Benefiting female patients, Hambetai ® Supplementary Application for New Indications for Gynecologic Oncology was approved

On January 3, 2023, Henlius announced that the company's self-developed Hanbetai ® (bevacizumab injection) supplementary application (sNDA) has been approved by the National Medical Products Administration (NMPA) to add two new indications for gynecological oncology of cervical cancer and epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Following metastatic colorectal cancer, advanced, metastatic or recurrent non-small cell lung cancer, recurrent glioblastoma and other tumors, Hambetel ® has once again been approved for the treatment of gynecological tumors, covering a wider range of patient populations.

Cervical and ovarian cancers are common gynaecological malignancies. According to the latest global cancer burden data, there were about 604,000 new cervical cancer patients and 314,000 ovarian cancer patients worldwide in 2020 [1]. In China, the incidence of gynecological tumors has been increasing year by year in recent years, in addition to breast cancer, cervical cancer and ovarian cancer are particularly worthy of attention due to high incidence and high mortality rate. In 2020, there were about 110,000 new cases of cervical cancer and about 59,000 deaths in China, and the incidence and mortality of cervical cancer accounted for almost one-fifth of the world, and about 15% of patients with early-stage and 58% of advanced cervical cancer patients relapsed during or after treatment; There are about 55,000 new cases of ovarian cancer and about 38,000 deaths [2], and the onset of ovarian cancer is insidious and about 70% of patients are diagnosed at an advanced stage, and the recurrence rate is extremely high. Epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer is a highly angiogenic tumor, with a high degree of malignancy and poor prognosis, which seriously endangers the life and health of Chinese women.

As a monoclonal antibody targeting vascular endothelial factor, bevacizumab can block VEGF from binding to its receptor by specifically binding vascular endothelial growth factor (VEGF), thereby inhibiting the formation of tumor neovascularization and preventing tumor growth and spread [3], and it has accumulated a lot of strong evidence-based medical evidence in the application of advanced ovarian cancer, cervical cancer and other gynecological tumors. And it is recommended as a standard or first-line treatment plan by major guidelines at home and abroad, effectively improving the prognosis and quality of life of patients with the above indications.

® Henlius is a biosimilar independently developed by Henlius in accordance with the "Technical Guidelines for the R&D and Evaluation of Biosimilars (Trial)", and has been supported by the "Twelfth Five-Year Plan" and "13th Five-Year Plan" National Science and Technology Major Special Projects (Major New Drug Creation), and was approved for marketing by the State Food and Drug Administration in November 2021. In pharmaceutical, non-clinical and clinical similarity comparison studies, Hanbetai ® shows high similarity with the original bevacizumab, and cervical cancer, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer has the same mechanism of action and target as previously approved indications, and has accumulated sufficient safety and immunogenicity data in previous clinical trials, which is in line with the "Technical Guidelines for Biosimilar R&D and Evaluation (Trial)" and "Guidelines for Biosimilar Similarity Evaluation and Indication Extrapolation Technical Guidelines" and other domestic regulations and policies on the requirements of indications extrapolation.

Henlius also continues to explore its clinical application around bevacizumab to broaden its therapeutic potential in a wider range of diseases, and is actively exploring the combination of Hans-like (serplulimab) with the company's core tumor immunotherapy product H drug Hans-like ® (serplulimab) for the immunotherapy of non-squamous ® non-small cell lung cancer, metastatic colorectal cancer and other tumor immunity combinations ® The Phase II clinical trial application for the combination of H drugs and the company's innovative anti-EGFR monoclonal antibody HLX07 for the first-line treatment of advanced hepatocellular carcinoma (HCC) has also been approved by the NMPA. In addition, according to the needs of ophthalmic drugs, the company has developed an ophthalmic preparation product recombinant anti-VEGF humanized monoclonal antibody injection HLX04-O based on Hambetei, which is intended for the treatment of wet age-related macular degeneration (wAMD), and is currently conducting clinical trials in China, Australia, ® the European Union and other countries and regions. It is expected to be the first bevacizumab approved for the treatment of ophthalmic-related diseases.

In the future, Henlius will continue to actively explore and develop more products with high safety and efficacy based on the clinical needs of patients, accelerate the market penetration and expansion of marketed products, and continuously improve product accessibility, so as to benefit a wider range of patients with high-quality biologics