Changling High-Tech: Integrated Multi-Park Development Drives Full-Chain Biopharmaceutical Growth, Emerging as a New Industry Hub

From traditional medicine to the entire medical innovation industry chain, Qilu is unveiling a new era of medical innovation.

Shandong Province, located on the eastern coast of China in the lower reaches of the Yellow River, was historically known as the land of Qi and Lu. As the only province in China with both a total population and a permanent resident population exceeding 100 million, Shandong boasts a highly developed economy, with its GDP ranking among the top three nationwide and surpassing RMB 8 trillion.

In the healthcare sector, Shandong is also a major province with a strong traditional pharmaceutical and chemical industry base, boasting significant advantages in both chemical drugs and traditional Chinese medicine. According to data reported by New Yellow River, in 2022, pharmaceutical industrial enterprises above designated size in Shandong generated operating revenue of RMB 349.5 billion and total profits of RMB 50.4 billion, accounting for approximately one-tenth of the national industry scale. Moreover, in recent years, Shandong has continuously promoted pharmaceutical innovation, achieving notable breakthroughs in the field of biopharmaceutical innovation and fostering clustered development.

Among these areas, the Changling High-Tech Zone in Lixia District, Jinan City, has entered a phase of rapid development and is becoming one of the “primary battlegrounds and main strongholds” for Lixia District’s current and future growth. It is reported that the Changling High-Tech Biopharmaceutical Park, meticulously developed by Lishan Health Group—a wholly owned subsidiary of Lixia Holding Group—covers an area of 1,500 mu. Equipped with zones for R&D incubation and acceleration, clinical trials, and large-scale production, the park is rapidly emerging as a new highland for the biopharmaceutical industry.

Amid the sweeping tide of medical innovation, Shandong—a traditional powerhouse in chemical pharmaceuticals with decades of accumulated advantages—is now strategically positioning itself toward innovative biopharmaceuticals.

In recent years, Shandong Province has focused on cultivating innovation capabilities in the biopharmaceutical industry, gathering a cluster of high-end platforms and boasting extensive market potential in applications such as immune cell storage, cell and gene therapy, anti-aging treatments, and premium health management. As the provincial capital, Jinan possesses a robust foundation and strong innovation capacity in the biopharmaceutical sector. Its industrial chain covers all segments, including R&D, manufacturing, services, and commercial distribution. With nearly 30,000 biopharmaceutical enterprises clustered within its jurisdiction, Jinan ranks first in the province.

Moreover, the Shandong Pilot Free Trade Zone (FTZ), approved in 2019, encompasses three areas: Jinan, Qingdao, and Yantai. These three areas have carried out in-depth, differentiated explorations, with the Jinan area focusing on the development of medical and health care services. As a strategic highland for deepening reform and opening-up in the new era, the FTZ holds potential institutional advantages in pioneering clinical research on stem cell technologies, accelerating the approval and market launch of innovative drugs and clinically urgent medicines, and advancing medical aesthetics.

Against this backdrop, Lixia District in Jinan City is leveraging its strengths in the biopharmaceutical industry to accelerate the construction of a new urban development pattern characterized by “one axis, three zones, and multiple parks,” aiming to establish the Changling High-Tech Zone as a cluster for emerging industries and a growth pole for high-quality development. Compared with other domestic biopharmaceutical clusters, the Changling High-Tech Zone stands out by integrating multiple innovation elements essential for biopharmaceutical development. The convergence of advantages in policy support, location, hospitals, and industrial service platforms will undoubtedly drive the rapid and high-quality advancement of the biopharmaceutical industry in the Changling High-Tech Zone.

First, in terms of geographical location, the Changling High-Tech Zone is situated in Lixia District, Jinan City. As the only industrial park located within the urban area of Jinan, it boasts a prime location and highly convenient transportation infrastructure.

