中天上海生技与合一生技共同授权特异性皮炎及气喘新药FB825予丹麦大厂利奥制药，签约里程金达5亿3000万美元
2020年4月15日，全球皮肤医学大厂利奥制药有限公司与合一生技及中天上海生技于丹麦巴勒鲁普/台北，共同签署异位性皮肤炎（AD）、过敏性气喘新药FB825合作研发与商化之全球独家授权协议。
FB825为全球首创新药，其独特药物机制能与过敏患者B细胞膜上免疫球蛋白E的CεmX片段结合，进而清除该类导致过敏的B细胞，如此一来可以降低病人体内的发炎介质和免疫球蛋白E值，治疗异位性皮肤炎。
利奥制药全球研发执行副总裁Kim Kjoeller博士表示:“在FB825的第一个人体功效试验上，我们看到其有效降低异位性皮肤炎面积及严重度指数（AD严重程度的指标），我们欢迎这个前景看好的创新候选药物，成为旗下之新药开发计划。”
“每一位AD患者的病症都不一样，满足该疾病全球医疗需求的努力远远不足，为此，利奥制药持续在AD治疗上增加多元的新药产品线，以提供各式药物和不同的治疗策略。”
中天生技集团总裁路孔明发言
根据协议，利奥制药将依约支付4000万美金的签约金，合计里程金共约5亿3000万美金，销售权利金将视销售金额由高额个位数到双位数不等。根据协议，合一生技将负责于美国执行异位性皮肤炎2a期临床试验，中天上海将于中国大陆执行过敏性气喘2a期临床试验。利奥制药将于这两项2a期临床试验后，承担后续药物开发之责任。
利奥制药简介
利奥制药以帮助皮肤病患恢复健康为宗旨，拥有强大的皮肤新药产品线，提供病患多样化的治疗方式，并凭借着创新精神，成为全球皮肤医学的领导药厂。利奥制药成立于1908年，由利奥基金会100%拥有，数十年来致力于皮肤医学研究及药物开发，为皮肤病患照护制定新标准。利奥制药总部位于丹麦，全球6000人的工作团队遍布 130个国家/地区，嘉惠9200万患者。2019年，利奥制药净销售额为108.05亿丹麦克朗。详情请至利奥官网 (www.leo-pharma.com)。合一生技简介
合一生技（TPEx：4743）在台湾柜买中心挂牌，投入糖尿病和免疫疾病相关的新药开发，满足全球未满足之医疗需求。除FB825外，合一生技的另一个重磅新药ON101，用于治疗糖尿病足溃疡，目前已完成了全球三期临床试验收案。根据第一次期中分析结果，ON101于16周内达到百分之六十以上的完全愈合率（p = 0.0065）。过去20年来，全球糖足溃疡三期临床试验均告失败。此外，合一生技的新药产品尚包括全人抗体抗IL-6、抗IL-33，与其他多项开发中新药。详情请至合一生技官网 (www.onenessbio.com.tw/en) 。中天上海简介
中天上海专注于癌症免疫和糖尿病药物的开发。中天上海将在中国大陆进行FB825有关过敏性气喘的二期试验。此外，中天上海透过其独特的微生物制药技术平台，进行核酸药物和微生态药物的研究与开发。中天上海自行开发微生物代谢研究库，包含数百种独特的厌氧共生细菌代谢产物，在糖尿病与癌症免疫疾病治疗上有重大发现，推动下一代新型药物开发更上一层楼。FB825简介
FB825为人源化单株抗体，专一性结合膜镶嵌型免疫球蛋白E上的CεmX片段，透过诱导细胞凋亡和抗体依赖性细胞毒杀作用（ADCC）杀死免疫球蛋白E阳性B淋巴细胞。FB825已规划执行两项二期临床试验，将于美国执行异位性皮肤炎试验，于中国大陆执行过敏性气喘试验。此外，FB825已取得美国FDA核准之高免疫球蛋白E症候群（HIES）孤儿药资格。异位性皮肤炎简介
异位性皮肤炎（AD），也称为“异位性湿疹”，是一种慢性发炎的异质性皮肤病，特征为强烈的瘙痒和湿疹性病变。
异位性皮肤炎是发达国家最常见的皮肤发炎疾病，美国、加拿大、欧洲和日本，多达百分之五的成年人饱受此疾病之苦。
气喘简介
过敏性气喘，因吸入过敏原而引发，是最常见的气喘类型。全世界约有三亿人为重度气喘患者，重度气喘使人衰弱，更可能致命，严重影响患者生活。不仅如此，重度气喘经常频繁严重发作，导致肺功能受损且生活品质不佳。新闻联络人
姓名：陈雅言 Cathy Chen
电话：0935200874
邮箱：cathy.chen@how-living.com
LEO Pharma Enters License Agreement with
Oneness Biotech and Microbio Shanghai for FB825
a Novel Atopic Dermatitis and Asthma Drug Candidate
BALLEUP, Denmark/TAIPEI, April 15, 2020 – LEO Pharma A/S, a global leader in medical dermatology, together with Oneness Biotech (Taiwan, TPEx: 4743) and Microbio Shanghai (China), biotech companies developing first-in-class drugs, announced today that they have signed a worldwide exclusive licensing agreement covering the development and commercialization of the novel Atopic Dermatitis (AD) and Allergic Asthma drug candidate, FB825.
