The Center for Drug Evaluation (CDE) website indicates that China-based Jiangsu Hengrui Medicine Co., Ltd’s (SHA: 600276) new indication filing for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, combined with the multi-kinase inhibitor famitinib, is set to receive Breakthrough Therapy Designation (BTD) status. The combination is intended as a first-line treatment for recurrent or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression in tumor cells (TPS ≥ 1%) and no EGFR/ALK gene abnormality. Additionally, Akeso Biopharma’s (9926.HK) AK112, a bispecific antibody (BsAb) targeting PD-1 and vascular endothelial growth factor (VEGF), is also set to receive BTD status for locally advanced or metastatic non-squamous NSCLC with EGFR mutations resistant to previous EGFR tyrosine kinase inhibitor (TKI) treatment.
Camrelizumab: Market Approval and Development
Camrelizumab gained its first market approval in China in May 2019 for use as a third-line treatment for classic Hodgkin’s lymphoma. The drug is currently being developed for multiple indications, including hepatocellular carcinoma (HCC), NSCLC, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, urinary tract tumors, and gynecological tumors, either as monotherapy or in combination with other drugs. Camrelizumab combined with famitinib are undergoing multiple clinical studies. The combination received BTD status for the treatment of recurrent metastatic cervical cancer in China in November 2020 and was approved for a Phase I/II clinical study in advanced solid tumors when combined with paclitaxel (albumin-bound) a year later. Another clinical approval was secured in December 2021 to treat advanced solid tumors in combination with SHR-1802, an in-house developed lymphocyte activation gene 3 protein (LAG-3).
Akeso’s AK112: Bispecific Antibody
Akeso’s self-developed AK112 is the world’s first PD-1/VEGF bispecific antibody to enter Phase III trials. The drug blocks the PD-1 and VEGF pathways simultaneously, aiming to produce synergistic anti-tumor effects. This innovative approach underscores Akeso’s commitment to advancing novel therapies for patients with challenging cancers.
Future Outlook
The upcoming BTD status for both Hengrui’s camrelizumab combination and Akeso’s AK112 highlights the significant progress being made by Chinese biopharmaceutical companies in developing innovative cancer treatments. These designations are expected to accelerate the clinical development and market availability of these promising therapies, offering new hope for patients with non-small cell lung cancer and other advanced malignancies.-Fineline Info & Tech
