A Single-center, Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Platinum-based Chemotherapy and Bayer Aspirin in Previously Untreated Patients With Extensive-stage Small Cell Lung Cancer.

Lung cancer remains a leading cause of cancer-related deaths worldwide, with small cell lung cancer (SCLC) accounting for 15-20% of all lung cancers. Extensive-stage SCLC (ES-SCLC) is associated with poor prognosis, with a median survival of 2-4 months without treatment. Although platinum-based chemotherapy is the standard first-line treatment, median survival remains under one year, highlighting the need for improved outcomes. Recent studies have demonstrated that combining PD-1 inhibitors with chemotherapy can significantly improve survival in ES-SCLC patients. Serplulimab, a novel PD-1 inhibitor, has shown promising results in extending overall survival when combined with chemotherapy in a Phase III trial. Additionally, aspirin has been found to enhance the anti-tumor effects of immunotherapy by inhibiting immune checkpoint proteins and reducing adverse events such as thrombosis and fever. This Phase II study aims to evaluate the efficacy and safety of combining serplulimab, platinum-based chemotherapy, and aspirin as a first-line treatment for patients with ES-SCLC.

开始日期2024-10-01

申办/合作机构

重庆市大坪医院

NCT06576921 / Not yet recruiting临床2期IIT

Efficacy and Safety of Serplulimab Combined With Nab-paclitaxel and SOX as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction: A Multicenter Randomized Controlled Trial

This is a multicenter, double-blind, randomized, phase 2 trial to investigate the efficacy and safety of serlulimab combined with nab-paclitaxel plus SOX versus nab-paclitaxel plus SOX alone as neoadjuvant treatment for locally advanced GC or AEG.
The goal of this clinical trial is to learn if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. It will also learn about the safety of serlulimab combined with nab-paclitaxel plus SOX. The main questions it aims to answer are:
Does serlulimab increase the pCR of participants with locally advanced AEG/GC ? What medical problems do participants have when taking serlulimab? Researchers will compare to a placebo (a look-alike substance that contains no drug) to see if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC.
Participants will:
Eligible patients were randomly assigned to receive serlulimab (4.5 mg intravenously on day 1) combined with chemotherapy (nap-paclitaxel 260 mg/m2 intravenously on days 1, OXA 130mg/ /m2, intravenously on days 1, and S-1 40 to 60 mg orally twice daily depending on BSA on days 1 to 14) or chemotherapy alone every 3 weeks for 3 preoperative cycles followed by 3 postoperative cycles. All patients will be followed for survival.

开始日期2024-09-01

申办/合作机构

西京医院第四军医大学

NCT06531291 / Not yet recruiting临床2期IIT

Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation: A Single-arm, Multi-cohort, Open-label, Single-center, Prospective, Exploratory Clinical Study

Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

开始日期2024-08-10

申办/合作机构

上海交通大学医学院附属仁济医院

100 项与斯鲁利单抗相关的临床结果

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100 项与斯鲁利单抗相关的转化医学

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100 项与斯鲁利单抗相关的专利（医药）

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431

项与斯鲁利单抗相关的文献（医药）

2024-12-31·Human vaccines & immunotherapeutics

Exploration of genetic characterization in hyperprogressive disease after immunotherapy retreatment in a patient with LCNEC: A case report

Article

作者: Chen, Jialu ; Yang, Jiayao ; Zhang, Yao ; Shu, Qijin ; Shou, Liumei ; Shao, Tianyu

Immune checkpoint inhibitors (ICIs) have emerged as a promising therapeutic option for large cell neuroendocrine carcinoma (LCNEC). However, various studies have suggested a potential risk of hyperprogressive disease (HPD) in patients receiving ICI, which might be associated with gene alterations. Here, this is the first report on an unknown primary LCNEC patient who had achieved a long-term response from ICI treatment (atezolizumab), but developed HPD after tumor progression due to receiving another ICI agent (serplulimab). The mutation region of FAT4, SMARCA4, CYLD, CTNNB1, and KIT was altered prior to serplulimab treatment compared to before atezolizumab treatment. This case suggested a potential association between these mutated genes and HPD. Patients with the aforementioned genes should caution when selecting ICI treatment. These findings required further confirmation in a larger study cohort.

2024-09-02·Journal of leukocyte biology

Anlotinib and anti-PD-1 mAbs perfected CIK cell therapy for lung adenocarcinoma in preclinical trials

Article

作者: Zhao, Hua ; Lv, Yingge ; Shen, Meng ; Liu, Liang ; Ren, Xiubao ; Meng, Yuan ; Sun, Qian ; Liu, Ting ; Liu, Shaochuan ; Yu, Wenwen

Abstract:

Murine cytokine-induced killer (CIK) cells are heterologous cells that kill various allogeneic and isogenic tumors and have functional and phenotypic characteristics of natural killer cells and T lymphocytes. However, the effect of CIK cells alone on solid tumor therapy is only limited. To enhance the therapeutic effect, it is vital to discover a mix of several therapy approaches. Immune cell function is inhibited by abnormal tumor vessels and the tumor microenvironment, which block lymphocyte entry into tumor tissue. To increase the effectiveness of CIK cells’ antitumor activity, antivascular therapy and CIK cell therapy can be combined. Furthermore, anlotinib is a tiny drug with multitarget tyrosine kinase inhibitors that can block cell migration, delay angiogenesis, and decrease blood vessel density. Compared with other antiangiogenesis drugs, anlotinib stands out due to the wider target of action and lower effective dose. In this work, anlotinib and murine CIK cells were coupled to boost CD3+ T cell infiltration, CD3+CD4+ T cell infiltration, and expression of granzyme B and interferon γ from CD3+CD8+ T cells, which increased the antitumor activity. Through the generation of cytotoxic cytokines by T lymphocytes, the therapeutic group using anti-PD-1 monoclonal antibodies in conjunction with anlotinib and CIK cells was more successful than the group receiving dual therapy. The preclinical study contributes to exploring the therapeutic alternatives for patients with lung adenocarcinoma, thus prolonging their lives.

2024-09-01·Med

Adding first-line PD-1 inhibition to anti-VEGF and XELOX in pMMR metastatic colorectal cancer: Steppingstones, stumbling blocks, and next phase

Article

作者: Søreide, Kjetil ; Veen, Torhild

In the randomized, double-blind, multicenter study by Wang et al.,¹ the addition of serplulimab (a PD-1 antibody) to anti-VEGF (HLX04; a bevacizumab biosimilar) together with chemotherapy (XELOX) was deemed to be tolerable and safe and may improve progression-free survival. However, even if adverse events were comparable, oncological endpoints including survival need to be confirmed in the next phase 3 study.

