/C O R R E C T I O N -- Akeso, Inc./
In the news release, Akeso's 2025 Interim Results: Commercial Sales Reach New All-Time Highs, issued 26-Aug-2025 by Akeso, Inc. over PR Newswire, we are advised by the company that under the "Key Highlights", the number should read "13" rather than "14" in the fifth bullet point and "10" rather than "11" in the eighth bullet point as originally issued inadvertently. The complete, corrected release follows:
Akeso's 2025 Interim Results: Commercial Sales Reach New All-Time Highs
IO 2.0 + ADC 2.0 Strategy Builds a "Next-Generation" Platform with Global Competitive Edge
Key Highlights:
Final analysis of HARMONi-A Study: Ivonescimab met the overall survival (OS) endpoint, demonstrating a statistically significant and clinically meaningful OS benefit
First international Phase III HARMONi study of Ivonescimab: High concordance between international and Chinese data
Ivonescimab secures approval for first-line treatment of NSCLC (significant positive outcomes from HARMONi-2 compared to pembrolizumab)
sNDA for ivonescimab in first-line treatment of sq-NSCLC (significant positive findings from HARMONi-6 compared to tislelizumab + chemotherapy)
Global development of ivonescimab: 13 registrational/Phase III trials (8 for lung cancer + 5 for major tumors including cold tumors and IO-resistant indications)
Cadonilimab approved for first-line treatment of cervical cancer (inclusive of all patient populations), addressing global gap in immunotherapy for PD-L1 negative patients
First international registrational clinical trial for cadonilimab: second-line HCC
Global development of cadonilimab: 10 registrational/Phase III trials (including major tumors in first-line and IO-resistant indications)
Inclusion of ivonescimab and cadonilimab in National Reimbursement Drug List (NRDL)
IO2.0 + ADC2.0 strategy rapidly advancing, with global clinical development of next-generation ADCs such as AK146D1 bispecific ADC
Penpulimab receives U.S. FDA approval, validating Akeso's international development and registration capabilities
Immunology and autoimmune breakthrough: ebdarokimab (IL-12/IL-23) received market approval, with successful Phase III trials for gumokimab (IL-17) and from manfidokimab (IL-4Rα)
HONG KONG, Aug. 26, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced its 2025 interim results for the six month period ending June 30, 2025, highlighting record commercial sales in China and major global advances in its oncology and autoimmune pipelines. The company has strengthened its leadership in IO bispecific antibodies for first-line cancers, cold tumors, and IO-resistant indications, while rapidly progressing next-generation bispecific-ADC therapies. Its "IO 2.0 + ADC 2.0" strategy is accelerating changes in the global oncology treatment landscape. Outside of oncology, Akeso is set to launch its third and fourth commercial products, boosting both its commercial portfolio and market capabilities. Driven by breakthrough clinical value, Akeso continues to optimize its oncology strategies, demonstrating leadership to reshape global treatment standards and clearly outlining its international expansion.
Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, said: "I want to sincerely thank the members of the Akeso family for their hard work, and also to say a big 'Thank You' to our partners for their strong support. Akeso has achieved historic results during this period.
First of all, in the first half of this year, we reached record commercial performance. With expanded indications for ivonescimab and cadonilimab, coupled with accelerated market access following their inclusion in the National Reimbursement Drug List (NRDL), our innovation driven commercialization has gained significant momentum.
Secondly, our 'IO 2.0 + ADC 2.0' strategy is establishing a lasting competitive advantage. Our first-in-class bispecific antibodies, cadonilimab and ivonescimab, position Akeso as a global leader in immuno-oncology bispecifics, reinforcing our pivotal role in shaping the future of cancer treatment.
We are advancing the global development of both cadonilimab and ivonescimab in first-line cancers, cold tumors, and immuno-oncology resistant settings. Together, they are being evaluated in 23 registrational/Phase III trials and in over 20 Phase II studies worldwide, highlighting our strong commitment to research and development and providing a solid foundation for global growth. Notably, ivonescimab's initial Phase III trial demonstrated a statistically significant overall survival (OS) benefit, affirming its value across multiple endpoints, including progression-free survival (PFS) and OS.
At the same time, our lead bispecific-ADC, AK146D1, and a next-generation ADC, AK138D1, have entered global early-stage clinical trials. Additional bispecific-ADC and ADC candidates are currently being developed.
Both ivonescimab and cadonilimab are first-in-class drugs that have achieved regulatory approvals. Backed by their breakthrough clinical profiles and broad indication coverage, along with our leadership in global commercialization and a robust ADC pipeline that includes bispecific and next-generation platforms, we are now fully deploying our IO2.0 + ADC2.0 strategy worldwide. This positions us to build a transformative, long-term competitive advantage across our portfolio.
Third, we are pioneering advancements in the field of autoimmune diseases and our non-oncology pipeline serves as a significant growth driver. With the recent launches of ebdarokimab (IL-12/IL-23) and ebronucimab (PCSK9), and upcoming launches of gumokimab (IL-17) and manfidokimab (IL-4Rα), alongside innovative candidates such as our IL-4R/ST2 bispecific and assets targeting neurological diseases, we are enhancing our non-oncology portfolio and broadening our competitive position globally.
Backed by progress in R&D, clinical development, commercialization, and global strategy, Akeso has entered a new stage of growth. We remain committed to pioneering innovation, delivering transformative therapies to patients, and creating shared value for healthcare providers, patient communities, investors, and our team as we become a fully integrated global biopharma."
Breakthrough IO Bispecific Antibodies Demonstrate Sustained Commercial Momentum with High-Quality Growth
In the first half of 2025, Akeso's total commercial ...
