Clinical Development Begins for Subcutaneous Cadonilimab, Advancing the Immuno-Oncology 2.0 Regimen
Recently, the clinical study of Akeso's world's first PD-1/CTLA-4 bispecific antibody cadonilimab (subcutaneous injection) combined with chemotherapy for the first-line treatment of gastric cancer has been approved by the National Medical Products Administration.
The intravenous dosage form of cadonilimab has been approved for 3 indications, including first-line gastric cancer, first-line cervical cancer, and recurrent/metastatic cervical cancer, and has conducted 11 registration/phase III clinical studies involving first-line treatment of various major tumors, IO-resistant treatment, and various cold tumor treatments, including international multi-center registration/phase III clinical studies for the first-line treatment of gastric cancer and the treatment of IO-resistant liver cancer.
Subcutaneous injection preparations have become an important development direction for global antibody drug delivery. The development of clinical research on cadonilimab subcutaneous injection preparations will provide a more convenient, safe and tolerable treatment and dosing plan for the majority of cancer patients, reduce medical treatment time, improve compliance, and provide support for medical institutions to optimize the allocation of medical resources.
Cadonilimab is the world's first new dual-antibody drug for tumor immunotherapy and was approved for marketing in 2022. Extensive clinical application in the real world and multiple phase III clinical studies have proven its breakthrough clinical value advantage in benefiting the entire population (including PD-L1 positive and negative), filling the clinical gap and being widely recognized by clinicians and patients. The advancement of clinical research on the subcutaneous injection form of cadonilimab will further leverage its dual immune checkpoint synergistic blocking mechanism and bring more breakthrough new treatment options to tumor patients.
Note: This article is a news release from Akeso to disclose the company’s latest progress. It is not a product promotion advertisement and does not constitute information disclosure or investment advice from Akeso.
About Kaitanni® (cadonilimab injection)
Cadonilimab is the world's first PD-1/CTLA-4 bispecific tumor immunotherapy drug independently developed by Akeso. It was approved by the National Medical Products Administration in June 2022 for the treatment of patients with recurrent or metastatic cervical cancer who have previously failed platinum-containing chemotherapy. In September 2024, the cadonilimab combination regimen was approved as a first-line treatment indication for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma; in May 2025, cadonilimab plus platinum-containing chemotherapy with or without bevacizumab was approved as a first-line treatment for persistent, recurrent or metastatic cervical cancer. Cadonilimab is the world's first new dual-antibody drug for tumor immunotherapy and China's first new bispecific antibody drug. The indications of cadonilimab for the treatment of recurrent or metastatic cervical cancer, first-line treatment of gastric cancer, and first-line treatment of cervical cancer that have failed platinum-containing chemotherapy have been included in the national medical insurance catalog.
Cadonilimab has conducted more than 30 clinical studies for more than 20 indications including gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. 11 phase III/registration clinical studies are in progress, and 3 studies have reached the research endpoint.
Cadonilimab is a tumor immunotherapy drug with a new mechanism. It can target PD-1 and CTLA-4 at the same time, exert a synergistic anti-tumor effect, and has excellent anti-tumor efficacy. Compared with combination therapy, its toxicity is significantly reduced, and it is safe and tolerable. Multiple clinical studies have shown that cadonilimab has excellent anti-tumor efficacy against both PD-L1 positive and negative patients with a variety of tumor diseases, and has breakthrough clinical value against IO-resistant and other types of cold tumors. Currently, cadonilimab has been highly recommended by 20+ clinical treatment guidelines and consensus, covering multiple indications such as gastric cancer, gynecological cancer, liver cancer, esophageal cancer, nasopharyngeal cancer, and biliary tract cancer.
About Akeso
Akeso (9926.HK) is a leading company integrating research, development, production and commercialization of the world's first or best-in-class innovative new biological drugs. Since its establishment in 2012, the company has always been patient-centered and clinical value-oriented, creating a unique end-to-end comprehensive new drug research and development platform for Kangfang. It has established an R&D innovation system with Tetrabody bispecific antibody development technology, antibody conjugation (ADC) technology, siRNA/mRNA technology and cell therapy technology as the core. It has an international standard GMP production system and an advanced commercialization system with an operating model. It has become a globally competitive biopharmaceutical innovation company.
