Recently, GalNAc‑L96‑Succinate, developed and manufactured by GOWELL Pharmaceutical, a manufacturing base of the GOWELL Group (Chengdu GOWELL), successfully completed U.S. Drug Master File (DMF) registration (Registration No.: MF044379, eCTD Sequence No.: 0001). This DMF filing marks GOWELL as one of the few domestic suppliers capable of providing liver‑targeted delivery core raw materials to global nucleic acid drug customers at commercial scale and through a fully compliant pathway. It also represents another milestone achievement for GOWELL in the field of small nucleic acid delivery system raw materials.

△ GOWELL GalNAc‑L96‑Succinate U.S. DMF Filing Acknowledgment

GalNAc‑L96: A Key Raw Material for Liver‑Targeted Nucleic Acid Drugs

GalNAc‑L96 is one of the most important raw materials in the current global liver‑targeted oligonucleotide delivery field. Numerous marketed or clinically investigational small nucleic acid products have adopted GalNAc‑L96‑based hepatocyte‑targeted delivery systems. To date, five small nucleic acid drugs developed using the GalNAc‑L96 delivery system have been approved for marketing, including Givosiran (Givlaari), Lumasiran (Oxlumo), Inclisiran (Leqvio), Vutrisiran (Amvuttra), and Fitusiran (Qfitlia).

Small nucleic acid drugs are hailed as the "third generation of drugs" following small‑molecule chemical drugs and antibody therapeutics. According to data from PharmaCube, the global small nucleic acid drug market has exceeded USD 10 billion, with over 20 small nucleic acid drugs currently approved. However, naked nucleic acids are unable to precisely reach target organs and typically require efficient delivery systems. GalNAc conjugation technology enables targeted enrichment and target gene silencing through high‑affinity binding to ASGPR (asialoglycoprotein receptor) on hepatocyte surfaces. The ability to stably obtain high‑purity GalNAc‑L96 with mature processes, full compliance, and traceability has become a critical link for nucleic acid drug companies worldwide in advancing R&D and manufacturing.

With this DMF filing, GOWELL can provide customers with reference support for the raw material section when submitting registration applications to the FDA, effectively streamlining the filing pathway, reducing compliance and quality control costs, and offering global small nucleic acid industry participants a compliant raw material option from China.

△ Chemical Structure of GalNAc‑L96‑Succinate

Eight Core Capabilities Building a Foundation for Stable GalNAc‑L96 Supply

The DMF filing marks the starting point of the compliance pathway, but the ability to deliver high‑quality products consistently and stably depends on systematic capabilities spanning process development to quality control. GOWELL has built a comprehensive capability matrix around GalNAc‑L96 production and supply, covering process development, scale‑up for industrialization, quality systems, structural confirmation, impurity control, intermediate quality control, customer audit support, and customized services.

1. Proprietary Process and Intellectual Property

GOWELL has established a proprietary manufacturing process with independent intellectual property rights, continuously advancing route optimization, impurity removal, and quality enhancement.

2. Industrialization and Scale‑Up Capabilities

The product has completed kilogram‑scale scale‑up production and possesses sustainable industrial supply capabilities. The current manufacturing facility is planned with an annual production capacity of over one metric ton, capable of supporting R&D, clinical, and commercial‑stage requirements.

3. API Quality System Support

Leveraging a comprehensive GMP production and quality management system for APIs, GOWELL strengthens process control, batch‑to‑batch consistency, data integrity, quality traceability, and supply stability.

4. Comprehensive Structural Confirmation

Structural and physicochemical characterization studies, including HRMS, ¹H NMR, ¹³C NMR, IR, UV, XRPD, and DSC/TGA, have been conducted on actual production batches, providing robust evidence for product identity confirmation and quality assessment.

