InnoCare Pharma Reports Q1 2025 Revenue of RMB 380 Million with Significant Pipeline Advancements

InnoCare (HKEX Stock Code: 09969; SSE Stock Code: 688428) recently released its first quarter 2025 results for the period ended March 31, 2025Performance Report and Recent Company Developments.

InnoCare’s Total Revenue in Q1 2025Year-on-year growth129.9%, reaching3.8100 million yuan, primarily attributed to its core product orelabrutinib (brand name: Yinuokai^®) continued strong sales volume and the upfront payment received by the Company from Prolium under the licensing agreement. Orelabrutinib in the current quarterYear-on-Year Growth89.2%, achieving3.1100 million yuan, primarily driven by the sustained volume growth of orelabrutinib’s three major indications, particularly marginal zone lymphoma, following their full inclusion in the National Reimbursement Drug List, as well as the continuous strengthening of the commercial team’s execution capabilities.

Meanwhile, InnoCare continued to improve its gross profit margin, with the gross margin in the first quarter of 2025 increasing by 5.1 percentage points year-on-year.Achieve 90.5%. The company's net profit for the first quarter of 2025 reached RMB 14 million,Achieved profitability in the quarter.

As of March 31, 2025, InnoCare held cash and cash equivalents totaling approximately RMB 7.78 billion. This robust cash position will enable the Company to accelerate the development of multiple Phase III registrational clinical trials and invest in its differentiated antibody-drug conjugate (ADC) portfolio and other pipeline assets, with a commitment to providing more and better treatment options for patients worldwide.

Co-founder, Chairman and CEO of InnoCareDr. Ji Song Cui“2025 will mark the 10th anniversary of our company’s development journey. We are delighted to have achieved a strong start in the first quarter, with breakthroughs in internationalization, sustained commercial growth, and significant progress across multiple pipeline assets. Our increasingly diverse portfolio of commercialized products will lay a solid foundation for the company’s long-term sustainable growth. We will continue to uphold our development philosophy of ‘Science-Driven Innovation, Patient-Centric Care,’ continuously enhancing our capabilities in innovation, commercialization, and global expansion. We will accelerate the advancement of multiple Phase III registrational clinical studies in China and worldwide, bringing benefit to more patients globally.”

2025 marked the second year of InnoCare’s rapid development phase in its 2.0 strategy. The Company continued to uphold its entrepreneurial and innovative spirit, advancing new drug research and development with high efficiency and speed, achieving a series of significant milestones:

● Yinuokai^®Approved in China for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and listed as a Class I recommendation in the “Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Lymphoma (2025 Edition).” ThisFirst-lineCLL/SLLapproval andILevel RecommendationThis will help benefit more lymphoma patients.

● Minnuokai^®(Tafasitamab) The marketing application for its innovative treatment regimen has been accepted in mainland China and included in the priority review process. It has already been approved for marketing in Hong Kong, Macao, and Taiwan, and authorized for use in Boao and the Greater Bay Area.InnoCare^®He Minuo Kai^®It will build InnoCare’s moat advantage in the field of hematologic malignancies.

● The company’s independently developed next-generation pan-TRK inhibitor, zurletrectinib (ICP-723)Granted Priority Review Status. The New Drug Application (NDA) for zurletrectinib, a novel therapy for patients with advanced solid tumors harboring NTRK gene fusions, has been accepted in China,Poised to become the first independently developed product approved for marketing in ChinaTRKInhibitor。

● The Company’s independently developed BCL2 inhibitor, mesutoclax (ICP-248), has received approval in China to conduct a Phase II single-arm registrational clinical trial for the treatment of relapsed/refractory mantle cell lymphoma. Patient enrollment is accelerating in the Phase III registrational clinical trial evaluating mesutoclax in combination with orelabrutinib as first-line therapy for CLL/SLL. Meanwhile, mesutoclax has been granted Breakthrough Therapy Designation.This is the first in China to receiveBTDRecognizedBCL2Inhibitors,This will help further strengthen InnoCare’s leading position in the field of hematologic malignancies.

