Innovent Biologics (1801) Investor Update summary

Industry transformation and innovation landscape

• China's biopharma sector has rapidly evolved from generics to global innovation, with a surge in first-in-class and best-in-class drug development, especially in oncology and biologics.

• Regulatory reforms, capital influx, and talent return have accelerated R&D, enabling faster drug approvals and increased accessibility and affordability for patients.

• Partnerships with multinational pharma and robust clinical trial execution have positioned China as a leader in novel targets and modalities, such as bispecific antibodies, ADCs, and cell therapies.

• Chinese data reliability and execution speed are now recognized globally, with repeated validation by international partners.

• The industry is entering a golden era, with China-originated innovations gaining global respect and market share.

R&D strategy and pipeline highlights

• Focus areas include next-generation immuno-oncology (IO), advanced ADC platforms, and multi-specific antibody technologies targeting hard-to-treat tumors.

• IBI363, a PD-1/IL-2α-bias bispecific antibody, exemplifies disruptive innovation, showing strong efficacy in cold tumors like mucosal melanoma, lung cancer, and CRC, with global multi-center trials underway.

• Dual payload and bispecific ADCs are advancing, offering improved safety, efficacy, and broader patient coverage, with several assets in phase I-III trials in China, Australia, and the U.S.

• The pipeline includes trispecific antibodies and novel cytokine-based therapies, aiming to break through efficacy ceilings and address IO resistance.

• Ambitious goals are set for global registration, with targets for multiple assets in late-stage trials and U.S. market entry by 2030.

Melanoma: Unmet needs and epidemiology

• Acral and mucosal melanoma are predominant in China, with poor prognosis and low response to immunotherapy compared to cutaneous melanoma in Western populations.

• Immunotherapy-treated melanoma patients globally have limited benefit from subsequent therapies, with ORR often below 20%.

• Acral and mucosal subtypes exhibit lower tumor mutation burden and higher immunosuppressive cell infiltration, contributing to innate immune resistance.