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Global First-in-Class AT2R Antagonist TRD205 Advances to Phase II: First Patient Dosed in Chronic Post-Surgical Neuropathic Pain Trial

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Beijing Tide Pharmaceutical, a subsidiary of Sino Biopharmaceutical (SBHMY), has initiated Phase II clinical trials for TRD205, a first-in-class AT2R antagonist targeting chronic post-surgical neuropathic pain (CPSP). The drug represents a breakthrough in non-opioid pain management, addressing a condition affecting 10% of surgical patients globally (30 million cases annually). TRD205 works by selectively blocking AT2R activation, which triggers pain sensitization, offering a safer alternative to opioids that show efficacy in only 25% of patients. The Phase II trial will evaluate 184 CPSP patients over six weeks. The drug has received approvals from both FDA and NMPA, with Phase I trials showing positive safety profiles. TRD205 targets a potential $10 billion market, with expansion possibilities into diabetic neuropathy and postherpetic neuralgia.
Beijing Tide Pharmaceutical, una controllata di Sino Biopharmaceutical (SBHMY), ha avviato le sperimentazioni cliniche di Fase II per TRD205, un antagonista AT2R di prima classe che mira al dolore neuropatico cronico post-chirurgico (CPSP). Il farmaco rappresenta una svolta nella gestione del dolore non oppioide, affrontando una condizione che colpisce il 10% dei pazienti chirurgici a livello globale (30 milioni di casi all'anno). TRD205 agisce bloccando selettivamente l'attivazione di AT2R, responsabile della sensibilizzazione al dolore, offrendo un'alternativa più sicura agli oppioidi, efficaci solo nel 25% dei pazienti. La sperimentazione di Fase II coinvolgerà 184 pazienti CPSP per sei settimane. Il farmaco ha ottenuto l'approvazione sia dalla FDA che dalla NMPA, con risultati positivi di sicurezza nelle Fasi I. TRD205 punta a un mercato potenziale da 10 miliardi di dollari, con possibilità di espansione verso la neuropatia diabetica e la nevralgia post-erpetica.
Beijing Tide Pharmaceutical, una subsidiaria de Sino Biopharmaceutical (SBHMY), ha iniciado ensayos clínicos de Fase II para TRD205, un antagonista AT2R de primera clase dirigido al dolor neuropático crónico postquirúrgico (CPSP). El medicamento representa un avance en el manejo del dolor no opioide, abordando una condición que afecta al 10% de los pacientes quirúrgicos a nivel mundial (30 millones de casos anuales). TRD205 actúa bloqueando selectivamente la activación de AT2R, que desencadena la sensibilización al dolor, ofreciendo una alternativa más segura a los opioides, que solo son efectivos en el 25% de los pacientes. El ensayo de Fase II evaluará a 184 pacientes con CPSP durante seis semanas. El medicamento ha recibido aprobaciones tanto de la FDA como de la NMPA, con perfiles de seguridad positivos en los ensayos de Fase I. TRD205 apunta a un mercado potencial de 10 mil millones de dólares, con posibilidades de expansión hacia la neuropatía diabética y la neuralgia posherpética.
Beijing Tide Pharmaceutical은 Sino Biopharmaceutical (SBHMY)의 자회사로서, 만성 수술 후 신경병증성 통증(CPSP)을 표적으로 하는 최초의 AT2R 길항제인 TRD205의 2상 임상시험을 시작했습니다. 이 약물은 전 세계 수술 환자의 10%(연간 3천만 건)에 영향을 미치는 이 질환을 비마약성 진통제로서 획기적으로 관리하는 신약입니다. TRD205는 통증 민감화를 유발하는 AT2R 활성화를 선택적으로 차단하여, 환자의 25%에게만 효과적인 마약성 진통제에 대한 더 안전한 대안을 제공합니다. 2상 임상시험은 184명의 CPSP 환자를 대상으로 6주간 진행됩니다. 이 약물은 FDA와 NMPA의 승인을 받았으며, 1상 시험에서 안전성 프로필이 긍정적으로 나타났습니다. TRD205는 100억 달러 규모의 잠재 시장을 목표로 하며, 당뇨병성 신경병증 및 대상포진 후 신경통으로의 확장 가능성도 가지고 있습니다.
Beijing Tide Pharmaceutical, une filiale de Sino Biopharmaceutical (SBHMY), a lancé les essais cliniques de phase II pour TRD205, un antagoniste AT2R de première classe ciblant la douleur neuropathique chronique post-chirurgicale (CPSP). Ce médicament représente une avancée majeure dans la gestion de la douleur non opioïde, visant une pathologie qui touche 10 % des patients opérés dans le monde (30 millions de cas par an). TRD205 agit en bloquant sélectivement l'activation de l'AT2R, responsable de la sensibilisation à la douleur, offrant ainsi une alternative plus sûre aux opioïdes, efficaces seulement chez 25 % des patients. L'essai de phase II évaluera 184 patients atteints de CPSP sur six semaines. Le médicament a obtenu les autorisations de la FDA et de la NMPA, les essais de phase I ayant montré un profil de sécurité positif. TRD205 cible un marché potentiel de 10 milliards de dollars, avec des possibilités d'extension vers la neuropathie diabétique et la névralgie post-zostérienne.
Beijing Tide Pharmaceutical, eine Tochtergesellschaft von Sino Biopharmaceutical (SBHMY), hat die Phase-II-Studien für TRD205 gestartet, einen neuartigen AT2R-Antagonisten, der chronische neuropathische Schmerzen nach Operationen (CPSP) behandelt. Das Medikament stellt einen Durchbruch in der nicht-opioid-basierten Schmerztherapie dar und richtet sich gegen eine Erkrankung, die weltweit 10 % der operierten Patienten betrifft (30 Millionen Fälle jährlich). TRD205 wirkt, indem es selektiv die Aktivierung von AT2R blockiert, welche die Schmerzempfindlichkeit auslöst, und bietet somit eine sicherere Alternative zu Opioiden, die nur bei 25 % der Patienten wirksam sind. Die Phase-II-Studie wird 184 CPSP-Patienten über sechs Wochen untersuchen. Das Medikament hat sowohl von der FDA als auch von der NMPA Zulassungen erhalten, und Phase-I-Studien zeigten positive Sicherheitsprofile. TRD205 zielt auf einen potenziellen Markt von 10 Milliarden US-Dollar ab, mit Expansionsmöglichkeiten in die diabetische Neuropathie und postherpetische Neuralgie.
Positive
  • First-in-class AT2R antagonist entering Phase II trials with potential to be first approved in class
  • Addresses large market opportunity of 30 million CPSP cases annually
  • Novel non-opioid mechanism avoiding addiction and respiratory depression risks
  • Dual FDA and NMPA approvals secured for clinical trials
  • Favorable safety and pharmacokinetic profiles demonstrated in Phase I
  • Targeting $10 billion market with potential expansion into additional indications
Negative
  • Early-stage drug development with no guarantee of clinical success
  • Competition emerging from other companies like Lilly-partnered CFTX-1554
  • Extended timeline required for Phase II completion and potential approval

