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InnoCare Pharma 2025 Earnings Report: Revenue Surges 135%, First-Time Profit After Losses

InnoCare Pharma (HKEX: 09969; SSE: 688428) today released its 2025 earnings report and corporate updates as of December 31, 2025.

The year 2025 marks the tenth anniversary milestone for InnoCare Pharma, and is also a critical year for achieving rapid growth and completing various strategic objectives.The company achieved profitability for the first time, with two innovative drugs newly approved for market launch. The commercialization of core products continued to gain momentum, globalization accelerated, and pipeline research saw multiple breakthroughs. The company used several 'firsts in China' to accelerate the advancement into the new stage of 2.0 development.This demonstrates the strong capability of transforming technological innovation into long-term sustainable growth.

Summary of Key Financial Results

· Revenue:In 2025, revenue increased by135.3%achievingRMB 2.37 billion[1], primarily due to ongoing commercial expansion and global business development (BD) income.

· Net profit: The company in 2025turned profitable for the first time, with net profit reaching640 million yuan, mainly driven by a significant increase in commercialization revenue from core products and a boost in BD revenue contributing to substantial performance growth.

· Gross margin:Gross margin in 2025 reached92.0%, up 5.7 percentage points compared to last year.

· Research and development investment:R&D investment in 2025 increased by 16.9% year-on-year, reaching950 million yuan. The increase in R&D investment was primarily due to the advancement of multiple Phase III registration clinical studies and increased investment in new technology platforms such as ADC and molecular glue, laying a solid foundation for the future.

· Company cash and related account balances[2]：As of December 31, 2025, amounted to7.81 billion yuan, with the net cash flow from operating activities also turning positive for the first time.Strong cash flow will help accelerate global clinical development of core pipelines and build new technology platforms.

Blockbuster deals set new records, accelerating the implementation of globalization strategy

In 2025, InnoCare Pharma is pushing ahead at full speed with the implementation of its globalization strategy, focusing on uncovering the global value of core pipelines, and has reached two out-licensing deals,further enhancing the company's global influence and financial performance, achieving a significant breakthrough in global layout. On October 8, the company reached a major licensing agreement with Zenas regarding the pipeline of Orelabrutinib and other autoimmune diseases. According to the agreement, Zenas will pay InnoCare up to 100 million US dollars in upfront and near-term milestone payments, while issuing 7 million shares of Zenas common stock. The total transaction amount of this cooperation exceeds 2 billion US dollars,setting a new record for out-licensing in China’s autoimmune small molecule field.

This strategic cooperation marks an important milestone in InnoCare Pharma’s globalization process. Both parties will leverage their respective strengths to jointly accelerate the global Phase III clinical development of Orelabrutinib for the treatment of primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS), fully promoting the maximization of Orelabrutinib’s clinical and commercial value in the global autoimmune field. Meanwhile, the development of two molecules, a novel oral IL-17 AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor, will be advanced.

In addition, in 2025, the company also reached a licensing agreement with Prolium, further expanding its global business footprint. Through equity arrangements, both parties will share the value unlocked from the collaboration assets to achieve mutual benefits. In early March 2026,Prolium announced that it has initiated dosing of healthy subjects in a single ascending dose study of ICP-B02 (PRO-203).An international multicenter Phase I/II clinical study targeting systemic sclerosis (SSc) is expected to launch in the second quarter of 2026. Additionally, treatment studies for other severe B-cell-driven autoimmune diseases will commence in 2026.

Co-founder, Chairman, and CEO of InnocareDr. Jisong Cuistated, "After more than a decade of solid growth, Innocare has continuously improved its integrated new drug creation platform covering innovation sourcing, clinical development, commercialization, manufacturing, and business development, achieving the strategic goal of breaking even ahead of schedule—a significant milestone in the company's history. Entering the rapid growth phase of 2.0, we will focus on core objectives, driving the approval and market launch of five to six innovative drugs, achieving global expansion for three to four products, and advancing five to ten differentiated molecules into clinical trials.We will accelerate the transformation of more innovative achievements, expedite our globalization process, significantly increase revenue scale, and make high-quality innovative medicines accessible to patients worldwide.contributing to the global pharmaceutical and healthcare industry."

