Fidelta doo

近日，由知名生物技术投资者Oleg Nodelman管理的生物技术对冲基金Ecor1 Capital已将其在比利时制药商Galapagos NV的持股比例增至9.9%，在这家制药商长期经营困难的背景下，此举表明Nodelman可能想要干预公司决策。 Ecor1在上周五向美国证券交易委员会（SEC）提交的文件中表示，Galapagos的股票“被严重低估，这是一个有吸引力的投资机会”。该文件披露了Ecor1增持Galapagos股份的情况。此外，文件还称，Ecor1打算就与公司“业绩、业务、运营、战略机遇和治理（包括董事会构成）”相关的各种话题与Galapagos的管理层和董事会进行沟通。 陷入重重困境的Galapagos 1999年成立的Galapagos曾被视为欧洲最成功的新药开发者之一，公司市值一度高达50亿欧元，曾位列欧洲Biotech市值前列，但由于一系列研发失败、药品被拒以及合作关系，该公司陷入了困境。 这一困境的核心问题就来自于核心管线filgotinib，这款管线最开始是由雅培（艾伯维）和Galapagos联合开发，但后来雅培放弃了合作，退还了权益，专心开发自己的竞品upadacitinib。虽然遭到退货，但是Galapagos仍然将filgotinib作为炎症领域的核心管线开发，后来找上了新买家吉利德。 2019年时，吉利德和Galapagos达成了关于JAK1抑制剂filgotinib的合作协议，首付款高达7.25亿美元。 然而，仅仅过去1年，在美申请上市时，用于治疗克罗恩病的filgotinib却遭到了FDA的拒绝，这对公司和其合作伙伴吉利德科学公司的股价造成了重大影响，迫使Galapagos不得不出售了旗下的CRO公司Fidelta，吉利德也因为股价受到严重影响，双方因此“分手”。 FDA当时担忧的是filgotinib的睾丸毒性，还有高剂量下的血栓问题，要求该公司用III期临床的另外两项中验证。 后来，克罗恩病关键III期临床果然失败，Galapagos无奈之下只能将filgotinib权益转手卖给Alfasigma公司，开始转型之路。 转型之路再度受挫 转型之路的掌舵人是传奇药物猎人、比利时人Paul Stoffels，他在强生公司（J&J）任职20年后短暂退休，随后在2022年出任Galapagos的首席执行官。 Stoffels承诺重塑Galapagos的研发工作，主要聚焦癌症CAR-T疗法，但这项工作进展缓慢，且从华尔街的角度来看，并无太多亮点。 祸不单行的是，临床还出了问题。 8月初时，Galapagos公司在其第二季度财报中宣布，将暂停该公司BCMA-CAR-T GLPG5301的所有临床。导致临床暂停的原因是一名患者出现了帕金森综合症，受到这一消息影响，Galapagos公司的股价截止8月2日收盘下降了约5%。 虽然不知道为何CAR-T会导致帕金森，这仍然是个相当危险的信号。虽然之前确实有CAR-T治疗过程中出现帕金森症，但出现临床暂停的还是首例，考虑到研究团队对于患者群体的担忧，这可能预示着BCMA有可能表达于患者纹状体，最终导致BCMA-CAR-T脱靶进而导致帕金森。 而目前Galapagos的企业价值为-21亿美元，这意味着：尽管公司可能拥有大量现金或其他有价值的资产，但市场对这些资产的估值可能远低于其实际价值，或者对公司的未来前景持悲观态度，从而导致企业价值出现负数。 Ecor1 Capital在这种情况下，进行干预可能是必要的。

▲3月7-8日 成都生物医药创新者峰会 · 点击立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。2023年10月30日，Galapagos宣布已和Alfasigma签署意向书，将Jyseleca业务转让给Alfasigma，包括欧洲和英国的营销授权、Jyseleca的商业、医疗和开发活动以及在14个欧洲国家的约400个职位。在拟议的交易中，Galapagos将获得5000万欧元的首付款、潜在的里程碑付款总额为1.2亿欧元以及欧洲销售额的中个位数至中两位数的特许权使用费。到2025年6月之前，Galapagos将向Alfasigma支付高达4000万欧元，用于Jyseleca的相关开发活动。此外，Galapagos还计划精简剩余业务，进一步提高效率，公司预计每年可节省1.5~2亿欧元。Jyseleca（filgotinib）是Galapagos和吉利德共同推出的JAK产品，2020年在欧洲和日本获批用于类风湿性关节炎，2021年在欧洲获批用于治疗溃疡性结肠炎，目前已在十多个国家/地区获批用于治疗类风湿性关节炎（RA）和溃疡性结肠炎（UC）。2012年，Galapagos曾与艾伯维合作开发filgotinib，但艾伯维在2015年退出后专注于内部药物Rinvoq（乌帕替尼）的研究。随后几个月，Galapagos就与吉利德签署协议进行该药物的进一步商业化，2020年底，filgotinib遭遇FDA批准的重重障碍，Galapagos和吉利德的股价分别下跌了29％和7％，Galapagos不得不出售了旗下的CRO公司Fidelta，而吉利德也调整了与其大部分合作。2023年2月，Galapagos公布了DIVERSITY试验的顶线结果，这是一项临床试验3期研究，旨在评估filgotinib（100mg或200mg，每日一次）在中度至重度克罗恩病（CD）患者的诱导和维持治疗中的安全性和有效性。该研究中的两个诱导队列均未达到filgotinib 100mg和200mg每日一次的临床缓解和内窥镜反应的共同主要终点。根据这些顶线数据，Galapagos决定不在欧洲提交上市许可申请。此次研究的失败，无疑是对陷入困境的JAK抑制剂造成了又一次打击。随后几个月，Galapagos只能将公司的唯一商业产品转让出去，进一步减少财政支出，以维系其他研究。Galapagos首席执行官兼董事长Paul Stoffels博士表示，转让Jyseleca的交易预计将释放公司的大量资源，公司能够在研发增长领域、业务发展和并购方面进行更多投资，这将支持并加速其转型为一家全球创新型生物技术公司，拥有一系列一流的药物，以满足大量未满足的需求。截止2024年1月8日收盘公司市值约28亿美元。https://companiesmarketcap.com/galapagos-nv/marketcap/01  公司介绍  药融云数据www.pharnexcloud.com监测显示：总部位于比利时的Galapagos创立于1999年，最初是Crucell和Tibotec的合资企业，2005年在纳斯达克上市。公司一直专注于小分子创新药物，疾病领域也聚焦在炎症、纤维化和肾脏疾病，2022年通过收购CellPoint和AboundBio，公司进军肿瘤学、CAR-T和生物制剂领域，作为公司战略转型的第一步，此次收购无疑加速了公司的管线多样化步伐。（注：CAR-T（Chimeric antigen receptor T cell，嵌合抗原受体T细胞）疗法，是指通过基因修饰技术，将带有特异性抗原识别结构域及T细胞激活信号的遗传物质转入T细胞，使T细胞直接与肿瘤细胞表面的特异性抗原相结合而被激活，通过释放穿孔素、颗粒酶素B等直接杀伤肿瘤细胞，同时还通过释放细胞因子募集人体内源性免疫细胞杀伤肿瘤细胞，从而达到治疗肿瘤的目的，而且还可形成免疫记忆T细胞，从而获得特异性的抗肿瘤长效机制。）自成立以来，公司总融资五轮，最近的一次是2019年7月，与吉利德科学达成了10年的全球研发合作协议，潜在金额高达50.5亿美元。根据协议，Galapagos获得39.5亿美元的预付款和11亿美元的股权投资。