New Ambition Of Suzhou Biomedical Industry Park: Antibody Drug, Cell And Gene Therapy

With the gradual resumption of production after the outbreak, the Suzhou Biological Pharmaceutical Industrial Park (hereinafter referred to as BioBAY) recently held the BioBAY two C area signing ceremony and the B area opening ceremony in the SAM tin island area. Its two phase project, which is located at the bio pharmaceutical industrialization base, is fully activated. It is reported that the enterprises settled in the field of antibody drugs, cell and gene therapy, will enhance the advantages of BioBAY in the industrial chain of antibody drugs, and further lay out new fields such as immunotherapy.

The evaluation and analysis report on the competitiveness of China's biopharmaceutical industry park released by the biotechnology development center of the Ministry of science and technology shows that Zhongguancun's National Independent Innovation Demonstration Zone, Shanghai Zhangjiang hi tech Industrial Development Zone, Suzhou Industrial Park, Wuhan East Lake high tech Zone and Ji'nan high tech location rank the top five of the National Bio Pharmaceutical Industrial Park's comprehensive competitiveness list. Among them, the industrial competitiveness of Suzhou Industrial Park ranks first.

The new crown epidemic is attacking and changing the market structure of China's pharmaceutical industry from all sides. In the post epidemic era, public health emergency system, innovative drug research and development, medical emergency supplies and so on will become an important part of the improvement of urban construction capacity.

Under the background of counter globalization, the biomedical industry with high technology, high investment, high risk, high added value, long cycle and multi discipline crossover is attracting more and more attention. At present, the industrial park has unique advantages not only in talent gathering, technology integration, fund integration, and achievement transformation, but also in depth with the inherent requirements of the development of the bio pharmaceutical industry, and has become an important support for the biopharmaceutical industry.

Strategic emerging industries cluster is a "transformer" to cope with changes in international economic environment and downward pressure on the economy, and it is a "stabilizer" to promote steady employment and steady growth. From innovation incubation, industrial fund to alliance, the biomedical industry park has grown into an indispensable part of China's pharmaceutical industry.

For innovative pharmaceutical companies, finding suitable parks at the right time is an important accelerator for enterprise development. McKinsey said in a recent release of the new crown epidemic how to change the pattern of China's pharmaceutical industry. There are also some new areas of concern and opportunities for investment growth expectations and the consequent supportive policies along with the economic recovery. The urgent task of pharmaceutical companies is to alleviate the short-term impact of the epidemic and prepare for the restoration of market changes after normal conditions.

Leader advantage and agglomeration effect

The two phase of the BioBAY project is located in the Suzhou Science Park Innovation area, Sang Tian island area. BioBAY aims to build it into a complete chain of biological medicine incubation, acceleration and industrialization. It covers an area of 21 hectares and is divided into three blocks. A area has a total construction area of 120 thousand square meters, and 9 standard factory buildings and 1 public supporting buildings have been built. At present, Baiji Shenzhou, reding medicine, Beckman Kurt, and other enterprises are entering. B area has a total construction area of 94 thousand square meters, and 13 standard factory buildings have been built. At present, a number of enterprises such as Lisheng medicine, Gen Xi, Yao Ming Ju, Ke Rui gene are stationed. The C area has a total construction area of 81 thousand square meters, and 8 standard factory buildings and 1 public supporting buildings have been built. It was officially opened in May 29th.

These enterprises cover many hot areas of biomedicine in recent years, including PD-1/PD-L1 and other immunotherapy, CAR-T and other cell and gene therapy. In 2019, domestic PD-1 new drugs developed by Jun Shi, XinDa, Heng Rui Sheng Di and Bai Ji Shenzhou four enterprises were approved to be listed, of which three drugs were developed or produced in BioBAY.