Strengthen Leadership in Hematological Tumors, Enrich Commercial Product Portfolio

In 2025, the company made significant progress in establishing a leading position in hematological tumors, primarily due to the coordinated advancement in commercial execution, late-stage clinical development, and global project expansion.

With the increasing adoption of Orelabrutinib (brand name: InnoCare®) for its exclusive indication of marginal zone lymphoma (MZL), and the approval and inclusion in the national medical insurance of new indications for first-line treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), as well as Tafasitamab (brand name: MinuoCare®) becoming the first approved CD19 antibody in China for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL), InnoCare's pharmaceutical revenue grew by 43.4% to reach1.44 billion yuan. Mesutoclax (ICP-248), the first BCL2 inhibitor in China to receive Breakthrough Therapy Designation, showcased multiple research findings at various international academic conferences. Several pivotal clinical trials for CLL/SLL, mantle cell lymphoma (MCL), acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS) are being accelerated both in China and globally. Orelabrutinib, Tafasitamab, and Mesutoclax further strengthen the company’s leadership in hematological malignancies.

Orelabrutinib

As a core therapy, Orelabrutinib is a key component of the company’s hematology pipeline. The drug has been approved for first-line treatment of CLL/SLL and included in the national medical insurance. It was also listed as a Tier I recommendation in the 'Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines (2025 Edition).' Currently, all four major indications of Orelabrutinib have been incorporated into the national medical insurance system, benefiting more patients.

In 2025, the company’s commercialization team further enhanced its execution capabilities and strategic focus, achieving strong sales performance throughout the year. Increased market penetration and improved operational efficiency will lay a solid foundation for continued revenue growth and long-term commercial success.

Outside of China, Orelabrutinib is progressing with global registrations. It has been approved in Singapore for treating relapsed/refractory marginal zone lymphoma. The company has also submitted a New Drug Application (NDA) in Australia for treating relapsed/refractory mantle cell lymphoma (R/R MCL).

Tafasitamab

The innovative therapy of Tafasitamab has been approved for treating relapsed/refractory DLBCL patients,marking it as the first approved CD19 antibody in China for R/R DLBCL., becoming another significant product in the company's hematological malignancies commercialization portfolio.

In September 2025, the first prescriptions of Tanximab were issued in hospitals across multiple provinces and cities nationwide. The year 2026 will be the first full year of sales for Tanximab in China. Tanximab has been listed as a Level II recommendation in the CSCO guidelines, helping to address unmet clinical needs among patients with DLBCL and bringing significant benefits to patients.

Mesutoclax (ICP-248)

As the first BCL2 inhibitor in China to receive Breakthrough Therapy Designation (BTD),Mesutoclax is accelerating several pivotal clinical studies with notable progress. Mesutoclax in combination with Orelabrutinib as a first-line treatment for CLL/SLLcompleted patient enrollment for a registrational Phase III clinical trial within 10 months,demonstrating rapid clinical advancement. The fixed-duration combination of ICP-248 with Orelabrutinib will provide deeper remission for previously untreated CLL/SLL patients and help avoid drug resistance mutations, offering hope of clinical cure and representing a highly promising therapeutic option.

The registrational clinical trial of Mesutoclax for the treatment of relapsed/refractory mantle cell lymphoma (MCL) after BTK inhibitor therapy is progressing rapidly. A Phase III randomized, double-blind, multicenter study comparing Mesutoclax in combination with Orelabrutinib versus the non-covalent (reversible) BTK inhibitor Pirtobrutinib for r/r MCL is set to commence in 2026.

Additionally, clinical trials of Mesutoclax for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are ongoing in China, the United States, and Australia.Data shows that the global markets for AML and MDS are projected to reach USD 8 billion and USD 11 billion respectively by 2034.

