Core Insights - The report from China Post Securities highlights the potential of dual antibodies in the field of autoimmune diseases, particularly in respiratory conditions like asthma and COPD, indicating significant room for improvement in existing therapies. The market potential for TSLP class dual antibodies is viewed positively [1]. Group 1: Clinical Progress of Dual Antibodies - Sanofi's lunsekimig (TSLP/IL-13 dual antibody) has entered Phase III clinical trials, with the first patient dosed on September 24. The trials aim to enroll 1,884 patients to evaluate the efficacy and safety of lunsekimig compared to placebo in adults with eosinophilic phenotype COPD [1]. - The primary endpoint of the studies is the annualized rate of moderate to severe COPD exacerbations from baseline to week 48. The company confirmed the completion of the first patient dosing during the Q3 earnings call on October 24 [1]. Group 2: Efficacy Data and Advantages - The first-phase data for Connoa's CM512 (TSLP x IL-13 dual antibody) in atopic dermatitis (AD) showed promising results, with EASI-75 and EASI-90 response rates of 58.3% and 41.7% respectively at the 300mg dose after 12 weeks, compared to 21.4% and 0% in the placebo group. This indicates a strong potential for deep relief and sustained stability [2]. - CM512's long half-life advantage suggests that it can effectively reduce dosing frequency in clinical use, thereby improving patient compliance [2]. Group 3: Ongoing Transactions and Research Activity - On October 28, Qianxin Biotech entered a global exclusive collaboration and licensing agreement with Roche for QX031N, a long-acting dual antibody targeting TSLP and IL-33, with an upfront payment of $75 million and potential milestone payments up to $995 million. This product is expected to be developed as a new treatment option for COPD and asthma [3]. - BGI Pharma showcased the OX40L/TSLP bispecific antibody CS2015 at the 2025 ACAAI, which demonstrated therapeutic potential in preclinical trials [3].

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]

Core Viewpoint - Sanofi announced preliminary data from the phase II TIDE-Asthma study for its anti-OX40L mAb, amlitelimab, which showed mixed results in treating moderate-to-severe asthma, alongside updates on other respiratory pipeline candidates [1][2][3]. Group 1: Amlitelimab Study Results - The highest dose of amlitelimab did not meet the primary endpoint of annualized exacerbation rate at week 48, while the medium dose showed nominal significance [2]. - At week 60, the medium dose demonstrated clinically meaningful reductions in asthma exacerbations, with a greater reduction observed at the high dose level [3]. - Amlitelimab also led to significant improvements in lung function and asthma control, which were secondary endpoints of the study [3]. Group 2: Other Respiratory Pipeline Developments - Sanofi is developing itepekimab in partnership with Regeneron Pharmaceuticals, currently in two phase III studies for chronic rhinosinusitis with nasal polyps [5]. - Itepekimab is also being evaluated for chronic obstructive pulmonary disease (COPD), with data expected in the second half of 2025 [6]. - Additional studies are ongoing for itepekimab in bronchiectasis and for lunsekimig in high-risk asthma and moderate-to-severe asthma, with data from these studies anticipated in 2026 [8][9]. Group 3: Market Performance - Year to date, Sanofi's shares have increased by 4.9%, contrasting with a 4.9% decline in the industry [4].