People in the pharmaceutical industry often say: “When we talk about drug innovation in China, we must think of Jiangsu; when we talk about drug innovation in Jiangsu, we must think of Lianyungang.” Lianyungang has become a national pioneer in drug innovation and a renowned “drug port”, which is already a common understanding in China’s pharmaceutical industry.
There is one exceptional pharmaceutical company in Lianyunguang. It only took 20 years to grow from the beginning to become the 22nd among the “Top 100 Pharmaceutical Industrial Enterprises of China” and top 3 most innovative company in the industry, National Technology Innovation Exemplary Enterprise, winner of second prize of State Science and Technology Progress for two 2 years in a row, owner of the ninth New Molecule Entity (NME) innovative drugs approved in China, and winner of China Patent Gold Award.
In his report at the 19th CPC National Congress, president Xi Jinping highlighted that: As socialism with Chinese characteristics has entered a new era, the principal contradiction facing Chinese society has evolved. What we now face is the contradiction between unbalanced and inadequate development and the people’s ever-growing needs for a better life.
At a modern show room with the theme of “Hansoh Dream • Health Dream”, Lyu Aifeng, president of Jiangsu Hansoh Pharmaceutical Group, said: “in the pharmaceutical industry, putting the guiding principles from the 19th National Congress into action we need to solve the contradiction between unbalanced and inadequate development of the pharmaceutical industry and the people’s ever-growing needs for a better life. As a domestic pharmaceutical company, we are very clear about our social responsibilities to provide safer, more efficient and affordable drugs through technology innovations and meet the unmet health needs of patients to improve their sense of well-being and provide a health guarantee for people to have a better life.
The Group’s 50,000 Square Meter Modern Drug R&D Center
Hansoh’s Mission: “Serve the society and build a healthy world”
“In the report, the president calls for the implementation of the Healthy China Initiative, and points out that innovation is the primary driving force behind development, which adds to our ‘health dream’ a sense of duty calling and gives us a sense of unprecedented development opportunities.” Zhang Chunlin, secretary of the Party Committee of Jiangsu Hansoh Pharmaceutical Group, said, “Since its inception, Hansoh has set out a clear mission to ‘serve the society and build a healthy world’ and a development path of “be the best domestic drug company and promote the concept of ‘Created in China’.”
Hansoh Pharma has been setting its development paths based on the health needs of patients in China. In the 90s when the company was initially founded, while China’s economy was growing rapidly, the contradiction between insufficient supply in the pharmaceutical industry and the people’s ever-growing health needs became more and more obvious. At the time, Hansoh Pharma developed the strategy of “Combining imitation and innovation to lay the groundwork and make breakthroughs”. In response to the unmet needs for international high-end drugs and insufficient supply, Hansoh, a then budding company, decided to develop the oncology drug Gainuo (Vinorelbine Tartrate Injection). The R&D team worked round the clock to overcome all the challenges, and successfully launched the product into the market in 2000, making huge splash in the industry both at home and abroad. Later on, it became the first product of Hansoh that reached RMB 100 million in sales and was named “Hi-tech Product in Jiangsu” and “National Key New Product”.
Through the successful launch and distribution of the product, decision-makers at Hansoh were very happy to see how their drugs improve people’s quality of life and how drugs become more accessible to tumor patients, while realizing the huge potential of hi-tech products and the key role played by technology innovation.
Drug Innovation to Improve Patients’ Sense of Gain
Since 2000, Hansoh Pharma has gradually increased its investment in R&D, which took up almost 10% of its sales revenue last year, far above the industry average. It has set up 2 R&D centers in Zhangjiang, Shanghai, and Lianyungang, Jiangsu, trained nearly 1,000 high quality researchers, and has multiple R&D platforms including a National Technology Center, a post-doctoral research station, a Jiangsu Academician Workstation, and a biological high-tech laboratory. Through collaborative innovation at various levels and in various domains and joint expert consultation, the Company will continue to improve its independent innovation ability and technology transfer capacity, and shift its R&D strategy from “Imitation First and Innovation Second” to “Innovation First and Imitation Second”.
“During the course of Hansoh Pharma’s technology innovation, leukemia drug Xinwei (Imatinib Mesylate Tablets) and Oulanning (Olanzapine Tablets), the first major drug for mental illnesses in China, are two types of drugs that can’t be overlooked.” When introducing the history of technology innovation of Hansoh, Zhang Chunlin, secretary of Party Committee of Hansoh Pharma Group, said, “These drugs are widely used in China but its treatment rate is very low, because the originator drugs cost hundreds of thousands Renminbi per year, thus unaffordable for ordinary households.”
Imatinib mesylate, the first drug to turn leukemia from an incurable cancer to a chronic disease, can provide a 10-year survival rate of 90% for patients in later phases of chronic myelogenous leukemia. In 2002, the drug entered the Chinese market, but it costs RMB250,000 each year and requires long-term administration. Most families cannot afford it.
Imatinib localization project was initiated by Hansoh Pharma in 2009. Due to its broad demand, it obtained the grant from the “National Science and Technology Major Project” of the “12th Five-Year Plan”. After five years of research, Hansoh’s researchers successfully cracked multiple patented technologies and invented a brand-new non-needle-shaped crystalline form and high-purity preparation technology. The new drug contains less genotoxic impurities than required by EU standards, features higher-yield synthetic route, better safety and improved eco-friendliness. In 2014 first China-version Imatinib mesylate, trade name: Xinwei, hit the market and cost only one-tenth of the originator drug’s price. Thanks to its reliable efficacy and relatively affordable price, Xinwei was quickly recognized by doctors and patients, capturing nearly 50% of the domestic market in a short time. Amidst the broad appeal from patients, Xinwei was included into the National Reimbursement Drug List (the “NRDL”) last February, meaning more patients with leukemia will receive better treatment at an affordable cost and a better chance to recover.
