A phase 1 pharmacokinetic study to assess and compare the relative bioavailability of a capsule and a tablet formulation of YTX-7739 following single oral doses administered with and without food in Healthy Volunteers - YTX-7739 formulation study

开始日期2022-01-11

申办/合作机构

Yumanity Therapeutics, Inc.

NL9172 / RecruitingN/A

Randomized, double-blind, placebo-controlled, multiple dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of YTX-7739, a novel oral inhibitor of Stearoyl-CoA-desaturases, in healthy volunteers and patients with Parkinson’s disease

开始日期2020-09-13

申办/合作机构

Yumanity Therapeutics, Inc.

NL-OMON55131 / CompletedN/A

开始日期2020-09-04

申办/合作机构

Yumanity Therapeutics, Inc.

100 项与 YTX-7739 相关的临床结果

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100 项与 YTX-7739 相关的专利（医药）

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项与 YTX-7739 相关的文献（医药）

2023-01-18·Science translational medicine1区 · 医学

Targeting de novo lipid synthesis induces lipotoxicity and impairs DNA damage repair in glioblastoma mouse models

1区 · 医学

Article

作者: Carvalho, Litia ; Moses, Charlotte ; Eyme, Katharina M. ; Williams, Kevin J. ; Tardiff, Daniel F. ; Chung, Chee Yeun ; Mnatsakanyan, Hayk ; Bensinger, Steven J. ; Neustadt, Rudolph ; Alnasser, Ahmad ; Jha, Roshani ; Pechdimaljian, Caline ; Su, Baolong ; Badr, Christian E. ; Sammarco, Alessandro

Deregulated de novo lipid synthesis (DNLS) is a potential druggable vulnerability in glioblastoma (GBM), a highly lethal and incurable cancer. Yet the molecular mechanisms that determine susceptibility to DNLS-targeted therapies remain unknown, and the lack of brain-penetrant inhibitors of DNLS has prevented their clinical evaluation as GBM therapeutics. Here, we report that YTX-7739, a clinical-stage inhibitor of stearoyl CoA desaturase (SCD), triggers lipotoxicity in patient-derived GBM stem-like cells (GSCs) and inhibits fatty acid desaturation in GSCs orthotopically implanted in mice. When administered as a single agent, or in combination with temozolomide (TMZ), YTX-7739 showed therapeutic efficacy in orthotopic GSC mouse models owing to its lipotoxicity and ability to impair DNA damage repair. Leveraging genetic, pharmacological, and physiological manipulation of key signaling nodes in gliomagenesis complemented with shotgun lipidomics, we show that aberrant MEK/ERK signaling and its repression of the energy sensor AMP-activated protein kinase (AMPK) primarily drive therapeutic vulnerability to SCD and other DNLS inhibitors. Conversely, AMPK activation mitigates lipotoxicity and renders GSCs resistant to the loss of DNLS, both in culture and in vivo, by decreasing the saturation state of phospholipids and diverting toxic lipids into lipid droplets. Together, our findings reveal mechanisms of metabolic plasticity in GSCs and provide a framework for the rational integration of DNLS-targeted GBM therapies.

2022-04-01·Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics

A Brain-Penetrant Stearoyl-CoA Desaturase Inhibitor Reverses α-Synuclein Toxicity

Article

作者: Tardiff, Daniel F ; McCaffery, Thomas D ; Shimanaka, Kazuma ; Choi, Jeonghoon ; Raja, Waseem ; Khurana, Vikram ; Bechade, Pascal A ; Chung, Chee Yeun ; Nuber, Silke ; Fanning, Saranna ; Chang, Belle ; Burke, Christopher ; Dettmer, Ulf ; Neves, Esther ; Xu, Ping ; Rhodes, Kenneth J ; Selkoe, Dennis J ; Scannevin, Robert H ; Jiang, Xin

Abstract:

