On January 9, the 2014 National Science and Technology Awards Conference was held at the Great Hall of the People in Beijing. Hansoh Pharma won another second prize for the Advancement of Science and Technology Award for its “new CNS drug olanzapine and the development and application of its preparations”, following the first such award to its drug Zeifei (generic name: Gemcitabine Hydrochloride for Injection).
Founded in 1995, after 19 years of sustained and steady growth, Jiangsu Hansoh Pharmaceutical Group Co., Ltd. has become a modern innovative pharmaceutical group that engages in the research of chemical medicine and biopharmaceuticals, synthesis of pharmaceutical intermediates and API, as well as preparation production and product marketing. For years in a row, Hansoh has been among the top 30 of “Top 100 Pharmaceutical Industrial Enterprises of China”, top 5 of “R&D-driven pharmaceutical companies in China”, and top 3 of “The 10 Most Innovative Pharmaceutical Enterprises in China".
With the mission to “serve the society and build a healthy world”, the Company aims at “producing our own quality drugs, promoting the concept of ‘created in China’, and enhancing the Hansoh brand”. It has established its vision as “staying focused, dedicated and professional to become a domestic forerunner in innovative drugs”, and is committed to growing into a world-renowned pharmaceutical company.
With the ever-increasing social pressure, the prevalence of mental diseases is constantly on the rise. Schizophrenia is a severe mental disease whose global prevalence among adults is as high as 7%, with 7.8 million patients in China and 24 million globally, and the numbers are still growing.
According to statistics, people with schizophrenia are 10 times more likely to develop homicidal behaviors than the general population, posing a grave threat to life and property of other people and a heavy burden on society.
Unlike conventional drugs such as chlorpromazine, haloperidol, etc., whose efficacy rates are only c.55%, Olanzapine’s efficacy rate is as high as nearly 80%, with reduced extrapyramidal side effects and a low incidence of tardive dyskinesia. In the 2007 Schizophrenia: Prevention and Treatment, Olanzapine is recommended as a first-line drug. However, the high price of imported drugs and expensive treatment inhibit the accessibility of Olanzapine. Producing our own Olanzapine becomes an urgent task that will significantly reduce the economic burden on the families of schizophrenia patients as well as on society and thus will generate far-reaching social benefits.
In existing researches on the development of Olanzapine, there are several technical difficulties: harsh reaction conditions makes it difficult to realize mass production; patent of Olanzapine polymorph crystal form by Eli Lilly increases the difficulty in developing our own version of Olanzapine; and the use of flammable and explosive materials creates high production risk. Hansoh Pharma, in collaboration with Shanghai Institute of Pharmaceutical Industry and China Pharmaceutical University, has successfully overcome the above challenges and developed our own Olanzapine. Major technological innovations include:
1. Development of an efficient synthesis process to product high quality products: Replacement of N-methyl piperazine by piperazine as a raw material in substitution reaction to reduce oxidation impurities (from 0.5% to 0.05%); addition of water absorbent to reduce hydrolyzation impurities (from 0.8% to 0.02%); improvement of yield from 32.7% to 64%.
2. Development of new crystal form and its preparation process. After a series of researches, we developed, based on the technology of crystal form screening, a new alcohol-ether mixed solvent crystallization method for the preparation of new Olanzapine crystal form, one of good liquidity and stability, as well as formula and process to ensure product stability during the preparation and storage processes. In vitro and in vivo data demonstrated the bioequivalence of our product to the originator drug. Product quality has met and surpassed European and US Pharmacopoeia standards and the Company has applied for US DMF (Application No. 24480).
3. Removal of high risk reagents to ensure safety and environmental friendliness. New acid-binding agent with high safety performance is used in condensation reaction, and usage of solvent is reduced from 70 times to 10 times, production cycle shortened from 4 days to 2 days, and yield improved from 50.7% to 66.7%. The new process is safe, controllable and green and can produce higher purity products.
Oulanning (generic name: Olanzapine Tablets) is a new drug for the treatment of depression and schizophrenia with an efficacy rate of more than 80%, as indicated by clinical outcomes, and has been recommended as a first-line drug in the treatment of mental illnesses.
Olanzapine was developed and launched in 1996 by a multinational pharmaceutical company and has since been under global monopoly. The drug is very expensive. Depression and schizophrenia patients in China cannot afford the high costs of diagnosis and treatment and thus have long been in an unstable state. In response to the national call for improving people’s well-being, Hansoh was committed to the tackling of technological difficulties in the development of Olanzapine and finally produced Oulanning, our own Olanzapine. After launch, Oulanning has been used in nearly 3,000 hospitals, and the price is less than half that of the originator drug, fulfilling the Company’s commitment of benefiting the people. In 2012, its share in domestic market achieved 70%, creating significant social and economic benefits.
The successful development and launch of Oulanning would not have been possible without Hansoh’s technology strategy. The Company’s R&D team formulated a number of solutions for mass production of the drug and continued to optimize them, finally overcoming the patent barrier by the originator drug manufacturer. The preparation method of Oulanning has been granted multiple invention patents and the title of “National Key New Product” by the Ministry of Science and Technology; its follow-up researches are included in National Science and Technology Major Project in the “Significant New Drug Development” category. In 2013, the product won the first prize of “Advancement of Science and Technology” from the All-China Federation of Industry & Commerce.
With its vision of being “China’s forerunner in innovative drugs” and after more than 10 years of persistent efforts, Hansoh has now become a leading innovative pharmaceutical company in China. It has been ranked among the 3 most innovative Chinese pharmaceutical companies in 2014, and has undertaken various major projects under “Significant New Drug Development”, “863 Program” and “National Fund for Innovation”. Hansoh has established a state-of-the-art research institute at Lianyungang where its headquarter is located, with a total floor area of 35,000 square meters and multiple research platforms such as national postdoctoral research stations, provincial academician workstations, and biopharmaceutics high-tech research laboratories etc. It has also set up R&D centers in Shanghai, focusing on the exploratory research on new targets, new mechanisms and new pathways. The Company already has a number of category 1.1 new drugs in various clinical trial phases.
To date, the company has commercialized 20 products covering areas of oncology, CNS, anti-infectives, diabetes, gastrointestinal and cardiovascular. Oncology drugs Zefei, Pulaile, Gainuo, CNS drug Oulanning, diabetes drug Fulaidi, and gastrointestinal drugs Ruiqi and Ruibote are all in leading positions among their peers in terms of market share.
In the future, Hansoh Pharma will further focus on the development of innovative drugs, with the aim to “produce our own quality drugs, promote the concept of ‘created in China’, and enhance the Hansoh brand”. It will seize development opportunities to speed up independent innovation and internationalization, achieve new breakthroughs for the Group, and make more contributions to China’s pharmaceutical industry.