● The Investigational New Drug (IND) application for the clinical trial of ICP-B794, a novel antibody-drug conjugate (ADC) independently developed by the Company, has been accepted. ICP-B794 consists of a humanized anti-B7-H3 monoclonal antibody conjugated via a protease-cleavable linker to a potent payload independently developed by the Company. The Company has established a highly differentiated ADC technology platform utilizing its proprietary linker-payload (LP) technology, aiming to provide effective and targeted therapies for cancer patients.

Autoimmune diseases have become the second-largest pharmaceutical market globally, after oncology, with the market size projected to reach $185 billion by 2029. As autoimmune diseases are mostly chronic conditions characterized by prolonged disease courses, complex clinical presentations, difficulty in achieving a cure, and significant physical and psychological burden on patients, they are often referred to as "chronic cancers."

Among more than 100 autoimmune diseases, psoriasis and atopic dermatitis (AD) each affect over 100 million patients worldwide. Many patients remain dissatisfied with current treatment options, indicating a substantial unmet clinical need.

Orelabrutinib is the first BTK inhibitor in China to venture into the “no-man’s land” of autoimmune diseases. Currently, global Phase III registrational clinical trials of orelabrutinib for the treatment of primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) are being initiated.Primary Immune Thrombocytopenia ( ITP）Phase III registration clinical trials are accelerating patient enrollment,Expected2026Submitted in the first half of the yearNDAMarketing Application, patient enrollment for the Phase IIb clinical trial of systemic lupus erythematosus (SLE) has been completed, with data readout expected in 2025.

InnoCare’s two self-developed TYK2 inhibitors are among the earliest to enter clinical trials. Soficitinib (ICP-332) and ICP-488 target multiple major indications, including atopic dermatitis (AD) and psoriasis, respectively. The Phase III clinical trial of soficitinib for AD is advancing rapidly, with nearly 200 patients enrolled to date, while clinical studies for other conditions such as vitiligo are also being initiated. For ICP-488 in the treatment of psoriasis, the first patient was dosed in the Phase III registrational clinical trial in the first quarter of this year, and its Phase II clinical data were presented as a late-breaking oral report at the 2025 American Academy of Dermatology Annual Meeting. As small-molecule oral agents, these drugs are expected to better benefit patients after launch due to the convenience of administration.

Chinese innovative drugs have become a new focal point in the global pharmaceutical industry, with their innovation capabilities gaining continuous recognition. In January 2025, InnoCare, together with Keymed Biosciences and Prolium Bioscience, entered into a licensing collaboration to authorize Prolium to develop and commercialize the CD20×CD3 bispecific antibody ICP-B02 (CM355). Under the terms of the agreement, Prolium will obtain the rights to develop, register, manufacture, and commercialize ICP-B02 in non-oncology indications worldwide and in oncology indications outside of Asia. InnoCare and Keymed Biosciences will receiveHighest5.2Total Payment of $100 Million, including an upfront payment and near-term payments, as well as additional payments upon the achievement of clinical development, regulatory approval, and commercialization milestones; both parties will also acquire a minority equity stake in Prolium. Meanwhile, InnoCare and Keymed Biosciences will receive tiered royalties on future net sales of the products.

InnoCare will continueAccelerate the globalization of other promising R&D pipelines. As part of its business development (BD) strategy, the Company is actively exploring international collaborations and out-licensing opportunities for key pipelines to expand its business partnerships beyond the Chinese market. Meanwhile, the Company will continue to strengthen its clinical development and regulatory affairs capabilities in key markets, thereby accelerating its internationalization process.

This report contains disclosures regarding certain forward-looking statements. All statements other than those of historical fact may be deemed forward-looking statements, namely, statements concerning actions, events, or developments that we or our management intends, expects, plans, believes, or anticipates will or may occur in the future. Such statements are based on assumptions and estimates made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments, and other relevant factors. These forward-looking statements do not guarantee future performance; actual results, developments, and business decisions may differ materially from those contemplated by such forward-looking statements. Our forward-looking statements are also subject to numerous risks and uncertainties that could affect our short-term and long-term performance.

InnoCare (SSE Code: 688428; HKEX Code: 09969) is a commercial-stage, high-tech biopharmaceutical company focused on the development of first-in-class novel drugs for malignancies and autoimmune diseases. The Company has multiple drug candidates in various stages of commercialization, clinical development, and preclinical research. InnoCare maintains branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.