吉利德获得一系列创新的化合物组合，以及在欧洲以外所有国家开发和商业化当前和未来项目的独家权益。此次合作最成功的结果就是Galapagos前不久决定转让的旗下唯一商业化的产品——JAK抑制剂Filgotinib。药融云数据库：融资情况02  战略评估重新定位  曾经公司市值高达120亿欧元（约140亿美元），在经历重大研发失利之后。公司进行重大战略调整，现在的Galapagos主要专注于免疫学、肿瘤学和其他治疗领域的研究创新。在免疫学中的管线主要涉及类风湿性关节炎（RA）、溃疡性结肠炎（UC）、轴向脊椎关节炎（AxSpA）、皮肌炎（DM）和系统性红斑狼疮（SLE）。肿瘤学管线主要涉及非霍奇金淋巴瘤（NHL）、慢性淋巴细胞白血病（NHL）和多发性骨髓瘤（MM）。根据Galapagos之前的报道，Filgotinib针对中轴型脊柱关节炎的研究进行到临床试验3期，该OLINGUITO试验包括两项平行研究，主要评估Filgotinib在活动性影像学中轴型脊柱关节炎（r-AxSpA）和非影像学中轴型脊柱关节炎（nr-AxSpA） 患者中的疗效和安全性。2023年4月，OLINGUITO试验的第一批患者已经进行给药，预计2025年下半年将取得顶线结果。在临床试验2期研究中，filgotinib 200mg在第12周（主要终点）的强直性脊柱炎疾病活动评分（ASDAS）显著改善，并且在对常规治疗无反应的活动性r-AxSpA患者中具有令人鼓舞的安全性。（注：中轴型脊柱关节炎（AxSpA）也称为强直性脊柱炎，是一种慢性炎症性疾病，主要累及骶髂关节和脊柱，其特征是疼痛、僵硬和疲劳，通常导致功能障碍）Alfasigma将继续该药物后续的研发。GLPG3667是一种研究性、新型、口服、可逆和选择性酪氨酸激酶2（TYK2）抑制剂，目前正在开发用于皮肌炎（DM）和系统性红斑狼疮（SLE），均进行到临床试验2期。2023年5月23日，Galapagos宣布针对皮肌炎的GALARISSO试验的首位患者已接受给药，这是一项随机、双盲、安慰剂对照、多中心研究，旨在评估GLPG3667的有效性和安全性。将在24周内对大约62名成年DM患者进行每日口服GLPG3667 150毫克或安慰剂的研究。如果获得批准，该药物有可能成为皮肌炎的第一个选择性口服TYK2抑制剂。2023年8月28日，针对系统性红斑狼疮的GALACELA试验的首例患者已随机分配，该试验是一项随机、双盲、安慰剂对照、多中心研究，旨在评估GLPG3667治疗成人活动性SLE的疗效、安全性、耐受性、药代动力学和药效学。药融云数据库：基本信息注：特发性炎症性肌病（IIM）是一组罕见的、以肌肉炎症和多种肌外表现为特征的异质性自身免疫性疾病，通常为慢性或亚急性发作，主要包含多发性肌炎（PM）、皮肌炎（DM）、包涵体肌炎（IBM）等亚型。系统性红斑狼疮是一种慢性、炎症性、自身免疫性疾病，发病机制特征是自身反应性T细胞和B细胞激活时全身性丧失，这导致主要针对多种核抗原的致病性自身抗体的产生，沉积在组织中并激活补体，导致器官损伤。GLPG5101是第二代CD19/4-1BB CAR-T候选产品，以单次固定剂量静脉输注给药。目前正在开发用于系统性红斑狼疮（SLE）和非霍奇金淋巴瘤（NHL），针对系统性红斑狼疮的研究处于临床前阶段，针对非霍奇金淋巴瘤的研究进入到临床试验2期。2023年12月初，Galapagos宣布剂量扩展队列中的首批惰性淋巴瘤和套细胞淋巴瘤患者已经给药。（注：非霍奇金淋巴瘤是一种起源于淋巴细胞的癌症，最初的症状通常是淋巴结肿大、发热和体重减轻。）GLPG5201正在开发用于慢性淋巴细胞白血病（CLL），目前进行到临床试验1/2期，这是一项开放标签、多中心研究，旨在评估GLPG5201在复发/难治性淋巴细胞白血病（rrCLL）和小细胞淋巴细胞淋巴瘤（rrSLL）患者中的可行性、安全性和有效性。GLPG5301是一种自体第二代/4-1BB B细胞成熟抗原（BCMA）导向的CAR-T候选产品，在床旁以单次固定剂量静脉输注新鲜产品的形式给药。进行到名为PAPILIO-1的临床试验1期，这是一项开放标签、多中心研究，旨在评估GLPG5301在既往一线治疗后的复发/难治性多发性骨髓瘤（rrMM）患者中的可行性、安全性和有效性。PAPILIO-1研究主要评估安全性并确定临床试验2期的推荐剂量。临床试验2期主要目的是评估GLPG5301的疗效，以客观缓解率（ORR）衡量。2023年12月19日，Galapagos宣布PAPILIO-1研究的首位患者已经给药。（关联阅读：是中国创新药不行吗？）注：多发性骨髓瘤（MM）的典型特征是浆细胞肿瘤增殖，产生单克隆免疫球蛋白，浆细胞在骨髓中增殖，可能导致广泛的骨骼破坏伴骨质减少，以及溶骨性病变伴或不伴病理性骨折。03  财务状况 从药融云数据库获悉，虽然Galapagos在2020年之后推出了商业产品，但是相关的支出也在增多。目前整体的营收并没有那么乐观，2022年集团净收入为5.053亿欧元，运营亏损为2.675亿欧元，净亏损2.18亿欧元。药融云数据库：公司年报截止2023年9月30日的前三个季度Galapagos的总收入为4.489亿欧元，与上年同期相比增加了9%，包括Jyseleca在欧洲的净销售额8210万欧元，合作伙伴关系收入为3.668亿欧元。与Jyseleca净销售额相关的产品销售成本为1360万欧元；研发费用为3.122亿欧元，上年同期为3.641亿欧元，减少了14%；一般、销售和管理费用为1.822亿欧元；营业亏损总额为1900万欧元；截至2023年9月30日，当期金融投资以及现金及现金等价物为38.117亿欧元，而截至2022年12月31日为40.941亿欧元（不包括990万欧元的应收利息净收入），2023年前9个月现金和现金等价物以及流动金融投资共净减少2.824亿欧元。重申了Jyseleca 2023年全年净销售额指引为1.00~1.2亿欧元，2023年全年现金消耗指引为3.80~4.2亿欧元。参考：NMPA/CDE药融云数据，www.pharnexcloud.comFDA/EMA/PMDA；相关公司公开披露（除标注外，正文图片均来自企业官网）https://www.glpg.com/；https://www.bloomberg.com/news/articles/2023-11-14/paul-stoffels-j-j-s-former-top-scientist-bets-on-china-for-biotech-turnaround；https://www.fiercepharma.com/pharma/galapagos-scraps-applications-jyseleca-europe-and-slashes-sales-projection；https://www.fiercepharma.com/pharma/galapagos-filgotinib-flops-phase-3-crohns-disease-trial-gives-eu-crohns-indication；https://www.163.com/dy/article/HAI9QRGA0552ZMOH.html；https://www.yxj.org.cn/detailPage?articleId=312359；等等。 本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐 活动推荐  3月 • NDC x 2024新药创新者峰会  关键词：  ADC，改良型新药，小分子新药，GLP-1药物（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

