Biopharma Forest Inc.

本文编译自FiercePharma《Top 10 drug launch disasters》 近日，FiercePharma推出了近五年获批上市的10款“最失败”新药，这些新药入选的原因一方面是因为上市后的销售明显低于预期；另一方面是因为尽管目前销售数据稳定，但正在遭遇重大挫折，其长期价值被质疑。 这10款新药的的适应证涵盖了肿瘤、免疫、传染病、眼科等多个领域，不仅有来自大的跨国药企，也有来自生物技术公司。具体原因也是多种多样，安全性、竞争力、定价……都是造成其“失败”的原因，FiercePharma希望通过这份名单，给业界以参考。 药物名称：Beovu       公司：诺华 首次获批：2019年10月 适应证：湿性年龄相关性黄斑变性 (AMD) 销售额预估：到 2021年43.8 亿美元 2020年销售额：1.9 亿美元 诺华的湿性年龄相关性黄斑变性 (AMD) 药物Beovu在上市前被认为对再生元的阿柏西普和罗氏的雷珠单抗构成了巨大威胁，但其安全性问题也使得这两家竞争对手找到了突破口。 2019年，Beovu初上市时，由于其给药间隔时间更长，患者用药更加便利，同时它的定价和疗效也与再生元和罗氏相当，市场分析人士对其抱有了很高的希望，有分析师认为，到2021年底，该药销售额将达到43.8亿美元，并将在2026年成为AMD药物销售额最高的产品。 但不幸的是，在后期的临床试验中，Beovu导致眼内炎症的概率是阿柏西普的四倍，甚至在2020年2月，美国视网膜专家协会 (ASRS)发出了安全警告，报告了14例Beovu用药发生眼内炎症的患者，其中11例患者的炎症足以导致视力丧失。 2020年4月，国外生物制药信息网站BioPharma Dive发布报道称，诺华已经证实Beovu具有更大的安全性风险，并认为 FDA 应该对该药物发出黑框警告。 2021年前三季度，Beovu的销售额仅为8700万美元，同比下降了16%。 药物名称：Dengvaxia       公司：赛诺菲 首次获批：2015年12月 适应证：登革热 销售额预估：到2020年10亿美元 2020年销售额：未披露 赛诺菲的登革热疫苗Dengvaxia的落败也是因为严重的安全性问题。 2015年，赛诺菲在全球多个国家获批上市了Dengvaxia，2016年，该疫苗在菲律宾首次进入大规模国家疫苗接种，但很快，赛诺菲披露了该疫苗可能导致未感染登革热的接种者可能会发生严重的不良反应。 菲律宾随后取消了接种计划，并要求赛诺菲退款。尽管如此，在已经接种的人当中，还是有儿童接种者死亡，2019年，菲律宾司法部起诉了赛诺菲。 安全性丑闻发生后，该疫苗再未得到大规模推广，甚至在2020年，赛诺菲都没有披露其销售额。 值得注意的是，根据赛诺菲此前披露，该疫苗的研发用了将近20年，斥资15亿欧元。 药物名称：Eucrisa      公司：辉瑞 首次获批：2016年12月 适应证：特应性皮炎 销售额预估：2020 年峰值销售额为 20 亿美元： 2020年销售额：未披露（2019 年为 1.38 亿美元） 2016年，辉瑞斥资52亿美元收购了生物技术公司Anacor Pharmaceuticals，该笔交易的核心是该公司的临床后期产品PDE4 抑制剂Eucrisa，适应证为被批准用于治疗年龄≥2岁的轻中度特应性皮炎儿童和成人患者，辉瑞当时预计该产品年销售峰值可达到20亿美元。 但赛诺菲的Dupixent仅比Eucrisa晚上市了三个月，却迅速占领了市场，被公认为“湿疹的首选”。 Dupixent的商业营销以及积极拓展适应证的有力竞争下，Eucrisa的销售额每况愈下，2019年全年，Eucrisa的销售额为1.38亿美元，低于前一年的1.47亿美元，而自2017年Eucrisa上市，到2019年9月，辉瑞在营销该产品上的支出已经达到了1.28亿美元。 2020年，Eucrisa已经消失在了辉瑞披露药品销售数据的名列。 药物名称：Lartruvo      公司：礼来 首次获批：2016年10月 适应证：软组织肉瘤（已撤回） 销售额预估：到 2021年为3.74亿美元 2020年销售额：无 Lartruvo在2016年获批时，礼来彼时的新任CEO John Lechleiter对其信心满满，认为2014年到2023年的十年间，礼来将推出20款创新药，Lartruvo将是其中较为重磅的一款。 FDA的审评审批也增加了礼来“夸下海口”的信心。Lartruvo获批用于一线晚期软组织肉瘤的整个审评审批过程都走在了快车道，获得了从快速通道到突破性疗法认定，再到优先审评，一路备受瞩目。FDA称其是40年来第一个一线软组织肉瘤的创新疗法。有分析师称其在5年内销售额将达到3.74亿美元。 但被捧到制高点时，Lartruvo却跌下神坛。2019年，礼来宣布Lartruvo的一项III期临床试验中，跟单独使用阿霉素相比，Lartruvo+阿霉素未能延长患者生存期（20.4个月 VS 19.7个月），并且几乎看不到任何的改善。 2019年4月，礼来将Lartruvo从全球市场撤回，2019年9月，礼来正式向FDA申请撤回Lartruvo。  药物名称：Nuplazid 公司：Acadia Pharmaceuticals 首次获批：2016年4月 适应证：帕金森 销售额预估：2020年达到8.4亿美元 2020年销售额：4.4亿美元 与上述遭遇严重安全性问题、撤回、竞争的情况不同，Nuplazid仍然被市场预期为潜在重磅炸弹，未达到市场预期的原因在于其安全性问题仍然被质疑。 2020年Nuplazid获批上市时，成为首个获批治疗帕金森（PD）患者所经历幻觉和妄想等精神症状的药物，Evaluate Pharma曾预测其到2020年销售额将达到8.4亿美元。 但Nuplazid也存在严重的导致患者死亡的风险，但最终FDA认为其所带来的患者获益远高于其披露的风险。2020年的新冠肺炎疫情也使得其销售额大受打击，远未达到预期。  药物名称：Ocaliva 公司：Intercept Pharmaceuticals 首次获批：2016年5月 适应证：原发性胆汁性胆管炎 销售额预估：超过86亿美元  2020年销售额：3.13亿美元 Ocaliva未达到预期的原因则是预期适应证未获批。 2017年Ocaliva获批用于治疗罕见的肝病原发性胆汁性胆管炎，但实际上，市场对该药的预期一直都是非酒精性脂肪性肝炎 (NASH)，该领域的市场规模有可能达到上百亿美元，而Intercept公司一直都是这一领域中的佼佼者。 目前，Intercept公司仍在与FDA积极沟通，预计到2022年获批NASH适应证。  药物名称：Rubraca      公司：Clovis Oncology 首次获批：2016年12月 适应证：卵巢癌和前列腺癌 销售额预估：2021年达到6.63亿美元 2020年销售额：1.64亿美元 Rubraca实际上是全球第二款上市的PARP抑制剂，比AZ的奥拉帕利晚了两年。2017年，分析师预测Rubraca的销售额在2021年销售额可能达到6.63亿美元。 但近年来，PARP抑制剂市场快速发展，Rubraca的竞争对手已经不仅是AZ一家，背靠GSK的Tesaro推出的尼拉帕利也是有力的竞争对手。有分析师称，维持治疗已经成为晚期卵巢癌患者的标准疗法，而在这一领域，前述两家都已经进入市场，Rubraca却姗姗来迟。  