InnoCare Pharma (9969) R&D Day 2024 summary

Financial and operational highlights

• Q3 2024 revenue grew 76.3% YoY, with drug sales up 76.3% and YTD sales up 45.2%; net loss reduced by 47.1% and gross margin improved to 86.0%.

• Orelabrutinib sales guidance for 2024 raised to over 45% growth, with Q3 sales up 75.5% YoY and YTD up 45.0%, reaching RMB 693 million.

• Cash and equivalents stood at RMB 7.8 billion as of September 30, 2024, supporting future growth and flexibility.

• Commercialization efforts and hospital access expanded, especially for r/r MZL, CLL/SLL, and MCL indications.

• Multiple NDAs and clinical trials advanced, including two NDA submissions in 2024 and several phase III trials initiated or planned.

Market and pipeline overview

• The global autoimmune disease market is the second largest after oncology, expected to reach $176 billion by 2030, with China’s market projected to exceed $23 billion.

• InnoCare’s pipeline covers hematologic malignancies, autoimmune, and solid tumors, with late-stage assets in Orelabrutinib (BTK), ICP-332 (TYK2/JAK1), ICP-488 (TYK2), and ICP-248 (BCL2).

• Orelabrutinib is the only approved BTK inhibitor for r/r MZL in China and is expanding into autoimmune indications such as MS, ITP, and SLE.

• ICP-332 and ICP-488 are advancing in atopic dermatitis and psoriasis, respectively, with best-in-class potential and phase III readiness.

• The company is pursuing global partnerships and out-licensing for late-stage assets, leveraging differentiated clinical profiles.

Clinical development and product updates

• Orelabrutinib demonstrated efficacy and safety in ITP phase II trials, with a 36.4% primary endpoint response and rapid onset (median 9 days); phase III trial underway.

• ICP-332 showed significant efficacy in phase II atopic dermatitis trials, with rapid itch relief, improved quality of life, and a safety profile similar to placebo.

• ICP-488 achieved PASI 75 response rates of 77.3% and 78.6% at 12 weeks in phase II psoriasis trials, with safety comparable to placebo.

• Both ICP-332 and ICP-488 target TYK2 pathways, offering differentiated mechanisms and broad potential across autoimmune indications.

• Preclinical and early clinical programs include novel small molecules, protein degraders, and biologics targeting B-cells, T-cells, and IL-17 pathways.