FB825 is a first-in-class drug candidate with a unique mechanism of action (MoA) targeting the CεmX domain ofthe membrane bound IgE (mIgE) causing a depletion of mIgE positive B-cells. This new MoA holds promise as a treatment for atopic dermatitis and is expected to reduce the disease burden by lowering relevant inflammatory mediators as well as IgE levels.
“Having seen the first-in-human data of FB825 and the reduction in Eczema Area and Severity Index scores (an indicator of AD severity), we feel that we are welcoming a promising novel drug candidate into our development pipeline,” said Dr Kim Kjoeller, Executive Vice President, Global Research & Development, LEO Pharma. “No two patients are alike, and as there is a high unmet need weare committed to building a diverse pipeline that represents a broad range of molecules and mechanisms of action”.
LEO Pharma and both Oneness Biotech and Microbio Shanghai see great potential in FB825. If the anticipated treatment profile can be confirmed in the upcoming trials, the product can be expected to help a significant number of patients suffering from atopic diseases.
Under the terms of the agreement, LEO Pharma will make an upfront payment of USD 40 million and milestone payments up to USD 530 million, followed by a tiered high single-digit to double-digit royalties. Under the agreement, Oneness will be responsible for executing the Phase 2a study for Atopic Dermatitis in the United States and Microbio Shanghai will execute the Phase 2a study for allergic asthma in China. LEO Pharma will assume all the development responsibilities after the Phase 2a studies.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for peoplewith skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million. For more information please visit: www.leo-pharma.com
About Oneness Biotech
Oneness Biotech, a listed biotech company in Taiwan (TPEx: 4743), is dedicated to fulfilling the unmet needs in diabetes-related and immune diseases. Besides FB825, Oneness Biotech has another new drug, ON101 in diabetic foot ulcer that completed recruitment of its first global Phase 3 trial. According to its interim analysis, ON101 has achieved over 60% complete healing rate within 16 weeks (p=0.0065). In the past 20 years, all Phase 3 clinical trials in DFU have failed. In addition, Oneness Biotech’s pipeline further includes fully-human antibody anti-IL6, anti-IL33 and other new drugs under development. For moreinformation please visit: www.onenessbio.com.tw/en
About Microbio Shanghai
Microbio Shanghai (‘MBS’) is a company focused on immune and metabolic diseases. MBS will conduct Phase 2 trial of FB825 in allergic asthma in China. In addition, MBS is specialized in research and development into nucleic acid medicines and microbiome via its unique microbial pharmaceutical technology platforms. Its library with hundreds of unique anaerobic commensal bacteria metabolites has obtained significant findings in treatment of diabetes and immune diseases which takes it a further step into next-generation medicines.About FB825
FB825 is a humanized monoclonal antibody that binds to the CεmX domain of membrane form IgE, leading to depletion of IgE+ B lymphocytes by inducing apoptosis and antibody-dependent cellular cytotoxicity (ADCC). FB825 is scheduled to be tested in Phase 2 trials for Atopic Dermatitis in US and for Allergic Asthma in China. In addition, FB825 is granted an orphan drug designation by US FDA in Hyper IgE Syndrom (HIES).
About Atopic Dermatitis
Atopic dermatitis (AD) – also known as ‘atopic eczema’ –is a chronic, inflammatory, heterogeneous skin disease characterized by intense itch and eczematous lesions1,2,4.
AD is the most common inflammatory skin disease in the developed world5, affecting up to 5% of adults across the US, Canada, Europe and Japan6, 7.
About Asthma
Allergic Asthma, which is the most common form of asthma triggered by inhaling allergens. The severe form of asthma affecting an estimated 300 million3 individuals worldwide, is a debilitating, potentially fatal disease that has a significant negative impact on patients’ lives, often leading to frequent, severe attacks, reduced lung function and a poor quality of life.
参考资料
1. Nutten, S. Ann Nutr Metab 2015. Atopic dermatitis: global epidemiology and risk factors.
2. Weidinger S, Novak N. Atopic dermatitis. The Lancet. 2016; 387:1109-22.
3. Msaoli et. al., Allergy 2004.
4. Weidinger S & Novak N. Atopic dermatitis. The Lancet 2016;387:1109-1122.
5. Weidinger S et al. Atopic Dermatitis. Nat Rev Dis Primers 2018; 4(1):1.
6. Barbarot S, Auziere S et al. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy. 2018;73(6):1284-1293. doi: 10.1111/all.13401.
7. Barbarot S et al. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy 2018;73:1284-1293.
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