by 2024, and reaching $110.1 billion by 2034 [4] Group 1: Market Dynamics - TCEs have achieved breakthroughs in hematological malignancies, with nine TCEs approved for various blood cancer indications by July 2025, contributing to a market exceeding $10 billion [4] - The development of TCEs for solid tumors is progressing, with innovative drugs like Amgen's Tarlatamab showing promising results [4][5] - TCEs are also being explored for autoimmune diseases, with early data indicating potential efficacy in conditions like rheumatoid arthritis [5] Group 2: Competitive Landscape - Over 150 TCE pipelines are currently in development in China, with a focus on key target combinations such as CD3/BCMA and CD3/CD19, aligning with global trends [6][29] - Companies like Vailizhi Bio and Kangnuo are making significant strides in TCE development, with comprehensive strategies covering hematological, solid tumors, and autoimmune diseases [8][11] - The competitive landscape is characterized by diverse strategies, with companies leveraging unique platforms and technologies to differentiate their offerings [20][23] Group 3: Company Strategies - Vailizhi Bio has adopted a three-dimensional strategy focusing on hematological cancers, solid tumors, and autoimmune diseases, supported by its LeadsBody platform [8][9] - Kangnuo's strategy involves extensive overseas licensing of its TCE assets, which may impact its long-term pipeline strength [11][13] - Shimai Pharmaceutical is addressing the challenges of solid tumor treatment through innovative platforms, aiming to establish itself as a leader in the TCE space [21][23] Group 4: Future Outlook - The TCE sector is expected to continue evolving, with a focus on overcoming technical challenges such as tumor microenvironment penetration and long-term safety validation [29] - The integration of TCEs with other therapies, such as ADCs and PD-1 inhibitors, is seen as essential for achieving competitive advantages in the market [29]

Core Insights - China's pharmaceutical innovation capabilities are gaining global recognition, as highlighted by reports from McKinsey and BCG, which affirm the rise of innovative drugs in various fields and acknowledge the innovation quality of the domestic pharmaceutical industry [1][21][24] - The "Fierce 15" list, published by Fierce Biotech, identifies 15 innovative biotech companies, many of which have corresponding domestic counterparts, indicating the forward-looking nature of China's innovation [1][18] Group 1: AI in Drug Development - AI is becoming a crucial innovation point in drug development, with four companies in the "Fierce 15" list utilizing AI in their drug discovery processes [5][17] - Character Biosciences, established in 2019, leverages vast insurance data to develop drugs for age-related chronic diseases, utilizing AI to create a drug development platform focused on age-related macular degeneration (AMD) [5][7] - The company has raised approximately $230 million, including investments from major players like Bausch + Lomb and Sanofi [5] Group 2: Domestic AI Drug Discovery Companies - Shanghai Drug Farm, founded in 2015, focuses on discovering new drug targets using genetics and AI, with two AI platforms that have identified over 20 innovative targets [8][10] - MoleculeAI, a domestic company, is pioneering AI-driven protein design, aiming to create new proteins on demand, which could represent a new foundation for the bio-economy [14] - Domestic companies are increasingly adopting AI to optimize clinical trial processes, with examples like Deep Intelligence and WuXi AppTec enhancing efficiency through AI tools [16] Group 3: Global Recognition of Chinese Innovation - The "Fierce 15" list includes Chinese companies like Ouro Medicines and Verdiva Bio, showcasing the global reach of Chinese innovation [18][19] - BCG's report indicates that China is becoming a key growth engine in global new modalities, with over 4,000 clinical projects, ranking second globally [21] - McKinsey's analysis highlights a fundamental change in China's position in the global innovative drug industry, predicting that by 2030, China will account for 10% to 15% of new drug listings globally [24][23]

Core Insights - The article highlights the resurgence of US dollar funds in the Chinese innovative drug market, with significant investments and licensing deals indicating a renewed interest in this sector [1][4][5]. Group 1: Investment Trends - In 2025, Heng Rui Medicine completed a licensing agreement with Braveheart Bio for the HRS-1893 project, with an upfront payment of $65 million and a total deal value of up to $1.013 billion, marking the fourth business development (BD) deal for Heng Rui this year, totaling over $15 billion [1]. - In the first half of 2025, the total value of outbound licensing deals for Chinese innovative drugs reached $48.448 billion, nearing the total for the entire year of 2024, with over 80% of these deals involving US dollar funds [4]. - The return of US dollar funds to the Chinese innovative drug market is characterized by a shift from direct investments to more strategic BD transactions, focusing on specific drug pipelines and products rather than entire companies [13][14]. Group 2: Market Dynamics - The article notes that from 2024 to 2030, major pharmaceutical companies in the US and Europe will face a revenue gap of approximately $360 billion due to patent expirations, prompting them to seek acquisitions in the Chinese innovative drug sector to fill this void [9]. - The quality of Chinese innovative drugs has significantly improved, with over 1,250 new drugs entering the research phase in 2024, closely approaching the number in the US [11]. - The competitive landscape has intensified, with not only US dollar funds but also European, Middle Eastern, and East Asian capital increasingly targeting Chinese innovative drug assets, leading to heightened competition for quality investments [12]. Group 3: Strategic Shifts - US dollar funds are transitioning from a broad investment strategy to a more focused approach, emphasizing "certainty first" in their investment decisions, which includes a preference for assets with clear international market potential [13][14]. - The NewCo model is gaining traction, allowing for deeper collaboration between US dollar funds and Chinese innovative drug companies, sharing risks and benefits more equitably [15][16]. - The article suggests that the current environment presents a strategic opportunity for Chinese innovative drug companies to leverage US dollar fund investments while maintaining a focus on original innovation and enhancing the value of their drug pipelines [23][24].

Core Viewpoint - 康诺亚-B (02162) has initiated its first Phase III clinical trial for the dual antibody drug CM336, which aims to treat relapsed or refractory multiple myeloma (R/R MM) patients who have previously undergone at least two lines of treatment [1] Group 1: Company Developments - 康诺亚's stock price increased by over 5% during trading, currently reported at 74.80 HKD with a trading volume of 89.07 million HKD [1] - The Phase III trial for CM336 is a randomized, open-label, multi-center study involving 280 patients [1] - The primary endpoint of the study is progression-free survival (PFS) [1] Group 2: Clinical Trial Background - CM336 has previously completed a Phase I/II study for R/R MM, where 23 patients were evaluated for efficacy [1] - In the dose escalation cohort, the objective response rates (ORR) for the ≤5mg, 20-40mg, and 80-160mg groups were 17%, 71%, and 80% respectively [1] - The rates of stringent complete response or complete response in these groups were 17%, 71%, and 60% respectively [1]