Next is the endorsement by a state-owned enterprise. Jinan Lixia Holding Group Co., Ltd. is a state-owned platform company approved and established by the People's Government of Lixia District. Its wholly-owned subsidiary, Lishan Health (Shandong) Group Co., Ltd. (hereinafter referred to as “Lishan Health Group”), is primarily responsible for resource integration, comprehensive industrial development, and the construction and operation of the ecological chain in the medical and elderly care health industry. The industrial and technical resources accumulated by Lishan Health Group will provide more professional industrial services and technical support for the park, thereby becoming a core competitive advantage of Changling High-Tech.

More importantly, Changling High-Tech boasts abundant medical resources. Jinan is currently home to three Grade 3A hospitals filed for cell therapy (Qilu Hospital, Shandong Provincial Hospital, and the Second Hospital of Shandong University), facilitating local clinical trials of cell-based drugs for enterprises settled in the park. Lixia District in Jinan hosts 103 provincial-level engineering technology research centers, 21 higher education institutions including Shandong University, and 11 large Grade 3A hospitals such as Qilu Hospital, Shandong Provincial Hospital, Shandong Qianfoshan Hospital, and Shandong Provincial Maternal and Child Health Care Hospital, offering unique advantages in medical and talent resources.

Abundant hospital resources have also brought more cooperation opportunities to Changling High-Tech. For instance, in terms of platform development, Lishan International Cell Medicine Industrial Park has collaborated with the Jinan Area of the China (Shandong) Pilot Free Trade Zone and Qilu Hospital of Shandong University to establish the Cell and Gene Therapy Industry Promotion Platform of the China (Shandong) Pilot Free Trade Zone. Additionally, Lishan Health Group has entered into a strategic partnership with Jinan Central Hospital, leveraging its health care and cell biology business segments to jointly cultivate a premier “industry-academia-research” brand hub integrating medical services, biotechnology, and wellness care.

In addition to these advantages, Changling High-Tech is surrounded by well-developed supporting facilities, with complete infrastructure, restaurants, hotels, and meeting venues.

For resident enterprises, in addition to policies, talent, and resource needs, innovative industrial ecosystem services are also an indispensable component supporting the park’s innovative development.

Based on this, the CGT CDMO pilot-scale base built and operated by Lishan Biologics can effectively help resident enterprises reduce their independent R&D and manufacturing costs, accelerate product commercialization, promote integrated innovation among upstream and downstream players in the industrial chain as well as large, medium, and small enterprises, integrate the innovation chain with the industrial chain, and optimize the regional layout of industrial development.

According to reports, the base is located in Building A of the Lishan International Cell Industry Park. The laboratory and production center have a total construction area of 6,500 square meters, equipped with internationally leading R&D and production equipment. The total investment in construction exceeds 150 million yuan, including a plasmid production center, a virus production center, and a cell production center, along with a process development laboratory and a quality control center.

In terms of plasmid manufacturing processes, the facility is equipped with advanced microbial fermentation and plasmid purification technologies. It has completed the optimization of the four-plasmid system for lentiviral (LV) vectors and the three-plasmid system for adeno-associated viral (AAV) vectors, enabling stable production of clinical-grade plasmids. The base has established high-density fermentation processes and the industry-standard three-step chromatographic purification process, while independently developing a two-step purification process that further reduces production costs. Plasmid yield per fermentation batch can exceed gram levels, marking the first large-scale production breakthrough of this technology in Shandong Province.

In terms of viral production processes, the facility has established robust manufacturing processes for adherent cell cultures using culture flasks, microcarriers, and sheet-like carriers. By leveraging optimized ultracentrifugation and chromatographic purification techniques, the yield of the two-step chromatographic purification process has been improved.

In terms of cell manufacturing processes, the facility has leveraged its software and hardware advantages to develop two CAR-T manufacturing processes, with CAR expression positivity rates and CAR-T cell culture viability ranking among the leading levels in China.

In terms of quality system construction, the base has completed the drafting of over 400 GMP quality management system documents for pharmaceutical production, implemented their operation, passed the ISO 9001 quality management system certification, and established a comprehensive quality assurance system. Meanwhile, it has independently developed more than 100 testing methods, including assays for plasmid supercoiling ratio, restriction enzyme mapping, and viral titer determination, providing robust support for process scale-up, finished product testing, and product validation.

