Haiyan Drives Isotope Industry Clustering
Recently, with the approval of the Zhejiang Provincial Medical Products Administration, Novartis Pharmaceutical Technology (Zhejiang) Co., Ltd. and Zhejiang Yeeqi Health Technology Co., Ltd., both located in the Haiyan Nuclear Technology Application (Isotope) Industrial Park, were granted the “Radioactive Pharmaceutical Business License”. These are the first such licenses issued in Zhejiang Province.
The radioactive pharmaceutical business license is a critical qualification in the pharmaceutical industry, essential for enterprises engaged in the sale of radioactive drugs. This milestone brings both companies closer to production.
"Leveraging Haiyan’s geographical advantages, we believe this project will significantly advance our radiopharmaceutical development across China," said Guo Huaxing, China Project Director of Novartis Global Technical Operations. In December 2023, Novartis announced a 600 million yuan investment to establish a radiopharmaceutical production base in Haiyan, Jiaxing, with construction commencing in July 2023.
"Introducing One, Attracting Many": the clustering effect has taken shape. Driven by Haiyan’s "professionalism + dedication" approach, the industrial park hosting the Novartis project has now attracted 23 medical isotope projects with total investments exceeding 8 billion yuan, alongside multiple high-end foreign-funded nuclear medicine projects under negotiation. The "grapevine effect" is becoming increasingly evident.
Signing is Just the Beginning
184+ Praises for “Dedication” from Novartis
"Two approvals at once!" Shan Yanfei, Director of the Radioactive Pharmaceutical Supervision Branch of Haiyan County Market Regulation Bureau, excitedly shared the news of the dual licenses with Zhang Yuefeng, Director of Qinshan Subdistrict Government Service Center.
The team had spent two months preparing for this application, including five preliminary review meetings.
"It’s exciting but expected—they always exceed expectations," a Novartis representative remarked with a smile. For Novartis, such enhanced services of “professionalism + dedication” have become integral to countless processes.
Initially, Haiyan could not fully handle all 184 questions raised by the company across 17 meetings.
To resolve this, Haiyan formed a dedicated isotope special team, established an expert advisory pool, and coordinated multi-level government support. The mantra was "ask when unsure, learn while doing," culminating in a flawless resolution within deadlines.
On December 1, 2023, Novartis signed with Haiyan county government, marking a landmark achievement in Zhejiang’s foreign investment attraction through value-added services.
Post-signing, Haiyan faced new challenges in serving the emerging nuclear medicine sector. For the subsequent business operation services, Haiyan County is also "crossing the river by feeling the stones".
To ensure progress, the county designed "tailored services": monthly dynamic issue lists overseen by county leadership, resolved through a "red-yellow-green" supervision system.
"Choosing Haiyan wasn’t just for Qinshan’s nuclear power-supplied isotopes, but for its pragmatic governance and resource-mobilizing business environment," said Zhang Ying, former President and Managing Director of Novartis China.
Notably, the project broke ground within two months of land acquisition—far faster than similar projects.
As mentioned earlier, the radioactive pharmaceutical business license is a critical qualification in the pharmaceutical industry, but there is no prior case for radioactive drug licenses in Zhejiang. Haiyan established a specialized regulatory branch under its Market Regulation Bureau to provide pre-approval guidance.
From Experience to Expertise
The lifecycle service chain gives rise to the industrial chain.
“Haiyan Base is Novartis’ sole ongoing production site in China, positioned as an Asia-Pacific Radiopharmaceutical Innovation Hub," Guo Huaxing said.
Radioligand therapy is an innovative drug that combines radionuclides and targeted drugs, and is known as a "tumor-targeting missile". This therapy is currently one of the most advanced cancer treatment methods in the world, and Novartis of Switzerland is one of the leading enterprises in the field of radioligand therapy.
After Novartis signed a contract with Haiyan, its presence has attracted upstream and downstream partners to Haiyan.
To accelerate industrial clustering, Haiyan has charted a "isotope production—drug development—medical application" roadmap. It plans a 1,900-acre national isotope industry demonstration base, supported by policy innovation and streamlined certification and licensing.
As the saying goes, there is no wasted journey in the world; every step counts.
