Jiangsu Recbio Technology Co., Ltd. (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the novel adjuvanted recombinant shingles vaccine REC610 independently developed by the Company has recently achieved positive results in the interim analysis of first-in-human (“FIH”) clinical trial in the Philippines.

Previously, the Company conducted a GSK Shingrix® active-controlled FIH clinical trial of REC610 in the Philippines. The Interim Analysis (IA) results showed that REC610 demonstrated overall favorable safety and tolerability profile in healthy participants aged 40 and above after two doses of the vaccination. REC610 induced strong gE-specific humoral and cellular immune responses, which were evident after the first vaccination and reached the peak at 30 days after the second vaccination. The humoral and cellular immune responses were comparable between REC610 and Shingrix® group, and the immune response level in REC610 group was numerically higher than that in Shingrix® group.

Safety: REC610 had good safety profile with the two-dose vaccination regimen. No SAE, AESI or TEAE leading to early discontinuation was reported. The incidences of vaccination related TEAEs, solicited local and systemic TEAEs, unsolicited TEAEs were comparable between REC610 group and Shingrix® group. Majority of vaccination related TEAE were Grade 1 or Grade 2, and all recovered in 1-3 days post vaccination. The common (≥5%) solicited TEAEs in REC610 group included injection site pain, injection site swelling, pyrexia, headache, and myalgia.

Immunogenicity: REC610 induced strong gE-specific humoral and cellular immune responses, which were evident after the first vaccination and reached the peak at 30 days after the second vaccination. The humoral and cellular immune responses were comparable between REC610 and Shingrix® group, and the immune response level in REC610 group was numerically higher than that in Shingrix® group. REC610 induced favorable humoral and cellular immune responses in both elderly and adult groups.

Both REC610 and Shingrix® groups induced high levels of gE-specific antibodies at 60 days after the first dose vaccination, and 30 days after the second dose vaccination. The GMT, GMI and SCR of gE-specific antibodies were comparable in REC610 group and Shingrix® group, especially, the GMT and GMI of gE-specific antibodies were numerically higher in REC610 group than those in Shingrix® group. Both REC610 and Shingrix® groups induced strong cellular immune response at 60 days after the first dose vaccination, and 30 days after the second vaccination. Tested by the internationally recognized ICS method, the frequencies and CMI response rates of CD4+ T cells secreting at least one or two of gE-specific cytokines were comparable in REC610 group and Shingrix® group, and the cellular immune response level was numerically higher in REC610 group than that in Shingrix® group.

Shingles is a common viral infectious disease. According to statistics, about 6 million new cases of shingles occur each year in China^[1-3], and the incidence of shingles has gradually become younger in recent years. According to global research data on shingles vaccines that have been marketed, as compared to attenuated live vaccines, novel adjuvanted recombinant shingles vaccines can provide stronger cellular immune and protective efficacy. REC610 is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibody. REC610 is intended to prevent shingles in adults aged 40 and above. According to statistics, China’s population aged 40 and above is approximately 700 million. Only GlaxoSmithKline’s Shingrix®, the new adjuvant recombinant vaccine, is on the market in China, and there is a strong demand for import substitution.

REC610 received a drug clinical trial approval notice (notice number: 2023LP02151) issued by the National Medical Products Administration in October 2023, and is approved for use as a preventive 3.3 biological product in its Phase I and Phase III clinical trials being carried out in China. The Company will adopt a randomized, double-blind, parallel controlled phase I clinical trial in 180 healthy adult subjects aged 40 and above in Mainland China in near term to evaluate the safety, tolerability and immunogenicity of REC610.

Reference:

[1]Bollaerts K et al. A systematic review of varicella seroprevalence in European countries before universal childhood immunization: deriving incidence from seroprevalence data. Epidemiol Infect 2017;145:2666–2677;

[2]Bricout H et al. Herpes zoster-associated mortality in Europe: a systematic review. BMC Public Health 2015;15:466;

[3] Kawai K, Gebremeskel BG, Acosta CJSystematic review of incidence and complications of herpes zoster: towards a global perspectiveBMJ Open 2014;4:e004833. doi: 10.1136/bmjopen-2014-004833.

About Recbio

Founded in 2012, Jiangsu Recbio Technology Co., Ltd. (hereafter referred to as Recbio or the Company; stock code: 2179.HK) is an innovative vaccine company propelled by internally developed technologies. Committed to our mission of " Protect human health with best-in-class vaccines", we have cultivated a robust portfolio of vaccine products with exclusive rights, addressing the substantial unmet needs in the realm of high-impact infectious diseases. Over the course of more than two decades, Recbio has meticulously built three pioneering platforms: a novel adjuvant platform, a protein engineering platform, and an immunological evaluation platform, making us one of the few global companies capable of both developing and manufacturing the complete range of novel adjuvants.

Leveraging the close integration of our three platforms, we are consistently creating promising vaccine candidates. Fueled by these innovative platforms, the Company has forged a high-value portfolio of innovative vaccines, encompassing over ten potential blockbuster varieties. These encompass areas such as cervical cancer, shingles, RSV infection, and other prevalent high-burden diseases, and have emerged as leading products in terms of development and clinical progress in China.

Having been honed and refined over the course of a decade, Recbio is poised to reap the benefits as several products are nearing commercialization.

Forward-looking statements

This Press Release may contain projections, estimates, forecasts, targets, opinions, prospects, results, returns and forward-looking statements with respect to the financial condition, results of operations, capital position, strategy and business of the Group which can be identified by the use of forward-looking terminology such as “may”, “will”, “should”, “expect”, “anticipate”, “project”, “plan”, “estimate”, “seek”, “intend”, “target”, “believe”, “potential” and “reasonably possible” or the negatives thereof or other variations thereon or comparable terminology (collectively, “forward-looking statements”), including the strategic priorities, research and development projects, and any financial, investment and capital targets and any other targets, commitments and ambitions described in writing or verbally herein. Any such forward-looking statements are not a reliable indicator of future performance, as they may involve significant stated or implied assumptions and subjective judgements which may or may not prove to be correct, accurate or complete. There can be no assurance that any of the matters set out in the forward-looking statements are attainable, will actually occur or will be realised or are complete or accurate. The assumptions and judgments may prove to be incorrect, inaccurate or incomplete, and involve known and unknown risks, uncertainties, contingencies and other important actors, many of which are outside the control of the Group. There is also no assurance that the Group may develop or market its core products or other pipeline candidates successfully. Actual achievements, results, performance or other future events or conditions may differ materially from those stated, implied and/or reflected in any forward-looking statements due to a variety of risks, uncertainties and other factors (including without limitation general market conditions, regulatory changes, geopolitical tensions or data limitations and changes). Any such forward-looking statements are based on the beliefs, expectations and opinions of the Group at the date the statements are made, and the Group does not assume, and hereby disclaims, any obligation or duty to update, revise or supplement them if circumstances or management’s beliefs,  expectations or opinions should change. For these reasons, you should not place reliance on, and are expressly cautioned about relying on, any forward-looking statements. No representations or warranties, expressed or implied, are given by  or on behalf of the Group as to the achievement or reasonableness of any projections, estimates, forecasts, targets, commitments, prospects or returns contained herein.

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Jiangsu Recbio Technology Co., Ltd.

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SOURCE ：Jiangsu Recbio Technology Co., Ltd.