Keze Yongxin Biotech Files IPO Prospectus Following FDA DMF Approval and Recognition as 2024’s Top Nucleic Acid Raw Material Supplier

Recently, Shanghai Keze Yongxin Biotechnology Co., Ltd. (hereinafter referred to as “Keze Yongxin”) announced that its upstream raw materials for small nucleic acids have successfully obtained U.S. FDA Drug Master File (DMF) registration.

The U.S. Food and Drug Administration (FDA) is one of the most authoritative drug regulatory agencies in the world. Drug Master Files (DMFs) are documents submitted to the FDA by holders, containing detailed information on manufacturing facilities, processes, quality control, and the raw materials and packaging materials used in the production, processing, packaging, and storage of drug products intended for human use.

As a reference document, the DMF is archived in the FDA’s Central Document Room (CDR) for use in one or more Investigational New Drug applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs), as well as amendments and supplements to these applications.

Raw material suppliers submit the required technical content directly to the FDA for filing in the form of a Drug Master File (DMF) and obtain a filing number,Drug applicants may directly use the Drug Master File (DMF) reference number in lieu of providing specific information on raw materials and excipients during the application process.。

The Drug Master File (DMF) system not only facilitates the organic integration of excipient review with drug approval, enabling regulatory authorities to effectively monitor production and post-marketing usage data, reduce approval costs, enhance approval efficiency, and ensure traceability during supervision and inspection; it also shortens registration cycles and minimizes redundant studies caused by discrepancies in registration requirements, thereby allowing excipient manufacturers to devote greater resources to research and development and elevating the overall standards of the excipient industry.

At the recently concluded “Nucleic Acid Hub: Industry Stars” 2024 Second China Nucleic Acid Drug and Novel Vaccine Industry Star Awards, Keze Yongxin stood out and was honored as the “2024 Best Raw Material Supplier.”

Keze Yongxin, headquartered in Shanghai, is a high-tech enterprise dedicated to the R&D and manufacturing of core raw materials and excipients for RNA backbone technologies. The company focuses on nucleotide monomers and phosphoramidites; delivery systems such as LNP and GalNAc; mRNA-related raw materials and excipients including nucleotides, Clean Cap, and fluorescently labeled derivatives like Biotin-TP (dNTP/NTP), CY3-TP (dNTP/NTP), and CY5-TP (dNTP/NTP); as well as custom synthesis of fluorinated and heterocyclic compounds via CRO & CDMO services. We provide cost-effective products and process routes, supporting production scales from milligrams to kilograms, and offering diverse engagement models including FTE, CRO, and CDMO.

Zhang Kun, Founder of Keze Yongxin

Founder Zhang Kun holds a comprehensive educational background in organic chemistry, spanning from his bachelor’s to doctoral degrees. During his advanced studies at ETH Zurich, he not only deepened his expertise but also connected with numerous elites in the biopharmaceutical sector through extensive academic exchanges. By chance, he visited Basel, the cradle of European pharmaceutical innovation, where he toured industry leaders such as Roche and Novartis. This extraordinary experience planted a seed in his heart, quietly taking root and sprouting, and ignited his strong vision to dedicate himself to the pharmaceutical industry.

Meanwhile, Zhang Kun’s former roommate at ETH Zurich, Dr. Li Mao (now at Shenzhen Bay Laboratory), has long been dedicated to research on nucleic acid delivery technologies—a field that represents a critical bottleneck urgently requiring breakthroughs in the development of small nucleic acid therapeutics. Inspired by this, Zhang Kun keenly recognized the industry’s needs and opportunities, resolutely choosing nucleic acid delivery as his core technological focus. He embarked on an entrepreneurial journey aimed at addressing industry challenges through innovative technology, thereby advancing progress and development in the pharmaceutical sector.

In March 2023, Keze Yongxin was officially founded.