817

项与斯鲁利单抗相关的新闻（医药）

2024-09-25

·E药经理人

独家！华润三九首登顶、恒瑞“杀”回、药明稳位、康方新晋。中国医药上市公司竞争力20强还有谁？

身处产业巨变之中，企业驾驭变革的能力正在面临考验，面对全新的生态环境带来的挑战，如何重塑竞争力以适应外部环境的变化，是一道必答题。 2024年中国医药上市公司竞争力20强（以下简称“竞争力20强”）榜单，展示出一种大破大立之后，医药产业正在回归的基本逻辑。对于中国医药产业而言，2023年充满挑战与机遇。这一年，医疗反腐席卷行业、医疗刚性需求凸显，医保控费、带量采购呈现常态化、长期化趋势，中国创新药出海迎来大爆发……在经历了全球融资热度下滑、行业进入资本寒冬的2023年后，产业似乎在调整期中觅得了生存和发展的关键：要有所为，更要有所不为。（后台回复“20强”获取评选指标体系）过去10年的竞争力20强评选中，榜首更替，化药一哥恒瑞拿下5次桂冠，器械一哥迈瑞也斩获3冠。却独独，未有一家中药企业登顶。破局者，终于在今年出现。华润三九成为了“新科状元”。对昆药集团的并表之后，华润三九的盈利能力更进一步。年报显示，2023年华润三九实现营业收入247.39亿元，同比增长36.83%；归属于上市公司股东的净利润28.53亿元，同比增长16.5%；扣除非经常性损益后的净利润27.11亿元，同比增长22.18%。整个中药板块，今年有六家企业上榜，这是近几年来中药企业上榜次数最多的一次。中药行业的黄金发展期，已经跃然纸上。自2021年以来，国家连续发布了加快中药特色发展、中药振兴等相关政策；2022年3月，国务院发布《“十四五”中医药发展规划》，明确“十四五”中医药发展规划目标和主要任务，这为中医药高质量发展明确了方向；2023年2月，国务院印发《中医药振兴发展重大工程实施方案》，该文件再次明确传承创新发展中医药是十四五期间的重要工作内容，也加大了对中医药发展的支持和促进力度，将长期对中药产业各方面加速迎来利好。昔日的“创新转型三剑客”，如今有了不同的“归宿”。制药一哥恒瑞，经历了“连续6年占据榜单前两名”“2023年消失在竞争力20强”后，今年强势回归，还站到了“上位圈”，冲回第五名。石药集团也基本“稳”住了其在竞争力20强中的位置。向来“旱涝保收”的CXO，开始失速，今年仅有药明康德“挺住了”。行业投融资大环境降温，药企纷纷收缩研发管线，加之2023年新冠订单锐减，CXO行业曾经高速增长态势一去不复返，业绩与市值遭遇“双杀”。正如丘吉尔曾说：“能看到更远的过去，才能看到更远的未来。”2024年的竞争力20强榜单正在让我们看到国内医药产业的耐心与韧性。崛起过去十年来，第一次有中药企业登顶竞争力20强的榜首，Top20中“破天荒”地同时出现6家中药企业。这是继去年4家中药企业进入Top20后，再刷新高。进榜的6家中药企业，大抵可以分为两类。一类是现代中药企业，以创新为主导，研发新的中药产品和进行创新营销。这类企业主要以医疗端的推广为主，同时也在OTC端打造自己的独立品牌，如华润三九、济川药业。另一类则是传统中药企业。有的具有老字号品牌力量，如同仁堂、达仁堂；有的则是以特定的产品形式出现，如东阿阿胶。不论是哪种形式，中药企业都展现了不俗的实力。首次登顶的华润三九，还是在榜的太极集团、东阿阿胶等品牌，都在2023年里实现了营收净利双增。实现对昆药集团的并表之后，华润三九的盈利能力更进一步。年报显示，2023年华润三九实现营业收入247.39亿元，同比增长36.83%；归属于上市公司股东的净利润28.53亿元，同比增长16.5%；扣除非经常性损益后的净利润27.11亿元，同比增长22.18%。这也是华润三九自2020年以来，连续四年实现扣非净利润增长。此前的2019年至2022年，华润三九分别实现营业收入147.94亿元、136.37亿元、155.44亿元、180.79亿元，净利润20.99亿元、15.97亿元、20.55亿元、24.49亿元，扣非净利润分别为12.03亿元、13.35亿元、18.53亿元、22.19亿元。当然，想要成为竞争力20强的榜首，并表昆药集团只是锦上添花。华润三九自身也具备较为突出的产品优势。一直以来，华润三九具备较为突出的产品优势。CHC健康消费品业务覆盖了感冒、皮肤、胃肠、止咳、骨科、儿科、膳食营养补充剂等近10个品类，处方药业务覆盖了抗肿瘤、心脑血管、消化系统、骨科、儿科等治疗领域。2023年，公司年销售额过亿元的品种39个。同时，强大的渠道体系管理和终端覆盖也是华润三九的核心优势之一。年报显示，华润三九的CHC业务依托于三九商道客户体系，与全国最优质的经销商和连锁终端广泛深入合作，覆盖全国超过40万家药店，线上与京东大药房、阿里健康大药房、平安好医生等建立战略合作，深入挖掘线上增长潜力及营销模式。 2023年，华润三九的CHC健康消费品业务实现营业收入117.07亿元，同比增长2.83%。其中，品牌OTC业务增长较好，康慢业务消化集采影响保持稳定增长，专业品牌业务由于普药品种规模调整略有下滑。对于2023年业绩增长，华润三九表示，公司坚持“品牌+创新”双轮驱动，聚焦高质量医药健康产品创新研发和智能制造，持续优化业务布局，强化品牌建设，积极探索产业链创新发展模式，构建中药全产业链竞争优势，战略性融合昆药集团业务，经营业绩及核心能力稳步提升。过去一年也是华润三九合并昆药集团之后首个完整会计年度，昆药集团的并表，很大程度上增厚了华润三九的业绩。 2022年5月，华润三九计划作价29.02亿元收购昆药集团28%股份，进行一场“A吃A”。当年12月30日，华润三九正式完成对昆药集团28%股份的收购，昆药集团成为华润三九的控股子公司。彼时，华润三九承诺，交易完成后五年内，按照法定程序，通过包括但不限于资产重组等方式，解决华润三九及其控制的企业与昆药集团及其控制的企业之间现存的同业竞争问题。期间涉及的同业竞争问题之一即是三七产业链整合。更细致的是，梳理双方核心产品血塞通软胶囊的同业竞争关系。血塞通软胶囊在全国市场上仅有昆药集团和华润圣火这两家进行生产。