HPV vaccine (Bravovax)

TAIZHOU, China, Feb. 13, 2023 /PRNewswire/ -- Jiangsu Recbio Technology Co., Ltd. (the "Company", together with its subsidiaries, the "Group") is pleased to announce that the Group has recently completed the first batch of subject enrollment for its novel adjuvanted recombinant shingles vaccine, REC610. The study is a randomized, observer-blinded, GSK Shingrix® active-controlled phase I clinical trial to evaluate the safety and immunogenicity of REC610 in healthy adult subjects aged 40 and above. According to research data on shingles vaccines that have been marketed around the world, the novel adjuvanted vaccine can provide stronger cellular immunity and protective efficacy as compared to live attenuated vaccines. 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. Preclinical studies have shown that REC610 has favorable immunogenicity and can induce high levels of gE-specific CD4+ T cell responses and IgG antibody, and its immune response is non-inferior to the controlled vaccine Shingrix®. About Recbio Founded in 2012, Jiangsu Recbio Technology Co., Ltd. (hereinafter referred to as Recbio or the Company; stock code: 02179.HK) is an innovative vaccine company driven by self-developed technologies. We are dedicated to the R&D, production and commercialization of innovative vaccines, leveraging our core technology platforms (novel adjuvant, protein engineering, immunological evaluation). Staying true to the mission of "Protect human health with best-in-class vaccines", the Company has established high-value pipelines consisting of several blockbuster vaccines with proprietary rights to satisfy the huge unmet demands in the markets of high-burden diseases. Through years of devotion to the vaccine industry, Recbio has developed three advanced innovative technology platforms, namely novel adjuvant, protein engineering and immunological evaluation platforms, and become one of the few companies in the world capable of developing novel adjuvant systems. We develop promising vaccine candidates constantly, taking advantage of the synergy between the novel adjuvant platform, optimized antigen designs, and immunological evaluation technologies. Recbio never ceases to optimize its technology platforms, and strives to achieve breakthroughs in mRNA vaccines using a joint venture model. With robust R&D capacity, the Company has developed high-value innovative vaccine portfolios consisting of ten-odd differentiated vaccines, covering cervical cancer, shingles, COVID-19, TB and other high-burden diseases. Our core product REC603, a recombinant 9-valent HPV vaccine in Phase III clinical trial, shows great promise of becoming the first marketed domestic 9-valent HPV vaccine. Apart from that, ReCOV, a recombinant COVID-19 vaccine with its commercialization in the offing, has been recognized as one of the most competitive next-generation COVID-19 vaccines in the world. Recbio has a clear commercialization strategy aiming to penetrate the diversified global vaccine market. Honed and refined for ten years, Recbio is going to reap the rewards as several products are approaching commercialization. For more information, please visit . 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. Please refer to the announcements published by the Company on the websites of The Stock Exchange of Hong Kong Limited () or of the Company () for further details. If there is any inconsistency between this Presentation and the announcements, the announcements shall prevail. Jiangsu Recbio Technology Co., Ltd. Investor Inquiry: Email: [email protected] Tel: +86-0523-86818860 Media Inquiry: Email: [email protected] Tel: +86-0523-86818860

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment. Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death. “Pushing the boundaries of what pembro can do, or what PD1 can do, with another I/O agent has been something that’s very important for the field,” Merck CEO Rob Davis said during the call. Still, analysts had questions about how Merck will continue to maintain Keytruda sales, deal with patent exclusivity losses on the horizon, and transition the portfolio away from Keytruda dependence. Merck expects Keytruda to lose exclusivity in the US and China in 2028, in Europe in 2030 and in Japan in 2032, Davis said, adding that the pharma is confident in its combination “I/O-I/O” strategy along with its broader effort to move into earlier stage cancer treatment. “I think the movement of I/O-I/O, not just in the metastatic space, but especially in the early space, will become important. And the ability to do that, requires your first I/O of that I/O-I/O to be approved in the early space,” Davis said. “And that is why we are so excited about moving into earlier spaces with Keytruda because that allows us to execute in an I/O-I/O strategy in early-stage cancers.” In other drug development advances, Merck Research Laboratories president Dean Li advised more data are coming on cardiovascular candidate sotatercept for pulmonary arterial hypertension at the American College of Cardiology (ACC) conference in March. He said Merck is talking to the FDA about a possible submission of rolling data “which is likely to result in a potential approval in early 2024.” Sotatercept is a daily pill aimed at lowering LDL cholesterol, Li said. In response to an analyst’s question about the potential burden of a daily oral, cardiologist-trained Li said, “Personally speaking, as someone who practiced as recently as five years ago, if I had an oral PCSK-9 LDL-lowering pill back then, I would be prescribing it with the other three to four oral pills that I’m prescribing an individual.” Overall, Merck reported 2022 total sales of $59.3 billion, marking a 22% growth year over year. Merck noted that if its Covid treatment Lagevrio, or molnupiravir, sales were excluded, growth would have been 12%. While Keytruda’s $20.9 billion (22% increase year-over-year) led Merck’s portfolio of gainers, HPV vaccine Gardasil sales jumped 27% to $6.9 billion, while breast cancer med Lynparza grew 18% to $1.12 billion. Sales of Lenvima, which is approved in combination with Keytruda to treat both endometrial and renal cell cancer, also grew by 28% for sales of $876 million in 2022. Merck forecast 2023 sales between $57.2 billion and $58.7 billion, which would mark a 2% to 4% decline over 2022.