F-star Therapeutics, Inc.

DUBLIN--( BUSINESS WIRE )--The "CD137 Antibodies Clinical Trials & Market Opportunity Insight 2027" report has been added to ResearchAndMarkets.com's offering. CD137, also known as 4-1BB, has emerged as a promising target for cancer immunotherapy in recent years. The potential of CD137-targeted therapies lies in their ability to stimulate and expand cytotoxic T cells leading to improved tumor cell killing and long-lasting immune memory. As a result, the field has gained attention from researchers and pharmaceutical companies alike, with several research publications hinting at a promising future for this cancer therapeutic approach. Moreover, data emerging from early clinical trials have already begun demonstrating therapeutic benefits, providing real-time validation of CD137-targeted drug development. With no licensed medications currently on the market, CD137-targeted therapies are still in their infancy. Nonetheless, there is an abundance of candidates in the pipeline in different phases of clinical development, with phase 2 being the highest. Several major pharmaceutical companies and biotech firms, including BioNTech, Genmab, Adagene, and Shanghai Henlius Biotech, are actively pursuing drug development programs after recognizing the potential of this target. This presents a significant opportunity for both established players and newcomers in the field of immuno-oncology. The ability of CD137-targeted treatments to get past some of the drawbacks of existing immunotherapies, like immune checkpoint inhibitors, is one of their main advantages. Although checkpoint inhibitors have fundamentally altered the way that cancer is treated, only a small percentage of patients and cancer types respond well to them. The range of individuals who can benefit from immunotherapy may be increased by CD137 agonists, which may enhance or supplement the effectiveness of these currently available treatments. The most advanced CD137-targeted therapies in clinical development are agonistic antibodies. The intended effect of these compounds is to stimulate T cell survival, proliferation, and effector activities via activating CD137 signaling. Regarding anti-tumor effectiveness and safety characteristics, early clinical trials have produced encouraging results. YH004, ADG106, ADG206, and ATOR-1017 are a few CD137 agonistic antibodies that are now undergoing clinical trials. There have been challenges, nevertheless, such as dose-limiting hepatotoxicity seen in certain candidates. Due to this, other strategies are being investigated that might provide better safety and efficacy profiles, such as bispecific antibodies and tailored ligands. Combining CD137-targeted therapies with other immunomodulatory drugs is one highly intriguing area of investigation. CD137 agonists have been shown to have synergistic benefits when paired with checkpoint inhibitors, chemotherapy, targeted therapy, or even radiation therapy, according to preclinical research and early phase clinical evidence. These combination approaches may result in more potent and more persistent anti-tumor responses, which would fulfill the unmet demand for efficient treatments for malignancies that are challenging to treat. The market potential for effective CD137 antibodies is significant, considering the wide range of applications of CD137-targeted treatments in cancer. New and efficient treatment modalities are highly sought after, as the global market for cancer immunotherapy is expected to grow to many billions of dollars in the next several years. A sizeable portion of this market may be taken up by CD137-targeted treatments, especially if they show greater efficacy and can treat conditions where immunotherapies have not been very successful. Furthermore, the versatility of CD137 as a target extends beyond oncology. Recent studies point to possible uses in transplantation, autoimmune diseases, inflammatory disorders, and infectious diseases. This wide-ranging therapeutic potential could open up additional market opportunities for drug developers, willing to explore these indications. Despite the promising outlook, several challenges need to be addressed in the development of CD137-targeted therapies. These include optimizing dosing regimens to balance efficacy and safety, identifying predictive biomarkers for patient section, and developing strategies to overcome potential resistance mechanisms. Overcoming these hurdles will be crucial for the successful translation of CD137-targeted therapies from bench to bedside. In conclusion, CD137-targeted therapies