The company has developed more than 50 innovative drug candidates for the treatment of major diseases such as tumors, autoimmunity, inflammation, and metabolic diseases. 26 drug candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs), 7 new drugs have been commercially sold, and the marketing applications for 2 new drugs for 4 indications are in the review and approval stage.
Akeso is the only pharmaceutical company in the world to have two new bispecific cancer immunotherapy drugs:
In June 2022, the company's world's first PD-1/CTLA-4 bispecific antibody cadonilimab was approved for marketing. It is the world's first approved new dual-antibody drug for tumor immunotherapy and the first new bispecific antibody drug in China. Currently, cadonilimab has been approved for first-line treatment of gastric cancer, first-line treatment of cervical cancer, and treatment of recurrent/metastatic cervical cancer, and 11 registration/phase III clinical trials are underway.
In May 2024, the company's world's first new PD-1/VEGF dual-antibody drug ivonescimab was approved for marketing for locally advanced or metastatic nsq-NSCLC that has progressed on EGFR-TKI treatment, becoming the world's first approved new dual-antibody drug with a "tumor immunity + anti-angiogenesis" mechanism. During the same period, ivonescimab obtained significant positive results in a "head-to-head" phase III clinical study with the global "drug king" pembrolizumab in a randomized, double-blind, controlled first-line treatment of PD-L1-positive NSCLC. ivonescimab can reduce the risk of disease progression/death in patients by 49%. ivonescimab became the first drug in the world to prove that its efficacy is significantly better than that of the "drug king" pembrolizumab in a head-to-head phase III clinical study. Based on the results of this study, the indication of ivonescimab was approved for marketing in April 2025, becoming a new standard treatment plan for first-line lung cancer treatment, providing patients with a new and better "de-chemotherapy" option. Currently, 15 registration/Phase III clinical studies of ivonescimab have been carried out/initiated, including 5 international multi-center registration Phase III clinical studies.
In December 2024, both cadonilimab and ivonescimab were included in the new national medical insurance catalog through medical insurance negotiations. In December 2025, except for the newly approved first-line hepatocellular carcinoma indication of Akeso, all other approved indications of Akeso's five independently commercialized and self-developed new drugs have been included in the national medical insurance directory.
In addition, based on the company's global leadership in the field of bispecific cancer immunotherapy drugs, the company is fully promoting the IO2.0+ADC2.0 global strategy and building a "cross-generation" international competitive advantage. At present, the company's independently developed first bispecific ADC drug Trop2/Nectin4 ADC (AK146D1) and new generation Her3 ADC (AK138D1) have been approved by China's NMPA and the US FDA, and are undergoing clinical research in China and Australia. A series of subsequent self-developed new generation ADCs/bispecific ADCs/dual toxin ADCs will also enter the clinical development stage. This will help the company's product portfolio establish a "cross-generation" competitive strategic advantage on a global scale.
International market development is Akeso's core development strategy. After being the first in China to license the rights to its independently developed CTLA-4 monoclonal antibody to Merck & Co. in 2015, the company once again set a Chinese record in December 2022 by licensing part of the overseas rights and interests of ivonescimab to the American company Summit with a plan of US$5 billion + a 2-digit percentage sales commission. This cooperation set a record for the highest transaction amount for foreign licensing of new drugs in China at that time. In addition, two indications of penpilimab for the treatment of nasopharyngeal cancer were approved by the U.S. Food and Drug Administration (FDA) in April 2025.
The company's non-tumor segment has also fully entered the commercial development stage: ebronucimab (PCSK9) has been approved for sale for two indications for the treatment of hypercholesterolemia; irokizumab (IL-12/IL-23) has been approved for sale for the indication of treating adult patients with moderate to severe plaque psoriasis; in addition, multiple phase III clinical studies of gumokimab (IL-17) and mandocinumab (IL-4R) have been successful and are in the marketing review stage. The company's product synergy and strategic combination capabilities in the non-oncology field have been further enhanced.
Akeso hopes to develop new drugs that are the first in the world and the best treatments of its kind through efficient and breakthrough R&D innovation, provide better disease solutions to patients around the world, and become the world's leading biopharmaceutical company.