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An anemia drug developed under an alliance between FibroGen and AstraZeneca will continue its commercialization in China fully in the hands of the pharmaceutical giant, which is buying the China business of its partner in a
由FibroGen与阿斯利康合作开发的一款贫血药物将继续在中国全面商业化,这家制药巨头正收购其合作伙伴的中国业务。
$160 million deal
1.6亿美元的交易
.
。
The agreement announced Thursday covers the rights to roxadustat in China, where the drug has become a top-selling product for treating anemia caused by chronic kidney disease. San Francisco-based FibroGen will use the cash from the deal to shore up its financial position as its focus turns toward clinical development of a cancer drug that has become its new lead asset..
周四宣布的协议涵盖了罗沙司他在中国的权益,该药物已成为治疗慢性肾病引起的贫血的畅销产品。总部位于旧金山的FibroGen将利用这笔交易的资金巩固其财务状况,因为它的重点已转向一种癌症药物的临床开发,该药物已成为其新的主要资产。
Roxadustat belongs to a class of drugs called HIF-PH inhibitors. These drugs lead to increased production of erythropoietin, a hormone that stimulates formation of red blood cells to counteract anemia. In 2019, China was
罗沙司他属于一类叫做HIF-PH抑制剂的药物。这些药物会增加促红细胞生成素的产生,这种激素能够刺激红细胞的形成,从而对抗贫血。2019年,中国
first to approve roxadustat
率先批准罗沙司他
for treating anemia from chronic kidney disease and the small molecule has since become a top-selling product in this indication. Roxadustat could further expand its scope in China, where it is currently under regulatory review as a treatment for chemotherapy-induced anemia.
用于治疗慢性肾病引起的贫血,这种小分子药物已成为该适应症的畅销产品。罗沙司他可能进一步扩大其在中国的适用范围,目前它正在中国接受化疗引起的贫血治疗的监管审查。
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改善医疗财务体验,助力护理流程顺畅
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Zelis首席执行官阿曼达·艾塞尔分享了她对公司如何解决支离破碎的健康金融系统问题以使所有人受益的看法。
By Stephanie Baum
作者:斯蒂芬妮·鲍姆
AstraZeneca’s partnership with FibroGen dates to 2013, when the companies struck two agreements. One deal covered the development and commercialization of roxadustat in the U.S. and the rest of the world, except for Europe and Japan, where Astellas Pharma previously licensed rights to the drug. The second agreement covered development and commercialization of roxadustat in China.
阿斯利康与 FibroGen 的合作可以追溯到 2013 年,当时两家公司达成了两项协议。其中一项协议涵盖了 roxadustat 在美国及其他地区(欧洲和日本除外,安斯泰来制药此前已获得该药物的许可权)的开发和商业化。第二项协议则涉及 roxadustat 在中国的开发和商业化。
Per terms of the China deal, profits are shared equally..
根据中国协议的条款,利润平均分配。
In 2021, roxadustat won European approval but was rejected by the FDA, which
2021年,罗沙司他获得欧洲批准,但被美国食品药品监督管理局(FDA)拒绝。
asked for another clinical trial
要求进行另一项临床试验
. Last year, AstraZeneca and FibroGen ended the roxadustat collaboration agreement in the U.S. and all other regions, excluding China and the territories licensed to Astellas Pharma. Now, the China collaboration is ending. Financial terms of the deal announced Thursday break down to $85 million in cash for the enterprise value of the China business, FibroGen International.
去年,阿斯利康和 FibroGen 终止了美国及其他所有地区(中国及安斯泰来制药获得授权的地区除外)的罗沙司他合作协议。现在,中国的合作也即将结束。根据周四宣布的交易财务条款,FibroGen International 的中国业务企业估值为 8500 万美元现金。
FibroGen will also get about $75 million in net cash held by that business and its subsidiaries. The deal is expected to close by the middle of this year..
FibroGen还将获得该业务及其子公司持有的约7500万美元的净现金。该交易预计在今年年中完成。
FibroGen has not given up on developing roxadustat for the U.S., where it still retains rights. In 2023, the drug
FibroGen 并未放弃在美国开发罗沙司他,该公司仍保有其在美国的权利。2023年,该药物
failed a Phase 3 test
未能通过第三阶段测试
evaluating it as a treatment for anemia from lower-risk myelodysplastic syndrome, a type of blood cancer.
评估它作为治疗较低风险骨髓增生异常综合征(一种血癌)引起的贫血的方法。
Bristol Myers Squibb
百时美施贵宝
and
和
Geron Corporation each have FDA-approved drugs in this indication
杰龙公司在此适应症上均有FDA批准的药物
, but FibroGen contends there is still significant unmet medical need. It plans to meet with the agency in the second quarter of this year to discuss potential development of the drug in the U.S.
,但FibroGen认为仍有显著的未满足医疗需求。该公司计划在今年第二季度与美国相关部门会面,讨论该药物在美国的潜在开发计划。
As of the end of 2024, FibroGen said its cash position was approximately $121.1 million. The company said it will use proceeds from the AstraZeneca deal to pay off debt. The company will also continue clinical development of FG-3246, an antibody drug conjugate in-licensed from Fortis Therapeutics in 2023.
截至2024年底,FibroGen表示其现金头寸约为1.211亿美元。该公司表示,将利用阿斯利康交易的收益来偿还债务。该公司还将继续推进FG-3246的临床开发,这是一种2023年从Fortis Therapeutics获得许可的抗体药物偶联物。
A Phase 2 test of this drug candidate is expected to start in the second quarter of this year, enrolling patients with metastatic castration-resistant prostate cancer. FibroGen said it expects its cash runway will extend into 2027..
该药物候选物的二期试验预计在今年第二季度开始,招募转移性去势抵抗性前列腺癌患者。FibroGen 表示,预计其现金跑道将延长至 2027 年。
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By Elation Health and MedCity News
由Elation Health和MedCity News发布
“After a thorough evaluation of alternatives, we believe selling our China operations and repaying our term loan is in the best interest of FibroGen’s stakeholders,” FibroGen CEO Thane Wettig said in a prepared statement.
“经过对各种替代方案的全面评估,我们认为出售我们在中国的业务并偿还我们的定期贷款符合FibroGen利益相关者的最佳利益,” FibroGen首席执行官Thane Wettig在一份准备好的声明中表示。
To William Blair analyst Andy Hsieh, the transaction represents the best case outcome for FibroGen’s China business. In a research note, Hsieh said the deal enables the company to bring China-generated cash back to the U.S. FibroGen extends its cash runway, which can now support clinical testing of FG-3246 and potentially roxadustat, if agreement is reached with the FDA.
对于威廉·布莱尔分析师谢安迪来说,这笔交易代表了FibroGen中国业务的最佳结果。谢安迪在一份研究报告中表示,该协议使公司能够将来自中国的现金带回美国。FibroGen延长了其现金跑道,现在可以支持FG-3246的临床测试,并且如果与FDA达成协议,还可以支持罗沙司他的临床测试。
For investors, the deal simplifies the investment story, now focused on two assets for which FibroGen has U.S. rights..
对于投资者而言,这笔交易简化了投资故事,现在专注于 FibroGen 拥有美国权利的两项资产。
Photo: Wong Yu Liang, Getty Images
照片来源:黄宇亮,Getty Images
Topics
主题
anemia
贫血
AstraZeneca
阿斯利康
biopharma nl
生物制药 nl
cancer
癌症
China
中国
chronic kidney disease
慢性肾病
Clinical Trials
临床试验
deals
交易
FibroGen
纤维原细胞
roxadustat
罗沙司他
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