InnoCare Releases 2024 Results and Business Highlights

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2024 annual results as of 31 December 2024.

Financial Highlights

● Revenue of Orelabrutinib increased by 49.1% to RMB 1,000.4 million in 2024, mainly driven by rapid growth of marginal zone lymphoma (MZL) indication and strong commercial execution. Total revenue increased by 36.7% to RMB 1,009.4 million in 2024.

● Gross Profit increased by 42.8% to RMB 871.0 million in 2024, with a gross profit margin of 86.3%, representing an increase of 3.7 percentage points, mainly due to the reduction in the unit cost of sales.

● Research and Development Expenses increased by 8.4% to RMB 814.0 million in 2024, primarily due to increased investment in advanced technology platforms and heightened spending on global clinical trials.

● The Loss decreased by 29.9% to RMB 452.9 million in 2024.

● Cash and Related Accounts Balance stood at approximately RMB 7.8 billion as of 31 December 2024. This robust cash position provides InnoCare with flexibility to expedite clinical development and invest in a competitive pipeline.

Accelerating Globalization 

China's innovative drugs have become a new focus of the global pharmaceutical industry, and its innovation capabilities are increasingly recognized worldwide. In January 2025, InnoCare Pharma and KeyMed Biosciences entered into an exclusive license agreement with Prolium Bioscience (Prolium) for the development and commercialization of ICP-B02 (CM355), a CD20xCD3 bispecific antibody. Under the terms of the agreement, Prolium will have the exclusive right to develop, register, manufacture and commercialize ICP-B02 in the non-oncology field globally and in the oncology field in ex-Asia regions. InnoCare and KeyMed will receive aggregate payments of up to US$ 520 million, including upfront and near-term payments and other payments subject to the achievement of certain clinical, regulatory and commercial milestones, as well as a minority equity stake in Prolium. InnoCare and KeyMed are also eligible to receive tiered royalties on future net sales of any product resulting from the collaboration.

InnoCare will continue to strengthen the globalization of its other promising pipeline assets. As part of its BD strategy, the Company has been actively exploring collaboration and licensing opportunities for key assets, with a focus on expanding its presence outside of China. The Company remains committed to accelerating the global reach of its products through strategic partnerships, as well as strengthening regulatory and clinical capabilities in key markets.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare, said, " 2024 marks the first year of the rapidly evolving InnoCare 2.0. Our commercial growth continued to accelerate, our R&D pipelines achieved key milestones, and our internationalization efforts gained momentum. 2025 marks our 10th anniversary. We will continue to pursue original innovation, advance multiple new molecules into clinical development, and accelerate multiple Phase III registration clinical studies in China and around the world. We will further strengthen our market expansion and establish a long-term successful commercial strategy, and further advance our globalization to bring more innovative projects to the global stage. "

Building A Leading Franchise in Hemato-Oncology

With orelabrutinib as the backbone therapy, it plays a central role in InnoCare’s extensive pipeline in hemato-oncology. Alongside orelabrutinib, tafasitamab’s BLA was accepted, and ICP-248 (mesutoclax) entered into a Phase III clinical trial in combination with orelabrutinib for the fixed-duration treatment of 1L CLL/SLL in the first quarter of 2025. Together, orelabrutinib, tafasitamab and ICP-248 form a robust product combination that will establish a solid foundation in hematology-oncology. With this powerful combination and ongoing developments from both internal and external sources, InnoCare is dedicated to becoming a leading player in hemato-oncology both in China and worldwide. The Company remains committed to addressing major diseases, such as NHL, leukemia and multiple myeloma, through both monotherapies and combination therapies to provide effective solutions for patients globally.

Orelabrutinib

All three approved indications, including relapsed and refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL), r/r mantle cell lymphoma (r/r MCL) and r/r marginal zone lymphoma (r/r MZL), have been covered in the National Reimbursement Drug List while maintaining stable pricing. Orelabrutinib has been approved as the first and only BTK inhibitor for r/r MZL in China. Meanwhile, commercial capabilities have undergone significant enhancement. The dedicated commercial team has been optimized to operate with heightened efficiency and strategic focus, ensuring effective execution of the market initiatives. All of the above factors resulted in an 49.1% increase in orelabrutinib’s revenue in 2024.

