Biyapay

开坦尼^®(Cadonilimab injection) and 依达方^®(Ivonescimab injection) have both been included in the most recent National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration. The most recent NRDL will become effective on January 1, 2025.

伊喜宁^® (PCSK9 Monoclonal antibody，Ebronucimab injection)， independently developed by the Company, has been granted marketing approval by the NMPA of China for the treatment of primary hypercholesterolemia, mixed hyperlipidemia and heterozygous familial hypercholesterolaemia (HeFH).Ebronucimab is Akeso’s first non-oncology drug.

开坦尼^®(Cadonilimab injection), a first-in-class PD-1/CTLA-4 bi-specific antibody independently developed by the Company, has been granted marketing approval by the NMPA for a new indication: cadonilimab in combination with fluoropyrimidine and platinum-based chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. This is the second indication approval for cadonilimab in China.

依达方^®(Ivonescimab injection) ，the first-in-class PD-1/VEGF bi-specific antibody  independently developed by the Company, has been granted marketing approval by the NMPA of China for the treatment of epidermal growth factor receptor (‘‘EGFR’’) mutated locally advanced or metastatic non-squamous non-small cell lung cancer (‘‘nsq-NSCLC’’) .

The anti PD-1 monoclonal antibody drug 安尼可^® (Penpulimab monoclonal antibody injection) has been granted marketing approval by the NMPA of China for the treatment of third-line metastatic nasopharyngeal carcinoma.

The anti PD-1 monoclonal antibody drug 安尼可^®(Penpulimab monoclonal antibody injection) has been granted marketing approval by the NMPA of China for the first-line treatment of locally advanced or metastatic sq-NSCLC.

Akeso out-licensed its breakthrough bispecific antibody, ivonescimab (PD-1/VEGF, AK112), with up to $5 Billion to Summit Therapeutics for development and commercialization in the U.S., Canada, Europe, and Japan.

开坦尼^®(Cadonilimab injection), a first-in-class PD-1/CTLA-4 bi-specific antibody independently developed by the Company, has been granted marketing approval by the NMPA of China for the treatment of recurrent or metastatic cervical cancer (R/M CC) patients that who has progressed on or after platinum-based  chemotherapy.

The anti PD-1 monoclonal antibody drug 安尼可^® (Penpulimab monoclonal antibody injection) has been granted marketing approval by the NMPA of China for the treatment of patients with r/r cHL after at least second-line systemic chemotherapy treatment.

HKEX Listing(Stock Code: 9926)

We established CTTQ-Akeso

We formed Sino Biopharm Collaboration to codevelop and co-commercialize penpulimab (AK105)

We obtained the IND approval for a clinical trial of AK112 (PD-1/VEGF) in theUnited States

We obtained the IND approval for AK104 from the FDA to begin a Phase Ib/II clinical trial in the United States

The Company was incorporated in the Cayman

Islands as an exempted company with limited liability

We initiated a Phase I clinical trial of ebronucimab (AK102) (PCSK9) in China

We obtained the IND approval for penpulimab (AK105) with respect to cervical cancer and solid tumors from the FDA in the United States

We initiated a Phase I clinical trial for AK101 (IL-12/IL-23)  in China

We initiated a Phase I clinical trial for penpulimab (AK105) (PD-1) in  Australia

We initiated a Phase I clinical trial (with chemotherapy) for AK104 (PD-1/CTLA-4) for the treatment of solid tumors in Australia

We out-licensed AK107 (CTLA-4) to Merck (code name in Merck is MK1308)

We initiated the development of innovative ACE Platform and “TETRABODY” technology

Akeso Biopharma (中山Biyapay生物醫藥有限公司), our principal operating entity, was established in Zhongshan, China