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ChemDiv Extends CMC Services for Ratutrelvir

On October 30, 2025, ChemDiv revealed a significant extension of its collaboration related to Chemistry, Manufacturing, and Controls (CMC) services, particularly directed at supporting the clinical development of Ratutrelvir—a new oral antiviral treatment for COVID-19. This announcement comes on the heels of advances by Traws Pharma, Inc., which recently initiated dosing in the Phase 2 clinical studies for Ratutrelvir, with key data expected by the end of this year.

Ratutrelvir is defined as an oral small molecule that acts as a Main protease inhibitor—specifically, a ritonavir-free one. It has been developed entirely in-house by ChemDiv, utilizing its own medicinal chemistry and virology service expertise. The drug was sparked to life through an innovative approach that leverages advanced tools such as Molsoft’s rational drug design platform and Expert Systems’ predictive pharmacology technology. This unique combination was pivotal in creating Ratutrelvir, distinguishing it from existing treatments for COVID-19 thanks to its high efficacy against a variety of both familiar and resistant strains of SARS-CoV-2 while maintaining a simplified 10-day treatment protocol that doesn’t require ritonavir. This is a crucial advantage, as it reduces the potential for drug-drug interactions that often restrict treatment options for patients.

Continuing its role in the project, Expert Systems has renewed its contract with Traws Pharma to facilitate ongoing clinical development, which includes a predictive safety pharmacology program. This collaborative effort utilizes AI-enhanced tools to minimize clinical risks and expedite regulatory readiness for Ratutrelvir.

ChemDiv’s collaboration encompasses a range of CMC activities, notably:

• - CMC Process Research and Scale-up: This includes development for Active Pharmaceutical Ingredient (API) and Drug Product (DP) manufacturing, which will support both non-GLP and GLP studies.
• - Medicinal Chemistry Support: This is directed at developing backup drug series.
• - Translational Pharmacology Services: These utilize computational modeling combined with lab validations.
• - Clinical Pharmacology Consulting: Aimed at refining dosing strategies for both Phase 2 trials and subsequent phases.

According to Ilya Baimetov, COO at ChemDiv, the organization is excited to contribute towards the progress of Ratutrelvir from its discovery phase through to clinical development. He stated, “By merging our proficient medicinal chemistry capabilities with advanced design tools and predictive pharmacology, we have developed a potentially first-in-class therapeutic for COVID.” He further emphasized that the extended CMC support would ensure Traws Pharma has the necessary infrastructure and analytical dexterity to enable successful clinical executions and completing necessary regulatory submissions.

Currently, Ratutrelvir is being tested in two Phase 2 clinical studies. One study is a non-inferiority trial comparing it against PAXLOVID®, while the second is a single-arm study focusing on patients ineligible for PAXLOVID®, particularly vulnerable groups with limited treatment pathways. Preliminary Phase 1 studies illustrate that Ratutrelvir maintains plasma concentrations that are approximately 13 times above the effective concentration needed for 50% inhibition (EC₅₀), following the 10-day regimen without ritonavir, which may help mitigate risks for viral rebound and Long COVID.

About Ratutrelvir

Ratutrelvir is currently under clinical development as a broadly acting oral therapy targeting SARS-CoV-2/COVID-19 without the need for ritonavir co-administration. Preclinical and early Phase 1 studies have already illustrated its unique efficacy against strains resistant to other drugs, along with a favorable pharmacokinetic profile.

About Expert Systems

Expert Systems is an advanced platform specializing in AI-driven tools across various stages of drug development, from target identification to clinical pharmacology. Their involvement in Ratutrelvir's progression is integral to the ongoing support of ChemDiv’s innovations.

About Traws Pharma

Traws Pharma (NASDAQ: TRAW) specializes as a clinical-stage biopharmaceutical company focusing on the development of novel antiviral therapies aimed at tackling critical health threats from respiratory viruses, including Ratutrelvir for COVID-19.

About ChemDiv

ChemDiv is a comprehensive drug discovery partner offering a vast array of services, featuring a compound library that boasts over 12 million compounds. Their expertise spans custom medicinal chemistry to clinical pharmacology support, employing cutting-edge AI tools to drive discovery outcomes.