AK112 Approval: Akeso Biopharma's $5 Billion Deal Transforms China's Lung Cancer Treatment

In a landmark event for the Chinese pharmaceutical sector, Akeso Biopharma's anti-PD-1/VEGF-A bispecific antibody, known as AK112, has received marketing approval from China's National Medical Products Administration (NMPA). This significant approval introduces a novel treatment option for patients with EGFR-mutant advanced or metastatic non-small cell lung cancer (NSCLC), and marks a pivotal achievement for Akeso, which recently entered into a $5 billion licensing agreement for this drug.

Commercially branded as Yidafang, AK112 is a humanized IgG1 bispecific antibody that targets VEGF-A and PD-1 simultaneously. By blocking the interactions between VEGF-A, PD-1, and their respective ligands, AK112 demonstrates substantial anti-tumor activity. The drug has been recognized multiple times by China's Center for Drug Evaluation (CDE) with Breakthrough Therapy Designations, highlighting its clinical importance.

Data presented at the 2024 European Lung Cancer Congress (ELCC) revealed that AK112, when used in combination with chemotherapy, showed promising outcomes for patients with EGFR-TKI-experienced, EGFR-mutant advanced non-squamous NSCLC. With a median follow-up period of 25.8 months, the treatment exhibited an objective response rate (ORR) of 68.4%, a disease control rate (DCR) of 94.7%, and a median duration of response (mDoR) of 8.7 months. Additionally, the median progression-free survival (mPFS) was recorded at 8.5 months, while the median overall survival (mOS) reached 22.5 months, with a 12-month overall survival rate of approximately 73.7%.

The impressive outcomes of AK112's Phase 2 clinical trials facilitated a significant licensing agreement. At the end of 2022, Akeso Biopharma granted Summit Therapeutics exclusive development rights for AK112 in the United States, Europe, Canada, and Japan. This agreement, valued at up to $5 billion, includes a $500 million upfront payment and tiered double-digit royalties on net sales. This deal represents a record-setting achievement for the out-licensing of a novel drug developed domestically in China.

Looking ahead, AK112 is undergoing six Phase 3 clinical trials, consisting of two international, multi-center studies led by Summit Therapeutics and four head-to-head trials against PD-1 monoclonal antibodies. The medical community is keenly anticipating further data from these trials, which will shed more light on AK112's potential to revolutionize the treatment of EGFR-mutant NSCLC.

The approval of AK112 and the substantial licensing deal underline the growing impact and global recognition of China's biopharmaceutical industry. Akeso Biopharma's success with AK112 is a testament to China’s ability to innovate and develop therapies that can compete internationally, offering essential treatment options to patients across the globe.

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