财务表现 - 公司总收入为106,544千美元，同比增长32.4%[23] - 产品收入净额为80,181千美元，同比增长67.0%[23] - 药品产品收入净额为25,216千美元，同比增长53.8%[23] - 税前亏损为50,472千美元，同比减少69.5%[26] - 净亏损为48,477千美元，同比减少70.5%[26] - 每股基本和稀释亏损为0.49美元[27] - 加权平均普通股股数为99,408股[28] 成本管控 - 公司正在实施大幅削减成本的计划,包括将美国员工人数减少约75%[1] - 研发费用为72,498千美元，同比减少57.4%[24] - 销售、一般及管理费用为45,097千美元，同比减少31.1%[24] 产品管线 - 将研发投资集中于FG-3246和PET46,这是一种首创的针对CD46的抗体-药物偶联物及其配套的PET成像剂,用于转移性去势抵抗性前列腺癌[1,4] - 在2024年美国临床肿瘤学会年会上公布了FG-3246联合enzalutamide治疗转移性去势抵抗性前列腺癌的积极初步数据[4] - 预计2025年上半年将公布FG-3246联合enzalutamide治疗转移性去势抵抗性前列腺癌的II期试验结果[7] - 计划于2025年第一季度启动FG-3246单药治疗转移性去势抵抗性前列腺癌的II期剂量优化研究[7] 产品销售 - 2024年第二季度roxadustat在中国的净销售额为9230万美元,同比增长21%,销量增长33%[8] - 预计2024年全年roxadustat在中国的净销售额将达到3.2亿至3.5亿美元[8] - 2024年第二季度总收入为5060万美元,同比增长14%,主要由于roxadustat在中国的强劲表现[10] - 2024年6月30日现金、现金等价物和应收账款余额为1.471亿美元,预计可为公司的运营计划提供资金支持至2026年[10]

FibroGen (NASDAQ:FGEN) stock is falling hard on Wednesday after the biopharmaceutical company reported results from failed clinical trials. The first failed clinical trial covers the treatment of metastatic pancreatic cancer with pamrevlumab. FibroGen said that this didn't meet its primary endpoint of overall survival. This was determined based on the protocol pre-specified Bayesian statistical analysis. The second failed study covered the use of pamrevlumab combined with gemcitabine + nab-paclitaxel to tre ...

Conference Call and Webcast Toll-free: 1-877-300-8521 International investors: 1-412-317-6026 Webcast: Click here About FibroGen For Investor Inquiries: David DeLucia, CFA Vice President of Corporate FP&A / Investor Relations InvestorRelations@fibrogen.com SAN FRANCISCO, July 30, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) will announce second quarter 2024 financial results on Tuesday, August 6 after the market close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Tim ...

SAN FRANCISCO, June 18, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced it will host the second part of its virtual KOL investor event series on Wednesday, June 26, 2024 at 10:00 AM ET. To register, click here. A live question and answer session will follow the formal presentation. Rahul Aggarwal, MD is a Professor of Medicine and Thomas Perkins Distinguished Professor of Cancer Research at the University of California San Francisco. He is the Associate Director for Clinical Research i ...

FibroGen to evaluate FG-3165, an anti-galectin 9 (Gal9) monoclonal antibody (mAb), as monotherapy treatment as well as in combination with LIBTAYO® in patients with select solid tumors FibroGen to evaluate FG-3175, an anti-c-c motif chemokine receptor 8 (CCR8) mAb, as monotherapy treatment as well as in combination with LIBTAYO® in patients with select solid tumors Both FG-3165 and FG-3175 have demonstrated complementary mechanisms of action with PD-1 inhibitors in preclinical studies SAN FRANCISCO, June 03 ...

FibroGen to evaluate FG-3165, an anti-galectin 9 (Gal9) monoclonal antibody (mAb), as monotherapy treatment as well as in combination with LIBTAYO® in patients with select solid tumors FibroGen to evaluate FG-3175, an anti-c-c motif chemokine receptor 8 (CCR8) mAb, as monotherapy treatment as well as in combination with LIBTAYO® in patients with select solid tumors Both FG-3165 and FG-3175 have demonstrated complementary mechanisms of action with PD-1 inhibitors in preclinical studies SAN FRANCISCO, June 03 ...

The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors Plan to begin enrollment in 2H 2024 SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. "The FDA's IND clearan ...

The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors Plan to begin enrollment in 2H 2024 SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. "The FDA's IND clearan ...