Through the Novartis project, Haiyan refined its "pre-event, mid-event, post-event" service framework. It launched online-offline platforms like the “Haiyan Enterprise Harmony & Facilitation Platform (Heyan Yueqi)” and offline centers to create "one-stop" solutions for isotope businesses.
The county integrates government, market, and social resources to offer lifecycle services: startup guidance, fund matching, certification support, and industry linkages.
Meanwhile, with support from national and provincial authorities, Haiyan has pioneered innovative approaches to overcome sector-specific challenges, including environmental impact assessments, licensing procedures, and logistics coordination for isotope enterprises. This trailblazing approach to professionalized, full-cycle services has enabled Haiyan to cultivate an ecosystem conducive to industrial cluster development.
“After our company moved from Beijing to Haiyan, many qualifications needed to be re-certified, such as high-tech enterprise and tax transfer. Based on past experience, these tasks were expected to be very troublesome. However, to our surprise, there was a dedicated team in Haiyan helping enterprises with these matters, which saved us a lot of trouble,” said Wang Tong, the Chief Operating Officer of Jiaxing Faber New Sky Pharmaceutical Technology Co., Ltd. This science and technology innovation enterprise mainly engaged in nuclear drug research and development and production, and last year it acquired nearly 10,000 square meters of factory buildings in Haiyan.
Services have no end.
The "grape cluster effect" of gathering chains into groups has emerged.
"The standard factory buildings are about to complete the final inspection and acceptance. Four enterprises will move in this month," said Chen Feng, deputy director of the Standing Committee of the People's Congress of Haiyan County and the head of the county's nuclear power-related and nuclear technology application (isotope) industry special team. According to the schedule, all the projects have been completed by now.
At present, Zhejiang Alpha Nuclide Medical Technology Co., Ltd has successfully passed the joint review and become the first enterprise to settle in the standard factory building.
At the temporary warehouse of Alpha, more than 30 wooden crates were neatly arranged, each containing the company's core production equipment. These will be assembled into a proton cyclotron accelerator with an energy of 30 MeV and a beam current of 750 uA, capable of producing curie-scale medical isotopes such as germanium-68, molybdenum-99, iodine-123, iodine-124, lead-203, copper-64, zirconium-89, scandium-44, and actinium-225.
When talking about these devices, Cui Tongjiang, the general manager of Alpha Nuclide (Zhejiang) Medical Technology Co., Ltd, was filled with emotions. According to the agreement, the standard factory building would not be delivered until the end of 2024, but their equipment arrived in August 2024. Moreover, the storage environment for the equipment is extremely strict, requiring constant temperature and humidity. What should they do?
"Haian has opened a green channel for us, completing the construction of the production workshop four months ahead of schedule and also helping us solve the problem of transporting the equipment by contacting the customs," said Cui, adding, "They kept in touch with us throughout the construction process of the factory building and responded to all our requests."
Unlike ordinary industrial enterprises, the walls of nuclear-related enterprises' factory buildings must be over 1.5 meters thick, which is ten times the thickness of ordinary walls; the floor load-bearing capacity must be 8 tons per square meter or more, while ordinary factory buildings only need about 0.5 tons per square meter...
“The factory building can be moved into immediately upon delivery. The efficient service of Haiyan has helped us save at least half of the time for preparation," said Cui, who is full of expectations for the future. The company mainly researches and produces radioactive isotope astatine-211 and related nuclear drugs. It is expected to start production in the middle of this year, and the annual output value will exceed 500 million yuan after reaching full production capacity.
Not far from the standard factory buildings, the self-built factory of China National Nuclear Corporation Qinshan Isotope Co., Ltd. was put into operation ahead of schedule at the end of last November and completed the production of the first batch of radioactive products. As the first enterprise to settle in the isotope industrial park, the company has a total investment of 460 million yuan, covering an area of about 45 mu (approx. 3 hectares), and has built five isotope production lines including carbon-14 and strontium-89. After full operation, it will be the largest domestic independent isotope production line.
Recently, the Future Industry Pilot Zone for Nuclear Technology Applications (Isotopes) in Haiyan has successfully entered the "provincial team", becoming the first isotopes industry platform in Zhejiang Province. Taking this opportunity, Haiyan will also promote the development of the isotopes industry towards clustering. The goal is to cultivate an industrial cluster with a total scale of over 30 billion yuan by 2030, filling the gap in the domestic nuclear medicine field.