Recently, Anhui poly Pharm Co., Ltd. (hereinafter referred to as "Anhui Primes") has made significant progress in the field of Boron Neutron Capture Therapy (BNCT). The Boron [¹⁰B] Melphalan (Borofalan ([¹⁰B])) API successfully completed its Drug Master File (DMF) submission to the U.S. Food and Drug Administration (hereinafter referred to as "FDA") on May 15, 2026.
At present, BNCT (Boron Neutron Capture Therapy), as a cutting-edge technology for cell-level precision radiotherapy, is advancing from the "technological exploration stage" into the "industrial explosion stage," leveraging its unique mechanism of "boron drug-targeted enrichment, precise neutron irradiation, and cell-scale killing."
On April 28, 2026, the Center for Drug Evaluation (CDE) of the National Medical Products Administration officially released the "Technical Guidelines for Clinical Research and Development of Boron Neutron Capture Therapy Drugs (Draft for Comments)," outlining a clear pathway for the industry and marking China's entry into a new stage of standardized and industrialized BNCT development. Combined with the "15th Five-Year Plan" national key special program that includes BNCT as a core research area in precision radiotherapy and lists it as a breakthrough therapy eligible for the priority review channel, policy dividends, capital attention, and clinical demand have formed a triple resonance. Globally, over 2 million new cases of refractory solid tumors are diagnosed each year, of which more than 30% are suitable for BNCT treatment—including head and neck tumors, brain tumors, and melanoma—and the BNCT market potential is estimated to exceed USD 8 billion. The opportunity is now.
Boron [¹⁰B] Melphalan (BPA, chemical name: 4-¹⁰Borono-L-phenylalanine) is the most clinically mature and best-evidenced boron drug API worldwide, primarily used for refractory solid tumors such as locally recurrent, unresectable head and neck squamous cell carcinoma. It was approved for marketing in Japan in March 2020 under the name Borofalan (Steboronine®). Its mechanism of action is unique: after intravenous injection, BPA is specifically enriched in tumor cells via L-type amino acid transporters, and upon neutron beam irradiation, releases high-linear energy transfer alpha particles that precisely kill tumors at the single-cell scale with minimal damage to normal tissues.
As an early mover in China's BNCT full-industry-chain layout, poly Pharm has always adhered to the philosophy of "rooted in tumor physiology and pathology, driven by pharmacological innovation, and culminating in therapeutic breakthroughs," aligning its full-chain platform capabilities with national strategy to help China's boron drugs transition from "catching up" to "leading the way."
Leveraging the global registration and compliance capabilities of the poly Pharm Group, Anhui poly has established an international registration system for its Boron [¹⁰B] Melphalan (BPA) API, with the U.S. DMF as the forerunner, becoming the first company in China to obtain an FDA Type II DMF number (044131) for a BPA API.
In China, as the API supplier for the Boron [¹⁰B] Melphalan injections of Hainan poly and Zhejiang Primes, Anhui poly is simultaneously advancing the API registration with China's NMPA. It has already supported the formulation in obtaining an Investigational New Drug (IND) approval, and its API quality and production system are managed in accordance with domestic and international GMP standards, laying a solid foundation for the full implementation of the "China-U.S. dual filing" strategy.
Currently, only the original Japanese product Steboronine® has achieved commercial supply of BPA globally, with limited production capacity and high pricing. According to QYResearch, the global market sales of BNCT boron drugs for injection reached USD 64 million in 2025 and are projected to grow to USD 138 million by 2032, with a CAGR of 11.6%. The overall global BNCT market (including equipment, drugs, and services) is growing even more rapidly, from approximately USD 528 million in 2026 to approximately USD 3.39 billion in 2032, with a CAGR of 36.3%. In China, new cases of head and neck cancer reach 146,000 annually, with over 80,000 deaths per year, and the incidence rate is rising at an average annual rate of 3%–5%. It is evident that high-purity BPA API is in severe global shortage, and the demand for domestic substitution is urgent.
Anhui poly possesses full-chain production capabilities spanning from boron-10 isotope raw materials → key intermediates → Boron [¹⁰B] Melphalan API. It also operates a flexible production system capable of flexibly matching batch requirements across different stages, including pilot-scale, scale-up, clinical, and commercial production. In terms of quality systems, Anhui poly has established a cGMP quality system covering European, American, and Chinese standards. Both product abundance and purity exceed 99% (the "dual 99" standard), with impurities strictly controlled below 0.1%, supporting formulation filings in regulated markets worldwide. Compared with the original Japanese product, Anhui poly offers core advantages including controllable production capacity, stable supply, more competitive costs, and faster delivery, enabling it to meet the raw material demands of the rapidly expanding global BNCT industry.
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 industries.
Anhui poly Pharm boasts a strong and efficient R&D and production team, is equipped with modern production facilities, and has established a strict cGMP quality system for high-end APIs in Europe and the United States, as well as a high-standard EHS system. While providing customers with high-quality APIs and intermediates, it also offers CDMO services, process technology upgrades, and more. The company currently has 3 API production workshops compliant with European, American, and Chinese GMP standards, 10 production lines, and 357 multi-functional pieces of equipment.
Leveraging strong R&D capabilities and technology transformation capabilities, the company 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 Pharm excipients (DOTA, SNAC, sodium sulfobutyl ether-β-cyclodextrin, calcium catelidol, cobiprostone calcium). The company focuses on high-end specialty APIs and innovative raw materials, with multiple products achieving domestic substitution and global exports, making it one of the most competitive API suppliers in the field of BNCT boron drugs.
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