这一事件也在今年6月有了结果，华润三九将自己持有的华润圣火股权转让给昆药集团。一方面，华润三九终于可以解决子公司的同业竞争问题，另一方面，昆药集团也可以顺势统一血塞通软胶囊市场。此后，双方将通过开展业务模式、渠道终端、品牌铸造、供应链等方面的协同，推动营销整合、提升运营效率。曾9次上榜，近年来却也在榜单中消失数年的东阿阿胶，终于重新找回了强劲增长的势头，2023年实现营收47.15亿元，同比增长16.66%。其实在2019年，东阿阿胶还在面临业绩暴雷、董事长出走的困境，股价较最高点几近腰斩。这是东阿阿胶自2019年业绩暴跌后连续第四年保持正增长，也是近6年来最高的增速。净利润也突破10亿大关，实现归母净利润11.51亿元，同比增长47.55%。分产品来看，阿胶及系列产品为东阿阿胶贡献了92.55%的业绩，营收达43.64亿元，同比增加了17.98%。值得注意的是，该品类占营收的比重不断提高，从2019年的69.06%一路攀升。从东阿阿胶的业绩情况来看，其价值重塑和品牌焕新战略已经带动业绩重回强劲增长，去年盈利11.51亿元，比上年同期增长47.55%。近年来中药企业业绩普遍增长的原因是多方面的，既有国内政策持续对中医药行业的支持、市场需求的提升，也包括公司自身的经营策略和产品创新等。在榜的中药企业，不论是老字号亦或OTC，都在发力中药创新，研投增长超20%似乎是“标配”。华润三九研发费用同比增长20.3%至7.15亿元；同仁堂研发费用同比增长28.68%至2.80亿元；太极集团研发费用同比增长113.52%至2.34亿元；达仁堂研发费用同比增长20.56%至1.85亿元……在中药企业重金投入下，中药新药也将逐渐迎来收获期。虽身处“天时地利人和”的黄金发展期，但中药行业也正在历经关键的转折时期，上游中药材涨价、药店客流量下滑、中药集采动态联动、消费不景气等因素影响下，今年上半年，中药企业的业绩尽显疲态。从具体数字来看，2024上半年，A股中药板块71家中药上市公司营收约1850亿元，同比下降2.8%，归母净利润216.1亿元，同比下降5.6%。即使是头部中药企业，前20家中药公司中，仅有7家公司实现营收增长，华润三九、同仁堂、东阿阿胶等头部中医药企业，实现了营收净利的双增长。其中，东阿阿胶营收增幅最大，达26.8%。而济川药业、太极集团、达仁堂等公司则是出现了营收净利双下滑的局面。失速虽然来的突然，却也有迹可循。数据显示，主要拖累业绩的是今年二季度的表现，整体营收和净利润均环比下滑了两位数，其中营收规模为864亿元，环比下降12.4%，归母净利润90.4亿元，环比下降28.1%。从半年报情况来看，集采导致的市占率变化、合规体系建设带来的短期成本增加，以及市场方面的消费波动等等。中药材价格持续上涨更是影响着大部分中药企业的毛利率。如同仁堂医药工业毛利率下降3.74%，前五名系列产品毛利率同比下降8.49%。同仁堂方面表示，毛利率下降主要系部分重点品种的主要原料成本上涨导致。类似情形也出现在片仔癀、以岭药业的业绩说明中。消失昔日躺赢的“卖铲人”开始大浪淘沙，药明康德成了榜单中硕果仅存的医疗服务企业。一向“旱涝保收”的医药研发外包服务（CXO）赛道，景气度正悄然发生着变化。CXO赛道的起势可以追溯到国内药品上市许可持有人制度的推行，医药研发生产的持续投入是CXO公司业绩的“根基”所在。MAH制度让更多创新型制药企业、小型研发公司可以委托CXO企业生产药品。此后，创新药企对CXO的需求也与日俱增，外加三年疫情也为CXO额外增加了大量订单。仅仅是从2018年到2022年，中国的CXO行业市场规模从548亿元跃升到1447亿元，年复合增长率为27.5%。若以药明康德为例，2018年至2022年，年营收额由96.14亿元增至393.55亿元，年复合增长率达42.24％。然而，野蛮生长不会长期存在。自2023年开始，行业投融资大环境降温，药企纷纷收缩研发管线，CXO企业整体订单数量下滑明显。加之2023年新冠订单锐减，CXO行业曾经高速增长态势一去不复返。头部CXO公司的营业收入增速已经放缓至个位数。去年尚且在榜的九洲药业，2023年业绩同比仅增长1.44%。纵然是“坚挺”如药明康德，也仅仅实现了同比2.5%的增长。如果要选出最近几年A股市场中给投资者造成亏损最严重的板块，CXO绝对会排在前列。将时钟拨回2022年，医疗健康产业进入资本寒冬，CXO公司也不能独善其身，A股29家CXO公司二级市场股价平均跌幅超过37%，总市值蒸发超过3000亿元。这只是估值跳水的开始。2023年，CXO公司们的市值继续缩水了1700亿元。到了2024年8月底，29家公司总市值8个月内又减少约2100亿元，只剩3100亿元左右。到今年7月，凯莱英、博腾股份作为上届20强选手，股价在三年间已经跌超70%，九洲药业也跌去了64%。估值三连杀的同时，过去一年多的时间里，中国CXO行业受地缘风险的影响导致命运更加多舛。投资者要问，CXO还能重回巅峰吗？企业经营者要问：面对周期调整还能在哪里找到业绩增长点？在充满博弈和变数的当下，对于CXO企业来说，在寻求增长的同时，还需规避未知风险，具备随时应战的能力，才能顺利穿越寒冬。失速的不仅仅是CXO，还有曾经在榜12年的复星医药。 2023年的复星医药过得并不轻松。市场对新冠相关产品的需求大幅减少，复星医药业绩失速明显，甚至出现上市以来的首次营收、净利润双下滑。对于业绩的大幅下滑，复星医药表示，营收的同比减少主要是由于新冠相关产品，如mRNA新冠疫苗、阿兹夫定片、新冠抗原及核酸检测试剂收入大幅下降所致。扣非净利润大幅下滑除新冠相关产品收入下降的原因之外，还包括对相关资产进行处置及计提减值准备共计约6.83亿元，财务费用同比增加3.37亿元，新并购子公司带来的支出压缩净利润等。若分板块来看，就2023年而言，尽管受新冠疫苗、阿兹夫定片需求衰减以及生物类似药集采影响，复星医药的制药板块营收仍达到302.22亿元，仅小幅降低1.91%。若不含新冠相关产品，制药业务则实现了同比13.50%的增长。