药物名称：Steglatro      公司：辉瑞和默沙东 首次获批：2017年12月 适应证：2型糖尿病 销售额预估：2022年达到10.9亿美元 2020年销售额：未披露 Steglatro的失败也是因为竞争对手的挤压。 2017年，辉瑞和默沙东联合推出了SGLT2抑制剂Steglatro，但此时市场上已经有强生、AZ、BI以及礼来等多家大药企的成熟产品，并已经有产品达到了重磅炸弹。 辉瑞与默沙东试图通过价格建立竞争优势，但其8.94美元/天的定价，在与礼来的13美元/天、AZ的11.57美元/天的价格竞争中并未产生多大波澜。 同时，诺和诺德的GLP-1产品也获批上市，这些产品不仅为2型糖尿病患者带来了更为卓越的疗效，还有更便捷的使用。 此外，在VERTIS CV心血管领域，Steglatro也没有获得有效进展，仍然落后于强生、AZ、BI以及礼来等公司。 2020年，这两家公司也没有披露Steglatro的销售额数据。 药物名称：Vascepa       公司：Amarin 首次获批：2012年7月 适应证：高胆固醇；心血管疾病预防（2019年获批） 销售额预估：2020年达到15亿美元 2020年销售额：6.14亿美元 Vascepa是Amarin的唯一产品，2019年获批了心血管疾病预防的适应证，彼时是FDA批准的第一个也是唯一作为最大耐受剂量他汀类药物的辅助疗法，Vascepal是首个获批能有效降低残余心血管事件发生风险的药物。 2020年9月，联邦上诉法庭维持了早前对于Amarin心血管药Vascepa专利的无效裁决。美国内华达州地区法院裁定，Amarin持有的Vascepa专利由于“明显性”理由而无效。“明显性”指的是专利所包含内容，对于本领域专家来说是显而易见的，不值得受到法律保护。 随后，Vascepa的仿制药大量进入市场，有分析师称，到2023年，Vascepa的销售额可能会下降6%到22%。 药物名称：Zynteglo       公司：蓝鸟生物 首次获批：2019年6月 适应证：β-地中海贫血 销售额预估：到2024年达到18.7亿美元 2020年销售额：无 蓝鸟生物在欧洲推出Zynteglo后遭遇了一系列问题，至今都未获FDA批准。 2019年，Zynteglo在欧洲获得了治疗输血依赖性β地中海贫血的附条件批准，但蓝鸟生物随后将上市时间推迟到2020年，因为需要改进其药品规格和制造工艺。由于新冠疫情的影响，Zynteglo迟迟未迎来第一位患者，直到2021年2月进行了第一位患者的给药。 但紧接着，2021年2月16日，蓝鸟生物又宣布，在镰状细胞病基因治疗的临床1/2期试验中发现两例血癌病例，一例急性髓系白血病（AML）和一例骨髓增生异常综合征（MDS）后，该公司已停止在欧洲销售Zynteglo。 不久前，蓝鸟生物又宣布作为其在欧洲业务逐步结束的一部分，预计到2022年初，将从欧盟和英国撤回基因疗法Zynteglo的营销授权。其另一款于今年7月在欧盟获批的基因疗法Skysona也在近日宣布撤出欧洲。 但值得注意的是，bluebird宣布上个月完成了Zynteglo治疗β-地中海贫血在FDA滚动提交申请。

YH001 is a potential best-in-class CTLA-4 antibody with enhanced ADCC and CDC effector functions YH001 is currently being dosed in multiple Phase 1 oncology trials sponsored by Eucure Biopharma in Australia and China TRACON intends to initiate a Phase 1 trial of YH001 in combination with envafolimab in soft tissue sarcoma as well as to study YH001 in multiple other selected tumor types SAN DIEGO, Oct. 11, 2021 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals, Inc. (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., announced today that it has entered into a collaborative partnership agreement with Eucure Biopharma, a subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen), and a China-based clinical stage biopharmaceutical company primarily focused on the research and development of biologics, for the development of YH001, a CTLA-4 antibody with enhanced ADCC and CDC effector functions, for development in multiple oncology indications, including soft tissue sarcoma, in North America. Under the terms of the agreement, TRACON will be responsible for the clinical development and commercialization of YH001 in multiple oncology indications in North America, with the majority of the development activities expected to occur in the U.S. TRACON will bear the costs of clinical trials and Eucure Biopharma will supply YH001. TRACON will be responsible for commercializing YH001 in multiple oncology indications in North America and will owe Eucure Biopharma escalating double digit royalties on net sales. YH001 was developed to potently inhibit CTLA-4 binding to the CD80/CD86 receptors and deplete regulatory T cells through enhanced ADCC and CDC effector functions. YH001 demonstrated superior activity in vitro