In the "Report on the Regional Heat Value Evaluation Index of Strategic Emerging Industries" released by the Qianzhan Industry Research Institute this year, eight districts in Guangzhou entered the top 100 of the regional heat value evaluation index of the biomedicine industry. Among them, Huangpu District of Guangzhou ranked 4th, topping all districts in Guangzhou, demonstrating the significant advantages and leading position of Huangpu District in the biomedicine industry.

In recent years, Guangzhou Development Zone and Huangpu District have formed an industrial spatial pattern of "research and development in the Bio-island, pilot production in the Science City, and manufacturing in the Knowledge City". Core industries such as large molecule drug manufacturing, small molecule innovative drugs, gene therapy, and in vitro diagnostics have gathered here, and a world-class biopharmaceutical production and manufacturing center has begun to take shape.

"Frontline Visits"

AI opens a new door to bioinformatics processing

In the Forperth Innovation Park located in the Huangpu Science City of Guangzhou, there is a place dedicated to the research and breeding of white mice, and that is Saiye (Guangzhou) Biotechnology Co., LTD. (referred to as "Saiye Biotechnology"). Taking the elevator up to the 14th floor, a faint smell of grain feed hit my nose. Through the laboratory glass window, one can see researchers in clean suits conducting research, while beside them are rows of transparent boxes, inside which white mice are crawling around.

Cyindustrial Biotech was founded in 2006. It is an innovative CRO enterprise that accelerates new drug research and development with data, algorithms and models. It has a population of over 500,000 large and small mice and can build more than 10,000 gene knockout/knock-in mouse models and transgenic mouse models every year. These models help pharmaceutical enterprises better understand the mechanism of action and safety of drugs, playing a key role in new drug development and basic research. Among them, the independently developed drug screening and evaluation mouse and rat model was selected as a "Famous and High-quality High-tech Product of Guangdong Province".

Before Han Lanqing, the chairman of Cyagen Biotech, ventured into the biotech industry, he was actually an engineer. In 2003, the Shenzhou V spacecraft achieved the first manned space flight. Han Lanqing, who was far away overseas, felt proud of his motherland and at the same time had the idea of returning to China to start a business. So he returned to China in 2006 and founded Saiye Bio in Huangpu, Guangzhou.

Although mice and humans seem to be two completely different species, they share a very high degree of homology. Han Lanqing said that 99% of the genes of mice and humans originate from a common ancestor. Therefore, in situ replacement of murine genes can simulate human physiological and pathological characteristics, and thus has gradually become the preferred tool for disease research.

After several years of exploration, Cytech Biotech has focused its business on the supply of genetic engineering laboratory mice for experiments and downstream pharmacological and pharmacodynamic technical services based on laboratory mice. To better meet the needs of global users, Cyagen Biotech expanded its R&D and production base in Fopus Innovation Park, Huangpu District in 2020 and established a public technical service platform for gene therapy drug screening. Help address issues such as the shortage of high-value instruments and equipment, the scarcity of animal model strains, and the difficulty in screening and evaluating new drugs in the development of future life and health industries including gene therapy, achieve the sharing of scientific and technological resources, improve the efficiency of scientific and technological resource utilization, meet the resource demands of a large number of enterprises and institutions within the jurisdiction, and promote Guangzhou's progress from a major city in scientific research resources to a strong city in scientific and technological innovation. Accelerate the listing process of advanced new drugs in the region.

In recent years, the demand for genetically engineered mice has been increasing and becoming more complex. With his acute observation of computer engineering, Han Lanqing wondered if AI algorithms and genetic model construction could be combined, allowing computers to assist in formulating design plans.

Under the impetus of Han Lanqing, Cyagen Biotech has successfully developed an "Alpha Mouse" - the AlphaKnockout gene targeting expert system. This system has made the process of designing the gene targeting technology to create genetically engineered mice artificial and intelligent. Through bioinformatics algorithms, it has achieved intelligent design of gene knockout mouse schemes, which can be presented in just 10 seconds.

A skilled researcher needs one to two hours to come up with a plan. However, by using artificial intelligence to carry out such work, dozens of factors can be considered simultaneously, and then the optimal result can be obtained through algorithms. The entire process takes less than half a minute. Han Lanqing said.

