Research and development of antitumor immune drugs with low profile layout in Baiji Shenzhou

After completing the clinical research stage, the first round of financing and the milestone payment of Merck xuelano for three candidate drugs, Baiji Shenzhou has focused on the possibility of immunoanticancer drug R & D pipeline appearing and landing on Nasdaq stock market Beijing - Baiji Shenzhou (Beijing) Biotechnology Co., Ltd has done everything in the past year The Zhongguancun Life Science Park Company, which recently completed 450 million yuan financing, is ready to enter the hot field of cancer immunotherapy drug research and development John oyler, CEO of Baiji Shenzhou, pointed out in an interview with Asia Pharmaceutical News that the company's anti-PD-1 and anti-PD-L1 antibodies are currently in the pre clinical research stage, and are expected to enter the clinical research stage in March this year "Cancer immunology is a research area that we have focused on in the past three years Whether in China or globally, we are at the forefront of immunooncology research." He also pointed out that the research in this field needs not only the innovation of biotechnology, but also the comprehensive strength and scale of drug development, while Baiji Shenzhou has not only both, but also other competitive advantages "In addition, most innovative biotech startups in the United States focus either on the development of small molecule drugs or on the development of large molecule drugs, and we have both experience in the development of these two drugs." So far, opdivo (nivolumab), an anti-PD-1 immunosuppressive checkpoint inhibitor of Bristol Myers Squibb, has been approved first in Japan among several key immunoantitumor monoclonal antibodies, and the drug has also been recognized as a breakthrough drug by the US FDA Keytruda (pembralizumab) of Merck was approved by FDA for the treatment of advanced melanoma The drugs acting on other targets (including PD-L1) include med14736 of AstraZeneca and mpd3280a of Genentech, a subsidiary of Roche, which are currently in the clinical research stage "The current clinical data shows that the performance of immunoantitumor drugs far exceeds the expectation, and the drug combination is the key, which will lead the next generation of solutions, and also a huge opportunity to achieve product differentiation We are building our own best combination products of targeted therapeutic drugs and immunomodulators, and using preclinical models with unique patented technology to understand the mechanism of drug combination, "oreqiang said Through cooperation with top hospitals and doctors in China, Baiji Shenzhou hopes to achieve the differentiation of its immunoantitumor drugs "The key to tumor immune research is drug combination," said Dr Luo Lisong, chief director of Baiji's Shenzhou Department of pharmaceutical research and biology It is challenging to choose which drug combination to develop We have unique advantages in the research and development of small and large molecule drugs that are key to drug combination in the future, including anti-PD-1 and PD-L1, which are the cornerstone of such drug combination More importantly, we are developing in vitro, in vitro and in vivo models to predict the clinical outcomes of different drug combinations These predictive models will give us a huge competitive advantage, enabling us to focus on a science based drug portfolio development model " The company has also built a humanized animal tumor (PDX) model Through cooperation with top doctors and hospitals (such as Beijing Cancer Hospital and some hospitals in Shanghai), the company has obtained hundreds of tumor tissues and established about 100 tumor models Dr Luo said that Baiji Shenzhou is constantly comparing with its competitors in preclinical research to assess which company is in the leading position in China in preclinical research He pointed out that there are still few Chinese pharmaceutical companies developing innovative drugs The philosophy of Baiji Shenzhou is that each project must have clear potential to become the best medicine in the world Our three phase I clinical projects have also proved that we have the ability to achieve this goal quickly and reach the world-class quality level Before joining the baiji Shenzhou co founded by Ou Lei Qiang and Wang Xiaodong (former director of Beijing Institute of Life Sciences), Dr Luo worked for the contract research organization bio Duro founded by Ou Lei Qiang, which was later acquired by pharmaceutical development company (PPD) Jason Yang, senior vice president and director of clinical development, said the compounds will be evaluated for safety and indications through global trials, while preclinical research will be done by the company itself The potential rewards for developing such new drugs are huge Last month, Pfizer and Merck