The pilot-scale base of the CGT CDMO offers flexible and diverse one-stop CDMO services, ranging from R&D and manufacturing to regulatory submission. It has established multiple product platforms, including GMP-grade plasmid vectors, GMP-grade viral vectors, and clinical-grade cell products, and has engaged in multi-faceted, in-depth business collaborations with numerous enterprises. Multiple products, such as CAR-T therapies, have been utilized in clinical studies, earning high industry recognition and building strong brand visibility, thereby laying a solid foundation for the subsequent aggregation of the industrial ecosystem in the Changling High-Tech Zone.

Bolstered by multiple core advantages and supported by a robust industrial foundation, Changling High-Tech has achieved visibly rapid development. Currently, the Lishan International Cell Medicine Industrial Park and the Lishan International Biopharmaceutical Production Base have both commenced operations with tenants moving in, while the Changling High-Tech Innovation Industrial Park is under rapid construction.

As planned, the Changling High-Tech Biopharmaceutical Industry Cluster will focus on developing an incubation and acceleration zone, a clinical trial zone, and a large-scale production zone. It aims to integrate the entire industry chain—from R&D and pilot-scale trials to mass production—thereby constructing a robust, multi-dimensional biopharmaceutical ecosystem characterized by vertical and horizontal integration. Furthermore, the cluster will actively expand upstream and downstream resources within the biopharmaceutical sector. By leveraging the synergistic effects of favorable regional policies, talent influx, increased capital investment, and corporate R&D efforts, it seeks to establish a long-term mechanism for sustained industrial growth.

As the first specialized biomedical park in the Changling High-Tech Zone, the Lishan International Cell Medicine Industrial Park is a professional cell industry park jointly planned by the Lixia District Government and the Administrative Committee of the Jinan Area of the China (Shandong) Pilot Free Trade Zone. Covering an area of approximately 56 mu with a total investment of about RMB 1.538 billion, it has now been fully operational.

The Cell Industry Park focuses on cutting-edge fields such as immune cell therapy, stem cell therapy, gene therapy, and regenerative medicine. It prioritizes the development of therapeutic technologies and drugs targeting tumors, autoimmune diseases, metabolic disorders, and neurodegenerative conditions, serving innovative enterprises and scientific research teams.

The park has established three major functional sectors: first, a production and development platform, an R&D innovation platform, and a pilot-scale base; second, two public service platforms, namely, the gene and sequencing service platform, and the CDMO pilot-scale base for immune cell and gene therapy.

Among these, the CDMO pilot-scale base is the only high-standard research and development platform for cell and gene therapy in Shandong Province approved by the Department of Science and Technology. The base maintains close collaborative ties with universities and research institutes, serves as an off-campus practical training base for Shandong First Medical University, and has successfully joined organizations such as the Chinese Society for Microbiology and the China Association of Pharmaceutical Biotechnology. In addition, it jointly established the Shandong Provincial Engineering Research Center for Protein and Peptide Drugs with Weifang Medical University, emerging as a new engine driving the development of Jinan’s biopharmaceutical industry. It provides R&D and manufacturing platforms for biopharmaceutical enterprises, laying the foundation for building a complete biopharmaceutical industry chain.

Currently, the industrial park has gathered leading enterprises in cell and gene therapy, such as Saier Biology, Vcanbio, Suhhe Biology, and Tianhu Biology, as well as renowned industry players including CTI Testing, Anbida, Tianhe Technology, Maihe Additive Manufacturing, and Junteng Technology. The companies established within the park primarily focus on biological products, pharmaceutical technology R&D, medical devices, and diagnostic testing services. Among them, there are currently five listed companies, nine high-tech enterprises, five Gazelle enterprises, and seven specialized and sophisticated “Little Giant” enterprises.

