A Randomized, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects

This study is an adaptive Phase III randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of Proxalutamide (GT0918) in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted globally. The study will compare GT0918 plus standard of care (SOC) with the placebo plus SOC. Approximately 762 subjects will be randomized in a 1:1 ratio to either GT0918 plus SOC or placebo plus SOC group.

开始日期2021-09-30

申办/合作机构

苏州开拓药业股份有限公司

NCT04869228 / Terminated临床3期

A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients

The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease

开始日期2021-08-04

申办/合作机构

苏州开拓药业股份有限公司

NCT05076851 / Unknown status临床2期IIT

A Randomized, Controlled, Double-blind, Single Center，Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer

This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,

开始日期2021-06-17

申办/合作机构-

100 项与普克鲁胺相关的临床结果

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100 项与普克鲁胺相关的转化医学

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100 项与普克鲁胺相关的专利（医药）

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项与普克鲁胺相关的文献（医药）

2024-03-01·International journal of antimicrobial agents

Small-molecule antiviral treatments for COVID-19: A systematic review and network meta-analysis

Review

作者: Xin, Chuanwei ; Yang, Wenjuan ; Han, Bing ; Zheng, Bei ; Ying, Yin ; Zhu, Jun ; Yang, Bo ; Zhang, Meiling ; Feng, Pinpin ; Zhao, Qinqin ; Li, Gonghua

OBJECTIVE:

This study aimed to explore the efficacy and safety of small-molecule antivirals for treating coronavirus disease 2019 (COVID-19).

METHODS:

Seven databases were searched from their inception to 01 June 2023. The risk of bias in randomised controlled trials and retrospective studies was evaluated individually using the Cochrane risk-of-bias tool and Newcastle Ottawa Scale.

RESULTS:

In total, 160 studies involving 933 409 COVID-19 patients were evaluated. Compared with placebo or standard of care, proxalutamide demonstrated remarkable efficacy in reducing mortality rates, hospitalisation rates, serious adverse events, and the need for mechanical ventilation. Furthermore, it significantly enhanced both the rate of clinical improvement and expedited the duration of clinical recovery when compared with control groups. In patients with mild-to-moderate COVID-19, proxalutamide exhibited the above advantages, except for mortality reduction. Triazavirin was the most effective treatment for reducing the time required for viral clearance and improving the discharge rate. Leritrelvir and VV116 were ranked first in terms of enhancing the viral clearance rate on days 7 and 14, respectively. Molnupiravir was the most effective treatment for reducing the need for oxygen support. Overall, these findings remained consistent across the various subgroups.

CONCLUSIONS:

A thorough evaluation of effectiveness, applicable to both mild-to-moderate and unstratified populations, highlights the specific advantages of proxalutamide, nirmatrelvir/ritonavir, triazavirin, azvudine, molnupiravir, and VV116 in combating COVID-19. Additional clinical data are required to confirm the efficacy and safety of simnotrelvir/ritonavir and leritrelvir. The safety profiles of these antivirals were deemed acceptable.

2023-08-15·International journal of cancer

Proxalutamide in metastatic castration-resistant prostate cancer: Primary analysis of a multicenter, randomized, open-label, phase 2 trial.

Article

作者: Fu, Cheng ; Ye, Dingwei ; Shi, Guowei ; Qin, Shengfei ; He, Dalin ; Song, Xishuang ; Meng, Qinggui ; Zhou, Tie ; Chen, Guanghua ; Hou, Jianguo ; Wang, Jingen ; Hu, Zhiquan ; Xu, Weidong ; Sun, Weibing ; Liu, Ben ; Zhang, Wei ; Gao, Xu ; Yang, Yong ; Tang, Shouyan ; Li, Song ; Wang, Dongwen ; Wang, Yinhuai ; Jin, Jie ; Sun, Zhongquan ; Chen, Lijun

We aim to assess the safety and efficacy of proxalutamide, a novel androgen receptor antagonist, for men with metastatic castration-resistant prostate cancer (mCRPC) in a multicenter, randomized, open-label, phase 2 trial. In our study, the enrolled mCRPC patients were randomized to 100, 200 and 300 mg dose groups at 1:1:1. The primary efficacy endpoint was prostate-specific antigen (PSA) response rate. The secondary endpoints included objective response rate (ORR), disease control rate (DCR) and time to PSA and radiographic progression. Safety and pharmacokinetics were also assessed. Finally, there were 108 patients from 17 centers being enrolled. By week 16, there were 13 (35.1%), 12 (36.4%) and 15 (42.9%) patients with confirmed 50% or greater PSA decline in 100 mg (n = 37), 200 mg (n = 33) and 300 mg (n = 35) groups, respectively. Among the 19 patients with target lesions at study entry, three (15.8%) had a partial response and 12 (63.2%) had stable disease. The ORRs of 20.0%, 22.2%, 0% and DCRs of 80.0%, 88.9%, 60.0% were, respectively, achieved in 100, 200 and 300 mg groups. By the maximum follow-up time of 24 weeks, there were 42.6% and 10.2% of cases experiencing PSA progression and radiographic progression, respectively. Overall, adverse events (AEs) were experienced by 94.4% of patients, most of which were mild or moderate. There were 28 patients experiencing ≥grade 3 AEs. The most common AEs were fatigue (17.6%), anemia (14.8%), elevated AST (14.8%) and ALT (13.0%), decreased appetite (13.0%). These findings preliminarily showed the promising antitumor activity of proxalutamide in patients with mCRPC with a manageable safety profile. The proxalutamide dose of 200 mg daily is recommended for future phase 3 trial (Clinical trial registration no. CTR20170177).

2023-07-25·Proceedings of the National Academy of Sciences of the United States of America1区 · 综合性期刊

Proxalutamide reduces SARS-CoV-2 infection and associated inflammatory response

1区 · 综合性期刊

Article

作者: He, Tongchen ; Su, Fengyun ; Cheng, Caleb ; Parolia, Abhijit ; Wang, Rui ; Zhang, Charles J. ; Zhou, Qianxiang ; Pretto, Carla D. ; Zhang, Yuping ; Wotring, Jesse W. ; Ellison, Stephanie J. ; Wang, Yini ; Yan, Honghua ; Zheng, Yang ; Qiao, Yuanyuan ; Ma, Liandong ; Qin, Jun ; Cao, Xuhong ; Jiang, Xia ; Eyunni, Sanjana ; Chinnaiyan, Arul M. ; Sexton, Jonathan Z.

