According to the information publicized on the official website of the Center for Drug Evaluation, NMPA, BL-B01D1 for injection applied by Baili Pharmaceutical, an enterprise in the park, has obtained the implied license for clinic trial.

       According to the information on the official website of Baili Pharmaceutical, BL-B01D1 is a bispecific antibody-drug conjugate (ADC), which can target EGFR and HER3 at the same time.

       # Bispecific antibody

       Bispecific antibody is an artificial antibody containing two kinds of specific antigen binding sites, which can build bridges between target cells and functional molecules (cells) and stimulate targeted immune response. It is a kind of genetic engineering antibody, and has become a hot spot in the field of antibody engineering, with broad application prospects in tumor immunotherapy.

       Baili Pharmaceutical's drug BL-B01D1 that is approved for clinical trial this time is a bispecific ADC targeting EGFR and HER3.

       ●EGFR is a group of cell surface receptors of epidermal growth factor family with tyrosine kinase activity. Abnormal activation of EGFR can activate genes related to tumor proliferation and differentiation, and then induce tumor formation and development.

       ●HER3 is a very important receptor in EGFR family and plays an important role in tumorigenesis, development and drug resistance. Moreover, targeting EGFR and HER3 is expected to further improve the anti-tumor effect of ADC.

       According to the official website of Baili Pharmaceutical, the company plans to develop BL-B01D1 for the treatment of lung cancer, esophageal cancer, head and neck squamous cell carcinoma and other indications.

       Since 2014, Baili Pharmaceutical has been focusing on the breakthrough effect of tumor treatment for seven years, and now it has built various "break-through" product lines, of which ADC drugs are an important part.

       Since the first ADC drug patent was applied in 2015, there have been 25 patent families including 65 formal patent applications in 13 countries and regions. On the unique SHRI-ADC platform of Baili Pharmaceutical, application for IND will be made for the first FIC/BIC strategy-based ADC project in 2021.

       In the coming three years, there will be another 12 projects on the ADC drug R&D pipeline of Baili Pharmaceutical entering clinical trials successively, covering the main categories of solid tumors and hematologic tumors. Baili Pharmaceutical's ADC drugs based on FIC/BIC strategy will always aim at breakthrough efficacy.

       Baili is on the way to become the strongest ADC company in the world.

        Baili Pharmaceutical

       Baili Pharmaceutical is a bio-pharmaceutical enterprise which focuses on global bio-pharmaceutical frontier field and is based on solving clinical unmet requirements. The Company has the drug research and development capability including small molecule chemical drugs, large molecule biological drugs and ADC drugs, has the integration advantage of from intermediates, APIs to preparations, and has the commercial operation capability covering the complete life cycle of “R&D - production - marketing”.

       The Company has 2 new drug R&D centers (SYSTIMMUNE in Seattle and BAILI PHARM/ BAILI-BIO located in Phase I of Tianfu Life Science Park), 1 antibody and ADC drug manufacturer, 1 chemical intermediate production enterprise, 1 chemical API manufacturer, 2 chemical pharmaceutical preparation manufacturers and 2 marketing companies.

This article is a combination from Baili Pharmaceutical,

Sichuan Tianfu Pharmaceutical Company Competitiveness Promotion Center, Biovalley