● The new drug application (NDA) of orelabrutinib for the first-line treatment of CLL/SLL was accepted in China. 

● In Australia, the NDA of orelabrutinib for r/r MCL was submitted.

● In Singapore, the NDA of orelabrutinib for r/r MZL was submitted.

● The Company is accelerating a global Phase III study of orelabrutinib for the first-line treatment of MCL, and a Phase III confirmatory study of orelabrutinib for MZL.

Tafasitamab

● The NMPA accepted and granted priority review to the Biologics License Application (BLA) for tafasitamab in combination with lenalidomide for adult patients with r/r diffuse large B-cell lymphoma (DLBCL) who are not eligible for Autologous Stem Cell Transplant.

● Based on a single arm, open label Phase II registrational trial of tafasitamab in combination with lenalidomide in patients with r/r DLBCL, the overall response rate (ORR) was 73.1%, with 34.6% of patients achieving complete response.

● The result of a five-year study from L-MIND shows that tafasitamab provided prolonged, durable responses in patients with r/r DLBCL.

● Tafasitamab in combination with lenalidomide was approved in the region of Hong Kong, Macau and Taiwan, and approved for use in Bo’ao and Greater Bay Area with first prescription issued respectively.

Mesutoclax (ICP-248)

● The first patient has been dosed in the Phase III clinical trial of ICP-248 in combination with orelabrutinib as a first line therapy for the treatment of CLL/SLL patients in China.

● As of the latest update, 42 patients with treatment-naïve (TN) CLL/SLL were enrolled and treated with ICP-248 in combination with orelabrutinib, with no clinical or laboratory evidence of tumor lysis syndrome (TLS) observed. At a median combination therapy duration of 5.5 months, the ORR and uMRD (undetectable minimal residual disease) rate were 100% and 46.2% respectively (MRD check point: 12 weeks after initiation of combo treatment).

● The Company is applying for registrational trial of BTKi-treated r/r MCL in China.

● The clinical trials of ICP-248 for the first line treatment of acute myeloid leukemia (AML) are ongoing in both China and globally.

● ICP-248 is a novel, orally bioavailable BCL2 selective inhibitor, developed as monotherapy or in combination with orelabrutinib for the treatment of CLL/SLL, MCL, AML and other NHLs.

ICP-490

● ICP-490 is a proprietary, orally available small molecule that modulates the immune system and other biological targets through multiple mechanisms of action. Phase I/II dose escalation and expansion studies with MM and NHL patients are underway in China.

● ICP-490 in combination with dexamethasone was well tolerated and the preliminary efficacy has been confirmed at the dose levels of 1.0mg + of ICP-490 in combination with dexamethasone in MM patients

Developing B-cell and T-cell Pathways in Autoimmune Diseases

Autoimmune diseases can affect almost every organ in the body and may arise at any

stage of life. The global market for autoimmune disease therapeutics anticipated to reach $185 billion by 2029. The Company has fortified its powerful discovery engine on cutting-edge global targets for the development of autoimmune therapeutics through B-cell and T-cell pathways, with the aim of delivering first-in-class and/or best-in-class treatments to address the massive unmet clinical needs and strong market potential in China and globally.

Orelabrutinib

● MS: In September 2024, the Company and the FDA reached an agreement to initiate a Phase III study of orelabrutinib in patients with Primary Progressive Multiple Sclerosis (PPMS). In February 2025, the FDA also approved the Phase III trial protocol of orelabrutinib in the Secondary Progressive Multiple Sclerosis (SPMS). The Company is accelerating the initiation of the Phase III studies for PPMS and SPMS, demonstrating its ongoing commitment to developing innovative and effective treatments to address unmet medical needs in patients with progressive multiple sclerosis (PMS).

● The Phase II results of orelabrutinib for the treatment of MS were presented at the 10th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS). The study showed that orelabrutinib was highly effective in treating patients with relapsing-remitting multiple sclerosis (RRMS). The 80 mg once daily (QD) dose showed the best efficacy and safety profile, thus was selected for Phase III studies in progressive MS.