and in transgenic syngeneic tumor models compared to ipilimumab (Yervoy®), both as a single agent and when combined with a PD-(L)1 antibody. “We are focused on advancing a dual checkpoint inhibitor strategy focused on the PD-(L)1 and CTLA-4 pathways, that we expect to leverage in sarcoma by combining YH001 with envafolimab, our novel, single-domain PD-L1 antibody, in sarcoma. Going forward, we intend to use YH001 rather than Yervoy in our future dual checkpoint inhibition trials in sarcoma, which we anticipate will result in meaningful cost savings from not needing to purchase Yervoy at retail prices,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “Moreover, we expect to study YH001 in other solid tumors in combination with PD-(L)1 antibodies, including in patients who have progressed on prior PD-(L)1 treatment.” “We believe that this collaboration with TRACON has potential to provide cancer patients in the United States with a best-in-class CTLA-4 checkpoint inhibitor. YH001 was optimized using Biocytogen’s discovery labs and proprietary transgenic mouse models to inhibit CTLA-4 binding and to deplete regulatory cells. In our ongoing Phase 1 clinical trials, YH001 has been tolerable as a single agent and in combination with the PD-1 antibody toripalimab,” said Dr. Yuelei Shen, CEO of Biocytogen and Eucure Biopharma. About YH001 YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756). In July 2021, the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug application to initiate multiple phase II clinical trials for YH001 in the United States. About Envafolimab Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, as well as in a Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164. About TRACON TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization. In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S. To learn more about TRACON and its product pipeline, visit TRACON's website at . About EucureBiopharma Eucure Biopharma, a subsidiary of Biocytogen, is a China based innovative biotechnology company with global vision, specializing in developing innovative antibody drugs with independent intellectual property rights. Relying on a strong clinical development team with extensive experience, the company has established a product pipeline for more than 10 targets. At present, three products have received clinical trial approvals in the US and China including that two products have obtained the phase II clinical approval from the FDA and have initiated the global phase II clinical trial, two products have entered the phase I clinical trial in China, four products have entered Phase I clinical stages in Australia. These lay a solid foundation for the development of Eucure Biopharma. As a wholly owned subsidiary of Biocytogen, Eucure Biopharma is focused on clinical development. Biocytogen is an international biotechnology company driven by innovative technology and committed to becoming the global birthplace of new drugs, with a mission to focus on technological innovation, continuously produce new drugs, and safeguard human health. For more