Approved clinical application of c118p for injection of Shenghe pharmaceutical

C118p for injection was applied by Nanjing Shenghe Pharmaceutical Co., Ltd and entered the CDE evaluation sequence in August 2014 It is a major special variety and a special approved variety, which has not been supplemented and issued At present, it has been approved for clinical use This product is a new type of tubulin polymerization inhibitor Compared with the listed tubulin inhibitors (such as vincristine, paclitaxel, etc.) and molecular targeted drugs (such as sorafenib, sunitinib, etc.), it has a unique anti-tumor mechanism At present, CA4P with similar structure and mechanism is in phase III clinical research stage in foreign countries C118p has novel structure, independent intellectual property rights, clear mechanism of action, obvious anti-tumor effect, wide anti-tumor spectrum, high stability in vitro and in vivo, good drug-making and safety, and is suitable for further clinical research and development News review: let more people enjoy healthy happiness with innovation as the source and integrity as the cornerstone China new drug Journal: we know that since its establishment, Shenghe pharmaceutical has been adhering to the enterprise tenet of "people-oriented, science and technology first, adhere to development, and create the future" It has not only created an impressive growth rate, but also made remarkable achievements in corporate culture construction You once said, "looking back on the road of Shenghe growth, innovation and integrity are the two flags we always adhere to." How has the innovation road of Shenghe Pharmaceutical Co., Ltd gone through and what are the milestones? Wang Yong: the survival and development of enterprises need constant innovation Innovation can bring good development opportunities Without innovation, enterprises can not survive, and can not play a role in promoting social progress I think innovation includes many aspects, such as innovation of ideas, systems, models and products In this interview with China new drug journal, I would like to talk about product innovation, i.e new drug innovation, and introduce the achievements of Shenghe pharmaceutical industry in new drug innovation In 2005, we introduced the exclusive product of xiaocaiping injection, which we thought was very valuable at that time After the introduction, we spent more than two years to carry out process transformation and quality research, as well as innovative research on the safety and effectiveness of the product In 2009, as a major scientific and technological research achievement of the national "major new drug creation", Shenghe pharmaceutical industry developed five research and development achievements The national first class innovative drug, l-ornidazole (trade name: unoan), with national invention patent and two international invention patents, has been successfully listed on the market These two key innovative products play an important role in the development of enterprises China new drug Journal: as we all know, new drug research and development is a long-term, high investment and high risk work What is the new drug research and development strategy and research and development model of Shenghe pharmaceutical? What investments have been made in new drug creation and improvement of innovation ability of enterprises? Wang Yong: new drug R & D is a big risk for pharmaceutical enterprises, which requires our determination and courage Shenghe pharmaceutical industry started to take the road of innovation in 2002 At that time, our output value was only tens of millions and the scale of the enterprise was not large But at that time, we realized that if the enterprise wants to survive and develop, it must carry out product innovation and concentrate on the research of innovative drugs However, new drug R & D investment is high and the risk is high, especially when the enterprise is not large, it requires us to have the courage and courage to stay in the dead and survive After our step-by-step development and expansion, funds and resources are gradually abundant At present, Shenghe pharmaceutical industry has adjusted its development strategy to a more scientific combination of imitation and creation In the past 10 years, Shenghe pharmaceutical industry has chosen to focus on the research and development of innovative drugs, but with the continuous development and change of enterprises, we have been thinking about the model of combination of imitation and innovation At present, the combination of imitation and innovation is a new drug R & D strategy of many pharmaceutical enterprises, but the imitation of Shenghe pharmaceutical industry is not a simple copy We aim at the new drugs coming to market abroad, and seize the priority by optimizing the preparations and drug delivery routes Compared with basic research, applied research has always been the priority development direction of our new drug research and development strategy Compared with the strength of foreign multinational pharmaceutical companies, Chinese pharmaceutical companies still have a large gap in R & D capability and R & D resources Shenghe pharmaceutical's R & D system mainly focuses on anti-tumor, anti infection and digestive diseases At present, the annual R & D budget investment is 8% of the sales revenue 10% of the resources are invested in basic research and 90% of the resources are used for application research However, R & D is the strategic demand of the enterprise If we need R & D, we will invest more For the human resource investment in new drug research and development, we mainly have two aspects: first, cultivate our own research and development team, establish a national postdoctoral workstation, and enrich the research and development ability At present, there are more than 100 members of the research and development team, most of whom are graduate students or above; second, introduce overseas high-end talents, and more than 10 foreign research and development personnel have been introduced On the basis of independent R & D and cooperative R & D, Shenghe Pharmaceutical Co., Ltd has embarked on its own R & D path We always believe that talents and equipment are the necessary conditions for enterprise innovation In recent years, through the introduction of researchers and engineers with high education and rich experience in new drug R & D and industrialization, we have formed a scientific research team capable of striving for success and pioneering, and formed an enterprise development pattern of science and technology leading development, innovation and harvest results, large input and high output In Shenghe pharmaceutical industry, there are 1 "thousand talents plan", 