Ivonescimab (PD-1/VEGF) Received Priority Review from China's NMPA for First-Line Treatment of PD-L1 Positive NSCLC

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Aug 14, 2024, 19:30 ET

The Second Indication of Ivonescimab in NSCLC
2L+ EGFRm NSCLC Already Approved in May 2024

HONG KONG, Aug. 14, 2024 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926.HK) ("Akeso,") today announced that the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) has granted priority review of the supplemental New Drug Application (sNDA) to 依达方® (ivonescimab), a first-in-class PD-1/VEGF bi-specific antibody developed by Akeso, as monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).

This marks the second indication for which ivonescimab has been granted priority review following the treatment of EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy, highlighting its significant clinical value.

This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study. At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent radiology review committee (BICR) compared to pembrolizumab, and the hazard ratio (HR) was significantly better than expected. There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

In May 2024, ivonescimab combination therapy for EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy was approved through priority review, making it the world's first approved bispecific antibody that combines "tumor immunotherapy" and "anti-angiogenesis" mechanisms.

About Ivonescimab (AK112/SMT112)

Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics' license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 5 Phase III trials including 2 global MRCTs and 4 registrational trials versus anti-PD-1 therapeutics. The Company is also conducting multiple clinical trials of ivonescimab covering 16 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer.

About Akeso

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.

With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases, with 19 drug candidates in the clinical stage, including 8 multispecific antibodies. Akeso has successfully promoted the commercialization of three innovative biological drugs, and marketing applications of multiple indications are submitted for 4 new drugs. 安尼可®, approved for marketing in August 2021, is currently the only differentiated PD-1 monoclonal antibody that applies the IgG1 subtype with modified Fc-null domain. 开坦尼® (PD-1/CTLA-4 bi-specific antibody, Cadonilimab injection) was granted marketing approval in June 2022, making it the world's first bi-specific antibody drug for tumor immunotherapy and the first bi-specific antibody new drug in China.In May 2024, 依达方® (PD-1/VEGF bi-specific antibody, Ivonescimab injection), the first-in-class PD-1/VEGF bi-specific antibody independently developed by Akeso, was granted marketing approval for the treatment of epidermal growth factor receptor ("EGFR") mutated locally advanced or metastatic non-squamous non-small cell lung cancer ("nsq-NSCLC"), making it the world's first approved PD-1/VEGF bi-specific antibody. The drug had been granted three Breakthrough Therapy Designations for the treatment of lung cancer by the Center for Drug Evaluation (CDE). In December 2022, a license agreement with total potential deal value of USD $5 billion, plus a low double-digit royalty of product net sales in the authorized countries of the new drug, 依达方®, set a new record in overseas licensing for the transaction amount of a single innovative drug in China.

Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

Shihui Zhu
[email protected]

SOURCE Akeso, Inc.