制药业务中，汉斯状（斯鲁利单抗注射液）、汉曲优（注射用曲妥珠单抗）、苏可欣（马来酸阿伐曲泊帕片）等重点品种收入保持快速增长，分别于报告期内实现收入11.2亿元（同比增长230.20%）、27.49亿元（同比增长58.19%）和9.22亿元（同比增长19.67%）。在复星医药2023年财报中，“超10亿元销售额”的单品已经被汉斯状、汉曲优、汉利康等抗肿瘤及免疫调节产品，以及肝素系列制剂所包揽。而汉斯状、汉曲优、汉利康等产品，都来自复宏汉霖。作为复星医药生物类似药及创新药业务核心子公司，复宏汉霖在2023年已实现盈利，是港股18A中首个盈利的biotech公司。复星医药若想要重回增长靠什么？在今年3月的复星医药业绩沟通会上，董事长吴以芳直言创新药是复星医药未来增长的新动能。他给出一则数据：复星医药整个创新药的收入增长，将争取在未来几年达到30%的年复合增长率。同时，复星医药会坚持仿、创结合，因仿制药的盈利很大程度上支持着复星医药创新的投入。未来创新制药板块的逐步扩大，复星医药能否重拾增长，时间会给出答案。有人掉队，自然也有人回归。经过2021年、2022年的业绩连续下滑后，恒瑞终于重回正增长，也“杀”回了今年的竞争力20强。这份“守得云开”的年报，让行业等了太久。过去一年，恒瑞实现营业收入228.20亿元，同比增7.26%；归母净利润43.02亿元，同比增10.14%；扣非净利润41.41亿元，同比增21.46%，经营性现金流净额76.44亿元，同比大增504.12%。具体来看，集采对恒瑞的影响正在进一步消化，创新转型也终于迎来了收获期。分业务来看，2023年恒瑞医药的仿制药销售有所下滑。如，注射用紫杉醇（白蛋白结合型）、醋酸阿比特龙片在部分省份的集采续约未中标及降价等因素影响，报告期内销售额同比减少7.02亿元，22年七批集采产品在23年内的销售同比减少9.11亿元等等。集采对恒瑞在仿制药的销售上，仍有不小压力。在创新药方面，可圈可点。2023年恒瑞医药创新药收入达到106.37亿元（含税，不含对外许可收入），同比增长22.1%，占公司总营收的46.61%。创新药收入的增长，弥补着仿制药收入下滑的缺口。从2024年半年报中，这种创新药业务带领王者归来之势更为明晰。今年上半年，恒瑞实现营收136.01亿元，同比增长21.78%。其中恒创新药收入达66.12亿元（含税，不含对外许可收入），同比增长33%，成为恒瑞业绩增长的主要动力。目前已有14款自研创新药和2款合作引进的创新药在国内获批上市。其中，瑞维鲁胺、达尔西利、恒格列净、阿得贝利单抗、海曲泊帕等创新产品，在纳入医保目录、进入惠民保、获得临床指南推荐等不同形式的“加持”下，销售收入都有了明显的增长。此外，像卡瑞利珠单抗、吡咯替尼及阿帕替尼等早期上市的创新药，在不断拓展新适应证的过程中，覆盖患者群体的增加，销售也在同步提升。值得注意的是恒瑞的出海，也成了恒瑞业绩增长的重要动力之一。据2024H1财报，恒瑞已将从默克获得的1.6亿欧元对外许可首付款确认为收入。集采带给恒瑞的“业绩刹车”逐渐弱化，在研发创新和国际化战略上的持续发力，创新药步入了收获期。经历过营收净利双降、股价一度跌去七成的恒瑞，正走出那段阵痛期。新生产业价值重构的语境里，竞争力20强榜单闯进了两位新角色，康方生物与新产业。这是竞争力20强榜单中第一次出现生物技术公司的身影。或许在回答未来还会有谁之前，要先探究另一个问题的答案：为什么会是他们？康方生物的进榜代表了一种趋势：2023年，中国的生物技术公司终于走进了盈利的时代。过去数年，大多数生物技术公司的成长路径是依靠核心当家产品的商业化收入拉动营收增长，实现跨越盈亏平衡线。只是，这条理想中的成长路径要经历“研发过程复杂、周期长、资金投入巨大、高风险”等问题，即使跨越万难步入商业化阶段，等待生物技术公司的并非坦途，他们还面临着市场份额、医保等难题。仅仅依靠产品的商业化收入来实现盈利对生物技术来说，已经成为了艰巨且有些难以完成的任务。好在已经有部分生物技术公司探索出与传统商业化创收之路不同的多元化盈利模式，并成功实现扭亏为盈。首次进榜就拿下“高位”的康方生物，正是这种多元化盈利模式的佼佼者。一方面依靠核心产品在商业化阶段“造血”的同时，产品的授权交易协力康方生物“吸金”。过去一年康方生物总收入同比增长440%，至45.26亿元，净利润19.42亿元。从产品收入端看，康方生物全年实现产品销售额16.31亿元，同比增长也达到了48%，康方生物全球首个获批上市的肿瘤免疫双抗卡度尼利单抗在2023年持续放量，销售爆发式增长，大卖13.58亿元，同比增长149%。从BD交易端看，2023年康方生物的技术授权与合作收入约29.23亿元，主要来自自研的全球首创双抗依沃西的部分海外市场权益许可给Summit的合作首付款。不过，康方生物也同样在被质疑的行列当中。45.26亿元的全年收入中，BD来的29亿元占了64%。若只计算创新药的营收，康方生物距离扭亏依然还有一段距离。但是在如今这个充满挑战的大环境中，或许依靠何种方式盈利已经一件羞于启齿的事。毕竟“黑猫白猫，抓住耗子就是好猫”，通过对外授权这种模式获得资金支持，反哺到自身的研发与商业化等环节，让企业能够长久且健康的活下去才是王道。榜单中另一位“一年生”新产业，虽首次进榜，却早已是IVD赛道中的强势存在。成立于1995年的新产业生物，一直专注于化学发光免疫分析领域的研究，经过十多年的潜心努力，在2008年9月顺利完成中国第一台全自动化学发光仪的注册，并成功推上市场。 2016年将智能化的“模块化生化免疫分析系统”成功推出，进一步丰富了公司产品线。2017年7月，新产业生物通过美国FDA 510(k)审核，成为中国第一家获得美国FDA准入的化学发光厂家。2018年，新产业生物成功发布超高速全自动化学发光免疫分析系统，开启化学发光超高速的新纪元。2019年7月，其自主研发的丙型肝炎化学发光产品成功通过欧盟CE List A认证，成为中国第一家丙肝试剂荣获欧盟CE认证的化学发光厂家。