开坦尼^? (Cadonilimab injection) is a novel, first-in-class PD-1/CTLA-4 bi-specific immunotherapy drug in-house developed by the Company, which is mainly used in the treatment of gastric cancer, liver cancer, lung cancer, cervical cancer, pancreatic carcinoma, esophageal squamous carcinoma and other malignant tumors. The research data show that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab demonstrates promising safety profile and efficacy.

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On June 29^th, 2022, 开坦尼^? has been granted marketing approval by the NMPA of China for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy. In September 2024，a new indication for cadonilimab has been approved for first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma，in combination with fluoropyrimidine and platinum-based chemotherapy. Currently, the new drug applications for Cadonilimab combined with platinum-based chemotherapy, with or without bevacizumab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer has been accepted by the CDE. Additionally, a series of clinical studies, including a phase III trial for adjuvant therapy in patients with a high risk of recurrence following curative resection of hepatocellular carcinoma, are being efficiently conducted.

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依达方^? is the world's first-in-class PD-1/VEGF bispecific immunotherapy drug, independently developed by Akeso. It has received marketing approval from China's National Medical Products Administration (NMPA) for the treatment of EGFR mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) in patients who have progressed after EGFR-TKI treatment. This approval marks it as the world's first-ever approved PD-1/VEGF bispecific antibody drug with a combined mechanism of tumor immunotherapy and anti-angiogenesis.

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Ivonescimab is currently being evaluated in several head-to-head studies, both domestically and internationally, across various lung cancer patient subgroups. China's NMPA has accepted a supplemental New Drug Application (sNDA) and granted priority review for ivonescimab as a monotherapy for the first-line treatment of NSCLC patients with positive PD-L1 expression. Ivonescimab is poised to establish a new standard of care as a chemo-free first-line treatment for lung cancer. This sNDA submission is supported by data from the AK112-303/HARMONi-2 study, which previously demonstrated ivonescimab's superior efficacy compared to pembrolizumab as monotherapy in a phase III head-to-head clinical trial, making ivonescimab the only drug achieved this milestone globally. Additionally, a phase III clinical trial is ongoing, comparing ivonescimab plus chemotherapy against tislelizumab plus chemotherapy as a first-line treatment for squamous NSCLC. Further studies sponsored by our partner, Summit, are also underway. These include a global multi-regional phase III study of ivonescimab combined with chemotherapy for the treatment of EGFR-mutant, locally advanced, or metastatic non-squamous NSCLC in patients who have progressed after EGFR-TKI treatment, as well as a global multi-regional phase III clinical trial comparing ivonescimab plus chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for squamous NSCLC patients.

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Ivonescimab has been studied in over 17 indications, both as a monotherapy and in combination therapy, including lung cancer, pancreatic cancer, breast cancer, hepatocellular carcinoma, and colorectal cancer.

安尼可^? (PD-1 Monoclonal Antibody, Penpulimab Injection) is currently the only differentiated PD-1 monoclonal antibody that applies the IgG1 subtype with modified Fc-nulldomain, which can more effectively enhance immunotherapeutic efficacy and reduce immune-related adverse reactions. It is used in the treatment of major diseases such as lung cancer, lymphoma, nasopharyngeal cancer, liver cancer, and gastric cancer, with improved safety and efficacy as demonstrated in clinical studies.

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安尼可^? has been approved by the National Medical Products Administration of China (NMPA) for the first-line treatment of locally advanced or metastatic squamous NSCLC, the treatment of relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) after at least second-line systemic therapy, and the third-line treatment of metastatic nasopharyngeal cancer chemo. The marketing applications of 安尼可^? for the first-line treatment of metastatic nasopharyngeal cancer was submitted in China. In addition, the clinical trials of 安尼可^? for the treatment of liver cancer and gastric cancer are being efficiently advanced.

伊喜宁? (Ebronucimab Injection) is an innovative PCSK9 monoclonal antibody independently developed by the company. On September 30, 2024, the National Medical Products Administration (NMPA) of China has approved the new drug application (NDA) of Ebronucimab for the treatment of primary hypercholesterolemia and mixed hyperlipidemia and heterozygous familial hypercholesterolaemia (HeFH). Ebronucimab is Akeso’s first non-oncology drug approved by NMPA.

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PCSK9 is the major regulator of low-density lipoprotein receptors (LDLR) level on the cell surface and can inhibit LDLR circulation pathway. By reducing the PCSK9 circulation level, Ebronucimab increases the expression of LDLR on the cell surface and increases the removal low-density lipoprotein cholesterol (LDL-C), thereby reducing the LDL-C level in the circulation. PCSK9 monoclonal antibody is known as the most effective lipid-lowering drug following the statin drugs. The marketed PCSK9 monoclonal antibody has demonstrated a significant reduction in cholesterol and a reduction in the incidence of heart attack or stroke in patients, based on the background treatment of statin drugs.

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The research subject of Ebronucimab, "Research and Development of New Anti-PCSK9 Monoclonal Antibody (AK102) for Cardiovascular Diseases", has been approved by Guangdong Province's R&D program of key fields (precision medicine and stem cells).