mRNA Covid-19 vaccine (Jiangsu Recbio Technology Co., Ltd.)

The nine-valent HPV vaccine and other blockbuster varieties have been advanced efficiently. Cash reserve was nearly RMB 1.5 billion, which provided support to sustainable innovation and commercialization. The novel adjuvants vaccine will create a strong growth engine. TAIZHOU, China, Aug. 29, 2022 /PRNewswire/ -- Recbio (HKEK:02179), an innovative vaccine company, released its interim result for the fiscal year 2022 in the evening of August 25. During the reporting period, the company efficiently advanced its core products, including nine-valent HPV vaccine and multiple vaccine candidates, and made significant progress. Therefore, the R&D expenses increased by 73.05% to RMB 354 million on a year-on-year basis. Phase III clinical trials of nine-valent HPV vaccine have been advancing rapidly. The demand for import substitution was strong. HPV vaccines currently comprise the largest component of Recbio pipeline portfolio, including five bivalent, newly adjuvant-based quadrivalent and nine-valent HPV vaccines. The Phase III clinical trial of recombinant 9-valent HPV vaccine REC603 in China was composed of three parts: main efficacy test, immune bridging test in young age groups, and immunogenicity comparison test with Gardasil 9. The trial was multicenter, randomized, blind and parallel controlled, with a total sample size of 16,050 subjects. This was the largest sample size of nine-valent HPV vaccine in Phase III clinical practice in China. At present, REC603 main efficacy trial is in the follow-up stage according to the protocol, and all subjects have been enrolled and inoculated in the bridging trials in the younger age group and head-to-head immunogenicity bridging trials with Gardasil 9. Phase I clinical data of REC603 showed that REC603 was safe and well tolerated with good immunogenicity. The high yield and stable expression of HPV virus-like particles can be satisfied by using the Humphrey's yeast expression system, which makes this vaccine candidate more suitable for commercial production. The demand for HPV vaccines, especially high-end HPV vaccine products, remains strong in China. The total volume of HPV products Gardasil and Gardasil 9 by MSD issued in China in 2021 reached 8.8 million and 10.2 million, respectively. Global sales of Gardasil/Gardasil 9 increased 40% to $5.673 billion, driven by the Chinese market. At present, no domestic nine-valent HPV vaccine has been approved for sale in China. China continues to face a manufacturing capacity bottleneck for HPV vaccines. It is estimated that 234 million women aged 9 to 45 years will remain unvaccinated by the year of 2025, leaving a gap of 702 million doses assuming a three-dose regimen. Based on the leading Phase III clinical progress, the largest sample size of nine-valent vaccine subjects in China, and the clinical trial site with higher incidence, REC603 is expected to become the first domestic nine-valent HPV vaccine approved for sale, realizing the domestic substitution of imported HPV vaccines and alleviating the situation of " supply falls short of demand ". In addition to the nine-valent products, REC601, a bivalent HPV vaccine (type 16/18) from Regbio, has completed Phase I clinical trials with data showing good safety and immunogenicity. The bivalent HPV vaccine (type 6/11) REC602 has been in Phase I clinical data analysis. REC602 is the most effective medical intervention for HPV-induced genital warts (male market), which cause high disease burden and have no effective treatment. In addition, Recbio new adjuvant quadrivalent HPV vaccine REC604a has completed preclinical studies and will IND in the second half of this year. With efficient and sustainable business development, the new adjuvant platform has huge potential. As a whole, the pipeline also covers COVID-19 vaccines, shingles vaccines and other major