InnoCare Releases 2022 Mid-Year Results and Business Highlights

BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced 2022 mid-year results which ended on June 30, 2022.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: "The announcement of 2022 mid-year results coincides with our seventh anniversary. In the challenging macro environment, we continue to make more achievements despite all the difficulties, and make breakthroughs in various fields in the first half of 2022: sharp revenue growth with orelabrutinib’s inclusion in China’s National Reimbursement Drug List (NRDL); the first prescription of tafasitamab in combination with lenalidomide in Boao Hope City and launch of registrational trial in mainland China; accelerating the pace of innovation and clinical development with 11 drug candidates entering clinical trials in a bid to meet the unmet clinical needs; advancing our international collaboration projects with Biogen and Incyte smoothly... "

Financial Highlights

• The revenue increased by 142% year-on-year from 102 million¹ for the six months ended 30 June 2021 to 246 million for the six months ended 30 June 2022, due to the increase of sales of orelabrutinib by 115% from 101 million to 217 million year-on-year after its inclusion in China’s NDRL.
• The research and development expenses increased from 185 million for the six months ended 30 June 2021 to 274 million for the six months ended 30 June 2022, mainly due to more drug candidates entering clinical trials and more ongoing phase III trials.
• The loss for the period excluding the impact of foreign exchange increased from 233 million for six months ended 30 June 2021 to 286 million for the six months ended 30 June 2022. The unrealized foreign exchange loss² in the first half was 160 million.
• The cash and cash equivalents³ slightly decreased from 6,550 million by the end of 2021 to 6,519 million for the six months ended 30 June 2022.

By now, InnoCare has built a robust pipeline, with orelabrutinib and tafasitamab at the commercial stage, 11 clinical stage assets and five other IND enabling stage candidates. Over 30 clinical trials are ongoing in China and globally.

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¹ Currency in the financial highlights refers to RMB
² Unrealized exchange loss because of exchange rate changes, which has not actually incurred.
³ Cash and cash equivalents refer to cash, bank balance and investments measured at fair value investments

Blood Tumor

Orelabrutinib (BTK inhibitor)

There are multiple registrational and exploratory trials ongoing for blood tumor in China and the U.S.

• Orelabrutinib’s supplemental New Drug Application (sNDA) was accepted 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.
• The sNDA for R/R waldenstrom’s macroglobulinemia (WM) was accepted by the NMPA.
• 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 more than halfway.
• In the U.S., a Phase II registrational trial for R/R Mantle Cell Lymphoma (MCL) is expected to complete patient enrollment in 2022.
• 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.
• Latest clinical data of orelabrutinib in combination of anti-PD-1 antibody in the treatment of relapsed or refractory primary central nervous system lymphoma (PCNSL) was presented at the European Association of Hematology (EHA). All patients were evaluable for response. The overall response rate (ORR) was 61.5%, with 38.5% complete remission (CR/CRu) and 23% partial remission. The combination is generally safe and well tolerated.
• Phase III registrational trial for first-line treatment of MCL is conducted in China.

ICP-B04 (Tafasitamab)

• The first prescription of tafasitamab in combination with lenalidomide was filled in China at the Ruijin Hainan Hospital for an eligible DLBCL patient.
• The Company initiated the phase II registrational trial to support approval in mainland China.
• The 2022 edition of the Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines was released. Tafasitamab in combination with lenalidomide was listed as a Level II recommended treatment for adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplantation (ASCT).
• The Biologics License Application (BLA) for tafasitamab was submitted in Hong Kong and will be submitted in Macao. Once approved in Hong Kong or Macao, this innovative drug can benefit patients in the Greater Bay Area.
• The strategic collaboration with Incyte will not only offer a good opportunity to explore the potential clinical benefit to combine tafasitamab with orelabrutinib and InnoCare’s other assets for the treatment of B-cell malignancy, but also enhance InnoCare’s strength in the field of hematology and oncology.

ICP-B02 (CM355)

• The first patient in China was dosed in clinical trial of CM355, a CD20xCD3 bispecific antibody developed by InnoCare and Keymed, for the treatment of CD20+ B-cell malignancies. CM355 binds to CD20 on the tumor cells and CD3 on the T cells, redirects and activates T cells to eradicate tumor cells through T-cell Directed Cellular Cytotoxicity (TDCC) in the treatment of CD20+ B-cell malignancies.

ICP-490

• The IND application of ICP-490 was accepted by the NMPA. ICP-490 was developed from InnoCare’s molecular glue platform. ICP-490 will be developed for the treatment of r/r multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL), including DLBCL.

ICP-248

• The IND application of BCL2 inhibitor ICP-248 was accepted by the NMPA. ICP-248 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.

Autoimmune Diseases

Orelabrutinib

• Phase II trial for systemic lupus erythematosus (SLE) delivered positive results
  • In all evaluable patients, the SLE Response Index (SRI)-4 response rates at week 12 were 50.0%(7/14), 61.5%(8/13) and 64.3%(9/14) in patients treated with orelabrutinib at 50 mg, 80 mg and 100 mg respectively, compared with 35.7%(5/14) in patients treated with placebo, which indicated a trend of dose-dependent improvement.
  • Trends of reduction in proteinuria level and improvement of immunologic biomarkers were observed.
  • Further clinical development of orelabrutinib in SLE patient is under final discussion.
• Phase II trial for multiple sclerosis (MS) in collaboration with Biogen is progressing to the final stage of patient enrollment.
• Phase II clinical trial of Orelabrutinib for the treatment of primary immune thrombocytopenia purpura (ITP) will complete patient enrollment soon.
• Phase II clinical trial of orelabrutinib for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in China was initiated.

