Boan Biotech (6955.HK) announced today that the first patient in Phase III clinical trial of its Nivolumab Injection (BA1104) in China has been enrolled. BA1104 is the first biosimilar to Opdivo® to undergo a Phase III study in China.
Nivolumab is a monoclonal antibody that can enhance the immune response of T cells against tumors by preventing the programmed cell death 1 (PD-1) receptor from binding to its ligands PD-L1 and PD-L2. As a broad-spectrum anticancer medication, Nivolumab has been approved for multiple indications both in China and abroad. These include its use as a neoadjuvant, an adjuvant, or a first-line or later-line therapy for advanced cancers. It can be used as a standalone treatment, in combination with chemotherapy, or alongside novel immune checkpoint inhibitors. Nivolumab has become a product of basic therapy for a variety of solid tumors.
The development of BA1104 follows the relevant guidelines for biosimilars. Pre-clinical studies show that BA1104 is highly similar to Opdivo® in pharmaceutical and non-clinical activities. The results of the completed Phase I clinical trial support a demonstration of biosimilarity to Opdivo® in terms of pharmacokinetics (PK), safety, and immunogenicity, and all study endpoints were met. The Phase III clinical trial is a randomized, double-blind, multicenter study designed to compare the efficacy, safety, and immunogenicity of BA1104 and Opdivo® combined respectively with chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma. According to the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars issued by the Center for Drug Evaluation of the National Medical Products Administration, after the completion of the Phase III clinical trial, BA1104 can apply and be approved for all the same indications as Opdivo® in China.
Immunotherapies such as PD-1 inhibitors have become one of the primary treatments for different types of cancer worldwide, and have consistently demonstrated clinical value and potential in the marketplace. Publicly available data shows that Opdivo®, the first approved PD-1 in the world, achieved global sales of approximately USD 8.249 billion in 2022. Frost & Sullivan predicts that the market for anti-PD-1/L1 antibodies in China will reach RMB 29.8 billion by 2025, with a compound annual growth rate of 63.4% from 2018 to 2025.
Dr. Dou Changlin, President of R&D and Chief Operating Officer at Boan Biotech, said:“As fundamental anticancer drugs, PD-1 inhibitors have a wide range of indications and the potential for use in combination with other drugs, holding promise for treating multiple types of cancer and meeting the needs of patients. We are at the forefront of developing Nivolumab as a biosimilar in China thanks to our strong CMC and R&D management capabilities. We will accelerate its clinical development and explore its potential to combine with other innovative antibodies in our pipeline such as BA1106 (a novel immune checkpoint inhibitor), BA1301 (an antibody-drug conjugate), and BA1202 (a CD3/CEA bispecific antibody). This will make our pipeline even stronger.”
Boan Biotech has built a strong portfolio thanks to its in-house innovation capabilities. In addition to 2 commercially available products, the company also has 7 innovative antibodies and 4 biosimilars in its pipeline. To meet the pressing treatment needs of patients, the company has developed a range of monoclonal antibodies, bispecific antibodies, and ADCs that stand out among investigational drugs in the same classes, targeting CD25, CEA/CD3, IL-4Rα, Claudin 18.2, etc. At the same time, all of the biosimilars in the company's pipeline are close to commercial launch. Their development is the fastest or among the fastest in China, boasting a first-mover advantage for commercial launch. Besides, the company is also seeking to register or conduct clinical trials for some candidates in its pipeline abroad in markets like Europe, the United States, and Japan.