SBP GROUP's TRD205 AT2R Antagonist Receives Breakthrough Therapy Designation from CDE

SBP GROUP (01177) has announced that TRD205, a novel AT2R antagonist developed by its subsidiary Beijing Tide Pharmaceutical Co., Ltd., has been included in the Breakthrough Therapy Drug List by the Center for Drug Evaluation (CDE).

This follows the successful completion of a Phase II clinical trial for the treatment of chronic post-surgical neuropathic pain (CPSNP).

TRD205 is a highly selective AT2R antagonist developed using the group's second-generation AI drug discovery platform.

Utilizing a target-driven de novo generation strategy, the platform designed novel molecules based solely on the three-dimensional geometric and physicochemical features of the AT2R target pocket, without relying on known ligand structures.

The drug's core innovation lies in its high selectivity for peripheral AT2R receptors, enabling multimodal analgesia through a dual mechanism.

It works by inhibiting macrophage migration to injury sites, downregulating neurotransmitters, reactive oxygen species, and inflammatory factors to reduce peripheral sensitization.

Additionally, in animal models, it suppresses the expression of pain-related ion channels in dorsal root ganglia, blocking nerve signal transmission.

As it acts only peripherally, TRD205 avoids common central nervous system side effects like drowsiness and dizziness, potentially improving long-term treatment tolerance for chronic pain patients and addressing a gap in current therapies.

CPSNP affects approximately 10% of the estimated 320 million surgical patients globally each year, with high incidence following procedures such as amputation and mastectomy.

Current treatment options for CPSNP are limited, with existing drugs often having poor efficacy for neuropathic pain or significant side effects.

The inclusion of TRD205 as a breakthrough therapy is based on positive results from a multicenter, randomized, double-blind, placebo-controlled Phase II dose-exploration study.

As a key output from the group's AI drug discovery platform, TRD205 validates the practical application of AI in molecular generation and candidate screening.

SBP GROUP will continue to advance the subsequent clinical development of TRD205 and explore its potential in other chronic pain indications, such as diabetic peripheral neuropathic pain, aiming to provide new solutions for chronic neuropathic pain.