Early in the COVID-19 pandemic, data suggested that males had a higher risk of developing severe disease and that androgen deprivation therapy might be associated with protection. Combined with the fact that TMPRSS2 ( transmembrane serine protease 2 ), a host entry factor for the SARS-CoV-2 virus, was a well-known androgen-regulated gene, this led to an upsurge of research investigating androgen receptor (AR)-targeting drugs. Proxalutamide, an AR antagonist, was shown in initial clinical studies to benefit COVID-19 patients; however, further validation is needed as one study was retracted. Due to continued interest in proxalutamide, which is in phase 3 trials, we examined its ability to impact SARS-CoV-2 infection and downstream inflammatory responses. Proxalutamide exerted similar effects as enzalutamide, an AR antagonist prescribed for advanced prostate cancer, in decreasing AR signaling and expression of TMPRSS2 and angiotensin-converting enzyme 2 (ACE2) , the SARS-CoV-2 receptor. However, proxalutamide led to degradation of AR protein, which was not observed with enzalutamide. Proxalutamide inhibited SARS-CoV-2 infection with an IC 50 value of 97 nM, compared to 281 nM for enzalutamide. Importantly, proxalutamide inhibited infection by multiple SARS-CoV-2 variants and synergized with remdesivir. Proxalutamide protected against cell death in response to tumor necrosis factor alpha and interferon gamma, and overall survival of mice was increased with proxalutamide treatment prior to cytokine exposure. Mechanistically, we found that proxalutamide increased levels of NRF2, an essential transcription factor that mediates antioxidant responses, and decreased lung inflammation. These data provide compelling evidence that proxalutamide can prevent SARS-CoV-2 infection and cytokine-induced lung damage, suggesting that promising clinical data may emerge from ongoing phase 3 trials.

