InnoCare Releases 2025 Interim Results and Business Highlights

19 August 2025 - InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases,  announced the 2025 interim results as of 30 June 2025.

Significant Revenue Growth from Orelabrutinib

Total Revenue of InnoCare increased by 74.3% year-on-year (YoY) to RMB731.4 million[1]  for the six months ended 30 June 2025, primarily attributable to the robust sales growth of orelabrutinib and license-out revenue from Prolium. Drug sales increased by 53.5% YoY to RMB641.2 million in the first half of 2025, driven by coverage expansion, an increase in the number of patients treated by orelabrutinib, especially in marginal zone lymphoma, as well as strong commercial execution. Loss for the period decreased by 86.7% to RMB35.6 million for the six months ended 30 June 2025, attributed to revenue growth and improved cost efficiency.

Research and development expenses increased by 6.9% YoY to RMB449.7 million for the six months ended 30 June 2025 primarily due to increased investment in advanced technology platforms and a greater number of Phase III clinical trials.

Cash and related accounts balances[2] stood at approximately RMB7.7 billion as of 30 June 2025. This robust cash position provides flexibility for the Company to expedite clinical development and invest in a competitive pipeline, including ADC programs.

Accelerating Innovation, Commercialization and Globalization

In the first half of 2025, InnoCare made substantial progress in advancing its pipeline with multiple key milestones achieved: Orelabrutinib received approval for first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), tafasitamab in combination with lenalidomide was approved for adult patients with relapsed or refractory DLBCL (R/R DLBCL), BCL-2 inhibitor Mesutoclax (ICP-248) entered two registrational clinical studies, the NDA for TRK inhibitor Zurletrectinib (ICP-723) was accepted and granted priority review, and the Company’s proprietary antibody-drug conjugate (ADC) platform reached a major milestone with IND approval.

Building on this R&D momentum, InnoCare further expanded its global footprint through strategic collaborations. In January, InnoCare partnered with Prolium to explore global potential for a CD3×CD20 bispecific antibody. InnoCare remains committed to advancing global partnerships that will enhance innovation, maximize the value of its pipeline, and support long-term growth.

Orelabrutinib drove significant revenue growth through strong commercial execution and broader market penetration. This momentum demonstrates the Company’s key abilities to translate scientific innovations into sustained business performance.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “Over the past decade, we have built a fully-integrated platform encompassing original innovation, clinical development, commercialization, manufacturing, and BD, achieving a series of great milestones. As we embark on the next decade, we will accelerate our company's rapid development of Stage 2.0, driving innovation, commercialization, and globalization. Over the next three to five years, we will launch multiple drugs into the market, significantly increasing commercial revenue. We will bring three to four products to the global market. We will also continue to deepen our innovation efforts and develop five to ten differentiated molecules. With our innovative and entrepreneurial spirit, the company is set to reach new heights.”

Building A Leading Franchise in Hemato-Oncology

In the first half of 2025, InnoCare took major steps toward establishing a leadership position in hematology-oncology, driven by three cornerstone therapies - orelabrutinib, tafasitamab, and mesutoclax. With orelabrutinib’s approval in first-line CLL/SLL and tafasitamab’s approval in combination with lenalidomide for adult patients with R/R DLBCL, InnoCare’s commercial hematology portfolio has significantly expanded.

InnoCare’s novel BCL2 inhibitor, mesutoclax, further strengthens this franchise with two registrational trials now underway: a fixed-duration combination regimen with orelabrutinib in 1L CLL/SLL and a study for BTKi-treated mantle cell lymphoma (MCL). Additionally, InnoCare completed dose exploration in the first line acute myeloid leukemia (AML), with data to be presented at ASH 2025, and received clearance to initiate a myelodysplastic syndromes (MDS) trials in both U.S. and China.

Tafasitamab

• Tafasitamab (trade name: Minjuvi®) is a potential best profile therapy for R/R DLBCL. In a pivotal Phase II study, it demonstrated a high overall response rate (ORR) with durable responses, achieving an ORR of 57.5%, a median duration of response of 43.9 months, and a median overall survival (OS) of 33.5 months.

• With a large patient base and significant unmet medical need, approximately 40-55% of DLBCL patients relapse or become refractory after standard treatment.

Mesutoclax (ICP-248)

• The registrational Phase III trial of mesutoclax in combination with orelabrutinib as first-line treatment for CLL/SLL is advancing rapidly. This fixed-duration therapy is expected to provide deeper remissions for treatment-naïve CLL/SLL patients, while avoiding resistance mutations and offering the hope for clinical cure. Together, these benefits position the regimen as a highly promising therapeutic approach.

• In a Phase II study of mesutoclax in combination with orelabrutinib, no tumor lysis syndrome (TLS) was observed. At week 36, data showed an ORR of 100%, target lesion complete response rate (CRR) of 57%, and undetectable minimal residual disease (uMRD) rate of 65%.