2020年12月，新产业生物获中国第一张化学发光领域IVDR CE认证证书，是其成为全球体外诊断领域先行者之路上重要的里程碑。新产业生物创下过多个第一。它是中国第一家拥有“免疫磁性微球”专利并将其作为化学发光系统关键分离材料的公司；是中国第一家拥有“人工合成的小分子有机化合物-ABEI”专利并用其代替传统的酶作为发光标记物的公司；也是中国第一家应用上述专利技术且获得国内注册证并实现批量生产全自动直接化学发光免疫分析仪器及配套试剂的公司。可以说，新产业的研发成果，填补了国内在体外诊断领域的空白，打破了该领域长期被国外厂家产品垄断和技术封锁的局面。重塑若从2015年的“7·22”算起，过去十年，药品审评审批改革、中国加入ICH、MAH制度全面推开、医保谈判与集采常态化……走在创新发展快车道上的中国的医药产业，在短短数年内迎来了让人意想不到的巨大进化。其实，医药产业每一次大周期背后，都有非常深刻的产业逻辑。一些“蛛丝马迹”隐藏在近些年的医药产业政策之中。集采等政策的推行倒逼中国药企转型，与此同时，政府大力支持以临床价值为导向的创新，国产创新药上市步伐加快，本土医药企业的研发也在加速向差异化、全球化转型。创新，已成为中国药企绕不开的话题。在“创新驱动”的战略引领下，中国的生物医药产业逐步从销售驱动向研发创新驱动转型，提升自主研发实力。加上一系列改革开放政策持续落地，创新药行业迎来发展机遇。身处产业巨变之中，企业驾驭变革的能力正在面临考验，面对全新的生态环境带来的挑战，究竟该如何重塑竞争力，来适应外部环境的变化，使企业在未来市场竞争中保有一席之地？有人说，十年太久，仅仅是将创新的时间线拉长到五年前，产业的语境与如今都是大相径庭的。过去五年内，伴随着港股18A开闸和科创板的设立，叠加突然而至的疫情，医疗行业被迅速推到了聚光灯下，逆市而上，在一二级市场都迎来了一段爆发式的上涨行情。只是，还未享受太久的热潮，资本寒冬以迅雷不及掩耳之势，戳破了过去几年才吹起来的泡沫。身处凛冬，磨练的是耐力、定力和内功。市场遇冷是一场对药企是否具备穿越周期能力的深刻考验，调整期中的“出清”，让企业愈发认识到做好资金预算、聚焦做差异化产品才是王道，而非心急扎堆快跟，也非广铺管线、大迈步子。正如麦肯锡的《中国生物医药：重塑价值创造之路》中所言，“中国生物医药企业在调整期中得以生存和发展的关键，需要有所为，更需要有所不为”。不论是市场聚焦、创新重点、全球价值实现的路径选择，并斟酌从实际出发的资金和能力范围内下注，每一家药企都迫切需要找准清晰的战略指引。这也许是个“最坏”的时代，周期下行，不论国内还是海外，被淘汰的药企都太多了。在依然漫长的“资本寒冬期”，产业的车轮究竟会走向哪里？未来我们将要面对一个怎样的市场环境？但这又是“最好”的时代，进入十年快速发展后的第一个调整期，适逢风云际遇，“出海”有着超预期表现，在明星赛道上表现活跃……很多药企在寒冬中展现出了更顽强的生命力。没有一个黑夜不会迎来黎明。整个行业已在寒冬的蛰伏中孕育出了更多的变化。只需要等待那声春雷，寒冬中的积淀，将会在春天迸发更强大的能量。以2015年作为创新新里程，2024年是第十个年头。站在创新十年的起点，研判未来十年趋势，我们需要聚焦“竞争力20强”——聚焦能代表中国医药产业竞争力的企业，挖掘出引领中国医药产业走向未来的领袖企业；发现中国最具发展潜力以及最具投资价值的产业领域，开启更加坚定不移的未来十年。会上，我们将隆重发布“2024中国医药上市公司竞争力20强”榜单，并对入榜企业进行颁奖。届时，企业家、科学家、投资家们将莅临思辨，把脉未来十年发展趋势、达成头部共识、夯实创新业务底色。由中国医药企业管理协会、中国医药生物技术协会、四川省医药行业协会共同主办，E药经理人、中国医疗健康产业投资50人论坛（H50）承办的2024’第十六届中国医药企业家科学家投资家大会（以下简称“2024启思会”），将于2024年11月13～15日在成都举行。 2024启思会以“创新十年·未来十年”为主题，赋能中国医药产业高质量发展，聚合最受关注临床项目、热门赛道头部上市公司、TOP企业买手团、一二级市场专家、持续创新的企业家科学家投资家，搭建基于“价值”的创新对接平台以及产业生态价值链接平台。欢迎莅临大会，共同助力产业创新持续新航程。组织机构主办单位：中国医药企业管理协会、中国医药生物技术协会、四川省医药行业协会承办单位：E药经理人、中国医疗健康产业投资50人论坛（H50）会议信息会议时间：2024年11月13～15日（11月13～14日全天报到）会议地点：成都会议主题：创新十年·未来十年参会人员：医药企业董事长、总经理及负责人，医药企业研发负责人，临床试验机构专家，科研院所学术带头人，创新创业家以及医药生产上下游服务供应商、生物医药园区负责人、金融投资机构负责人、医药行业分析师等。日程框架 11月13日 2024年度中国券商十大医药技术研报分享会（Online）永安生命科学30人论坛中国工程院“我国医药创新能力和竞争力战略研究”研讨会（定邀）中药企业思想家闭门会（聚焦中医药传承与创新，探讨推进中医药高质量发展的路径与方法）核药创新论坛 11月14日开幕式(基础研究、监管、支付、使用、资本五大风向标) 中国医药创新趋势论坛(主论坛，企业家科学家投资家畅谈行业趋势) 中国医疗健康投资50人论坛秋季理事会（闭门） 11月15日第七届中国医药营销创新论坛 “激流勇进的分子”首届中国重磅炸弹新药商业化策略峰会（定向邀请创新药公司C Level高管，发布在中国已上市或潜在的重磅炸弹药物本土与全球商业化的前景和市场策略，现场邀请二级市场基金经理和分析师交流研讨） 2024-2025最受关注临床进展TOP20发布论坛（定向邀约Pharma和Biotech的BD，按疾病领域邀约未上市的临床阶段项目发布最新进展）中国药企国际化论坛同舟逆旅·首届中国医药董秘价值创新年会 CGT药物创新论坛 ADC药物创新闭门会 BT+IT生态沙龙小核酸药物创新论坛透皮贴剂专委会理事会（闭门）一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

