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InnoCare Pharma 2026 Interim Results Report: Profitability Continues to Materialize, Pipeline Hits Dense Milestones

InnoCare Pharma (HKEX: 09969; SSE: 688428) today released its interim results for the six months ended June 30, 2026, along with updates on recent business developments.

Standing at a new starting point for InnoCare Pharma's next golden decade of development, the company maintained robust revenue growth and further strengthened its profitability in the first half of 2026, driven by the continued ramp-up of commercialized products and the realization of value from global business development (BD) activities. In the first half of 2026, the company's revenue increased by 55.5% year-over-year to RMB 1.14 billion, while net profit reached RMB 240 million, marking a turnaround from loss to profit compared to the same period last year. The company's sustainable profitable development model has been further validated, with the effectiveness of its triple-drive strategy—innovation, commercialization, and globalization—continuing to shine through.

In the first half of 2026, InnoCare Pharma continued to accelerate its innovative R&D efforts, achieving a cluster of milestones across multiple core pipelines.

· One approval for market launchOrelabrutinib was approved for market launch in Australia.

· Two marketing applications acceptedThe marketing application for orelabrutinib for the treatment of primary immune thrombocytopenia (ITP) and the marketing application for zolvertinib for the treatment of pediatric solid tumors have been accepted.

· Two Phase III trials met primary endpointsTwo novel TYK2 inhibitors, soficitinib (ICP-332) and fadeucravacitinib (ICP-488), have met their primary endpoints in Phase III clinical trials for the treatment of atopic dermatitis and psoriasis, respectively.

· Launch of three Phase III trials: Initiation of Phase III clinical trials for orelabrutinib in the treatment of systemic lupus erythematosus (SLE); for the novel BCL-2 inhibitor mesutoclax (ICP-248) in combination with orelabrutinib for the treatment of relapsed/refractory mantle cell lymphoma; and for mesutoclax-based combination therapy in a head-to-head comparison with venetoclax-based combination therapy for previously untreated acute myeloid leukemia (AML).

· Four new drug Investigational New Drug (IND) applications: Clinical trial approvals were granted for the VAV1 molecular glue degrader ICP-538, the novel oral IL-17AA/AF inhibitor ICP-054, and the innovative CDH17-targeting antibody-drug conjugate (ADC) ICP-B208. The IND application for ICP-B381, a novel bispecific ADC targeting PSMA and STEAP1, has been accepted.

Dr. Cui Jisong, Co-founder, Chairman, and CEO of InnoCare Pharma, stated: "In the first half of the year, we delivered an exciting performance. The Company maintained its profitability, continued to ramp up commercial sales, achieved milestone progress in multiple key Phase III pipelines by meeting primary endpoints, and orderly expanded its global footprint. We will accelerate the implementation of our 2.0 strategy, adhering to the coordinated development of innovation, commercialization, and globalization, to benefit more patients worldwide with high-quality innovative medicines."

Summary of Key Financial Results

· Revenue: Revenue in the first half of 2026 increased by 55.5% year-over-year，reaching RMB 1.14 billion. This was primarily driven by strong growth in commercialized products and the realization of milestone value from global business development (BD) projects.

· Pharmaceutical product revenue: Revenue from pharmaceutical products in the first half of 2026 amounted to RMB 920 million, a year-over-year increase of 43.2%,Primarily driven by the sustained high-speed growth of orelabrutinib, as well as revenue contributions from tislelizumab and zoletrectinib.

· Net profit：Net profit for the first half of 2026 reached RMB 240 million, mainly due to a significant increase in commercialization revenue from core products, the continued realization of business development (BD) income, and ongoing improvements in cost efficiency.

· R&D investment:R&D expenditure for the first half of 2026increased by 10.5% year-on-year to RMB 500 million, with the rise in R&D spending primarily attributed to increased investment in frontier technology platforms such as antibody-drug conjugates (ADCs) and molecular glues, as well as the accelerated advancement of clinical trials in China and globally.