109

项与普克鲁胺相关的新闻（医药）

2024-03-29

·美通社

开拓药业2023年度业绩：探索皮科多渠道商业化路径，深挖多管线研发及商业价值

苏州 2024年3月29日 /美通社/ -- 北京时间2024年3月29日，开拓药业（股票代码：9939.HK），一家专注于潜在同类首创和同类最佳创新药物研发及产业化的生物制药公司，公布了近期业务亮点及截至2023年12月31日全年业绩。 2023年度业绩总览业务概览皮科双核心产品全球临床研发持续推进在研多管线显露研发及商业合作价值多项研究成果入选重要学术会议及于核心期刊发表财务概览资金使用效率有效提升，在手现金支持公司战略布局奖项荣誉斩获认可，屡次入选生科公司榜单一、业务概览作为专注于潜在同类首创和同类最佳创新药物研发及产业化的生物制药公司，开拓药业前瞻性布局了包含小分子创新药、生物创新药及联合疗法的多元化产品管线，目前拥有6款在中国和全球开展临床I-III期研究的新药项目。 1. 皮科双核心产品全球临床研发持续推进我们在皮科领域拥有丰富的研发经验，目前两款核心药物KX-826及GT20029已分别推进至临床III期及临床II期，并正积极探索核心产品于皮科领域的商业化路径。此外，我们亦在开发更多化合物，拓展皮科领域的适应症布局。 KX-826 ，公司自主开发的外用雄激素受体（AR）拮抗剂，超千人使用显示良好的安全性和有效性，连续使用6个月后，患者目标区域内的平均非毳毛数（TAHC）较基线增加最高可达22.7根/cm 2 。 2023年，KX-826完成了中国男性脱发III期临床试验、美国男性脱发II期临床试验及中国痤疮II期临床试验，同时，我们启动了中国脱发长期安全性III期临床试验及KX-826与米诺地尔联合使用的中国脱发Ib/III期临床试验。针对脱发适应症，我们已验证KX-826在不同的人群中的良好安全性及有效性。长期安全性III期临床试验预计将为公司提供长期使用KX-826的安全性及有效性的数据支持。与米诺地尔联合疗法的探索将进一步挖掘KX-826于脱发领域的治疗效果。针对痤疮适应症，II期临床试验的结果为公司后续研究开展奠定了基础。 2024年2月1日，公司自主研发的KX-826和米诺地尔联合治疗中国男性患者雄激素性脱发Ib/III期临床试验获得中国国家药品监督管理局（NMPA）批准开展。 2023年11月27日，公司公布KX-826治疗男性脱发的中国III期临床试验顶线数据。分析结果显示，该试验整体安全性优良，KX-826展示了极佳的安全性能。治疗24周后，KX-826组TAHC结果显示，KX-826与基线相比促进了毛发生长，具有统计学意义（ p <0.0001）。与安慰剂相比，KX-826 0.5%BID组TAHC在各个访视点均有提高，显示疗效趋势，但差异在统计学上未达到显著性。 2023年11月15日，KX-826治疗脱发的长期安全性III期临床试验完成全部患者入组。该试验于2023年4月18日获得NMPA批准开展。 2023年8月28日，公司宣布KX-826治疗痤疮的中国II期临床试验已成功完成。结果显示KX-826具有良好的安全性和有效性。 2023年5月11日，公司宣布KX-826治疗男性脱发的美国II期临床试验已成功完成。与基线相比，治疗24周后的结果具有统计学和临床意义，且安全性良好。 GT20029 ，外用AR-PROTAC化合物，基于公司自有PROTAC平台开发，是全球首个进入II期临床试验的外用PROTAC化合物。 2023年，GT20029完成了美国脱发及痤疮的I期临床试验。其于中国开展的脱发II期临床试验预计将在近期读出顶线结果。基于GT20029治疗痤疮于中国及美国I期临床试验的结果，我们正在计划开展GT20029用于痤疮治疗的II期临床试验。 2023年8月22日，GT20029治疗男性脱发的中国II期临床试验完成全部180名患者入组，公司正在清理各个入组中心的数据，预计将在近期读出顶线结果，并据此确定后续的临床策略，如开展中国脱发男性III期临床试验等。 2023年2月10日，公司公布GT20029治疗脱发及痤疮的美国I期临床试验的顶线结果。结果显示，GT20029在健康受试者、脱发受试者和痤疮受试者中均展示良好的安全性、耐受性和药代动力学特征。基于GT20029治疗痤疮于中国及美国I期临床试验的结果，我们正在准备开展GT20029用于痤疮治疗的II期临床试验，进一步拓展我们在痤疮治疗领域的研究范围。 2. 在研多管线显露研发及商业合作价值通过多年积累，公司拥有另外4款处于临床阶段的产品，前期的临床试验已初步验证该等产品具有良好的安全性及疗效。公司亦开展多项临床前研究，潜在化合物展现出优异的开发及临床合作价值。 GT1708F ，公司自主开发的针对多种实体瘤的创新药物，并首次将适应症扩大至罕见病领域 2023年10月，GT1708F治疗IPF的中国II期临床试验获得NMPA有条件批准开展。 2023年5月8日，公司宣布GT1708F治疗恶性血液疾病的中国I期临床试验成功完成。结果显示，GT1708F展现出良好的安全性和耐受性，所有患者均未发生剂量限制性毒性（DLT）和与研究药物有关的严重不良事件（SAE）。在剂量递增阶段，自180mg剂量组起，在多线治疗失败的急性骨髓性白血病（AML）患者中观察到初步疗效，AML患者髓系原始细胞较基线最高下降了62%。此外，我们还拥有公司license in的首款大分子药物，具有极佳的联合用药潜力的 ALK-1 ，公司自主开发的有潜力成为同类最佳药物的二代AR抑制剂的普克鲁胺（ GT0918），公司自主开发的分子胶化合物，在多种癌细胞中表现出纳摩尔级别的抗肿瘤活性的 c-Myc分子胶。 3. 科研学术影响力不断增强 2023年以来，开拓药业多个产品管线研究进展入选国际学术大会和在期刊上发表，公司创新能力持续提升，进一步验证公司产品管线First-in-Class的潜力。 KX-826和GT20029治疗雄激素性脱发和痤疮的临床进展在2023年美国皮肤病学会年会（AAD 2023）备受关注 Hedgehog/SMO抑制剂GT1708F治疗急性髓系白血病（AML）的最新临床前研究结果入选第65届美国血液学年会（ASH 2023）及2023年美国癌症研究协会年会（AACR 2023）普克鲁胺治疗转移性乳腺癌Ic期临床试验结果于第46届圣安东尼奥乳腺癌研讨会（SABCS 2023）及2023年欧洲肿瘤内科学会年会（ESMO 2023）亮相 ALK-1联合Nivolumab治疗晚期肝细胞癌的Ib/II期临床研究获《BMC医学》（影响因子11.806)发表 c-Myc分子胶研究获《Nature》子刊《Nature Communications》（影响因子16.6）发表 c-Myc分子胶研究结果于ASH 2023亮相二、财务概览 1. 研发费用 *：下降66.6% 截至2023年12月31日，撇除减值及跌价影响，公司的研发成本共计人民币245.8百万元，同比截至2022年12月31日人民币735.0百万元下降66.6%。研发成本减少主要是由于报告期内公司聚焦核心皮科管线，该等投入较其余管线有极大节约。 * 研发费用已撇除减值及跌价影响 2. 行政开支 *：下降34.6% 截至2023年12月31日，撇除减值影响，公司的行政开支共计人民币86.4百万元，同比截至2022年12月31日人民币132.2百万元下降34.6%。行政开支减少主要是由于报告期内员工薪酬及股权激励费用减少。公司已于2023年底进行雇员规模及薪酬调整，并将视乎业务推进情况采取进一步行动。 *行政开支已撇除减值影响 3. 在手现金截至2023年12月31日，公司持有现金和现金等价物以及定期存款为人民币456.3百万元，另外，公司持有动用的银行授信为人民币110.5百万元。在手现金能够支持公司的临床和研发推进，以及为实现产品商业化的必要性支出。三、奖项荣誉斩获认可，屡次入选生科公司榜单开拓药业凭借其在药物创新研发领域长期的钻研不懈，获得业界的广泛认可，荣膺多项行业和资本市场奖项，包括第十届港股100强"生物科技股15强"、入选"中国小分子药物企业创新力TOP30"排行榜（米内网2022年度中国生物医药企业创新力百强系列榜单）、智通财经评选"最佳中小市值公司"等。四、董事长寄语创始人、董事长兼首席执行官童友之博士表示：新药研发之路注定布满荆棘。2023年对于开拓而言，是在荆棘之路不断磨砺、在重重迷雾中坚定脚步的历程。虽然面临重重挑战，开拓药业始终没有放弃对新药研发的追求。公司上下怀揣着推出首款创新药物的共同目标，付诸自己的努力与汗水。我们在皮科领域的探索始终处于前沿地位，两款皮科核心药物KX-826及GT20029具备优秀临床和商业化潜质。我们已在超1,000位受试者中验证了KX-826的安全性和有效性，得益于我们的药物，这些受试者的平均TAHC较基线增加最高可达22.7根/cm 2 。GT20029计划在近期披露中国脱发II期临床试验的顶线结果并准备开展用于痤疮的II期临床试验。此外，我们亦在开发更多化合物，拓展皮科领域的适应症布局。在非皮科领域，我们正通过联合开发或对外授权方式挖掘更高的药物价值，为患者提供更多的用药选择。展望2024年，我们将继续发挥公司在皮科领域的独特优势，积极探索多方位的商业化路径。同时，我们会提高资金使用效率，期待通过长期可持续发展，为患者、股东创造更多价值。 * 详情请参阅公司于2024年3月28日发布的2023年度业绩公告