带量采购财报核酸药物高管变更

2024-09-24

·PRNewswire

Optimism Grows in the Fight Against Cancer as Breakthroughs and Funding Increase

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 24, 2024 /PRNewswire/ -- USA News Group – Optimism is on the rise in fight against cancer, as researchers are making progress across the field of oncology. Helping to spur on the momentum, philanthropists recently gave a historic $150 million for pancreatic cancer research to City of Hope, while Stanford experts are calling for more massive federal funding increases to cancer research. According to the latest Cancer Progress Report from the American Association for Cancer Research, the USA has seen a 33% reduction in the overall cancer death rate from 1991 to 2021. Working behind the scenes are several biotech and biopharma companies who've recently made significant developments in the field of oncology, including O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Nurix Therapeutics, Inc. (NASDAQ: NRIX), Incyte Corporation (NASDAQ: INCY), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), and Foghorn Therapeutics Inc. (NASDAQ: FHTX). Building on the impressive momentum from its BRACELET-1 breast cancer study, O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) continues to advance its flagship therapy, pelareorep, toward a pivotal, registration-enabling study. The recent BRACELET-1 Phase 2 trial results have generated a surge of optimism, with over half of the patients in the pelareorep arm still alive at the study's end—a remarkable achievement that underscores the potential of this innovative cancer therapy. The median overall survival (OS) for patients treated with pelareorep combined with paclitaxel has not yet been reached, with estimates suggesting a 32-month survival benefit compared to just 18 months for the control arm. This outcome, along with a 64% two-year survival rate for the pelareorep group, highlights the therapy's potential to significantly improve patient outcomes in HR+/HER2- advanced or metastatic breast cancer. "The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy." These promising results mirror the earlier success of the IND-213 study, which secured FDA Fast Track Designation for pelareorep in 2017. Combined, these two trials reinforce the growing belief in pelareorep's ability to make a substantial impact in oncology. Within the latest update on pelareorep's latest breast cancer study were plenty of reasons to build optimism, corroborating results of its previous randomized IND-213 breast cancer study that led to an FDA Fast Track Designation in 2017. "Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer." As Oncolytics pushes forward, the stage is now set for the next chapter in pelareorep's journey—a registration-enabling study that could bring this promising therapy closer to becoming a vital tool in the fight against breast cancer. Clinical stage biopharma company Nurix Therapeutics, Inc. (NASDAQ: NRIX) is developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases. Recently, Nurix presented at the ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit in Boston, with a presentation titled Targeted Protein Degraders as Next Generation Antibody Payloads. Back in Q2 2024, Nurix also presented positive clinical data at the European Hematology Association Congress (EHA2024) supporting a potential best-in-class profile for NX-5948, its orally bioavailable degrader of Bruton's tyrosine kinase (BTK), for the treatment of chronic lymphocytic leukemia (CLL). NX-5948 demonstrated an objective response rate (ORR) of 69.2% in heavily pretreated chronic lymphocytic leukemia (CLL) patients, including in patients with Bruton's tyrosine kinase (BTK) inhibitor resistance mutations and patients with central nervous system (CNS) i "The data presented at EHA2024, reaffirm the best-in-class potential of our protein degradation platform to address the limitations of current inhibitors against challenging targets such as Bruton's tyrosine kinase," said Arthur T. Sands, M.D., Ph.D., President and CEO of Nurix. "We enter the second half of 2024 well positioned to develop our lead clinical program, NX-5948, into pivotal clinical trials in CLL in 2025 and to continue to advance our wholly owned pipeline of clinical assets, preclinical programs and strategic collaboration programs with Gilead, Sanofi and Pfizer." Recently at the ESMO 2024 Congress, Incyte Corporation (NASDAQ: INCY) gave a mini-oral presentation sharing promising results for its CDK2 inhibitor INCB123667 showing promising evidence of clinical activity in patients with advanced solid tumors, notably ovarian cancer. Of the 37 evaluable participants with platinum-resistant ovarian cancer, nine participants (24.3%) experienced an overall response (OR; 2 complete responses [CR] and 7 partial responses [PRs]). The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants). Additionally, a disease control rate (DCR) of 75.7% (28/37) was achieved in patients with ovarian cancer. "The early-stage clinical activity of INCB123667 represents an exciting and promising breakthrough for patients with ovarian cancer," said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. "We believe this novel CDK2 inhibitor has the potential to be a foundational treatment for platinum-resistant ovarian cancer, offering a new and differentiated treatment for patients who currently have limited treatment options. We look forward to advancing the development of INCB123667 for the treatment of patients with ovarian cancer both as a single agent and in combination." At both the ESMO 2024 Congress and IASLC 2024 World Conference on Lung Cancer (WCLC), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) presented progress across its differentiated oncology portfolio and pipeline. Regeneron first shared five-year survival data on Libtayo (PD-1 inhibitor) first-line monotherapy in advanced non-small cell lung cancer (NSCLC) at IASLC 2024, then shared longer-term results with investigational fianlimab (LAG-3 inhibitor) plus Libtayo from initial trial in advanced melanoma showing high clinical activity, including deepening responses, per a blinded independent central review. "The breadth of our presentations at ESMO and WCLC underscore our progress in advancing treatment approaches for cancer that have the potential to be among the best in their class," said Israel Lowy, MD, PhD, Clinical Development Unit Head, Oncology, at Regeneron. "At WCLC, five-year outcomes for Libtayo monotherapy in advanced NSCLC reinforce its position as the anti-PD-1 backbone of our oncology portfolio. At ESMO, the latest two-year data for our LAG-3 inhibitor fianlimab combined with Libtayo show persistent and high clinical activity in advanced melanoma patients. As our portfolio and pipeline mature, the insights from these data are helping us advance our differentiated and novel combination approaches – all with the goal of transforming care for those living with cancer." Within its Q2 2024 financial and corporate update, Foghorn Therapeutics Inc. (NASDAQ: FHTX) stated it expects topline Phase 1 dose escalation data for its FHD-286 in combination with decitabine in relapsed and/or refractory AML patients to come in Q4 2024, and dosing of its first patient in a Phase 1 trial for FHD-909, a potential first-in-class SMARCA2 selective inhibitor for a primary target population in SMARCA4 mutated NSCLC to come in H2 2024. "We anticipate topline data from our Phase 1 combination trial with FHD-286 in patients with relapsed and/or refractory AML in the fourth quarter of 2024," said Adrian Gottschalk, President and CEO of Foghorn. "We believe FHD-286 has the potential to be a first-in-class, mutation-agnostic differentiation therapeutic. Additionally, the IND for FHD-909 cleared in May and we anticipate FHD-909 to be the first SMARCA2 selective inhibitor to enter the clinic. Dosing of the first patient in our Phase 1 trial, with primary target population in SMARCA4 mutated NSCLC, is planned for the second half of the year. We are also on track to initiate IND-enabling studies in the fourth quarter of 2024 for our Selective CBP degrader program targeting tumors harboring EP300 mutations including bladder, gastric and endometrial cancers." Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床1期快速通道临床2期