Nowadays, Han Lanqing holds another position as the director of the Artificial Intelligence Innovation Center of the Tsinghua University Pearl River Delta Research Institute. He serves as the person in charge of the field of artificial intelligence, with the main aim of applying neural networks/deep learning to the biomedical field.

Leveraging the vast amount of bioinformatics and gene editing data accumulated by Cyagen over the past decade or so, Cyagen and the Tsinghua University Pearl River Delta Research Institute have developed the rare disease database RDDC, integrating open-source data and information from both domestic and international sources such as epidemiology, drug development, disease-related gene maps, gene mutation sites, and mouse and rat models. Based on genetic big data resources and in combination with artificial intelligence and bioinformatics technology, RDDC has deployed AI tools such as mutation pathogenicity prediction and mutation splicing prediction, which have greatly promoted research related to rare diseases.

Huangpu laboratory mice "go out"

At the end of 2023, after passing the quarantine by Luogang Customs under Huangpu Customs, 10 specific pathogen-free (SPF grade) experimental mice of Cytech Bio were loaded onto vehicles and dispatched to Hong Kong Science Park for clinical safety evaluation experiments before the drug was marketed.

Spf-grade experimental mice have extremely strict requirements for storage environment, transportation conditions, etc. For instance, the environmental air cleanliness is required to be at level 10,000. For this reason, Luogang Customs has repeatedly guided us to prepare the materials in advance, helping us complete the constant temperature test and comprehensive disinfection before shipment, and then pack them into SPF-grade packaging boxes and transport them by constant temperature vehicles. Wang Xia, the marketing director of Cyagen Biotech, said.

The biopharmaceutical industry has gathered and developed in Guangzhou Development Zone and Huangpu District, demonstrating outstanding advantages leading domestically. Besides the independent innovation of enterprises, it also requires a favorable local business environment and policy support.

To ensure the healthy "going global" of experimental mice, Luogang Customs has implemented a "one enterprise, one policy" approach, providing assistance and guidance to enterprises in terms of technical trade measures and actively coordinating with port customs to jointly optimize the supervision model for the export of biomedicine. At the same time, a "green channel" for the entire process of electronic ledger declaration, local inspection and quarantine, and port departure has been smoothed out. This enables on-demand inspection and dedicated handling by specific personnel, timely completion of on-site quarantine and issuance of certificates, shortening the time for supervision and customs clearance, and facilitating the smooth export of experimental mice.

It is very difficult to raise SPF-grade experimental animals. If the mice can be exported healthy, all our efforts will not have been in vain. With the help of the customs, our customs clearance time has been shortened and the transportation cost has also decreased significantly. Wang Xia said. Huangpu District is adjacent to Hong Kong and Macao and enjoys huge market potential. Biopharmaceutical enterprises can more easily access domestic and foreign markets and capital here. The experimental mice and rats of Cyagen have been exported to dozens of countries around the world, covering the mainstream global markets.

Today, Huangpu biopharmaceutical enterprises are constantly making breakthroughs in the wave of globalization, with many new products and technologies making their global debut

In the field of pharmaceuticals, the 3Cl-targeted drug for the treatment of COVID-19 infection, Leitrelvir Tablets, jointly developed by the Guangzhou National Laboratory, the Guangzhou Institute of Respiratory Health, and Zhongsheng Ruichuang, has been approved for marketing. It is the world's first eptide-like single-drug 3CL anti-COVID-19 Class 1 innovative drug.

Two biosimilars, bio-tocilizumab and bevacizumab, have been approved by the US Food and Drug Administration for marketing in the United States. These are currently the only two biosimilar products developed by Chinese pharmaceutical companies and approved for marketing by the US Food and Drug Administration.

The PD-1/VEGF bispecific antibody new drug Edafang ® independently developed by Cansino Biologics (Generic name:) Ivoximab injection has been officially approved for marketing. This is the world's first bispecific antibody new drug approved for marketing based on the "tumor immunity + anti-angiogenesis" mechanism. It is also the second bispecific antibody new drug approved for marketing in China after Kaitanib, a bispecific antibody new drug for tumor immunotherapy developed by Cansino Biologics, filling the clinical gap of bispecific antibody drugs for immunotherapy in the global lung cancer field.