While attracting industrial enterprises to settle in, the park will also focus on entrepreneurial projects led by PhDs and postdoctoral researchers, building a complete incubation chain for the biopharmaceutical industry comprising “mass innovation spaces–incubators–accelerators.” By collaborating with universities, research institutes, hospitals, leading enterprises, and social capital to establish a platform resource pool, the park will provide comprehensive physical spaces, hardware facilities, and soft services for talent-led startups. This initiative aims to stimulate corporate innovation vitality, drive the rapid growth of small and medium-sized enterprises (SMEs), and foster a vibrant entrepreneurial ecosystem within the park.

The development of the Lishan International Cell Medicine Industrial Park fundamentally resolves the “last mile” challenge in transitioning from R&D to industrialization, aiming to establish the biopharmaceutical sector as a new hallmark of Lixia District’s industry and contribute to the growth of Jinan’s biopharmaceutical industry.

Lishan International Biopharmaceutical Production Base is another specialized biomedical industrial park jointly planned by the Lixia District Government and the Administrative Committee of the Jinan Area of the Pilot Free Trade Zone, following the Lishan International Cell Medicine Industrial Park.

Unlike the Cell Industry Park, this park is positioned to “strengthen and extend the industrial chain.” Adopting a “one building, one enterprise” model, it targets mature biopharmaceutical companies with proven capabilities in translating research outcomes, meeting their needs for integrated office, R&D, and production facilities within standalone buildings.

Upon completion, the industrial park will prioritize the introduction of biopharmaceutical R&D enterprises specializing in antibodies, vaccines, and genetic engineering drugs, while actively fostering the broader health industry, including biological products, traditional Chinese medicine (TCM), and medical devices. Currently, leading domestic medical diagnostic service provider Dian Diagnostics (Shandong) Base and Yaowang Pharmaceutical have already established operations within the park.

In the future, the Lishan International Biopharmaceutical Production Base will continue to facilitate the establishment and growth of leading enterprises in the biopharmaceutical industry, aggregating more high-quality resources for strategic emerging industries. By adopting a dual-drive model integrating R&D offices with manufacturing capabilities, the base will attract biopharmaceutical companies offering services ranging from accelerated incubation to industrial investment and financing. This approach has established a comprehensive industrial platform development framework, evolving from isolated points to a broader landscape, thereby efficiently supporting the innovative and outstanding advancement of the biopharmaceutical industrial platform.

In addition to the two parks mentioned above, the Changling High-Tech Innovation Industrial Park is located adjacent to the Cell Industry Park, approximately a five-minute drive south of the production base. Serving as an R&D and pilot testing center with a core focus on cell and gene therapy, the park primarily attracts enterprises in the fields of cell and gene therapy, antibodies, and vaccines, thereby fostering industrial clustering.

In the future, Changling High-Tech Innovation Industrial Park will continue to leverage its closed-loop ecosystem to facilitate the establishment and growth of leading biopharmaceutical enterprises, gather more high-quality resources for strategic emerging industries, and serve as the backbone for the high-quality development of Changling High-Tech’s biopharmaceutical sector.

In summary, the Changling High-Tech Innovation Industrial Park, the Cell Medicine Industrial Park, and the Biopharmaceutical Production Base are characterized by industrial synergy and functional complementarity. The coordinated development of these three parks will accelerate the integration of the entire biopharmaceutical industry chain—spanning “R&D and testing, pilot-scale production and regulatory filing, clinical application, and large-scale manufacturing”—thereby achieving industrial agglomeration and economies of scale in the biopharmaceutical sector, and supporting the high-quality development of the Changling High-Tech Zone.

As can be seen, Changling High-Tech has made comprehensive preparations across R&D, industrial, and service sectors, poised to support the advancement of a growing number of pharmaceutical innovation enterprises. Beyond Shandong, extensive layouts around the biopharmaceutical industry are underway across China, further unlocking growth potential and revealing new, broad opportunities.

Changling Hi-Tech Biopharmaceutical Industry Cluster, as a landmark integrated multi-park agglomeration zone, will continue to focus on industrial innovation, promote synergy within the industrial ecosystem, and support the sustained high-quality development of the biopharmaceutical industry.