Gyre Therapeutics (GYRE) investor relations material

Corporate strategy and structure

• Formed by merging two entities to cover the full pharmaceutical value chain from discovery to commercialization, leveraging strengths in both early-stage R&D and established commercial operations in China.

• Operates wet labs in Shanghai, a commercialization team in Beijing, and R&D and strategic leadership in San Diego, enabling global coordination and efficient resource allocation.

• Generates cash flow from profitable China operations to fund broader R&D, allowing parallel development of multiple products and reducing risk.

• Maintains flexibility to advance programs in China or globally based on data, risk, and market validation, with decisions tailored case by case.

• Business model is considered difficult to replicate due to the need for sustained revenue and integrated infrastructure across geographies.

R&D and clinical pipeline

• Prioritizes oncology, autoimmune diseases, and pain, with a focus on dual degrader and degrader-antibody conjugate platforms for enhanced potency and safety.

• Top programs include CDK2/cyclin E degrader (targeting resistant and overexpression cancers), TYK2/JAK1 degrader (for autoimmune diseases), and a dual TrkA/TrkB degrader for cancer-induced bone pain.

• CDK2/cyclin E program is expected to enter clinical trials early next year, aiming for improved efficacy and safety in multiple cancer types.

• Degrader-antibody conjugates are anticipated to comprise a significant portion of the future portfolio, leveraging China's ADC expertise.

• Data-driven prioritization ensures only the most promising programs advance to global development.

Commercial operations and revenue model

• Commercial infrastructure in China includes a nationwide sales network of about 500 people and in-house manufacturing, supporting rapid product launches.

• Existing lung fibrosis drug demonstrates lifecycle management and market reach, with preparations underway for a second product targeting HBV-associated liver fibrosis.

• Pending NDA approval for HBV liver fibrosis could significantly boost near-term revenue and support further R&D.

• Revenue from China operations funds internal research, while partnerships remain a key strategy for validation and additional cash flow.

• Commercial experience and infrastructure enable efficient scaling and launch of new products, especially in fibrosis and oncology.