HONG KONG , Sept. 9, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) announced that data from a Phase Ib/II clinical study evaluating the combination of cadonilimab and pulocimab (an anti-VEGFR-2 antibody) in patients with immunotherapy (IO)-resistant NSCLC were presented in a Mini Oral session at the 2025 World Conference on Lung Cancer (WCLC). This marks the first clinical data release for cadonilimab in IO-resistant lung cancer. The cadonilimab combination therapy for advanced squamous non-small cell lung cancer (NSCLC) progressing after PD-(L)1 inhibitor treatment, has previously received Breakthrough Therapy Designation from the NMPA.

The combination of cadonilimab and pulocimab also offers a potentially chemo-free option for advanced IO resistant NSCLC patients. The data presented at the 2025 WCLC demonstrated that the cadonilimab plus pulocimab regimen shows encouraging efficacy and broad clinical potential in patients with advanced or metastatic NSCLC who progressed after first-line standard immunotherapy-based treatment, offering a promising effective and safe therapeutic option for IO-resistant lung cancer patients:

• As of January 13, 2025, with a median follow-up of 16.7 months, the cadonilimab-based combination achieved a median overall survival (mOS) of 15.6 months and a median progression-free survival (mPFS) of 5.8 months in IO-resistant NSCLC.
• In the squamous NSCLC (sqNSCLC) subgroup, mOS was 16.7 months, mPFS was 7.1 months, the disease control rate (DCR) reached 96.2%, and the objective response rate (ORR) was 11.5%. In the non-squamous NSCLC (nsq-NSCLC) subgroup, mOS was 12.8 months, mPFS was 5.5 months, DCR was 95.2%, and ORR was 14.3%.

Based on the promising clinical efficacy and safety data, preparation is underway for a Phase III clinical study evaluating the combination of cadonilimab and pulocimab for IO-resistant lung cancer. Additionally, ivonescimab (PD-1/VEGF), another novel bispecific antibody developed by Akeso, has shown unique efficacy and significant expansion potential in the IO-resistant NSCLC population. A registrational Phase III trial for ivonescimab has already been initiated.

As first-in-class bispecific antibodies, both cadonilimab and ivonescimab are showing increasing advantages across a broadening range of disease areas. By leveraging dual-targets with synergistic mechanisms, they both address critical clinical challenges, such as limited efficacy or resistance to single-target agents like PD-1 inhibitors. This positions the bispecific antibodies as superior treatment options for patients worldwide.

In recent years, immunotherapy has made significant progress in lung cancer treatment. PD-1/L1 inhibitors, either alone or with platinum-based chemotherapy, are the first-line treatment for driver-negative advanced NSCLC. However, 60%–70% of patients experience disease progression within a year. Docetaxel is the standard therapy for IO-resistant patients, but its effectiveness is limited. Improving outcomes for NSCLC patients after IO resistance remains a critical unmet need. Previous Phase III trials for IO-resistant lung cancer, including those with PD-1 inhibitors and ADCs, have not demonstrated meaningful clinical benefits. There is currently no approved standard treatment for NSCLC after resistance to IO therapies.

The combination of cadonilimab and pulocimab has shown strong clinical potential in IO-resistant lung cancer, notably extending patient survival. The cadonilimab and pulocimab combination has also shown promising clinical data in other treatment-resistant cancers, including IO-resistant hepatocellular carcinoma and gastric cancer. Cadonilimab's proven efficacy for patients across all levels of PD-L1 expression, positions it as a key solution for IO-resistant cancers. This breakthrough offers a potentially new option for NSCLC patients that currently have limited treatment options after resistance to cancer immunotherapies.

Forward-Looking Statement of Akeso, Inc.

This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

About Akeso

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.

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