In 2010, high-tech industrial parks began to focus on the development of the biomedical industry. At that time, the Jinan Innovation Zone (JIZ), located in Shandong Province in eastern China, had 123 biomedical companies with sales revenue of RMB 7.3 billion. Over the past 10 years, more than 4,000 biomedical companies gradually entered JIZ. In 2020, the value of its industry was set to exceed RMB 100 billion.
The development of the biomedical industry in JIZ is largely thanks to the Jinan Medical Valley built by the National Shandong Innovative Drug Incubation Base and the Life Science City that are located in an eastern area of the high-tech zone.
1. Jinan Medical Valley
The National Shandong Innovative Drug Incubation Base constructed Jinan Medical Valley. It was a major science and technology project of the Ministry of Science and Technology during the “Eleventh Five-Year” period. Jinan Medical Valley is run based on the incubation services at the National High-tech Entrepreneurship Service Center, the National Overseas Student Pioneer Park, and the Zhongguancun Leading Innovation Space. It is supported by the national major new drug creation platform, the national innovative drug incubation base and other major national special platforms. Its goal is to introduce and cultivate businesses working in the five major fields of biomedicine, health, biomaterials, bioenergy, and bioenvironmental protection.
2. Jinan Life Science City
In the “Thirteenth Five-Year Plan”, JIZ proposed to build a “one district, two cities and two valleys” development pattern, in order to cultivate four to five RMB 100 billion-level industrial clusters with high-end advantages and driving capabilities. One of the “two cities” is Jinan Life Science City, which was positioned to develop the biomedical industry. The Jinan Life Science City has a total planned area of 53.8 square kilometers. It is laid out along both sides of Jingshi East Road to build an industrial cluster area of 21.6 square kilometers north of Jingshi East Road and a medical service area of 32.2 square kilometers south of Jingshi East Road.
Qilu Pharmaceutical is located in Jinan City, Shandong Province. It was formerly known as Qilu Pharmaceutical Factory. The company is a large-scale pharmaceutical backbone enterprise in China with over 50 years of development. It is mainly engaged in the development, production and sales of preparations and their raw materials for the treatment of tumors, cardiovascular and cerebrovascular diseases, infections, the nervous system, the respiratory system, the digestive system, and ophthalmological diseases.
Qilu Pharmaceutical has seven production bases including drug preparations, chemical synthesis and biotechnology, and antibiotic fermentation. The production of APIs includes fermentation, chemical synthesis, biochemical synthesis, genetic engineering, freeze-drying and solvent crystallization, etc., and includes tablets, capsules, granules, creams , sprays, eye drops and other dosage forms.
Xuanzhu Biopharm is an international innovative drug research and development company established in 2002 with a registered capital of RMB 50 million. It is mainly engaged in the research and development of new molecular entity drugs and is a subsidiary of Sihuan Pharmaceutical Holdings Group. The company’s research fields mainly include anti-infection, anti-cardiovascular and metabolic diseases, anti-tumor, neurological diseases and other cutting-edge new drug development fields.
So far, several major technology platforms have been established, such as the New Drug Design and Synthesis Center, the New Drug Animal Pharmacodynamic Evaluation Center in vivo and in vitro, the in vivo and in vitro Pharmacokinetic Evaluation Center, the Early Animal Toxicity Evaluation Center, and the Compound Mass Production and Preparation Center. A complete new drug research and development system has been formed, including a complete drug development system from new drug structure design to drug screening and evaluation to establish clinical candidate compounds.
Shandong ACV Biotech
Shandong ACV Biotech is a high-tech enterprise focusing on the development, promotion and service of clinical biomedicine and laboratory molecular biology products. Since its establishment, the company has adhered to the service concept of “creating customer value” to provide users with overall laboratory technical solutions. The company’s core business is to develop and promote high-throughput molecular diagnostic products and detection systems with independent intellectual property rights that are used in the field of human life and health.
The company’s main products include multiple amplification detection reagents, immune repertoire multiple amplification reagents, ACV-Plex detection reagents, fluorescent quantitative PCR detection reagents, and others. In recent years, the company has carried out collaborative innovation in many aspects with many international and Chinese scientific research institutes by virtue of its cutting-edge innovative testing technology platform.
Yinfeng Biological Group
Yinfeng Biological Group was established in 2011. It is the main body of investment, management, and operations for Yinfeng Group in the biological field. It is mainly engaged in human cells, tissue, organ storage, gene sequencing technology, cell technology research and clinical application and other high-tech development.
