Luhan Pharmachem Co., Ltd.

China's bio pharmaceutical development is in a stage of rapid development and change. At the national level. many policies have been introduced to promote and promote the level of the pharmaceutical industry. and globalization and innovation cooperation become the focus of the future. Pharmaceutical enterprises. especially the unprecedented challenges and opportunities faced by domestic pharmaceutical companies in china. Enterprises must actively respond to international cooperation and innovation. strengthen bio pharmaceutical research and development. introduce overseas projects. shorten the R & D cycle. and carry out short-term / long-term business cooperation. so as to occupy a place in the market as soon as possible.

The "2017 International Innovation Industry Summit" sponsored by biological valley will be held in Shanghai from 02 to 03 November 2017. This meeting will focus on domestic and international drug innovation latest development trend. opportunities and cooperation in the development of enterprises under the new policy. trying to build the pharmaceutical industry innovation cooperation high-end image. Invite industry leaders and innovative enterprises to share new breakthroughs and new progress. mode innovation. cooperation cases and so on. To discuss the current development of China's pharmaceutical industry opportunities and challenges. The organizers invite domestic and foreign pharmaceutical enterprises together to uphold innovation. cooperation and win-win concept. to jointly promote the China pharmaceutical industry to grow healthily and orderly.

New drug research and development is not so easy, but should be practical clinical value to select the focus of R & D.

Cancer is a serious malignant disease which seriously threatens human health. The prognosis of most malignant tumors is poor, the survival time of patients is short, and there is no cure for them. Therefore, new treatment techniques and drugs are needed urgently.It is precisely because of the refractory disease and the urgent need of the clinical, that anti tumor drugs have become the focus of research and development of innovative drugs.According to data from the WHO. Since it surpassed lipid lowering drugs in 2007, antineoplastic drugs have been a leader in the global pharmaceutical market, with sales exceeding $70 billion in 2012. However, with the increasing difficulty of drug innovation, In the past few decades, pharmaceutical companies in various countries have also increased their investment in the field of antitumor drugs.

According to statistics, in the first half of 2016, FDA approved 4 innovative drugs and 13 new indications. BCL-2 inhibitor Venclexta including chronic lymphocytic leukemia in April 11th approved the first treatment of 17p chromosome 4 due to the lack of innovative drugs (Aibo Wei / Genentech), FDA breakthrough therapy, to speed up the approval authorization, priority review, orphan drug status; Approved tyrosine kinase inhibitor Cabometyx (Exelixis) for progressive renal cell carcinoma () approved in April 25th for FDA breakthrough therapy licensing, rapid channel review, and priority review. The first PD-1 ligand treatment in May 18th approved metastatic transitional cell carcinoma of the bladder 1 inhibitor monoclonal antibody drug Tecentriq (Genentech), FDA breakthrough therapy authorization, to speed up the approval, priority review, is the first drug treatment field. As well as the Netspot (ADVANCED ACCELERATOR appLICATIONS INC USA) approved for the localization of somatostatin receptor positive neuroendocrine tumors in June 1st, FDA priority review was obtained. These drugs highlight the recent trends in pipeline research and development of anti-cancer drugs.

In our country, "China anti cancer drugs Market Research Report 2014" think, at present, China's anti-tumor drugs market scale is about 40 billion yuan, the average annual growth rate is about 20%.

In order to get rid of the embarrassing situation of excessive dependence on imported drugs in the domestic market, the government has made great efforts to promote drug research and development from financial to policy, and drug research and development has gradually become hot. Imitation medicine is practical and has a short cycle, but the development of a new class of new medicine is the core competitiveness of Chinese medicine. As a chemical compound, 1.1 kinds of new drugs can be regarded as the essential trump card for Chinese pharmaceutical companies to move to the international stage. According to statistics, in 2013 to the first half of 2014, State Food and Drug Administration CFDA approved 1.1 kinds of new drugs clinical declaration list, known functions of antineoplastic drugs in 33 items, accounting for about 30% of the declaration list, is undoubtedly the most attention to pharmaceutical companies of the species.

At present, the number of research drugs is increasing, and its R & D characteristics, indications and distribution are consistent with the disease spectrum According to GBI Research Report, in the first quarter of 2016, in the study of anti-tumor drugs to breast cancer, lung cancer and colorectal cancer products as the leading, its R & D pipeline growth of more than 15%.In addition to a slight reduction in the number of CNS diseases and immunotherapy products, the number of drugs in the remainder of the treatment area grew by more than 5%. Women's health products, despite their smallest treatment, are among the fastest growing, with research and development lines up 55%.

The future development of new drugs or biological medicine in favor of similar, 2016 FDA approved the listing of Zarxio, this is the United States approved the first biological drug like, opened a new class of biological products door, may help to control the rising cost of biological products. It is expected that the number of biological drugs to be approved by FDA will rise in 2016. At present, 4 producers of antitumor biological drugs have submitted BLA applications, 3 of which have been accepted by FDA. In addition, oral anticancer drugs is also a point of growth, due to its low injection route is more convenient, in the research of drugs more than 5 years ago, is more common, and oral drug antitumor drugs accounted for the proportion of the total cost is greater than before.

From the object of view, these anti-cancer drugs can be divided into three main categories:

The first action on tumor related enzymes, such as imatinib and leelo Maihua erlotinib, the two is a tyrosine kinase inhibitor, in human cancer suppressor gene product or oncogenic RNA viruses, control the proliferation of cancer cells.

Second kinds of role in the signal transduction pathway, such as ring with Deji, through inhibiting hedgehog signal pathway (Hedgehog pathway) to the regulation of human stem cell proliferation, tumor stem cell self-renewal.

The third category is the target of inhibitors, such as double Tartini him, on PI3K protein kinase and histone deacetylase (HDAC) dual target inhibition, signal transduction, cell synthesis of important products, so as to control the killing of cancer cells.

In general, there are advantages and disadvantages in the development of three types of medicines. The first class of drug efficacy significantly, development cost is relatively low, but it usually also will affect the normal operation of the human body, such as tyrosine kinase inhibition on growth, cell proliferation and differentiation in human health plays an important role, and there may be a number of pharmaceutical companies have similar functions to substitute. The second drugs also have similar disadvantages and are more expensive, but the new drugs will be highly competitive if inhibiting signaling pathways can significantly reduce the incidence of tumor complications. Third kinds of drug target attack, for tumor cells treatment, the impact on the human body is relatively small, but also in the development of high cost, high risk shortcomings.

With the increasing incidence of cancer, anticancer drugs and immunomodulators has become the medicine purchase amount ranked first in the sample hospital. China is the world's new cancer in most countries, rigid demand is so big, the domestic anti tumor drugs market is developing rapidly, and the demand of antitumor drugs in short supply situation, and can not meet the demand for direct driven drug innovation.