· Company cash and related account balances:As of June 30, 2026reached RMB 8.43 billion[1]. Strong cash flow helps the company accelerate global clinical development of its core pipeline and invest in new technology platforms.

Continued deepening of commercialization

In the first half of 2026, all four approved indications for orelabrutinib (brand name: Yinuokai®) were included in the National Reimbursement Drug List (NRDL). Notably, the new indication for first-line treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) saw rapid volume growth after NRDL inclusion, while marginal zone lymphoma (MZL) maintained its exclusive indication advantage.

Two innovative drugs approved for market launch in 2025 contributed to new sales volumes. Tanxituximab (brand name: Mingnuokai®) became China’s first approved CD19 monoclonal antibody for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Zolalertinib (brand name: Yinouxin®) became China’s first self-developed and approved next-generation TRK inhibitor.

The company has formed a diversified product portfolio, driving a 43.2% year-on-year increase in pharmaceutical revenue to RMB 920 million in the first half of 2026.

Strengthening leadership in hematologic malignancies

Leveraging synergistic breakthroughs in commercialization, key clinical development, and global pipeline expansion for its three core products—orelabrutinib, tanxituximab, and mesutoclax (ICP-248)—the company continues to strengthen its leading position in the field of hematologic malignancies.

In the first half of 2026, all four approved indications for orelabrutinib were included in the National Reimbursement Drug List (NRDL). Following NRDL inclusion, the first-line CLL/SLL indication experienced continuous volume growth, while MZL maintained its exclusive indication advantage. The combination therapy of tanxituximab for second-line and subsequent treatment of DLBCL received a Category I recommendation in the "2026 CSCO Guidelines for Diagnosis and Treatment of Lymphoma." Results from the global Phase III frontMIND study were not only published in the main issue of The Lancet but also prominently presented as an oral report at the plenary session of the 2026 European Hematology Association (EHA) Annual Congress. The results showed that, compared with the current standard first-line R-CHOP regimen, the tanxituximab combination therapy significantly prolonged progression-free survival (PFS), holding promise to provide a new standard first-line treatment option for DLBCL patients.

As the first novel BCL-2 inhibitor in China to receive Breakthrough Therapy Designation, mesutoclax is accelerating multiple clinical developments in China and globally. It is poised to become a globally competitive innovative therapy, further consolidating the company’s leading position in hematologic malignancies.

1) A registrational Phase III clinical trial in China has been initiated for mesutoclax combined with azacitidine versus venetoclax combined with azacitidine in previously untreated acute myeloid leukemia (AML), with overall survival (OS) as the primary endpoint.

Clinical trials of mesutoclax for AML and myelodysplastic syndromes (MDS) have successfully enrolled patients in China, the United States, and Australia and are accelerating. Clinical data were presented as an oral report at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating exceptional efficacy and safety.

· As of April 13, 2026, among evaluable patients with previously untreated AML, the composite complete response rate (cCR, including CR and CRi) was 81.8%, and 86.5% of patients who achieved an overall response reached minimal residual disease (MRD) negativity. 83% of cCR patients achieved cCR within the first cycle, indicating that the mesutoclax regimen can help patients achieve faster and deeper responses. In terms of safety, no dose-limiting toxicities (DLT) occurred, and the maximum tolerated dose (MTD) was not reached. Among patients with previously untreated AML, early mortality (at 30 and 60 days) was 0%. The 6-month overall survival rate at the recommended dose was 90.5%.

As of April 20, 2026, among evaluable treatment-naïve MDS patients, the overall response rate (ORR) reached 100% per IWG 2006 criteria, with a complete response (CR) rate of 40% and a marrow CR rate of 60%. Per IWG 2023 criteria, the composite CR rate was 90%, with 60% of patients achieving CR.

2) Patient enrollment has been completed for the Phase III study of fixed-duration combination therapy with Mesutoclax and Orelabrutinib in treatment-naïve CLL/SLL. Data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting showed an ORR of 100% for Mesutoclax plus Orelabrutinib in first-line CLL/SLL treatment.