Increasing evidence has shown that Parkinson’s disease (PD) impairs midbrain dopaminergic, cortical and other neuronal subtypes in large part due to the build-up of lipid- and vesicle-rich α-synuclein (αSyn) cytotoxic inclusions. We previously identified stearoyl-CoA desaturase (SCD) as a potential therapeutic target for synucleinopathies. A brain-penetrant SCD inhibitor, YTX-7739, was developed and has entered Phase 1 clinical trials. Here, we report the efficacy of YTX-7739 in reversing pathological αSyn phenotypes in various in vitro and in vivo PD models. In cell-based assays, YTX-7739 decreased αSyn-mediated neuronal death, reversed the abnormal membrane interaction of amplified E46K (“3K”) αSyn, and prevented pathological phenotypes in A53T and αSyn triplication patient-derived neurospheres, including dysregulated fatty acid profiles and pS129 αSyn accumulation. In 3K PD-like mice, YTX-7739 crossed the blood–brain barrier, decreased unsaturated fatty acids, and prevented progressive motor deficits. Both YTX-7739 treatment and decreasing SCD activity through deletion of one copy of the SCD1 gene (SKO) restored the physiological αSyn tetramer-to-monomer ratio, dopaminergic integrity, and neuronal survival in 3K αSyn mice. YTX-7739 efficiently reduced pS129 + and PK-resistant αSyn in both human wild-type αSyn and 3K mutant mice similar to the level of 3K-SKO. Together, these data provide further validation of SCD as a PD therapeutic target and YTX-7739 as a clinical candidate for treating human α-synucleinopathies.

2022-04-01·Molecular neurobiology2区 · 医学

Non-clinical Pharmacology of YTX-7739: a Clinical Stage Stearoyl-CoA Desaturase Inhibitor Being Developed for Parkinson’s Disease

2区 · 医学

Article

作者: Rhodes, Kenneth J ; Chung, Chee Yeun ; Le Bourdonnec, Bertrand ; Chang, Belle ; Scannevin, Robert H ; Wrona, Iwona ; Lucas, Matthew ; Tardiff, Daniel F

Summary Stearoyl-CoA desaturase (SCD) is a potential therapeutic target for Parkinson’s and related neurodegenerative diseases. SCD inhibition ameliorates neuronal toxicity caused by aberrant α-synuclein, a lipid-binding protein implicated in Parkinson’s disease. Its inhibition depletes monounsaturated fatty acids, which may modulate α-synuclein conformations and membrane interactions. Herein, we characterize the pharmacokinetic and pharmacodynamic properties of YTX-7739, a clinical-stage SCD inhibitor. Administration of YTX-7739 to rats and monkeys for 15 days caused a dose-dependent increase in YTX-7739 concentrations that were well-tolerated and associated with concentration-dependent reductions in the fatty acid desaturation index (FADI), the ratio of monounsaturated to saturated fatty acids. An approximate 50% maximal reduction in the carbon-16 desaturation index was observed in the brain, with comparable responses in the plasma and skin. A study with a diet supplemented in SCD products indicates that changes in brain C16 desaturation were due to local SCD inhibition, rather than to changes in systemic fatty acids that reach the brain. Assessment of pharmacodynamic response onset and reversibility kinetics indicated that approximately 7 days of dosing were required to achieve maximal responses, which persisted for at least 2 days after cessation of dosing. YTX-7739 thus achieved sufficient concentrations in the brain to inhibit SCD and produce pharmacodynamic responses that were well-tolerated in rats and monkeys. These results provide a framework for evaluating YTX-7739 pharmacology clinically as a disease-modifying therapy to treat synucleinopathies.

项与 YTX-7739 相关的新闻（医药）

2024-03-06

·SYNAPSE

Yumanity's end: J&J pays $26M for neuroscience assets as reverse merger erases biotech