△ HRMS, ¹H NMR, ¹³C NMR, IR, UV, XRPD, DSC/TGA spectra (GOWELL production batch)

5. High Purity and Fine Impurity Control

GOWELL can provide product specifications of 98%+ (single impurity ≤0.2%) and 99%+ (single impurity ≤0.15%) to meet the requirements of different R&D stages and quality standards.

6. Full‑Process Quality Control of Key Intermediates

All three key intermediates can achieve purity of 98%+, ensuring the quality stability of GalNAc‑L96 through systematic control of starting materials, intermediate processes, and final products.

7. DMF and Customer Audit Support

The U.S. DMF filing has been completed, and GOWELL is ready to support customers with technical assessments, document reviews, and on‑site/remote audits, facilitating the advancement of international projects.

8. Serialized Products and Customization Services

Beyond the core GalNAc‑L96 product, GOWELL also offers key intermediates, as well as conjugated/solid‑supported forms such as PS and CPG, helping customers reduce multi‑vendor switching costs and improve project transition efficiency.

Product Matrix and Supply Assurance

GOWELL has established a complete supply system for GalNAc‑L96, spanning from key intermediates to final products, covering various R&D stages and customer needs.

△ Core Capabilities Overview

△ Core Products

△ Key Intermediates

△ GOWELL GalNAc‑L96 Core Product Line

Beyond the Succinate series, GOWELL can also provide solid‑supported products such as PS and CPG to accommodate diverse synthetic routes and R&D needs. Depending on customer development progress, GOWELL can flexibly offer key intermediates and corresponding conjugated forms. In terms of supply assurance, GOWELL has established stable large‑scale production capabilities and strategic raw material inventories, supported by end‑to‑end quality control and traceability systems, as well as efficient global logistics and on‑time delivery capabilities, ensuring full‑cycle supply from R&D to commercialization.

About the GOWELL Group

Sichuan GOWELL Pharmaceutical Co., Ltd. is the core manufacturing entity under the GOWELL Group (Chengdu GOWELL). Founded in 2005 and headquartered in the Chengdu High‑Tech Zone, the Group is a professional, innovation‑driven pharmaceutical group integrating drug R&D, manufacturing, and sales. The Group includes subsidiaries such as Sichuan GOWELL Pharmaceutical Co., Ltd., Shanghai Ou Cuien Biotechnology Co., Ltd., and Chengdu Zhengkang Pharmaceutical Co., Ltd., with over 800 employees.

△ GOWELL Pharmaceutical Manufacturing Base

GOWELL has established three major R&D technology platforms covering generics, innovative drugs, and fish oil, with an R&D team of over 200 members. Core team members have been recognized under prestigious talent programs including the Tianfu Qingcheng Plan, Tianfu Emei Plan, and Rongpiao Plan. From 2017 to 2025, cumulative R&D investment exceeded RMB 700 million, fueling sustained innovation.

The company has filed a total of 123 patent applications, with 43 granted, including 33 invention patents, and has registered 185 trademarks.

Looking Forward Together: Embarking on the Nucleic Acid Journey with Compliance as Our Anchor

With this GalNAc‑L96‑Succinate U.S. DMF filing as a new starting point, GOWELL offers global nucleic acid drug customers a compliant option from China, backed by stable quality, proprietary processes, compliant international outreach, and reliable supply capabilities. We sincerely invite domestic and international nucleic acid drug companies as well as CRO/CDMO partners to collaborate in advancing the R&D and industrialization of liver‑targeted small nucleic acid drugs.

Contact Us / Request Samples / Technical Documentation

For GalNAc‑L96 and intermediate samples, COAs, technical documentation, quality specifications, commercial quotations, or on‑site/remote audit support, please contact Sichuan GOWELL Pharmaceutical Co., Ltd.:

△ For more product details or to request a technical information package, please contact the GOWELL sales team. We will match you with the corresponding product specifications and supply solutions as quickly as possible.

This document is intended for industry exchange and technical reference only and does not constitute a commercial offer or product commitment. Product specifications are subject to the final contract and COA