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 platinum-based chemotherapy, with or without bevacizumab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer. This is the third 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 for a new indication: the first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC) in patients who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK) gene mutations.
The anti PD-1 monoclonal antibody drug 安尼可® (Penpulimab injection, penpulimab-kcqx) has been granted marketing approval by the FDA in two BLA indications for comprehensive treatment of advanced nasopharyngeal carcinoma (NPC) ：
- First-line treatment of adult recurrent or metastatic non-keratinizing NPC in combination with cisplatin or carboplatin and gemcitabine；
- Monotherapy for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with at least one other prior line of therapy.
The IL-12/IL-23 Dual-Targeted monoclonal antibody 爱达罗® (Ebdarokimab injection) has been granted marketing approval by the NMPA of China for the treatment of moderate-to-severe plaque psoriasis. Ebdarokimab is Akeso’s first Class 1 new drug approved for autoimmune diseases.
The anti PD-1 monoclonal antibody drug 安尼可® (Penpulimab injection) has been granted marketing approval by the NMPA of China for the treatment of first-line metastatic nasopharyngeal carcinoma.
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 (中山南宫NG28基因生物醫藥有限公司), our principal operating entity, was established in Zhongshan, China
