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Industry Update: 2023 ASCO Conference on CLDN182 Drugs

The 2023 American Society of Clinical Oncology (ASCO) conference highlighted significant advancements in domestic CLDN182-targeting innovative drugs within the pharmaceutical biotechnology sector. Key developments include:

• Event Overview: Creative Bio Group presented updated data for its Osemitamab (TST001) as a first-line treatment for gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in an I/IIa phase trial. Stone Pharma also debuted clinical results for its CLDN182-ADC product, SYSA1801, in treating CLDN182-expressing advanced solid tumors. These drugs showed promising efficacy and safety profiles, positioning them as potential leaders in early and later-line therapies.

• Osemitamab Performance: Osemitamab outperformed Zolbetuximab in clinical outcomes. With an objective response rate (ORR) exceeding Zolbetuximab and a median progression-free survival (mPFS) of 95 months versus 82 months, it demonstrated broader patient eligibility, including lower CLDN182 expression levels. Common side effects were manageable gastrointestinal events.

• SYSA1801 Advances: Stone Pharma's SYSA1801 ADC achieved high response rates (ORR, 47.1%) and disease control rates (DCR, 62.7%) in gastric cancer patients, including those who had prior CLDN182-targeted therapy failures. It showed good safety and tolerability, with plans for further clinical phases.

• Competition and Other Drugs: Comparative analysis with doses like lower CLDN182 expression cutoffs and DCR rates, outperformed other agents such as Zolbetuximab andASKB589. The ASCO session also covered other CLDN182 drugs, like the CAR-T product CT048 by Cytation, showing promise but needing more data.

• Risks: Potential issues include suboptimal clinical trial results, delays in commercial partnerships, and increased competition from other CLDN182 drugs entering the G/GEJ adenocarcinoma market.

• Investment Advice: The report maintains a "stronger than market" rating, emphasizing potential for these drugs to outperform due to their enhanced efficacy and patient coverage.

Additional points: The drugs primarily target G/GEJ adenocarcinoma, with a focus on improving response rates and tolerability for late-stage patients. Risks are noted for unmet expectations in trials or market dynamics.