Principal Activities
Principally engaged in research and development, production and sale of biopharmaceutical products.
Latest Results
The Group's loss attributable to shareholders for the year ended 31-12-2025 amounted to RMB 1.11 billion. Basic loss per share was RMB 1.2328. No dividend declared. Turnover amounted to RMB 3.06 billion, an increase of 43.9% over the same period last year, gross profit margin down 7.7% to 78.7%. (Announcement Date: 26 Mar 2026)
Business Review - For the year ended December 31, 2025
Akeso, Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of innovative antibody drugs that are affordable to patients worldwide. The Company has built a proprietary end-to-end integrated drug research and development (R&D) platform, establishing an innovative R&D system centered around Tetrabody bispecific/multispecific antibody development technology, antibody-drug conjugate (ADC) technology, T-cell engager (TCE) technology, siRNA/ mRNA technology and cell therapy technology. The Company’s R&D capabilities, along with GMP manufacturing that meets the highest international standards and a well- established commercialization system, position it as a competitive biopharmaceutical innovator on a global scale.
The Company currently has a portfolio of over 50 innovative programs covering the therapeutic areas of oncology, autoimmune, metabolic diseases, and neurodegenerative disorders. 7 products independently developed by the Company are in the commercial stage, including開坦尼(cadonilimab, PD-1/CTLA-4),依達方(ivonescimab, PD-1/ VEGF), ANNIKO (penpulimab, PD-1),伊喜寧* (ebronucimab, PCSK9),愛達羅(ebdarokimab, IL-12/IL-23),普佑(pucotenlimab, PD-1) which was licensed out to Lepu Biopharma Co., Ltd. (stock code: 2157.HK), and科泰萊(tagitanlimab, PD- L1) which was licensed out to Sichuan Kelun-Biopharmaceutical Research Institute Co., Ltd. 3 products covering 4 new drug applications/new indication applications are under review by the NMPA as of March 2026. The Company’s overseas partner, SUMMIT, has submitted the first indication application for ivonescimab, which has been accepted for review by the U.S. Food and Drug Administration (FDA). The Company has a total of 27 products in the commercial/clinical research stage, with 12 products in Phase III clinical research and 15 products in Phase I/II clinical research. Among the pipeline products, 18 are global first-in-class or potentially global first-in-class bispecific antibodies/ multispecific antibodies/ADCs and other drugs with novel mechanisms.
The Company’s vision is to become a leading global biopharmaceutical company through R&D focused on first-in-class therapeutic innovation, building world- class manufacturing systems and a diversified commercial franchise across multiple therapeutic areas.
During the Reporting Period, the Company recorded revenue of approximately RMB3,056.3 million, representing a year-on-year increase of 43.90% compared to approximately RMB2,123.9 million in the corresponding period last year. Among which, commercial sales revenue amounted to RMB3,033.1 million, a year-on-year increase of 51.48% from approximately RMB2,002.4 million in the corresponding period last year.This growth was primarily attributable to significant sales contributions from the first- time inclusion of certain indications of two oncology immunology bispecific antibodies,開坦尼(cadonilimab, PD-1/CTLA-4) and依達方(ivonescimab, PD-1/VEGF), in the China National Reimbursement Drug List (NRDL), as well as sales contributions from newly approved first-line indications with large addressable patient populations during the Reporting Period. The successful commercial launch of two newly approved products in the cardiovascular and autoimmune fields,伊喜寧(ebronucimab, PCSK9) and愛達羅(ebdarokimab, IL-12/IL-23), has commenced and generated sales. The two newly approved indications of ANNIKO (penpulimab, PD-1) in China have also contributed to sales. At the end of November 2025, all 12 approved indications of the Company’s five commercialized novel drugs mentioned above were included in the 2025 version of the NRDL, officially effective from January 2026.
The Company’s domestic commercialization has fully entered a phase of high-quality development. As of December 31, 2025, the Company has established a specialized and systematic sales team of approximately 1,300 people, comprehensively covering the two core areas of oncology and specialty drugs. Following the inclusion of products in the NRDL and achieving deep penetration in hospital access and broad coverage of medical institutions, the Company actively promotes“academic promotion”and extensively explores diversified channels such as commercial health insurance, driving sustainable growth for the existing product portfolio and maximizing synergistic advantages.
Business Outlook - For the year ended December 31, 2025
In 2025, the global biopharmaceutical landscape entered a deeper phase of restructuring, while China’s innovative drug industry demonstrated unprecedented validation and growth. Leveraging its global leadership in IO 2.0 and its self-reliant, continuously innovative R&D capabilities, the Company is committed to addressing the core needs of patients worldwide, upgrading the existing treatment landscape, strengthening its long- term competitiveness, and advancing the global clinical value for Chinese innovative drugs.
