Human papillomavirus 9-valent vaccine, recombinant (Merck Sharp & Dohme)

TAIZHOU, China, March 20, 2024 /PRNewswire/ -- Innovative vaccine company Recbio (02179.HK) announced its latest progress and annual results for 2023. The company always adhered to the mission of " Protect Human Health With Best-In-Class Vaccines", and achieved the following milestones and progress in research pipeline and business operations. BUSSINESS HIGHLIGHTS REC603-Recombinant HPV 9-valent Vaccine We are in the process of conducting phase III clinical trial of REC603 in China and follow-up is being conducted in accordance with the clinical protocol. We have completed the 24th month follow-up visit and are conducting the 30th month follow-up visit observation. We plan to take the pathological endpoint for interim analysis and submit BLA application after meeting the conditions. The "Technical Guidelines for the Clinical Trials of Human Papillomavirus Vaccines (for Trial Implementation)" issued by the Center for Drug Evaluation of NMPA clearly states that "randomized, double-blind, placebo-controlled design is currently the best strategy to confirm the protective efficacy of first-generation vaccines". Our phase III clinical protocol for the 9-valent HPV vaccine strictly follows the guidelines of the regulatory authorities; and we have the largest HPV 9-valent phase III clinical trial subjects in China and are conducting clinical trials in Henan, Shanxi and Yunnan provinces with high HPV infection rates. Currently, the Company is conducting follow-up visits according to the established protocol, maintaining ranking among the leading group in China in term of the clinical development progress. We are actively promoting the commercialization of recombinant HPV 9-valent vaccine REC603 in overseas markets. In January 2024, we have signed the framework agreement with SPIMACO, a pharmaceutical company in Saudi Arabia, for the recombinant HPV 9-valent vaccine REC603 and entered into an authorization and strategic cooperation. According to the agreement, we exclusively license SPIMACO to develop, register and commercialize recombinant HPV 9-valent vaccine REC603, in 15 Middle East and North Africa countries, including Saudi Arabia. In addition, we have successively achieved intention of cooperation with partners in the United Arab Emirates, the Philippines and India on the recombinant HPV 9-valent vaccine to jointly promote clinical registration and market expansion. REC610 – Novel Adjuvanted Recombinant Shingles Vaccine We have completed enrollment of all subjects in the phase I clinical trial in China. The study proposes to adopt a randomized, double-blind, parallel controlled design for enrolled 180 healthy adult subjects aged 40 and above in Pu'er, Yunnan Province to evaluate the safety, tolerability and immunogenicity of REC610. REC610 has obtained the Notice on Drug Clinical Trial Approval (notice number: 2023LP02151) issued by the NMPA in October 2023, which is authorized to carry out phase I and phase III clinical trials in China as a Category 3.3 biological product for preventive use. Positive results from the first-in-human ("FIH") clinical trial interim analysis in the Philippines. Previously, the Company's REC610 commenced the FIH clinical trial with GSK Shingrix® active controlled 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. REC625–Novel Adjuvanted Recombinant Respiratory Syncytial Virus Vaccine The REC625 is equipped with the novel adjuvant BFA01 independently developed by us and intended to prevent the diseases caused by respiratory syncytial virus infection in the elderly population. Preclinical studies have shown that REC625 has favorable immunogenicity and can induce high levels of specific neutralizing antibodies, and its immunogenicity is comparable to that of international mainstream varieties. The project adopted our independently designed vaccine antigen structure and relevant invention patents application has been submitted. We plan to complete the preclinical studies of this project in 2024. Others The two independently developed novel adjuvants, BFA01 and BFA03, have been successfully included in the adjuvant supply pool managed by the Coalition for Epidemic Preparedness Innovations ("CEPI") due to their significant advantages in efficacy and safety, as well as their commercial-scale industrialization capabilities, to meet the demand for innovative adjuvants from vaccine developers around the world. We actively promote the cooperation of adjuvant empowerment and work with partners to achieve the upgrade and iteration of vaccines, and will share the incremental value of innovative varieties in the future. We have successively signed joint development agreements with two industry chain partners to provide innovative adjuvants and related technical services to jointly develop novel adjuvant respiratory syncytial virus vaccine and novel adjuvant rabies vaccine. FINANCIAL HIGHLIGHTS Cash and bank balances Cash and cash equivalents were approximately RMB 912 million as of December 31, 2023, compared to RMB 1.325 billion as of December 31, 2022. R&D and administrative expenses Operating expenses (R&D and administrative expenses) in 2023 were RMB 631 million .Compared to 2022, the reduction was approximately 27.55%. Loss for the year The loss for the year was approximately RMB 572 million, narrowed by 22.22% year-on-year 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. 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

Pictured: Merck & Co. headquarters in Silicon Valley iStock/Sundry Photography Merck has unveiled plans to ramp up its human papillomavirus portfolio with a new vaccine, starting a trial launch in the fourth quarter of this year, the company announced Wednesday at the EUROGIN 2024 HPV Congress. The new multi-valent HPV vaccine aims to give broader protection against multiple types of the viral infection. According to Merck, the company has been working to identify new candidates to protect against a more comprehensive array of HPV, with its latest addition to the pipeline using its virus-like particle technology to incorporate more particles and expand coverage. This includes several types that impact Asian and African populations and those of African and Asian descent. Merck is also planning to conduct trials in male and female patients to evaluate the safety and efficacy of a single-dose regimen of Gardasil 9 versus the approved three-dose regimen. “Evidence continues to emerge showing the importance of Gardasil and Gardasil 9 to public health,” Merck CMO Eliav Barr said in a statement. “These significant investments build upon our leadership and importantly provide the opportunity to further impact the global burden of certain HPV-related cancers and disease.” Merck is planning for two separate clinical trials in males and females between 16 and 26 years of age to examine a single dose’s short- and long-term efficacy and immunogenicity. The trials are expected to enroll patients in the fourth quarter of 2024. The vaccine is currently cleared for females aged nine through 45 years to prevent several types of cancers caused by HPV types, including cervical, vulvar, oropharyngeal, and head and neck cancers. Gardasil and Gardasil 9 are key earners for Merck, as the vaccine pulled in over $8.8 billion in revenue in 2023, a 29% increase from 2022. However, Merck is not stopping with just HPV vaccines. The company is looking to challenge Pfizer in the pneumococcal vaccine arena as the FDA granted priority review for a Biologics License Application for V116, Merck’s investigational 21-valent pneumococcal conjugate vaccine, with a PDUFA date set for June 17, 2024. Merck is also working with Moderna to create a combination of its cancer drug Keytruda and an mRNA vaccine, which has shown improvement in melanoma at the three-year mark. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.