BEIJING, May 5, 2025 /PRNewswire/ -- Beijing Tide Pharmaceutical Co., Ltd., a subsidiary of Sino Biopharmaceutical Limited (1177.HK), has achieved a milestone in developing its first-in-class analgesic drug (research code: TRD205), a highly selective angiotensin II type 2 receptor (AT2R) antagonist, with the first patient successfully dosed. As the first globally innovative drug targeting chronic post-surgical neuropathic pain (CPSP) to enter Phase II clinical development, TRD205 is positioned to overcome the limitations of existing opioid therapies and provide a safer, more effective solution for hundreds of millions of patients worldwide.

Mechanistic Breakthrough: Pioneering Non-Opioid Analgesic Pathways via AT2R Targeting

CPSP affects approximately 10% of surgical patients globally, translating to over 30 million cases annually. Current treatments face significant constraints: opioids demonstrate efficacy in only 25% of patients while carrying risks of addiction and depression, whereas NSAIDs and antidepressants show limited efficacy against neuropathic pain. TRD205's core innovation lies in its precise inhibition of AT2R, a receptor whose abnormal activation post-peripheral nerve injury triggers macrophages to release reactive oxygen/nitrogen species. This process exacerbates calcium influx in dorsal root ganglion (DRG) sensory neurons, amplifying pain sensitization. By selectively blocking this pathway, TRD205 suppresses pain signaling at its source without engaging the central nervous system, thereby avoiding opioid-related risks such as addiction and respiratory depression. The drug has secured clinical trial approvals from both the U.S. FDA and China's NMPA, with Phase I trials in healthy Chinese volunteers confirming favorable safety and pharmacokinetic profiles.

Addressing the Urgent Unmet Need in CPSP: A Public Health Priority

CPSP defined as pain persisting for over three months following surgery, impacts approximately 10% of the 320 million annual surgical patients globally. It is particularly prevalent after procedures such as limb amputation (50%-85%), thoracotomy (30%-50%), breast surgery (25%-50%), and hernia repair (5%-35%), etc. Beyond physical suffering, CPSP is closely linked to anxiety, depression, and other symptoms. Existing therapies address less than 30% of clinical demand, highlighting the critical need for novel mechanisms like TRD205's opioid-free approach. The Phase II study plans to enroll 184 patients with CPSP to evaluate pain score (NRS) improvements across dose groups over a six-week period.

Market Potential and Strategic Positioning in a $10 Billion Landscape

Global AT2R-targeted drug development remains nascent, with only a few competitors like Lilly-partnered CFTX-1554 (Phase I). TRD205's approval would make it the first AT2R therapy for CPSP, with expansion potential into indications such as diabetic neuropathy and postherpetic neuralgia—a combined market exceeding $10 billion.

TRD205's Phase II trial initiation marks a pivotal transition from opioid-dependent analgesia to precision targeting. Successful clinical validation would deliver a novel therapeutic paradigm for over hundreds of millions of patients globally.

Cision View original content:https://www.prnewswire.com/news-releases/global-first-in-class-at2r-antagonist-trd205-advances-to-phase-ii-first-patient-dosed-in-chronic-post-surgical-neuropathic-pain-trial-302445546.html

SOURCE Beijing Tide Pharmaceutical Co., Ltd.

FAQ

What is TRD205 and how does it work for chronic pain?

TRD205 is a first-in-class AT2R antagonist that selectively blocks AT2R activation, which triggers pain sensitization. Unlike opioids, it suppresses pain signaling without engaging the central nervous system, avoiding addiction risks.

What are the market opportunities for SBHMY's TRD205?

TRD205 targets a $10 billion market opportunity, addressing 30 million annual CPSP cases globally, with potential expansion into diabetic neuropathy and postherpetic neuralgia.

How does TRD205's efficacy compare to existing pain treatments?

While current opioids show efficacy in only 25% of patients and carry addiction risks, TRD205 offers a novel non-opioid approach with potentially better safety profile, demonstrated in Phase I trials.

What is the current development stage of SBHMY's TRD205?

TRD205 has entered Phase II clinical trials with 184 CPSP patients, following successful Phase I completion and approvals from both U.S. FDA and China's NMPA.

Who are the competitors for SBHMY's TRD205 in AT2R pain treatment?

The AT2R drug development space is nascent, with only a few competitors, including Lilly-partnered CFTX-1554 in Phase I trials.
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