InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced 2023 interim results as of 30 June 2023.
Financial Highlights
Revenue increased by 53.5% year-on-year to 377.5 million[1] in the first half of 2023, compared to 246.0 million in the first half of 2022. Sales of orelabrutinib increased by 47.8% YoY to 320.7 million in the first half of 2023, compared to 217.0 million in the first half of 2022. The significant increase resulted from the continuous growth of orelabrutinib after its inclusion in the National Reimbursement Drug List (NRDL).
Research and development expenses increased by 30.9% YoY to 358.1 million in the first half of 2023 from 273.5 million in the first half of 2022, primarily due to the advancement of numerous clinical trials, including global multi-center trials.
Cash and cash equivalents[2] reached 8.7 billion as of 30 June 2023, compared with 6.6 billion as of 30 June 2022, primarily due to the successful STAR Board listing on Sept. 21, 2022.
The adjusted loss for the first half of 2023 as illustrated under Non-HKFRSs[3] measures narrowed to 206.3 million.
Accelerating Pipeline Development in Stage 2.0
InnoCare marked its 8th anniversary on August 18, 2023. For the past eight years, the Company has concentrated on addressing significant market needs in cancer and autoimmune diseases, establishing a comprehensive biopharmaceutical platform with robust in-house research, clinical development, manufacturing, and commercialization strengths. The flagship product, orelabrutinib, has received marketing approval in China and Singapore and has been included in China's NRDL. Additionally, the tafasitamab regimen has secured approval in Hong Kong and Bo’ao, complemented by 13 innovative drugs currently in clinical trials.
In the rapid expansion of Stage 2.0, InnoCare plans to accelerate global clinical trials and research capabilities, with the goal of introducing five to six innovative drugs onto the market within three to five years.
InnoCare’s innovative drug pipeline covers multiple novel targets and indications with significant market potential, including small molecule drugs, monoclonal antibodies, and bispecific antibodies for the treatment of blood tumors, autoimmune diseases, and solid tumors.
Building A Leading Franchise in Hemato-Oncology
With orelabrutinib (BTK inhibitor) serving as the backbone therapy and a key component of InnoCare’s extensive pipeline in hemato-oncology – including tafasitamab (anti-CD19 antibody), ICP-248 (BCL2 inhibitor), ICP-B02 (CD20xCD3 bispecific antibody), ICP-490 (CRBN E3 Ligase modulator), and potential future developments from internal and external sources – InnoCare strives to become a leading player in hemato-oncology both in China and worldwide. Orelabrutinib's exceptional safety and efficacy profiles promise synergistic benefits when combined with other pipeline drugs, such as ICP-248 (BCL2 inhibitor). InnoCare intends to address various segments, such as non-Hodgkin lymphoma (NHL), multiple myeloma (MM), and leukemia, utilizing both single and combination therapies. Particularly, InnoCare has designed a comprehensive combination therapy toolkit aimed at providing effective solutions for diffuse large B-cell lymphoma (DLBCL).
Orelabrutinib
■ Orelabrutinib was approved by the National Medical Products Administration (NMPA) for the treatment of relapsed/refractory marginal zone lymphoma (r/r MZL) in April 2023. Orelabrutinib has thus become the first and only BTK inhibitor for r/r MZL in China, which also marks orelabrutinib’s third indication approved in China.
■ Patient enrollment of the Phase III registrational trial of orelabrutinib for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) was completed in China in the first half of 2023.The Company expects to submit the NDA in 2024.
■ In the U.S., patient enrollment of the Phase II registrational trial for relapsed/refractory mantle cell lymphoma (r/r MCL) was completed. The Company expects to submit the NDA to the U.S. Food and Drug Administration (US FDA) in the middle of 2024.
■ Orelabrutinib was approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with r/r MCL, which marks InnoCare’s entrance onto i...
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