Empowerment through the Commercial System: Realizing Value from Diversified Products
The Company possesses a portfolio of seven marketed products covering multiple major therapeutic areas, including oncology, autoimmune diseases, and metabolic diseases. It has established an efficient and mature commercialization system that continues to be optimized. The Company will continue to uphold its patient-centric philosophy, rooted
in the“IO 2.0”academic promotion strategy. By targeting large patient populations that can benefit from approved and NRDL-listed indications, the Company aims to achieve sustainable growth through rapid access, swift uptake, and market share expansion.
Akeso will focus on leveraging the unique advantages of its core bispecific antibody products to consolidate and expanding market leadership while accelerating the approval and market access of subsequent indications. By continuously enriching its product portfolio and driving the parallel growth of its oncology and specialty drug business units, the Company will accelerate the global reach of Chinese innovative therapies, fostering sustainable sales growth, and creating diversified new growth drivers.
Leading the Global IO 2.0 Wave: Maximizing Global Value of Core Products
•The Company will continue to enhance the global clinical accessibility of cadonilimab, fully unleashing its clinical benefits for patients worldwide. The global multi-regional Phase III clinical study for cadonilimab in first-line gastric cancer and the global multi-regional registrational Phase II clinical study for second-line hepatocellular carcinoma have both been initiated. Further global exploration of other indications and collaborative development directions is planned.
•As the global frontrunner in PD-1/VEGF, ivonescimab possesses multiple advantages: significant first-mover advantage, high certainty, and vast potential across a broad number of indications. Multiple data readouts from Phase III studies in China and globally have fully validated ivonescimab’s statistically significant and clinically meaningful PFS and OS benefits, along with high consistency between global and Chinese data, confirming its product profile worldwide. Ivonescimab is emerging as a foundational IO 2.0 drug, with global development across multiple additional indications, and playing a key role in an increasing number of combination treatments.
•Ligufalimab is the only CD47 antibody globally to have entered Phase III clinical studies in solid tumors. The Company will accelerate the clinical development of ligufalimab in China and globally across multiple indications, including solid tumors and hematologic malignancies.
•IO 2.0 + ADC 2.0: The Company’s self-developed ADC drugs, AK138D1 (HER3 ADC) and AK146D1 (Trop2/Nectin4 ADC), are progressing through Phase I clinical trials globally and in China, with Phase II clinical studies in combination with cadonilimab/ivonescimab being initiated. The Company also has multiple ADC candidates expected to accelerate into clinical trials in the future.
Efficient Advancement of Global First-in-Class and Early-Stage Molecules:Accelerating Translation from Innovation Platforms
The Company will continue to efficiently advance the Phase I and II clinical trials of a series of self-developed bispecific antibodies covering oncology, autoimmune diseases, and Alzheimer’s disease. These include AK139 (IL-4Rα/ST2), AK152 (anti-Aβ/BBB receptor), AK150 (ILT2/ILT4/CSF1R), mRNA tumor vaccine AK154, AK130 (TIGIT/ TGF-β), and AK137 (CD73/LAG-3). These molecules will be evaluated as monotherapies and in combination regimens to cover broader indications. These novel therapies will solidify the Company’s presence in globally critical therapeutic areas with major unmet needs, including oncology, autoimmune diseases, and neurodegenerative disorders, while constructing a next-generation, leading and strategically positioned therapy matrix that aims to create significant life-saving and quality-of-life benefits for patients worldwide.
Zero-to-one Breakthroughs Across Multiple Frontier Therapeutic Areas
The Company will continue to resolutely leverage its technological and product leadership, continuously exploring and combining new targets and novel mechanisms.Akeso will persistently strengthen fundamental innovation and core technology development, actively building and optimizing platforms such as the Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/ mRNA technology platform, and cell therapy technology platform.
The Company has built an AI-driven, integrated drug discovery platform covering the full spectrum of antibody and nucleic acid drug R&D, with expansion into emerging frontiers. In antibody discovery, AI is deeply embedded across key stages—from target screening to preclinical candidate selection—leveraging virtual screening, structure prediction, sequence optimization, and developability assessment to significantly enhance efficiency and success rates. In nucleic acid therapeutics, core technologies such as mRNA sequence optimization and LNP encapsulation are accelerating the development of next-generation therapies.
The Company has established a proprietary AI technology suite encompassing high- accuracy structure prediction, immunogenicity prediction, fully automated humanization, and one-step sequence optimization, enabling end-to-end precision empowerment from sequence design to clinical development. The integration of AI into key areas of R&D program will further enhance and accelerate the Company’s leading position in the development of innovation and first-in-class therapies.
Akeso will continue to execute its strategy of independent innovation and global development. While efficiently advancing global clinical development of its therapies, the Company actively explores diverse collaboration opportunities. The Company aspires to advance more of its self-developed innovative therapies through clinical development and regulatory registration in international markets, thereby translating Chinese innovation achievements for the benefit of patients worldwide.
Source: Akeso (09926) Annual Results Announcement