From the latest issue of the National Statistical Chronology of Drug Registration, two groups of data can be found, one bringing joy while one bringing worries. Specifically, the former shows the number of new drug research and development in Shanghai, ranking first, especially in Zhangjiang area with obvious advantages. For every three new drug research and development approved by the National Medical Products Administration, one is from Zhangjiang. In terms of the one bringing worries, the number of new drug production batches in Shanghai has been zero for several consecutive years, falling to 10 in the national ranking of the pharmaceutical industry, and the gap with the largest province in the national pharmaceutical output value having reached nearly six times. "Receive recognition only from outsiders " truly reflects the low transformation rate of achievements in Shanghai's pharmaceutical industry. How can scientists not only do research and development in Shanghai, but also enjoy the results of industrialization, thus addressing the "last mile" of transformation?
Incapability of Staying in Shanghai
Shanghai's pharmaceutical industry had a glorious past. Before the 1990s, Shanghai's pharmaceutical industry had been the national leader.
However, in the new century, the ranking of Shanghai's pharmaceutical industry has declined year by year, and now it has fallen to the 14th. There are only 5 top 100 pharmaceutical enterprises in Shanghai, while there are 12 in Jiangsu, 14 in Shandong and 12 in Zhejiang, which are near Shanghai but far superior to Shanghai.
Why does Shanghai's pharmaceutical industry decline rapidly? Serious loss of technological achievements and difficult transformation of achievements are the biggest causes. Statistics show that in recent years, the number of biomedical research projects in Zhangjiang Park alone has reached 5,117, and the completed projects has totaled 2,824. However, the approval for new drug production in Shanghai in 2013 was zero, with only 5 generic drugs receiving approval, accounting for only 1.6% of the country's total, almost bottoming out in economically developed areas, reflecting the embarrassing situation of Shanghai's biomedical industry that "only blossoms but does not bear fruit".
In fact, it has always been difficult to transform medical achievements. Usually, scientists or entrepreneurs will face the dilemma of how to produce and how to sell a new drug after completing a new drug technology is developed. In order to realize the production of new drugs in China, it is necessary to transform from R&D institutes to production-oriented enterprises, and to have land and GMP factories that meet the pharmaceutical production standards. Most scientists are often helpless in the face of the follow-up problems of the transformation of achievements. The objective problems of funds, resources, experience and roles become invisible obstacles, suppressing innovation.
In Shanghai and Zhangjiang, this problem is even more prominent. The high cost of land and scarce resources in Shanghai mean that the cost of building a pharmaceutical production base in Shanghai is staggering. According to estimates, the construction cost of each GMP plant generally amounts to hundreds of millions while 200 mu of industrial land can only be used to build several pharmaceutical plants, showing low land use rate. Tang Shiqing, the director of the Science and Technology Commission of Pudong New Area, believes that the traditional industrialization model of building separate factories can never be applied to Shanghai. There must be a unique path for Zhangjiang and even Shanghai to develop the pharmaceutical industry, so as to greatly improve the efficiency of transformation of achievements.
Hope of Staying in Shanghai
On the one hand, it is the realistic constraint of land cost, and on the other hand, it is the urgency of achievement transformation. For the researchers of new drugs in Shanghai, whether to leave or stay is a realistic problem.
The good news is that Shanghai Tianci International Pharmaceuticals Co., Ltd., established by joint investment of private capital and Shanghai state-owned capital, is trying a new mode of "A + W" pharmaceutical production in Zhangjiang area, which makes "staying" more possible.
With a total investment of 2.4 billion yuan, the Base for Transformation of Tianci International Biomedical Achievements covers 211 mu and a total floor area of 270,000 square meters, with 20 factories and 80 GMP production lines planned to be built. Although the base is still under construction, its concept has attracted much attention. In the so-called "A + W" mode, "A" means that Tianci International will use 8 factories and 20 production lines in the base to industrialize 42 high-end generic drugs and 4 class I new drugs, while "W" stands for "We Pharma", that is, "Everyone will make drugs together". Tianci will invite researchers and entrepreneurs of new drug research and development to settle in the remaining 12 factories and 60 production lines of the base, so that they can complete the "last mile" of the transformation of achievements in Shanghai.
