Micot Pharma's MT200605 Achieves Primary Endpoint in Phase II Trial, Novel Integrated Multi-stage Neuroprotection Mechanism to Be Presented at WSC 2026

HONG KONG, August 7, 2026 - (ACN Newswire) -On August 3, 2026, Shaanxi Micot Pharmaceutical Technology Co., Ltd. ("Micot Pharma"; 2335.HK) announced positive topline data from the Phase II clinical trial of MT200605, a proprietary drug candidate independently developed by Micot Pharma for the treatment of acute ischemic stroke (AIS). The trial successfully met its primary endpoint with statistically significant results.Simultaneously, the organizing committee of the 18th World Stroke Congress (WSC 2026) officially notified the company that its abstract, titled "MT200605: A Novel Bifunctional Neuroprotectant for Ischemic Stroke", has been accepted for an oral presentation during the congress.The WSC is a premier international academic platform in the field of stroke, bringing together leading global experts in stroke research and clinical practice to showcase cutting-edge research, clinical trials, and innovative therapeutic strategies. Micot Pharma's selection for WSC 2026 will allow the company to share the non-clinical and Phase I results of MT200605 with global stroke experts, signifying that its innovative mechanism of action has garnered attention and recognition from mainstream international academia.Phase II Data Demonstrates Significant Improvement in Functional Outcomes with a Favorable Safety ProfileAccording to the announcement, the Phase II trial was a multicenter, randomized, double-blind, placebo-controlled study enrolling a total of 360 subjects with acute ischemic stroke. Data on the primary efficacy endpoint showed that the proportion of patients achieving a modified Rankin Scale (mRS) score of 0&ndash;1 at 90 days was higher in both the medium- and high-dose MT200605 groups than in the placebo group. In the high-dose group, the proportion of patients achieving mRS 0&ndash;1 was more than double that of the placebo group, with a statistically significant between-group difference. Consistent efficacy trends were also observed across the secondary efficacy endpoints.Throughout the trial period, no serious adverse events related to the investigational drug were reported. Treatment-emergent adverse events of grade 3 or higher were evenly distributed among the groups, and no new safety risks were identified, indicating overall good tolerability. This positive set of topline data provides a crucial clinical rationale for advancing MT200605 to the next stage of clinical development.Core Competitiveness Stems from a Globally Unique Mechanism of Action in Clinical StageThe core competitiveness of MT200605 originates from its globally unique mechanism of action among clinical-stage stroke therapies. To the best of the Company's knowledge, MT200605 is the only clinical-stage small-molecule agonist capable of crossing the blood-brain barrier, targeting the BDNF/TrkB pathway, and exerting neurorestorative activity. The drug achieves comprehensive intervention across the upstream, midstream, and downstream stages of ischemic brain injury via a single molecule:- Upstream &ndash; improving blood flow: By modulating calcium signaling in vascular smooth muscle, MT200605 induces vasodilation, relieves secondary ischemia caused by microvascular spasm, improves microcirculation and enhances cerebral perfusion.- Midstream &ndash; limiting acute injury: MT200605 potently scavenges reactive oxygen species (ROS), limiting oxidative injury. It also activates TrkB to attenuate excitotoxicity and reduce neuronal apoptosis, helping rescue threatened neurons in the ischemic penumbra&mdash;the potentially salvageable tissue surrounding the infarct core.- Downstream &ndash; promoting repair: Sustained TrkB activation mimics the function of endogenous brain-derived neurotrophic factor (BDNF), initiating repair programs including synaptogenesis, axonal regeneration and neural network remodeling, and supporting subsequent functional recovery.Compared to existing drugs that only block damage through single or dual targets, MT200605 establishes a complete therapeutic cascade of "blood flow improvement &ndash; cellular protection &ndash; neural restoration." It holds the potential to become the first neuroprotectant in China to receive Class I recommendation and Level A evidence in clinical guidelines, potentially strengthening its differentiated competitive position.Massive Unmet Clinical Need Supported by National and International RecognitionThe Global Burden of Disease study reveals that in 2021, there were approximately 7.8 million incident cases of ischemic stroke globally. In China, the total number of stroke patients exceeds 26 million, with approximately 4 million new cases annually. The Global Stroke Report 2025 indicates that in terms of economic burden, the combined direct medical costs and productivity losses of stroke globally reached $890 billion in 2021 and are projected to surpass $1.8 trillion by 2050. This highlights a massive market demand that remains largely unmet.Currently, clinical treatment in this field has long faced two major pain points: some patients achieve successful vascular recanalization but still struggle with neurological recovery, while a large number of patients are unable to achieve recanalization and lack effective therapeutic options.To date, no neuroprotective agent has been approved for acute ischemic stroke in Europe or the United States, and relevant drugs marketed or used in parts of Asia still lack internationally recognized, high-level evidence-based support.In domestic clinical practice, neuroprotectants currently in use, such as butylphthalide and edaravone/edaravone dexborneol, only hold Level II recommendations with Grade B evidence according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023, with no products possessing Class I recommendation and Level A evidence. Existing therapies focus solely on the single aspect of "damage control" and lack pathways for synchronous neurological restoration, leaving a massive unmet clinical need in the market. Data from Moyi Pharma Intelligence shows that the peak terminal market size of just two mainstream neuroprotectants exceeds 6 billion RMB, and the overall market for traditional Chinese medicines for cardiovascular and cerebrovascular diseases in China reached 93.5 billion RMB in 2024. This indicates vast growth potential for a new generation of neuroprotective drugs with differentiated advantages.Among all ischemic stroke therapies currently in the clinical stage, MT200605 is the only small-molecule agonist capable of penetrating the blood-brain barrier, targeting the BDNF/TrkB pathway, and exerting neurotrophic effects.Just this May, MT200605 was successfully selected for the National Science and Technology Major Project for Innovative Drug Development and incorporated into the national strategic layout for tackling cardiovascular and cerebrovascular diseases, making it one of the few candidate drugs in the domestic neuroprotective innovation sector to receive national-level project endorsement. Furthermore, the drug received Orphan Drug Designation from the US FDA for Huntington's disease in March 2026, providing policy support for its further expansion in neurological diseases.The company's breakthrough selection for the WSC, stepping onto the most influential academic stage, also marks MT200605's completion of a critical closed loop across three dimensions: "National Strategic Support &ndash; International Regulatory Recognition &ndash; Top-tier Academic Validation." This serves not only as a scientific endorsement of its original innovative mechanism but also as a significant milestone in its transition from the laboratory to global clinical practice.With the MT200605 Phase II study meeting its primary endpoint, its differentiated mechanism has demonstrated positive signals in clinical research for the first time. Against the backdrop of widespread clinical failures for new stroke neuroprotectants, MT200605, with its unique mechanism and robust Phase II efficacy and safety data, stands as a potential first-in-class candidate in China and positions Micot Pharma as one of the core value targets worthy of long-term tracking in the cerebrovascular innovative drug sector. Copyright 2026 JCN Newswire. All rights reserved. www.jcnnewswire.com