Phase II clinical development and supplement of puquitinib mesylate

The delivery information of puquitinib mesylate appeared in Xinchang pharmaceutical factory of Zhejiang Pharmaceutical Co., Ltd on February 17, which is likely to be a clinical supplement and needs the company to submit additional information Praquitinib mesylate and its tablets, a new anti-tumor drug, were approved by the State Food and Drug Administration on October 12, 2007 The product is a new anti-tumor drug independently developed by the company with independent intellectual property rights and PCT patents At present, there is no similar product in the world The second phase of clinical application has been filed in February 2012 and lasted for two years The drug has a wide range of antitumor effects, especially for non-small cell lung cancer, gastric cancer, colon cancer and other good effects, and less side effects The market generally believes that because of its own anti-cancer effect and strong synergistic effect with other TiNi drugs, it will become a heavy product with huge market potential The review progress of the drug has also become a hot spot of market concern Zhejiang Pharmaceutical Co., Ltd is a large-scale joint-stock pharmaceutical enterprise established on May 16, 1997 by the former Zhejiang Xinchang Pharmaceutical Co., Ltd., Zhejiang Xianju Pharmaceutical Group Co., Ltd and Zhejiang Pharmaceutical Co., Ltd in the form of new merger Related research and development figures reported that "drug Mania" Ye Weidong led the development of the international original anti-tumor drug - puquitinib mesylate Ye Weidong is not good at words, but he talks about his new drug research and development Ye Weidong, born in October 1963, graduated from Zhejiang University in 1987, entered Zhejiang medicine Xinchang pharmaceutical factory in 1990, and joined the party in May 1993 Up to now, he has presided over the task of more than 10 national new drugs, such as ofloxacin, levofloxacin, vitamin H, gatifloxacin hydrochloride, and filled in many domestic gaps From an ordinary scientific researcher, he stepped onto the podium of the second prize of national technological invention Ye Weidong's growth road witnessed the rise of Xinchang pharmaceutical factory People who know Xinchang pharmaceutical factory know that the "levofloxacin" of the factory is selling well After the product is put on the market, the accumulated sales volume has exceeded 1.3 billion yuan, and has achieved huge economic and social benefits Many people may not know that this is the second national new drug led by Ye Weidong In 1990, at the age of 27, ye Weidong changed his job from a research institute in Ningbo to Xinchang pharmaceutical factory, which was working on the development of state-level new drugs at that time Ye Weidong said that he had good luck Within 10 days of reporting, he entered the research room and participated in the research and development of the first national new drug "ofloxacin" in the pharmaceutical factory One year and ten months later, "ofloxacin" got the production approval In 1992, the project won the second prize of Zhejiang science and technology progress, which filled in the domestic gap The researchers who participated in the research and development work recalled that the new plant area had not been completed at that time, and the experimental conditions were quite difficult The "pilot test" of the product was conducted in a temporary simple work shed, with poor ventilation and relatively simple equipment They all said that "no project can be won without firm will" When "ofloxacin" was put into production, ye Weidong, as the project leader, served as the workshop director After the production was stable, ye Weidong began to tackle the key problem of "levofloxacin" "Levofloxacin" is to remove the non effective right-handed molecule of ofloxacin, and only retain the effective left-handed molecule, so as to reduce the side effects and improve the efficacy For now, getting rid of the right turn seems to be a simple matter However, at that time, ye Weidong couldn't sleep all night to complete the operation After hundreds of experiments, it's going to be successful, but it's stuck by another problem! In the infrared spectrum, he found that the result was wrong "I couldn't sleep all night at that time I was thinking when I was walking, eating and sleeping." Ye Weidong said that once on his way, he suddenly realized that the product "became salt" in the reaction process After going to "salt", the "levofloxacin" appeared After the product was put on the market, great economic and social benefits have been achieved, and so far the cumulative sales volume has exceeded 1.3 billion yuan Then, ye Weidong led the team to develop biotin, vitamin A and other products successfully In June 2001, the national new drug biotin (vitamin H) was industrialized and rapidly occupied the international and domestic market The plant's biotin production has accounted for 60% of the world's market, with a total sales volume of 950 million yuan and profits and taxes of 250 million yuan In 2003, it was listed in the national torch plan, and in 2004, it was listed as a national new product, and won the second prize of national technological invention in January 2006 The vitamin territory of "Xinchang pharmaceutical" is expanding in the world In the eyes of many people, the relationship between Ye Weidong and vitamin