Today （January 15）， Science and Technology Daily published a long report entitled "Focusing on Innovation and Marching Towards New Peak, Hansoh Pharma Won Second Prize of National Science and Technology Progress Award Again" on the special edition of the National Science and Technology Progress Award. people.com.cn, gmw.cn, china-finance.com.cn and other domestic mainstream online media all published reports at the same time, celebrating Hansoh Pharma's first brand building success in 2015.
Link to the original text: http://digitalpaper.stdaily.com/
Original text:
Hansoh Pharma Won Second Prize of National Science and Technology Progress Award Again
On January 9, the conference of National Science and Technology Award 2014 was held at the Great Hall of the People in Beijing. Hansoh Pharma won the second prize of National Science and Technology Progress Award again after Zefei （generic name: gemcitabine hydrochloride for injection） for its project "Development and Application of Olanzapine, a New Antipsychotic Drug, and Its Preparations" this year.
Established in 1995, Jiangsu Hansoh Pharmaceutical Group Co., Ltd. has become a modern and innovative pharmaceutical group integrating chemical and biological drug research, pharmaceutical intermediates, API synthesis, preparation production and product sales after 19 years of continuous and steady development. It has been ranked among the top 30 of "Top 100 in China's Pharmaceutical Industry", the top 4 of "China's Best Industrial Enterprises in Pharmaceutical R&D Pipeline", and the top 3 of "Top 10 Innovative Pharmaceutical Enterprises in China" for consecutive years.
The company adheres to the corporate mission to "create excellence in pharmaceuticals, enhance innovation in China, and increase Hansoh Pharma 's brand influence", and the corporate vision of "staying concentrated, focused and professional to become the leader of innovative drugs in China", striving to build itself into a domestic first-class and world-renowned pharmaceutical company.
With the increasing social pressure, the prevalence of mental diseases continues to rise. Schizophrenia is a severe mental disease, and its global prevalence in adults is as high as 7‰。 There are more than 7.8 million schizophrenic patients in China and 24 million worldwide, and the numbers are increasing day by day. Due to their particularity, mental diseases have brought a heavy burden to families and the society, and have been included in the scope of national health insurance for critical diseases.
According to statistics, schizophrenic patients are 10 times more homicidal than ordinary people, seriously threatening the lives and property of others and causing a serious social burden.
Traditional therapeutic drugs such as chlorpromazine and haloperidol have an effective rate of only about 55%, while olanzapine has an effective rate of about 80%, with small extrapyramidal side effects and low incidence of delayed dyskinesia. Olanzapine is recommended as a first-line therapeutic drug in the 2007 edition of the Guidelines for the Prevention and Treatment of Schizophrenia. However, the high price of imported drugs and the high cost of treatment affect the drug accessibility of patients. Therefore, it is an urgent task to realize domestic production of the drug. The implementation of this project will significantly reduce the burden on families and communities from schizophrenia, resulting in far-reaching social benefits.
In the existing research of olanzapine, there are mainly the following technical difficulties: the harsh reaction conditions in the production process are not conducive to commercialization; Lilly's crystalline patent blockade makes domestic production difficult; and the use of flammable and explosive materials poses high production risks. Hansoh Pharma has successfully solved the above difficulties and realized domestic production of olanzapine through industry-university-research cooperation with Shanghai Institute of Pharmaceutical Industry and China Pharmaceutical University. The main scientific and technological innovations are as follows:
1. Development of an efficient synthesis process to produce high-quality products. The substitution reaction uses piperazine instead of N-methylpiperazine as raw material, which is less likely to produce oxidation impurities （0.5% reduced to 0.05%）; water absorbent is added to avoid hydrolysis impurities （0.8% reduced to 0.02%）; the yield increases from 32.7% to 64%.
2. Development of a new crystalline form and matching preparation technology. This project adopts the crystalline form screening technology, and through a series of studies, a new alcohol-ether mixed solvent crystallization system is developed to prepare a new crystalline form of olanzapine, which has good fluidity and stability; a matching prescription process is created to ensure product stability in the preparation and storage process. In vitro and in vivo data prove that the project products are bioequivalent to imported drugs. The product quality meets and exceeds the pharmacopoeia standards of developed countries in Europe and the US, and has been filed to the US DMF （filing number: 24480）。
3. Elimination of high-risk reagents, which is safe and environmentally friendly. In the condensation reaction, a new acid binding agent with high safety is used, the solvent usage is reduced from 70 times to 10 times, the production cycle is reduced from 4 days to 2 days, and the yield is increased from 50.7% to 66.7%. The new process is safe, controllable, green and environment-friendly, and the product purity is high.
Oulanning （generic name: olanzapine tablets） is a therapeutic drug for the treatment of psychotic depression and schizophrenia. Clinical results show that its effective rate is over 80%, and it has long been a first-line drug in the field of psychiatric treatment.
Olanzapine was developed and marketed by a foreign multinational pharmaceutical company in 1996, and has been under global monopoly and sold at high price. Many domestic patients with psychotic depression and schizophrenia had to stay in an unstable state for a long time because they couldn't afford the huge diagnosis and treatment costs. In response to the call of the state, Hansoh Pharma has actively committed itself to improving people's health, started the scientific and technological research of Oulanning, and finally developed Oulanning successfully and realized the domestic production of the drug. Since its launch, Oulanning has been used in nearly 3,000 hospitals at a price less than half of that of imported drugs, turning the original intention of benefiting the people into reality. In 2012, Oulanning's domestic market share reached 70%, delivering remarkable economic and social benefits.
The successful development and launch of Oulanning is an important manifestation of Hansoh Pharma 's technology strategy. The R&D team has designed a large number of industrial routes and continuously optimized them, successfully breaking through the patent barriers of the original drug manufacturer. Oulanning has been granted several invention patents for its preparation method, and has been recognized as a "National Key New Product" by the Ministry of Science and Technology; its follow-up research has also been included in National Major Scientific and Technological Special Projects. In 2013, the product won the first prize of "Science and Technology Progress Award of All-China Federation of Industry and Commerce".
With the vision of being the "leader of innovative drugs in China", Hansoh Pharma has become one of the leading companies of innovative drugs in China after more than ten years of unremitting efforts. It has been ranked among the top three innovative pharmaceutical companies in China 2014, and has undertaken a number of major projects including "National Major New Drug Innovation Initiative", "863 Program" and "National Innovation Fund". Hansoh Pharma has built a domestic first-class research institute in Lianyungang headquarters, which covers a total construction area of 35,000m2 and consists of a number of technical platforms such as national postdoctoral research workstation, provincial academician workstation and biopharmaceutical high-tech research laboratory. The company has also established R&D centers in the US and Shanghai to engage in exploratory research on new targets, new mechanisms and new pathways. A large number of national Class 1.1 new drugs have entered various clinical stages.
Up to now, the company has put more than 20 varieties in the six fields of anti-tumor, cardiovascular, psychiatric, diabetes, gastrointestinal and antibiotics on the market. The anti-tumor drugs "Zefei", "Pulaile" and "Gainuo", psychotropic drug "Oulanning", diabetes drug "Fulaidi", and gastrointestinal drugs "Ruiqi" and "Ruibote", are all among the top of their kind in terms of market share.
In the future, Hansoh Pharma will focus more on the innovation of new drugs, and will, in light of the goal to "create excellence in pharmaceuticals, enhance innovation in China, and increase Hansoh's brand influence", seize development opportunities, accelerate the pace of independent innovation and go-global, continuously achieve new leaps and breakthroughs in the development of the group, and make new contributions to the development of China's pharmaceutical industry. （By Li Hui and Tang Xunrui）
