AI-Driven Drug Development Enters Critical Phase in 2026 with Multiple Candidates Advancing to Clinical and Regulatory Milestones

　　【Pharmaceutical Network Industry News】In recent years, AI has been accelerating its transition from a "third-party enabling tool" to the "core R&D infrastructure" of pharmaceutical companies themselves. Meanwhile, multiple AI-driven / AI-assisted novel drugs from pharmaceutical companies in China and overseas have already received Investigational New Drug (IND) approval, entered pivotal clinical trials, or been launched.
 

Recently, the clinical trial application (Application No.: CXHL2600606) for STC009 injection, a Class 1 innovative drug independently developed by Chengdu SunNovo Shengtai, a wholly-owned subsidiary of SunNovo, has been officially accepted by the National Medical Products Administration (NMPA). It is intended for the treatment of "secondary hyperparathyroidism (SHPT)".
 

STC009 Injection is a calcium-sensing receptor (CaSR) peptide agonist developed by Nuoheshengtai, leveraging the company’s proprietary iCVETide® peptide drug discovery platform. This platform deeply integrates computer-aided drug design (CADD) with artificial intelligence technology, establishing a closed-loop R&D system bridging computation and wet-lab experiments. Encompassing the entire workflow of molecular docking, molecular dynamics simulation, automated peptide synthesis, and biological evaluation, it efficiently facilitates the progression from molecular discovery to lead compound screening and optimization.
 

On April 29, Insilico Medicine announced on the Hong Kong Stock Exchange that the clinical trial application for its independently developed inhaled formulation of Rentosertib (ISM001-055) for adult idiopathic pulmonary fibrosis (IPF) has been approved by the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA). This marks the 13th project in the company's AI-driven R&D pipeline to receive clinical trial approval.
 

This clinical trial approval supports the conduct of a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of the Rentosertib inhalation formulation.
 

In April, U.S.-based Elevar Therapeutics announced that the U.S. FDA has accepted the New Drug Application (NDA) and granted priority review designation for lirafugratinib (also known as RLY-4008). The application seeks approval for its use as a second-line treatment option for patients with previously treated cholangiocarcinoma whose tumors harbor FGFR2 fusions or rearrangements.
 

Lirafugratinib is a highly selective oral FGFR2 inhibitor, originally designed by Relay Therapeutics utilizing its dynamic structure computational platform. As of December 2024, the global development and commercialization rights for this drug were licensed to Elevar Therapeutics.
 

In March, ReviR, an XtalPi-incubated company, announced that its independently developed small-molecule drug RTX-117 has completed first-in-human dosing. Co-discovered by XtalPi and ReviR, the drug is an AI-driven, RNA-targeting small-molecule candidate.
 

The trial was initiated at compliant clinical centers in China to evaluate the safety and preliminary efficacy of RTX-117 in relevant indications. This dosing marks the formal entry of the pipeline into Phase I clinical development, providing critical clinical validation for AI-driven RNA-targeted novel drug development.
 

Overall, since 2026, AI-driven innovative drugs have made continuous progress in clinical trial applications and market approvals, clearly demonstrating that AI drug discovery is accelerating from the "proof-of-concept" stage into a new cycle of "scaled output." Looking ahead, more clinical data readouts and marketing applications from AI-enabled pipelines will be submitted.
 

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