Mesutoclax as a monotherapy or in combination with Orelabrutinib demonstrated significant efficacy and safety across all tested dose levels for CLL/SLL. The overall response rate (ORR) for first-line treatment of CLL/SLL using Mesutoclax combined with Orelabrutinib was 100%, with a complete response rate (CRR) of 57.1%, and a peripheral blood undetectable minimal residual disease (uMRD) rate of 65% at 36 weeks. Mesutoclax monotherapy showed outstanding efficacy in MCL patients, particularly offering notable value for those who are refractory to BTK inhibitors. Among BTK inhibitor-refractory MCL patients, the ORR was 84.0% and the CRR was 36.0%. Mesutoclax combined with Orelabrutinib exhibited good safety profiles across subtypes of B-cell malignancies (MCL, MZL, CLL/SLL). This oral, chemotherapy-free regimen holds promise as a novel treatment option for B-cell non-Hodgkin lymphoma (B-NHL). Updated data will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

Mesutoclax combined with Azacitidine demonstrated favorable safety and encouraging anti-tumor activity in AML and MDS patients. Among 35 evaluable treatment-naive AML patients, 85.7% achieved composite complete remission (cCR), with an uMRD rate of 86.7%, and no deaths occurred within 90 days of initiating treatment. Preliminary data on treating MDS patients were also encouraging. No dose-limiting toxicity (DLT) or tumor lysis syndrome (TLS) events were reported. Detailed data will be disclosed at the 2026 ASCO Annual Meeting.

Accelerating multiple Phase III registration clinical trials for autoimmune diseases

Autoimmune diseases can affect almost every organ in the body and may occur at any stage of life. The global autoimmune disease market is projected to reach $185 billion by 2029.[5]InnoCare is further strengthening its drug discovery platform by targeting cutting-edge global targets in the field of autoimmune diseases through B-cell and T-cell pathways, creating a differentiated pipeline for autoimmune diseases. The aim is to provide first-in-class or best-in-class therapies for substantial unmet clinical needs. These innovative drugs hold significant market potential worldwide.

Orelabrutinib

Primary immune thrombocytopenia (ITP):Data indicates that globally, there are over 200,000 new ITP cases annually, with approximately 60,000 new cases in China each year, reflecting a vast unmet need. The Phase III registration clinical trial for Orelabrutinib in treating ITP has been completed.A New Drug Application is expected to be submitted in the first half of 2026.ITP represents Orelabrutinib's entry from hematological tumors into the hematology field for autoimmune disease indications, showcasing significant commercial potential. Leveraging the advantages of BTK inhibitors in treating ITP, such as reducing macrophage-mediated platelet destruction and decreasing pathogenic autoantibody production, Orelabrutinib is poised to become the preferred BTK inhibitor for ITP treatment.

Systemic Lupus Erythematosus (SLE):There are approximately 8 million SLE patients worldwide.Orelabrutinib has become the world's first BTK inhibitor to demonstrate efficacy in a Phase II clinical trial for the treatment of SLE.Orelabrutinib treatmentSLE Phase IIb studyhas met the primary endpoint, and the Phase III registration clinical trial was initiated in the first quarter of 2026.Under strict hormone tapering requirements, at week 48, the SLE Responder Index-4 (SRI-4) response rate in the once-daily (QD) 75 mg orelabrutinib dose group was significantly higher than that in the placebo group (57.1% vs. 34.4%), with high statistical significance (p<0.05), reaching the primary endpoint. In the subgroup of patients with baseline disease activity BILAG ≥1A or ≥2B and a clinical SLEDAI-2K score ≥4, the SRI-4 response rate in the 75 mg QD orelabrutinib dose group was 68%, which is a 43% improvement compared to the placebo group. More importantly, the Phase IIb clinical trial strictly followed international standards for designing a hormone tapering regimen. In the 75 mg group, 71.1% of patients reduced their steroid dosage to ≤7.5 mg, compared to 43.6% in the placebo group.

