PD-1/VEGF Bi-Specific Antibody (AK112) Obtained Approval to Initiate a Phase II Clinical Trial for Monotherapy or Combined Chemotherapy Neoadjuvant/Adjuvant Therapy of Resectable Non-Small Cell Lung Cancer

HONG KONG,Nov. 2,2021 -- Akeso,Inc. (the Company,9926.HK) announces that AK112 (PD-1/VEGF bi-specific antibody),the novel immuno-oncology drug independently developed by the Company,obtained approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People's Republic of China to initiate a phase II clinical trial for monotherapy or combined chemotherapy neoadjuvant/adjuvant therapy of resectable non-small cell lung cancer (NSCLC).

This is an open and multi-center phase II randomized clinical trial aiming to evaluate whether pre-operative AK112 monotherapy or combined chemotherapy neoadjuvant/adjuvant therapy can improve the surgical pathological remission rate for patients with resectable NSCLC.

Lung cancer is one of the cancers with the highest morbidity and mortality in the world,of which about 85% are NSCLC,and about 30% of patients belong to resectable early and midstage NSCLC when they are first diagnosed. Certain clinical trials have shown that neoadjuvant immunotherapy can play an important role in the comprehensive treatment of early stage NSCLC,with controllable adverse reactions and less surgery delay.

Currently,the consensuson NSCLC neoadjuvant immunotherapy is: patients with resectable phase IB-IIIA NSCLC may consider neoadjuvant immunotherapy combined with platinumcontaining dual-agent chemotherapy or neoadjuvant immune monotherapy before surgery. The efficacy of immunotherapy combined with chemotherapy is better than chemotherapy with controllable safety,but the improvement of pathological remission rate is limited.

Immune checkpoint inhibitors plus anti-angiogenic drugs have been synergistically observed in multiple tumor types,PD-1/VEGF bi-specific antibody combined with chemotherapy is therefore expected to obtain better clinical benefits.

AK112 has shown good safety and tolerability in early clinical trials on various types of lung cancers including NSCLC and small cell lung cancer (SCLC),and has also shown excellent anti-tumor effects.

AK112 is the world's leading drug which entered phase III clinical trial among the same type of drugs. AK112 is another first-in-class bi-specific antibody drug developed by the Company to enter advanced clinical stage after the first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody,research and development code: AK104) entered the review stage.

In addition,the registrational phase III clinical trial of AK112 for the treatment of NSCLC after treatment failure by epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI) has been initiated; the phase III clinical trial of AK112 for the first-line treatment of driver-gene negative PD-L1 positive NSCLC and the phase III clinical trial of AK112 for the first-line treatment of extensive stage SCLC are about to be initiated.

INFORMATION ABOUT AK112 (PD-1/VEGF BI-SPECIFIC ANTIBODY)

AK112 is a first-in-class and the first to enter clinical trial PD-1/VEGF bi-specific antibody independently developed by the Company. Engineered with our unique Tetrabody technology,AK112 blocks PD-1 binding to PD-L1 and PD-L2,and blocks VEGF binding to VEGF receptors. PD-1 antibody in combination with VEGF blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma,non-small cell lung cancer and hepatocellular carcinoma). In the view of the co-expression of VEGF and PD-1 in the tumor micro environment,AK112,as a single agent to block these two targets,may block these two pathways more effectively and enhance the anti-tumor activity,as compared to combination therapy.

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