In the field of high-end medical devices, the human DNA methylation detection kit (reversible end termination sequencing method) of Rnas Medical has been included in the National Innovation Channel product directory. The research team from Guangzhou Health Institute has successfully cultivated human mid-stage kidneys in pigs, marking the first time worldwide that a successful case of humanized functional organ xenogeneic cultivation has been reported.

According to the District Market Supervision Bureau, the first batch of "white list" for imported items used in biopharmaceutical research and development in Guangzhou Development Zone was recently released, marking the implementation of the first batch of "white list" in the province, benefiting 9 imported items from 3 enterprises. As the first pilot area for the "white list" system for the import of items used in biomedicine research and development in the province, Huangpu District is committed to creating a high-quality business environment that matches the scale of the industry, exploring and implementing multiple policies for the biomedicine industry, and building a highland for biomedicine innovation.

"Observation from a Single Line

The competition in the track is becoming increasingly fierce, and innovation is becoming more and more important

In recent years, as certain sectors of the domestic biopharmaceutical industry have become increasingly competitive, innovation has become increasingly important. During the visits to biopharmaceutical enterprises in Huangpu District, the responsible persons of the enterprises all mentioned "innovation" in unison.

It is understood that in recent years, biopharmaceutical enterprises in Huangpu District have continuously increased their research and development efforts, with their innovation levels constantly improving and remarkable scientific and technological achievements.

For a biotech company like Moen Biotech, innovation is reflected in the harmonious dance of technology and nature. As an innovative biotechnology company dedicated to commercializing microbial resources, Moen Biotech has established a globally highly competitive microbial strain library of over 260,000 strains. Through international advanced microbial isolation and culture technologies, it has successfully developed a series of efficient and innovative agricultural microbial preparations. These products not only help improve the growth environment of crops, increase crop yield and quality, but also reduce the use of chemical fertilizers and pesticides, promoting sustainable agricultural development.

For a pharmaceutical research and development outsourcing service company like Yunzhou Biotech, innovation is reflected in the deep integration of life sciences and digital technology. As a leading player in the field of gene delivery and gene drug research and development, its unique "one-stop" intelligent vector design platform adopts the Lego model, modularization an infinite variety of vectors to create a "parts library" of sequence fragments. Researchers can independently design and order personalized vectors online, accelerating the global life science and gene drug research and development process.

For an intelligent technology company like Jingzhi Future, innovation lies in applying modern technology to benefit humanity. The "MEMS + AI" breath VOC detection platform it has developed integrates the MEMS Micro gas chromatograph (Micro GC) with the Jingzhi Future Cloud ·XCloud digital and intelligent data analysis platform, providing non-invasive, fast, accurate and inclusive solutions for early cancer screening, rapid disease diagnosis and home monitoring of chronic diseases. This not only enriches the application scenarios of the new quality productivity of gas analysis technology, but also contributes scientific and technological strength to improving people's health levels and promoting the development of the medical and health industry.

It is understood that some of the experimental equipment of Saiye Biotech is purchased from the company downstairs. It is very convenient to purchase related equipment because our park has a complete biomedicine industrial chain, and both sides have demands. For instance, our mice are also supplied to the pharmaceutical enterprises in the park. This undoubtedly accelerates the research and development and implementation process of new drugs and new medical devices in Huangpu District. A relevant person in charge of Saiye Biology introduced.

Talent aggregation, industrial agglomeration, favorable policies... A variety of innovation-driven factors interact and promote each other, providing a strong guarantee for the sustained and healthy development of the biopharmaceutical industry in Huangpu.

Huangpu District is like a huge innovation engine, helping enterprises lead the life science field into a new stage of development through technological innovation. Huangpu District has been focusing on the cutting-edge of the biopharmaceutical industry. In recent years, it has successively introduced a series of policies such as the "10 Policies for Biopharmaceuticals", "8 Policies for High-End Biopharmaceuticals", "10 Policies for Traditional Chinese Medicine", and "30 Policies for High-Quality Development" to promote the high-quality development of the biopharmaceutical industry.

