Akeso, Inc. has officially announced that the National Medical Products Administration (NMPA) in China has accepted its supplementary New Drug Application (sNDA) for ivonescimab, a PD-1/VEGF bispecific antibody. The application seeks approval for ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). This is a significant milestone as it represents the third accepted application for ivonescimab in China. Earlier submissions included its combination therapy for EGFR-TKI resistant, locally advanced or metastatic non-squamous NSCLC (nsq-NSCLC), and its use as a monotherapy for treating PD-L1 positive advanced NSCLC.
The new sNDA is supported by encouraging data from the Phase III AK112-306/HARMONi-6 trial, which showed that ivonescimab, when combined with chemotherapy, demonstrated superior results compared to tislelizumab plus chemotherapy. These strong clinical results follow previous evidence of ivonescimab outperforming pembrolizumab, another widely used PD-1 inhibitor, establishing the therapy as a potentially more effective option in the evolving field of cancer immunotherapy. As PD-1 therapies combined with chemotherapy are increasingly seen as a backbone of oncology treatment, ivonescimab’s continued progress marks a major advancement in therapeutic approaches for difficult-to-treat cancers.
More than a dozen Phase III clinical trials or international registrational trials are presently involving ivonescimab. These trials span a wide range of cancer types, including multiple forms of lung cancer, colorectal cancer, pancreatic cancer, head and neck squamous cell carcinoma, biliary tract cancer, and triple-negative breast cancer. Among them, six are head-to-head trials directly comparing ivonescimab to other PD-1/L1 inhibitors, reinforcing its role as a front-runner in immuno-oncology innovation.
Akeso’s more comprehensive approach, known as “IO+ADC” 2.0, places ivonescimab at the center of its next cancer treatment portfolio. The company is actively exploring its potential in combination with antibody-drug conjugates (ADCs) and other novel modalities targeting emerging biological mechanisms.
In its forward-looking statement, Akeso highlights that while it remains committed to advancing ivonescimab through clinical development and regulatory processes, various external risks and uncertainties may influence final outcomes. These include regulatory, competitive, economic, and scientific challenges. The company advises that no assurance can be given regarding the final approval or commercial success of its pipeline products.
