BEIJING, Aug. 24, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the interim results and business highlights for the six months ended 30 June 2026.
InnoCare delivered robust revenue growth and strengthened profitability in the first half of 2026, driven by strong commercial execution and global business development collaborations. In the first half of 2026, the Company's revenue grew by 55.5% year-on-year to RMB 1.1 billion, and profit reached RMB 239.7 million, a turnaround from a loss in the same period last year. These results reflect the successful implementation of the Company's strategy driven by innovation, commercialization and globalization.
In the first half of 2026, InnoCare continued to accelerate innovation, achieving a series of key milestones.
-- 1 NDA approval: Orelabrutinib was approved in Australia.
-- 2 NDA acceptances: The NDA applications for orelabrutinib in primary
immune thrombocytopenia $(ITP)$ and for zurletrectinib in pediatric solid
tumors have been accepted.
-- 2 Phase III studies met primary endpoints: The two novel TYK2 inhibitors,
soficitinib (ICP--332) and fadeucravacitinib (ICP--488), achieved their
primary endpoints in the Phase III trials for atopic dermatitis and
psoriasis, respectively.
-- 3 Phase III trials initiated: Phase III trials were initiated for
orelabrutinib in systemic lupus erythematosus $(SLE)$; for the novel BCL2
inhibitor mesutoclax (ICP--248) in combination with orelabrutinib in
relapsed/refractory mantle cell lymphoma (r/r MCL); and for a
head-to-head trial of mesutoclax with azacitidine versus venetoclax with
azacitidine in treatment naïve (TN) acute myeloid leukemia (AML) in
China.
-- 4 Investigational New Drugs $(IND)$: The VAV1 molecular glue degrader
ICP-538, the novel oral IL-17AA/AF inhibitor ICP-054, and the novel
CDH17-targeting ADC ICP-B208 received IND approvals. The IND application
for the PSMA- and STEAP1-targeting ADC ICP-B381 has been accepted.
Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "We have delivered a strong performance in the first half of 2026. We sustained profitability, continued our commercial expansion, achieved milestones across multiple pivotal phase III pipelines with primary endpoints met, and advanced our global footprint. Looking ahead, we will accelerate the implementation of Strategy 2.0, continue to achieve rapid growth in commercialization while advancing innovation and global expansion to benefit patients worldwide."
Financial Highlights
Revenue grew by 55.5% year-on-year (YoY) to RMB 1.1 billion in the first half of 2026, mainly driven by robust commercial growth and global business development collaborations.
Drug sales increased by 43.2% YoY to RMB 918.1 million for the six months ended 30 June 2026 driven by robust growth of orelabrutinib and the new launches of tafasitamab and zurletrectinib.
Profit reached RMB 239.7 million, mainly due to significant commercial growth, global BD, and sustained improvement in cost efficiency.
Research and Development Investment increased by 10.5% YoY to RMB 497.1 million for the six months ended 30 June 2026, reflecting our advancements in global clinical development, as well as increased investment in new technology platforms such as ADCs and molecular glue.
Cash and Related Accounts Balance stood at approximately RMB 8.4 billion(1) as of 30 June 2026. This strong cash position provides InnoCare with the flexibility to expedite global clinical development and invest in new technology platforms.
Enhanced Commercialization
In the first half of 2026, all four approved indications of orelabrutinib were included in the updated National Reimbursement Drug List (NRDL). Orelabrutinib sales grew rapidly following the NRDL inclusion of the first line chronic lymphocytic leukemia/small lymphocytic lymphoma (1L CLL/SLL) indication, while the orelabrutinib maintained its exclusive indication advantage in marginal zone lymphoma (MZL). Additionally, both tafasitamab and zurletrectinib have been approved for marketing and have begun to contribute to sales. Tafasitamab became the first CD19 antibody approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in China, while the next-generation TRK inhibitor, zurletrectinib, is now being prescribed in hospitals across China. As a result, drug sales increased by 43.2% YoY, reaching RMB 918.1 million in the first half of 2026.
Leading Franchise in Hemato-Oncology
In the first half of 2026, InnoCare made significant progress toward building a leading franchise in hemato-oncology, driven by coordinated advances in commercial execution, late-stage clinical development, and global program expansion across its three cornerstone therapies: orelabrutinib, tafasitamab, and mesutoclax (ICP-248).
