On April 23, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428) reported its results and business highlights for the first quarter of 2026 as of 31 March 2026.
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Over the past decade, InnoCare has achieved remarkable results. 2026 marks the beginning of the Company’s next golden decade of development. Driven by its outstanding performance in 2025, the Company continued its rapid progress in the first quarter of 2026, increasing its investment in innovation, commercialization and globalization to achieve its 2.0 strategic goals.
Commercialization & BD Drive Sustainable Profitability
InnoCare’s drug sales in the first quarter of 2026 increased by 44.5% year-on-year (YoY), reaching RMB 450.5 million, and total revenue grew by 38.7%YoY to reach RMB 528.6 million, primarily driven by commercial growth and incremental income generated from global business development (BD) initiatives. Orelabrutinib has grown rapidly since the inclusion of its new indication for first line chronic lymphocytic leukemia/small lymphocytic lymphoma (1L CLL/SLL) in the National Reimbursement Drug List (NRDL), while maintaining its exclusive indication advantage in marginal zone lymphoma (MZL). Meanwhile, the commercialization of tafasitamab and zurlectrectinib has brought new growth opportunities.
Based on its first full year profitability in 2025, InnoCare remained profitable in the first quarter of 2026, with net profit increasing by 607.7% YoY to RMB 102.4 million.
InnoCare’s Research and Development (R&D) Investment increased by 10.4% YoY to RMB 229.2 million in the first quarter of 2026, reflecting advancements of global registrational trials, as well as increased investment in new technology platforms such as ADCs and molecular glue.
Cash and Related Accounts Balance1 stood at approximately RMB 7.9 billion as of 31 March 2026. This strong cash position provides InnoCare with the flexibility to expedite global clinical development of key assets and invest in new technology platforms.
Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "Standing at the new starting point of the next decade of development, we maintained strong growth momentum in the first quarter of 2026, with enhanced market penetration, accelerated globalization, and breakthroughs across multiple pipelines, laying a solid foundation for high-quality development throughout the year of 2026. Upholding the core value of ‘Science driving innovation for the benefit of patients’, we will continue to uplift our innovation, commercialization and globalization, and accelerate clinical trials in China and globally, so as to benefit more patients worldwide."
Enhanced Commercialization
In the first quarter of 2026, all four approved indications of orelabrutinib were included in the updated NRDL. InnoCare achieved rapid growth in orelabrutinib following the inclusion of 1L CLL/SLL in the NRDL, while maintaining its exclusive indication advantage in MZL. Additionally, both tafasitamab and zurletrectinib have been approved for marketing in 2025 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, has been prescribed in hospitals across China. As a result, drug sales increased by 44.5%, reaching RMB 450.5 million in the first quarter of 2026.
The Company’s commercial team has further strengthened its execution capabilities and focused on strategic priorities, laying a solid foundation for sustained revenue growth and long-term business success.
Continued Breakthroughs Across Multiple Pipelines
Effective 27 March 2026, the special "U" designation was officially removed from the Company’s stock ticker in the STAR market, marking InnoCare’s entry into a phase of sustainable growth and development. Ten years of hard work have laid a solid foundation, and 2026 marks the beginning of a new decade for the Company. Building on its outstanding performance throughout 2025, the Company continued its high-quality and rapid development in the first quarter of 2026. The following are the main achievements during this period.
The Phase III clinical trial of the novel BCL2 inhibitor mesutoclax (ICP-248) in combination with orelabrutinib as a first-line treatment for CLL/SLL has completed patient enrollment. This fixed-duration therapy is expected to achieve deeper remissions in treatment-naïve CLL/SLL patients, while avoiding resistance mutations and offering the hope for a clinical cure.
As the first BCL2 inhibitor granted breakthrough therapy designation (BTD) in China, mesutoclax’s latest data will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The registrational trial in BTKi-treated mantle cell lymphoma (MCL) is progressing rapidly. In addition, global clinical trials of mesutoclax in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are advancing across China, U.S., and Australia.
The New Drug Application (NDA) for orelabrutinib in primary immune thrombocytopenia (ITP) is expected to be submitted in the first half of 2026. The Phase III trial of orelabrutinib in systemic lupus erythematosus (SLE) has been initiated. Orelabrutinib’s two Phase III clinical trials for Primary Progressive Multiple Sclerosis (PPMS) and for Secondary Progressive Multiple Sclerosis (SPMS) are progressing.
The first healthy volunteer has been dosed in the clinical trial of ICP-538, the first VAV1 degrader approved to enter clinical trials in China and the second globally. ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors. ICP-538 will be developed for the treatment of autoimmune diseases, such as inflammatory bowel disease (IBD), systemic lupus erythematosus (SLE), and multiple sclerosis (MS).
The novel oral IL-17AA/AF inhibitor ICP-054 (ZB021) has received IND approval. ICP-054 is a novel, oral, highly potent and selective IL-17AA/AF inhibitor with significant therapeutic potential in autoimmune and inflammatory diseases. ICP-054 can effectively block the signal transduction pathways of IL-17AA homodimer and IL-17AF heterodimer, thereby inhibiting the release of pro-inflammatory cytokines and chemokines, exerting an anti-inflammatory effect. Simultaneously, it reduces excessive proliferation of keratinocytes and inflammatory cell infiltration, improving skin lesions and thus suppressing the occurrence of autoimmune and inflammatory diseases.
The CD20xCD3 T-cell engager (TCE) ICP-B02 (PRO-203) has completed single ascending dose (SAD) trials of healthy volunteers for severe autoimmune diseases. Meanwhile, Prolium, InnoCare’s partner, expects to initiate a multinational Phase I/II trial in systemic sclerosis (SSc) in the second quarter of 2026, with additional studies in other severe B-cell-driven autoimmune diseases to start this year.
The novel TYK2 inhibitor soficitinib (ICP-332) has completed patient enrollment in its Phase III clinical trial for moderate to severe atopic dermatitis (AD). The Phase II clinical study of soficitinib in patients with vitiligo has also completed patient enrollment. Data from the Phase II clinical trial of soficitinib in patients with moderate-to-severe AD was published in JAMA Dermatology. The journal concluded that soficitinib demonstrated a favorable safety profile and encouraging efficacy in patients with AD.
The novel TYK2 inhibitor ICP-488 has completed patient enrollment in its Phase III clinical trial for psoriasis, potentially providing a new oral treatment option for patients with psoriasis.
The next-generation TRK inhibitor zurletrectinib was granted priority review for the treatment of pediatric patients (ages 2–12) with solid tumors harboring NTRK fusions.
The novel B7-H3 targeted ADC ICP-B794 showed promising preclinical data and was selected for presentation at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. The Phase I ascending dose trial is progressing.
The IND application for the novel CDH17-targeted ADC ICP-B208 has been submitted which will be developed for the treatment of gastrointestinal cancers, including gastric, colorectal, pancreatic ductal adenocarcinoma, and cholangiocarcinoma. Preclinical studies show that ICP-B208 demonstrates potent anti-tumor activity even in CDH17-low tumors.
Accelerating Globalization
In 2025, InnoCare accelerated its globalization strategy, focusing on unlocking the global value of its core pipelines, and completed two out-licensing transactions, further enhancing the Company’s globalization efforts and financial performance, and marking a significant breakthrough in its global expansion.
In 2026, InnoCare will continue to build long-term, win-win partnerships through business development, promote the Company’s globalization process, and bring more benefits and growth opportunities to the Company and its partners, while benefiting patients worldwide.
(Press release, InnoCare Pharma, APR 23, 2026, View Source [SID1234664740])