KRAKOW, Poland, March 30, 2023 /PRNewswire/ -- Selvita S.A. [WSE: SLV] – one of the largest CRO (Contract Research Organization) companies in Europe has published a full-year report for 2022*. The Group reported record results for 2022, in excess of meeting the objectives of its ambitious development strategy for 2022-2025. In 2023 the Company is strengthening the base for further dynamic growth of its business scale. In 2022 Selvita (excl. Ardigen) generated EUR 75.4 million in revenue from commercial services, marking an increase of 29% y/y. EBITDA profit reached EUR 22.7 million, 41% higher than in 2021 (EBITDA margin reached 30.0%, 2.6 p.p. higher y/y). At the end of March, Selvita announced that it had completed construction of its new research space in Krakow, to which it is moving part of its high-margin drug discovery services business. Selvita's new research center is capable of providing workspace for approximately 250 scientists, marking a significant milestone in the Company's development and laying the foundation for the Company's continued organic growth. Selvita's backlog for 2023 reached EUR 43.3 million (as of March 28, 2023) and is 7% higher than the value reported a year earlier (as of March 24, 2022), despite a very high base. There are many indications that in 2023 the dynamics of contracting between quarters will be different than usual. The company is observing an increased caution from its customers, resulting in contracting for shorter periods, which makes it possible to count on extensions in subsequent quarters of 2023. Due to investments in infrastructure and team development, the Company entered 2023 with a higher cost base, which taking into account slowing growth rates, is putting pressure on margins. Today, Selvita is fundamentally positioned for continued strong growth, and the Management Board's priority is to return to high revenue growth and margin levels. Selvita is actively responding to this situation, focusing on identifying markets and customers with the largest research budgets, significantly intensifying sales activities in selected areas - primarily in the US market and towards big pharma. The Company is already observing the first effects of these activities and expects further positive results from the tactics adopted in the coming months. In parallel, the Company is taking advantage of this more challenging period to identify areas where optimizations can be made, and is improving its savings policies, which should have a positive impact on margins both in the coming quarters and in the long term. Boguslaw Sieczkowski, co-founder, major shareholder and Chief Executive Officer at Selvita, comments: - 2022 was a record year for us. We made good use of several years of excellent economic conditions, growing more than three times faster than our environment and more than quadrupling the scale of the business between 2019 and 2022. At the same time, we have built a solid base for further dynamic growth and are now focusing on increasing and diversifying our revenue base. There are many indications that this year the distribution of backlog between quarters will be different than