Orelabrutinib has grown rapidly following the NRDL inclusion of its 1L CLL/SLL indication while maintaining its exclusive indication advantage in MZL.
The tafasitamab combination regimen received a Grade I Recommendation for second-line and subsequent-line treatment of diffuse large B-cell lymphoma (DLBCL) in the 2026 CSCO Lymphoma Diagnosis and Treatment Guidelines. Results from the global Phase III frontMIND study of the tafasitamab regimen were published in The Lancet, a top-tier international medical journal, and featured as a high-impact oral presentation at the plenary session of the 2026 European Hematology Association (EHA) Annual Congress. The results demonstrated that, compared with R--CHOP, the current first--line standard--of--care, the tafasitamab regimen significantly prolonged progression--free survival $(PFS)$, with the potential to establish a new first--line standard--of--care for patients with DLBCL.
As the first BCL2 inhibitor granted Breakthrough Therapy Designation (BTD) in China, mesutoclax has rapidly advanced across multiple clinical programs throughout China and globally, positioning it to become a globally competitive innovative therapy, further consolidating the Company's leading position in hemato-oncology.
1) The head-to-head registrational Phase III trial of mesutoclax with azacitidine versus venetoclax with azacitidine in treatment naïve (TN) acute myeloid leukemia (AML) was initiated in China, with overall survival (OS) as the primary endpoint.
Global clinical development of mesutoclax in AML and myelodysplastic syndrome (MDS) is accelerating in China, the U.S., and Australia. Clinical data of mesutoclax in AML and MDS has been released at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation, demonstrating outstanding efficacy and safety profiles.
-- As of April 13, 2026, among the evaluable TN AML patients, 81.8% achieved
composite CR (cCR, CR+CRi). Among patients who achieved overall response,
86.5% were negative for minimal residual disease (MRD). Among cCR
responders, 83% achieved cCR in the first treatment cycle, demonstrating
that the mesutoclax regimen enables rapid and deep remission. No
dose-limiting toxicities (DLTs) were observed, and the maximum tolerated
dose $(MTD)$ was not reached. Notably, both 30-day mortality and 60-day
mortality were 0% among TN AML patients. At the recommended dose, the
6-month overall survival (OS) rate was 90.5%.
-- As of April 20, 2026, among evaluable TN MDS patients, the overall
response rate $(ORR)$ per IWG 2006 criteria was 100%, including complete
response $(CR)$ in 40%, and marrow CR in 60%. The composite CR rate was 90%
per IWG 2023 criteria, including 60% CR.
2) The Phase III trial of the fixed-duration combination of mesutoclax with orelabrutinib in 1L CLL/SLL has completed patient enrollment. Data presented at the 2026 ASCO Annual Meeting showed that the combination achieved an overall response rate (ORR) of 100% in 1L CLL/SLL.
3) The registrational Phase II clinical trial of mesutoclax in BTK inhibitor-treated mantle cell lymphoma (MCL) is being expedited and has received Breakthrough Therapy Designation (BTD). It is the first BCL2 inhibitor to receive BTD recognition in China. Data presented at the 2025 ASH Annual Meeting demonstrated an ORR of 84.0% among MCL patients who were BTK inhibitor refractory.
4) The registrational Phase III clinical trial of mesutoclax in combination with orelabrutinib in r/r MCL is ongoing in China. Phase I data presented at the 2026 ASCO Annual Meeting demonstrated that the combination regimen achieved an ORR of 100% in patients with r/r MCL.
5) Mesutoclax in combination with orelabrutinib has been granted BTD in China for the treatment of patients with MZL who have received at least one prior therapy. Data presented at the 2026 ASCO Annual Meeting demonstrated that the combination achieved an ORR of 100%, with an excellent efficacy and safety, in this patient population.
Accelerating Autoimmune Pipeline
The global market for autoimmune disease therapies is anticipated to reach US$185 billion by 2029. Leveraging our strong capabilities in oral small-molecule drug discovery, InnoCare has built a differentiated and comprehensive autoimmune portfolio targeting both B-cell and T-cell-mediated disease pathways. InnoCare's strategy focuses on developing first-in-class and best-in-class oral therapies, anchored by orelabrutinib in B-cell-driven diseases and a robust TYK2 franchise addressing T-cell-mediated inflammation. In parallel, the Company has continued to advance early-stage programs targeting novel immune pathways to sustain long-term innovation and portfolio depth.
Orelabrutinib