此外，信达生物综合管线矩阵丰富，多元化出海。心血管代谢及内分泌科来看：玛氏度肽、PCSK9已获 批，在研管线聚焦心血管相关的"四高"广阔人群;眼科：双抗分子有望通过差异化机制提升患者生存质 量;皮肤科及风湿科：匹康奇拜单抗(IL23p19)率先获批，具备BIC潜力;其余产品管线以FIC/BIC为目的解 决未满足需求。IBI3002为全球同类首创的免疫双抗分子，TSLP和IL4Rα为靶点，在哮喘患者初步展示 疗效信号。随着临床进展不断推进，有望持续拓展公司在创新管线的全球授权合作，同时获批产品和成 熟品种在全球多地区上市加速和拓展准入多元化公司出海模式，加速全球化布局。 中邮证券发布研报称，首次覆盖信达生物(01801)，给予"买入"评级，预计公司2025-2027年归母净利润 9.8/15.8/32.5亿元，对应PE为162/100/49。公司发布25年中期业绩公告，25H1公司收入59.5亿元，同比 +50.6%，其中产品收入52.3亿元，同比增长37.3%。EBITDA为14亿元，净利润为12亿元，在手现金146 亿元。信达在国内肿瘤药物领域具备领先地位，综合管线矩阵布局丰富，逐步获批上市有望双轮驱动业 ...

报告中称，公司IBI363获批开展全球三期临床，逐步验证新一代IO基石潜力。IBI363是由信达生物研发 的全球首创PD-1/IL-2α-bias双特异性融合蛋白，同时具有阻断PD-1/PD-L1通路和激活IL-2通路两项功 能。2025年8月公司宣布IBI363的IND获FDA批准，开展治疗鳞状非小细胞肺癌首个全球关键三期临床 研究：招募约600名患者，比较IBI363单药与多西他赛在IO经治的肺鳞癌的疗效与安全性，研究的主要 终点为总生存期(OS)。此前363在2025年ASCO上363亮相三项口头报告：对"免疫耐药"、"冷肿瘤"等具 备亮眼的疗效数据。公司开发策略清晰：优先瞄准IO经治的空白市场，在肺癌、黑色素瘤和三线肠癌 将在2025年陆续开展注册临床;在一线的肺癌、肠癌开展PoC研究，预计在2026读出。公司同步开展联合 疗法拓宽适应症，验证新一代IO基石的潜力。 此外，信达生物综合管线矩阵丰富，多元化出海。心血管代谢及内分泌科来看：玛氏度肽、PCSK9已获 批，在研管线聚焦心血管相关的"四高"广阔人群;眼科：双抗分子有望通过差异化机制提升患者生存质 量;皮肤科及风湿科：匹康奇拜单抗(IL23p19 ...

Core Insights - The report by Zhongyou Securities focuses on the development of drugs in the autoimmune (self-immune) field, analyzing market demand, dual-antibody research priorities, and related investment targets [1][3]. Market Demand - The autoimmune field has a large patient base and long medication cycles, leading to the potential for blockbuster drugs, such as Dupilumab (Dupi), which has annual sales exceeding $10 billion. Key indications like atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD) have millions of affected patients, with nearly 9 million patients accessible to biological agents [1][2]. - Existing therapies still have unmet needs, including the need for long-acting formulations to reduce dosing frequency and improve efficacy, as well as expanding the patient population currently limited by screening criteria [1][2]. Dual-Antibody Research Focus - From the perspective of type 2 inflammation mechanisms, targets can be categorized into upstream (e.g., TSLP, IL-33) and downstream (e.g., IL-4, IL-13). Single-target monoclonal antibodies have limited efficacy, making dual antibodies an important direction due to their synergistic effects. In respiratory diseases, the TSLP×IL-13 (or IL-4R) dual antibody shows significant advantages, with clinical data indicating better reductions in FeNO and eosinophils compared to single-target drugs [2][3]. - The report emphasizes the potential of TSLP dual antibodies, highlighting leading global progress from companies like Sanofi (Lunsekimig) and Pfizer (triple antibodies), as well as domestic advancements from companies like Kangnuo (CM512) and Innovent (IBI3002) [2][3]. Investment Targets - Key investment targets include Kangnuo (CM512), which is leading in domestic progress, Innovent (IBI3002), and Qianxin Biotechnology (QX030N), with a focus on dual-antibody development [3]. Conclusion - Overall, TSLP dual antibodies in the autoimmune field show significant potential and may become the next generation of blockbuster drugs, driven by high patient numbers and unmet medical needs [1][3].

Investment Rating - The industry investment rating is "Strong Outperform" [2] Core Insights - The report emphasizes the potential of TSLP-targeted bispecific antibodies in addressing unmet needs in the autoimmune sector, particularly in asthma and atopic dermatitis [4][6] - The success of Dupilumab (Dupi) illustrates the demand for long-acting, multi-indication therapies in a market characterized by high patient numbers and chronic conditions [5][15] - The report identifies a significant market opportunity driven by high disease prevalence and the need for new therapeutic options [5][15] Summary by Sections High Disease Prevalence Creates Market Opportunities - The report highlights the large patient populations for conditions like asthma and atopic dermatitis, with millions affected, indicating a substantial market for new treatments [14][15] - Existing therapies have unmet needs, particularly in terms of long-acting formulations and improved efficacy [18][19] Focus on Bispecific Antibodies - The report suggests prioritizing bispecific antibodies that target TSLP and IL-13, as they have shown clinical promise in enhancing efficacy and expanding patient populations [6][22] - Companies such as 康诺亚, 信达生物, 荃信生物, and 联邦制药 are identified as key players in this space [6] Respiratory Diseases and Bispecific Antibodies - In the respiratory disease sector, particularly asthma and COPD, the report notes the need for long-term management and the potential of bispecific antibodies to address this challenge [25][37] - The market for asthma biologics is projected to reach approximately $7.5 billion by 2023, with significant growth expected [25][28] Clinical Data and Efficacy - The report discusses the clinical efficacy of various biologics, noting that Dupilumab and Tezepelumab have shown significant improvements in asthma control and quality of life [34][35] - The combination of TSLP and IL-4R is highlighted as a promising therapeutic strategy, with early clinical data supporting its potential [37][47]