Multiple Sclerosis (MS): The US market size for SPMS and PPMS exceeds 12 billion USD [6].Based on the significant collaboration achieved, the company is working with Zenas to accelerate two global Phase III clinical studies of orelabrutinib for the treatment of PPMS and SPMS, further expanding orelabrutinib’s global value in the autoimmune disease market.

· The Phase III PriMroSe clinical trial of orelabrutinib for the treatment of PPMS was initiated in the third quarter of 2025, a multicenter, randomized, double-blind, placebo-controlled global registration Phase III trial aimed at evaluating the efficacy and safety of orelabrutinib in PPMS patients. For more information about the PriMroSe Phase III clinical trial (NCT07067463), visit clinicaltrials.gov.

· The Phase III Monarch trial of orelabrutinib for non-active secondary progressive multiple sclerosis (naSPMS) is planned to be initiated: Monarch is a multicenter, randomized, double-blind, placebo-controlled global Phase III registration trial aimed at evaluating the efficacy and safety of orelabrutinib in naSPMS patients, with an expected start date in the first quarter of 2026. For more information about the Monarch Phase III clinical trial (NCT07299019), visit clinicaltrials.gov.

Two TYK2 inhibitors

Data shows that the dermatology drug market has enormous potential, with over 500 million patients globally suffering from dermatological conditions. By 2035, the global dermatology disease market size is projected to reach nearly 100 billion US dollars. InnoCare has independently developed two TYK2 inhibitors to strategically target this vast dermatology market, covering diseases such as atopic dermatitis (AD), psoriasis, vitiligo, prurigo nodularis, urticaria, and cutaneous lupus erythematosus (CLE).Data shows that the global AD market is expected to reach 30 billion US dollars by 2030[7], the vitiligo market is projected to reach 3 billion US dollars by 2032[8], the urticaria market is estimated to reach 3 billion US dollars by 2029[9], the psoriasis market is expected to reach 58 billion US dollars by 2032[10], the prurigo nodularis market is forecasted to reach 3 billion US dollars by 2034[11], and the CLE market is expected to reach 7.9 billion US dollars by 2032[12].

Soficitinib (ICP-332)

Soficitinib (ICP-332), a novel TYK2 inhibitor independently developed by the company, is being evaluated forthe treatment of moderate-to-severe atopic dermatitis (AD) in a Phase III registration clinical trial, which has completed patient enrollment. Data readout is expected by mid-2026.. Meanwhile, the treatment with soficitinibfor vitiligo has completed patient enrollment in its Phase II clinical trial. Clinical trials of soficitinib for treating prurigo nodularis, urticaria, psoriasis, and others are progressing rapidly. A series of clinically significant data from soficitinib is expected to be released by 2026.

In January 2026, JAMA Dermatology published the results of a Phase II clinical study on the use of soficitinib in treating patients with moderate-to-severe atopic dermatitis (AD). The article stated that monotherapy with soficitinib demonstrated good safety and excellent efficacy in patients with moderate-to-severe atopic dermatitis.

The study showed that soficitinib met multiple efficacy endpoints. Soficitinib can effectively and quickly improve skin lesions. By the fourth week of treatment, the percentage improvement of EASI scores from baseline was 78.2% and 72.5% for the 80 mg QD and 120 mg QD treatment groups, respectively, compared to 16.7% for the placebo group. The EASI-75 response rate for both treatment groups at week four was 64.0%, showing an improvement of 56.0% compared to the placebo group (8.0%). In the 80 mg QD treatment group, 36.0% of patients achieved vIGA 0/1 with a score improvement of ≥2 points, significantly higher than the placebo group (4.0%, P=0.005). Meanwhile,soficitinib demonstrated properties of rapid itch relief and significant improvement in quality of life.As early as the second day of treatment, the two treatment groups, 80 mg QD and 120 mg QD, observed a significant decrease in NRS severity and frequency scores for itching compared to the placebo group (both P-values < 0.05), with continuous improvement over time during the treatment period.

