InnoCare Releases 2022 Third Quarter Results: Star Board Listing for Long-term Growth and Rapid Increase of Orelabrutinib Sales

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 orelabrutinib for the first-line treatment of Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) is expected to complete patient enrollment by mid-year of 2023;

• Phase III registrational study of orelabrutinib for the first-line treatment of MCD subtype diffuse large B lymphoma (DLBCL) is conducted in China. InnoCare has developed a comprehensive tool-kit to treat all stages of DLBCL patients with combination therapies;

• Phase II registrational trial for R/R Mantle Cell Lymphoma (MCL) is conducted in the U.S.

ICP-B04 (Tafasitamab)

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

• Phase II registrational trial of tafasitamab in combination with lenalidomide in China has enrolled about 20% of patients;

• The biologics license application (BLA) for tafasitamab in combination with lenalidomide was accepted by the Department of Health, the Hong Kong Special Administrative Region, China. Once getting approval, it 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-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-248

• BCL2 inhibitor ICP-248 has entered clinical trial, 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-B02 (CM355)

• ICP-B02, a CD20xCD3 bispecific antibody developed by InnoCare and Keymed, is in the clinical study for the treatment of CD20+ B-cell malignancies in China.

Ø  Solid Tumor

ICP-192 (Gunagratinib)

• Initiate registrational trial in cholangiocarcinoma, and progress Phase II trial in urothelial cancer in China;

• Progress basket trial, including gastric and head & neck cancer in China, Australia and U.S.

ICP-723

• The first adolescent patient has been dosed in clinical trial with InnoCare’s second generation pan-TRK inhibitor ICP-723 at the Sun Yat-sen University Cancer Center. This is also the first time that ICP-723 will be evaluated in the clinical study of adolescent (12 to 18 years old) patients after showing good safety and efficacy in adult patients. InnoCare will also expand ICP-723 clinical study to treat pediatric patients (2 to 12 years old);

• Based on the Proof-of-Concept (POC) data obtained, InnoCare will promote a registration clinical study of ICP-723 in China. The Company has also conducted a clinical study of ICP-723 in the United States.

ICP-B05（CM369）

• Monoclonal antibody ICP-B05 targeting CCR8 jointly developed by InnoCare and Keymed Biosciences has entered into clinical stage, 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.

Ø  Autoimmune Disease

Orelabrutinib

• Phase II trial for systemic lupus erythematosus (SLE) delivered positive results, and further clinical development of orelabrutinib in SLE has been initiated;

• Phase II trial for multiple sclerosis (MS) in collaboration with Biogen is progressing to the final stage of patient enrollment;

• Phase II clinical trials of orelabrutinib for the treatment of primary immune thrombocytopenia purpura (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) are undergoing in China.

ICP-488

• Tyrosine kinase 2 (TYK2) JH2 allosteric inhibitor ICP-488 has completed single dose escalation study and started multi-dose escalation trial. ICP-488 is developed for the treatment of inflammatory diseases such as psoriasis, SLE and inflammatory bowel disease (IBD).

ICP-332

• Phase II clinical trials of the novel TYK2 inhibitor ICP-332 for the treatment of atopic dermatitis (AD) of were initiated.

"In the challenging market environment, we still fulfilled the preset goals beyond expectations," said Dr. Cui. "Looking forward, we will continue to maintain our original aspiration, hold on the core value of ‘Science drives innovation for the benefit of patients’, strengthen the product pipelines, and accelerate the business development, in order to leverage our innovations achievements to generate greater values for the society.”

To know more about the detailed financial data of InnoCare 2022 third quarter results, please log in https://cn.innocarepharma.com/en/investor-relations/.

Conference Call Information

InnoCare will host a conference call and webcast on Nov. 14, 2022 at 9:30 a.m. Beijing time. Details are as follows:

Live streaming and online interaction:

http://roadshow.sseinfo.com/roadshowIndex.do?id=11059

Register if you are CICC customers:

https://net.comein.cn/roadshow/home/124797?institute=zjgs

The call will be conducted in Mandarin.

Forward-looking Statement

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

About InnoCare

InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on liquid cancer, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the United States.

[1] Cash and cash equivalents refer to cash, bank balance, investments measured at fair value investments and interest receivable

[2] eClinicalMedicine