ZSP-1603

The prevalence of idiopathic pulmonary fibrosis has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of idiopathic pulmonary fibrosis and the growing research and development activities to develop novel therapies to treat idiopathic pulmonary fibrosis to drive the market. The companies developing the potential therapies in the last stage of development include FibroGen, Boehringer Ingelheim, and several others. LAS VEGAS, May 25, 2023 /PRNewswire/ -- DelveInsight's ' Idiopathic Pulmonary Fibrosis Pipeline Insight – 2023 ' report provides comprehensive global coverage of pipeline idiopathic pulmonary fibrosis therapies in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space, and future growth potential of the idiopathic pulmonary fibrosis pipeline domain. Key Takeaways from the Idiopathic Pulmonary Fibrosis Pipeline Report DelveInsight's idiopathic pulmonary fibrosis pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for idiopathic pulmonary fibrosis treatment. Key idiopathic pulmonary fibrosis companies such as FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, AstraZeneca, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd, Ark Biosciences, Ocean Biomedical, and others are evaluating new idiopathic pulmonary fibrosis drugs to improve the treatment landscape. Promising idiopathic pulmonary fibrosis pipeline therapies in various stages of development include Pamrevlumab, Treprostinil, Nitric oxide inhalation - INOpulse, MN-001 (tipelukast), VAY736, ENV-101, PLN-74809, ND-L02-s0201, KD025, GKT137831, AP 01, LYT-100, TAS-115, BMS-986278, GB0139, CSL312, CC-90001, C21, BI1015550, ZSP1603, HEC585, Jaktinib Dihydrochloride Monohydrate, Ifenprodil, HZN-825, DWN12088, MG-S-2525, Saracatinib, LTI-03, BBT-877, AZD5055, KIN001-IPF, Treprostinil palmitil inhalation powder (TPIP), Brilaroxazine, ANPA 0073, SHR 1906, AK 3280, OCF 203, and others. In May 2023, Kinarus Therapeutics announced the signing of a strategic convertible loan agreement for a CHF 1.5 million investment by ChaoDian (Hangzhou) Investment Management Co., Ltd., an investment company based in Hangzhou City, China ("CDIM"). Further, this agreement forms the basis for discussions on the introduction, development and commercialization of KIN001 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in China. Great Health Companion Group Ltd (GHCG), a subsidiary of Hakim Unique Group, introduced CDIM to Kinarus. In April 2023, AGC Biologics announced it signed a service agreement with The Jikei University in Japan. Under the agreement, AGC Biologics will assume a technology transfer and feasibility study for a drug product focused on the treatment of Idiopathic pulmonary fibrosis at the CDMO's center of Cell and Gene Excellence in Milan. In February 2023, Insilico Medicine announced that the US Food and Drug Administration (FDA) had granted Orphan Drug Designation to INS018_055 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). In February 2023, Arrowhead Pharmaceuticals Inc. announced that it had dosed the first subjects in a Phase I/IIa clinical trial of ARO-MMP7, the company's investigational RNA interference (RNAi) therapeutic designed to reduce the expression of matrix metalloproteinase 7 (MMP7) as a potential treatment for idiopathic pulmonary fibrosis (IPF). In February 2023, South Korea's Daewoong Pharmaceutical