GNT Pharma Signs cGMP Manufacturing Contract with China's Huiyu for Stroke Treatment "Nellonemdaz Lyophilized Injection"

Full-Scale Global Phase 3 Clinical Trials Begin

GNT Pharma, a drug development venture company, announced on April 28 that it has signed a cGMP (current Good Manufacturing Practice) production contract for its investigational stroke treatment "Nellonemdaz lyophilized injection" with China's Sichuan Huiyu Pharmaceutical.

Under this contract, Huiyu Pharmaceutical will be responsible for the cGMP manufacturing of Nellonemdaz lyophilized injection for use in upcoming multinational Phase 3 clinical trials (titled RENEW) in the United States, European Union (EU), China, and other regions.

GNT Pharma's 'Nellonemdaz', under development as a treatment for stroke. GNT Pharma

GNT Pharma is also actively pursuing global fast-track designation within this year. The company plans to formally apply for Breakthrough Therapy Designation (BTD) for Nellonemdaz to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the National Medical Products Administration (NMPA) of China, among others.

Additionally, GNT Pharma intends to proactively initiate domestic clinical trials this year, having already received approval from the Ministry of Food and Drug Safety, and will complete overseas Investigational New Drug (IND) applications as well. In the first half of next year, the company plans to expand clinical trial sites to major countries such as the United States, European Union (EU), China, Canada, and Australia.

According to last year’s report from the World Stroke Organization (WSO), approximately 5 million people worldwide experience permanent disability due to stroke annually, and more than 7 million die each year.

Currently, vascular recanalization therapies such as thrombolytics (tPA) or thrombectomy are being performed, but they cannot prevent neuronal cell death occurring during the restoration of blood flow. As a result, over 60% of patients either die or are left with severe disabilities.

Nellonemdaz, developed with support from the Ministry of Science and ICT and Gyeonggi Province, is the world’s first dual-acting neuroprotectant. It blocks acute neuronal cell death by selective inhibition of NR2B NMDA receptors and suppresses delayed cell death through potent antioxidant effects.

GNT Pharma stated, "Nellonemdaz is emerging as a next-generation treatment option that can overcome the current limitations of recanalization therapy. In particular, our confidence in Nellonemdaz’s global success is based on outstanding efficacy data confirmed in previous stroke clinical trials."

An analysis of stroke patients who received Nellonemdaz within 60 minutes of arriving at the emergency room and underwent thrombectomy showed the drug group had a 5.43-fold greater improvement in disability compared to the placebo group, which was statistically significant.

In a dichotomous analysis evaluating the proportion of patients able to perform independent daily activities (mRS 0–2), the placebo group was 38.46%, while the Nellonemdaz group reached 70%, a marked improvement. The proportion of patients who fully recovered to a state of no disability (mRS 0) increased significantly from 11.54% in the placebo group to 40% in the Nellonemdaz group. Furthermore, the mortality rate (mRS 6) decreased from 11.5% in the placebo group to 3.3% in the Nellonemdaz group.

The results from the Barthel Index, which assesses patients’ ability to perform daily activities and independence, were also encouraging. At 12 weeks after administration, the proportion of patients achieving a "Barthel Index of 95 or higher," indicating near-complete independence, was 67.86% in the Nellonemdaz group, compared to just 23.53% in the placebo group.

Byung-Joo Kwak, CEO of GNT Pharma, stated, "Through this cGMP production contract for the lyophilized injection, we have established the core infrastructure for global clinical trials and commercialization of Nellonemdaz for stroke and cardiac arrest indications. As the target stroke patient group with proven efficacy in domestic clinical trials has now been clearly defined, we will rapidly advance global Phase 3 trials with world-class researchers and significantly accelerate the timeline for the commercialization of this innovative new drug."

This content was produced with the assistance of AI translation services.