Innocare guides for ~134% full-year revenue growth in 2025 earnings pre-announcement
Innocare, a high-tech biopharmaceutical company (SSE: 688428; HKEX: 09969), issues preliminary unaudited 2025 annual results.
According to preliminary calculations by the finance department, Innocare expects to achieve revenue of approximately 2.37 billion for the full year of 2025, representing a year-on-year increase of about 134%. Meanwhile, Innocare anticipates its net profit attributable to shareholders to turn profitable for the first time in 2025, reaching approximately 630 million. This is primarily attributed to the continued scaling of commercialization and revenue from global licensing deals activities.
Driven by the increasing market penetration of Orelabrutinib (brand name: 宜诺凯®) for its exclusive indication of Marginal Zone Lymphoma (MZL), the approval and launch of its new first-line treatment indication for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), as well as the approval of Tafasitamab (brand name: Minjuvi®) as China's first CD19 monoclonal antibody for the treatment of relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL), Innocare's product revenue achieved rapid growth in 2025.
In 2025, Innocare continued to efficiently advance its 2.0 strategic goals, achieving a series of important progress in its core pipelines as follows:
Orelabrutinib was approved for first-line treatment of CLL/SLL and included in the National Reimbursement Drug List (NRDL). It was also listed as a Grade I recommendation in the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines for Lymphoma (2025 edition). Currently, all four indications of Orelabrutinib are included in the NRDL, facilitating access for more patients. Additionally, Orelabrutinib was approved in Singapore for the treatment of relapsed/refractory Marginal Zone Lymphoma (MZL).
The innovative therapy Tafasitamab was approved for the treatment of patients with relapsed/refractory DLBCL. This marks the first CD19 monoclonal antibody approved in China for treating R/R DLBCL.
China's first self-developed next-generation TRK inhibitor, Zurletrectinib (brand name: 宜诺欣®), was approved for marketing, indicated for the treatment of adult and adolescent patients (12 years and older) with solid tumors harboring NTRK gene fusions.
Innocare's self-developed BCL2 inhibitor, mesutoclax (ICP-248), is accelerating two registrational Phase III clinical studies. The registrational Phase III clinical trial combining mesutoclax with Orelabrutinib for first-line treatment of CLL/SLL is nearing completion of patient enrollment, while the registrational clinical trial for treating BTK inhibitor-relapsed/refractory Mantle Cell Lymphoma (MCL) is progressing rapidly. Clinical trials for mesutoclax in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) are advancing in China and globally. Mesutoclax was granted Breakthrough Therapy Designation (BTD), making it the first BCL2 inhibitor in China to receive this designation.
Innocare's self-developed novel TYK2 inhibitor, soficitinib (ICP-332), has completed patient enrollment for its Phase III registrational clinical trial in moderate-to-severe Atopic Dermatitis (AD). Concurrently, patient enrollment has also been completed for the Phase II clinical trial of soficitinib in vitiligo. Clinical trials for soficitinib in Prurigo Nodularis, Urticaria, and Psoriasis, among others, are being accelerated.
The Phase II clinical trial for Cutaneous Lupus Erythematosus (CLE) is progressing rapidly.
Innocare's differentiated Antibody-Drug Conjugate (ADC) platform has achieved a breakthrough, with its first ADC innovative drug, ICP-B794, entering clinical trials.