临床3期临床2期临床成功

2024-01-03

·赛柏蓝

2024｜医药领域的机会、风险

2023年是中国成为医药创新发源地的第一年，医药魔方数据显示，中国2023年创新药license out（国内转国外）交易总金额超350亿美元，比2022年增长27%以上。底层原因既有自研进步、创新前置的理想叙事，也有投融资艰难、以BD首付款获得输血的现实主义悲歌。部分Biotech把核心管线卖得干干净净，虽然活下来，却要从头再来。2024年，医药行业澎湃的内生增长动力，将遇到两个冰冷的现实。海外资本寒冬正在结束，CXO、XBI、IBB自2023年11月1日以来狂飙突进，而国内未盈利创新药企IPO及再融资阻滞局面，还没有结束的时间表。在大国科技角力的背景下，这将长期损害中国生物科技的活力。很多人还没注意到，医保局官网的基本医疗保险基金收支情况，从2023年10月起不再公布同比增速数据。随着低基数效应消失，预计2024年医保支出将回归高个位数增长（2018~2022医保支出CAGR9.6%）。当然，国家维持卫生费用增速接近GDP增速2倍，也是尽力了。在投融资及支付环境紧平衡的条件下，存量及结构性增量争夺战将更加惨烈，2024年呈现极致分化的局面，让我们由寒及热，快速俯瞰新一年的可能性。0110亿市值以下10亿港元市值以下的港股18A公司增至9家，占带有B标识的生物科技公司比例17%。参考2004-2018年间通过纳斯达克IPO上市的424家创新药企，至今不再存续的比例达47%，且存续企业有37%市值小于1亿美元，预计港股带有B标识的生物科技公司，市值小于10亿港元的比例长期向30%靠拢。在接近半数Biotech消失后，美国创新药产业没有完蛋，而是更加强大，所以不必自作多情。而国内生物科技要形成正常的新陈代谢（退出）生态，需要10亿港元以下市值结构扩容，以降低并购门槛，让管线实现货币化流动。对10亿港元以下Biotech不必悲观，只要现金储备充裕，管线有临床价值，还有重塑自身的机会。而且10亿港元，对国内大型综合药企已不构成资金门槛，参考美股亘喜生物，一个并购可以引发脉冲式爆发。02平静等待结局开拓药业正在平静等待自己的结局。曾经5个月10倍，成为全球医药股涨幅王，即使在随后漫长的下跌途中也充满诱惑力，出现约10次单日上涨超10%的机会。相比最高点89元，已经跌去98%。Biotech可以犯几次错？开拓药业经历过3次III期临床失败，普克鲁胺蹭疫情热度失败了，现在连治疗前列腺癌、脱发的基本盘都丢失了。2023H1，亏损2亿元，现金储备7亿元，一年内或按要求偿还借款1亿元。还有逆天改命的奇迹吗？开拓药业股价冲天时，没有从新冠疫情取得收益，资本市场的迷人之处在于，画饼更能充饥，算出来的钱比拿到手的钱更值钱。生物科技领域，随着少数老板和背后运作团队做局能力的升维，画饼现在很难被识破。在一门遵循证据的科学中，任何高端局终将败露，早期临床数据不规范或有水分，但III期注册临床揭盲将飞出黑天鹅。0310亿大单品有多难？2024年，才是Biotech真正的商业化验证期，我们可能会发现一个单品要逾越10亿门槛有多难？随着支付政策对创新药倾斜，长周期大品种的销售峰值将边际改善，但在质变发生之前，动辄10亿到50亿的预测模型，是否过于理想化？Biotech商业化进程已出现危险信号，部分上市3年左右的明星药物有停止爬坡的迹象。再鼎医药核心产品PARP抑制剂则乐2022年刚刚跨过10亿大关，2023Q3销售额环比下降3.3%；荣昌生物ADC药物维迪西妥单抗2021年6月获批上市，至今距离10亿大关遥不可及，维迪西妥单抗+泰它西普2023前三季度合计销售额7.7亿元，付出的代价是5.4亿元销售费用。荣昌生物是一家令人困惑的公司，IPO两次，目前现金却只能撑半年，2023前三季度亏损10.3亿元，货币资金+交易性金融资产7.9亿元，自免重磅药物泰它西普或眼科重磅药物RC28可能不得不寻求对外BD，以补充现金流。中腰部Biotech摊子铺得太大，一旦造血能力没有跟上消耗，不排除阶层跌落的可能。04防御型资产2024年，传统药企将大举反攻。商业变现能力强、现金流充裕是基本盘，部分传统药企有了本质进化，对Biotech的玩法、套路都学得差不多了，在管线立项、BD能力上都日益成熟，进可攻，退可守。传统药企的创新模式主要有三种。一是以百洋医药、康哲药业为代表，基于对终端医疗场景的深刻洞察，以商业化基因指导前端管线立项。百洋医药集团承担产业投资人和孵化器的角色，在创新药、高端医疗器械、基础研究平台上广泛布局，创新产品培育成熟一个，优先考虑向上市公司输送一个，上市公司基本与创新风险隔离，并从源源不断注入的创新产品获得长期成长动力。