• In R/R MCL patients who were refractory to prior BTKi treatment, ORR reached 84% with a 36% CRR.

• In the dose-expansion study of mesutoclax in combination with azacytidine as first-line treatment for AML, the regimen demonstrated strong efficacy with a favorable safety profile, with a CRR of 70%, a uMRD rate of 57%, and a 60-day mortality rate of 0%.

Accelerating Multiple Phase III Clinical Trials 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[3]. The Company has fortified its powerful discovery engine to focus on cutting-edge 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 medical needs and strong market potential in China and worldwide.

Orelabrutinib to Provide Novel Treatment for ITP Patients

The Company has completed patient enrollment of 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.

ITP represents hundreds of thousands of patients globally with a prevalence of 23.6 cases out of 100,000 in U.S. and a prevalence of 9.5 cases out of 100,000 in China. Current therapies, including corticosteroids and thrombopoietin receptor agonists, lack long-term tolerability or durable sustained responses. New safe and effective treatment options are needed for patients who have inadequate responses to previous lines of therapy.

BTK is a key kinase in the B cell receptor signaling pathway, which is essential for the activation of B lymphocytes, macrophages, and other immune cells as well as the production of antibodies in the pathological process of ITP. No BTK inhibitor has yet been approved for the treatment of patients with ITP. Orelabrutinib, with its high target selectivity and good safety profile, has the potential to become a novel treatment option for ITP patients.

InnoCare is accelerating the global Phase III studies for Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS). The Phase IIb clinical trial for orelabrutinib in SLE completed patient enrollment in 2024, with data readout expected Q4 2025.

InnoCare's two in-house developed TYK2 inhibitors have demonstrated good efficacy with excellent safety profiles in Phase II studies. Soficitinib (ICP-332) is being developed for multiple autoimmune indications. Its Phase III trial for AD is expected to complete patient enrollment this year, while the phase II/III of clinical trial in vitiligo is advancing rapidly, and a global Phase II study in prurigo nodularis (PN) is about to be initiated.

The registrational Phase III trial of ICP-488 in psoriasis is also expected to complete patient enrollment this year, and its Phase II clinical data were presented as a high-impact oral report at the 2025 American Academy of Dermatology (AAD) Annual Meeting.

As oral small-molecule therapies for autoimmune indications, these drugs are expected to leverage convenient administration to better benefit patients.

Building Innovative Solid Tumor Assets

As part of InnoCare’s strategic focus on solid tumor therapeutics, the Company is building a competitive and diversified drug portfolio to address significant unmet medical needs across multiple tumor types.

Precision Medicine: Zurletrectinib

In March 2025, the new drug application of zurletrectinib for the treatment of adult and adolescent patients (12 to 18 years) with NTRK gene fusion-positive tumors was accepted by the CDE and granted priority review. The registrational trial for pediatric patients (2 to 12years) is ongoing, with NDA submission later 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%. Zurletrectinib has also shown a long duration of response, with longest beyond 36 months.

Proprietary ADC Platform with First ADC Drug Entering the Clinic

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 first in-house ADC candidate, ICP-B794, a B7-H3–targeting ADC, received IND approval in July 2025, and the Company expects first patient-in and clinical proof-of-concept later this year.

ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to potent in-house developed payload 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 cancer, head and neck squamous cell carcinomas, prostate cancer, and others. Currently, there are no B7-H3 targeted therapies approved for marketing globally. B7-H3 is a type I transmembrane protein that is highly expressed in a variety of solid tumors. Due to its specific expression in tumor cells, it is considered a highly promising anti-tumor target.

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

Upon achieving proof-of-concept, it is anticipated that multiple ADC-based molecules from this platform will have IND submissions next year, which will significantly expand the solid tumor pipeline.

Through these efforts, InnoCare aims to establish a robust and innovative oncology portfolio, positioning the Company as a future leader in innovative therapies for solid tumors.

To know more about the detailed financial data and business updates of InnoCare 2025 interim results, please log in to https://www.innocarepharma.com/en/investor/home .

Conference Call Information

InnoCare will host a conference call at 8:30 p.m. Beijing time on August 19 in English and at 9:00 a.m. Beijing time in Chinese on August 20, 2025. Participants must register in advance of the conference call. Details are as follows:

For English conference call, please register through the below link:

https://goldmansachs.zoom.us/webinar/register/WN_bjP8R32QQAiGSvqrEesMHA#/registration

For Chinese conference call, please register through the below link:

https://s.comein.cn/gqvufh8e

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.

[1] The financial figures in this article are based on Hong Kong Financial Reporting Standards

[2] Include cash and bank balances, other financial assets balance and interest receivables balance.

[3] iHealthcareAnalyst, Inc., Oct. 3, 2023