commencement of clinical trial for three new drugs of fosun pharma’s controlling subsidiaries
on 24 december 2016, as stated in the announcement of fosun pharma (stock code: 600196.sh, 02196.hk), phase i clinical trials for anti-egfr humanized monoclonal antibody injection (hereinafter referred to as the “new drug 1”) developed by henlix biotech co., ltd. (established in taiwan, hereinafter referred to as “henlix biotech”) as well as recombinant humanized anti-vegf monoclonal antibody injection (hereinafter referred to as the “new drug 2”) and recombinant anti-tnfα fully human monoclonal antibody injection (hereinafter referred to as the “new drug 3”) developed by shanghai henlius biotech co., ltd. (hereinafter referred to as “shanghai henlius”) have recently been commenced.
new drug 1 is an innovative bio-better for monoclonal antibody self-developed by fosun pharma group, which is used for treatment of various solid cancers such as colorectal cancer. previously, it has been approved for clinical trials in mainland china, taiwan and usa, which accomplished the globalization strategy of product research and development. the phase i clinical trial will first be conducted in taiwan.
new drug 2 and new drug 3 are biosimilar drugs of monoclonal antibody biological drugs self-developed by fosun pharma group, which have been approved for clinical trial by the china food and drug administration. new drug 2 is used for metastatic colorectal cancer and non-small-cell lung cancer indications, whilst new drug 3 is mainly used for rheumatoid arthritis.
as of november 2016, the r&d expenses for new drug 1, new drug 2 and new drug 3 contributed by fosun pharma at the current stage amounted to approximately rmb40 million, rmb35 million and rmb38 million, respectively.
in addition, two indications for recombinant murine/human chimeric anti-cd20 monoclonal antibody injection, the first monoclonal antibody developed by shanghai henlius, and the breast cancer indication for hlx02 recombinant humanized anti-her2 monoclonal antibody, the second monoclonal antibody developed by shanghai henlius, are currently in clinical studies. henlix biotech plays a leading role in domestic research and development of trastuzumab biosimilar. hlx02 breast cancer indication and hlx01 non-hodgkin lymphoma (nhl) indication has successfully entered phase iii clinical trial.
fosun pharma always regards independent innovation as essential to its corporate development and continuously optimizes its pharmaceutical r&d system that integrates imitation and manufacture. in recent years, fosun pharma has been increasing investment in r&d and gained competitive edge in internationalized r&d capability. up to now, the company has a staff of nearly 900 in its r&d team, spreading over shanghai, chongqing, taipei and san francisco, forming a systematic research system by interacting and integrating with each other. the company continues to raise investment in its four major platforms, aiming to establish highly-effective r&d platforms covering small-molecular drugs, large-molecule bio-similars, high-value generic drugs and specialized pharmaceutical technology.