Global First! Kangong Bio's Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) New Drug Application for Cervical Cancer Accepted by NMPA
【Hong Kong, September 23, 2021】 Akeso, Inc. (9926.HK) announced that the National Medical Products Administration (“NMPA”) has formally accepted its marketing application for cadonilimab (Candonilimab, development code: AK104), a global first-in-class PD-1/CTLA-4 bispecific antibody, for the treatment of recurrent or metastatic cervical cancer, and granted it priority review.
This means that cadonilimab, independently developed and industrialized by Akeso, has become the first PD-1-based bispecific antibody drug globally to submit a marketing application, as well as China’s first independently developed bispecific antibody drug.
Cadonilimab was the first to submit a marketing application and gain acceptance globally, marking that China’s biopharmaceutical capabilities are rapidly advancing to the forefront of the world. This milestone will significantly boost the global standing of China’s biopharmaceutical industry, facilitate China’s transition from a major pharmaceutical producer to a leading pharmaceutical power, and support the realization of the “Healthy China 2030” strategy.
For Akeso, cadonilimab is the second independently developed innovative antibody drug for which it has submitted a marketing application, and represents the fifth new drug marketing application filed by Akeso in China and the United States.
Clinical study data demonstrate that cadonilimab exhibits significant efficacy and a favorable safety profile in patients with recurrent or metastatic cervical cancer who have progressed after platinum-based chemotherapy. In the target indication population, cadonilimab has shown superior efficacy compared to publicly available data for marketed PD-1 monoclonal antibodies. Relevant clinical data will be presented at international conferences and published in peer-reviewed journals.
Professor Wu Xiaohua, Director of the Department of Gynecologic Oncology at Fudan University Shanghai Cancer Center, stated that although PD-1 monoclonal antibodies with indications for cervical cancer have been approved globally, clinical study results show that they achieve an objective response rate of no more than 15% only in patients who are PD-L1 positive and have received two or more prior lines of therapy. The monotherapy efficacy and safety data demonstrated by cadonilimab in its registrational Phase II clinical trial are encouraging. It not only achieved a high response rate in the PD-L1-positive population but also showed notable efficacy in the PD-L1-negative population, with a significant improvement in median progression-free survival, thereby providing better treatment options for patients with advanced cervical cancer in China. The year 2030 is a critical milestone for both the "Global Strategy to Accelerate the Elimination of Cervical Cancer" and the "Healthy China 2030" planning outline. As China’s first independently developed bispecific antibody product, cadonilimab is expected to contribute to the successful implementation of global and national health strategies for cervical cancer elimination.
Professor Kong Beihua, Director of the Department of Obstetrics and Gynecology at Qilu Hospital of Shandong University and President-Elect of the Gynecologic Oncology Branch of the Chinese Medical Association, stated that cervical cancer is the most prevalent gynecologic malignancy in China. Patients with late-stage metastatic or recurrent disease are difficult to cure with conventional therapies, representing one of the greatest challenges facing gynecologic oncologists and highlighting a significant unmet clinical need. While the clinical efficacy of immune checkpoint inhibitor monotherapy has been unsatisfactory, combination therapies, although promising in enhancing efficacy, are associated with severe adverse effects that greatly limit their clinical application. Clinical trials have demonstrated that cadonilimab achieves high response rates with low toxicity and a favorable safety profile in patients with advanced, metastatic, or recurrent cervical cancer who have failed conventional treatments. Having entered the national priority review pathway, this development is welcome news for physicians and a boon for patients. It will position China at the forefront of the new era of immunotherapy in oncology on the global stage, elevate the standards of cervical cancer prevention and treatment in China, and bring substantial benefits to a broad patient population—a truly commendable achievement.
Dr. Xia Yu, Founder, Chairman, and CEO of Akeso, Inc., expressed his delight, stating: “Cadonilimab is a novel monoclonal antibody drug developed through years of dedicated research by Akeso’s scientists. It holds global patents as a bispecific antibody simultaneously targeting PD-1 and CTLA-4, and it is the first PD-1-targeting bispecific antibody worldwide to file for marketing approval. We extend our sincere gratitude to the Akeso team, clinical research centers, medical experts, and regulatory authorities at all levels for their outstanding efforts. Akeso will fully leverage its leading advantages in the field of bispecific antibodies to accelerate the clinical development of Cadonilimab for additional indications. We look forward to Cadonilimab’s dual immune checkpoint blockade benefits reaching more cancer patients.”
Key Milestones of Cadonilimab in the Treatment of Cervical Cancer:
● In July 2021, the Phase III clinical trial of cadonilimab combined with chemotherapy as first-line treatment for advanced cervical cancer was officially launched
● In February 2021, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to cadonilimab for the treatment of cervical cancer
● In July 2020, the FDA granted cadonilimab Fast Track designation for the treatment of recurrent or metastatic cervical cancer that has progressed after platinum-based chemotherapy.
● In October 2020, cadonilimab for the treatment of recurrent or metastatic cervical squamous cell carcinoma after standard therapy was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration to be included in the “Breakthrough Therapy Designation” list.
Currently, the key indications under development for cadonilimab include gastric cancer, lung cancer, liver cancer, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma. Notably, the Phase III clinical trial of cadonilimab as first-line therapy for gastric cancer has officially been initiated.
Cadonilimab (AK104) is a novel, first-in-class PD-1/CTLA-4 bispecific antibody for tumor immunotherapy, independently developed by Akeso. Its primary indications include various malignant tumors such as lung cancer, liver cancer, gastric cancer, cervical cancer, renal cell carcinoma, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma. Interim data from related tumor studies demonstrate that cadonilimab significantly reduces toxicity compared with the combination therapy of PD-1 and CTLA-4 inhibitors, offering distinct advantages in both safety and efficacy. Cadonilimab was supported as a key project under the National Major Science and Technology Program for "Major New Drug Innovation" during the 13th Five-Year Plan period, jointly launched by the National Health Commission of China and the Ministry of Science and Technology in 2017. It was also included in the 2017 Guangdong Province "Pearl River Talent Plan" for supporting introduced innovation and entrepreneurship teams. The development of cadonilimab was recognized as one of the "Top Ten Advances in Chinese Pharmaceutical Biotechnology in 2017" by the Chinese Association of Pharmaceutical Biotechnology and the journal *Chinese Journal of Pharmaceutical Biotechnology*.
Akeso, Inc. (HKEX Stock Code: 9926.HK) is a biopharmaceutical company dedicated to the research, development, production, and commercialization of innovative antibody-based novel drugs that are affordable for patients worldwide. Since its establishment, the company has built an end-to-end comprehensive drug development platform (ACE Platform), covering fully integrated drug discovery and development capabilities, including target validation, antibody discovery and development, CMC process development, and GMP-compliant large-scale manufacturing. The company has also successfully established a bispecific antibody drug development platform (Tetrabody Platform). Akeso currently possesses a pipeline of more than 20 innovative drug candidates for the treatment of major diseases such as cancer, autoimmune disorders, inflammatory conditions, and metabolic diseases, among which 13 have entered clinical studies, including two first-in-class bispecific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). In August 2021, the company’s first independently developed differentiated PD-1 monoclonal antibody, Penpulimab Injection (Anniko), was approved for marketing. Akeso aims to become a globally leading biopharmaceutical enterprise by efficiently and breakthroughly developing first-in-class and best-in-class innovative therapies.