28 March 2023,InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced 2022 annual results as of 31 December 2022.
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “The company achieved high-quality development in various fields in 2022: rapid growth of orelabrutinib sales after its inclusion in the National Reimbursement Drug List (NRDL), oralabrutinib’s approval in Singapore marking the commercialization go international, successful listing on the STAR Board of the Shanghai Stock Exchange, approval of tafasitamab in combination with lenalidomide in Hong Kong and first prescription in Boao, and 13 innovative drugs entering clinical trials... The Company has achieved many milestones in the 1.0 development stage. We are accelerating our concerted efforts towards the goal of Company 2.0, committing to building a leading franchise in Hema-Oncology, competitive drug portfolio for autoimmune diseases and solid tumor, so as to launch more drugs on the market, driving a substantial revenue increase year by year.”
Financial Highlights
The revenue reached about RMB625 million in 2022, including about RMB566 million from orelabrutinib, a year-on-year increase of 163.6%, mainly due to the continuous growth of orelabrutinib after its inclusion in the NRDL;
The research and development expenses reached RMB639 million in 2022. Excluding the impact of the upfront payment to Incyte last year, the R&D expenses increased by 29.0% year-on-year;
The cash and cash equivalents rose to RMB9.56 billion, an increase of 37.4% year on year in 2022, mainly due to the fund raised from the STAR Board listing;
The total assets expanded to RMB10.32 billion in 2022, an increase of 39.5% compared with 2021;
Adjusted loss for 2022 as illustrated under Non-HKFRSs Measure reached RMB 474 million.
Orelabrutinib for the treatment of Multiple Sclerosis (MS)
The 12-week interim analysis data of the MS global phase II trial has met the primary endpoint. Orelabrutinib significantly reduced disease activity in RMS patients. The primary objective of detecting significant reduction in cumulative number of new gadolinium (Gd) + T1 lesions at week 12 compared to placebo was met in all three active treatment groups in a dose-dependent manner. The 50 mg QD, 50 mg BID and 80 mg QD group showed the reduction of 70.1% (P=0.0238), 80.8% (P=0.0032) and 92.1%(P=0.0006) respectively, supporting further development.
Developing B-Cell and T-Cell Pathways in Autoimmune Diseases
The Company has fortified powerful discovery engine in the global frontier targets for the development of autoimmune therapeutics through B-cell and T-cell pathways for the purpose of providing the first-in-class or best-in-class treatments to the massive unmet clinical needs with a promising market potential in global and/or regional markets.
Orelabrutinib
Phase IIa trial for systemic lupus erythematosus (SLE) delivered positive results, initiated the Phase IIb trial for a larger population clinical trial;
Phase II clinical trial for the treatment of primary immune thrombocytopenia purpura (ITP) achieved proof-of-concept (PoC). The data from 22 patients with previous response to glucocorticoids (GC) or intravenous immunoglobulin (IVIG) were analyzed as a sub-group: 75.0% patients at the 50mg arm achieved the primary endpoint.
Phase II clinical trial for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) undergoing in China.
ICP-488
The single ascending doses (SAD) part, two cohorts of multiple ascending doses (MAD) have been completed. ICP-488 is developed for the treatment of inflammatory diseases such as psoriasis, SLE and inflammatory bowel...
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