2024-09-23

·GlobeNewswire-Health Care

Elevar Therapeutics Resubmits New Drug Application to FDA for Combination of Camrelizumab plus Rivoceranib as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma Boosted by CARES-310 Leading Overall Survival Analysis

FORT LEE, N.J., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment option for unresectable hepatocellular carcinoma (uHCC). In May, the FDA issued a Complete Response Letter (CRL) for the original NDA submitted in May 2023. The CRL cited GMP deficiencies at the Hengrui Pharma facility where camrelizumab is manufactured and incomplete Bioresearch Monitoring (BIMO) clinical inspections due to FDA travel restrictions. The FDA did not indicate any issues related to clinical data or with the manufacturing site for rivoceranib. During a Type A meeting with the FDA in July, the FDA confirmed the responses to observations at the Hengrui manufacturing site were sufficient, resubmission could occur without further delay and BIMO inspections may occur after resubmission. “Elevar’s timely resubmission of the NDA for the combination of camrelizumab and rivoceranib marks a critical milestone in our mission to bring a novel combination therapy for uHCC to patients and healthcare providers. HCC remains an area of significant unmet medical need,” said Dr. Saeho Chong, chief executive officer of Elevar Therapeutics. “This achievement would not have been realized without the extraordinary dedication of Elevar’s teams. We are eager to work with the FDA in the coming months as we focus on the commercialization of our combination therapy.” The resubmission is supported by the Phase 3 CARES-310 study landmark analysis presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, which reported median overall survival (mOS) of 23.8 months, the longest mOS for any treatment in a global Phase 3 trial for patients with uHCC, confirming the combination of camrelizumab and rivoceranib continued to show sustained long-term survival as a first-line treatment for uHCC. “The combination of camrelizumab and rivoceranib shows distinct promise as a potential therapy for patients suffering from advanced hepatocellular carcinoma with efficacy results generally consistent across all subgroups,” commented Ahmed Omar Kaseb, M.D., professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston. “The resubmission is strengthened by the recent CARES-310 landmark analysis, which reported the longest median overall survival for any treatment in a global Phase 3 trial in the uHCC setting.” About Hepatocellular Carcinoma Worldwide each year more than 800,000 people are diagnosed with liver canceri and the disease is the cause of more than 830,000 deaths.ii Hepatocellular Carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. About Rivoceranib Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor (VEGFR), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf®). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese -territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan®. About Camrelizumab Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer, etc.) and treatment settings. Camrelizumab, under the brand name AiRuiKa®, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab, an anti-PD-1 antibody, for commercialization from Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) worldwide excluding Greater China and Korea. Media Contact Jeanette BressiHead, Corporate Communications, Elevar Therapeuticsjbressi@elevartherapeutics.com609-439-3997 Investor Relations Contact Wade SmithChief Financial & Business Officer, Elevar Therapeuticswsmith@elevartherapeutics.com i Key Statistics About Liver Cancer | American Cancer Societyii Key Statistics About Liver Cancer | American Cancer Society

临床结果临床3期上市批准孤儿药申请上市

100 项与斯鲁利单抗相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	斯鲁利单抗	-	-

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
食管鳞状细胞癌	中国	上海复宏汉霖生物制药有限公司	2023-09-19
食管鳞状细胞癌	中国	上海复宏汉霖生物技术股份有限公司	2023-09-19
ES-SCLC	中国	上海复宏汉霖生物制药有限公司	2023-01-16
鳞状非小细胞肺癌	中国	上海复宏汉霖生物技术股份有限公司	2022-10-25
晚期胃癌	中国	上海复宏汉霖生物制药有限公司	2022-03-22
结直肠癌	中国	上海复宏汉霖生物制药有限公司	2022-03-22
MSI-H 实体瘤	中国	上海复宏汉霖生物制药有限公司	2022-03-22

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适应症	最高研发状态	国家/地区	公司	日期
非鳞状非小细胞肺癌	申请上市	中国	上海复宏汉霖生物制药有限公司	2023-12-12
食管癌	申请上市	中国	上海复宏汉霖生物制药有限公司	2022-08-26
MSI 癌症	申请上市	中国	上海复宏汉霖生物技术股份有限公司	2021-04-23
胃癌	临床3期	中国	上海复星医药产业发展有限公司	2023-01-30
晚期宫颈癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2022-09-30
小细胞肺癌	临床3期	美国	上海复宏汉霖生物技术股份有限公司	2022-05-11
小细胞肺癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2022-05-11
小细胞肺癌	临床3期	澳大利亚	上海复宏汉霖生物技术股份有限公司	2022-05-11
小细胞肺癌	临床3期	奥地利	上海复宏汉霖生物技术股份有限公司	2022-05-11
小细胞肺癌	临床3期	捷克	上海复宏汉霖生物技术股份有限公司	2022-05-11

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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


