Industry Investment Rating - The industry investment rating is "Outperform the Market" and is maintained [1] Core Viewpoints - The report highlights significant clinical advancements in the dual-antibody sector, particularly focusing on the TSLP/IL-13 dual antibody Lunsekimig by Sanofi, which has entered Phase III clinical trials for COPD, with the first patient dosed on September 24 [4][5] - The report emphasizes the potential of dual antibodies in autoimmune diseases, particularly in respiratory conditions like asthma and COPD, indicating a substantial market opportunity [7] Summary by Relevant Sections Industry Basic Situation - The closing index level is 8665.0, with a 52-week high of 9323.49 and a low of 6764.34 [1] Clinical Progress Updates - Sanofi's Lunsekimig is in Phase II/III trials for COPD, aiming to enroll 1884 patients to evaluate its efficacy and safety compared to a placebo [4] - The CM512 dual antibody by Connoa shows promising results in atopic dermatitis, with EASI-75 and EASI-90 response rates of 58.3% and 41.7% respectively, compared to 21.4% and 0% in the placebo group [5] Market Activity and Collaborations - The report notes ongoing collaborations, such as the agreement between Qianxin Biotech and Roche for QX031N, which targets both TSLP and IL-33, with an upfront payment of $75 million and potential milestone payments up to $995 million [6] - The report also mentions the presentation of the CS2015 dual-specific antibody by Basestone Pharmaceuticals at the ACAAI conference, showcasing its therapeutic potential [6] Investment Recommendations - The report suggests focusing on companies like Connoa, Innovent Biologics, Qianxin Biotech, and Basestone Pharmaceuticals, as dual antibodies are expected to reshape treatment paradigms in autoimmune diseases [7][9]

(2)康诺亚CM512(TSLP x IL-13双抗)特应性皮炎(AD)1期数据读出：在12周，300mg剂量组EASI-75及 EASI-90(湿疹面积及严重程度指数评分较基线降低≥90%)应答率分别可达58.3%和41.7%，安慰剂组为 21.4%和0%。CM512的EASI-90数据表现亮眼，预示着深度缓解和持久稳定的优势。CM512本身具有长 半衰期的优势，意味着在临床使用中可以有效降低给药频次，提升患者依从性。 赛道交易与研发热度持续 1)BD交易：10月28日荃信生物与罗氏就QX031N达成全球独家合作与许可协议，首付款7500万美金，至 多9.95亿美金的里程碑付款以及潜在未来产品销售的梯度特许权使用费。QX031N是同时靶向TSLP和 IL-33的长效双抗，有望被开发成为COPD及哮喘等呼吸系统疾病的治疗新选择。2)基石药业于2025年美 国过敏，哮喘和免疫学会(ACAAI)展出了OX40L/TSLP双特异性抗体——CS2015。在临床前试验中展现 了疗效潜力。 风险提示 智通财经APP获悉，中邮证券发布研报称，双抗在自免领域有望重塑现有治疗格局，在呼吸科疾病，如 哮喘和COPD中现有疗法的迭 ...

消息面上，荃信生物宣布，公司自主研发的长效双抗QX027N注射液获得国家药品监督管理局药品审评 中心的临床试验默示许可，拟用于治疗哮喘及特应性皮炎。该候选药物的临床许可标志着公司在自免及 过敏疾病领域的创新双抗矩阵正式迈入临床阶段。 值得注意的是，10月28日，荃信生物宣布与罗氏就其自主研发的长效自免双抗QX031N达成全球独家合 作与许可协议。根据协议，罗氏将被授予研究、开发、注册、生产及商业化QX031N的全球独家权益。 荃信生物将获得7500万美元的首付款，以及至多9.95亿美元里程碑付款、潜在未来产品销售的梯度特许 权使用费。 来源：智通财经网 荃信生物-B(02509)早盘涨超8%，截至发稿，涨8.45%，报22.08港元，成交额560.3万港元。 ...

