Huayi Isotopes Co.

What Huayi Isotopes Co. does

Huayi Isotopes Co. (HIC) is a privately held Chinese cGMP manufacturer of radiochemicals and radiopharmaceutical precursors, headquartered at 18 Fuyu Road, Haiyu town, Jiangsu, China, and operating as a division of Jiangsu Huayi Radiopharmaceuticals Co., Ltd. Founded in 2002, the company operates three wholly-owned manufacturing entities in China (Jiangsu, Liaoning, Guangdong), with the Liaoning facility GMP-certified in 2024. HIC built the first industrialized H218O water production line in China, with annual output of 65 kg at 98% abundance, which remains a cornerstone product.

The company's core offering spans seven categories: (1) Stable Isotopes, principally cGMP Oxygen-18 water supplied under one-time and long-term delivery contracts; (2) Biochemicals, comprising precursors and reference standards for 18F tracers (Mannose Triflate for [18F]FDG, TET for FET, MMSE for FES, BDNT for FLT) and 68Ga/177Lu/90Y theranostics (PSMA-11, PSMA I&T, R-PSMA I&T, DOTA-TOC-95, DOTA-95, NOTA-95); (3) Total Solutions for PET Consumables — reagent kits, cartridges, cassettes, filters, syringes; (4) Sterile Vials with USP Type I glass in 2ml–250ml volumes; (5) Radiation Shielding equipment in tungsten and lead; (6) CMO Services for cGMP contract manufacturing of APIs, reagents, cassettes, and sterile fillings; and (7) Custom Synthesis services for academic and government institutions under strict confidentiality. Underlying technology is a molecular-imaging platform adaptable across fluorine-18, carbon-11, technetium-99m, gallium-68, and lutetium-177 radionuclides for PET and SPECT imaging.

HIC's commercial model is B2B direct sales, with customers submitting inquiries through the company website or by direct email/phone contact; pricing is not publicly disclosed. Customer segments are hospitals, academic and government research institutions, and radiopharmaceutical manufacturers using mainstream synthesis modules. Differentiators include a cGMP quality system audited and approved by IBA, Siemens, and GMS; FDA Drug Master Files for HDP, PSMA-I&T (accepted), and PSMA-11 (DMF No. 038399 found Adequate to support an ANDA submission); CE certification for sterile vials; and European Pharmacopoeia compliance for R-PSMA I&T. Distribution is global via direct sales, supplemented by participation in industry events such as the EANM Annual Congress 2025 in Barcelona. Marketing channels are predominantly inquiry-based and event-driven, with no third-party resellers or public pricing.

Name

Huayi Isotopes Co.

Legal name

Huayi Isotopes Co.

Website

https://hic.cc

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

1–10 employees

Short description

Huayi Isotopes Co. is a Chinese cGMP manufacturer of radiopharmaceutical precursors and radiochemicals, producing Oxygen-18 water, PET/SPECT precursors (including PSMA-11 and PSMA-I&T), sterile vials, and radiation shielding for hospitals, radiopharma manufacturers, and academic research institutions worldwide.

Ownership category

akta.pro rank

Product category

Radiopharmaceuticals

NAICS

Chemical Manufacturing (325), Irradiation Apparatus Manufacturing (334517), Analytical Laboratory Instrument Manufacturing (334516)

SIC

Chemicals & Allied Products (2800), Industrial Inorganic Chemicals (2810), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Radioisotope Production (Reactor/Cyclotron/Gamma) (HLAIAGAD)

akta.pro secondary industries

Nuclear Medicine Imaging Tracers & PET/SPECT Supply Chain (FDG, Ga-68, logistics/cold chain) (EUAKAIAE), Medical Radioisotope Production (Reactor/Cyclotron, Mo-99/Tc-99m, I-131, Lu-177, etc.) (EUAKAIAA), Radiopharmaceutical & Nuclear Medicine Distributors (HLAIAJAI)

Keywords

• Radiopharmaceutical manufacturing
• Stable isotope production
• PET precursor chemicals
• Radiation shielding products
• CGMP contract manufacturing

Headquarters

HQ city

Suzhou

HQ country

China

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Supply Chain, Personnel, Technology or R&D, Infrastructure, Marketing or Sales

Distribution channels1 record

Marketing channels3 records

Core offering

Huayi Isotopes Co. (HIC) manufactures and supplies radiochemicals, stable isotopes, and supporting consumables for the nuclear medicine and radiopharmacy industry. Its product portfolio includes cGMP Oxygen-18 water, PET and SPECT precursors (PSMA-11, PSMA I&T, R-PSMA I&T, Mannose Triflate, TET, MMSE, BDNT, MDP, HDP, DOTA-TOC-95, DOTA-95, NOTA-95), sterile vials (USP Type I glass, 2ml–250ml), tungsten and lead radiation shielding products, and QC equipment. The company also offers cGMP contract manufacturing (CMO) services and custom synthesis for academic and government institutions.