With the development of cell and gene therapy as one of the most rapidly developing fields in medical industry, Suzhou's recently published biologic medicine landmark project is also regarded as the key area for future development of the park. In this signing and opening business, there are also a number of innovative enterprises in this field, including medicine, Nueno, Gen Xi, and Rui.

The biomedicine industry is one of the four leading industries in Suzhou. The Suzhou municipal Party committee and the municipal government issued the guiding opinions on speeding up the development of Suzhou's biopharmaceutical industry cluster. "Measures to speed up the quality development of Suzhou's bio pharmaceutical industry" have been led by the Suzhou municipal government to set up the leading group of Suzhou biological medicine industry development, and vigorously support the bio pharmaceutical industry from various perspectives.

"First, from a positioning point of view, Suzhou put forward benchmarking and learning Boston experience, doing research and development of industrial landmarks, layout bio medicine is inevitable; second, BioBAY after more than ten years of development, the foundation and platform have certain advantages in China, with a large number of enterprises in the capital side, listing or financing, there are many successful products listed on the product side, this advantage will be. Bigger and bigger. There are still a long way to go from companies to platforms, resources, policies, finance, industrial ecosphere, and parks. Pang Junyong, general manager of Suzhou Industrial Park bioindustry Development Co., Ltd., in an interview with the twenty-first Century economic report, said BioBAY's positioning and development is also a microcosm of the development of China's new drug industry. "We start with small molecule innovative drugs, and then to antibody drugs, including current cell therapy. We are fortunate that in these important stages of development, the best companies have been recruited, forming a cluster of industrial ecology in the park.

In the two phase of the project, apricot pharmaceutical company, which focuses on antibody drugs, has been listed on the Hong Kong stock market. The total investment of apricot joint pharmaceutical industry will exceed 1 billion yuan, and the first phase will invest 400 million yuan. The commercial base of this opening will be used for the commercialization of its first product, SM03, which has been listed in the three phase of clinical trials for rheumatoid arthritis and is expected to be submitted for listing in 2021.

"In the future, R & D, production and sale will be put in Suzhou," said Jing Qiang, executive director of apricot pharmaceutical company, in an interview with the twenty-first Century economic report. Small molecule macromolecules, talent introduction, R & D communication, information communication, joint drug use, including joint use and joint development, all have advantages.

Pang Junyong pointed out that selecting cells and gene therapy as another important direction in the future is to have a comprehensive layout in the field of immunotherapy, such as the formation of cluster effect and the formation of industrial chains, including research and development, production, treatment, commercialization and so on. It will refer to the experience in the field of antibody, such as making some support in the key nodes of the industrial chain. For example, we are considering finding the best virus preparation company in the world or the whole country as a key link in building the industry chain in this field.

Capital enrichment

According to the report of the Ministry of science and technology, the total output value of the biological medicine industry in 2018 was about 1 trillion and 820 billion yuan, an increase of 260 billion yuan compared with 2017, and the growth rates of 2017 and 2018 were 18.88% and 16.95%, respectively. In 2018, the total amount of bio medicine industry in China was about 4 trillion and 550 billion yuan, accounting for 5.05% of GDP in 2018.

In 2018, the proportion of the total output value of the biomedical industry in the research park increased from 18.39% in 2016 to 20.17%, especially in the state-level high-tech zones. The proportion of the total output value of the state-level high-tech zones rose from 21.74% in 2016 to 23.58% in 2018, which has gradually become one of the pillar industries in the park.

The three major regional industrial clusters of China's bio pharmaceutical industry are obviously concentrated in the three regions of the Bohai rim, the Yangtze River Delta and the Pearl River Delta. In addition to maintaining a strong position in the eastern region, the scale of bio pharmaceutical industry in the five Central and western provinces has grown, and the development in other regions is relatively slow. Specifically, in 2018, the total industrial output value of the eastern coastal Biological Park accounted for 75.34% of the total output value of the research park.