Li Hanpu, chairman of Shanghai Tianci International Pharmaceuticals Co., Ltd., said that "A+W" is a "flexible, open and giving" sharing platform. The Base for Transformation of Achievements is mostly characterized by this: after scientists settle in the base, they only need to devote themselves to research and development, and other "roles" are completed with the help of the base. For example, the base will provide public system services, administrative office, unified warehousing, life support and other issues in one stop. The base will also be a financing platform to provide personalized financial services for R&D teams. With a professional pharmaceutical sales team of 4,000 people, the base will also provide pharmaceutical registration services for enterprises, assist residents to obtain production approval, truly achieving contract production and marketing, integrate the resources of the whole industry chain of biomedical industry from R&D, production to sales, and provide a professional service platform for innovative entrepreneurs.
“The role of entrepreneurs, financiers and distributors, which are unfamiliar to scientific researchers, is played by the base. The long-term benefit-sharing mechanism is established between Tianci and scientists. As long as the project can pass the demonstration of Tianci International Expert Committee, Tianci is willing to share profits with the residents even if they require up to 80% of the production profit. If the annual profit tax of products reaches more than 100 million yuan, Tianci will also transform its achievements free of charge.” Li Hanpu said that this innovative mode of transforming new drug achievements by "providing funds", "providing factories", "helping approval" and "helping sales" would break down the limitations of the traditional industrial mode and would be a brand-new attempt.
A Bright Prospect
Can the model of "making medicine together" solve the dilemma of Shanghai's pharmaceutical industry? At present, both the government and the market are quite confident about it.
Ma Jing, the deputy director of Shanghai Municipal Commission of Economy and Informatizaiton, believes that Tianci Base adopts the innovative mode of “unified construction, separate operation, integrated resources and benefit sharing", maximizing the industrialization ability of Shanghai's land resources, so that as many technological achievement holders as possible can keep the industrialized production of new drug products in Shanghai while their long-term interests are guaranteed. This model is expected to promote the biomedical industry to become a pillar industry in Shanghai."
Scientists have a better say in it. Professor Xie Delong, who had studied Chinese patent medicine for a long time before retirement in Shanghai Pharmaceuticals Holdings Co., Ltd., is now a beneficiary of Tianci Base. Professor Xie won a patent for American Pharmaceutical Invention in 2013 through his personal invention, which is a Chinese patent compound extracted from the huperzia serrata, used to improve memory and treat Alzheimer's syndrome, commonly known as "senile dementia". Preliminary experiments showed that the compound could effectively inhibit the precipitation of brain proteins and promote the smooth flow of brain nerves. However, Professor Xie, who holds the “treasure”, can only hide the patent. "From R&D to production, we need fund, a team, a piece of land and a production line, which is not what a retired professor can have. Of course, there were also foreign pharmaceutical companies that wanted to buy my patent, which I refused. Our fruits should still be left on our own land.”
When Mr. Xie was in distress, the emergence of Tianci brought him back to life. “I sign a contract with Tianci. They provide me with scientific research conditions and production environment, and help me apply for production approval and subsequent product sales. I share the market dividend with Tianci. Once the product enters the market, I split the profits half with Tianci." With the help of the base, Lao Xie has set up a scientific research team of 67 people. Talking about the future, the old professor is very excited.
Like Mr. Xie, there are many scientists who are eager to try. At present, Tianci Base has signed a settlement agreement with more than 10 new drug research and development teams. The projects involve many biomedical fields such as female climacteric syndrome, drug detoxification, anti-cancer, anti-hepatitis B, diabetes and so on. A number of R&D patents are expected to lead to further joyful results.
As an open platform, Tianci Base has also attracted worldwide attention. In the United States, the Sino-American Pharmaceutical Professionals Association (SAPA), a non-governmental organization composed of more than 4,000 top Chinese scientists in the field of biomedicine, has recently signed a strategic cooperation agreement with Tianci International, making the base become the cooperation base of SAPA for the transformation of achievements in China. Tianci has also reached a cooperation agreement on the transformation of medical and technological achievements with Israel's famous Matam Park - Haifa. Through integration of talents, technology, R&D, production, capital and information and data, Tianci International is preparing to build a platform of industry chain aggregation with global influence, so that more scientists from all over the world can "make medicine together" in Shanghai.