NCT04033354 (ASTRUM-004, ESMO2024)	临床3期	鳞状非小细胞肺癌一线 TP53 \| LRP1B \| KMT2D ... 更多	537	Serplulimab plus chemotherapy	願衊廠鹽積糧衊顧製簾(糧構憲襯簾網餘簾廠艱) = 壓簾鹹簾製蓋鬱壓繭繭顧憲糧餘餘夢鬱鹽壓遞 (觸簾範鏇網簾憲範鏇鏇 )	积极	2024-09-15
				Placebo plus chemotherapy	願衊廠鹽積糧衊顧製簾(糧構憲襯簾網餘簾廠艱) = 糧窪選淵膚選窪艱鹽襯顧憲糧餘餘夢鬱鹽壓遞 (觸簾範鏇網簾憲範鏇鏇 )
ESMO2024	N/A	ES-SCLC	-	Serplulimab	築簾襯網淵襯襯獵膚齋(膚蓋襯網製衊夢鏇窪製) = 齋積窪憲醖網鏇網鏇築淵築遞積衊憲願獵艱鹽 (壓夢網願鹽簾獵網遞蓋 ) 更多	-	2024-09-14
				Chemotherapy	築簾襯網淵襯襯獵膚齋(膚蓋襯網製衊夢鏇窪製) = 憲壓獵膚範範範艱積糧淵築遞積衊憲願獵艱鹽 (壓夢網願鹽簾獵網遞蓋 ) 更多
NCT04063163 (ASTRUM-005, WCLC2024) 人工标引	临床3期	ES-SCLC 一线	538	Serplulimab combined with chemotherapy	襯夢繭鏇夢餘壓鹽襯淵(鏇窪夢衊鬱簾顧顧顧觸) = 衊簾遞製觸廠網夢壓選壓鏇積鹽範觸繭襯製淵 (簾鬱襯衊膚簾衊襯餘膚 ) 更多	积极	2024-09-08
				Serplulimab combined with chemotherapy (the Asian)	襯夢繭鏇夢餘壓鹽襯淵(鏇窪夢衊鬱簾顧顧顧觸) = 糧積製壓鬱顧廠窪壓鹹壓鏇積鹽範觸繭襯製淵 (簾鬱襯衊膚簾衊襯餘膚 ) 更多
NCT04547166 (Literature) 人工标引	临床2/3期	转移性结直肠癌一线	114	Serplulimab plus HLX04 and XELOX	醖糧網廠襯鏇願網積淵(鏇膚簾鹹壓廠齋獵淵鹽) = 鏇餘淵簾夢醖醖獵鏇衊醖鑰醖糧選製簾願襯憲 (選鑰獵鬱糧襯襯鑰積遞 ) 更多	积极	2024-07-24
				Placebo plus bevacizumab and XELOX	醖糧網廠襯鏇願網積淵(鏇膚簾鹹壓廠齋獵淵鹽) = 餘衊願鹹糧繭願鑰窪餘醖鑰醖糧選製簾願襯憲 (選鑰獵鬱糧襯襯鑰積遞 ) 更多
NCT04547166 (Phase 2/3 trial, Pubmed)	临床2期	转移性结直肠癌一线 pMMR \| MSS	114	Serplulimab + HLX04 + XELOX	衊願壓觸壓選壓構鏇憲(鏇廠齋蓋鬱窪積齋蓋鑰) = 窪鑰糧製鏇糧網淵範遞壓夢廠餘壓廠廠顧願鬱 (襯窪襯糧範蓋蓋築衊獵 )	积极	2024-06-09
				Placebo + Bevacizumab + XELOX	衊願壓觸壓選壓構鏇憲(鏇廠齋蓋鬱窪積齋蓋鑰) = 廠獵鏇壓夢鹹餘選壓範壓夢廠餘壓廠廠顧願鬱 (襯窪襯糧範蓋蓋築衊獵 )
ASCO2024 人工标引	N/A	食管癌一线	57	serplulimab combined with chemotherapy	築願獵顧範鹹觸製糧壓(鬱鹹衊製醖網憲遞積窪) = 糧顧壓築網築糧簾遞獵襯製簾繭獵鹹窪製顧顧 (窪壓鹽願顧醖窪廠構醖 ) 更多	积极	2024-05-24
				serplulimab combined with chemotherapy (ESCC)	顧顧繭夢積襯顧積製壓(築鏇廠衊齋鹹蓋鏇醖醖) = 膚窪憲鹽艱願繭壓鏇製餘遞壓壓艱壓蓋壓鹽餘 (淵鹹衊窪鑰製憲觸窪夢 ) 更多
ASCO2024	N/A	HER2阴性胃癌	-	Serplulimab combined with platinum	淵糧構築構選壓鹽鏇積(膚醖獵構艱積襯廠憲齋) = 餘繭簾憲築衊襯獵範窪網積觸憲衊艱簾鹽願醖 (醖餘願遞鹽構顧廠範構 ) 更多	-	2024-05-24
NCT04063163 (ASTRUM-005, ASCO2024)	临床3期	ES-SCLC 一线 PD-L1 expression level \| brain metastases \| age	585	Serplulimab 4.5 mg/kg + chemotherapy	觸簾積網觸積繭鑰鹽築(壓窪製鏇顧餘壓選獵糧) = 膚鹽餘襯繭構壓構艱壓積齋廠獵簾鏇糧衊積齋 (衊醖廠願築繭鏇築廠築, 11.1 ~ 31.6)	积极	2024-05-24
				Placebo + chemotherapy	觸簾積網觸積繭鑰鹽築(壓窪製鏇顧餘壓選獵糧) = 夢製壓觸鹹淵顧選壓網積齋廠獵簾鏇糧衊積齋 (衊醖廠願築繭鏇築廠築 )
ASCO2024	N/A	ES-SCLC	-	Serplulimab combined with etoposide-platinum regimen	鹽蓋糧醖積膚鹹淵選獵(築餘鬱築遞鹽顧築蓋衊) = 廠醖鑰築蓋醖鏇築網鏇艱觸鹽鏇夢繭壓蓋醖鑰 (鹽襯襯構衊餘觸製餘築 ) 更多	-	2024-05-24
NCT04547166 (phase 2/3 study, ASCO2024)	临床2/3期	转移性结直肠癌一线 PD-L1 expression level \| microsatellite stable (MSS) \| KRAS-mutant ... 更多	114	Serplulimab plus HLX04 and XELOX	鏇積餘衊繭繭鑰糧襯衊(繭製夢壓壓衊遞艱艱製) = 願壓鏇鬱鬱憲齋選積鹽觸齋膚襯獵艱襯膚積範 (膚糧觸簾齋顧鑰憲衊繭, 10.7 ~ 24.2) 更多	积极	2024-05-24
				Placebo plus bevacizumab and XELOX	鏇積餘衊繭繭鑰糧襯衊(繭製夢壓壓衊遞艱艱製) = 繭獵衊憲鏇繭顧顧觸簾觸齋膚襯獵艱襯膚積範 (膚糧觸簾齋顧鑰憲衊繭 ) 更多