Head and neck malignancies are clinically common cancers, with approximately 146,000 new cases and nearly 81,000 deaths annually in China, and the incidence is rising year by year. For patients with unresectable, locally recurrent, or advanced head and neck tumors, conventional surgery, radiotherapy, and chemotherapy have significant side effects and limited efficacy. Boron neutron capture therapy (BNCT), as a binary precision radiotherapy technology, has become a highly valuable new treatment pathway for these refractory tumors.
BNCT works through the synergy of "boron-targeted drugs + neutron beams." After a patient is injected with the boron carrier BPA, the drug specifically accumulates in tumor cells. Upon irradiation with low-energy neutrons, the boron-10 isotope in the drug undergoes a nuclear reaction, releasing lethal particles only within the tumor while maximally protecting surrounding normal tissues. In this entire treatment system, the boron drug API is the fundamental core that determines efficacy and safety. Even minor deviations in isotopic abundance and chemical purity can directly affect tumor-targeted accumulation and the risk of radiation damage to normal tissues.
For a long time, the global supply of commercialized BPA APIs has been highly dependent on Japanese innovator companies, resulting in long lead times, high procurement costs, and restricted overseas quotas. As domestic BNCT policies continue to be implemented, domestic neutron therapy equipment accelerates its regulatory applications, and multiple domestic boron drugs enter clinical stages, the "bottleneck" gap in upstream high-purity compliant BPA APIs continues to widen. Achieving independent and controllable raw material supply has become an inevitable path for the large-scale development of China's BNCT industry.
The year 2026 marks a critical year for China's BNCT industry to transition from laboratory technological exploration to commercialization. The stable mass production of upstream high-purity BPA APIs has become an important foundation for promoting the coordinated implementation of domestic BNCT drugs and equipment.
China's drug regulatory system has successively issued multiple dedicated policies, simultaneously opening up review and approval channels at both the equipment and drug ends, clarifying standards and implementation timelines for the development of the entire industry chain:
December 2025: The National Medical Products Administration issued the "Catalogue of Priority Review of High-End Medical Devices (2025 Edition)," officially including boron neutron capture therapy systems in the priority review list, accelerating the market launch process of domestic neutron therapy equipment.
January 2026: The National Medical Products Administration held a dedicated work advancement meeting on boron neutron capture therapy systems, explicitly proposing to "strengthen coordinated review of drugs and devices." It required that, on the premise of safeguarding safety, the rapid implementation of BNCT high-end medical equipment be promoted, achieving synchronized review and supporting alignment of equipment and drugs.
April 28, 2026: The CDE of the National Medical Products Administration issued the "Technical Guidelines for Clinical Development of Boron Neutron Capture Therapy Drugs (Draft for Comments)," the world's first official guidance document for the clinical development of BNCT drugs. The document comprehensively covers the mechanism of action of BNCT, clinical trial design, drug labeling specifications, and full-process risk management, unifying domestic standards for boron drug development, quality control, and clinical evaluation, and ending the industry's long-standing lack of unified regulatory standards.
The successive implementation of multiple policies has established a complete policy system featuring "priority review for equipment + coordinated drug-device review + unified clinical standards for drugs," providing clear policy support for the coordinated industrialization of upstream APIs, formulations, and neutron equipment in the BNCT field.
Poly Pharm's self-developed boron [10B] melphalan for injection officially obtained implied clinical trial approval from the National Medical Products Administration on January 26, 2025, with acceptance number CXHL2401266. The indications cover unresectable locally recurrent head and neck squamous cell carcinoma and unresectable locally advanced head and neck non-squamous cell carcinoma. In July 2025, the Phase I clinical trial of this formulation combined with domestic BNCT neutron equipment was officially launched. On August 5, 2025, the project completed the enrollment of the first subject, making it a BNCT clinical project in China that is fully equipped with domestic raw materials, domestic equipment, and domestic formulations.