● ITP: The Company is accelerating patient enrolment in the Phase III registrational trail of orelabrutinib for the treatment of Immune Thrombocytopenia (ITP) and expects to submit the NDA application in the first half of 2026. By leveraging the BTK inhibitor’s advantage in ITP, such as decreased macrophage-mediate platelet destruction and reduced production of pathogenic autoantibodies, orelabrutinib is well positioned to become a preferred BTK inhibitor in the field of ITP.

● SLE: The Phase IIa trial for systemic lupus erythematosus (SLE) demonstrated positive results, with remarkable SLE Responder Index (SRI)-4 response rates observed in a dose dependent manner, along with trends indicating a reduction in proteinuria levels. The Phase IIb clinical trial for orelabrutinib in SLE has completed patient enrollment in 2024, with data readout expected in the fourth quarter of 2025. Orelabrutinib is the first and only BTK inhibitor globally, to have ever demonstrated efficacy in Phase II SLE trials.

Soficitinib (ICP-332)

● The company is accelerating patient enrollment in the Phase III trial of ICP-332 for atomic dermatitis (AD), with over 110 patients enrolled to date.

● The Phase II/III trial for vitiligo was initiated in China, and the Company is planning the Phase II global trial for prurigo nodularis.

● In the U.S., the Phase I trial of ICP-332 was completed, and the Company will engage with the FDA regarding the subsequent clinical development plan.

● Data on ICP-332 for the treatment of patients with moderate-to-severe AD has been released at the 2024 American Academy of Dermatology (AAD) Annual Meeting as a late-breaking oral presentation.

● ICP-332 demonstrated an outstanding efficacy and safety profile. ICP-332 achieved multiple efficacy endpoints in the 80 mg QD and 120 mg QD dosing groups respectively, including the percentage change in Eczema Area and Severity Index (EASI) score from baseline, EASI 50, EASI 75, EASI 90 (improvement of at least 50%, 75% and 90% in EASI score from baseline), Investigator’s Global Assessment (IGA) 0/1 (score of 0 ‘clear’ or 1 ‘almost clear’) with >= 2 points improvement, and Pruritus Numerical Rating Scale (NRS) score from baseline, etc.

●The mean percentage change from baseline of the EASI 50 score reached 78.2% and 72.5% at the 80 mg QD and 120 mg QD groups respectively, both with a highly significant P value, compared to 16.7% for the patients receiving placebo. The percentages of patients achieving at least 75% improvement in EASI 75 were significantly higher in the ICP-332 80 mg QD (64.0%) and 120 mg QD (64.0%) groups than that of placebo (8.0%). These results exceed the reported efficacies of multiple approved innovative drugs after 12 or 16 weeks of treatment (not a head-to-head comparison).

● ICP-332 was safe and well tolerated in AD patients. The overall incidence rates of adverse events (AEs) and AEs related to infections and infestations in the two treatment groups were comparable to that of the placebo group.

● ICP-332 is a novel tyrosine kinase 2 (TYK2) inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders.

ICP-488

● The first patient has been dosed in the Phase III registrational trial of ICP-488 for the treatment of moderate-to-severe plaque psoriasis in China.

● Data on ICP-488 for the treatment of patients with moderate-to-severe plaque psoriasis has been released at the 2025 AAD Annual Meeting as a late-breaking oral presentation. The study results demonstrated that ICP-488 is highly effective in treating psoriasis at both the 6 mg QD and 9 mg QD doses. Moreover, ICP-488 exhibited favorable safety and tolerability profiles, reinforcing its potential as a valuable treatment option for moderate-to-severe psoriasis patients.

● At week 12, the percentage of patients achieving PASI 75 was significantly superior in the ICP-488 6 mg QD group (77.3%) and the 9 mg QD group (78.6%) than that of the placebo group (11.6%); the percentages of subjects achieving PASI 90 and sPGA of 0 (clear) or 1 (almost clear) were also significantly higher in the ICP-488 6 mg QD group (36.4%, 70.5%) and 9 mg QD group (50.0%, 71.4%) compared to the placebo group (0%, 9.3%).

● All treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) and were mild or moderate.

● ICP-488 is a potent and selective TYK2 allosteric inhibitor that binds to the pseudo kinase JH2 domain of TYK2 and blocks IL-23, IL12, type 1 IFN, and other cytokine receptors.