二是以恒瑞医药为代表，对创新药所有高景气赛道全布局，ADC、GLP-1、自免、阿尔茨海默症、痛风无一遗漏，并且进度领先。三是以华东医药为代表，跨越多线，形成创新药（GLP-1、ADC）、医美（全产品线）、工业微生物的稳定架构。血制品依靠资源禀赋、刚需属性，龙头不仅是龙头，还会成为寡头，将成为跨越周期的防御型资产。主打平价替代、下沉市场的首仿和生物类似药将有强劲的市场需求。以仿制药为代表的板块业绩增速企稳，2023年利润规模有望达到集采以来的最高点。仿制药CRO龙头百诚医药、阳光诺和业绩增速亮眼，在手订单充沛，也验证了仿制药企盈利能力稳定、不受投融资环境影响的逻辑。部分仿制药企正向仿创升级，手握创新药大单品，进一步增加抗风险能力。05ADC继续最热中国企业部分ADC产品已具备BIC优势。目前，国内进入全球前三的ADC资产已经快被MNC抢光。据InScienceWeTrust BioAdvisory 统计，在过去两年，除罗氏以外，所有肿瘤领域的MNC都已完成ADC引进交易。中国Biotech成为全球早期ADC资产的主要来源，2023年，中国Biotech ADC对外授权交易的首付款总额是2022年的5倍 (57亿美元vs12亿美元)。InScienceWeTrust BioAdvisory创始人唐钧博士预计ADC将在2024年甚至更远的时间里继续成为肿瘤学最热门的领域。ADC赛道持续升温，乐普生物性价比凸显，研发进展不断，EGFR ADC新药MRG003获得FDA授予快速通道资格，用于治疗复发性或转移性鼻咽癌，TF靶向ADC新药MRG004A用于治疗胰腺癌获FDA授予孤儿药资格认定。06头部格局初定2015年，中国进入创新药元年，经历10年迷雾和混战，各个细分领域的头部正在明朗。新生代创新药企已呈现两巨头格局。百济神州2024年创新药收入或将超过恒瑞，如果能平衡好研发与财务，市值有希望超过恒瑞医药。信达生物体现出超强的临床开发效率，在国内KRAS G12C新药竞争胶着状态中，上市许可申请率先获得受理。信达生物的受试者入组速度可能是国内最快之一，临床研究III期的患者招募期间，CRA（临床监查员）一周七天可能都在出差，每天在医院工作到十二点。猎头专门来挖信达这批CRA，已经出去的CRA每介绍一个项目组内的CRA成功入职就能拿到3000美金的推荐费。12月26日，信达生物启动GLP-1双靶点减肥药玛仕度肽头对头挑战司美格鲁肽的III期临床试验，如果有战胜司美格鲁肽的成绩背书，玛仕度肽成为中国药王将无悬念。创新药有多个高景气赛道，以下只分析少数，并且广泛布局的综合型药企不再重复列举。血液瘤领域头部为诺诚健华、亚盛医药，这一赛道特点是存量患者多，生存期长，药物有较长销售爬坡期，容易诞生爆款。肾科领域头部为云顶新耀、信瑞诺医药，这一赛道特点是患者基数大且多为35岁以下，为避免肾功能衰竭，有着急迫的治疗需求。自免领域头部为康诺亚、康方生物、三生国健、诺诚健华、再鼎医药、泽璟制药、荃信生物，这个赛道的特点是自免疾病之间存在共患率，一款创新药甚至可以捆绑约10个适应症，一旦首个适应症获批，就有成为集束炸弹的可能，2024年，首个国产白介素家族、首个国产JAK抑制剂新药将获批上市。阿尔茨海默症领域存在预期差，国产药物布局较弱，临床诊断的商业价值可能更高。Science最近一篇论文提到，Aβ单抗治疗阿尔茨海默症，为确保安全性，全程检查费是药费的3倍。阿尔茨海默症检测金标准是 PET/CT 脑显像或脑脊液检测，但脑脊液检测需要穿刺，侵入性低的PET/CT 脑显像将成为主流，东诚药业靶向 Aβ的18F-洛贝平注射液已向CDE 申报上市，Tau 蛋白PET示踪剂18F-Florzolotau处于全球 III 期临床阶段，有望复制福瑞股份在NASH检测领域的逻辑。血液生物标志物检测是最新趋势，侵入性低，成本低，可及性更高，结合淀粉样斑块、Tau 病理、神经损伤共三种血液标志物来识别评估与阿尔茨海默症相关的生物学变化。亚辉龙、诺唯赞、热景生物、金域医学和迪安诊断正在布局 AD 血液检测试剂和诊断服务市场。2024H1，礼来靶向Aβ单抗Donanemab获批上市将成为赛道催化剂。医药生物即将超越银行，成为A股行业市值第一，其内部有着复杂多变的现实，极寒极热并存，风险机会共生，2024年将是一个重要节点。END作者 | 阿基米德君来源 | 阿基米德Biotech医药代表交流群扫描下方二维码加入医药代理商转型交流群扫描下方二维码加入

