InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.
Financial Highlights
● Revenue increased by 18.1% to RMB738.5 million in 2023, including RMB670.7 million from orelabrutinib, an increase of 18.5%, mainly due to the continuous and rapid ramp-up of orelabrutinib sales.
● Gross Profit increased by 26.6% to RMB610.1 million in 2023, with a gross profit margin of 82.6%, representing an increase of 5.5%, mainly due to the increase of orelabrutinib sales and the reduction in the unit cost of sales.
● Research and Development Expenses increased by 17.5% to 751.2 million in 2023, primarily due to heightened spending on global clinical trials that have made significant progress and strategic investments in early-stage candidates poised to become key future assets.
● The Loss decreased by 27.8% to RMB645.6 million.
● Cash and Bank Balance stood at approximately RMB8.2 billion. With this robust cash position, the Company is well-positioned to expedite the clinical development of key projects and invest in a competitive pipeline.
Accelerating Pipeline Development for the Benefit of Patients
In 2023, InnoCare has continued to advance its robust pipeline across various clinical stages, continuously unleashing the power of innovation to meet unmet medical needs. Orelabrutinib has become the first and only BTK inhibitor approved for the treatment of relapsed or refractory Marginal Zone Lymphoma (r/r MZL) in China, an indication which has been included in the updated 2023 National Reimbursement Drug List (NRDL) without a price cut. The Company has continuously forged ahead on the road to improving public health. Additionally, the Phase II study results of our novel TYK2 inhibitor, ICP-332, met the primary endpoints in patients with moderate-to-severe atomic dermatitis. From research, clinical development, manufacturing, commercialization, to global collaboration, InnoCare not only established an integrated platform, but also formulated a clear growth strategy aimed at benefiting patients worldwide as we embark on the Company 2.0 phase.
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.
Orelabrutinib
Orelabrutinib was approved for the treatment of relapsed/refractory marginal zone lymphoma (r/r MZL) in April 2023 and included in the NRDL. 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 the 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 the third quarter of 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 third quarter of 2024.
The Company is initiating a global Phase III study of orelabrutinib for the first-line treatment of MCL.
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 international commercial markets. The Company expects to submit r/r MZL NDA in Singapore in 2024.
The Company is initiating a Phase III MZL confirmatory study with...
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