usual. Thus, we expect growth rates to increase and margins to improve in the second half of 2023. Returning to the high dynamics of revenues and margin levels that we got our investors accustomed to is our top priority at the moment. Both biotechnology and pharmaceutical companies have high cash reserves and are gradually increasing their R&D spending, outsourcing an increasing portion of its activities. At the same time, access to new capital has been difficult for several quarters, making our clients more cautious with their budgets. This situation allows us to hope that as market sentiment improves, our clients will quickly return to bolder investments in R&D. In the long term, we operate in an attractive market, which gives us excellent prospects for growth. While funding for the global biopharmaceutical sector more than doubled in the pandemic years - 2020-2021 – in 2022 it dropped to the 2019 levels, with the largest amount of capital (more than 70%) going to companies in the U.S. market. In Europe, the U.K. market stands out positively. Selvita is very active in both these markets, based on its local sales offices in major biotech centers. Dr. Milosz Gruca, Executive Vice President and Chief Commercial Officer at Selvita, said: - We are trying to play on our numerous competitive advantages and focus on the most attractive markets and customers at the moment. We took the first steps towards strengthening sales back in 2022, and since the beginning of this year we have significantly intensified these activities. In 2022 Selvita completed the integration of Fidelta, the Croatian company, acquired in early 2021. Selvita has strengthened its market position, significantly increased its customer portfolio and introduced new high-margin services. At the same time, the Company continued to invest in team and infrastructure development. In March 2023, Selvita announced the completion of its new headquarters in Krakow, which constitutes nearly 4 000 sq. m. of new research space and can provide workspace for approximately 250 scientists. FINANCIAL PERFORMANCE AND MARKET ENVIRONMENT In 2022, Selvita's drug discovery services generated EUR 63.7 million (up by 24% y/y) and accounted for 84% of Selvita's commercial services revenue. Services in the area of regulatory research constituted the remaining part of commercial services revenues and amounted to EUR 11.7 million (up by 61% y/y). Dr. Milosz Gruca adds: - We are continuing very strong business development activities. While in 2022 we participated in more than 80 events, this year we plan to take part in more than 110 shows and conferences. We are working hard to strengthen our visibility and scientific recognition. The bioinformatics segment (Ardigen) generated in 2022 EUR 10.2 million in external revenues, indicating a 51% year-on-year increase. EBITDA in this segment of the business amounted to EUR 1.3 million. The company continues its intensive development investments. Starting in 2023, Ardigen will not be consolidated in Selvita's results. For the full year 2022, Selvita Group generated EUR 88.8 million in revenue, showing an increase of 31% year-on-year. EBITDA amounted to EUR 24.0 million (stable profitability at 