represent a significant opportunity to transform treatment of cancer and various other diseases involving the immune system. The increasing comprehension of CD137 biology, in conjunction with developments in antibody engineering and combination strategies, offers a robust basis for novelty in this domain. CD137-targeted therapies have the potential to fill a significant gap in the medical community and gain a significant portion of the cancer immunotherapies market, which presents a strong case for development and innovation. CD137 Antibodies Clinical Trials & Market Opportunity Insight 2027 Report Highlights: Currently No Drug Commercially Available In Market More Than 80 Drugs In Clinical Trials Highest Clinical Trials Phase: Phase II (7 Drugs) CD137 Drugs Market Opportunity In Initial 24 Months Of Launch: > US$ 400 Million Global & Regional Trends (Clinical & Commercial) CD137 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase CD137 Therapeutic Approaches By Antibodies Classification Role Of CD137 & Clinical Progress By Indication Key Topics Covered: 1. Brief Introduction To CD137 1.1 Clinical Overview 1.2 Biological History Of CD137 1.3 CD137 Hosting An Era Of Agonists Over Antagonists 1.4 Bi-Directional Signaling In CD137 2. Global CD137 Antibody Market Outlook 2.1 Current Research & Market Scenario 2.2 Future Commercialization Opportunities 3. CD137 Antibody Clinical Developments by Regions 3.1 China 3.2 US 3.3 South Korea 3.4 Europe 3.5 Australia 4. Role Of CD137 & Clinical Progress By Indication 4.1 Cancer 4.1.1 Leukemia 4.1.2 Lymphoma 4.1.3 Lung Cancer 4.1.4 Melanoma 4.1.5 Breast Cancer 4.1.6 Colorectal Cancer 4.2 Autoimmune & Inflammatory Diseases 4.3 Microbial Infections 4.3.1 Viral Infections 4.3.2 Bacterial infections 5. Global CD137 Antibodies Clinical Trials Overview 5.1 By Company 5.2 By Country 5.3 By Indication 5.4 By Phase 5.5 By Patient Segment 6. CD137 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase 6.1 Research 6.2 Preclinical 6.3 Phase I 6.4 Phase I/II 6.5 Phase II 7. CD137 Targeting Proprietary Technology Platforms By Companies 8. CD137 Therapeutic Approaches By Antibodies Classification 8.1 Monoclonal Antibody Based Strategies 8.2 Bispecific Antibody Centered Approaches 8.3 Trispecific Antibody Established Strategies 8.4 Tetraspecific Antibody Strategies 9. Combination Therapies With CD137 Antibodies 10. Competitive Landscape ABL Bio Adagene Alligator Bioscience BeiGene Bicycle Therapeutics BioNTech Biotheus Crescendo Biologics Eutilex F-star Therapeutics Genmab I-MAB Biopharma Lyvgen Biopharma OriCell Therapeutics Pieris Pharmaceuticals Shanghai Henlius Biotech Sichuan Baili Pharmaceutical SystImmune For more information about this report visit https://www.researchandmarkets.com/r/uh1uil About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Levicept announced Tuesday that its first-in-class non-addictive analgesic candidate LEVI-04 met all primary and secondary efficacy endpoints of a Phase II study, demonstrating significant pain relief in patients with moderate-to-severe osteoarthritis at all evaluated doses.The drug is a proprietary p75 neurotrophin receptor fusion protein that inhibits neurotrophin-3 (NT-3) activity and restores neurotrophin balance in chronic pain states. “LEVI-04 provides analgesia…while avoiding the use-limiting side effects of anti-NGF antibodies,” commented Simon Westbrook, the biotech’s founder and chief scientific officer, adding that “the important trophic effects of the neurotrophins, including joint re-modelling” are still retained.The study randomised 518 patients with pain and disability from knee osteoarthritis, to receive either LEVI-04 0.3 mg/kg, 1.0 mg/kg, 2.0 mg/kg, or placebo. The primary endpoint is change in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale from baseline to week 17. Top-line results showed a significant reduction of over 50% in the WOMAC pain score at all three doses tested, compared with placebo. LEVI-04 also beat placebo on key secondary endpoints, including WOMAC subscales of joint function and stiffness, patient global assessment, and daily pain scores. The company noted that the drug was well tolerated, without an increased incidence of radiologically-indicated rapidly progressive osteoarthritis. Complete data will be published in a peer-reviewed journal at a later date.Westbrook discovered LEVI-04 during his stint at Pfizer and subsequently acquired the asset upon founding Levicept. Eliot Forster was appointed as the company’s CEO last year, after having served as the chief executive of F-star and Immunocore.