Yumanity Therapeutics has struck two agreements to erase itself from existence. Johnson & Johnson has stepped in to take on Yumanity’s lead program and unpartnered discovery-stage candidates, while Kineta has laid claim to its Nasdaq listing and Merck collaboration through a reverse merger. Boston-based Yumanity sounded the alarm earlier this year, outlining plans to lay off 60% of its staff and seek a buyer for its assets. The actions followed the imposition of a partial hold on multi-dose trials of the biotech’s lead drug, stearoyl-CoA desaturase (SCD) inhibitor YTX-7739, that exacerbated its mounting cash crisis. Yumanity’s search for an exit has led to two deals, including J&J's Janssen Pharmaceutical unit picking up the biotech’s unpartnered pipeline. In return for $26 million in cash, the Big Pharma will secure the rights to YTX-7739 and unpartnered discovery-stage neuroscience product candidates and targets. YTX-7739 spearheaded Yumanity’s advance in its early years, helping it raise more than $100 million and then join Nasdaq through a reverse merger with Proteostasis in 2020. The interest in the molecule reflects evidence of the effects of SCD inhibition, which include the reversal of the toxicity of misfolded alpha-synuclein in mice. Yumanity moved YTX-7739 into a clinical trial in Parkinson's disease patients on the strength of the mice data, but its data drop received a frosty reception late last year. Investors drove down the share price of the biotech after seeing top-line data from a phase 1b clinical trial of 20 patients. The FDA compounded the situation by slapping a partial hold on YTX-7739 in January. With J&J picking off Yumanity’s in-house R&D programs, private immuno-oncology biotech Kineta has swept up the rest of the business. Shareholders in Kineta will own 85% of the combined biotech, which will retain the Kineta name and focus on immuno-oncology while continuing to support Yumanity’s research collaboration with Merck & Co. Merck formed the collaboration in 2020 to work with Yumanity on treatments for amyotrophic lateral sclerosis and frontotemporal lobar degeneration. Late last year, Merck accepted the first data package from the collaboration, triggering a $5 million payment to Yumanity in a deal that could ultimately earn it $530 million.

2023-02-02

·生物谷

Sci Transl Med：一种新药或有望通过靶向作用癌细胞的脂质代谢来抵御胶质母细胞瘤

来自麻省总医院等机构的科学家们通过研究发现，一种抑制硬脂酰辅酶A去饱和酶1（SCD，stearoyl CoA Desaturase 1）的药物或能干预上述过程，当给患有胶质母细胞瘤的小鼠用药时由于胶质母细胞瘤是一种高度侵袭性和致死性的脑瘤，其对传统的疗法具有一定的耐受性，因此研究人员一直在研究来寻找胶质母细胞瘤细胞的特征，旨在寻找有希望的药物靶点。其中一个特征就是细胞依赖的所谓的新型脂质合成机制，或者将碳水化合物转化成为脂肪，从而支持细胞的能量需求。近日，一篇发表在国际杂志Science Translational Medicine上题为“Targeting de novo lipid synthesis induces lipotoxicity and impairs DNA damage repair in glioblastoma mouse models”的研究报告中，来自麻省总医院等机构的科学家们通过研究发现，一种抑制硬脂酰辅酶A去饱和酶1（SCD，stearoyl CoA Desaturase 1）的药物或能干预上述过程，当给患有胶质母细胞瘤的小鼠用药时，该药物就能减缓肿瘤的生长，并增加胶质母细胞瘤对抗癌疗法的敏感性，相关研究结果有望帮助开发治疗胶质母细胞瘤患者的新型疗法。在脂质从头合成的一个步骤中，SCD能将饱和脂肪酸转化为单不饱和脂肪酸，此前研究人员通过研究发现，胶质母细胞瘤细胞依赖SCD的激活以及单不饱和脂肪酸的可用性。这项研究中，研究人员检测了名为YTX-7739的SCD抑制剂的抗胶质母细胞瘤的潜能，该抑制剂能跨越血脑屏障，目前正在I期临床试验中进行评估其是否能作为一种口服药物来治疗帕金森疾病患者。图片来源：https://www-science-org.libproxy1.nus.edu.sg/doi/10.1126/scitranslmed.abq6288 研究人员发现，YTX-7739对患者机体衍生的胶质母细胞瘤干细胞具有一定的毒性，通过阻断SCD，细胞就会积累很多饱和脂肪酸，这一过程被称之为脂肪毒性（lipotoxicity），此外，当给与患有肿瘤的小鼠时，YTX-7739还能抑制胶质母细胞瘤细胞中参与脂肪酸代谢的过程，并增加细胞对常规胶质母细胞瘤化疗疗法的敏感性。当研究人员分析YTX-7739对肿瘤细胞作用效应背后的详细分子机制时，他们发现，MEK/ERK信号通路会使得胶质母细胞瘤更易于受到YTX-7739的影响，而AMPK信号通路则能发挥保护胶质母细胞瘤的作用，并能使其在YTX-7739存在时所出现的脂质合成损失时产生一定的耐受性。研究者Badr说道，基于当前研究结果，我们指出，在肿瘤活检组织中能检测到的MEK/ERK和AMPK活性或许能作为预测性的生物标志物来帮助指导患者的选择以及对患者进行分层研究治疗。换句话说，机体肿瘤中表现出强大MEK/ERK活性的患者或许能从诸如YTX-7739等疗法中获益，而肿瘤中表现出较高AMPK活性的患者或许并不会因这种疗法而获益，这一研究发现或能帮助调整疗法模式从而使得患者的治疗效果最大化。比如，一些广泛使用的药物，即抗炎性制剂水杨酸盐或抗糖尿病化合物二甲双胍都是AMPK潜在的激活剂，其不利于YTX-7739或新型脂质合成靶向性疗法的疗效。综上，本文研究结果中，研究人员揭示出了胶质母细胞瘤干细胞样细胞中代谢可塑性的一种新型机制，同时提供了一种特殊框架来合理性地整合解除脂质合成管制的胶质母细胞瘤靶向性疗法。（生物谷Bioon.com）原始出处： KATHARINA M. EYME,ALESSANDRO SAMMARCO,ROSHANI JHA, et al. Targeting de novo lipid synthesis induces lipotoxicity and impairs DNA damage repair in glioblastoma mouse models, Science Translational Medicine (2023). DOI:10.1126/scitranslmed.abq6288