3) The Phase II registrational clinical trial of Mesutoclax for mantle cell lymphoma (MCL) previously treated with BTK inhibitors is accelerating and has received Breakthrough Therapy Designation (BTD), making it the first BCL-2 inhibitor in China to receive such designation. Data from the 2025 American Society of Hematology (ASH) Annual Meeting showed an ORR of 84% for monotherapy in BTK-pre-treated MCL.

4) The registrational Phase III study of Mesutoclax combined with Orelabrutinib for relapsed/refractory mantle cell lymphoma (r/r MCL) is advancing rapidly. Data from the 2026 ASCO Annual Meeting indicated that the Phase I portion of the combination regimen for r/r MCL demonstrated an ORR of 100%.

5) Mesutoclax combined with Orelabrutinib has been granted Breakthrough Therapy Designation (BTD) for the treatment of patients with marginal zone lymphoma (MZL) who have received at least one prior therapy. Data released by ASCO this May showed an ORR of 100% for Mesutoclax plus Orelabrutinib in MZL patients with at least one prior line of therapy, demonstrating superior efficacy.

Accelerated realization of value in the autoimmune pipeline

The global market size for autoimmune disease therapeutics is projected to reach $185 billion by 2029. InnoCare Pharma focuses on B-cell and T-cell mediated autoimmune diseases, having built a rich and differentiated pipeline dedicated to developing first-in-class or best-in-class oral innovative drugs with breakthrough potential for the global market. Among these, Orelabrutinib for B-cell mediated diseases and two TYK2 inhibitors targeting T-cell inflammatory pathways are accelerating in value realization. Meanwhile, the company continues to advance early-stage projects targeting novel immune pathways, enriching its pipeline layout and building long-term competitiveness.

Orelabrutinib

New Drug Application (NDA) for Orelabrutinib in the treatment of primary immune thrombocytopenia (ITP)has been accepted. This is the first NDA acceptance for Orelabrutinib in the field of autoimmune diseases, marking a significant milestone in its expansion from hematologic oncology to autoimmunity, and is expected to meet the treatment needs of more patients.

Phase III registrational clinical trial of Orelabrutinib for systemic lupus erythematosus (SLE)Patient enrollment has been successfully completed and development is accelerating. Results from the Phase IIb study of orelabrutinib for the treatment of systemic lupus erythematosus (SLE) were presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Annual Congress, meeting both primary and secondary endpoints. Orelabrutinib is the only BTK inhibitor to demonstrate efficacy in a Phase II clinical trial for SLE globally. It is poised to become the first-in-class oral BTK inhibitor for the treatment of SLE.

Two global registrational Phase III clinical trials of orelabrutinib for the treatment of primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) are being accelerated.Four related research abstracts were selected for presentation at the 2026 Multiple Sclerosis Toronto Conference (MS Toronto 2026), including:

1) Efficacy and safety of orelabrutinib in relapsing-remitting multiple sclerosis (RRMS): 24-week results from a randomized, double-blind, placebo-controlled Phase II study

2) Pharmacokinetic study of orelabrutinib in the Phase II RRMS trial

3) Orelabrutinib for non-active secondary progressive multiple sclerosis (naSPMS): Study design of the Monarch Phase III randomized controlled trial

4) Orelabrutinib for PPMS: Study design of the PriMroSe Phase III randomized controlled trial

Two novel TYK2 inhibitors—Soficitinib (ICP-332) and Fadeucravacitinib (ICP-488)

Focusing on various T-cell-mediated autoimmune diseases, InnoCare Pharma's two independently developed, differentiated oral TYK2 inhibitors have established a deep pipeline in dermatological conditions such as atopic dermatitis (AD), psoriasis, vitiligo, prurigo nodularis (PN), chronic spontaneous urticaria (CSU), cutaneous lupus erythematosus (CLE), and Sjögren's syndrome (SS), offering broad market potential. In the first half of 2026, key Phase II/III data readouts for both TYK2 inhibitors met primary endpoints, positioning them as innovative drugs with global potential.

