Alliance of four domestic major pharmaceutical enterprises leading the project.
New domestic anticancer drugsDCBCI0901receiving clinical trials


「DCBCI0901」, a new anticancer drug that is mTOR inhibitor-targeted, supported by the Ministry of Economic Affairs, has been independently developed by the Development Center for Biotechnology(DCB). The research results show that「DCBCI0901」is remarkably active in inhibiting the growth of cancer cells, especially against lung cancer, mastocarcinoma, prostate cancer, etc. Research conducted with the National Taiwan University, College of Medicine, also shows that this new type of drug has typical inhibitory activity towards lung adenocarcinoma cancer cells.

R&D achievements related to「DCBCI0901」have been completely arranged by DCB, who has put forward patent application in 16 countries and regions including the Republic of China, the US, Japan, etc.

In order to push forward the commercialization of 「DCBCI0901」, four domestic pharmaceutical enterprises, including STANDARD CHEM&PHARM, YUNG SHIN PHARM ,China Chemical & Pharmaceutical Corporation and Intech Biopharm, formed a professional alliance to develop this new type of drug, via authorizing and organizing professional teams together with DCB. Having integrated domestic research institutions and pharmaceutical resources, the R&D team, with the support of NRPB, has been working hard for four years and has successively completed pre-clinical trials and preparations, such as the Pre-clinical toxicology, processing, agential R&D, manufacturing, etc. Up to now, the R&D team has successively achieved the application for Investigative New Drug approved by the FDA and TFDA. The team also got permission to carry out Phase one clinical trial and will soon conduct test cognizance in Medical Centers such as the National Taiwan University Hospital, National Cheng Kung University Hospital and Taipei Veterans General Hospital, etc.

To realize the commercialization of the new drug「DCBCI0901」,the alliance has been doing much work, including intermediate synthesis and manufacturing of BPC, final product manufacturing, analysis method development as well as drug effect and stability testing. Eventually, it has successfully integrated the value chain of related domestic pharmaceutical industries in a timely manner via vertical labor division and horizontal integration. 「DCBCI0901」, a new anticancer drug that has been a primary national plan has been developed via alliance and specialized division of labor, which has enhanced the core technology and value of the domestic pharmaceutical industry, and has accelerated the commercialization of new domestic drug development, boosting the competitive niche market of new drugs in Taiwan.

QianZongliang, Vice Minister of Science and Technology, also agrees with the great efforts the team has made. He said that alliance made up of domestic pharmaceutical enterprises cannot only increase our competitiveness, but also lead the trend in global pharmaceutical development. Since the R&D of new drugs needs more labor, capital and professional techniques in various areas, while resources in Taiwan are very limited, a key method to succeed is alliance and cooperation. In the near future, with support from the government, we will accelerate to establish and integrate bio-industries through all levels, and drive to upgrade manufacturers of the whole industry so as to integrate with the international market, other industries, R&D institutions and the academic field.

Li Zhongxi, Chief Executive of DCB, said with much delight that the R&D of the new anticancer drugs that are an mTOR inhibitor is not merely a successful integration of production, academics and research, but also a significant milestone of DCB’s academic implementation of the「 Project for new micro-molecule anticancer drug development 」. It is expected that the whole clinical testing process of the independently-developed new type of micro-molecule anticancer drugs will be a successful example of domestic pharmaceutical R&D, which can hopefully boost domestic R&D capability of biotechnology.

According to the report of WHO, in 2012, there were 14 million people suffering from cancer which caused the death of 8.2 million people. While in the coming 20 years, the number will increase to 22 million. For years, drugs for oncology have been the most used ones throughout the world, with a sales volume of 61.6 billion dollars in 2012 and a growth rate of5.1%. With a growing number of patients suffering from cancer, more and more anti-carcinogens are manufactured and approved to be listed. Actually, more patients tend to take targeted anti-carcinogens with a high unit price. Plus, the fast increasing number of aged people continuously enlarges the tumor-drug market. It is estimated that the tumor-drug market size will reach 74-84 billion dollars in 2017. According to the statistics of the Health Promotion Administration, the Ministry of Health and Welfare, there were 480,000 patients suffering from cancer in 2013 in Taiwan. It is estimated that the number will be over 500,000 in 2014. The value of the pharmaceutical market in Taiwan will beTWD135.4 billion NTD, among which anti-tumor drugs and drugs for the immune system, the top used drugs in Taiwan, will amount to TWD 22.9 billion NTD, accounting for 16.9% of the market share.

mTOR-typed anticancer drug 「DCBCI0901」, developed by DBC, will concentrate on lung cancer and prostate cancer treatment. Datamonitor materials indicate that the market for targeted cancer therapies is estimated to be almost $36 billion dollars in 2015. The successful R&D of new mTOR anticancer drugs will provide patients with more choices of effective pharmacy treatment, and create more domestic pharmaceutical production value. Furthermore, it will upgrade national pharmaceutical competitiveness, accelerating the improvement of the pharmaceutical R&D capability of domestic manufacturers so that domestic pharmaceutical enterprises will work together to penetrate new pharmaceutical industries with a high unit price and added value.