information, please visit . About Biocytogen Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotech company that drives the research and development of new drugs with innovative technologies. The company is committed to becoming a global headstream of new drugs and bringing the benefits to patients around the world as its mission. Based on the fully human antibody RenMabTM and RenLiteTM mice for fully human antibodies production with robust humoral responses, highly diverse antibody repertoire and superior affinity, Biocytogen has integrated its platforms in single-cell antibody discovery, gene editing, large-scale animal model supply, and screening to form a new approach to streamline the entire drug development process. Biocytogen actively promotes the independent and cooperative development of new drugs. For more, please visit Forward-Looking Statements Statements made in this press release regarding matters that are not historical facts are “forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON's and Eucure’s plans to further develop YH001, potential benefits of the collaboration between TRACON and Eucure, expectations regarding the timing, design and scope of clinical trials, potential payments and activities under the collaboration with Eucure, expected development milestones, and potential benefits of YH001 and TRACON’s product candidates. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all; the impact of the COVID-19 pandemic; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that the collaboration agreement with Eucure Biopharma is subject to early termination; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. TRACON Contacts: Company Contact: Investor Contact: Mark Wiggins Brian Ritchie Chief Business Officer LifeSci Advisors LLC (858) 251-3492 (212) 915-2578 mwiggins@traconpharma.com britchie@lifesciadvisors.com Biocytogen and Eucure Biopharma Contacts: Company Contact: Investor Contact: Chaoshe Guo Yongliang Wang Vice President, Business Development and Licensing Deputy General Manager Biocytogen Pharmaceuticals (Beijing) Co., Ltd. Biocytogen Pharmaceuticals (Beijing) Co., Ltd. Chaoshe.guo@bbctg.com.cn Yongliang.wang@bbctg.com.cn

Los Angeles, USA, March 17, 2021 (GLOBE NEWSWIRE) -- Celiac Disease Pipeline Insights: Analysis of Emerging Therapies, Key Pharma Players and Novel Approaches Celiac disease pipeline report provides an analysis of 18+ key companies and 18+ key pipeline therapies. Larazotide by 9 Metres Biopharma represents the only Phase 3 therapeutic in development for celiac disease, with interim analysis expected in the first half of 2021. DelveInsight’s  “Celiac Disease Pipeline Insights, 2021” report puts forward detailed insights into the present clinical development landscape of the therapeutic agents and upcoming trends owing to the launch of the therapies. The report is designed to help its clients to have a clearer understanding of the Celiac disease pipeline landscape, key companies working to develop Celiac disease treatments, novel therapies under clinical trials and investigations segmented into stages