On March 26, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported 2020 annual results which ended on Dec. 31, 2020 (Press release, InnoCare Pharma, MAR 26, 2021, View Source [SID1234577218]).
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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "During 2020, an extraordinary year filled with uncertainty, InnoCare has nonetheless achieved significant progress that builds upon the foundation created by the previous five years of rapid development. The commitment and focus of our employees, along with the support of our partners, has allowed us to reach a series of milestones during the year. We successfully listed on the Hong Kong Stock Exchange (HKEX) on March 23, 2020 despite facing the outbreak of the epidemic and its related impact on the US and worldwide stock markets. InnoCare became the first biotech company listed on HKEX in 2020, thus paving the way for the listing of more Chinese biotech companies on this exchange. Our innovative BTK inhibitor, orelabrutinib, was approved for marketing in China on December 25, 2020. This significant regulatory achievement was predicated upon years of advancement in the laboratory and in the clinic. It marks the entry of Innocare into the commercial stage. At the same time, we have set up a strong commercial team to promote orelabrutinib to benefit more Chinese patients. We completed the construction of the first phase of the Guangzhou drug production site in only 16 months. In addition to the approval of orelabrutinib, our drug pipeline has been progressing on a timely basis, achieving a series of milestones in the fields of malignant tumors and autoimmune diseases."
"Looking forward to 2021, we will continue to advance our product pipeline. We will continue to push forward our clinical development and more drug candidates into clinal stage. In the next 18 months, we expect to have six to eight drug candidates approved for clinical trials, which will bring our total number of drug candidates in clinic to over 10. Meanwhile, our commercial team will continue to explore strategic business opportunities so that orelabrutinib can benefit more patients," added Dr. Cui.
Product Highlights and Milestones
Orelabrutinib
On Dec. 25, 2020, orelabrutinib received approval from the National Medical Products Administration (NMPA) for the treatment of patients with r/r CLL/SLL and the treatment of patients with r/r MCL. Currently, InnoCare’s commercial team is actively marketing orelabrutinib to benefit more patients.
Over 400 patients have been dosed with orelabrutinib across all of our B-cell malignant cancer trials, showing favorable safety and efficacy profiles.
The registrational trail for r/r WM has completed patient enrollment. It is expected to submit the NDA in the first half of 2022.
The registrational trial for r/r MZL is expected to complete patient enrollment in the second half of 2021.
Both phase III trial for orelabrutinib as a first-line treatment for CLL/SLL and phase III trial of orelabrutinib in combination with R-CHOP as a first-line treatment for MCL were initiated.
Phase II trial for r/r CNSL has been making progress.
Phase I trial of orelabrutinib in combination with next generation CD20 antibody MIL-62 is near completion. The preliminary clinical results are promising, which is expected to be announced in the second half of 2021.
Phase II trial for r/r MCL was initiated in the U.S., which was granted Orphan Drug Designation by the U.S. FDA in the fourth quarter of 2020.
In addition to oncology, the use of orelabrutinib for the treatment of various autoimmune diseases is undergoing. Global Phase II trials for MS in the U.S., Europe and China was in progress. And in China, phase IIa trial for SLE was launched.
ICP-192 (gunagratinib)
Phase I trial of gunagratinib was completed, showing good tolerability. Phase II trials has been progressing well. Of the 30 patients that were dosed, 12 patients with FGF/FGFR gene aberrations, the ORR was 33.3% including 1 cholangiocarcinoma patient (8.3%) achieving CR and 3 patients (25%) with PR. The DCR was 91.7% (11 of 12 patients)
In the U.S., first subject dosing completed earlier in 2021.
ICP-723
Phase I clinical trial in China was conducted to assess the safety, tolerability and PK of ICP-723 in advanced solid tumors. In the phase I dose escalation, two cohorts (1 and 2 mg) were completed and no treatment related serious AE (SAE), and no DLT were observed. Dose was escalated to 3 mg in the third cohort and patient with NTRK gene fusion was already enrolled for efficacy evaluation.