财务数据和关键指标变化 - 第一季度总收入为5590万美元,同比增长55%,主要由于中国产品销售收入增加和终止与AstraZeneca的美国和其他地区合作而确认的一次性药品收入 [92][93][94] - 中国roxadustat产品销售收入为3050万美元,同比增长26%,销量增加39% [92][93][97] - 经营成本和费用为8700万美元,同比下降23%,主要由于研发和销售费用的减少 [101][102][103][104][105][106][107] - 净亏损为3290万美元,每股亏损0.33美元,去年同期净亏损7670万美元,每股亏损0.81美元 [107][108] 各条业务线数据和关键指标变化 - roxadustat在中国的销售表现持续强劲,第一季度销售额同比增长24%至7940万美元,公司份额为3050万美元,同比增长26% [49][92][93][97] - 公司正在等待中国当局对roxadustat用于化疗引起贫血的适应症的批准决定,这将为roxadustat业务带来重大收入增长 [52][53][54][55] - 公司收回了roxadustat在美国和其他地区(除中国和韩国)的权利,可以与潜在合作伙伴探讨在贫血相关适应症如低危骨髓增生异常综合征的开发机会 [59][60][61][62][63][64][65] 各个市场数据和关键指标变化 - roxadustat在中国的市场份额达到47%,为行业领导地位 [51][130][131][132][133][134][135] - roxadustat在欧洲的渗透率持续提高,公司相信未来将继续增长,因为roxadustat是欧盟唯一获批用于治疗慢性肾病相关贫血的HIF-PHI药物 [56][57][58] 公司战略和发展方向及行业竞争 - 公司的四大战略支柱包括:pamrevlumab在胰腺癌的临床进展、roxadustat在中国和全球的商业化、早期肿瘤管线以及强大的现金头寸 [12][19][20] - pamrevlumab在局部晚期和转移性胰腺癌的两项关键III期临床试验将在2024年内公布顶线数据 [12][37][38][39][40][41][42][43][44][48] - FG-3246是一种首创的针对CD46的抗体偶联药物,正在开展单药和联合enzalutamide的临床试验,有望成为前列腺癌的新疗法 [66][67][70][71][73][74][75][76][77][78][79][80][81][82][83][84][85][86][87][88][89] 管理层对经营环境和未来前景的评论 - 公司有望在2024年下半年获得roxadustat用于化疗引起贫血适应症的中国批准,这将为roxadustat业务带来重大收入增长 [52][53][54][55] - 公司收回roxadustat在美国和其他地区的权利,可以与潜在合作伙伴探讨在其他适应症如低危骨髓增生异常综合征的开发机会 [59][60][61][62][63][64][65] - 公司有望在2024年内公布pamrevlumab在胰腺癌两项关键III期试验的顶线数据,pamrevlumab有望成为这一领域的重大突破 [12][37][38][39][40][41][42][43][44][48] - FG-3246在转移性去势抵抗性前列腺癌单药和联合用药的临床试验结果令人鼓舞,有望成为这一领域的新疗法 [66][67][70][71][73][74][75][76][77][78][79][80][81][82][83][84][85][86][87][88][89] 问答环节重要的提问和回答 问题1 **Andy Hsieh 提问** 询问LAPIS试验事件发生率放缓的原因 [123] **Thane Wettig 回答** LAPIS试验是一个事件驱动的试验,随着患者存活时间延长,剩余需要观察的事件数量减少,这是常见的情况。公司会密切关注事件发生情况,预计在第三季度公布顶线数据 [124][125][126][127][128][129] 问题2 **Andy Hsieh 提问** 询问roxadustat在中国市场份额上升的原因 [130] **Chris Chung 回答** 主要有两个原因:1)国家医保目录价格下调7%,可能提高了价格敏感性;2)新的HIF类药物进入市场,也带动了整个类别的增长,roxadustat作为领先品种从中受益 [131][132][133][134][135] 问题3 **Dina 提问** 询问公司计划进行FG-3246的II期剂量优化试验的原因 [146] **Thane Wettig 和 Deyaa Adib 回答** 根据FDA的最新要求,公司需要在III期试验前进行II期剂量优化,以确定最佳剂量。同时公司还计划在II期试验中使用PET46生物标志物筛选患者,以提高治疗效果 [147][148][149][150][151][152][153][154]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36740 FIBROGEN, INC. (Exact name of registrant as specified in its charter) Delaware 77-0357827 (State or Other Jurisdiction of ...