In 2017, Yinfeng Biotechnology obtained more than 10 high-tech enterprise certificates, more than 70 patent certificates, and more than 100 various certification certificates. It has established cell tissue banks and genetic information databases in 13 places across China, and has become a high-tech bio-industry base integrating stem cell resource storage, cell biotechnology and product research and development, biomedical technology transformation and genetic testing.
Since the first discovery of new human HLA genes in March 2004, Yinfeng Bio has discovered 7 new human HLA genes. The first 5 newly discovered human HLA genes have all been officially named by the World Health Organization, and the other 2 are under review.
Up to RMB 100 million to promote rapid industry development
On December 11, 2019, in order to effectively promote the implementation of the “Jinan Biomedical Industry Development Plan” and the “Jinan International Medical Health City Development Plan”, Jinan accelerated the promotion of the high-quality development of biomedicine and general health industries, and introduced several policies for the promotion of the health industry.
1. Product development & innovation
For companies that have newly obtained the national first-class new drug production approval number (including traditional Chinese medicine and natural medicine, chemical drugs, and biological products), each product will be given a one-time reward of RMB 20 million. Other types of new drugs have related rewards ranging from RMB 1 million to 5 million.
A one-time reward of RMB 2 million will be given to companies that have newly obtained three types of innovative medical devices or large-scale medical equipment. For companies that have obtained the first registration certificates of three types of medical devices, a single product will be given a one-time reward of RMB 1 million.
2. Clinical trials
For the first- and second-class new drugs that are independently researched and developed by the company, and enter clinical trials after obtaining approval, each project will be given a one-time award of RMB 500,000, and each enterprise will be awarded a maximum of RMB 6 million yuan that same year. For the three types of medical devices newly registered by the enterprise (except those that are exempt from clinical trials), a one-time reward of RMB 500,000 will be given after they complete product registration inspections or obtain approval for clinical trials. For the newly registered non-in vitro diagnostic reagents of Class II medical devices (except for those exempt from clinical trials), a one-time reward of RMB 200,000 will be given after product registration inspection is complete.
3. Generic drug consistency evaluations
For the products that have passed the generic drug quality and efficacy consistency evaluation, each product will be given a one-time reward of RMB 3.5 million. The top three Chinese products will be given a one-time reward of RMB 4 million yuan. The number of rewards for the same company should not exceed three, but the top three of the same product in China that have passed the consistency evaluation are not limited by number.
4. Innovative platform construction
A one-time reward of RMB 5 million will be given to the newly approved units of innovation platforms such as the National Medical Center, the National Regional Medical Center, the National Clinical Medical Research Center, and the National Key Laboratory of Ministries and Commissions. For new projects on public R&D platforms above the provincial level in the biopharmaceutical industry, a one-time subsidy will be given to the purchasing unit of 20% of the purchase amount of new equipment (including supporting software), with a single project subsidy of up to RMB 3 million.
5. Business qualification certification
Those who obtain GLP certification for the first time reach three and five items, will be awarded RMB 1 million and RMB 2 million, respectively. Those who have obtained GCP qualification certification will be awarded RMB 500,000 for each new professional discipline. Those who have obtained CNAS certification for the first time will receive a reward of RMB 200,000.
For newly-obtained pharmaceutical and medical device companies that have obtained FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), PMDA (Japan Pharmaceuticals and Medical Devices Agency) and other international authoritative certifications, each product will be rewarded with RMB 1 million. A single company can earn up to RMB 5 million in rewards.
6. Accelerate R&D
SJIZ will support competitive companies in acquiring or merging with leading overseas companies or in establishing overseas R&D center, establishing international standards for non-clinical drug research quality management, expanding the international market for drug preclinical research and development, and accelerating the biomedicine industry R&D international development process. A one-time subsidy will be provided for the evaluation, audit, legal counsel, and other preliminary expenses incurred in overseas acquisitions and mergers of enterprises, with a maximum subsidy of RMB 3 million for a single project.
7. Personnel policy
Regarding top talent resources, JIZ gives a comprehensive subsidy of up to RMB 100 million.
After more than ten years of development, the biomedical industry in JIZ has gradually formed diversified industrial development, upgrading of dual innovation carriers, prominent industrial layout cluster effects, and high-end international cooperation resources. It has laid a solid foundation for building a world-class high-tech park.