— Anti-EGFR Humanized Monoclonal Antibody In the 1970s, scientists discovered that monoclonal antibodies could precisely target tumor-specific molecules, sparking a revolutionary shift in cancer treatment. Since 1999, Biotech Pharma has been dedicated to researching the clinical applications of monoclonal antibody drugs in cancer therapy. In April 2008, TaiXinSheng (Nimotuzumab), a humanized monoclonal antibody targeting the epidermal growth factor receptor (EGFR), was officially launched. By March 2009, it was incorporated into the NCCN Clinical Practice Guidelines (China Edition), becoming the only targeted therapy currently approved specifically for nasopharyngeal carcinoma. EGFR plays a critical role in cancer development by disrupting cell proliferation and apoptosis through downstream signaling pathways, contributing to the progression of various malignancies. Globally, TaiXinSheng has received approval for head and neck cancers in 24 countries, including the U.S., Germany, Canada, Japan, Cuba, and India, while it’s also approved for esophageal cancer in 7 nations. Clinical studies have demonstrated that TaiXinSheng exhibits promising therapeutic outcomes in treating a range of cancers, including head and neck tumors, nasopharyngeal carcinoma, pancreatic cancer, breast cancer, gliomas, and non-small cell lung cancer, often leading to prolonged survival for patients. Currently, multi-center, registration-based clinical trials are underway across China, evaluating TaiXinSheng in combination with radiotherapy and chemotherapy for head and neck cancers, esophageal cancer, pancreatic cancer, cervical cancer, and high-grade pediatric gliomas. These trials have already led to the inclusion of TaiXinSheng in several national clinical practice guidelines and expert consensus documents for nasopharyngeal carcinoma, head and neck cancers, and pancreatic cancer. Patients—both domestically and internationally—have widely reported mild adverse reactions, with excellent tolerability and compliance, making TaiXinSheng a relatively safe biologic agent. Renowned oncology experts and scholars in China generally agree that this drug effectively targets tumor cells while sparing healthy ones, offering distinct advantages such as high specificity, superior bioavailability, and minimal side effects—qualities that make it a trusted option for cancer treatment. Thanks to its remarkable efficacy and outstanding safety profile, TaiXinSheng was included in the first batch of drugs selected for national medical insurance negotiations in 2017. Two years later, the renewal was successfully completed, cementing its status as one of China’s most significant domestically produced monoclonal antibody therapies for cancer. The clinical application of TaiXinSheng has significantly advanced the adoption of molecularly targeted therapies in cancer treatment across the country.

——Anti-EGFR humanized monoclonal antibody

In the 1970s, scientists found out that monoclonal antibodies can specifically target tumor cells, which triggered significant changes in cancer treatment since then. BPL has focused on the clinical application of monoclonal antibodies to treat patients with cancer since 1999, and developed China’s first humanized monoclonal antibody Nimotuzumab (Tai Xin Sheng), which was approved to treat patients with nasopharyngeal cancer in China and put into market in 2008. Nimotuzumab targets epidermal growth factor receptor (EGFR), and is believed to be candidate for the treatment of multiple solid tumors, concerning EGFR participates in the occurrence and development of various malignant tumors by leading to cell proliferation and apoptosis.  
According to various clinical trials of Nimotuzumab, it demonstrates great efficacy in treating patients with head and neck cancer, pancreatic cancer, breast cancer, gliomas, NSCLC and so on, and significantly improve the quality of life of patients and extent their life cycle. Now clinical trials of Nimotuzumab along with/without chemotherapy and radiotherapy to treat patients with H&N cancer, esophageal cancer, pancreatic cancer, high-grade pediatric gliomas are under going.
What distinguishes Nimotuzumab from other antibodies is its outstanding safety profile, which has been confirmed by tens of thousands of patients at home and abroad. It is widely agreed that Nimotuzumab can protect normal cells while killing tumor cells, which results in the strong specificity and high bioavailability. Therefore, Nimotuzumab has been successfully recorded into the national medical insurance catalogue in 2017, 2019 and 2021, which enables more cancer patients can benefit from its use.