CISI FIN released a research report initiating coverage on DUALITYBIO-B (09606) with an "Overweight" rating. The company focuses on the ADC (antibody-drug conjugate) field, leveraging collaborations with global leaders like BioNTech to rapidly advance global multicenter clinical trials, securing a competitive edge.

Key developments include: - **DB-1303** for HER2+ (including high/low expression) endometrial cancer is nearing approval in the U.S. and China. - **DB-1311** shows potential in treating CRPC and other differentiated indications. - Next-gen ADC therapies, including ADC+IO 2.0 combinations, differentiated IO bispecific ADCs, autoimmune ADCs, and novel toxin ADC pipelines, are progressing well, supporting long-term growth.

**Recent Updates**: - On October 23, 2025, DUALITYBIO-B hosted an R&D Day, outlining ADC pipeline progress and future directions. - On November 11, 2025, partner BioNTech showcased clinical plans for DUALITYBIO-B’s ADC candidates combined with PD-L1/VEGF immune antibodies. - On November 14, 2025, the autoimmune ADC **DB-2304 (BDCA2 ADC)** for systemic lupus erythematosus dosed its first patient in the Phase 2a portion of a global 1/2a study. - On November 24, 2025, DB-2304’s single-dose escalation results were presented at AIC 2025, demonstrating strong tolerability and pharmacokinetics. The company will also disclose Phase 1/2a data for **DB-1310 (HER3 ADC)** in HR+/HER2- breast cancer at SABCS 2025.

**Global Clinical Progress**: - **DB-1303 (HER2 ADC)**: U.S. BLA submission for endometrial cancer expected in 2026. A global Phase 3 trial for HR+/HER2-low breast cancer and a China Phase 3 trial for 2L+ HER2+ breast cancer (primary endpoint met in September 2025) are underway, with a China BLA planned by year-end. - **DB-1311 (B7H3 ADC)**: A global Phase 2 basket trial (covering SCLC, CRPC, etc.) is ongoing, with potential in frontline SCLC treatment via combination with PD-L1/VEGF bispecific antibodies.

**Autoimmune ADC Breakthrough**: - **DB-2304 (BDCA2 ADC)** exhibits promising tolerability and pharmacokinetics, positioning it as a potential first-in-class ADC for autoimmune diseases.

**Risks**: Policy changes, intensifying competition, and delays in regulatory approvals.