reached an agreement to pay $850 million to acquire and share the right to develop the anti-PD-L1, an immune drug tested by Merck Merck will also receive milestone revenue of up to US $2 billion in succession They also plan to jointly develop Pfizer's anti-PD-1 antibody ("Pfizer seizes long term immunology opportunity with Merck deal" - the pink sheet daily, Nov 172014 8:43 pm GMT) Dr Luo said that although some Chinese companies have also been involved in the development of immunoantitumor drugs, they pay more attention to small molecule drugs Of the 27 new anti-tumor drugs of class 1.1 applied for clinical research in 2013, 13 targets were vefgr and 10 were her / EGFR In order to meet the needs of clinical development, Baiji Shenzhou is expanding its staff to improve its clinical development ability "We hope that the clinical development department will increase its staff to more than 50, including medical and project managers, to support the ongoing international clinical trials and the upcoming Chinese trials next year." Said Dr Yang Before joining Covance, Dr Yang served as chief scientist of Pfizer's tumor biomarker and transformation medicine for 7 years ("Asia on the move: Bayer China executive moves to beigene" - pharmasia news, Oct 82014 11:21 pm GMT) Baiji Shenzhou also obtained a large amount of external financing in November, and plans to use the $750 million financing for the research and development of three small molecular compounds currently in phase I clinical, namely, the second generation BRAF and EGFR inhibitors bgb-283, Prap inhibitors bgb-290 and Btk inhibitors ("beigene rains new funds for O ncology pipeline" - pharmasia news, Nov 182014 10:17 pm GMT) The first two products have been licensed to Merck's syrano, so Baekje won milestone payments of $5 million and $9 million in May and November, respectively Dr Yang believes that expanding clinical development capabilities will help the Beijing based company expand its existing trials to other countries such as the United States, which is the most critical challenge it faces So far, these tests are being carried out in Australia, which is because the new drug development cycle is too long to carry out early research in China "The three new drugs in clinical trials are benefiting some patients in Australia, and we hope that these drugs can enter clinical trials in China as soon as possible and benefit cancer patients," Dr Yang said Bgb-283 is being expanded to multi site BRAF and non BRAF cancer types, when the drug is expected to become the best of its kind or even a new type of anticancer drug He pointed out that as the first new drug, bgb-283 has made more careful progress, while the second and third drugs will speed up the research and development progress The company also expects to increase the capacity of the Department of biology by about 10 high-level biologists, o'reiqiang said A strong biological team will create truly differentiated products, he added ("John oyler on investing in biotechnology in China: an interview with pharmasia news (Part 2 of 2)" - pharmasia news, Mar 172014 6:42 pm GMT) One of the disadvantages of developing biologics in China is the high cost and the lack of compensation mechanism Although China accounts for about 25% of the world's cancer patients, its market share of anti-tumor drugs only accounts for 3% of the world's cancer patients, said Dr Luo at a meeting held in September ("EFPIA tours innovative medicine model in China" - pharmasia news, Oct 62014 12:34 AM GMT) The solution depends on the price competitive advantage of the product Baiji expects to develop biologics that are cheaper than multinationals, Dr Yang said He added that cost savings were mainly determined by the final stages of development and production, rather than preclinical research After a year of intensive preparations, Baiji Shenzhou is speeding up the pace of landing on the US Nasdaq stock market, and is likely to be listed in 2015, said ou Many U.S and international biotechnology companies are listed on Nasdaq, and the biotechnology sector performed well in 2014 Exchange traded funds (ETFs) include biotechnology companies, with BBH shares up nearly 40% in a year The launch of a wave of new products is expected to further boost the US pharmaceutical and biotechnology market in 2015 Baiji Shenzhou hopes to catch up with the booming market, and the company has discussed with investors and other partners about the preparation of the initial public offering Despite the temptation, several Chinese pharmaceutical companies, biotechnology companies and cros have pulled out of the US stock market and returned to privatization Baiji expects its rich clinical pipeline and China strategy to attract and persuade us investors Original address: http://www.elsevirmed.cn/news/detail/paekche ABCD lowkey ABCD layout ABCD ANTIUMOR ABCD immune ABCD drugs