secured an exclusive licensing agreement with CS Pharmaceuticals for a first-in-class PRS inhibitor Bersiporocin in the Greater China region, including mainland China, Hong Kong, Taiwan, and Macau. Under this agreement, CSP will in-license Bersiporocin for Idiopathic Pulmonary Fibrosis (IPF) and potentially other fibrotic indications for a total consideration of up to $336 million, including up to $76 million in upfront and development milestone payments and double-digit royalties on Net Sales. In January 2023, Insilico Medicine announced the positive topline results of safety, tolerability, and pharmacokinetics (PK) from the Phase 1 clinical trial of INS018_055, a potential first-in-class drug discovered by Insilico's end-to-end AI platform for idiopathic pulmonary fibrosis (IPF). In January 2023, Pliant Therapeutics announced 12-week interim data from the 320 mg dose group of INTEGRIS-IPF, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). In December 2022, Vallon Pharmaceuticals announced that they entered into a definitive agreement (the "Merger Agreement") pursuant to which GRI Bio will merge with a wholly-owned subsidiary of Vallon in an all-stock transaction (the "Merger"). The combined company will focus on advancing GRI Bio's innovative pipeline of NKT cell regulators for the treatment of inflammatory, fibrotic and autoimmune diseases. Following the closing of the Merger, the combined company is expected to operate under the name "GRI Bio, Inc." Request a sample and discover the recent advances in idiopathic pulmonary fibrosis drug treatment @ Idiopathic Pulmonary Fibrosis Pipeline Report The idiopathic pulmonary fibrosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage idiopathic pulmonary fibrosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the idiopathic pulmonary fibrosis clinical trial landscape. Idiopathic Pulmonary Fibrosis Overview Idiopathic pulmonary fibrosis (IPF) is a rare, chronic, progressive fibrosing interstitial pneumonia that primarily affects middle-aged and older adults. It affects lung tissue by thickening, stiffening, or persistent and progressive scarring that worsens irreversibly over time. Scarring affects the air sacs of IPF patients, decreasing the amount of oxygen that enters the circulation. With less oxygen in the blood, ordinary tasks such as walking can cause dyspnea. This set of lung illnesses is also known as 'Diffuse Parenchymal Lung Diseases,' and it is distinguished by a broader umbrella of 'Interstitial Lung Diseases (IDLs)'. The cause of IPF is uncertain; experts believe the condition is caused by a mix of hereditary and environmental factors. There is a significant chance that genetic variations enhance a person's risk of acquiring IPF and then being exposed to environmental variables that aggravate the condition. However, much remains unknown about this new field of study. Find out more about drugs for idiopathic pulmonary fibrosis @ New Idiopathic Pulmonary Fibrosis Drugs A snapshot of the Idiopathic Pulmonary Fibrosis Pipeline Drugs mentioned in the report: Learn more about the emerging idiopathic pulmonary fibrosis pipeline therapies @ Idiopathic Pulmonary Fibrosis Clinical Trials Idiopathic Pulmonary Fibrosis Therapeutics Assessment The idiopathic pulmonary fibrosis pipeline report proffers an integral view of idiopathic