临床1期

2023-01-27

·Endpoints

Exclusive: Cell therapy biotech brings on Loxo vet amid global expansion plans; Retirement beckons for Vir's George Scangos

Bree Harlin , who used to be director of clinical operations at Loxo Oncology , now Loxo@Lilly , is now in the C-suite for the first time. Harlin started at TC BioPharm on Wednesday as chief clinical officer, the biotech announced Friday — but her journey starts more than 20 years before then. After graduating from college, she moved to Boston, working in academia at some of the Harvard teaching hospitals in endocrinology and CNS. She later got convinced to interview with a company her neighbor founded, which was developing a gadolinium-based contrast agent used in diagnostic imaging. That’s where she got her start in the industry, moving from a clinical trial associate position to a clinical research associate role and got her first experience filing an NDA. While that NDA was rejected, it made an impact on Harlin. “It got me really hungry to learn more about how trials are run and more about the industry and in general,” Harlin added. That impact drove Harlin to other biotech and pharmaceutical companies, including Pfizer , Forest Pharmaceuticals (pre-buyout from Actavis / Allergan ) and Shire , with her latest stint being director of clinical operations at Loxo and helping to run Phase I to Phase IV trials. For Harlin, all of those jobs working with clinical trials and being a part of NDA and IND filings have conglomerated into a cornucopia of experience that, in her words, can be applied to her new job at TC BioPharm in order to “hit the ground running.” She’s already started meeting the team, hopping on meetings and instituting plans to get clinical trial sites on board in the US and outside the UK, where TC BioPharm is based. Currently the biotech is looking at expanding its cell therapy candidate outside the UK. Harlin’s goal is to utilize her experience to start recruiting trial sites in the US and in the EU, and navigate the clinical trial process to bring on board the right people. As far as the US goes, TC BioPharm is looking to file an IND with the FDA later this year in a bid to start up a Phase I trial, most likely in acute myeloid leukemia. CEO Bryan Kobel told Endpoints News that it was obvious Harlin was the right fit for the job, calling the entire process a matter of serendipity after the previous clinical director stepped aside to pursue a personal passion. “That put us in a really weird position where we had to find a chief clinical officer, and do it quickly,” Kobel added. After company leadership put together a sort of candidate attribute wishlist, Kobel said that he started cold-calling people — and Harlin was the first interview. After talking with eight to 10 more candidates, Harlin was still the top choice, and was brought on board. The chief executive added that the company looks for people who have experience working as part of a team and know how to communicate with them in high pressure situations without adding more stress or tension. While also noting the aspects of leading by example, “It’s hard to build a culture; it’s really easy to destroy it. So we need to be really, really prudent with who we add, how we add them, and the time we take to add them,” Kobel said. — Paul Schloesser → Although he “retired” after 14 years as CEO of Exelixis in 2010, and “retired” again from the top spot at Biogen in 2016, George Scangos assured Endpoints on Wednesday that Vir Biotechnology would be the last company he leads. We don’t know what the rest of 2023 holds in the industry, but we’ll be hard-pressed to find a bigger CEO transition this year than the 74-year-old Scangos passing the baton to Bayer ’s high-flying business leader Marianne De Backer on April 3. On De Backer’s watch, Bayer would swing deals like the acquisitions of AskBio and Vividion before either of them had the opportunity to go public. “I’m going to be called the IPO terminator,” De Backer said jokingly after the Vividion buyout . After turning Biogen’s fortunes around with the approval of MS drug Tecfidera in 2013, Scangos set off for Vir, where he put the biotech on the map by teaming up with GSK on sotrovimab for