disease areas which bring great global public health burden. During the reporting period, the recombinant COVID-19 vaccine ReCOV made steady progress. Equipped with BFA03, a new adjuvant independently developed by the company, ReCOV can induce high-titer broad-spectrum neutralizing antibodies and Th1-biased T-cell immune response, which has good cross-neutralizing effect and immune persistence against Omicron, Delta and other variant viruses. At present, the company has carried out international Phase II/III clinical studies in the Philippines and the United Arab Emirates, and obtained clinical approval from China Food and Drug Administration. The Phase II study of the basic immunization of ReCOV in the Philippines is in the data analysis phase. Preliminary data showed that the overall safety and tolerability were pleasing , and no serious vaccine-related adverse reactions occurred. In the Phase II booster immunization study in the Philippines, the immunogenicity study of ReCOV versus Pfizer mRNA vaccine as a positive control took only 2 weeks from the receipt of approval to the completion of vaccination in all subjects. The company plans to submit the EUA simultaneously in China and overseas markets in the second half of 2022 to contribute to the global containment of COVID-19. During the reporting period, the company's vaccine quality management system also achieved rapid development. The ReCOV production base located in Taizhou has obtained the conformance statement issued by the EU Quality Authorizer (QP), which indicates that the company's Taizhou production base and quality management system comply with the EU GMP standard, and lays a solid foundation for the high-quality development and future international commercialization of ReCOV. The subsidiary company Recogen took the lead in breaking through the lyophilization process of mRNA vaccines. The world's first lyophilized dosage form mRNA vaccine R520A was designed against Omicron variant and has been approved clinical trails by the Philippines and New Zealand. Preclinical research papers have been published on the preprint platform bioRxiv, and the data show that R520A can be stored and transported at 2-8 degrees Celsius, and has extensive cross-neutralization effect. New adjuvants have increasingly become an important bottlenecking technology in China's vaccine industry. Through its novel adjuvant development platform, Recbio is able to develop and iterate on FDA-approved adjuvants (AS01, AS03, AS04, MF59, and CpG1018). With this capability, Recbio is not dependent on any specific adjuvant supplier and is able to develop the next generation of novel vaccines with more clinical value. Its recombinant shingles vaccine candidate REC610 uses a novel adjuvant with AS01, which greatly improves cellular immunity. Head-to-head studies have shown that its immunogenicity is not inferior to GSK's Shingrix. During the reporting period, the company has continuously recruited high-quality talents in an orderly manner, and the staff has rapidly expanded to 478 people. Ms. Wang Jing, Chief Quality Officer, Ms. Feng Yanfei, Chief Business Officer, and other industry experts with rich experience in quality management and global business cooperation have joined Recbio, laying a solid foundation for efficiently promoting the market access and commercialization of candidate vaccines, including nine-valent HPV vaccine REC603 and COVID-19 vaccine ReCOV. At present, the company's cash reserve is nearly RMB 1.5 billion, which provide support to the company's research and development innovation and sustainable development. In terms of the execution of the R&D pipeline, cash reserves and the layout of high-end talents, Recbio has made full preparations to realize the commercialization and localization of high-end HPV vaccines and the technical landing of other major diseases. "In the context of the huge global