ICP-488

The company's independently developed novel TYK2 inhibitor ICP-488 for treatingpsoriasis has completed patient enrollment in its Phase III registrational clinical trial, the Phase II clinical trial for the treatment of cutaneous lupus erythematosus (CLE) is accelerating. The IND application for ICP-488 in the treatment of Sjögren's syndrome has been submitted, and other indications and combination therapy strategies are also under evaluation.

Data released at a key oral presentation during the 2025 American Academy of Dermatology (AAD) Annual Meeting showed that the Phase II clinical study results of ICP-488 in treating moderate to severe plaque psoriasis demonstrated significant efficacy at doses of 6 mg QD and 9 mg QD, with favorable safety and tolerability profiles, offering a valuable therapeutic option for patients with moderate to severe psoriasis.

At week 12, the PASI 75 response rates were 77.3% and 78.6% for the 6 mg QD dose group and the 9 mg QD dose group, respectively, compared to 11.6% in the placebo group, showing a statistically significant difference. The PASI 90 response rates for these two dose groups reached 36.4% and 50.0%, respectively, significantly higher than the placebo group (0%). The static Physician Global Assessment (sPGA) 0/1 (indicating complete or almost complete clearance of skin lesions) response rates were 70.5% and 71.4%, respectively, also significantly higher than the placebo group (9.3%).

ICP-538

China’s first VAV1 molecular glue degrader ICP-538 approved for clinical trials has dosed its first subject.ICP-538 is a novel, orally available, highly potent and selective molecular glue degrader targeting VAV1 developed by InnoCare Pharma. VAV1 is a key protein downstream of T cell and B cell receptors. ICP-538 induces rapid and efficient degradation of VAV1 protein in a dose-dependent manner by selectively mediating the formation of a ternary complex between CRBN E3 ubiquitin ligase and VAV1 protein.It is being developed to treat various refractory autoimmune diseases,such as inflammatory bowel disease (IBD), SLE, and MS. Currently, there are no approved VAV1-targeting drugs available globally.

ICP-054

A novel oral IL-17AA/AF inhibitor, ICP-054 (ZB021), has submitted an IND application in China.ICP-054 is a novel, orally administered, highly potent and selective IL-17AA/AF inhibitor with significant therapeutic potential in the field of autoimmune and inflammatory diseases. It effectively blocks signaling from both IL-17AA homodimers and IL-17AF heterodimers, thereby inhibiting the release of pro-inflammatory cytokines and chemokines to exert anti-inflammatory effects. Additionally, it reduces excessive proliferation of skin keratinocytes and infiltration of inflammatory cells, improving skin lesions, thus suppressing the occurrence of autoimmune and inflammatory diseases.

Based on the collaboration agreement, Zenas has obtained exclusive rights for the development, production, and commercialization of the IL-17 AA/AF inhibitor outside Greater China and Southeast Asia.

Innovative solid tumor pipeline: ADC platform targeting difficult-to-treat cancers

Nuo Cheng Jian Hua is building a strong and diversified product portfolio to address significant unmet medical needs across various types of solid tumors. The company combines targeted small-molecule drugs with next-generation antibody-drug conjugates (ADCs) to maximize clinical benefits while minimizing systemic toxicity. Nuo Cheng Jian Hua is committed to addressing tumor types with high unmet medical needs and developing therapies that are differentiated in mechanism of action, efficacy, and safety. Precision treatments represented by Zolocitinib (ICP-723), along with its proprietary ADC technology platform aimed at hard-to-treat cancers, will allow the company to establish a robust competitive position in the field of solid tumor treatment.

Zolocitinib (ICP-723)

China's first domestically developed next-generation TRK inhibitor, Zolocitinib (brand name: Yinoxin®), has been approved for marketing, indicated for the treatment of adult and adolescent patients aged 12 years and above with solid tumors carrying NTRK fusion genes, becoming the company’s third innovative drug to be approved for marketing.