It is not an isolated case. In 2001, Hansoh successfully launched a new CNS drug named “Oulanning”, the China-version olanzapine. It’s considered great news for Chinese patients. In addition, because of its beneficial efficacy, minor side effects and one-fourth of the originator drug’s price, Oulanning quickly dominated the market and became the best-selling olanzapine brand in China since 2010.
Oulanning is used by nearly 3,000 hospitals, with approximately 90% market share and RMB2 billion annual sales. In 2013, the Olanzapine Localization project was awarded the grant from “National Science and Technology Major Project” and prized as “National Key New Product” by Ministry of Science and Technology. Thanks to the drug’s significant social implications, Oulanning’s Research and Application program won the Silver Prize of the State Science and Technology Progress Awards, the second time for Hansoh.
Hansoh was supported and recognized by the authorities for its outstanding achievements and performance in drug innovation. So far, Hansoh has undertaken more than 60 government projects, some of them are part of the “New Important Drugs Invention Program”, “National 863 Program” or “National Torch Program”, etc., and completed them ahead of schedule.
The QC head of Hansoh said: “Our APIs were certified by FDA with “zero defects” as early as 2003. In 2012, Gainuo and Zefei were approved by FDA and became the first lyophilized powder drugs that got this certification. We have established a whole life cycle QC system with the guidance principle of “All Responsible, Whole Process and Continuous Improvement”, covering from R&D design, manufacturing to transportation. We are the multi-time winner of “Model Pharmaceutical Company with Outstanding Product Quality and Integrity”.
So far, Hansoh has over 50 varieties on the shelf covering six areas including oncology, CNS, anti-infectives, gastrointestinal, etc. It’s roughly estimated that Hansoh’s drugs have accumulatively benefited tens of millions of patients and saved c. RMB30 billion in medical expenses for the society.
Technological Innovation Drives “Invention in China”
“Technological innovation is at the core of our development, helping us realize leapfrog development over the past 22 years. From the perspectives of the world, the nation, the industry, or ourselves, technological innovation is a development strategy we must stick to. It will lead us to transform from “made in China” to “invented in China”, achieving the final vision of ‘Hansoh Dream: A Healthy World’.” said Lyu Aifeng, President of Jiangsu Hansoh Pharma Group.
Through combination of imitation and innovation, Hansoh Pharma has successfully overcome patent barriers by foreign originator drug producer on major drugs that are urgently needed in domestic clinical treatments. It brings advanced technologies into domestic market, and produces high value-added hi-tech products while ensuring efficacy and safety. That provides core competitive strength for Hansoh’s products to quickly gain market shares. Also, significant reduction of treatment cost and improvement of drug accessibility as well as customers’ sense of well-being help increase the company’s influence in the industry in a very short time.
“Generic drugs solved the problem of drug accessibility, but it cannot solve all the problems. Given China’s large population and growing needs for health, in the long run, Chinese pharmaceutical enterprises must shoulder more social responsibilities via independent innovation and development of originator drug.” said Lyu Aifeng.
In May 2014, Hansoh Pharma’s new drug Mailingda (morinidazole sodium chloride injection), a category 1.1 drug, after 13 years of R&D, finally went to market. The drug is the 9th new molecular entity innovative drug in domestic market and has better curative effect with higher safety to gynecology inflammation such as pelvic inflammation, a significant step for Hansoh in its transformation from “combination of imitation and innovation” to “independent innovation”.
Hansoh Pharma has category 1.1 innovative drugs in various development stages in nearly 20 countries. Those drugs will be marketed in near future and improve survival quality of patients with better safety, effectiveness and economics. Hansoh’s upcoming important drug Polyethylene Glycol Loxenatide has attracted great attention as a long-acting drug for diabetes. It can change 1-3 daily dosing into once a week dosing, to effectively improve patients’ compliances and life quality; Imatinib Mesylate Tablets is the second generation of targeted drug for leukemia and better in safety and effectiveness in comparison with the first generation drug.
However, Hansoh’s drug innovation is more than that. It is expanding footprint in domestic market with an eye to international market. On the basis of internationalization of APIs, Hansoh started to explore overseas high-end market in 2006. In 2012 the company’s oncology injections Zefei and Gainuo passed the FDA authentication firstly in domestic market. In 2016 oncology injections Pulaile and CNS drug Oulanning received approval from FDA and Japanese PMDA. Currently Hansoh has established trade relationships with 50 countries and regions including the US and EU, forming an overseas marketing network covering the whole world, and was awarded as “Leading Enterprise in the Internationalization of Pharmaceuticals”.
To further accelerate the pace of internationalization, Hansoh has also carried out clinical research for innovative drugs in multiple international centers, while vigorously acquiring overseas high-end talents, making more innovative drugs enter international clinical research to allow more people in the world to enjoy sense of health and well-being brought by innovative drugs.
There are many enterprises in Jiangsu similar to Hansoh which shoulder the responsibility of rejuvenating China. They are willing to take responsibility and be creative, making their own efforts for the nation’s rejuvenation. We believe that China’s dream will come true with the help of those enterprises.