4 "Zijin talents" and 3 "333 high level talents training project" At present, many doctors and scholars who have been studying in Europe and the United States for many years and have rich experience in drug research and development and marketing have joined Shenghe pharmaceutical industry China new drug Journal: with the launch and implementation of the national "major new drug creation" science and technology major project, a new round of climax of new drug creation in China has been set off How does Shenghe pharmaceutical industry grasp this direction and seek its own development? What are the new drug projects under development? Wang Yong: the major science and technology projects of "major new drug creation" have really helped the development of pharmaceutical enterprises in China The innovation ability of pharmaceutical enterprises in China is not strong, and they need the support of policies and the help of advantageous resources from the state Meanwhile, the enterprises themselves are seriously thinking about how to use the encouragement policies of the state, adjust the development direction of enterprises, and strengthen the research of innovative drugs At present, Shenghe Pharmaceutical Co., Ltd has undertaken the national "major new drug creation" science and technology major projects, including "Research on quality control system of anti-tumor traditional Chinese medicine xiaochanping injection", "phase IV clinical research on national class 1 new drug levononidazole sodium chloride injection" and "construction of enterprise innovative drug incubation base (construction of chiral anti infection and targeted anti-tumor and other innovative drug incubation bases)" The project of "Research on the new generation of nitroimidazole and its preparation" has been accepted At present, Shenghe pharmaceutical industry is developing the following innovative drugs: 1 Levononidazole tablet was applied for production to CFDA in 2012 At present, the supplementary information has been submitted to CDE, and it is expected to obtain the class 1 new drug certificate and production approval document in 2014 C118p for injection, a new inhibitor of tubulin polymerization The project has completed all pre clinical work and is applying for clinical trials C118p has a unique anti-tumor mechanism compared with the listed tubulin inhibitors (such as vincristine, paclitaxel, etc.) and molecular targeted drugs (such as sorafenib, sunitinib, etc.) which act on blood vessels At present, CA4P with similar structure and mechanism is in phase III clinical research stage abroad C118p has novel structure, independent intellectual property rights, clear mechanism of action, obvious anti-tumor effect, wide anti-tumor spectrum, high stability in vitro and in vivo, good drug-making and safety, and is suitable for further clinical research and development We intend to select the sensitive, high incidence and common malignant solid tumors as the main indications for clinical research, in order to develop new safe and effective tubulin inhibitor drugs suitable for Chinese patients It is intended to be used alone or in combination for the treatment of advanced solid tumors, including non-small cell lung cancer, liver cancer and colon cancer Third generation bcr-abl inhibitors against adult chronic myeloid leukemia (CML) Imatinib has achieved great success in the treatment of CML, but because of the long-term medication and the wide use of imatinib in clinic, imatinib induced drug resistance Nilotinib and dasatinib, the second generation of anti CML drugs approved by FDA, can overcome the majority of imatinib induced bcr-abl target gene resistance mutations, but nilotinib and dasatinib are ineffective for T315I mutations accounting for 15% ~ 20% of all mutations In 2012, the US FDA approved ponatinib for marketing, mainly for the treatment of CML and Philadelphia chromosome positive acute lymphoblastic leukemia We selected ponatinib as the lead compound, optimized its structure, and finally obtained the candidate compounds with better activity in vitro and in vivo or equivalent to the positive drugs, and in some important indicators, especially the toxicity index is better than ponatinib The candidate compound has entered a comprehensive preclinical study, and it is expected to declare CFDA for clinical study in 2015 4 anti hepatitis C drugs The incidence rate of hepatitis C has been increasing in recent years Hepatitis C has become a serious public health problem In recent years, NS3 / 4A protease inhibitors and NS5B polymerase inhibitors of nucleosides are the hot spots in the research and development of anti HCV drugs Shenghe pharmaceutical also launched the research and development of NS5B and NS5A inhibitor projects At present, we are further optimizing the design according to the obtained activity information, in order to obtain better drug-resistant compounds and officially determine the candidate compounds At present, the generic drugs under research in Shenghe Pharmaceutical Co., Ltd are dasatinib, which is expected to be marketed in 2016-2017; the ones under review are moxifloxacin hydrochloride injection, paramivir trihydrate sodium chloride injection, etc.; the ones to be applied for clinical research are azacitidine, rocuronium, parexib, gefitinib, erlotinib, imatinib, ziprasidone, celecoxib, etc China new drug Journal: finally, what is the future development blueprint of Shenghe pharmaceutical industry? What are your expectations and hopes for Shenghe pharmaceutical? Wang Yong: in 2010, Shenghe pharmaceutical entered the top 100 of China's pharmaceutical industry We have always regarded "let more people enjoy the happiness of health" as the common mission of every Shenghe person, and let Shenghe become the most trusted brand for doctors and patients Shenghe pharmaceutical will continue to take the road of innovation Ideological innovation brings us the courage to be the first; scientific and technological innovation brings us the power of vigorous development; institutional innovation brings us the guarantee of lasting for a hundred years Shenghe people have the confidence and courage to continuously create high-quality products, provide satisfactory services, dedicate the best reputation, and create "Centennial Shenghe" with the spirit of continuous innovation We believe that Shenghe pharmaceutical will be among the top 80 pharmaceutical companies in China in the next five years Shenghe Pharmaceutical Co., Ltd will enhance the research and development capacity of new drugs through standardized management and increased investment in research and development, and create safer and more effective products for the society through the joint efforts of all Shenghe people