Zolocitinib, as a broad-spectrum anticancer drug not limited by tumor type, has demonstrated excellent efficacy and safety. Results from registrational clinical studies show an ORR of 89.1%, a disease control rate (DCR) of 96.4%, a 24-month progression-free survival (PFS) rate of 77.4%, and a 24-month overall survival (OS) rate of 90.8%.

The company expects to submit a new drug application for Zolocitinib in pediatric patients (ages 2 to 12) in the second quarter of 2026.

Self-developed antibody-drug conjugate (ADC) platform

The company has developed a highly differentiated ADC technology platform using proprietary linker-payload (LP) technology, aimed at providing effective and targeted therapies for cancer treatment. The platform is dedicated to developing a highly differentiated ADC pipeline that enhances efficacy and safety, with key features including:

· Irreversible bioconjugation:Ensures stable antibody-linker bioconjugation to improve stability.

· Hydrophilic linker:Enhances the stability of ADC drugs,Drug-to-antibody ratio (DAR) of 8.

· Novel potent payloads:It exhibits highly efficient cytotoxicity and bystander killing effects.

The company will gradually build a robust pipeline of ADCs with significant tumor-killing efficacy and an expanded therapeutic window, offering broader treatment options and enhanced clinical benefits for cancer patients. As the platform continues to evolve, the company plans to expand its product portfolio through multiple differentiated ADC candidates, further advancing precision oncology treatments.

ICP-B794 – A novel B7-H3-targeted ADC for the treatment of solid tumors

The company’s self-developed innovative ADC drug, ICP-B794, which targets B7-H3, is currently progressing through Phase I dose escalation trials.ICP-B794 is composed of a humanized anti-B7-H3 monoclonal antibody linked via a protease-cleavable linker to a potent payload developed in-house. This combination ensures precise targeting of tumor cells while minimizing off-target effects, providing promising treatment options for patients with solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinoma, and prostate cancer. In animal models, ICP-B794 has demonstrated superior antitumor activity compared to other products, showing significant tumor-killing effects even in large tumors.

Early clinical observations indicate thatICP-B794 demonstrates favorable pharmacokinetics and tolerability, exhibiting antitumor activity, validating the application of the company’s proprietary ADC platform in the development of solid tumor therapies.

ICP-B208 – A novel CDH17-targeted ADC for the treatment of solid tumors

Building on the encouraging efficacy and safety profile of ICP-B794, the company's next ADC candidate, ICP-B208, targets CDH17, a member of the cadherin family that plays a crucial role in tumor cell proliferation, migration, and metastasis. Tumor-specific expression and its functional role in cancer biology make CDH17 an attractive and differentiated target for ADC therapy, enabling potent payloads to be specifically delivered to tumor cells while minimizing toxicity. It holds potential for treating various gastrointestinal cancers, including colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, and cholangiocarcinoma. Preclinical studies have shown that ICP-B208 demonstrates strong antitumor activity even in tumors with low CDH17 expression.The company submitted the IND application for ICP-B208 in China in mid-March 2026.

InnoCare Pharma plans to submit IND applications for at least two additional ADC innovative drugs by 2026, further expanding the company's differentiated solid tumor product pipeline.

For financial data from InnoCare Pharma’s 2025 earnings report, please visit the official InnoCare Pharma website for inquiries.

[1] Currency in Renminbi

[2] Including financial assets in cash and other liquid assets, other non-current assets, as well as interest receivable

[3] Global Growth Insights

[4] Nova One Advisor, Insight Code: 8817

[5] iHealthcareAnalyst, Inc., October 3, 2023

[6] Zenas estimate based on reported prevalence and current pricing of B cell therapies approved for MS

[7] Grand View Research

[8] Data Bridge Market Research

[9] The Business Research Company

[10] Fortune Business Insights

[11] Global Market Insights

[12] Data Bridge Market Research

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