pulmonary fibrosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Idiopathic Pulmonary Fibrosis Pipeline Report Coverage: Global Idiopathic Pulmonary Fibrosis Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Idiopathic Pulmonary Fibrosis Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Idiopathic Pulmonary Fibrosis Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravitreal, Subretinal, Topical Idiopathic Pulmonary Fibrosis Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Idiopathic Pulmonary Fibrosis Therapeutics Assessment By Mechanism of Action: Connective tissue growth factor inhibitors, 5-lipoxygenase inhibitors, Leukotriene D4 receptor antagonists, Leukotriene receptor antagonists, Phospholipase C inhibitors, Thromboxane A2 receptor antagonists, Type 3 cyclic nucleotide phosphodiesterase inhibitors, Type 4 cyclic nucleotide phosphodiesterase inhibitors, Integrin alphavbeta1 inhibitors, Integrin alphaVbeta6 inhibitors, Antibody-dependent cell cytotoxicity, Interleukin 4 receptor antagonists, SMO protein inhibitors, Galectin 3 inhibitors Key Idiopathic Pulmonary Fibrosis Companies: FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, AstraZeneca, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd, Ark Biosciences, Ocean Biomedical, and others. Key Idiopathic Pulmonary Fibrosis Pipeline Therapies: Pamrevlumab, Treprostinil, Nitric oxide inhalation - INOpulse, MN-001 (tipelukast), VAY736, ENV-101, PLN-74809, ND-L02-s0201, KD025, GKT137831, AP 01, LYT-100, TAS-115, BMS-986278, GB0139, CSL312, CC-90001, C21, BI1015550, ZSP1603, HEC585, Jaktinib Dihydrochloride Monohydrate, Ifenprodil, HZN-825, DWN12088, MG-S-2525, Saracatinib, LTI-03, BBT-877, AZD5055, KIN001-IPF, Treprostinil palmitil inhalation powder (TPIP), Brilaroxazine, ANPA 0073, SHR 1906, AK 3280, OCF 203, and others. Dive deep into rich insights for new drugs for idiopathic pulmonary fibrosis treatment; visit @ Idiopathic Pulmonary Fibrosis Medications Table of Contents For further information on the idiopathic pulmonary fibrosis pipeline therapeutics, reach out @ Idiopathic Pulmonary Fibrosis Drug Treatment Related Reports Idiopathic Pulmonary Fibrosis Market Idiopathic Pulmonary Fibrosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key idiopathic pulmonary fibrosis companies, including FibroGen, Hoffmann-La Roche Ltd, United Therapeutics, Boehringer Ingelheim, Pliant Therapeutics, Inc., Galecto Biotech, Horizon Therapeutics, CSL Behring, Kadmon Corporation, LLC, among others. Idiopathic Pulmonary Fibrosis Epidemiology Forecast Idiopathic Pulmonary Fibrosis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and idiopathic pulmonary fibrosis epidemiology trends. Pulmonary Fibrosis Pipeline Pulmonary Fibrosis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key pulmonary fibrosis companies, including Roche, Boehringer Ingelheim, Galecto Biotech, Cipla, Gilead Sciences, Fibrogen, Bristol-Myers Squibb, among others. Pulmonary Fibrosis Market Pulmonary Fibrosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pulmonary fibrosis companies, including Roche, Boehringer Ingelheim, Galecto Biotech, Cipla, Gilead Sciences, Fibrogen, Bristol-Myers Squibb, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