荃信生物-B(02509)早盘涨超8%，截至发稿，涨8.45%，报22.08港元，成交额560.3万港元。 消息面上，荃信生物宣布，公司自主研发的长效双抗QX027N注射液获得国家药品监督管理局药品审评 中心的临床试验默示许可，拟用于治疗哮喘及特应性皮炎。该候选药物的临床许可标志着公司在自免及 过敏疾病领域的创新双抗矩阵正式迈入临床阶段。 值得注意的是，10月28日，荃信生物宣布与罗氏就其自主研发的长效自免双抗QX031N达成全球独家合 作与许可协议。根据协议，罗氏将被授予研究、开发、注册、生产及商业化QX031N的全球独家权益。 荃信生物将获得7500万美元的首付款，以及至多9.95亿美元里程碑付款、潜在未来产品销售的梯度特许 权使用费。 ...

消息面上，荃信生物宣布，公司自主研发的长效双抗QX027N注射液获得国家药品监督管理局药品审评 中心的临床试验默示许可，拟用于治疗哮喘及特应性皮炎。该候选药物的临床许可标志着公司在自免及 过敏疾病领域的创新双抗矩阵正式迈入临床阶段。 智通财经APP获悉，荃信生物-B(02509)早盘涨超8%，截至发稿，涨8.45%，报22.08港元，成交额560.3 万港元。 值得注意的是，10月28日，荃信生物宣布与罗氏就其自主研发的长效自免双抗QX031N达成全球独家合 作与许可协议。根据协议，罗氏将被授予研究、开发、注册、生产及商业化QX031N的全球独家权益。 荃信生物将获得7500万美元的首付款，以及至多9.95亿美元里程碑付款、潜在未来产品销售的梯度特许 权使用费。 ...

Core Viewpoint - The stock of Zai Lab Limited (荃信生物-B) has increased by over 10%, reaching HKD 20.92, following announcements regarding its business strategies and partnerships in the biopharmaceutical sector [1][2]. Group 1: Business Developments - The board of Zai Lab has proposed a new annual cap for related transactions under the QX001S framework agreement for the fiscal years 2026 to 2028, with profit-sharing limits expected to rise significantly from RMB 55 million in 2026 to RMB 290 million in 2028 [1]. - Zai Lab has entered into a global exclusive collaboration and licensing agreement with Roche for its self-developed long-acting dual antibody QX031N, which includes an upfront payment of USD 75 million and potential milestone payments up to USD 995 million, along with tiered royalties on future product sales [2]. Group 2: Market Position and Outlook - Zai Lab is recognized as a leader in the domestic self-immune innovative drug sector, with a strong foundation in this field [2]. - The company's mature pipeline is approaching a monetization phase, and its innovative pipeline is seeing successful international licensing agreements, which further supports its stable operations [2].

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The rhythm of innovative drug licensing-out transactions has recovered, with a total of 103 transactions and a total amount of $92.03 billion in the first three quarters of 2025, representing a 77% increase compared to the total amount for 2024 [2] - The research and CXO sectors continue to lead the recovery in the pharmaceutical industry, with significant profit growth in these areas [4] - The medical device bidding market has shown a steady recovery, with a year-on-year growth of 29.8% in the third quarter of 2025 [5] - The self-immune field has seen breakthroughs in overseas licensing, indicating a growing alignment with global R&D trends [6] - The weight loss market is experiencing competitive mergers and acquisitions, highlighting its attractiveness and potential impact on Chinese companies [7] - Trends in respiratory infectious diseases are expected to influence the demand for detection and treatment medications [8] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 1.74 percentage points in the last week, ranking 9th among 31 primary industry indices [21] - In the last month, the pharmaceutical industry underperformed the CSI 300 index by 1.83 percentage points, ranking 24th [25] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical industry index has a current PE (TTM) of 38.80, above the five-year historical average of 31.26 [42] 3. Recent Research Achievements - The report highlights various recent research outputs, including weekly industry reports and insights on innovative drug licensing trends [48] 4. Recent Industry Policies and News - The National Healthcare Security Administration has initiated reforms for immediate settlement of medical insurance funds, aiming for 80% coverage by the end of 2025 [50] - Recent news includes significant breakthroughs in GLP-1 therapies and the approval of new drugs for chronic hepatitis B [51][52] 5. Recommended Companies and Profit Forecasts - The report provides a list of recommended companies with their respective EPS and PE ratios, indicating a positive outlook for several firms in the pharmaceutical sector [10]