of their clinical development, therapeutic assessment on the basis of RoA, MoA and so on. Gain rich insights into recent happenings, NDA approvals (if any), collaborations, licensing, mergers and acquisition, funding, designations, and other product-related details and product development activities in the Celiac disease domain. Want to learn more about the leading candidates in different clinical stages of trials? Reach out @ Celiac Disease Pipeline Insights Celiac Disease: Overview Celiac disease is an autoimmune disorder that occurs in individuals who develop an immune reaction to gluten. Celiac disease symptoms in adults include weight loss, abdominal bloating, constipation or diarrhea, vomiting, and pale, fatty, foul-smelling stools. Celiac disease gets genetically inherited and is diagnosed with the help of blood tests. People suffering from Celiac disease are at two times greater risk of developing coronary artery disease and four times higher risk of getting bowel cancers. At present, the only option available to the patients for its treatment is lifelong adherence to a strict gluten-free diet as there is no available Celiac disease cure. However, the scientific community and pharmaceutical companies are energetically driving the development of pipeline therapies forward. Some of the key pointers extracted from the Celiac disease pipeline landscape report: Interested in knowing more? Request for the sample @ Celiac Disease Drug in Development The Celiac disease drugs pipeline report proffers a crystal clear view of the celiac disease treatments, drugs in development, clinical trial activity, patent information of the Celiac disease drugs, and collaborations and licensing in the space to help clients get a holistic view of the domain. The report is designed to help clients get a better understanding of the pipeline therapeutic activity, gauge the Celiac disease pipeline domain and opt for strategies that are set to yield better RoI with minimum risks. Want to learn more about the leading candidates in different clinical stages of trials? Reach out @ Celiac Disease Pipeline Insights At a Glance: Celiac Disease Emerging Drugs and Therapies Read more @ Celiac Disease Pipeline Activity Celiac Disease Therapeutic Assessment By Product Type By Stage By Route of Administration By Molecule Type By Mechanism of Action By Targets By Stage and Molecule TypeBy Stage and Route of AdministrationBy Stage and Product Type To know more, Visit Celiac Disease Pipeline Landscape Scope of the report Coverage: GlobalKey Players:  9 Metres Biopharma, Amgen, Allero Therapeutics, Takeda, Calypso Biotech, Anokion, Zedira GmbH, Millennium Pharmaceuticals, ImmunogenX, GlaxoSmithKline, ImmusanT, ActoBio Therapeutics, Amyra biotech and several others.Key Celiac disease Pipeline Therapies: Larazotide, Latiglutenase, AMG 714/ PRV-015, TAK-101, ZED1227, CALY 002, KAN 101, PvP001, GSK 3915393, ALL-001 and several others. Key Questions Answered in Celiac Disease Pipeline Assessment Report Got queries? We will be happy to resolve. 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