InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced 2022 third quarter results and latest corporate development.
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, “We successfully got listed on the STAR Board of the Shanghai Stock Exchange, which makes InnoCare become the double-listed biotech company and will inject new momentum to the Company’s long-term development. We further uplifted our commercialization capabilities with continued revenue growth of orelabrutinib after its inclusion in China’s National Reimbursement Drug List (NRDL). We accelerated the pace of innovation and clinical development in the field of malignant tumors and autoimmune diseases with 13 drug candidates entering clinical trials in a bid to meet the unmet clinical needs. Our Guangzhou site was approved for commercial production of orelabrutinib…We have achieved high-quality development in various fields, and we are committed to becoming a world leading biopharma company with innovations as the key driving force. "
Financial Highlights
• The revenue reached about RMB442 million in the first three quarters of 2022, including about RMB400 million from drug sales, a year-on-year increase of 129%, mainly due to the continuous growth of orelabrutinib sales after its inclusion in the NRDL;
• The research and development expenses reached RMB475 million in the first three quarters of 2022 due to more on-going projects, with an increase of 30% year-on-year excluding the impact of the upfront payment to Incyte last year;
• The cash and cash equivalents[1] rose to RMB9.23 billion, an increase of 37.5% year on year in the first three quarters of 2022, mainly due to the fund raised from the STAR Board listing;
• The total assets expanded to RMB10.4 billion in the first three quarters of 2022, an increase of 40.7% compared with the end of 2021;
• Excluding the impact of foreign exchange loss, the loss for the first three quarters of 2022 was RMB444 million, mainly due to the increase of research and development expenses. The foreign exchange loss was RMB399 million, which had no actual impact on the Company's business operations.
STAR Board Listing
On September 21, 2022, InnoCare got listed on the STAR Board of the Shanghai Stock Exchange, raising a total of RMB2.92 billion. The listing on the STAR Board will further enhance InnoCare's innovative advantages in blood tumors, solid tumors and autoimmune diseases, and contribute to achieving its strategic goal of benefiting global patients with its self-developed innovative drugs.
Pipeline Progress
InnoCare has built a robust pipeline. Orelabrutinib was in commercial stage with NRDL inclusion, tafasitamab was approved for use in the Boao Lecheng International Medical Tourism Pilot Zone, with 13 drug candidates in clinical trials and several others in IND enabling stage. In addition to monotherapy, InnoCare is also exploring the potential of the drug pipelines in combination with standard therapy or other therapies. The followings are the latest developments:
Ø Blood Tumor
Orelabrutinib
Orelabrutinib is expected to be approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) soon;
The supplemental New Drug Application (sNDA) for orelabrutinib for the treatment of patients with relapsed or refractory Waldenström’s Macroglobulinemia (R/R WM) is under review by the NMPA. A phase II study of orelabrutinib for the treatment of R/R WM patients was published in eClinicalMedicine, a journal owned by The Lancet. At a median follow-up of 16.4 months, the MRR was 80.9%, the overall response rate was 89.4%, and the PFS rate was 89.4% at 12 months[2];
The sNDA of orelabrutinib for the treatment of R/R Marginal Zone Lymphoma (MZL) has been accepted and granted priority review by the NMPA. So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and orelabrutinib is expected to fill the gap in this therapeutic area;
Phase III registrational trial of orelabr...
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