特发性肺纤维化（IPF）是一种慢性纤维化间质性肺炎，发病机制不明，且预后不良。目前只有两款治疗药物—吡非尼酮和尼达尼布上市，他们主要延缓肺功能下降，延缓IPF进程。尽管疗效有限且耐受性差，这两款药物在2021年仍达成11亿和25亿美元的销售额。鉴于IPF的发病机制不明确、患者人数少，在中国被纳入罕见病目录，限制了其药物开发和临床研究。但对IPF的研究从未停止，近年来相继有创新靶点药物被开发出来并进入临床研究阶段。根据研发客研究院统计，国内共有21款产品开展IPF临床研究，药物靶点较为分散且进展缓慢，进入临床III期仅有罗氏的RG6354和FibroGen公司的pamrevlumab。国内企业自主研发进入II期临床的产品有泰德制药的TDI01、众生药业的ZSP1603、泽璟制药的杰克替尼、天方药业的YPS345，以及两款二代吡非尼酮，分别是爱科百发的AK3280和东阳光药的伊非尼酮。两款进入III期临床pamrevlumab（FG3019）是FibroGen公司开发的一种人源性CTGF单克隆抗体，正在开展治疗IPF的III期临床研究，是目前唯一证明在IPF患者中有临床疗效的抗体药物。一项II期随机、双盲、安慰剂对照试验（PRAISE）中，在第48周时，主要疗效终点—用力肺活量（FVC）百分比占预计值的下降比例，pamrevlumab组相比安慰剂组降低了60.3%，pamrevlumab组疾病进展的患者比例低于安慰剂组，耐受性良好，安全性与安慰剂相似。4月，FibroGen宣布完成III期临床ZEPHYRUS-1的首例患者给药，预计在2023年完成试验。抗结缔组织生长因子（CTGF）是一种多效生长因子，参与上皮-间充质转化、胶原沉积和纤维化细胞过程，通常低水平表达，但在几乎所有纤维化病症中显著富集。国内此领域在研的产品很少，恒瑞医药正在开展I期临床的SHR-1906，虽未公开靶点，但根据恒瑞医药的专利信息推测，其有可能是CTGF抗体。国外Pieris Pharmaceuticals的PRS-220在I期临床中。另一进展至III期临床的产品是罗氏的RG6354。RG6354（曾用名PRM-151）是罗氏在2019年通过收购Promedior公司获得，是内源性人类先天免疫蛋白PTX-2的重组类似物，已被FDA授予治疗IPF的突破性疗法认定。研究表示，PTX-2（pentraxin-2）可有效抑制由TGFβ1驱动的所有促纤维化不良病变，给包含IPF在内所有纤维化疾病的治疗提供了新思路。Promedior公开的II期数据显示，117名IPF患者接受28周治疗后，RG6354组的FVC预测值百分比变化为-2.5%，减缓肺功能下降明显优于安慰剂组的-4.8%，此外患者依从性达到97%。在失败中探索IPF本身疾病机制难以明确，且患者人数不多，2020年全球约有160万人受影响，已被收录于国家《第一批罕见病目录》中，这给IPF治疗药物的研发增加一定难度，相继有企业因各类原因终止产品开发。例如在抗炎途径IL-13和IL-4拮抗剂领域，礼来在2013年启动IL-13单抗lebrikizumab的II期临床后未见有进一步结果公布，赛诺菲于2017年终止了IL4/IL13双特异性抗体romilkimab治疗IPF的研究。被放弃的项目中，ATX抑制剂ziritaxestat（GLPG1690）是唯一一款进入III期研究宣告失败的产品。2021年2月，Galapagos与吉利德联合宣布，从获利-风险考虑终止ziritaxestat治疗IPF的III期研究ISABELA，并停止产品所有临床试验。同领域的其他药物仍在积极开展临床研究。中国公司恒诺康医药研发的HNC664已经完成治疗IPF的Ia期临床研究，并布局了二代ATX抑制剂HNC1058，产品未申报临床。国外方面，Bridge Biotherapeutics将BBT-877推进至II期临床。据研发客研究院统计，ATX-LPA通路是IPF药物开发针对最多的靶点。有研究发现在博来霉素肺纤维化模型小鼠及IPF患者中均发现溶血磷脂酸（LPA）水平升高，自分泌运动因子（autotaxin，ATX）是一种生成血液中LPA的关键细胞外酶。溶血磷脂酸受体1（LPA1）拮抗剂开发中，百时美施贵宝的BMS-986278在中国启动了II期临床，另外，公司还有一款同类产品BMS-986337处于临床I期阶段，一款BMS-986020在临床前。ziritaxestat临床失败给ATX-LPA通路研究增加了不确定性。另一方面，整合素抑制剂在IPF领域的探索也喜忧参半。2022年7月，Pliant Therapeutics宣布PLN-74089治疗IPF的IIa期临床研究达到主要疗效终点，PLN-74809剂量依赖性的显著延缓FVC下降，且具备良好的耐受性。PLN-74809是αvβ6/avβ1双重整合素抑制剂，通过抑制纤维化组织中的关键介质TGFβ通路，发挥治疗纤维化的作用。渤健开发的αvβ6整合素拮抗剂BG00011在2019年9月因安全性问题终止临床。更多在研创新产品特发性肺纤维化的未满足需求吸引众多国内企业布局，这些在研产品靶点分散，产品大部分处于早期临床阶段。其中进入到临床II期阶段是泽璟制药的杰克替尼、勃林格殷格翰的BI 1015550、众生药业的ZSP1603、天方药业的YPS345。杰克替尼是一款口服JAK抑制剂，泽璟制药在2020年7月启动了治疗IPF的II期临床研究。勃林格殷格翰开发的PDE4B（磷酸二酯酶4B）抑制剂BI 1015550，于近期在国内递交了治疗IPF的临床申请。公司5月于NEJM杂志公布的临床数据显示，BI 1015550能够有效减缓IPF患者的肺功能衰退，在减缓IPF患者肺功能恶化方面优于安慰剂的概率大于98%。在血小板衍生生长因子（platelet-derived growth factor，PDGF）抗体领域，国内公司众生药业开发的ZSP1603正处于II期临床试验中，IPF适应症上，是国内同靶点第一个获批临床的产品。YPS345是天方药业与中国科学院生物物理研究共同开发的1类新药，正在开展治疗胸部肿瘤放疗引起的肺炎及肺纤维化的II期临床试验，产品靶点未公开。据研发客研究院统计，10个处于I期临床阶段的药物中，有很多公司未公开其产品靶点，例如人福医药的HW021199、海思科的FTP-198、智康弘仁的SC-1011以及普沐生物的PMG1015。值得一提的是AI制药企业英矽智能的ISM001-055，是公司首款由AI发现设计、治疗IPF的产品，靶点未公开。据英矽智能公布信息，ISM001-055靶向公司通过PandaOmics平台发掘出的新颖纤维化靶点Target X，该靶点与多种纤维化疾病相关。7月，英矽智能宣布ISM001-055完成了I期临床的首例患者给药。TDI01是一款高选择性ROCK2抑制剂，由中国生物制药附属公司泰德制药自主研发，目前正在开展治疗IPF的I期临床试验。这款药物还在2021年2月成功出海，Graviton Bioscience公司获得其在大中华以外地区共同开发和商业化权益，泰德制药获得的首付款及研发、销售里程碑付款最高可达5.175亿美元。安立玺荣生物开发的CSF-1R拮抗剂EI-1071在2022年8月被FDA授予治疗IPF的孤儿药资格认定，处在I期临床研究中。同类产品中，国内还有宝船生物的BC006在临床前阶段。复星医药子公司复星弘创自主研发的新型选择性肌醇酶（IRE1）抑制剂ORIN1001，已在美国完成治疗IPF的Ib期临床，国内已获得IND批准。间充质干细胞（MSCs）也被开发用来治疗IPF，国内公司中，莱馥医疗的人脐带间充质干细胞、生创精准的SC01009（宫血间充质干细胞）都开展了治疗IPF的I期临床研究。除了上述产品，国内还有部分公司在已上市的吡非尼酮基础上开发二代产品。临床应用结果显示吡非尼酮的耐受性差、疗效有限，约有一半患者使用吡非尼酮后，选择停止治疗、减少剂量或改用其他治疗方式。爱科百发和东阳光药开发的二代吡非尼酮，能一定程度上延缓一代吡非尼酮的耐受。东阳光药业的伊非尼酮已步入临床II期研究，爱科百发在2022年5月宣布启动AK3280治疗IPF的II期临床。总第1712期访问研发客网站可浏览更多文章www.PharmaDJ.com