Product overview

Huayi Isotopes Co. (HIC) offers a comprehensive portfolio of radiopharmaceutical products and services for PET and SPECT imaging. The portfolio consists of: (1) Stable Isotopes including cGMP Oxygen-18 water; (2) Biochemicals including precursors for [18F]FDG (Mannose Triflate), PSMA compounds (PSMA11, PSMA I&T, R-PSMA I&T), and various PET tracers (TET, MMSE, BDNT, FLT compounds); (3) Total Solutions for PET Consumables including reagent kits, cartridges, cassettes and syringes; (4) Sterile Vials (2ml-250ml USP Type I glass); (5) Radiation Shieldings including tungsten and lead containers, syringe shields, vial adapters, L-Blocks, and dispensing systems; (6) QC Equipment including dose calibrators and QC stations; (7) CMO Services for custom API and sterile manufacturing; and (8) Custom Synthesis services. The company supports production of 18F, 11C, 68Ga, and 177Lu tracers with mainstream synthesis modules.

Differentiator

Problem solved

Functional benefit

Products and services

• Oxygen-18 Water (Stable Isotopes)

Quantifiable outcome

• FDA DMF submission for HDP acknowledged by US FDA
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators3 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Cardinal Health Nuclear & Precision Health Solutions: Operates one of the largest US radiopharmacy distribution networks and manufactures radiopharmaceuticals. Comparable to HIC in radiopharmaceutical distribution, sterile vial handling, and supply to hospital nuclear medicine departments.
• Curium Pharma: Global nuclear medicine manufacturer and distributor producing SPECT/PET radiopharmaceuticals, precursors, and sealed sources. Comparable to HIC in radiopharmaceutical manufacturing, distribution network, and cGMP supply to hospital radiopharmacies.
• ABX advanced biochemical compounds: German-based manufacturer of precursors for PET radiopharmaceuticals (FDG, FLT, FET, PSMA, DOTA). Directly comparable to HIC in biochemical precursors, custom synthesis, and GMP-grade supplies for nuclear medicine customers.
• Lantheus Holdings: Specialty radiopharmaceutical company focused on diagnostic imaging agents (e.g., PYLARIFY PSMA-PET) and radiotherapeutic platforms. Comparable to HIC in PSMA-based imaging focus and radiopharmaceutical product development for oncology.
• PETNET Solutions (Siemens Healthineers): Largest PET radiopharmacy network in North America/Europe, producing and distributing FDG and other PET tracers. Directly comparable as both a customer-qualifier of HIC's cGMP quality system and a potential direct competitor in precursor supply.

Broad incumbents

• GE HealthCare: Major medical imaging and radiopharmaceutical player with broad portfolio including PET tracers, cyclotrons, and radiopharmacy services. Overlaps with HIC in PET tracer manufacturing and supply, though as part of a much broader diagnostic imaging portfolio.
• IBA (Ion Beam Applications): World leader in cyclotron and PET radiopharma equipment, also radiopharmaceutical production. Comparable to HIC as both a customer (auditor of cGMP quality) and broad incumbent in nuclear medicine infrastructure and tracer production.

Regional players

• China Isotope & Radiation Corporation (CIRC): Chinese state-owned nuclear technology enterprise producing medical isotopes, radiopharmaceuticals, and radioactive sources. Directly comparable as a domestic Chinese radiopharmaceutical supplier competing in overlapping isotope and source categories.
• Sinotau Pharmaceutical Group: Chinese radiopharmaceutical company developing and manufacturing molecular imaging agents and therapeutic radiopharmaceuticals. Comparable to HIC as a domestic Chinese peer in the PET/SPECT imaging and theranostics product space.

Emerging players

• Telix Pharmaceuticals: Emerging radiopharmaceutical company developing diagnostic and therapeutic agents, particularly in PSMA and other oncology-targeted radiopharmaceuticals. Comparable to HIC in PSMA product focus (PSMA-I&T) and theranostic pipeline development.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/HuayiIsotopes
• Facebookfacebook.com/profile.php
• LinkedInlinkedin.com/company/huayi-isotopes-co-hic

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Huayi Isotopes Co.