本次活动以“面向临床 成就产业”为主题，设一场主论坛和四场主题论坛，从技术创新、供应链、临床研究、审评审批、资本推动等多个角度推动细胞药物产品开发，加速细胞制药产业化进程。 1898年，戊戌变法失败，梁启超等一众知识分子登上大岛丸号军舰，于10月20日经广岛港踏上东京土地。 这是一个历史性时刻，标志着中国开始突破一国视野之局限，同时也预示了日本开始成为中国政治、经济等诸多方面的参考对象——强悍的亚洲小国似乎掌握某种造富密码，导向速成之径。 当下正经历产业周期的中国医药人，和一百多年前的维新者一样，都认为日本曾经“令人羡慕”。事实也确实如此。 20世纪80年代，日本的巅峰时刻，人均GDP赶英超美。医药业同样如日中天，十年间日本发现的新化学实体（NCE）达到130个，占该时期全球发现的29%，同时，日本NCE产值占GDP比重高于美国。 现在，即使经历了政治打压带来的数十年“失落期”，日本制药产业也依然是体型不小的瘦骆驼。 由于本土市场利润微薄，全球业绩成为其主要的产业经济来源。比如常驻全球TOP20榜单的武田制药，2023年全年营收42638亿日元，其中只有约10%来自本土市场，51%营收来自美国，其次是欧洲、加拿大等全球市场。 中国医药企业极少能占有如此规模的全球市场，CXO龙头药明康德去年赚到的400多亿元倒是有八成来自于境外市场，但服务商的角色，转眼就变成了地缘政治火力的活靶子。更牢固的国际化通路，指回创新药的全链条出海。 有人说，中国医药产业正在重演日本三四十年前的光景，时间差赋予了日本医药产业史更多参考价值——日本医药产业可以说是其经济危机中非常有价值的避险板块。 从日本股市日经指数来看，1983年到2012年，日本日经指数上涨114%，而同期医药指数上涨了312%。更重要的是，在日本经济衰落的几十年中（1992年到2012年），日经指数下跌25.6%，而医药指数却上涨了92%。这20年中，有14年医药指数都跑赢了日经指数。 这个数字，是否让忧心宏观经济影响的医药人，短暂松了一口气？进一步追问发现，日本医药产业当日能够逆势实现增长，主要原因在于“国际化”，但是是指坚挺的国际市场份额带动资产回流，而非核心技术资产被外资集中收割，这也是中国医药人最关切的要题。 当然，作为方法的日本，其上世纪医药产业大航海时期的策略，并不适宜中国医药产业直接“拿来”，但却在源头创新、成果归属、地缘政治危机等方面予以提醒。且看下文。 1 最后一根稻草：药价控制 中日医药政策端变化相似度较高，最初的时差达约三四十年，但目前正飞速缩小。 比如，日本1960年前后建成全民医保体系，中国在2013年实现。日本在90年代参与建立ICH，中国在2017年加入。 近十年内，中国医药政策端密集完成的一系列改革，诸如一致性评价、引入MAH制度、药价管理等，在日本对应的时段为上世纪80年代开始的三十年。 日本医药行业在80年代迎来蓬勃发展期，这是一个关键节点。 在此之前是日本创新药的酝酿期——40年代，日本开始承认药品专利；60年代，为了鼓励创新发展，日本政府出台创新药享受药品高价政策。加上政府对外资企业的限制措施（如西方药品需要通过本土企业代售等），促使本土me-too药物涌出，日本制药产业迎来第一波繁荣。 支付方的问题紧接着浮出水面。日本70年代初期时65岁老年人占比就已超7%（与2000年时中国的情况一致），且增速惊人，全国医疗开支负担越来越重，于是日本政府控制药品费用——1988年起，日本政府规定全国药价每两年降价一次，每次平均降幅需超过6%。 药企的利润空间被大大压缩，大药企几近“为爱发电”，小药企更是看不到商业化希望。 巨头武田制药两款重磅产品（头孢替安和头孢甲肟）均降价超12%，其市场占有率超40%的维生素产品在政策打压下对销售额的贡献只剩9%。 药品控费政策施行一段时间后，欧洲或美国单一地区的药品利润空间，甚至超过日本地区的三倍以上。严格的医药利润管制打击了资本方的投资热情，进一步影响制药公司的存亡。最辉煌时日本曾有1700余家医药企业，其中四成倒在新世纪以前，还有四成消失在2015年以前。 对于那时的日本药企来说，商业化情况或比中国当下更为严峻。出海拓展全球市场，或依靠外资似乎更有“活下去”的可能。 日本医药产业第一波大规模出海就发生在这样的历史背景下，主角是me-too产品。这时的日本医药企业，由于此前代理销售欧美外资企业药品而建立了广泛的合作网络，且手握不少优质分子。 2 决定命运的关键：创新动力 武田制药、卫材、第一三共、安斯泰来等作为日本医药产业出海的佼佼者，共同的特点是：注重海外市场的主导权，及时转向创新投入。 出海BD交易的方式有很多种，为的是创新资源的抓取和整合。归结到“买”与“卖”上，可以买公司、买产品、买权益，也可以“卖”。