依达方®
(PD-1/VEGF bispecific, Ivonescimab injection)
Ivonescimab is a globally first-in-class PD-1/VEGF bispecific immunotherapy drug, independently developed by Akeso. It is also the first bispecific antibody approved worldwide with a combined mechanism of tumor immunotherapy and anti-angiogenesis. By simultaneously targeting PD-1 and VEGF, ivonescimab combines the broad anti-tumor activity of PD-1 blockade with the potent tumor growth inhibition associated with VEGF-targeted anti-angiogenic therapy. This synergistic mechanism not only enhances antitumor efficacy, but also helps overcome limitations traditionally associated with each individual target, supporting the drug’s breakthrough clinical value and establishing a new direction in the development of cancer immunotherapy bispecific antibodies.
In May 2024, ivonescimab received marketing approval from the China's National Medical Products Administration (NMPA) for the treatment of patients with EGFR mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) whose disease had progressed following EGFR-TKI therapy. In April 2025, the NMPA approved ivonescimab as a monotherapy for the first-line treatment of advanced NSCLC patients with positive PD-L1 expression, providing patients with a newchemotherapy-free treatment option. The approval was supported by the Phase III HARMONi-2 study, in which ivonescimab demonstrated superior efficacy to pembrolizumab in a head-to-head comparison, making it the first drug globally to show positive Phase III results against pembrolizumab in this setting. In August 2026, ivonescimab in combination with chemotherapy was approved for the first-line treatment of advanced squamous NSCLC (sq-NSCLC). In a randomized, double-blind, controlled Phase III trial, the regimen became the first globally to demonstrate statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared with a PD-1 antibody plus chemotherapy regimen. These findings established a new benchmark for first-line treatment of squamous NSCLC and marked an important milestone in lung cancer therapy. To date, two approved indications for ivonescimab have been included in China’s National Reimbursement Drug List (NRDL), and the drug has been recommended by 13 authoritative domestic and international clinical guidelines.
Ivonescimab is currently being evaluated as both monotherapy and combination therapy across more than 40 indications, including lung cancer, colorectal cancer, head and neck squamous cell carcinoma, biliary tract cancer, pancreatic cancer, and breast cancer, with more than 60 clinical studies underway or completed. These include 16 registrational or Phase III studies, among them six international multicenter registrational Phase III trials. In December 2022, Akeso entered into a landmark licensing agreement with U.S.-based Summit Therapeutics, granting Summit certain overseas rights to ivonescimab in a deal valued at up to US$5 billion, including a US$500 million upfront payment, double-digit royalties on net sales, and equity consideration. The transaction set a new benchmark for overseas licensing of an innovative drug developed in China and represented a major milestone in the global expansion of Chinese biopharmaceutical innovation.
开坦尼®
(PD-1/CTLA-4 Bispecific Antibody, Cadonilimab Injection)
Cadonilimab (开坦尼®) 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.
On June 29th, 2022, cadonilimab was 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,cadonilimab was 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; In May 2025,cadonilimab was approved for the first-line treatment of persistent, recurrent, or metastatic cervical cancer,in combination with platinum-based chemotherapy, with or without bevacizumab. All the above-approved indications are included in China's latest National Reimbursement Drug List (NRDL).
Additionally, a series of clinical studies are being efficiently conducted for cadonilimab, encompassing a Phase III adjuvant therapy trial in high-risk hepatocellular carcinoma post-resection, as well as two global, multicenter, registrational trials in immunotherapy-resistant HCC and first-line gastric cancer.
Anikora ®
(PD-1 Monoclonal Antibody, Penpulimab Injection)
Anikora® (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, nasopharyngeal cancer, liver cancer, and gastric cancer, with improved safety and efficacy as demonstrated in clinical studies.
Anikora® has been approved by the National Medical Products Administration of China (NMPA) for :
The first-line treatment of recurrent or metastatic nasopharyngeal cancer (NPC) in combination with chemotherapy;
The first-line treatment of locally advanced or metastatic squamous NSCLC;
The third-line treatment of metastatic nasopharyngeal cancer chemotherapy.
In addition, the clinical trials of Anikora® for the treatment of liver cancer and gastric cancer are progressing efficiently.
The U.S. Food and Drug Administration (FDA) has approved Penpulimab-kcqx (Anikora®) in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent 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.
伊喜宁®
(PCSK9 MONOCLONAL ANTIBODY, EBRONUCIMAB INJECTION)
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.
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.
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).
爱达罗®
(IL-12 / IL-23 MONOCLONAL ANTIBODY, EBDAROKIMAB INJECTION)
爱达罗® (Ebdarokimab Injection) is a novel humanized monoclonal antibody targeting IL-12/IL-23, developed by Akeso. Ebdarokimab is indicated for the treatment of psoriasis, ulcerative colitis, and other autoimmune disorders.
By inhibiting the biological activity of cytokines IL-12 and IL-23, it provides therapeutic benefits in autoimmune diseases. Psoriasis pathogenesis is associated with dysregulated immune responses, where IL-12 and IL-23, cytokines sharing a common p40 subunit, play pivotal roles in inflammation and immune modulation. IL-12 induces the activation and proliferation of Th1 cells (T helper cells 1), which secrete interferon-γ and TNF-α (tumor necrosis factor α), while IL-23 is involved in the differentiation of Th17 cells (T helper cells 17), leading to the release of IL-17 (interleukin-17). These cytokines are key mediators in inflammatory processes. Ebdarokimab binds to the p40 subunit of IL-12 and IL-23, preventing their interaction with cell surface receptors, thereby attenuating the release of cytokines such as interferon-γ, TNF-α, and IL-17 from T cells. This inhibition of cytokine-driven immune responses effectively modulates the aberrant immune activity in psoriasis.
On April 18, 2025,爱达罗® has been granted marketing approval by the NMPA of China for the treatment of moderate-to-severe plaque psoriasis.
Adverse Event Reporting
(click to enter adverse event reporting platform)