China Post Securities released a research report stating that bispecific antibodies (BsAbs) in the autoimmune field have the potential to reshape the current treatment landscape, particularly in respiratory diseases such as asthma and COPD, where existing therapies offer significant room for iteration. The firm is optimistic about the market potential of TSLP-targeting BsAbs in this space. The advancement of Lunsekimig's Phase 3 clinical trials also signals increased confidence in the efficacy of TSLP/IL-13 BsAbs for COPD treatment.

In the Th2-driven disease atopic dermatitis (AD), KEYMED BIO-B's (02162) CM512 has demonstrated deep remission potential, further reinforcing the broad-spectrum applicability of TSLP-targeting BsAbs. Key highlights from China Post Securities include:

**Clinical Updates in Autoimmune BsAbs** 1. **Sanofi’s Lunsekimig (TSLP/IL-13 BsAb) enters Phase 3 and completes first patient dosing**: On September 24, global clinical trial records showed that Sanofi’s TSLP/IL-13 BsAb Lunsekimig (SAR443765) progressed to Phase II/III, initiating two trials (THESEUS and PERSEPHONE) for COPD. The studies aim to enroll 1,884 patients to evaluate the efficacy and safety of subcutaneous Lunsekimig (two doses) versus placebo in poorly controlled eosinophilic COPD. The primary endpoint is the annualized rate of moderate-to-severe COPD exacerbations from baseline to Week 48. By October 24, Sanofi confirmed the first patient dosing in its Q3 earnings call. The Phase 3 progression underscores the therapeutic promise of TSLP/IL-13 dual targeting in respiratory diseases.

2. **KEYMED BIO-B’s CM512 (TSLP/IL-13 BsAb) reports Phase 1 AD data**: At Week 12, the 300mg dose group achieved EASI-75 and EASI-90 (≥90% reduction in eczema severity) response rates of 58.3% and 41.7%, respectively, versus 21.4% and 0% in the placebo group. CM512’s strong EASI-90 performance suggests deep and durable remission benefits. Its extended half-life may reduce dosing frequency, improving patient compliance.

**Sustained Trading and R&D Activity** 1. **BD Deal**: On October 28, QX Biotech and Roche entered a global exclusive agreement for QX031N, a long-acting BsAb targeting TSLP/IL-33, with a $75M upfront payment and up to $995M in milestones plus tiered royalties. QX031N is a potential novel therapy for COPD and asthma.

2. **CStone Pharmaceuticals (2616.HK) showcased CS2015 (OX40L/TSLP BsAb) at the 2025 ACAAI meeting**, highlighting preclinical efficacy.

**Risk Factors**: - Delays in innovative drug development; - Intensified market competition; - Geopolitical risks; - Unexpected policy changes.