IPO临床3期引进/卖出

2023-12-13

·PRNewswire

Metastatic Prostate Cancer Market to Exhibit Positive Growth at a CAGR of 22% and 7.5% for mHSPC and mCRPC, respectively During the Study Period (2019-2032), Assesses DelveInsight

The dynamics of the metastatic prostate cancer market are anticipated to change in the coming years owing to the rise in the number of companies taking interest in the development of specific drugs for mCRPC and nmCRPC along with increasing awareness and penetration of already approved prostate cancer drugs. LAS VEGAS, Dec. 13, 2023 /PRNewswire/ -- DelveInsight's Metastatic Prostate Cancer Market Insights report includes a comprehensive understanding of current treatment practices, metastatic prostate cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metastatic Prostate Cancer Market Report As per DelveInsight analysis, the total market size in the 7MM for metastatic castration-resistant prostate cancer (mCRPC) was estimated to be nearly USD 6.4 billion in 2022, which is expected to show positive growth by 2032. In 2022, the United States held the highest market share for mCRPC and mCSPC in the 7MM, at 63% and 61%, respectively, followed by the EU4 countries and the UK. As per DelveInsight estimates, the total prevalent population of prostate cancer in the 7MM was nearly 8 million cases in 2022. These cases will increase during the study period, i.e., 2019–2032. Leading metastatic prostate cancer companies such as AstraZeneca, Merck Sharp & Dohme, Hinova Pharmaceuticals, Pfizer, Astellas Pharma, Modra Pharmaceuticals, AB Science, Eli Lilly and Company, Zr Pharma & GmbH, Bristol-Myers Squibb, Ipsen, Exelixis, Takeda, Janssen Research & Development, Tesaro, Lantheus Holdings, Kintor Pharmaceutical, MacroGenics, Daiichi Sankyo, Madison Vaccines, Novartis, Point Biopharma, Xencor, Essa Pharma , Telix International, Bayer, Arvinas, and others are developing novel metastatic prostate cancer drugs that can be available in the metastatic prostate cancer market in the coming years. The promising metastatic prostate cancer therapies in the pipeline include HC-1119, Talazoparib, Enzalutamide, Niraparib, Boosted Oral Docetaxel, Masitinib, EPI-7386, Verzenio, 177Lu-PSMA-617, Capivasertib, I-131-1095, Proxalutamide (GT0918), MGC018, DS-7300, MVI-816, ARV-110, 177Lu-PNT2002 (PNT2002), Vudalimab (XmAb20717), 177Lu-DOTA-rosopatamab (TLX591), and others. Established therapies in the metastatic prostate cancer market include Astella/Pfizer's and Jansenn's blockbuster products XTANDI and ZYTIGA, respectively, approved for metastatic patients for over a decade now. Even though ZYTIGA's generics have entered the US market since 2019, and the EU since late 2022, leading to a drastic decline in the revenue mainly in the US, the product is extensively being evaluated in combination with novel emerging therapies, leading to an increase in patient share on the compound abiraterone acetate. Whereas, Jansenn's XTANDI, the biggest revenue generator in the prostate cancer market, has witnessed stable growth since 2021 owing to increased competition. Quantitatively mCRPC pipeline seems to be quite strong, however with recent failures/terminations of several trials of certain therapies in the past year, we have mentioned the most promising ones, which include ESSA Pharma's EPI-7386, Macrogenics, and Daiichi's anti-B7-H3 Antibody Drug Conjugates, MGC-018 and DS-7300 respectively, Arvinas, AR-targeted PROTAC protein degrader, and Point Biopharma's Radioligand therapy. Except for Point Biopharma's therapy, none of these potential players have initiated a Phase III trial, even though Arvinas is planning to opt for an accelerated approval based on its Phase II data readout. The landscape of mHSPC has evolved tremendously in the past decades. The treatment paradigm has shifted from androgen deprivation therapy (ADT) alone to doublet combinations comprising ADT with docetaxel or an androgen receptor inhibitor, and now triplet therapy involving all three classes of agents. Apart from XTANDI, ZYTIGA, and ERLEADA in the mCSPC market, Bayer's NUBEQA is another rising contender with a strong uptake in a short period. Bayer is further strategizing to increase the prescription by volume for NUBEQA by label expansion in patients who are not eligible for chemotherapy in the ARANOTE Phase III trial. PARP inhibitors such as AKEEGA and TALZENNA are also currently being evaluated in the mHSPC space alone and with ARIs. Novartis' radioligand therapy, PLUVICTO approved in 2022, has generated an unexpected revenue from the third-line mCRPC setting, further plans to expand in an earlier line in mCRPC by 2024 in the United States. The approval of PLUVICTO has also marked a crucial advancement in treating progressive mCRPC, offering improved survival rates for those with limited treatment options. The drug had an exceptionally robust initial market performance, garnering a stronger-than-expected uptake in the US. The drug is currently being studied in the Phase III PSMAddition study to see if that triplet combination is better than ADT and an androgen receptor signaling inhibitor alone in patients with mHSPC. Discover which therapies are expected to grab the major metastatic prostate cancer market share @ Metastatic Prostate Cancer Market Report Metastatic Prostate Cancer Overview Prostate cancer, a form of malignancy specific to the prostate gland within the male reproductive system, can advance to a metastatic stage, spreading from the prostate to other areas of the body. This advanced stage is often referred to as metastatic or advanced prostate cancer, commonly extending to lymph nodes or bones. Prostate cancer symptoms can differ widely among individuals. Although some men might not experience any symptoms, typical signs may include the presence of blood in the urine or semen, painful ejaculation, discomfort or a burning sensation during urination, and various other related symptoms. The primary diagnostic method involves prostate-specific antigen (PSA) testing, which detects elevated PSA levels in individuals affected by prostate cancer or other prostate-related conditions. Screening processes may also include a digital rectal exam to identify any notable prostate tumors, alongside additional methods such as prostate ultrasound and MRI scans. However, a conclusive diagnosis typically necessitates a transrectal ultrasound-guided (TRUS) prostate tissue biopsy. Metastatic Prostate Cancer Epidemiology Segmentation As per DelveInsight analysis, the United States had the highest number of diagnosed prostate cancer cases in 2022, with approximately 2.9 million reported cases. In 2022, total cases of metastatic CSPC/HSPC and metastatic CRPC were around 100K and 120K, respectively, in the 7MM. These cases are expected to increase by 2032. The metastatic prostate cancer market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalent Cases of Prostate Cancer Total Diagnosed Cases of Prostate Cancer Age-Specific Cases of Prostate Cancer Total Diagnosed Cases of Prostate Cancer by Clinical Stages Total Metastatic Cases of Prostate Cancer Total Treated Cases of mCRPC Total Treated Cases of mCSPC Metastatic Prostate Cancer Treatment Market Metastatic Castration-Resistant Prostate Cancer (mCRPC) is a stage of prostate cancer that has spread to other parts of the body, such as lymph nodes or bones, and no longer responds to treatment that lowers testosterone. Despite currently approved therapeutics, mCRPC