As the wholly-owned raw material platform of Poly Pharm Group, Anhui Poly Pharm supplies the BPA API for this clinical formulation, establishing a solid safety baseline for clinical medication through stringent quality control standards:
✅ Boron-10 isotopic abundance ≥99%, ensuring tumor cell killing efficiency under neutron irradiation;
✅ Chemical purity ≥99%, reducing unknown safety risks posed by irrelevant impurities;
✅ Total impurity content strictly controlled below 0.1%, with isomers, heavy metals, and residual organic solvents all far below the limits set by the Chinese, U.S., and European pharmacopoeias.
Isotopic abundance and chemical purity constitute the industry-recognized "double 99" quality control threshold. At present, Anhui Poly Pharm's BPA API is stable, with purity reaching above 99.9%, boron-10 abundance ≥99%, and total impurities controlled below 0.1%, with relevant quality indicators meeting international production requirements. Relying on directional isotope synthesis technology and automated production lines, the company can ensure stable targeted accumulation of boron drugs in tumor tissues from the molecular source, reduce non-specific uptake in normal tissues, and provide core raw material support for clinical efficacy and patient safety.
The BNCT industry has global diagnostic and therapeutic attributes. Only when API manufacturers simultaneously meet the pharmacopoeial and regulatory standards of multiple countries both domestically and overseas can they adapt to the dual market demands of clinical and commercial applications at home and abroad. Anhui Poly Pharm has established a unified cGMP quality management system covering China's NMPA, the U.S. FDA, the EU EMA, and the WHO. The plant has repeatedly passed on-site inspections and GMP compliance audits by these four major regulatory authorities, and possesses globally compliant supply qualifications.
On May 15, 2026, Anhui Poly Pharm completed the formal submission of a Type II DMF for its boron [10B] melphalan (BPA) API to the U.S. FDA and was assigned a DMF number, becoming the first company in China to have an FDA Type II DMF on file for a BPA API. Meanwhile, the U.S. application for Poly Pharm's boron [10B] melphalan for injection and domestic BNCT equipment as a combination product is also being actively prepared and steadily advanced. This marks that the drug-device combination of BNCT drugs and equipment independently developed in China has the quality foundation and registration layout to participate in global competition.
The domestic market is simultaneously advancing NMPA API registration. The raw material qualifications are fully aligned with the Group's clinical approval for boron [10B] melphalan for injection, and can concurrently meet the application needs of various domestic BNCT formulation R&D companies and clinical medical institutions, achieving parallel dual-track registration at home and abroad.
The industry's overall growth space is clear, with both the segmented track and the full-industry-chain market size showing steady expansion and rapid growth, respectively. All data are from publicly available dedicated reports by the globally authoritative industry consulting firm QYResearch.
In 2025, global sales of injectable BNCT boron drugs reached USD 64 million, and the market size is projected to reach USD 138 million by 2032, with a compound annual growth rate (CAGR) of 11.4% from 2025 to 2032.
In 2025, the global BNCT full-industry market size was USD 372 million, and it is projected to reach USD 6.528 billion by 2032.
Currently, global commercial BPA raw material supply channels are scarce and have long relied on Japanese innovator products. As multiple domestic BNCT treatment centers are established and clinical projects at home and abroad continue to increase, medium- and long-term raw material demand in the market will continue to expand.
Anhui Poly Pharm currently has dedicated production sections suitable for BPA isotope synthesis, equipped with fully automated control systems, stably controlling the three key indicators of boron-10 abundance, chemical purity, and impurities. Relying on flexible production capacity, it can adjust batch sizes on demand across pilot, scale-up, clinical, and commercial specifications, comprehensively covering customers across the entire industry chain and continuously ensuring raw material supply for the BNCT industry.
The long-term development of the BNCT industry cannot be sustained without support from diversified boron carriers. Leveraging its mature isotope synthesis and industrial production platform, the company has completed process development for BSH and key carborane-series intermediates in addition to its flagship product BPA. It can provide various pilot- and scale-up-stage samples to the industry, meeting the frontier R&D needs for innovative boron reagents, targeted boron-conjugated drugs, and other advanced applications. At the same time, by supporting upstream novel boron drug R&D and combined clinical trials, and by continuously optimizing isotope synthesis and purification processes through flexibly modified production sections, the company can rapidly complete process scale-up and achieve stable large-scale supply once a novel boron carrier completes clinical validation. This continuously improves the full-chain boron raw material support system and enhances the global accessibility of BNCT therapeutic drugs.