Huangpu District is actively building innovation platforms, striving to enhance the level of the science and technology innovation hub in the Greater Bay Area, continuously consolidating fundamental and strategic support, and creating impetus for the transformation of scientific and technological achievements

The Guangzhou Disruptive Technology Innovation Center was inaugurated and began operation, aiming to create a national model for disruptive technology innovation.

The only national-level innovation platform in the nanotechnology industry, the "National Nanotechnology Intelligent Manufacturing Industry Innovation Center", has been approved for construction to solve technical problems in fields such as nanomedicine.

The first international innovative drug transformation and innovation platform in China has also been established in Huangpu, promoting international medical and pharmaceutical innovation cooperation.

The "Guangdong-Hong Kong-Macao Greater Bay Area Biosafety Innovation Port", the country's first customized biosafety industrial park mainly focusing on pilot-scale production, has been put into use, serving the manufacturing of high-end pharmaceutical and medical devices.

The Guangzhou Yixing Medical Device Concept Validation Center was inaugurated on Guangzhou International Bio-Island, enhancing the effectiveness of the transformation of medical science and technology achievements.

The quality and quantity of science and technology innovation incubation carriers have been improved and expanded. In the list of national-level science and technology business incubators announced in March 2023, 16 units from across the province were selected, including 9 from Guangzhou City and 6 from Huangpu District, ranking first among all districts in terms of quantity.

【 Data on Huangpu Biomedicine 】

Up to now, Huangpu District has gathered 4,810 biopharmaceutical enterprises, among which 140 are large-scale industrial enterprises. The total industrial output value has reached 36.8 billion yuan, and the revenue scale has exceeded 230 billion yuan, ranking first among all districts in Guangzhou.

The total number of listed companies in the district has reached 85, ranking first among all districts in Guangzhou and first among national-level economic and technological development zones. Among them, there are 19 listed companies in the biomedicine field, accounting for 76% of the listed companies in the biomedicine category in the city.

In September 2023, the Guangzhou Industrial Fund of Funds Conference was held, and the first batch of projects of the 150 billion yuan Guangzhou Industrial Investment Fund of Funds and the 50 billion yuan Guangzhou Innovation Investment Fund of Funds were signed and implemented. The total scale of contracts signed at the conference exceeded 40 billion yuan, and more than half of the projects were implemented in Huangpu.

In 2023, Huangpu District was granted a total of 100 clinical drug approval documents (including 81 Class 1 innovative drugs), accounting for approximately 93% of the total in Guangzhou City. A total of 59 Class III medical device registration certificates were approved, accounting for approximately 83% of those in Guangzhou. A total of 356 Class II medical device registration certificates were approved, accounting for approximately 65% of the total in Guangzhou. The above figures rank first among all districts in Guangzhou, highlighting the city's strong scientific research capabilities.

In recent years, a series of policies have been successively introduced, including the "10 Measures for Biomedicine", the "8 Measures for High-End Biopharmaceuticals", and the "10 Measures for Traditional Chinese Medicine". In May 2023, on the basis of the original policies, the "30 Measures for High-Quality Development" were released with great significance, providing strong support for strategic emerging industries represented by biomedicine, with the maximum support for key enterprises reaching 100 million yuan. In the same month, the detailed implementation rules of the "10 Measures for Traditional Chinese Medicine" were issued to promote the rapid development of the traditional Chinese medicine industry.

[Interview with a Big Shot

AI is reshaping the future of life sciences

- A Conversation with Han Lanqing, the Chairman of Cyagen Biotech

Huangpu Media: How does Saiye Biotech maintain its competitiveness in the current highly competitive market environment?

Han Lanqing: The research and development of new drugs and the conquest of diseases cannot do without the help of animals, among which the contribution of laboratory mice is particularly prominent. The genetic modification of mice is a niche industry. The industry's own capacity is only a few hundred million US dollars, but its radiation range is very wide, directly affecting the output value of downstream drug research and development and scientific research projects worth hundreds of billions of US dollars.

Nowadays, competition in all industries is extremely fierce, and everyone is competing in a homogeneous manner on the same platform. In such a highly competitive environment, it requires us to think about what others dare not think about and do what others dare not do. In the final analysis, it all comes down to innovation.

As a company specializing in the research and development of genetically engineered mice and preclinical CRO services, we provide more efficient and high-quality services through innovation. Based on ES target shooting technology.