IL-17 Small Molecule

n IL-17 (Interleukin-17) is a pro-inflammatory cytokine that plays a critical role in the pathogenesis of several autoimmune and inflammatory diseases, such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis. Oral small molecules targeting IL-17 represent a new and promising class of therapeutics, offering the potential for easier administration, flexible dosing, and broader patient access. InnoCare identified a novel, orally available, small molecule that can potently block the binding of both IL-17AA and IL-17AF to IL-17R, thereby modulating immune responses and reducing inflammation.

Building Innovative Solid Tumor Assets

With ongoing efforts to address the growing needs in solid tumors, InnoCare is committed to building a competitive drug portfolio aimed at treating a broad range of solid tumor indications. The Company is expanding the scope of its pipeline through a combination of targeted therapies, immune-oncology approaches, and cutting-edge ADC technology. The R&D team is focused on discovering and developing novel platforms that target various solid tumors, utilizing innovative technologies to identify and advance potential drug candidates that offer significant clinical benefits. InnoCare’s proprietary ADC technology platform, alongside promising precision medicine candidates like ICP-723, positions the Company to establish a strong presence in the field of solid tumor treatment.

Zurletrectinib (ICP-723)

● The Company has completed the Phase II registrational trial for ICP-723 in adult and adolescent patients (12+ years of age) with advanced solid tumors harboring NTRK gene fusions. The NDA is expected to be submitted at the end of March 2025.

● Zurletrectinib was shown to overcome acquired resistance to the first generation TRK inhibitors, bringing hope for patients who failed prior TRKi therapy.

● Zurletrectinib demonstrated outstanding efficacy with a good safety profile, achieving an ORR of 85.5%.

● Registrational trial for pediatric patients (2 to 12) ongoing, targeting NDA submission in later 2025

ICP-189

● The Company has completed the Phase 1b dose finding study of ICP189 combined with firmonertinib, with no DLTs observed. The dose expansion study is currently ongoing, and the Phase 1b data readout is expected in 2025.

● InnoCare and ArriVent reached a clinical development collaboration to evaluate the anti-tumor activity and safety of the combination of InnoCare’s novel SHP2 allosteric inhibitor, ICP-189, with ArriVent’s third generation EGFR inhibitor firmonertinib in patients with advanced non-small cell lung cancer (NSCLC). Currently, the combination study is underway. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases.

In-House Developed Antibody-Drug Conjugate (ADC) Platform

● The Company has developed a cutting-edge ADC platform with proprietary linker-payload (LP) technologies, aimed at the delivery of potent and targeted therapies for cancer treatment. This platform allows for the creation of highly differentiated ADCs with improved efficacy and safety profiles. Key features of the platform include:  

● Novel connector: Irreversible connector to avoid linker detachment caused by instability.

● Hydrophilic linker: enhancing ADC stability and achieving high drug-to-antibody ratio (DAR).

● Novel payload: incorporating highly potent cytotoxic payloads with strong bystander killing effect.

● The platform is expected to deliver ADCs with strong tumor-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients and improving their clinical outcomes. As the platform continues to evolve, the Company is poised to expand its portfolio with multiple differentiated ADC candidates, further advancing precision medicine in oncology.

ICP-B794: A Novel B7-H3 Targeted ADC for Solid Tumors

● ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to in-house developed potent payload (a novel topoisomerase 1 inhibitor) via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal caner, head and neck squamous cell carcinomas, prostate cancer, etc. The company will submit an IND application for ICP-B794 in the first half of 2025.

● ICP-B794 has demonstrated superior anti-tumor activity in animal model compared to other ADCs, and exhibited significant tumor-killing effect even in large tumors.

Leveraging AI to Drive Innovation and Enhance Efficiency

InnoCare is committed to harnessing the power of artificial intelligence (AI) to accelerate drug discovery, optimize research and development (R&D) processes, and improve operational efficiency. AI-driven technologies enable to analyze vast datasets, identify promising drug candidates with greater precision, and streamline clinical trial design. By integrating AI into various aspects of the operations, the Company will enhance decision-making, reduce development timelines, and increase the probability of success in bringing novel therapies to patients. Moving forward, InnoCare will continue to explore AI’s potential to drive innovation and create transformative treatment solutions.

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 with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.