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Shenzhen and Hong Kong Join Hands to Promote the Development of the Hetao Shenzhen-Hong Kong Science Technology Innovation Co-operation Zone
HONG KONG SAR - Media OutReach Newswire - 30 July 2025 - The Greater Bay Area International Clinical Trial Institute of Hong Kong ("GBAICTI"), the Greater Bay Area International Clinical Trials Center of Shenzhen ("BAY TRIAL"), Immuno Cure BioTech ("Immuno Cure") in Hong Kong are pleased to jointly announce today the signing of a tripartite Memorandum of Understanding ("MOU") in Shenzhen on July 29, 2025. This collaboration aims to advance the globalization of clinical trials in the Guangdong-Hong Kong-Macau Greater Bay Area ("GBA"), further deepens clinical research cooperation between Hong Kong and Shenzhen, and implements the first ever cross-border multi-centre Phase II clinical trial project for ICVAX, a therapeutic DNA vaccine for HIV/AIDS, developed through collaboration between Immuno Cure and the AIDS Institute at the University of Hong Kong. This marks a significant milestone in the development of the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone.

From left to right: Professor Bernard CHEUNG Man-yung, Chief Executive Officer of GBAICTI; Dr. Xia JIN, Chief Executive Officer of Immuno Cure; Ms. TANG Hongmei, Executive Director of BAY TRIAL

This collaboration is witnessed by a Hong Kong Government delegation led by the Director of Health, Dr. Ronald LAM, and a Shenzhen Government delegation led by the Deputy Director General of Public Hygiene and Health Commission of Shenzhen Municipality, Ms. ZHOU Liping, following their GBA Clinical Trial Collaboration meeting held in Shenzhen.

GBAICTI and the BAY TRIAL plan to establish the GBA Clinical Trial Collaboration Platform ("Platform") by the end of this year. The Platform is expected to offer a range of services, including project evaluation, trial design consultation, and subject recruitment planning for multi-centre clinical trials, provided by a joint Shenzhen-Hong Kong advisory team; integration of artificial intelligence technologies to assist with matching clinical trial institutions and researchers, as well as offering intelligent consultation services; establishment of a coordinated ethics review mechanism between the two regions to enhance approval efficiency; promotion of talent exchange, collaboration, and professional training; creation of a research talent pool to facilitate talent mobility and regional collaboration; and as a pilot, the development of clinical databases and biobanks based on disease areas of strength in both Shenzhen and Hong Kong.

Professor Bernard CHEUNG Man-yung, Chief Executive Officer of GBAICTI, said: "The ICVAX vaccine, developed by Immuno Cure and the AIDS Institute at the University of Hong Kong, is now poised for cross-border clinical trials in the Greater Bay Area. This highlights the achievements and potential of innovation and technology in China and the Hong Kong SAR. If the clinical trial results are positive, the new vaccine would bring hope to HIV/AIDS patients worldwide, particularly in Belt and Road countries. We aim to leverage the strength of both Guangdong and Hong Kong to establish the Guangdong-Hong Kong-Macao Greater Bay Area as a global hub for clinical trials."

Dr. LI Yichong, Director of BAY TRIAL, said: "This collaboration marks the first cross border clinical trial project between the BAY TRIAL and Hong Kong, signifying a new phase in the cooperation between Shenzhen and Hong Kong in the biopharmaceutical sector of GBA. We will fully leverage the synergistic advantages of both regions to establish an international clinical trial platform with the BAY TRIAL, continuously injecting new momentum into the high-quality development of the Bay Area's pharmaceutical and medical device industry."

Since the first discovery of AIDS in 1981, 40 million people have died from HIV infection. Currently, there are still over 39 million people living with HIV worldwide. Although antiretroviral therapy ("ART") can effectively control HIV, it cannot cure the disease, highlighting the importance of immunotherapy. Immunotherapy aims to enhance the host's immune response, with the expectation of controlling viral replication without ART, ultimately achieving complete viral suppression and functional cure. Immuno Cure's ICVAX induces broad-spectrum, multifunctional virus-specific T cells to achieve the goal of controlling viral replication without ART.

Immuno Cure completed the first-in-human Phase I clinical trial of the ICVAX vaccine in November 2024. The results demonstrated excellent safety and good immunogenicity. This year, two multi-center Phase II clinical trials will be conducted to evaluate the mechanism of action and efficacy, respectively, of ICVAX in humans. Both are randomized, double-blind, placebo-controlled, dose-escalation studies, with clinical trial centres in the Prince of Wales Hospital in Hong Kong and eight Grade 3A hospitals in China, including The Third People's Hospital of Shenzhen, Beijing Ditan Hospital, Beijing Youan Hospital, Guangzhou Eighth People's Hospital, Tianjin Second People's Hospital, The Sixth People's Hospital of Zhengzhou, Chengdu Public Health Clinical Medical Center, and Chongqing Public Health Medical Center.

Dr. Xia JIN, Chief Executive Officer of Immuno Cure, said: "We are delighted to receive support from both GBAICTI and BAY TRIAL, integrating medical resources from both regions to advance Immuno Cure's therapeutic vaccine for HIV, ICVAX, to multi-center Phase II clinical trials. We will continue to collaborate with the HKU AIDS Institute to drive innovation in drug development, leverage local advantages in drug research and translation, accelerate ICVAX towards commercialization, provide more effective treatment options for HIV patients, and contribute to global health."

GBAICTI, BAY TRIAL, and Immuno Cure look forward to further deepening clinical trial cooperation between Shenzhen and Hong Kong in future collaborations, jointly promoting the development and globalisation of innovative drug development, and supporting the national "Healthy China" strategic goals.

Hashtag: #ImmunoCure #醫克生物 #医克生物

The issuer is solely responsible for the content of this announcement.

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