InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced 2021 annual results as of 31 December 2021.
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “We are delighted to announce 2021 results on the occasion of our 2nd anniversary of listing on Hong Kong,China, Stock Exchange. We have witnessed an unusual year 2021, in which we overcame tremendous difficulties and challenges and achieved many significant milestones. We have achieved satisfactory results in the first year of commercialization. The inclusion of orelabrutinib in the National Reimbursement Drug List (NRDL) at the end of 2021 will help access to more patients. We have made major breakthroughs in internationalization by reaching license-out and license-in collaboration with Biogen and Incyte respectively. We have deepened our efforts in innovation and accelerated the progress of our global multicenter clinical trials so as to further advance our drug candidate to benefit more patients…”
Financial Highlights
• The revenue increased sharply from 1.4 million for the year ended 31 December 2020 to 1.043 billion for the year ended 31 December 2021, due to sales of orelabrutinib and upfront payment from Biogen.
• The research and development expenses increased from 402.8 million for the year ended 31 December 2020 to 721.6 million for the year ended 31 December 2021, primarily due to the upfront payment of tafasitamab license-in, etc.
• The cash and cash equivalent increased from 3.9696 billion by the end of 2020 to 6.5505 billion by the end of 2021.
• The loss for the reporting period decreased from 391.9 million for the year ended 31 December 2020 to 66.7 million for the year ended 31 December 2021, mainly due to the increase of revenue, etc.
(Note: Currency: RMB)
Key Highlights and Milestones
Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib
• Commercial achievements
InnoCare successfully launched the first prescription of orelabrutinib in mid-January 2021. InnoCare’s commercial team about 250 experienced members rapidly covered over 1000 leading hospitals in more than 260 cities all over China by the end of 2021, generating a gross revenue of RMB 241 million.
In December 2021, orelabrutinib was included in China’s NRDL to help access to more patients in 2022 and beyond.
• Business development
In September 2021, InnoCare received the upfront payment of US$ 125 million from Biogen based on the license-out agreement for orelabrutinib for the potential treatment of multiple sclerosis (MS). In addition, InnoCare is eligible to receive up to US$ 812.5 million in potential development milestones and commercial payments should the collaboration achieve certain development and commercial milestones. The Company is also eligible to receive a tiered royalties in the low to high teens percentage rate on potential future net sales resulting from the collaboration.
Currently, the global Phase II trial for MS is ongoing in US, Europe and China.
• R&D development
Orelabrutinib for the treatment of Systemic Lupus Erythematosus (SLE)
Orelabrutinib Phase II trial for the treatment of SLE was completed at the end of 2021.
The Phase II results showed that oral orelabrutinib was safe and well tolerated in patients with mild to moderate SLE. A dose-dependent efficacy was observed in all treated evaluable patients. The SLE Responder Index (SRI)-4 response rates at 12-week were 35.7%, 50.0%, 61.5% and 64.3% in patients treated with placebo, 50 mg/day, 80 mg/day and 100 mg/day of orelabrutinib respectively.
Treatment with orelabrutinib led to a reduction in levels of proteinuria, and improvements of immunologic markers, including reduced immunoglobulin G, increased complements C3 and C4.
Further clinical development of orelabrutinib in SLE patient is warranted and planned.
Orelabrutinib for the first-line treatment of MCD DLBCL
A Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of orelabrutinib plus R-CHOP versus placebo plus R-CHOP in first-line treatment of patients ...
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