For a pharmaceutical enterprise, generic drug is a topic that can’t be avoided.

For the sake of mankind, it’s an established international rule that the patents of drugs used to cure serious diseases will automatically expire after a few decades so that developing countries can produce generic drugs for their people.

China is a late starter in modern pharmaceutical production. The enterprises capable of developing generic drugs produced by big pharma companies didn’t exist until 2 or 3 decades ago. Therefore, it was only until 2 or 3 decades ago Chinese patients were able to access high-end generic drugs.

An indisputable fact is that the emergence of a generic drug means significant decrease in medical costs for the patients. However, is it easy to develop generic drugs? Does it require innovation to develop generic drugs? How long is the journey from generic drugs to originator drugs?

Developing generic drugs is no easy thing

Developing generic drugs is generally regarded as drawing a tiger using a cat as a model.

Hansoh Pharma has a deeper understanding as a the fourth largest oncology pharmaceutical company in China.   

Despite the formulation, arduous efforts are needed to produce a generic drug with similar efficacy to its originator drug. Zhong Huijuan, president of Hansoh Pharma, sees originator drug as a mountain, the height of which tests the research and production process of an enterprise developing generic drugs. It took them 10 years to climb over the mountain.  

In recent years, the incidence rate of non-small cell lung cancer is very high, the most common malignant tumor in China with 500,000 new cases annually. To address this demand, Hansoh cooperated with Shanghai Institute of Organic Chemistry in 1999, hoping to break the technological barrier and localize the drug.    

Internationally, the drug used to cure this disease was developed and produced by Eli Lilly with high price and monopoly position since its release. Quality equipment is important assurance of product quality. Hansoh has built high-standard plant of 200,000 square meters for preparations, and acquired a hundred of testing instruments occupying hundreds of square meters to ensure all products are strictly inspected before delivery. These equipment costed tens of millions of yuan.         

In order to ensure drug particles are uniform in diameter, they imported expensive equipment such as atomic absorption spectrophotometer, particle size analyzer. Zhong Huijuan said, “We look for the best equipment globally in order to make the best generic drugs.” Such equipment enabled its technology to meet standards without decreasing therapeutic effect at last.  

Their efforts finally paid off. Gemcitabine hydrochloride, a non-small cell lung cancer drug  developed by the company, has now become a first-line drug in the area.

Innovation in imitation

Making generic is no easy task, but it can improve the technical ability of an enterprise, and pave the way for innovation. In the development process of Gemcitabine Hydrochloride, Hansoh Pharma has adopted many new substitution technologies in solving various difficulties.    

In the process, they have published 21 academic papers, including 15 SCI, and filed 9 national invention patents with 1 licensed patent. The company has hosted to formulate 2 national standards for APIs and preparations. In 2008 the company became the first enterprise to get the FDA authentication for APIs. In 2012 Gemcitabine hydrochloride (Zefei) became the only preparations in domestic market which received FDA approval. And it met USP standards.

The successful development of Zefei broke the international technology monopoly. With the same therapeutic effect, Zefei is only at half the price of imported drug. In recent years the product has entered nearly 300 Grade-A hospitals and accumulatively cured more than 300,000 patients. In 2011 Zefei topped the domestic market with a 65% share. The APIs is high in quality and low in price and has been exported to markets in Europe and the US, with revenue of more than US$100million in total, accounting for one fourth of global use per year. Therefore the drug was awarded as “National New Important Product”, and the subsequent research has been listed as state key scientific research program, creating huge economic and social benefits.       

From generic to originator drug　　

The enterprise engaged in R&D of high-end drug must have creative ability and creative infrastructure, same to the top pharmaceutical enterprises in the world.  

Hansoh has committed to creative fundamental work since founded in 1995. It focuses on three aspects. Firstly, huge investment in R&D. Annual R&D cost accounts for close to 10% of sales revenue, well above its peers. The accumulated R&D cost is more than RMB1billion. Secondly, building R&D team. Among its 4,000+ employees, the number of employees with college degree or above accounts for 63%, with master degree or above is nearly 300, and with doctor degree is above 50. There are 2 persons who enjoy the State Council Special Allowance and 2 persons are members of the National Thousand Talents Program; thirdly, building of R&D centers. The company has R&D centers in Lianyungang (Jiangsu), Zhangjiang (Shanghai). Each step from information collection, screening of chemical compound, preclinical research, clinical research, approval of new drug to optimization of production process has all been included in creative research, forming a systemic and perfect research system, strongly supporting technological innovation of the enterprise. The company has also carried out various cooperation with research institutes, universities at home and abroad.  

Hansoh currently has 65 new products under development, including 17 category 1.1 drugs with 10 approved to enter the process of clinical research, ranking top among peers. Imatinib Mesylate Tablets, leukemia drug, has completed clinical research, and diabetes drug Polyethylene Glycol Loxenatide is about to finish clinical research. Now the company has established a product echelon of “one generation in production, one generation in pipeline and one generation in R&D”.

The company has also undertaken 13 “Significant New Drug Development”, 4 category 1.1 new drug creation programs, and 4 key technological transformation projects. The products of the company has shifted from pure chemical drugs to combination of biological medicine and chemical drugs, covering the six fields of oncology, CNS, gastrointestinal, anti-infectives, endocrinology and cardiovascular. The company has also transformed from making generic drugs, combination of generic drugs and originator drug to self-creation of drugs. In 2012, Hansoh Pharma ranked 5th of “China’s Top 10 Creative Pharmaceutical Enterprises” listed by the State Statistical Bureau, and regarded as “National Technology Innovation Exemplary Enterprises“ by the Ministry of Industry and Information Technology and the Ministry of Finance.

The history of Hansoh Pharma demonstrates that it is entirely possible for Chinese enterprise to move towards innovation from imitation.