remains a terminal diagnosis with an aggressive disease course. ADT is a stalwart therapy for the initial treatment of metastatic disease. Unfortunately, most men in this situation will go on to develop mCRPC and require secondary systemic therapy. This disease state can be very challenging to treat. Docetaxel was the only agent available for the treatment of mCRPC until 2010, which showed an increase in overall survival compared with the standard of care. It was approved in 2004 for mCRPC with prednisone. Patients failed to first-line docetaxel for many years, and no standard treatment option was approved. However, in the last few years, several drugs such as JEVTANA, ZYTIGA, XTANDI, LYNPARZA, TALZENNA, AKEEGA, and others have received regulatory approval for mCRPC in the United States. Most recently, PARP inhibitors have shown tremendous development in this area with AKEEGA (Janssen), followed by TALZENNA (Pfizer/Astellas Pharma) and LYNPARZA in combination (AstraZeneca/Merck) getting approved in mCRPC in 2023. The approval of PLUVICTO has also marked a crucial advancement in treating progressive mCRPC, offering improved survival rates for those with limited treatment options. The drug had an exceptionally robust initial market performance, garnering a stronger-than-expected uptake in the US. Quantitatively, the mCRPC pipeline seems to be quite strong. ADCs such as MGC018 and DS-7300 have both displayed encouraging results in clinical trials involving patients with mCRPC. However, except for Point Biopharma's therapy, none of these potential players have initiated a Phase III trial, even though Arvinas plans to opt for an accelerated approval based on its Phase II data readout. Metastatic Castrate-Sensitive Prostate Cancer (mCSPC) is an advanced form of cancer in which cancer cells have spread from the prostate to other body areas. However, the patient is still sensitive to androgen deprivation therapy (ADT) (some mCSPC patients have never had ADT, while others may have had ADT but have recovered testicular function). The backbone of all treatments in mCSPC is androgen deprivation therapy (ADT) with medications that suppress the level of testosterone in the body because testosterone is the fuel for prostate cancer and gives the signals to grow and spread. Studies over the last decade have demonstrated that intensification of androgen deprivation with different treatment modalities correlates with prolongation of survival. The options for intensification include docetaxel chemotherapy, different androgen receptor-targeted agents, including abiraterone acetate, apalutamide, and enzalutamide, and radiation to the prostate. Most recently, the treatment paradigm for mHSPC shifted to triplet therapy, NUBEQA combined with ADT and chemotherapy. According to the findings presented at the ASCO GU 2023, the regimen should be considered the new standard of care for this patient population. To know more about metastatic prostate cancer treatment guidelines, visit @ Metastatic Prostate Cancer Management Metastatic Prostate Cancer Pipeline Therapies and Key Companies Capivasertib (AZD 5363): AstraZeneca Bavdegalutamide (ARV-110): Arvinas MVI-816 (pTVG-HP): Madison Vaccines PT-112: Phosplatin Therapeutics HC-1119: Hinova Pharmaceuticals OPDIVO (nivolumab): Bristol Myers Squibb KEYTRUDA (Pembrolizumab/MK-3475): Merck MGC018 (vobramitamab duocarmazine): MacroGenics DS-7300: Daiichi Sankyo Ceralasertib: AstraZeneca Ladiratuzumab vedotin: Seagen/Merck BMS-986218: Bristol-Myers Squibb TAS-115: Taiho Pharmaceutical ModraDoc006/r: Modra Pharmaceuticals Vudalimab: Xencor (Lu-177) - PNT2002: Point Biopharma LNTH-1095 (MIP-1095): Lantheus Holdings ZEN-3694: Zenith Epigenetics EPI-7386: Essa Pharma 177Lu-DOTA-rosopatamab: Telix Pharmaceuticals Proxalutamide: Kintor Pharmaceutical Masitinib: AB Science VERZENIO (Abemaciclib/LY2835219): Eli Lilly and Company CABOMETYX (cabozantinib): Exelixis Learn more about the FDA-approved drugs for metastatic prostate cancer @ Drugs for Metastatic Prostate Cancer Treatment Metastatic Prostate Cancer Market Dynamics The dynamics of the metastatic prostate cancer are expected to change in the coming years. Before 2010, docetaxel was the primary therapeutic option for metastatic castration-resistant prostate cancer (mCRPC), demonstrating improved overall survival compared to the established standard of care. Its approval in 2004, alongside prednisone, marked a milestone in mCRPC treatment. Following initial docetaxel therapy failure, patients faced a dearth of approved second-line treatments for numerous years. However, recent years have witnessed regulatory approvals of multiple drugs in the United States for mCRPC, transforming the treatment landscape. Notably, medications such as JEVTANA, ZYTIGA, XTANDI, LYNPARZA, TALZENNA, AKEEGA, and several others have gained approval. Of late, significant advancements have emerged in the realm of mCRPC, particularly with PARP inhibitors. AKEEGA from Janssen, TALZENNA jointly developed by Pfizer and Astellas Pharma, and the combination of LYNPARZA by AstraZeneca and Merck garnered approval in 2023, showcasing remarkable progress in this domain. PLUVICTO's approval is a significant leap forward in the management of progressive metastatic castration-resistant prostate cancer, bringing improved survival rates to patients with limited treatment alternatives. The drug witnessed an exceptional and robust initial performance in the US market, exceeding expectations. In numerical terms, the pipeline for metastatic castration-resistant prostate cancer appears robust. Antibody-drug conjugates like MGC018 and DS-7300 have demonstrated promising outcomes in clinical trials among mCRPC patients. Nevertheless, except for Point Biopharma's treatment, the majority of these prospective treatments have yet to commence a Phase III trial. Despite this, Arvinas intends to pursue an expedited approval pathway leveraging its Phase II data for regulatory approval. Scope of the Metastatic Prostate Cancer Market Report Therapeutic Assessment: Metastatic Prostate Cancer current marketed and emerging therapies Metastatic Prostate Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Metastatic Prostate Cancer Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metastatic Prostate Cancer Market Access and Reimbursement Discover more about metastatic prostate cancer drugs in development @ Metastatic Prostate Cancer Clinical Trials Table of Contents Related Reports Prostate Cancer Epidemiology Forecast Prostate Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and prostate cancer epidemiology trends. Metastatic Prostate Cancer Pipeline Metastatic Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic prostate cancer companies, including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis , among others. Metastatic Castration-Resistant Prostate Cancer Market Metastatic Castration-Resistant Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic castration-resistant prostate cancer companies including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis among others. Metastatic Hormone-Refractory Prostate Cancer Pipeline Metastatic Hormone-Refractory Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key metastatic hormone-refractory prostate cancer companies, including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis, 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] +91-9650213330 Logo: SOURCE DelveInsight Business Research, LLP