mild-to-moderate Covid-19. In an interview with John Carroll where he expressed his admiration for De Backer and a desire to travel with family, Scangos also discussed his risk-taking approach — invoking Kenny Rogers in the process. “I’ve always felt in my career that I would rather go down in flames by having failed big time than live my life in mediocrity because I was afraid to try,” Scangos said. “You can’t be in this industry if you’re not an optimist, but you have to be realistic and you have to know when to hold them and when to fold them.” → Kimball Hall has left the CDMO Abzena to become president and CEO of Irish biotech Innocoll , encompassing both Innocoll Biotherapeutics and the CDMO subsidiary Syntacoll . Hall, who rose to VP of manufacturing during her 14 years at Amgen , then moved on to Genentech as SVP of manufacturing biologics drug substance. She joined Abzena in 2019 as operations chief and was elevated to president a year later. → Launched in November and scouring the “secretome” for new therapies, Juvena Therapeutics has filled several leadership positions, with chief corporate development officer Neil Berkley leading off. A business development veteran with GSK and Cadence Pharmaceuticals (which was sold to Mallinckrodt in 2014), Berkley had a yearlong stay at AbCellera as CBO before leaving on June 29, according to an SEC filing . AbCellera CEO Carl Hansen has yet to name a replacement. Juvena has also welcomed the following: Amgen and Merck vet Gayathri Swaminath (SVP of discovery); Mo Tabrizi (VP of preclinical and nonclinical development), another Merck alum and the former senior director of pharmacology for Ascendis Pharma ; and Eddie Moler (VP of data science). Mubadala Capital and Horizons Ventures headlined Juvena’s $41 million Series A financing . → Jane Henderson has landed at immunology and inflammatory disease biotech Apogee Therapeutics , which emerged from stealth with a $149 million Series B and $169 million in total. The new CFO — no relation to Apogee’s CEO Michael Henderson — owned the same title at Invivyd , the Tillman Gerngross antibody developer that hit the scene with a lot of flash and a boatload of money as Adagio Therapeutics . But a substantial flop with its Covid-19 candidate led to a shakeup that included the departures of Gerngross , Henderson and the dismissal of an undisclosed number of staffers. She was previously the CFO of Voyager and Turnstone Biologics , and has board seats at Akero Therapeutics , Ventus Therapeutics and Iveric Bio . → The xenotransplantation experts at eGenesis have picked up Knut Niss as chief technology officer. Niss carried the same title at Mustang Bio , and he was part of the CMC leadership team at Novartis for Kymriah before it earned the distinction as the first approved gene therapy in the US. Last April, Michael Curtis replaced Paul Sekhri as CEO of eGenesis, the CRISPR upstart that’s trying to beat its xeno competitors to the clinic with its gene editing tech. Sekhri is currently the chief executive at vTv Therapeutics . → Thyroid eye disease biotech Sling Therapeutics , located south of the University of Michigan campus, has tapped Jeffrey Kent as CMO. Kent logged more than 10 years at Horizon and was EVP, medical affairs and outcomes research when Amgen struck M&A gold with a $28 billion deal in December. Sling’s lead asset linsitinib was in-licensed from Astellas , where Kent worked as an executive medical director before joining Horizon. We caught up with Gossamer Bio chief Faheem Hasnain when he was named chairman of Sling, which debuted with a $35 million Series A last June. → It’s been an eventful week for Pliant Therapeutics , raising $250 million after touting positive Phase IIa data with its idiopathic pulmonary fibrosis (IPF) drug bexotegrast . The Pliant news continues with the selection of Lily Cheung as chief human resources officer. Cheung brings HR experience from Actelion and Rigel Pharmaceuticals , and she had been VP of human resources for Synthekine since December 2021. → Right on Cue: Matteo Levisetti has been promoted to CMO at Cue Biopharma , setting the stage for acting medical chief Kenneth Pienta to step into a clinical advisory role. We had