Soficitinib (ICP-332)

1) The registrational Phase III clinical trial of soficitinib (ICP-332), a novel TYK2 inhibitor independently developed by the Company, for the treatment of moderate-to-severe atopic dermatitis (AD) has achieved its primary endpoint and multiple key secondary endpoints. The safety profile is consistent with previous clinical trials, with no new safety signals identified, confirming the superior efficacy and favorable safety of soficitinib for AD. The Company plans to submit a New Drug Application (NDA) after completing the 52-week safety follow-up.

2) The Phase II portion of the Phase II/III clinical trial for non-segmental vitiligo has achieved its primary endpoint. Phase II results showed significant improvement in the Facial Vitiligo Area Scoring Index (F-VASI) from baseline at Week 24. The once-daily 80 mg soficitinib group saw a 38.8% decrease from baseline, the once-daily 120 mg group saw a 41.2% decrease, compared to 2.2% in the placebo group. The differences between both soficitinib dose groups and the placebo group were statistically significant (P<0.0001). Soficitinib demonstrated a favorable safety profile consistent with previous clinical studies, with good overall tolerability and no new safety signals observed. The Company will accelerate the advancement of the Phase III clinical trial.

3) The global Phase II clinical trial for the treatment of prurigo nodularis (PN) has successfully completed patient enrollment in the US and Europe and is progressing rapidly.

4) Patient enrollment for the Phase II portion of the Phase II/III clinical trial for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) has been completed.

5) Patient enrollment for the Phase II clinical study for the treatment of patients with moderate-to-severe plaque psoriasis has been completed.

Fadeucravacitinib (ICP-488)

1) The registrational Phase III clinical trial of fadeucravacitinib (ICP-488), a novel TYK2 inhibitor independently developed by the Company, for the treatment of psoriasis has successfully achieved its primary endpoint and all key secondary endpoints. The safety profile of fadeucravacitinib is consistent with previous clinical trials, with no new safety signals observed, confirming its superior efficacy and favorable safety in the treatment of psoriasis.

2) The Phase II clinical trial for the treatment of cutaneous lupus erythematosus (CLE) is being accelerated.

3) The Phase II clinical study for the treatment of Sjögren's syndrome (SS) is underway.

Other autoimmune pipeline assets

Novel oral IL-17AA/AF inhibitor ICP-054 (ZB021)Phase I clinical trials are underway. The single ascending dose (SAD) and multiple ascending dose (MAD) studies conducted in collaboration with Zenas are being accelerated, with relevant data expected to be released by the end of 2026.

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. ICP-054 effectively blocks signaling from IL-17AA homodimers and IL-17AF heterodimers, thereby inhibiting the release of pro-inflammatory cytokines and chemokines to exert anti-inflammatory effects. It also reduces excessive proliferation of keratinocytes and infiltration of inflammatory cells, improving skin lesions and thus suppressing the onset of autoimmune and inflammatory diseases.

ICP-538, the first VAV1 molecular glue degrader to enter clinical trials in China and the second globallyPatient enrollment has been successfully completed, and clinical development is being accelerated.。

ICP-538 is a novel, orally administered, highly potent and selective molecular glue degrader targeting VAV1, independently developed by InnoCare Pharma. VAV1 is a key protein downstream of T-cell and B-cell receptors, and ICP-538 is being developed to treat various refractory autoimmune diseases, such as inflammatory bowel disease (IBD), systemic lupus erythematosus (SLE), and multiple sclerosis (MS).

CD20xCD3 T-cell engager (TCE) ICP-B02 (PRO-203)R&D in the field of severe autoimmune diseases has commenced, and healthy volunteer studies for the single ascending dose trial have been completed. Our partner, Prolium, launched an international multicenter Phase I/II clinical study for systemic sclerosis (SSc) in June 2026. Meanwhile, an investigator-initiated clinical trial of ICP-B02 for refractory lupus nephritis has completed the 26-week follow-up for all enrolled patients. In the future, we will further explore the therapeutic potential of ICP-B02 for other B-cell-driven severe autoimmune diseases.