demand for innovative vaccines, we will accelerate the commercialization process of products in the global market through continuous innovation and international cooperation, and promote the innovation of the whole value chain of product pipeline from R&D to commercialization, so as to create more value for shareholders and investors," said Dr. Yong Liu, founder, Chairman of the Board and general manager of Recbio. About Recbio Founded in 2012, Recbio is an innovative vaccine company. With the vision of "Become the Leader of Innovative Vaccine in the Future," Recbio takes "Protect Human Health with Best-in-Class Vaccines" as its mission. It has established three major cutting-edge technology platforms including novel adjuvants platform, protein engineering platform, immunological evaluation platform and mRNA vaccine platform. Recbio has a high-value vaccine portfolio consisted of HPV vaccine candidates, COVID-19 vaccine candidates, shingles vaccine candidates, influenza vaccine candidates, adults TB vaccine candidates etc. The core management team has more than 20 years of experience in the development and commercialization of innovative vaccines. 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: ir@recbio.cn Tel: +86-0523-86818860 Media Inquiry: Email: media@recbio.cn Tel: +86-0523-86818860 View original content to download multimedia: SOURCE Jiangsu Recbio Technology Co., Ltd. Company Codes: HongKong:2179

本文转载自江苏生物医药投融资大数据中心公众号文章：江苏创新｜2022年上半年江苏新药研发情况概览在药品审评体系改革的脚步中，2022年全国以及江苏省上半年国产药品申报、批准上市、新药研发的情况如何，最新数据统计如下：012022年上半年国产药品受理总体情况2022年1-6月份CDE共承办新的药品注册申请共计有2534个（以品种计,下同），其中化药1542个，生物制品423个，中药565个；江苏医药企业药品注册申请共计402个，占全国总量的15.86%，排名全国第一，其中受理化学药305个，生物制品受理71个，中药受理27个。图1: 2022年1-6月CDE受理江苏药企药品注册申报情况数据来源：江苏生物医药投融资大数据中心、药智数据整理022022年上半年国产创新药注册申请受理情况2022年上半年CDE受理全国1类创新药申请339个（以品种计,下同），江苏99个，涉及消化道代及代谢和血液和造血器官等领域。以药品类型统计，全国1类创新药注册申报中化药申请150个，生物制品申请169个，中药申请20个；江苏化药申请48个，生物制品申请46个，中药申请5个。以注册申请类别统计，全国受理1类创新药临床试验申请（以下简称IND）品种324个，1类创新药上市许可申请（以下简称NDA）品种17个；受理江苏药企1类创新药IND品种90个，NDA品种9个。图2: 2022年1-6月CDE受理江苏药企1类创新药受理情况数据来源：江苏生物医药投融资大数据中心、药智数据整理032022年上半年国产新药批准情况2022年上半年，CDE共批准上市1类及2类新药33个，其中1类新药11个。江苏1类及2类新药NDA共10款药品上市，其中1类创新药4个。表1:2022年上半年江苏药企1类及2类新药批准上市情况042022年上半年江苏省药企新药研发进展01瑞科生物2022年6月，瑞科生物宣布，公司研发的新型冠状病毒mRNA疫苗R520A获得菲律宾国家食品药品监督管理局的临床试验批准。R520A采用自行开发的冻干技术，可以有效地维持mRNA-LNP的理化性质和生物活性，并在2-8℃下实现长期储存。02南京凯地生物2022年5月，美国临床肿瘤学会（ASCO）2022年会摘要发布，多款国产CAR-T细胞治疗产品亮相，产品覆盖血液瘤及实体瘤，其中提及南京凯地生物构建了一种新型的双特异性CAR-T细胞(KD-496)，KD-496 CAR在体外和体内显示出卓越的抗肿瘤疗效和安全性，供试器官未见明显病理改变，目前该药物处于临床前研究阶段。03智核生物2022年6月29日，智核生物宣布，其自主研发的68Ga标记PD-L1的放射性显影剂药物 （SNA002），已获得中国国家药品监督管理局药品审评中心（CDE）的新药临床试验（IND）的临床试验默认许可。可实现精准筛选出对 PD-1 治疗有效的人群，指导肿瘤患者精准用药；打破有创取样进行免疫组化的传统检测方式，既减轻患者痛苦又能够根据疾病发展情况随时进行显影检查。此前，该药物已于今年4月获得美国食品药品监督管理局IND批准。04康禾生物近日，康禾生物宣布，其在研新药注射用K11获得国家药品监督管理局临床试验默示许可，适应症为促进软骨再生，可适用于骨关节炎、退行性软骨磨损等病变的治疗。康禾生物将于近期启动该药的1期临床试验。05荃信生物2022年5月，CDE官网显示，荃信生物的1类新药QX008N注射液获得临床试验默示许可，用于治疗哮喘及慢性阻塞性肺疾病。QX008N注射液是一款TSLP单抗，TSLP受体(TSLPR)属于造血因子受体家族成员，为I型细胞因子受体蛋白。06宜联生物2022年6月，宜联生物宣布，其自主研发的首个创新抗体偶联药物YL201在美国顺利完成临床I期试验的首例患者给药。该药物拟用于实体肿瘤的治疗，会在如非小细胞肺癌，前列腺癌和食管鳞癌适应症上探索研究。07苏州星曜坤泽近日，苏州星曜坤泽宣布，CDE正式受理了公司首个慢性乙肝治疗产品HT-101注射液的临床申请（IND）。星曜坤泽是由复星医药旗下复健资本新药创新基金孵化的创新肝病治疗平台公司，HT-101是一款GalNAc偶联的siRNA创新药物实体，主要针对乙肝表面抗原(HBsAg)的清除。08南京三迭纪医药近日，南京三迭纪医药宣布，公司首个3D打印药物产品T19获得国家药品监督管理局的药物临床试验（IND）批准。该产品在中国按照2.2类改良型新药进行注册申报，是已知公开的首个在中国获得IND批准的3D打印药物产品。该产品根据时辰治疗学原理，针对类风湿性关节炎症状的昼夜节律进行设计。患者睡前服用T19，血液中的药物浓度在疼痛、关节僵硬及功能障碍等疾病症状最严重的早晨达峰，并维持其日间血药浓度，从而取得最佳的药物治疗效果。09勤浩医药近日，由勤浩医药申报的1类新药GH55临床试验申请已经获得受理。与此同时，GH55的美国临床试验申请也在积极筹备中。体内外研究表明，GH55具有极高的活性和选择性，对多种不同的KRAS或BRAF突变肿瘤都有良好的体内药效，且代谢性质优异，口服生物利用度高，且安全性良好，具有较大的安全窗，是一个极具开发潜力的小分子抗肿瘤药物。江苏生物医药投融资大数据中心江苏生物医药投融资大数据中心是江苏省社会发展重大科技示范项目。中心通过运用大数据技术，采取线上线下联动方式，汇聚和整合各类创新资源，为江苏生物医药企业创新创业提供行业研究、路演对接、培训交流、上市培育等综合性投融资服务。官方网址：www.pharmedata.cn欢迎关注来源 | 江苏生物医药产业大数据服务中心（药智网授权转载）责任编辑 | 惜  姌声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。责任编辑 | 惜  姌媒体合作 | 17316793441（微信号：18323856316）转载授权 | 18523380183（同微信）发现“分享”和“赞”了吗，戳我看看吧