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [4] Core Views - The report emphasizes the potential opportunities in the autoimmune dual-antibody sector amidst the ongoing trend of international expansion. It highlights the increasing interest from multinational corporations (MNCs) in Chinese innovative drugs, particularly in the context of patent cliffs faced by leading MNCs [3][8] - The report suggests that the pharmaceutical sector is poised for growth in 2025, driven by several factors including the successful transition from traditional to innovative growth drivers, the increasing capabilities of Chinese companies in international markets, and the rising demand due to an aging population [4][47] Summary by Sections Market Performance - From August 4 to August 8, the pharmaceutical index declined by 0.84%, underperforming the CSI 300 index by 2.07%. Notable gainers included Nanmo Biology (+42.48%), Haichen Pharmaceutical (+41.29%), and Sino Medical (+39.52%). Conversely, Nanxin Pharmaceutical (-18.5%) and Qizheng Tibetan Medicine (-16.11%) were among the largest decliners [5][24] BD Opportunities - The report notes a surge in BD (business development) transactions, particularly in the autoimmune sector, with a total of over 100 license-out transactions in China from January 1 to August 7, 2025, amounting to $840.5 billion. The focus of these transactions has been primarily on oncology and metabolic fields, with a notable lack of activity in the autoimmune sector [9][8] Investment Recommendations - The report recommends focusing on innovative drugs and medical devices, particularly those with low valuations and potential for marginal improvement. Key companies to watch include Heng Rui Pharmaceutical, Keren Pharmaceutical, and Innovent Biologics [4][49] - It also highlights the importance of the aging population and the increasing demand for chronic disease treatments, suggesting that companies like Kunming Pharmaceutical and Yuyue Medical could benefit from this trend [48][47] Valuation Insights - As of August 8, 2025, the overall PE valuation for the pharmaceutical sector stands at 38.77X, indicating that the sector is still at a relatively low historical valuation compared to other sectors [36][47] Future Outlook - The report anticipates a rebound in the pharmaceutical sector in 2025, driven by innovative drugs and the ongoing internationalization of Chinese pharmaceutical companies. It emphasizes the need to focus on sectors with structural growth potential, such as innovative drugs, medical devices, and the aging population market [47][48]

报告摘要 点击注册小程序 查看完整报告 特别申明： 本订阅号中所涉及的证券研究信息由光大证券研究所编写，仅面向光大证券专业投资者客户，用作新媒体形势下研究 信息和研究观点的沟通交流。非光大证券专业投资者客户，请勿订阅、接收或使用本订阅号中的任何信息。本订阅号 难以设置访问权限，若给您造成不便，敬请谅解。光大证券研究所不会因关注、收到或阅读本订阅号推送内容而视相 关人员为光大证券的客户。 风险分析： 控费政策超预期、研发失败风险、政策支持不及预期、板块估值下挫风险。 行情回顾： 发布日期： 2025-04-20 上周，A股医药生物指数下跌0.36%，跑输沪深300指数0.94pp，跑赢创业板综指0.17pp，在31个子行业中排名 第24，表现较差。港股恒生医疗健康指数上周收涨0.57%，跑输恒生国企指数0.66pp。 上市公司研发进度跟踪： 上周，百济神州的BGB-C354、恒瑞医药的SHR-4506注射液的临床申请新进承办；百济神州的BGB-21447片、 海思科的HSK45030分散片的IND申请新进承办。上周，石药集团的IBI3002、正大天晴的HRS-5817正在进行三 期临床；海思科的TQB3473正 ...

Investment Rating - The report maintains a "BUY" rating for Innovent Biologics, indicating a potential return of over 15% over the next 12 months [16]. Core Insights - Innovent Biologics is entering a phase of sustainable profitability, having achieved a full-year non-IFRS net profit of RMB332 million in FY24, driven by strong product revenue growth and one-off license fee income [8]. - The target price has been revised upwards from HK$57.67 to HK$61.71, reflecting a 33.6% upside potential from the current price of HK$46.20 [3][8]. - The company is advancing its next-generation immuno-oncology (IO) therapies and antibody-drug conjugates (ADCs), with significant clinical programs underway [8]. Financial Summary - Revenue is projected to grow from RMB6,206 million in FY23 to RMB11,356 million in FY25, representing a year-on-year growth of 51.8% [2][13]. - Net profit is expected to turn positive in FY25, reaching RMB445.7 million, with EPS projected at RMB0.27 [2][11]. - R&D expenses are forecasted to remain stable, while gross profit margin is expected to expand to 84.9% in FY24 from 82.8% in FY23 [2][8]. Share Performance - The market capitalization of Innovent Biologics is approximately HK$75.68 billion, with a 52-week high of HK$51.15 and a low of HK$30.00 [3][4]. - The stock has shown strong performance, with a 1-month absolute return of 14.2% and a 3-month return of 29.8% [5]. Pipeline and Growth Potential - Innovent has a robust pipeline with over 10 ADC clinical programs and is focusing on combination trials with its next-generation IO therapy, IBI363 [8]. - The company aims to initiate multiple Phase 3 trials by 2030, targeting global markets with its innovative therapies [8].