E should be inseparable Including the reporter, of course, he should be a researcher of Xinchang pharmaceutical factory who has made remarkable contributions in the field of vitamins Unexpectedly, when the reporter raised this question, his first reaction was to shake his head: "in the field of vitamin E research and development of Xinchang pharmaceutical, it's not me who makes the greatest contribution In the past, there have been media reports about this, but they are different from the facts " This surprised me a lot - it was not his contribution to vitamin E research and development, but his pragmatic spirit As early as 2002, ye Weidong was included in the "cross century academic and technical leaders of Zhejiang Province" training personnel (Zhejiang "151" talent project) In September 2004, he was awarded a model worker in Zhejiang Province In 2006, it was rated as one of 100 young pioneers of independent innovation in Zhejiang Province In 2008, he was elected as the representative of the 11th Zhejiang Provincial People's Congress Behind his almost "brilliant" honor, there is a kind of almost "rigid" preciseness and devotion In many people's eyes, he has been very successful But he has said more than once: "if the original new drug succeeds, my life will be worth it!" According to Ye Weidong, at present, most of the drugs produced by domestic pharmaceutical companies are generic drugs that have passed the patent protection period by international giants, which are called "non patent drugs" in the industry In his view, "without originality, China's pharmaceutical industry can only be controlled by others." So, next, Mr Ye's goal is to be an internationally first drug In this context, praquitinib mesylate was developed According to reports, there are very few "targeted" anti-tumor drugs in the world, which can concentrate the drug force on the tumor site, so as to kill the tumor cells, while praquitinib mesylate can not only attack the tumor cells precisely, but also cut off their "nutrition" and "starve" tumor cells in the growth process of tumor cells through various channels In addition to praquitinib mesylate, ye Weidong also led the team in the development of seven other international first-time new drugs In more than 20 years since Ye Weidong entered Xinchang pharmaceutical factory, he has many identities: workshop director, vice president of Research Institute, President of Research Institute and chief engineer of the company However, the identity of "Party member" has become a fixed role of him since 1993 How to complete the role transformation has become another topic that ye Weidong must study At present, there are more than 150 researchers in the Research Institute How to give full play to the innovative spirit of young people and better play the role of the team? This is also the project of Ye Weidong's "tackling key problems" Biotin, also known as vitamin H or coenzyme R, is mainly used as a cofactor of various complexases, and has a wide range of applications in medicine, biology, feed additives and other fields As early as 2006, Xinchang pharmaceutical factory successfully developed biotin, which changed China from a pure import country to an export country Vitamin H product is another vitamin product developed by the factory after vitamin E to fill the gap in China At present, the plant's biotin production has accounted for more than 60% of the world's largest producer The successful development of vitamin H products is the result of close cooperation between Ye Weidong and his team "Without Mr Ye, I don't think we have the courage to go on at that time." Chen Jianhui was the project leader at that time He said that ye Weidong had made great contributions to the success of the project Chen Jianhui told reporters that at that time, the "small test" had been successful, and ye Weidong began to let the seven young people in the group do the "medium test" by themselves "We did it for a month, but it was not successful We almost broke a batch of raw materials every day, and lost 100000 yuan when we did it At that time, 200000 yuan could buy a good house in Xinchang County." At that time, they were under a lot of pressure to think that several people would lose half of their houses every day, Chen said At this time, ye Weidong resolutely took over the burden of young people's thinking: "you don't need to worry, no matter how much the loss is, it's up to me." At that time, ye Weidong lived and ate with the team, and worked late every night "When he is with us, on the one hand, he always pays attention to the progress of the experiment, on the other hand, he encourages us to stick to it." Chen Jianhui said that this kind of encouragement is too important for young people Their will to overcome difficulties is like a sail, which is full of wind "Later, we found that the reason why the experiment was not successful was that there were some problems in the proportion of raw materials and the stirring of reactor After improvement, the project was successful." "Ye Weidong has brought out a team that can fight and win In particular, the successful development of vitamin H has contributed to China's aquaculture and animal husbandry " Li Chunbo, chairman of Zhejiang Pharmaceutical, said so In this utilitarian and impetuous society, when there are more and more academic frauds full of eyeballs, ye Weidong's spirit of "seeking truth" is actually valuable.