ICP-332

• Phase I clinical trial of the novel tyrosine kinas 2 (TYK2) inhibitor was completed, showing a positive safety profile. Phase II trials for the treatment of atopic dermatitis (AD) and psoriasis were initiated.

ICP-488

• First cohort of phase I trial was completed. ICP-488 is a potent and selective TYK2 allosteric inhibitor, binding to the TYK2 JH2 domain, developed for the treatment of inflammatory diseases such as psoriasis, SLE and inflammatory bowel disease (IBD).

Solid Tumor

ICP-192 (Gunagratinib)

• Completed dose escalation ranging from 2 mg to 26 mg with no dose-limiting toxicities (DLT) observed.
• 20 mg dose of gunagratinib showed good efficacy in cholangiocarcinoma patients. According to the data posted at ASCO, among the patients who have completed at least one tumor assessment, the ORR was 62.5% and the disease control rate (DCR) was 100%.
• Well positioned to enter potential registrational trial in cholangiocarcinoma.
• Progressing Phase II trial in urothelial cancer in China.
• Progressing basket trial, including gastric and head & neck cancer in China, Australia and U.S.

ICP-723

• ICP-723 is a second generation TRK inhibitor, which overcomes acquired resistance to the first generation of TRK inhibitor.
• Phase I dose escalation trials were treated with ICP-723 at doses of 1 mg to 16 mg once daily. ICP-723 was safe and well tolerated with no DLT observed.
• 100% ORR was observed in various types of solid tumors carrying NTRK gene fusion positive at dosages of 4 mg and above.
• Well positioned to enter potential registration trial in China.
• Study to expand potential use in adolescent and pediatric patients.
• Clinical trial was initiated in the U.S.

ICP-189

• The first patient was dosed in clinical trial of the novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189 in China. ICP-189 is developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. ICP-189 has entered into clinical stage in China and the U.S.

ICP-033

• The first patient was dosed in clinical trial of the novel RTK (Receptor Tyrosine Kinase) ICP-033 in China. ICP-033 is a multi-kinase inhibitor mainly targeting discoid in 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 will be potentially used as monotherapy and/or in combination with immunotherapy and other targeted drugs to treat liver cancer, renal cell carcinoma, colorectal cancer and other solid tumors.

ICP-B05 (CM369)

• The NMPA accepted the IND application for monoclonal antibody CM369 targeting CCR8 jointly developed by InnoCare and Keymed Biosciences. CM369 is an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody and a potential first-in-class drug. It will be developed as a monotherapy or combined with other therapies to treat advanced solid tumors, including lung cancer, digestive tract cancer, etc.

Other Corporate Development

• Financing
  The China Securities Regulatory Commission approved the InnoCare’s application for the registration of the Proposed RMB Share Issue on Sci-tech Innovation Board of Shanghai Stock Exchange.

• Manufacturing
  • Guangzhou: InnoCare Guangzhou site was approved for commercial production of orelabrutinib starting from June 30. The approval marked the embarking of InnoCare’s self-production, thereby providing patients with high-quality products and services.
  • Beijing: The ground-breaking ceremony of InnoCare Innovative Drug Site was launched. Integrating the headquarters, research and development center and large molecule production base, this site can meet the company's growing business needs.
• Authoritative Certificates
  InnoCare was recognized as “technologically-advanced small giant” by Beijing Government Agency due to its innovation capability and market competitiveness in the pharma industry. The “technologically-advanced small giant” enterprises have become the key to improve the stability and competitiveness of the industrial ecosystem and supply chain.
  
  Orelabrutinib was awarded with the "Beijing New Technology and New Product (Service) Certificate", recognized by five major government departments in Beijing including Science & Technology Commission, Commission of Development and Reform, Bureau of Economy and Information Technology, Commission of Household and Urban-Rural Development and Bureau of Market Supervision and Administration.

“Looking forward to the second half of 2022, we will continue our efforts to fulfill our mission of ‘Science drives innovation for the benefit of patients’, strengthen the development of our R&D platform, accelerate clinical trials globally, and actively explore international business opportunities to further unleash our potential for innovation and create greater value for the society,” added Dr. Cui.

To know more about the detailed financial data and business update of InnoCare 2022 mid-year results, please log in https://cn.innocarepharma.com/en/investor-relations/.

Conference Call Information

InnoCare will host a conference call and webcast on Aug. 22, 2022 at 9:00 a.m. Beijing time. Participants must register in advance of the conference call. Details are as follows:

Register below if you are outside Mainland China: https://morganstanley.webcasts.com/starthere.jsp?ei=1559134&tp_key=510cd87f77

Register below if you are within Mainland China: https://morganstanley.gmwebcasts.cn/starthere.jsp?ei=1559134&tp_key=510cd87f77

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 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 lymphoma, 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 United States.