Currently, the greatest challenge facing the field of oligonucleotide therapeutics lies in drug delivery technologies, with achieving efficient extrahepatic targeted delivery emerging as a critical issue requiring urgent resolution.

Zhang Kun told VCBeat that, given the frequent dosing often required for chronic disease treatment, patient adherence has become a major challenge. With advantages such as a low propensity for drug resistance and sustained efficacy, small nucleic acid drugs offer a new pathway to reduce dosing frequency and improve patients’ quality of life, and are regarded as the next breakthrough in chronic disease management. As research and development deepen, the application of small nucleic acid drugs is gradually expanding from rare diseases to the field of chronic diseases.

However, the widespread application of small nucleic acid drugs remains constrained by delivery technologies. Due to their susceptibility to degradation by nucleases in vivo, as well as challenges in crossing cell membranes attributable to their molecular size and negative charge, highly efficient delivery systems are required to ensure that these therapeutics reach target tissues safely and effectively. Currently, small nucleic acid drugs are primarily delivered via liver-targeted approaches; however, Keze Yongxin is actively exploring novel pathways for extrahepatic targeting to overcome this technical bottleneck.

Meanwhile, Zhang Kun also pointed out that small nucleic acid drugs are currently more expensive than traditional drugs. To achieve better accessibility, further optimization of their pricing is required.

Keze Yongxin regards the research and development of novel delivery systems as a long-term strategy, while simultaneously establishing a complete industrial chain for upstream raw materials in three major business segments: small nucleic acid drugs (e.g., nucleosides, phosphoramidite monomers, and a series of GalNAc delivery systems), mRNA-related upstream raw materials (e.g., NTPs, Clean Cap, etc.), and labeled nucleotides for gene sequencing and detection. The company has developed a portfolio of star products to meet diverse scientific research and clinical application needs, including 2'-O-Methyl Phosphoramidites, 2'-Fluoro Phosphoramidites, 2'-O-MOE Phosphoramidites, 2'-O-TBDMS Phosphoramidites, C16/C22 Phosphoramidites, 5’(E)-VP(2’-OMe/2’-F) Phosphoramidites, LNA Phosphoramidites, GNA Phosphoramidites, ENA Phosphoramidites, UNA Phosphoramidites, cEt Phosphoramidites, Reverse (2’-F/OMe/O-MOE) Phosphoramidites, PMO Phosphoramidites, Dye Phosphoramidites, Spacer Phosphoramidites, PNA Phosphoramidites, HNA Phosphoramidites, chiral monomers (PSI, PSM), dimer and trimer monomers, the GalNAc delivery system series, and the labeled nucleotide series (Cy3-dCTP, Biotin-UTP, Cy5-UTP).

Leveraging a 4,000-square-meter R&D and pilot-scale platform, as well as the Anhui production base,Keze Yongxin can provide custom manufacturing services from gram-scale to ton-scale., flexibly respond to diverse downstream demands and ensure the rapid delivery of high-quality products.

“We aim to always prioritize quality, striving to become a specialized, refined, distinctive, and innovative enterprise in this field,” stated Zhang Kun. Keze Yongxin has established in-depth collaborations with several well-known domestic pharmaceutical companies to jointly promote the research, development, and application of nucleic acid therapeutics. Furthermore, the company has partnered with numerous senior scholars in nucleic acid delivery research from institutions such as ETH Zurich, the University of California, Davis, and the Shenzhen Bay Laboratory, with the goal of better advancing the development of small nucleic acid drugs.

References:

1. “Zhang Kun, Founder of Keze Yongxin: Quality First, Developing Novel Delivery Systems to Address Challenges in Oligonucleotide Raw Materials,” Hall of Fame in the Pharmaceutical Industry

2. [Exclusive] Focusing on Upstream Raw Materials for Small Nucleic Acids and Breaking Through the Delivery Challenges of Nucleic Acid Drugs, Keze Yongxin Completes Tens of Millions in Financing