27.0%), a result which is 32% higher than a year earlier. Net profit reached EUR 13.5 million (up by 28% y/y, profitability of 15.2%). In Q4 2022 alone, the Group generated EUR 23.1 million in revenue, up by 16% year-on-year. EBITDA amounted to EUR 5.6 million, and due to Ardigen's intensive investments, remained at a similar level to a year earlier. There are numerous indications that in 2023 the dynamics of contracting between quarters will be different than usual. Selvita's backlog for 2023 reached EUR 43.3 million (as of March 28, 2023) and is 7% higher than the value reported a year earlier (as of March 24, 2022), despite a demanding market environment and a high base. The Company expects intensified contracting in the second part of the year. The market in which Selvita operates is at the advanced stages of the longest and deepest cycle of restrictions on access to new financing seen in the last 15 years. Both biotech and pharma companies have high cash reserves, but due to heightened uncertainty, they are investing in R&D activities more cautiously, and what follows R&D outsourcing is also handled more cautiously. Selvita is expecting this situation to improve swiftly once market sentiment improves. Boguslaw Sieczkowski adds: - We are looking ahead to 2023 with a lot of caution but also optimism. We have taken numerous measures focused on business development growth, targeting the market sectors which are currently most attractive. At the same time, we are implementing various optimization measures, and have introduced cost-saving policies that will have a positive impact on Selvita's efficiency both in the coming quarters and further in the future. *The results do not include non-cash costs of the non-dilutive employee incentive program. Backlog as of March 28, 2023. About Selvita Selvita is one of the largest preclinical contract research organizations in Europe, driven by a clear mission: to offer a comprehensive scope of services bridging the gap between early drug discovery and the clinical stage of drug development. Selvita provides comprehensive solutions supporting Clients and their drug discovery projects, across a broad range of therapeutic areas, specializing in infectious diseases, inflammation, fibrosis, and oncology. The Company offers a range of stand-alone or fully integrated drug discovery and development solutions spanning the entire value chain from early drug discovery to preclinical development. On top of that Selvita also offers analytical support for drug development and contract testing studies. Selvita, established in 2007, operates globally with almost 900 highly qualified employees, of which over 40% hold a PhD degree. The Company's research sites are in Krakow (HQ), Poznan, Poland, and Zagreb, Croatia. The international offices are located in Cambridge, MA, and San Francisco Bay Area, in the U.S., as well as in Cambridge, UK. Ardigen, a bioinformatics company harnessing advanced Artificial Intelligence methods for novel precision medicine, is part of Selvita Group portfolio of companies. The company employs over 180 professionals. Selvita is listed on the Warsaw Stock Exchange (WSE: SLV). For more information, please see . SOURCE Selvita S.A.