InnoCare Releases 2022 Annual Results and Business Highlights

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 disease (IBD).

ICP-332

• Developed for the treatment of various autoimmune disorders, the Company has completed the Phase I clinical trial of ICP-332. Based on the data of safety, PK/PD, and biomarkers with no significant decrease of platelet and hemoglobin, InnoCare initiated Phase II study in atopic dermatitis (AD).

Building A Leading Franchise in Hema-Oncology

With Orelabrutinib as a backbone therapy and the support of our abundant pipeline in hematology, such as Tafasitamab, ICP-248, ICP-490, ICP-B02 and potential future internal and external pipeline development, InnoCare aims to become a leading player in hematology in China and worldwide by covering multiple myeloma (MM), Non-Hodgkin Lymphoma (NHL), and Leukemia by single or combo therapy. A particular combination therapy toolkit is well designed and aims to position a full coverage of DLBCL.

Orelabrutinib (BTK inhibitor)

• Orelabrutinib’s supplemental New Drug Application (sNDA) was under priority review by the China National Medical Products Administration (NMPA) for the treatment of patients with relapsed or refractory Marginal Zone Lymphoma (R/R MZL). So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and hope that orelabrutinib can fill the gap in this therapeutic area.

• In the U.S., patient enrollment of a Phase II registrational trial for R/R Mantle Cell Lymphoma (MCL) was completed, and expect to submit NDA in 2024.

• Orelabrutinib was approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with R/R MCL, which marks the commercialization of InnoCare go international.

• Phase III registrational trial for the first-line treatment of Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) is conducted in China. Patient enrollment is expected to be completed this year.

• Strengthen development in diffuse large B lymphoma (DLBCL)

• A Phase III registrational study of orelabrutinib for the first-line treatment of MCD DLBCL was initiated.

• The latest data of orelabrutinib in the treatment of DLBCL in a real-world analysis were released at the 2022 American Society of Clinical Oncology (ASCO). Orelabrutinib-containing regimens demonstrated encouraging efficacy and well-tolerated safety profile among patients with MCD DLBCL.

• A comprehensive tool-kit including orelabrutinib, tafasitamab, ICP-B02 and ICP-490 offers a unique position to treat all stages of DLBCL patients with combination therapies.

ICP-B04 (Tafasitamab)

• The first prescription of tafasitamab in combination with lenalidomide was filed at the Ruijin Hainan Hospital at Bo’ao, who achieved complete response (CR) after 2 cycles of treatment;

• The Company is advancing the registrational trial of tafasitamab in combination with lenalidomide, as well as the exploratory clinical trial of orelabrutinib in Combination with tafasitamab + lenalidomide in China;

• Tafasitamab in combination with lenalidomide was approved by the Department of Health, the Hong Kong Special Administrative Region, China, which will benefit the DLBCL patients in greater bay area;

• Tafasitamab has been included in the overseas Special Drug list of commercial insurance in more than 10 provinces and cities, which improves the access of DLBCL patients in these regions. 

ICP-B02 (CM355)

• ICP-B02 is a CD20xCD3 bispecific antibody. First patient for the treatment of lymphoma was dosed in January 2022 and Phase I dose escalation is progressing. So far, the almost complete B-cell depletion was observed in patients treated with low dose of ICP-B02. The IND application for ICP-B02 subcutaneous (SC) formulation was approved for clinical trial by the CDE in March 2023.

ICP-490

• Novel targeted protein degrader ICP-490 has entered clinical trial in China for the treatment of R/R multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL). ICP-490 is much more potent, which can overcome acquired resistance against earlier-generation of CRBN modulators.

ICP-248

• First subject has been dosed in the clinical trials of BCL2 inhibitor ICP-248, which is developed to treat malignant hematological tumors such as NHL and acute lymphoblastic leukemia (ALL) as single drug or in combination with other drugs such as BTK inhibitor. ICP-248 is expected to have extraordinary blockbuster potential.

Building a competitive drug portfolio for solid tumor in China and worldwide

To benefit patients more, the Company strived to expanding the breadth of the pipeline covering solid tumors through the precision medicine philosophy and intend to provide the right medicine to the right patient at the right time. InnoCare believes the potential best-in-class molecules ICP-192 and ICP-723 will enable the Company to establish a solid initial presence in the field of solid tumor treatment.

ICP-192 (Gunagratinib)

• In January 2023, the latest data of gunagratinib in patients with cholangiocarcinoma (CCA) was presented at 2023 ASCO-GI. Gunagratinib is safe and well-tolerated with high response rate (52.9%) compared to other approved FGFR inhibitors in previously treated patients with locally advanced or metastatic CCA harboring FGR2 gene fusions or rearrangements. Currently, patient enrollment for ICP-192 registrational trial in CCA is ongoing.

ICP-723 (Zurletrectinib)

• Phase II dose expansion study is going with recommended phase II dose (RP2D) at 8 mg, 75% ORR observed in various types of solid tumors carrying NTRK fusion in different dosage. Based on the Proof-of-Concept (PoC) data obtained, InnoCare will promote a registration clinical study of ICP-723 in China.

• The first adolescent patient (12 to 18 years old) has been dosed in clinical trial with ICP-723. This is also the first time that ICP-723 will be evaluated in the clinical study of adolescent patients after showing good safety and efficacy in adult patients. The IND submission for additional pediatric population (<12 years old) was accepted by CDE in January 2023.

ICP-B05 (CM369)

• The first subject has been dosed in the clinical trial of monoclonal antibody ICP-B05 targeting CCR8 jointly developed by InnoCare and Keymed Biosciences. As the potential first-in-class, the drug is developed as a monotherapy or combined with other therapies to treat advanced solid tumors, including lung cancer, digestive tract cancer, etc.

ICP-189

• The clinical trials of Novel SHP2 allosteric inhibitor ICP-189 are conducted in China and the U.S., developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. As of 8 February 2023, dosage has been escalated up to 40 mg with no DLT observed and demonstrated favorable PK profile and long half-life. Preliminary efficacy was observed in ICP-189 monotherapy. One patient with cervical cancer in 20 mg dose cohort achieved confirmed PR.

Other Corporate Development

• STAR Board Listing

On September 21, 2022, InnoCare got listed on the STAR Board of the Shanghai Stock Exchange. 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.

• Manufacturing

Guangzhou: Guangzhou InnoCare has been approved for commercial production of orelabrutinib, and provided this innovative drug to patients in 30 provinces (autonomous regions and municipalities).

Beijing: InnoCare’s Beijing Innovative Drug Base has started construction for the R&D center and large molecule production facility, and is expected to be completed in 2025.