Zhongguancun, Shanghai Zhangjiang and Suzhou Industrial Park are the first tier. The comprehensive competitiveness and technological competitiveness of Zhongguancun's national independent innovation demonstration zone are ranked first. The leading competitiveness of Shanghai Zhangjiang hi tech Zone ranks first, with strong industrial, environmental and technological strength; Suzhou Industrial Park ranks first in industrial competitiveness; Wuhan East Lake high tech Zone ranks first in the competitiveness of talents; Shenzhen high tech Zone ranks first in the environmental competitiveness.

Another important indicator of the park comes from the performance of enterprises in the capital market. With the opening of the pharmaceutical industry to Hong Kong stock market, the number of BioBAY listed companies has reached 10. Among them, XinDa biology, cornerstone pharmaceutical, Yacheng medicine, China antibody, Corelle Jerry and pioneer pharmaceutical industry have landed in Hong Kong stock market; Baiji Shenzhou, re Ding medicine and Huang medicine are listed on the U. S.

Yao Ming Nuo is an innovative biotechnology company specializing in the latest cell therapy technology. In June 2018, CAR-T, a product of JWCAR029, received a large clinical approval. Now it has applied for the drug production license in Su Shen. Yao Ming Nuo has launched a commercial layout to promote the industrialization of JWCAR029, and plans to go to Hong Kong as soon as possible this year.

In terms of financing, there are large sums of money, such as Corelle Jerry 60 million US dollars, happy living creature 85 million dollars, branch hope biological 100 million dollars, and platinum 75 million dollars. At present, the total amount of financing in the park is RMB 7 billion yuan.

BioBAY, based in the United Kingdom, received $85 million in financing in 2019. As a biopharmaceutical company at the stage of clinical development, FasTCAR, TruUCAR, Dual CAR and Enhanced CAR-T cell therapies are currently being developed for the treatment of leukemia, lymphoma, myeloma and solid tumors.

CAR-T is a highly personalized method. Each person's cells and treatment are different. Many patients have received various treatments before receiving CAR-T treatment, such as bone marrow transplantation, chemotherapy, targeted therapy, etc., and the preparation and programming of T cells will also be different. In addition to PD-1/PD-L1, CAR-T is another product area where domestic enterprises are advancing and catching up with the world's major forces.

Gene therapy is also a "sky high" drug family. In 2017, Novartis Kymriah and Kite Pharma CAR-T products Yescarta was approved and launched the commercialization process of CAR-T. In May 24, 2018, FDA approved the listing of AveXis gene therapy Zolgensma in Novartis, but the controversy was its pricing of up to $2 million 125 thousand. This is also Novartis's first CAR-T gene therapy Kymriah, which is priced at $475 thousand, and another product that shocks the market with prices.

CAR-T technology involves two problems, including the construction of genetic engineering vectors and the preparation of CAR-T cells, including the collection and treatment of immune cells, cell culture, transfection, amplification and reinfusion. Because of the cost of reagents and other materials, the detection cost of CART cell quality control, the cost of cell product GMP workshop operation, the third party certification and quality inspection fees are very high, the terminal cost is very difficult to fall, resulting in the high price of landing in the future. This is also the reason why Novartis and Kite Pharma make high cost of treatment.

"Developing highly effective and affordable gene therapy drugs is a great proposition for the Chinese people to take up, and at the same time, enterprises have certain returns. To solve this huge proposition, we must rely on technological innovation. Cao Wei, President of Gen Xi bio, told the twenty-first Century economic report that "we may be much cheaper than the products that have been listed." Previous strategic investments also illustrate our recognition of our intellectual property rights, innovative technology platforms, business models and business teams.

For the next listing plan, Cao Wei said that he was considering IPO in the international capital market, including NASDAQ and Hong Kong stock market. "As a biopharmaceutical enterprise, we are not worried about the recent audit of some Chinese enterprises. Listing in the international capital market may be more appropriate, such as technical cooperation with US companies or mergers and acquisitions will have fewer obstacles.