临床3期上市批准临床结果临床2期

100 项与普克鲁胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	普克鲁胺	-	DB16065

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
新型冠状病毒感染	巴拉圭	苏州开拓药业股份有限公司	2021-07-16

未上市

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适应症	最高研发状态	国家/地区	公司	日期
严重急性呼吸综合征	临床3期	巴西	Sutro Biopharma, Inc.	2021-02-02
转移性去势抵抗性前列腺癌	临床3期	中国	苏州开拓药业股份有限公司	2019-04-30
转移性去势抵抗性前列腺癌	临床3期	中国	中国药科大学	2019-04-30
去势抵抗性前列腺癌	临床3期	中国	苏州开拓药业股份有限公司	2018-09-21
去势抵抗性前列腺癌	临床3期	中国	中国药科大学	2018-09-21
转移性乳腺癌	临床2期	中国	苏州开拓药业股份有限公司	2023-04-27
HR阳性乳腺癌	临床1期	中国	苏州开拓药业股份有限公司	2019-06-18
HR阳性乳腺癌	临床1期	中国	中国药科大学	2019-06-18
转移性前列腺癌	临床1期	美国	苏州开拓药业股份有限公司	2016-02-10

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04870606 (MRCT, CTgov)	临床3期	新型冠状病毒感染	733	Proxalutamide (GT0918) (GT0918+ Standard of Care)	鏇製壓衊膚範淵窪鏇糧(襯廠淵獵簾廠糧壓糧繭) = 艱構選積選醖鹽選獵醖製齋獵壓廠齋築壓製鏇 (築蓋鏇構鹽膚膚衊襯壓, 鹹鏇網遞製窪遞淵蓋鹹 ~ 艱壓醖夢膚艱簾襯範範) 更多	-	2024-01-02
				Placebo (Placebo+ Standard of Care)	鏇製壓衊膚範淵窪鏇糧(襯廠淵獵簾廠糧壓糧繭) = 願衊願顧鏇蓋衊齋繭窪製齋獵壓廠齋築壓製鏇 (築蓋鏇構鹽膚膚衊襯壓, 壓糧獵製衊願襯鬱鬱衊 ~ 鏇繭艱構鏇網餘網積鹹) 更多
NCT03899467 (CTgov)	临床2期	转移性去势抵抗性前列腺癌	61	GT0918 (Arm 1: 400 mg /Day of GT0918)	選淵製獵構襯襯壓築鹽(廠糧廠網製鬱淵鹽壓鏇) = 鹽艱繭積範襯顧顧積壓顧獵製淵廠簾簾築鹹簾 (壓窪窪鏇夢壓衊艱選鹹, 醖築衊簾顧廠鹹窪廠鑰 ~ 積獵製壓壓淵窪齋鹽積) 更多	-	2024-01-02
				GT0918 (Arm 2: 500 mg/Day of GT0918)	選淵製獵構襯襯壓築鹽(廠糧廠網製鬱淵鹽壓鏇) = 窪鏇選網淵壓憲網襯遞顧獵製淵廠簾簾築鹹簾 (壓窪窪鏇夢壓衊艱選鹹, 鏇顧網顧製齋鏇網鏇壓 ~ 鬱膚簾鹹壓蓋簾遞鹽構) 更多
SABCS2023	N/A	转移性乳腺癌一线 HR+ \| HER2- \| AR+	38	Proxalutamide plus Fulvestrant	艱鬱襯醖衊範構糧壓構(鹽選選網獵鹹鹹築鬱膚) = 顧繭醖鑰窪夢淵鹹憲鬱廠壓範鬱夢獵遞糧齋鹽 (衊鹹構構艱壓淵築艱淵, 3.2% ~ 37.9%) 更多	-	2023-12-05
CTR20191063 (ESMO2023) 人工标引	临床1期	AR阳性/ER阳性/HER2阴性乳腺癌 HR positive \| HER2 negative \| AR positive	37	proxalutamide plus fulvestrant	鹹製選襯艱憲艱鑰網鹹(積廠齋範窪範製壓鏇願) = 製艱艱簾鹽鬱網獵餘獵夢窪鹽製衊鹹齋艱構醖 (鹽壓餘簾鬱觸衊網廠觸 ) 更多	积极	2023-10-21
				proxalutamide plus fulvestrant (part 1)	願鑰願壓積簾糧鏇餘齋(製鏇餘網醖觸鑰繭膚積) = 顧夢艱淵糧膚鹹鏇製鏇願範鹹顧顧壓選遞製齋 (鹽網製夢鏇鹽艱窪選襯 ) 更多
NCT04103853 \| CTR20170757 (Pubmed)	临床1期	转移性乳腺癌	63	Proxalutamide 200 mg	願簾鬱醖齋構網積憲獵(選衊鑰願鑰網艱憲範製) = 膚憲鹹壓膚遞艱鏇選淵鹹蓋艱製簾廠廠醖觸壓 (鏇鏇繭鹹艱願繭蓋遞齋, 11.9 ~ 39.4) 更多	-	2022-09-28
				Proxalutamide 300 mg	願簾鬱醖齋構網積憲獵(選衊鑰願鑰網艱憲範製) = 夢製糧醖窪範鏇衊膚鹹鹹蓋艱製簾廠廠醖觸壓 (鏇鏇繭鹹艱願繭蓋遞齋, 11.9 ~ 39.4) 更多
NCT04870606 (MRCT, NEWS) 人工标引	临床3期	新型冠状病毒感染	733	Standard of Care+Proxalutamide	膚膚觸積糧簾餘壓醖餘(製鑰夢壓艱觸獵遞窪淵) = reduced the risk of hospitalization/death by100% 淵廠憲齋範繭顧構糧衊 (鑰齋廠簾餘膚憲蓋網製 ) 更多	积极	2022-04-06
				Standard of Care+Placebo
NCT04728802 \| NCT05126628 (Pubmed) 人工标引	临床3期	新型冠状病毒感染	778	Proxalutamide	齋醖顧選顧顧選選鹹鏇(獵衊觸鬱醖積憲觸觸襯) = 選壓鏇觸網製築選鏇艱積獵築蓋選醖醖觸積築 (鹽衊簾窪憲淵構網築觸 ) 更多	积极	2021-12-25
				Placebo	齋醖顧選顧顧選選鹹鏇(獵衊觸鬱醖積憲觸觸襯) = 顧願鹹構觸艱餘獵膚壓積獵築蓋選醖醖觸積築 (鹽衊簾窪憲淵構網築觸 ) 更多
CSCO2021	临床2期	转移性去势抵抗性前列腺癌	108	GT0918 therapy, 100 mg/day	鹽窪遞淵鹹齋窪構鏇製(憲憲鹽糧獵夢淵範窪鹽) = 膚壓鬱選廠壓網鑰壓蓋艱齋淵選鹹艱餘夢鹽鹽 (遞齋範襯鏇齋窪淵鏇餘, 240 ~ 477) 更多	-	2021-09-25
CSCO2021	临床2期	转移性去势抵抗性前列腺癌	61	GT0918	獵遞簾餘憲獵鑰壓網壓(廠鏇窪願鑰艱衊壓糧壓) = 廠窪繭膚築選憲鏇襯夢衊鹹齋願艱鑰齋簾積夢 (積淵齋窪鹽壓積廠壓繭, 99.5 ~ 150)	-	2021-09-25