Investment Rating - The report maintains a positive outlook on the pharmaceutical industry, particularly focusing on innovative drugs, medical devices, and the innovation chain [10][12]. Core Insights - The pharmaceutical sector's revenue for Q1-Q3 2025 showed a slight decline of 1.9% year-on-year, with net profit down by 6.8%. However, Q3 2025 saw a revenue increase of 0.5% compared to the previous year, indicating a potential recovery [16]. - The "innovation chain" segment is highlighted as the fastest-growing area within the pharmaceutical industry, with significant contributions from CXO services [16][19]. - The report emphasizes the importance of focusing on differentiated products and internationalization in the innovative drug sector, suggesting a shift from quantity to quality in product offerings [10][12]. Summary by Sections Market Review - The report notes that the medical device index rose by 1.21%, outperforming the CSI 300 index by 1.64 percentage points, ranking 13th among 30 sectors [7]. - The top-performing stocks included 合富中国, 诺思格, and C禾元-U, while the worst performers were 赛诺医疗 and 惠泰医疗 [7]. Industry and Stock Events - The report identifies key trends in various segments, including innovative drugs, medical devices, and traditional Chinese medicine, with specific companies recommended for investment [10][12][19]. - The report highlights the recovery in the bidding volume for imaging equipment and the growth of home medical devices, suggesting a favorable market environment for companies like 迈瑞 and 鱼跃 [10]. Overall Pharmaceutical Industry - The pharmaceutical industry reported a total revenue of 177.2 billion yuan for Q1-Q3 2025, with a notable decline in the traditional pharmaceutical manufacturing sector [16]. - The innovative drug sector's revenue reached 450.7 billion yuan in Q1-Q3 2025, marking an 8.1% increase year-on-year, despite a significant drop in net profit [19]. - The raw material drug sector showed resilience, with a revenue decline of only 5.2% in Q1-Q3 2025, and companies are encouraged to explore CDMO business opportunities [21][22].

Core Insights - Roche has entered into a global exclusive collaboration and licensing agreement with Qianxin Biotech for the development, production, and commercialization of QX031N, with a total deal value of up to $1.07 billion [1][2][10] Group 1: Product Overview - QX031N is a long-acting bispecific antibody targeting TSLP and IL-33, proteins involved in respiratory diseases such as COPD and asthma [2][3] - The potential market for QX031N is significant, with nearly 100 million COPD patients in China and an increasing prevalence of asthma, affecting approximately 45.7 million individuals aged 20 and above [3] Group 2: Company Performance - Qianxin Biotech reported a revenue of RMB 206.5 million for the six months ending June 30, 2025, a year-on-year increase of 359.69%, while the loss for the period was reduced by 83.11% to RMB 30.9 million [6][7] - The company has established a leading integrated antibody drug development platform, which supports the efficient discovery and development of differentiated candidate molecules [4] Group 3: Market Position and Future Prospects - The company has one approved product, QX001S, a biosimilar to ustekinumab, and aims to commercialize three self-developed products by 2027 [8][9] - The revenue for the first half of the year was primarily driven by licensing agreements, including upfront payments and milestone fees related to QX030N and QX004N [9]

Investment Rating - The report maintains a "Buy" rating for the stock, expecting a relative increase of over 20% compared to the benchmark index within six months [14]. Core Insights - The report highlights a global exclusive collaboration and licensing agreement between the company and F. Hoffmann-La Roche Ltd for the self-developed long-acting dual antibody QX031N, which targets TSLP and IL-33, potentially offering new treatment options for respiratory diseases like COPD and asthma [4][5]. - The agreement includes an upfront payment of $75 million and up to $995 million in milestone payments, reflecting the company's innovative capabilities and the market potential of the self-immune field [5][6]. - The company is recognized as a leader in domestic self-immune innovative drugs, with a mature pipeline entering a monetization phase and ongoing collaborations with global giants to expand market reach [8]. Company Overview - Latest closing price: HKD 25.26 - Total shares: 2.27 billion, with a market capitalization of HKD 57 billion - 52-week high/low: HKD 36.50 / HKD 5.95 - Debt-to-asset ratio: 80.94% - Price-to-earnings ratio: -27.3 [3]. Financial Projections - Expected revenue growth rates for 2025-2027 are 123%, 98%, and -33%, respectively, with EPS projected at -0.72, 0.48, and -0.72 CNY per share [8][10]. - The company anticipates a significant increase in operating income, with projections of HKD 354 million in 2025 and HKD 703 million in 2026, before a decline to HKD 473 million in 2027 [10][11].