BNCT is a complex systems engineering effort involving the coordinated operation of "neutron source equipment + boron-targeted drugs + precision dosimetry." Industrial maturity cannot be achieved without the collaborative efforts of multiple parties across upstream raw materials, midstream formulations, downstream equipment, and clinical institutions. Leveraging its three core competitiveness advantages, Anhui Poly Pharm continues to play a core upstream supporting role in China's BNCT industry chain: upholding the raw material quality baseline with the "double 99" quality standard of ≥99% isotopic abundance and ≥99% chemical purity; opening up domestic and overseas market channels with dual compliance qualifications of FDA DMF and NMPA registration; and matching the industry's sustained growth demand with flexible, large-scale production capacity.
Breaking the long-standing overseas monopoly on BPA APIs and achieving independent and controllable supply of high-purity boron drug raw materials can not only reduce procurement costs and shorten lead times for domestic BNCT clinical projects, but also give more patients with recurrent and advanced head and neck cancer the opportunity to receive this novel precision radiotherapy regimen. In the future, Anhui Poly Pharm will continue to deepen its R&D and industrialization of BNCT boron drug raw materials, supply high-purity, stable, and compliant boron drug APIs and intermediates to the global market, and join hands with domestic equipment companies, pharmaceutical companies, and clinical medical institutions to build a complete domestic BNCT industry chain, promoting precision oncology treatment technologies to benefit more cancer patients at home and abroad.
Anhui Poly Pharm Co., Ltd., founded in 2018, is located in the Anqing National High-Tech Industrial Development Zone. It is a professional supplier of active ingredients, providing high-quality specialty raw materials through chemical synthesis and biosynthesis to the global pharmaceutical, healthcare, and skincare sectors.
Anhui Poly Pharm has a strong and efficient R&D and production team, equipped with modern production facilities, and has established a strict high-end European and American API cGMP quality system and a high-standard EHS system. While providing customers with high-quality APIs and intermediates, it also offers CDMO services, process improvement, and other services. The company currently has 3 API production workshops compliant with Chinese, European, and American GMP standards, 10 production lines, and 357 pieces of multi-functional equipment.
Relying on strong R&D capabilities and technology translation capabilities, it has completed the commercial R&D and production of a series of products, including contrast agents (gadoterate meglumine, gadoteridol, gadobutrol, iomeprol, iopromide, ioversol, iopamidol, iodixanol, etc.), synthetic biology products (semaglutide, ectoine, salidroside), antitumor drugs (cyclophosphamide), other APIs (magnesium hydroxide, apremilast, crisaborole, voriconazole, memantine hydrochloride), and other pharmaceutical excipients (DOTA, SNAC, sodium sulfobutyl-β-cyclodextrin, calteridol calcium, cobutrol calcium). The company focuses on high-end specialty APIs and innovative raw materials, with multiple products achieving import substitution and global exports, making it one of the most competitive raw material suppliers in the BNCT boron drug field.
Inquiries and cooperation are welcome!
Business contact: lisubin@hnpoly.com
Disclaimer & Forward-Looking Statement
This article is intended solely for pharmaceutical science popularization and corporate information introduction. Its content integrates publicly disclosed materials and summaries of the company's R&D progress, and is for reference only. Statements regarding drugs and projects herein do not constitute medical diagnosis or treatment advice, investment advice, or commitments to future results. Cooperation arrangements such as commissioned production and API supply require the completion of quality system establishment and compliant registration, and are ultimately subject to regulatory authority approval. The data and views contained in this article are based on public information available as of the date of publication, and the company assumes no obligation to continuously update them.
Forward-looking statements herein concerning registration applications, market planning, business development, and other matters are made based on existing information and reasonable assumptions and are subject to uncertainty. Affected by various risk factors such as market conditions and industry policies, actual circumstances may differ materially from those anticipated. The company has no obligation to revise the relevant content due to subsequent changes. Readers are kindly requested to fully understand the risks and exercise prudent judgment.
