Medicilon’s Formulation CDMO Platform Advances Taiji Group’s Next-Generation RNA Polymerase Inhibitor DSC158A Tablets to Clinical Stage

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Chongqing Fuling Pharmaceutical Factory Co., Ltd., a wholly-owned subsidiary of Chongqing Taiji Industry (Group) Co., Ltd., has received the Clinical Trial Approval Notice for DSC158A Tablets from the National Medical Products Administration (NMPA). A next-generation RNA polymerase inhibitor, DSC158A Tablets are developed for the treatment of influenza A and influenza B in adult patients.

As a long-term strategic partner of Taiji Group, Medicilon relies on its GMP-compliant oral solid formulation production facilities and professional formulation R&D platform to deliver pilot scale-up and clinical trial sample manufacturing services for DSC158A Tablets, supporting the smooth clinical progression of this novel innovative drug.

Urgent Unmet Clinical Needs for Influenza Prevention and Treatment

Influenza remains a persistent global public health threat. Viral mutations can trigger large-scale global pandemics, resulting in substantial unmet clinical needs worldwide. Seasonal influenza outbreaks occur annually across the globe, with major epidemics recorded in 2009 and 2023. In China, the seasonal influenza infection rate ranges from 5% to 10%, causing approximately 88,100 influenza-related respiratory deaths per year, accounting for 8.2% of total respiratory disease mortalities nationwide.
RNA polymerase inhibitors target cap-dependent endonuclease, blocking viral mRNA synthesis and suppressing viral replication at the source. These agents can rapidly reduce viral load and shorten disease duration, making them mainstream therapeutics for influenza treatment.

Precision Viral Blockade: Innovative New Solution for Influenza Treatment

Independently developed by Taiji Group, DSC158A Tablets are a novel next-generation RNA polymerase inhibitor indicated for adult influenza A and B treatment. Preclinical studies have demonstrated that DSC158A Tablets can effectively relieve influenza symptoms in animal models at low doses, while exhibiting favorable tolerability and a broad safety window. Classified as a Class 1 New Chemical Entity, the drug features an innovative structure with no approved counterparts globally.

The successful progression of DSC158A Tablets into clinical development marks a significant breakthrough for Taiji Group’s R&D pipeline in the field of innovative chemical drugs, demonstrating the Group’s R&D prowess under its innovation-driven strategy.

Empowered by Professional Platforms to Accelerate Innovative Drug Industrialization

Compliant manufacturing of clinical trial samples is a critical translational step and a key technical challenge in new drug development and commercialization. Medicilon’s Formulation Division delivers full-cycle formulation development services, covering project evaluation and initiation, formulation process optimization, quality standard establishment and validation, clinical sample production, and regulatory filing support.

Medicilon operates GMP-compliant production workshops for oral solid, inhalation and semi-solid preparations, enabling fully standardized manufacturing to support clinical development of innovative drugs. In addition, the company has built two core technical platforms to address key bottlenecks and drive innovation in formulation research and development:

Poorly Soluble Innovative Drug Technical Platform: Equipped with core technologies including solid dispersion, micronization, solubilization and inclusion complexation, as well as integrated in vitro dissolution and in vivo PK comprehensive evaluation systems, the platform effectively resolves common industry challenges such as poor solubility and low membrane permeability of drug candidates.

High-End Formulation Technical Platform: Focusing on cutting-edge drug delivery technologies including inhalation, ophthalmic, transdermal, sustained/controlled release and novel particulate delivery systems, the platform continuously upgrades its technical system to meet the diverse R&D demands of innovative and complex dosage forms.

Medicilon extends sincere congratulations to Taiji Group on the clinical trial approval of DSC158A Tablets. We look forward to smooth clinical progress of this candidate, which will bring a highly effective and safe new antiviral therapy to influenza patients worldwide in the near future. Moving ahead, Medicilon will continue to optimize its one-stop preclinical R&D service platform, empowering more innovative drug candidates to accelerate from Target to IND.

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