InnoCare has a strong pipeline of IND-enabling stage drug candidates, and the Company has been pushing into clinical stage.
In the field of autoimmune diseases, InnoCare has ICP-332, ICP-488 and ICP-490. ICP-332 is a small-molecule inhibitor of Tyrosine Kinase 2 (TYK2), which is developed for the treatment of various autoimmune disorders. ICP-488 is a small molecule binder of the pseudokinase domain (Janus Homology 2 or JH2) of TYK2, which is developed for the treatment of inflammatory diseases such as psoriasis and IBD. ICP-490 is a proprietary, orally available small molecule that modulates the immune system and other biological targets through multiple mechanisms of action. By specifically binding to CRL4CRBN-E3 ligase complex, ICP-490 can induce ubiquitination and degradation of transcription factors including Ikaros and Aiolos.
In the field of solid tumors, InnoCare has ICP-189, ICP-033 and ICP-B03. ICP-189 is a potent oral allosteric inhibitor of SHP2 with excellent selectivity over other phosphatases. ICP-033 is a multi-kinase inhibitor mainly targeting discoidin domain receptor 1 (DDR1) and vascular endothelial growth factor receptor (VEGFR) that inhibits angiogenesis and tumor cell invasion, normalizes abnormal blood vessels, and reverses the immunosuppressive state of the tumor microenvironment. ICP-033 is intended to be used in combination with immunotherapy and other targeted therapy drugs for liver cancer, renal cell carcinoma, colorectal cancer and other solid tumors. ICP-B03 is a tumor-conditional pro-interleukin (IL)-15 targeting and changing immune cells inside tumor microenvironment.
In the field of liquid tumors, InnoCare has ICP-490 and ICP-248. ICP-248 is a novel, orally bioavailable B-cell lymphoma-2 (BCL-2) selective inhibitor, which is developed in combination with orelabrutinib for the treatment of AML, ALL, FL, CLL, DLBCL and other hematological malignancies.
Other Corporate Development
On February 3, InnoCare brought on Hillhouse as strategic investor and Vivo Capital increased holdings. The biotech industry needs continuous innovation and capital support. Through joint efforts, InnoCare will develop more high-quality innovative drugs to benefit more patients
In March 2021, InnoCare appointed Dr. Sean Zhang who has rich experience in clinical development as Chief Medical Officer in March 2021, who is based in U.S., demonstrating the Company’s ongoing commitment to globalization
In October 2020, InnoCare appointed Dr. Manish Tandon as VP of Business Development to further strengthen the Company’s BD capabilities.
"After five years of solid and rapid development, InnoCare has established a balanced product pipeline. At the same time, we have built a sound financial system, which laid a good foundation for our businesses," said Dr. Cui.
Financial Highlights
InnoCare’s revenue and other incomes & gains increased from 105.7 million for 2019 to 272.7 million for 2020. As orelabrutinib was approved for marketing, InnoCare’s revenue will become more diversified.
InnoCare’s cash and bank balances increased from 2.2918 billion for 2019 to 3.9696 billion for 2020.
InnoCare’s research and development costs increased from 213.1 million for 2019 to 402.8 million for 2020.
The loss decreased from 2,150.4 million for 2019 to 464.3 million for 2020, including fair value changes of a loss of 1,814.0 million by convertible redeemable preferred shares to common shares after the IPO for 2019 (This loss for 2020 is 141.6 million).
(Note: Currency: RMB, InnoCare financial year refers to Jan. 1 to Dec. 31 for a certain year.)
To know more about the detailed financial data of InnoCare 2020 full year financial report, please log in View Source .
Conference Call Information
InnoCare will host a conference call on March 29, 2021 at 9:00 a.m. Beijing time. Participants must register in advance of the conference call. Details are as follows:
Registration Link: View Source
Conference ID: 4956225
The call will be conducted in English.
Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.