Levisetti in this space in February 2021 when he was named SVP of clinical development at the Boston biotech, whose pipeline is centered on IL-2. He’s been around the block in Big Pharma (Merck, Roche , Pfizer ) and spent a year as global clinical lead for sitravatinib at Mirati . → Sri Ryali has signed on as CFO of Codexis , the enzyme engineering outfit that sent 18% of its staff packing in November under first-year CEO Stephen Dilly . An Amgen finance alum, Ryali just completed four years as CFO of Eiger BioPharmaceuticals and was VP of finance at Aimmune from 2015-18. Earlier, he played a few quick measures at Jazz Pharmaceuticals as senior director, financial planning & analysis. → Targeting cancer and inflammatory bowel diseases like Crohn’s and ulcerative colitis with site specific immunomodulators (SSIs), Qu Biologics out of British Columbia has enlisted Matt Cahill as COO. Cahill was on the original crew at another Canadian company, Deep Genomics , as VP of finance & business operations, and he’s still on the board of directors with founder/CEO Brendan Frey , Nessan Bermingham and others. → Shawn Levy has been promoted to CSO and SVP of applications at DNA sequencing company Element Biosciences . Peer Review introduced you to Levy in February 2022 when he first came to Element as SVP of applications and scientific affairs. → Molecular diagnostics shop BillionToOne , which kept the cash flowing with a $125 million Series C in March 2022, has installed Amgen alum Gary Palmer as CMO, oncology. The ex-VP of medical affairs at Foundation Medicine and Genomic Health also had a three-year run as CMO of Tempus Labs . → Aurora, CO-based neuro biotech Cerebral Therapeutic s has appointed Julie Foster as COO. Foster put in 35 years at Medtronic , taking on such roles as VP of the cardiac and vascular businesses in the EMEA (Europe, Middle East and Africa) region and VP of customer experience, diabetes. → IO Biotech was one of the last trains out of the IPO station in late November 2021 before things went pear-shaped in the market, and this week the IDO/PD-L1 player has recruited Devin Smith as general counsel and chief compliance officer. Smith is an EMD Serono legal vet who was general counsel at Yumanity before it reverse merged with Kineta and shipped off Parkinson’s drug YTX-7739 — along with an assortment of other candidates — to J&J back in June. → CEPI’s mRNA vaccine partner SK bioscience has a pair of new execs : Richard Kensinger (VP of R&D project management) is an 18-year Sanofi veteran who comes from Affinivax , where he was executive director of process development and protein sciences. And Kenneth Lee (VP of the biologic business development department at SK’s R&D center in Pangyo, South Korea) led the commercial division in the Americas region for GenScript ProBio , the CDMO subsidiary of GenScript that racked up a $224 million Series C last week. → Speaking of CDMOs, Columbus, OH’s Forge Biologics has $90 million more in the bank and a couple more VPs on the team. Chris McPherson (VP of GMP manufacturing), a WuXi AppTec alum, just finished a four-and-a-half-year tenure at Samsung Biologics , and Taleen Barsoumian (VP of client development) is an ex-senior sales consultant at Novartis who was recently US director of sales and business development for cell and gene therapy at Barkey . Meanwhile, Adam Davis has been promoted to VP of analytical development. Davis ventured off to Forge Biologics in October 2020 after serving as director of manufacturing for Abeona Therapeutics . → Bayer-backed cryogenic electron microscopy (cryo-EM) specialist Gandeeva Therapeutics has elected Brenda Cooperstone to the board of directors. Cooperstone had held the roles of chief development officer, rare disease and Pennsylvania site head at Pfizer, but left the Big Pharma in December after 24 years overall. → Ex- Adicet Bio interim chief Donald Santel has been given a seat on the board of directors at Aerovate Therapeutics , chaired by Kala Pharmaceuticals CEO Mark Iwicki . Santel also helmed Hyperion Therapeutics and is chairman of Tentarix Biotherapeutics and Ocelot Bio .

临床1期高管变更IPO

100 项与 YTX-7739 相关的药物交易

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