#China #Hong Kong #Akeso #Ivonescimab #Chemotherapy

Akeso's Ivonescimab Achieves Priority Review for Biliary Tract Cancer

On November 4, 2026, Akeso, Inc. reported a significant milestone in cancer treatment as their drug, ivonescimab, has received Priority Review designation from China's National Medical Products Administration (NMPA). This designation is crucial as it aims to expedite the review process for ivonescimab administered alongside chemotherapy, intended for the first-line treatment of locally advanced or metastatic biliary tract cancer (BTC).

The approval stems from the promising results demonstrated in the Phase III clinical trial known as HARMONi-GI1 (AK112-309). In this randomized, double-blinded study, ivonescimab, when paired with chemotherapy, outperformed the commonly used combination of durvalumab and chemotherapy. The Independent Data Monitoring Committee (IDMC) found that this combination not only met but exceeded the primary endpoint for overall survival (OS). Moreover, it showed a statistically significant and clinically relevant improvement over the current global standard treatment.

Details from HARMONi-GI1 were unveiled as a Late-Breaking Abstract during the ESMO Presidential Symposium in October 2026, marking a notable advancement in the clinical landscape for biliary tract cancer therapies. This trial is particularly groundbreaking as it is the first Phase III study to provide clear evidence of an overall survival benefit against the established PD-L1 inhibitor combined with chemotherapy standard of care.

The data revealed by this trial positions ivonescimab as a leader in the treatment of BTC, which previously had limited effective options. The study results not only highlighted improved OS metrics but also met all necessary secondary endpoints, including progression-free survival (PFS) and objective response rate (ORR).

On October 21, 2026, Akeso also reported that they affiliate with ECOG-ACRIN Cancer Research Group in a significant clinical trial collaboration. This project intends to further evaluate the safety and efficacy of ivonescimab with chemotherapy compared to other treatments like pembrolizumab or durvalumab, as part of a registration-enabling Phase II/III study (EA2251).

Understanding Ivonescimab

Ivonescimab stands out as a first-in-class bispecific antibody developed independently by Akeso. It uniquely merges PD-1 and VEGF targeting mechanisms, a pioneering achievement in the realm of immuno-oncology treatments. This innovative design marks ivonescimab as the very first bispecific antibody that integrates two potent therapeutic strategies into one drug.

Akeso has ambitious plans to expand ivonescimab’s indications further, currently engaging in over 17 Phase III clinical trials worldwide across multiple cancer types. Among these studies are trials aimed at treating lung cancer, various colorectal cancers, pancreatic cancer, and others, demonstrating a robust pipeline that reaffirms Akeso's commitment to improving cancer treatment standards globally.

Additionally, it's important to mention that Akeso has entered into a strategic partnership with Summit Therapeutics, granting them exclusive rights for developing and commercializing ivonescimab across several regions, including the United States and Europe, under a lucrative agreement estimated to yield up to $5 billion.

About Akeso

Founded in 2012, Akeso, Inc. (HKEX: 9926.HK) has emerged as a prominent biopharmaceutical company, focusing on developing innovative biological medicines. The company boasts a diverse R&D ecosystem, driven by a variety of proprietary technologies and platforms, including AI-assisted drug discovery and dual-shield antibody technology aimed at addressing significant healthcare challenges across a plethora of diseases, including cancer.

In conclusion, the Priority Review of ivonescimab not only symbolizes hope for patients battling biliary tract cancer but also underscores Akeso's pivotal role in transforming cancer treatment landscapes through innovative scientific advancements and strategic partnerships. As this journey continues, stakeholders, including patients, investors, and the medical community, will keenly anticipate forthcoming results and approvals, potentially altering the future of cancer therapies significantly.