资金充沛的体量中大型药企可以考虑在外建厂、收购海外企业实现快速出海。 2022年前后，我国生物医药界曾迎来一波对外投资潮：复星医药出手买下了新加坡最大的私立肿瘤专科医疗中心OncoCare；中国生物制药拟斥资逾1.6亿美元收购F-star Therapeutics，补全抗体药物管线；凯莱英宣布以约5794万美元收购美国Snapdragon Chemistry，等等。 从数量比例上来说，中国当下Biotech占多数，资本寒冬后，这部分企业当下更关注的是跨境出售，大多交易集中在产品权益上。 上世纪80年代，日本药企出海主力军是资金雄厚的大型药企，主要依托仿制药和me-too药物，手段主要有建立合资公司、代理销售、专利授权、股权投资等。但为了应对瞬息万变的市场形势，出海策略随时应变。 深谙“买买买”才能成为大型跨国药企的道理，武田制药是me-too药物出海潮中的代表者，前期通过联合研发和销售实现全球市场扩张。 1985年，武田与雅培共同成立联合投资公司Takeda Abbott Products（TAP Pharma），通过TAP Pharma，两家公司在美国推出亮丙瑞林。同年，武田在北卡罗纳州开办了一家工厂，主要生产维生素类产品。在雄厚的资本支持下，武田先后与GSK、诺和诺德和礼来等企业达成合作，建立天津武田、英国武田、爱尔兰武田、美国武田等众多分公司。在海外市场相继推出兰索拉唑、坎地沙坦和吡格列酮等多款重磅me-too产品。 90年代me-too药物的成功出海让日本企业规模迅速扩大，这一波浪潮的影响在2010年前后达到最大化，日本五大药企先后进入世界Top30，武田迈入Top15。 然而，FDA很快收紧了me-too药物的审批，这使日本药企在海外市场的扩张受到限制，创新势不可挡。想在国际市场站稳脚跟的日本大药企，一边面对即将到来的专利悬崖，另一边是终于要直面长期跟随导致自身源头创新动力不足的致命问题。 然而，武田制药内生创新力依然严重掣肘，只能疯狂并购以弥补创新差距。在2000-2018年期间，武田的研发投入共约为448亿美元，并购支出却达880亿美元。有人说，武田的内核已非日本药企，困在无限的国际并购里。 不得不提武田与夏尔约622亿美元的收购案，该事件曾引起一波关于收购性价比的讨论。路透社的一篇文章认为，这笔交易并没有给武田股东带来任何价值，但不可否认的是该交易使武田大大降低了对日本的依赖，提高了来自利润更丰厚的美国和欧洲市场的收入份额。 另一家日本大型药企——第一三共，在并购出海潮时略显落后，情急之下快速收购了兰伯西，试图借此进入美国仿制药市场。然而兰伯西在收购完成后被FDA突击检查发现数据造假，使第一三共蒙受巨大亏损。 此前“失败”的收购却为第一三共带来了生物仿制药开发中的抗体生产技术，利用该技术深挖ADC药物研发，促使第一三共抓住了ADC创新风口，在创新主导的国际市场中拥有一席之地。 3 更复杂的局面 Me-too的时代已经过去，低垂的果实所剩无几，中国医药产业所面对的全球环境，对创新浓度要求更高。从微创新到源头创新，中国创新药产业还有很长的路要走。 中国生物医药行业相比此前的日本体量更大，构成更多元。从药物研发规模来讲，中国医药企业拥有丰厚的资源和庞大的规模，Citeline发布的《2023年医药研发年度回顾》显示，截至2023年1月，中国拥有正在开发中的药物管线5033个，占全球总管线比例23.6%，仅次于美国，位列全球第二。 目前，出海主力军是Biopharma和Biotech对外授权，占比近70%。但传统中大型药企往往聚焦国内市场，国际化布局不足。 若想打通全球市场，同时守住创新果实。往往需要传统药企、Biotech、Biopharma多元产业主体互相配合、联合出海，狠下心投入资金以建立可复用的商业路径，掌握创新产品国际化的主导权。 至少，中国创新药的土壤首先需要孕育出几家国际化的大型药企。 一个可见的优势是，得益于中国医药行业规模和工程师红利时代，当下可选择的出海目的地更多样化，既可以向美国、欧洲等创新高势能地区出海，也可以向“一带一路”沿途低势能地区出海。 地缘政治因素或许是一种“不可抗力”，但未必会带来绝对的负面影响。在刚落幕的同写意T20大会上，也有专家提及，《生物安全法案》事件后，中国CXO反而签了更多海外订单。 80年代的日本“全民出海”时代也曾吸引西方政治力量的打压。1985年，美、日、德、英、法在美国广场国际大酒店达成“广场协议”，强迫日本货币升值，允许美元单方面贬值，以此来牵制日本产业的对外扩张。而医药产业凭借其独特的科学属性，依然能适应环境逆势生长。 显然，从当下创新实力来看，中国医药产业手握更多筹码。无需过度担心“脱钩”，国际化趋势不可逆。 更多优质内容，欢迎关注↓↓↓