Breakthrough Approval for AK112: Akeso Biopharma's $5 Billion Licensing Deal Reshapes China's Lung Cancer Landscape

In a significant development for the Chinese pharmaceutical industry, Akeso Biopharma's anti-PD-1/VEGF-A bispecific antibody, AK112, has been approved for marketing by China's National Medical Products Administration (NMPA). This breakthrough approval not only provides a new treatment option for patients with EGFR-mutant advanced or metastatic non-small cell lung cancer (NSCLC) but also marks a remarkable milestone for the company, which recently secured a lucrative $5 billion licensing deal for the drug.

AK112, marketed as Yidafang, is a humanized IgG1 bispecific antibody that simultaneously targets VEGF-A and PD-1. By competitively blocking the interactions between VEGF-A, PD-1, and their ligands, AK112 exerts potent anti-tumor activity. The drug has previously been granted Breakthrough Therapy Designation by China's Center for Drug Evaluation (CDE) on three occasions, further underscoring its clinical significance.

According to the data presented at the 2024 European Lung Cancer Congress (ELCC), AK112 in combination with chemotherapy demonstrated impressive results in the treatment of EGFR-TKI-experienced, EGFR-mutant advanced non-squamous NSCLC. With a median follow-up of 25.8 months, the objective response rate (ORR) was 68.4%, the disease control rate (DCR) was 94.7%, and the median duration of response (mDoR) was 8.7 months. Notably, the median progression-free survival (mPFS) was 8.5 months, and the median overall survival (mOS) reached 22.5 months, with a 12-month OS rate of approximately 73.7%.

The stellar performance of AK112 in its Phase 2 clinical trials has led to a remarkable licensing deal. In late 2022, Akeso Biopharma granted Summit Therapeutics the exclusive development rights for AK112 in the United States, Europe, Canada, and Japan, in a deal valued at up to $5 billion, including a $500 million upfront payment and tiered double-digit royalties on net sales. This transaction has set a new record for the out-licensing of a domestically developed novel drug from China.

Looking ahead, AK112 has six ongoing Phase 3 clinical trials, including two international, multi-center studies led by Summit Therapeutics and four head-to-head trials against PD-1 monoclonal antibodies. As more data from these trials becomes available, the medical community eagerly awaits the further demonstration of AK112's potential to transform the treatment landscape for patients with EGFR-mutant NSCLC.

This approval and the accompanying licensing deal underscore the growing strength and global recognition of China's biopharmaceutical industry. Akeso Biopharma's success with AK112 serves as a testament to the country's ability to develop innovative therapies that can compete on the international stage and provide much-needed treatment options for patients worldwide.