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Generex Biotechnology Corporation's subsidiary, Olaregen Therapeutix, has secured approval from the Malaysian Ministry of Health for its Excellagen wound care products. This follows a Distribution Agreement with Nexgen Medical, which commits to purchasing 1,000 units in the first year. The deal opens distribution channels in Malaysia and potentially other Southeast Asian countries, addressing a growing market driven by increasing diabetes rates and better healthcare access. This marks a significant step in Olaregen's international expansion efforts following the restart of its manufacturing operations.
NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology (GNBT), announced a $535 million valuation from an independent appraisal firm as of November 2020. Significant advancements in their Ii-Key-SARS-CoV-2 vaccine development have been achieved, including GMP manufacturing completion and a forthcoming IND submission to the FDA. The vaccine's manufacturing process is designed for stability at room temperature, enhancing commercial viability. The first-in-human clinical trial is anticipated post-FDA clearance to assess the vaccine's safety and immune response against SARS-CoV-2.
Generex Biotechnology Corporation (GNBT) announced that its subsidiary NuGenHealth has entered into a contract with Westside Medicine & Cardiology, Inc. to implement a Remote Patient Monitoring (RPM) system. The NuGenHealth SaaS platform will enhance patient engagement and allow for real-time monitoring of health data. This partnership is expected to reduce healthcare costs and improve patient outcomes by enabling timely interventions. Generex's CEO highlighted the potential for rapid nationwide adoption of the NuGenHealth system, aiming to expand RPM services further.
Generex Biotechnology Corporation (OTCQB:GNBT) provided updates on its Ii-Key-SARS-CoV-2 vaccine program and announced the appointment of Dr. Craig Eagle as Chairman of NuGenerex Immuno-Oncology. The company is re-launching Excellagen in the VA Hospital Network and introducing a Remote Patient Monitoring (RPM) service called NuGenHealth. Generex is advancing its Ii-Key COVID Complete Vaccine™ to human clinical trials with a manufacturing process that requires no frozen storage. The acquisition of AltuCell is also anticipated, with ongoing clinical trials for Type I diabetes treatment.
Generex Biotechnology Corporation (OTCQB:GNBT) announced that its subsidiary, NuGenHealth, has secured a contract with Florida Health Care Associates to implement a Software as a Service (SaaS) platform for Remote Patient Monitoring (RPM). This collaboration will enhance patient engagement by offering tools to monitor health data, ultimately aiming to improve outcomes and reduce hospitalizations. The agreement includes supplying connected medical devices and training for healthcare staff, positioning NuGenHealth for growth in RPM services following increasing demand from the pandemic.
Generex Biotechnology Corporation (OTCQB:GNBT) announced a $2 million agreement with Beijing Youfeng Biological Technology for the development of its Ii-Key SARS-CoV-2 vaccine. Under the agreement, Youfeng will conduct clinical trials and provide data for US and international approvals. Youfeng gains exclusive sales rights outside of the US and certain Latin American countries upon successful trial execution. Additionally, Youfeng will supply Generex with a comprehensive development plan and regulatory documents. CEO Joseph Moscato expressed optimism regarding the collaboration.
Generex Biotechnology Corporation (OTCQB:GNBT) announced details for a shareholder conference call on May 6, 2021. The call aims to address the surge in participant interest and improve access for shareholders. Pre-registration is encouraged through a provided link to facilitate attendance. President & CEO Joseph Moscato will update shareholders on key developments, including progress on the Ii-Key-SARS-CoV-2 Complete Vaccine™ and expansion of Arizona operations. The company emphasizes its commitment to enhancing shareholder engagement and communication.
Generex Biotechnology Corporation's subsidiary, Olaregen Therapeutix, has signed a Distribution Agreement with Nexgen Medical to exclusively sell the Excellagen wound care products in Malaysia. Nexgen anticipates obtaining commercial approval from the Malaysian Ministry of Health by the end of May 2021, with an initial purchase commitment of 500 units of Excellagen. The agreement could expand further into Southeast Asian markets, where demand for wound care products is rising. The company also expects a significant investment to support its sales program for Excellagen, potentially generating tens of millions in revenue.
Generex Biotechnology Corporation (OTCQB:GNBT) has secured a $2 million payment from its Chinese partners to assist in the IND submission process for its Ii-Key-SARS-CoV-2 Vaccine to the NMPA. This partnership involves prominent Chinese institutions for the development and regulatory approval of the vaccine in China. Generex will provide necessary research data and documentation as part of the collaboration, aimed at expediting the vaccine’s regulatory process. The company retains rights to the vaccine outside China and anticipates a supportive regulatory environment for the submission.
Generex Biotechnology Corporation (OTCQB:GNBT) announced the submission of a response package to the FDA addressing Pre-IND comments regarding their Ii-Key SARS-CoV-2 vaccine. The package includes data on epitope sequences, immunogenicity studies, GMP manufacturing, and a revised protocol. The vaccine aims to produce long-term immune memory through targeted T cell activation, offering a potential alternative to existing vaccines. The company is preparing for clinical trials, with a fill date set for May, and aims to address the global vaccination demand amid ongoing challenges with current vaccines.
