MacroGenics MT200605 Phase II Clinical Trial Achieves Primary Endpoint; Unique Full-Chain Neuroprotective Mechanism to be Featured at International Stroke Conference

Meco Pharma's Phase II Clinical Trial for MT200605 Achieves Primary Endpoint: Unique Full-Chain Neuroprotective Mechanism to be Presented at International Stroke Congress

On August 3, 2026, "The First Share of Innovative Polypeptide Drugs in Hong Kong Stock Market," Meco Pharma (2335.HK), announced that the Phase II clinical trial of its candidate drug MT200605, which possesses global independent intellectual property rights and is used to treat acute ischemic stroke (cerebral infarction), has obtained top-line data. The clinical trial has achieved its primary research endpoint, and the results are statistically significant.

At the same time, the organizing committee of the 18th World Stroke Congress (WSC 2026) officially issued a letter stating that the company's abstract titled "MT200605: A Novel Dual-Functional Ischemic Stroke Neuroprotectant" has been accepted by its scientific committee and will be presented as an oral report during the conference.

WSC is an important international academic exchange platform in the field of stroke globally. Top experts in the fields of stroke research and clinical practice from around the world will gather there to centrally showcase cutting-edge stroke research, clinical trials, and innovative treatment strategies. Meco Pharma's selection for WSC 2026 this time will share the preclinical and Phase I results of MT200605 with global stroke experts, marking that its innovative mechanism has gained attention and recognition from the mainstream international academic community.

Phase II Data Significantly Improves Patient Functional Outcomes with Good Safety Profile

According to the announcement, this Phase II clinical trial was a multicenter, randomized, double-blind, placebo-controlled trial, enrolling a total of 360 subjects with acute ischemic stroke. Data from the primary efficacy endpoint showed that the proportion of patients scoring 0-1 on the 90-day mRS in both the medium and high-dose groups of MT200605 was higher than that in the placebo group. Among them, the advantage of the high-dose group in achieving good functional outcomes was more than 100% higher than that of the placebo group, and all secondary efficacy endpoints also showed consistent trends of effectiveness. No serious adverse events related to the investigational drug occurred throughout the trial period. Adverse events of grade ≥3 were evenly distributed among groups, and no new safety risks were identified. The drug had good overall tolerability. This set of positive top-line data provides key clinical evidence for MT200605 to enter the next stage of clinical development.

The core competitiveness of MT200605 stems from its unique mechanism of action in the global clinical stage. As the only small-molecule agonist currently capable of penetrating the blood-brain barrier, targeting the BDNF/TrkB pathway, and possessing neurorestorative activity, this drug achieves full-chain intervention covering the upstream, midstream, and downstream of cerebral infarction injury with a single molecule simultaneously:

Upstream improves blood flow: By blocking the calcium ion signaling pathway of vascular smooth muscle to dilate blood vessels, it relieves secondary ischemia caused by microvascular spasm, improves microcirculation, and enhances cerebral blood supply.

Midstream stops acute damage: It strongly clears oxygen free radicals and reduces oxidative stress; meanwhile, it activates TrkB receptors, inhibits neuronal apoptosis and excitotoxicity, accelerates the clearance of oxygen free radicals, and rescues dying nerve cells in the "ischemic penumbra" (the "half-dead" area surrounding the core of cerebral infarction).

Downstream promotes repair: It continuously activates the TrkB pathway, equivalent to supplementing the function of "brain-derived neurotrophic factor (BDNF)" naturally existing in the brain, initiating endogenous repair programs such as synaptogenesis, axonal regeneration, and neural network reconstruction, laying the foundation for subsequent functional recovery for patients.

Compared to existing drugs that only block damage through single or dual targets, MT200605 connects the complete treatment chain of "blood supply improvement - cell protection - nerve repair." It is expected to 冲击 (impact/compete for) the first guideline Class I recommendation and Grade A evidence neuroprotectant in China, building a deep and broad technological moat.

Huge Gap in Clinical Needs, Backed by Both National and International Levels

A Global Burden of Disease study showed that there were approximately 7.8 million new cases of ischemic stroke (cerebral infarction) worldwide in 2021. The total number of stroke patients in China exceeds 26 million, with about 4 million new cases annually. The "Interpretation of 2025 Global Stroke Report Data" report pointed out that in terms of economic burden, the direct medical costs and productivity losses of strokes worldwide reached 890 billion US dollars in 2021, and are expected to exceed 18 trillion US dollars by 2050. The huge market demand has not been fully met.

Currently, there have long been two major pain points in clinical treatment in this field: some patients successfully achieve vessel recanalization, but their neurological functions remain difficult to recover; and there are still many patients who cannot achieve vessel recanalization, lacking effective treatment methods.

To date, there are still no approved neuroprotective drugs for acute ischemic stroke in Europe and America. Some relevant drugs already listed or used in Asia still lack internationally recognized high-level evidence-based support.

Currently used neuroprotectants in domestic clinical practice, such as Butylphthalide and Edaravone/Edaravone Right Camphor, only received Class II recommendation and Grade B evidence from the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023." There are no products with Class I recommendation and Grade A evidence. Existing drugs only focus on a single link of "stopping damage" and lack pathways for simultaneously repairing neurological functions. The market has a huge unmet clinical need. Data shows that the peak terminal market size of just two mainstream neuroprotectants combined exceeds 6 billion yuan. The overall market size of traditional Chinese medicines for cardiovascular and cerebrovascular diseases in China reached 93.5 billion yuan in 2024. The growth space for the new generation of neuroprotective drugs with differentiated advantages is broad.

Among all ischemic stroke treatment drugs currently entering the clinical stage, MT200605 is the only small-molecule agonist capable of penetrating the blood-brain barrier, targeting the BDNF/TrkB pathway, and having neurotrophic effects.

Just this May, MT200605 was successfully selected for the National Major Science and Technology Project for Innovative Drug R&D, being included in the national strategic layout for tackling cardiovascular and cerebrovascular diseases. It is one of the few candidate varieties in the domestic neuroprotective innovative drug track to receive endorsement from national-level projects. In addition, the drug obtained the US FDA Orphan Drug Designation for Huntington's Disease in March 2026, providing policy support for its further expansion in the field of nervous system diseases. Meco Pharma's breakthrough selection for WSC, standing on the most influential academic stage, also marks that MT200605 has completed a key closed loop across three dimensions: "National Strategic Support — International Regulatory Recognition — Top Academic Verification." This is not only a scientific endorsement of its source innovation mechanism but also an important milestone in its journey from the laboratory to global clinical practice.

The Phase II study of MT200605 reached its primary endpoint, and its differentiated mechanism received positive signals in clinical research for the first time. Against the backdrop of widespread clinical failures of new stroke neuroprotective drugs, MT200605，凭借 (relying on) its unique mechanism, robust Phase II efficacy and safety data, has become a potential domestic pioneer variety. Meco Pharma is one of the targets with core value for long-term tracking in the cardiovascular and cerebrovascular innovative drug track.