TYK MEDICINES-B (02410) announced its 2025 interim results, showing research and development costs of RMB 88.758 million, narrowing by 35.6% year-on-year; administrative expenses of RMB 38.775 million, decreasing by 3.3% year-on-year; and net loss attributable to owners of approximately RMB 112 million, narrowing by 48.79% year-on-year.
Since its establishment in 2017, the group has built a pipeline consisting of 11 drug candidates, including core product TY-9591, seven clinical-stage products, and three preclinical or early clinical development stage products. The company is currently preparing a conditional New Drug Application (NDA) for TY-9591 for first-line treatment of epidermal growth factor receptor (EGFR) mutation lung cancer brain metastasis, and is conducting a registrational Phase III clinical trial in China for TY-9591 monotherapy as first-line treatment for locally advanced (Stage IIIb to IV) or metastatic NSCLC with EGFR L858R mutations.
The company will continue to focus on market demand and deepen research and development innovation of self-developed frontier products. Leveraging artificial intelligence model technology, the company will strengthen collaborative cooperation between internal teams and top international teams to efficiently advance new molecule development. Additionally, while relying on internal teams, the company actively collaborates with external AI drug discovery platforms, striving to achieve more breakthrough progress in drug development to continuously enhance research efficiency and core value, inject new momentum for business upgrading and development, and ultimately help the company achieve long-term sustainable development goals.
The "New Solid Dosage Manufacturing Facility Project" is the company's industrialization project, adding tablet and capsule production lines. Upon completion, the company's annual production capacity will reach 150 million tablets or capsules, meeting both clinical drug production and partial commercialization production requirements for TY-9591. The Phase I project completed civil construction acceptance on June 30, 2024, with Phase I production line construction expected to complete GMP compliance certification by 2026 and achieve production readiness. The company believes this project's completion will provide production support for commercializing more pipeline products.
The company's commercialization team has completed initial establishment, with core management members possessing extensive promotion and commercialization operation experience. Moving forward, the company will steadily advance systematic team building to precisely match full-scenario commercialization promotion requirements.
The company will continue to aggregate multi-dimensional advantages of capital, talent, and technology, on one hand improving the functional layout of clinical research platforms, and on the other hand accelerating industrial base construction progress, with dual-wheel drive for commercialization implementation. Meanwhile, the company plans to systematically build sales and marketing systems through a combination of internal efforts and external partner collaboration, leveraging partners' mature market operation experience, extensive channel networks, and comprehensive resource reserves to form complementary commercialization synergy.