Accelerated breakthroughs in the innovative solid tumor pipeline

The company has established a diversified solid tumor pipeline, focusing on unmet clinical needs across various types of solid tumors. By integrating targeted small molecules with next-generation antibody-drug conjugate (ADC) technology, we aim to enhance both efficacy and safety. We are dedicated to developing innovative therapies with differentiated mechanisms of action, efficacy, and safety profiles. Leveraging our proprietary technology platforms and patient stratification strategies, we are accelerating clinical development and speeding up the commercialization process to bring better innovative treatment options to patients with solid tumors as soon as possible.

Next-generation TRK inhibitor zolletrectinib (ICP-723)Granted priority review for the treatment of pediatric patients (aged 2 to 12) with solid tumors harboring NTRK gene fusions; the marketing application has been accepted. Zolletrectinib has demonstrated exceptional efficacy and safety in treating pediatric solid tumors, with an Objective Response Rate (ORR) of 100% as assessed by independent review committee.

In December 2025, zolletrectinib was approved for the treatment of adult and adolescent (aged 12 and above) patients with solid tumors harboring NTRK gene fusions, marking the approval and launch of China's first independently developed next-generation TRK inhibitor. In the first half of this year, this innovative drug has already been implemented in clinical practice at major hospitals.

ICP-B794, a novel ADC innovative drug targeting B7-H3Patient enrollment has been successfully completed, accelerating the Phase I dose-escalation trial. Preclinical study data were selected for presentation at the 2026 American Association for Cancer Research (AACR) Annual Meeting, demonstrating potent anti-tumor activity and a safety window far superior to peer drugs. ICP-B794 is composed of a humanized anti-B7-H3 monoclonal antibody linked via a protease-cleavable linker to the company's self-developed potent payload. This combination ensures that the ADC innovator precisely targets tumor cells while minimizing off-target effects, offering a promising therapeutic option for patients with solid tumors such as lung cancer, esophageal cancer, nasopharyngeal carcinoma, head and neck squamous cell carcinoma, and prostate cancer.

ICP-B208, a novel ADC innovative drug targeting CDH17Clinical trials have successfully enrolled patients and are advancing rapidly. It is being developed for the treatment of various gastrointestinal cancers, including colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, and cholangiocarcinoma. Preclinical studies show that ICP-B208 exhibits potent anti-tumor activity even in tumors with low CDH17 expression.

ICP-B381, a new bispecific antibody-drug conjugate (ADC) targeting PSMA and STEAP1The Investigational New Drug (IND) application has been accepted for the treatment of solid tumors such as prostate cancer.This is the company's first bispecific ADC developed based on its proprietary ADC platform.Preclinical studies demonstrated that ICP-B381 exhibited potent, dose-dependent anti-tumor activity in the 22Rv1 human prostate cancer xenograft model. At equivalent dosing levels, it showed superior efficacy compared to corresponding single-target PSMA-ADC and STEAP1-ADC agents, with a favorable tolerability profile. The company plans to submit an Investigational New Drug (IND) application in the United States.

Accelerating global expansion

In the first half of 2026, the company accelerated the implementation of its globalization strategy. Orelabrutinib was sequentially launched in Singapore and Australia. Coupled with the rapid advancement of the global clinical pipeline and the realization of business development (BD) value, this further solidified the foundation for the company's global growth.

Looking ahead, the company will continue to unlock innovative value globally through diverse channels such as out-licensing, regional collaborations, and building internal capabilities, creating more growth opportunities for all stakeholders and benefiting patients worldwide.

For financial data from InnoCare Pharma's 2026 interim report, please visit the official InnoCare Pharma website for details.

[1] Cash and cash equivalents include cash balances, other financial assets (wealth management products), and interest receivable.

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