2025 marked InnoCare's 10th anniversary and a milestone year of transformative growth and strategic execution. The Company achieved its first full year profitability, secured two new drug application (NDA) approvals, enhanced market penetration of its core products, accelerated globalization, and made breakthroughs across multiple pipelines. With numerous "China First" achievements, InnoCare continues to accelerate its 2.0 development strategy, demonstrating its strong ability to translate scientific innovations into sustainable long-term growth.
Financial Highlights
Revenue grew 135.3% year-on-year to RMB 2,375 million1 in 2025, mainly driven by robust commercial growth and two strategic business development (BD) deals.
Profit reached RMB 644 million, achieving profitability for the first time, mainly due to significant commercialization growth and global out-licensing deals.
Gross Profit Margin increased by 5.7 percentage points to 92%.
Research and Development Investment increased by 16.9% to RMB 952 million in 2025, reflecting advancements of multiple Phase III registrational trials, as well as increased investments in new technology platforms such as ADCs and molecular glue.
Cash and Related Accounts Balance2 stood at approximately RMB 7.8 billion as of December 31, 2025 and achieved positive operating cash flow for the first time. This strong cash position provides InnoCare with the flexibility to expedite global clinical development of key assets and invest in new technology platforms.
_______________1 The financial figures in this article are based on Hong Kong Financial Reporting Standards2 Include cash and bank balances, other current assets, financial assets among other non-current assets, and interest receivable
Accelerating Globalization with Transformative Deals
In 2025, InnoCare accelerated the implementation of its globalization strategy, unlocking global value of its core pipeline with two out-licensing deals, further enhancing the Company's global influence and financial performance, and marking a significant step forward in its global expansion.
On Oct. 8, InnoCare entered into a transformative licensing agreement with Zenas for its autoimmune disease pipeline, including orelabrutinib. The agreement includes up to US$100 million in upfront and near-term milestone payments, and up to 7,000,000 shares of Zenas common stock, with a total deal value exceeding US$ 2 billion, setting a new record for small molecule autoimmune out-licensing in China.
This strategic collaboration marks a significant milestone in InnoCare's globalization journey and will leverage shared focus to accelerate the global Phase III clinical development of orelabrutinib for the treatment of primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS), maximizing its clinical and commercial value worldwide, and advance a novel oral IL-17 AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor into clinical trials.
In addition, InnoCare entered into a licensing agreement with Prolium to further its global presence in 2025. In March 2026, Prolium announced first dosing of healthy volunteers in an ongoing single ascending dose study of ICP-B02 (PRO-203) and expects to initiate a multinational Phase I/II study of ICP-B02 in systemic sclerosis (SSc) in the second quarter of 2026, with additional studies in B-cell-driven autoimmune disease expected to follow.
Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "Building on an inspiring decade of solid growth, we have continuously enhanced our fully integrated platform ranging from original innovation, clinical development, commercialization, manufacturing, to business development, achieving our strategic goal of break-even ahead of schedule, marking a significant milestone in our development history. As we enter our 2.0 phase of rapid development, we are focused on key strategic priorities, including securing approvals for five to six innovative drugs, advancing three to four products globally, and progressing five to ten differentiated molecules into clinical trials. We will further accelerate globalization, significantly increase revenue, and deliver more high-quality innovative therapies to benefit patients worldwide."
Building A Leading Franchise in Hemato-Oncology
In 2025, InnoCare made significant progress toward building a leading hemato-oncology franchise, driven by advances in commercial execution, late-stage clinical development, and global expansion.
InnoCare continued to strengthen its commercial portfolio with orelabrutinib approved for first line chronic lymphocytic leukemia/small lymphocytic lymphoma (1L CLL/SLL) and successfully included in the updated National Reimbursement Drug List (NRDL), while tafasitamab became the first CD19 antibody approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in China. As a result, drug sales increased by 43.4% to RMB 1,442 million in 2025.
Mesutoclax (ICP-248), the first BCL2 inhibitor granted Breakthrough Therapy Designation in China, continues to advance across multiple indications, including CLL/SLL, mantle cell lymphoma (MCL), acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), with clinical trials ongoing in China and globally. Together, these three assets form the core of InnoCare's hemato-oncology strategy, supporting near-term revenue growth with a pipeline of differentiated, late-stage therapies.
OrelabrutinibOrelabrutinib serves as a backbone therapy in InnoCare's extensive hemato-oncology pipeline. Its newly approved 1L CLL/SLL indication has been included in the NRDL and is recommended as a Class I treatment in the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines for Malignant Lymphoma. With all four approved indications now covered under the NRDL, orelabrutinib offers stable annual treatment costs, benefiting more lymphoma patients.
The commercial team further strengthened execution capabilities and sharpened strategic focus, delivering strong sales performance throughout 2025. Improved market penetration and operational discipline laid a solid foundation for sustained revenue growth and long-term commercial success.
Internationally, orelabrutinib continued to expand its regulatory footprint, with approval granted for relapsed or refractory marginal zone lymphoma (R/R MZL) in Singapore and NDA submission for R/R MCL successfully completed in Australia.
TafasitamabIn May 2025, the tafasitamab regimen received NDA approval for adult patients with R/R DLBCL, representing the first CD19 antibody therapy approved in China for this indication and a key addition to InnoCare's commercial portfolio.
Building on the initial commercial launch in September 2025, 2026 will mark the first full year of tafasitamab sales in China. Moreover, tafasitamab has been included as a Class II recommendation in the CSCO Guidelines, which will help address unmet clinical needs in this patient population and provide meaningful benefits.
Mesutoclax (ICP-248)As the first BCL2 inhibitor granted BTD in China, mesutoclax has rapidly advanced across multiple registrational studies. The Phase III combination regimen with orelabrutinib for 1L CLL/SLL completed patient enrollment within 10 months, demonstrating strong clinical execution. This fixed-duration combination regimen has the potential to deliver deeper remissions, bringing hope for clinical cure and representing a promising treatment option.
A registrational trial in BTK inhibitor-treated MCL is progressing rapidly, and a Phase III randomized, double-blind, multicenter study of mesutoclax in combination with orelabrutinib versus pirtobrutinib (a reversible BTK inhibitor) in r/r MCL is expected to ...
