On December 5^th, 2019, the MIL60 phase III clinical study jointly sponsored by Betta Pharmaceuticals Co., Ltd. and Beijing Mabworks Biotech Co. Ltd. has reached its primary endpoint. This study is a randomized, double-blind, multicenter phase III comparison of the efficacy and safety of MIL60 with Avastin combined with paclitaxel and carboplatin in the treatment of advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). The study was led by Professor Jie Wang of the Cancer Hospital of the Chinese Academy of Medical Sciences and recruited 50 clinial sites nationwide.

MIL60 is a recombinant humanized monoclonal antibody against human vascular endothelial growth factor (VEGF) jointly developed by Betta Pharmaceuticals Co., Ltd. and Beijing Mabworks Biotech Co. Ltd., and is a bevacizumab biosimilar drug. According to the “Technical Guiding Principles for the Development and Evaluation of Biosimilar Drugs (Trial Implementation)” issued by the former National Medical Products Administration (NMPA) in 2015, MIL60 has successfully completed the preclinical comparison study, clinical PK comparison study, and phase III efficacy comparison study with bevacizumab.

  Bevacizumab is a recombinant humanized monoclonal antibody that selectively binds to VEGF and blocks its biological activity. It contains an Fc region of a human antibody and an antigen-binding region of a humanized murine antibody that is capable of binding to VEGF and can inhibit the binding of VEGF to its receptors on endothelial cells - Flt-1 and KDR. By deactivating VEGF's biological activity, tumor angiogenesis is reduced, this drug could thereby inhibit tumor growth. Avastin was approved by the NMPA on July 9^th, 2015. When used in combination with carboplatin and paclitaxel, it is used as the first-line treatment for unresectable advanced, metastatic or recurrent non-squamous NSCLC patients.

  Professor Jie Wang from the Cancer Hospital of the Chinese Academy of Medical Sciences commented: “The morbidity and mortality of lung cancer patients in China remain high. The launch of high-quality a bevacizumab biosimilar will provide more and better choices for lung cancer patients in China”.

  Professor Li Mao, Senior VP and Chief Medical Officer of Betta Pharma, commented: "The results of the MIL60 study are encouraging. This is the result of the joint efforts of clinicians and the Betta clinical research team. This process also fully reflects the professional quality and organizational capability of Betta Pharma in clinical development. Betta's mission is to make more affordable medicines to the general public, meet more medical needs, and benefit more patients. "

  Dr. Feng Li, Chairman and General Manager of Mabworks Biotech Co. Ltd., commented: “MIL60 is highly similar to bevacizumab shown in pharmacological, preclinical, and phase I clinical studies. It is confirmed that the efficacy of a domestically developed biosimilar is comparable with that of the original drug. We look forward to continuing to work closely with Betta’s team to get MIL60 launched early to benefit more cancer patients.”

  In recent years, Betta Pharma has expanded its pipeline for multiple products through independent R&D and strategic collaboration. The company has more than 30 innovative drugs under development covering multiple tumor indications such as lung cancer, renal cancer, and breast cancer. Among them, ensartinib hydrochloride has submitted a domestic NDA application and is included in the priority review by the NMPA. Its global multi-center phase III clinical study is now progressing smoothly, and ensartinib hydrochloride is expected to become the first globally launched lung cancer targeted innovative drug developed by a Chinese pharmaceutical company.

About Betta

Betta Pharmaceuticals Co., Ltd. (Stock code: 300558.SZ) is a national level high-tech enterprise, established by the experienced talent team of overseas returnees, with research and development (R&D) of innovative drugs as its core focus, integrating R&D, manufacturing and marketing. The company independently developed China's first small-molecule targeted anticancer drug, icotinib hydrochloride (trade name: Conmana). It was recognized as a major breakthrough in the Chinese public healthcare industry and has won China Patent Gold Award twice as well as the first National Scientific and Technological Progress Award in China's chemical and pharmaceutical industry. Until the third quarter in 2019, icotinib has benefited 230,000 patients of advanced lung cancer, with the cumulative sales reaching nearly 7 billion RMB. The company has established a comprehensive new drug R&D platform, with its R&D centers in Hangzhou and Beijing, and more than 30 innovative drugs under development, covering multiple tumor indications such as lung cancer, renal cancer, and breast cancer. The company has also reached strategic collaboration with leading domestic and foreign pharmaceutical companies such as Amgen, Xcovery, Tyrogenex, Merus, Mabworks, and InventisBio, to work together to promote the health and well-beings of the general public.

About Mabworks

Mabworks is a national high-tech enterprise founded by a team of overseas returnees focusing on the antibody design and research, clinical development and commercialization. Mabworks has a leading antibody discovery and development platform. Its MIL60 program, currently in the stage of clinical study, is targeting vascular endothelial growth factor (VEGF), and is being developed for 7 solid tumor indications including non-small cell lung cancer, colorectal cancer and breast cancer.