A Multicenter, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects With Immune Thrombocytopenia

This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.

开始日期2024-04-02

申办/合作机构

和黄医药（中国）有限公司

CTR20223101 / Completed临床1期

单中心、开放、多剂量设计，研究中国成年男性健康受试者多次口服 HMPL-523 片随后单次口服 300 mg/150 μCi [14C]HMPL-523 混悬液后人体内物质平衡的 I 期临床试验

主要研究目的：评价中国成年男性健康受试者多次口服 HMPL-523 片、随后单次口服[14C]HMPL-523 混悬液后体内的吸收、代谢和排泄次要研究目的：评价多次口服 HMPL-523 片、随后单次口服[14C]HMPL-523 混悬液在中国成年男性健康受试者中的安全性和耐受性

开始日期2023-02-09

申办/合作机构

和记黄埔医药（上海）有限公司

NCT05781906 / Active, not recruiting临床1期

Single-center, Open-label, Multi-dose Study to Investigate the Human Mass Balance in Healthy Adult Male Following Multiple Oral Doses of HMPL-523 Tablets Followed by a Single Oral Dose of 300 mg/150 µCi [14C]HMPL-523 Suspension

To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects following multiple oral doses of HMPL-523 tablets followed by a single oral dose of [14C]HMPL-523 suspension

开始日期2023-02-08

申办/合作机构

和黄医药（中国）有限公司

100 项与索乐匹尼布相关的临床结果

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100 项与索乐匹尼布相关的转化医学

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100 项与索乐匹尼布相关的专利（医药）

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项与索乐匹尼布相关的文献（医药）

2024-01-01·Journal of Pharmacology and Experimental Therapeutics

Preclinical Pharmacology Characterization of Sovleplenib (HMPL-523), an Orally Available Syk Inhibitor

Article

作者: Sai, Yang ; Cheng, Min ; Xu, Yan ; Dai, Xiaoming ; Li, Xiong ; Cai, Yu ; Jia, Hong ; Ren, Yongxin ; He, Jianlin ; Wu, Zhipeng ; Wang, Jian ; Su, Weiguo ; He, Weigang ; Wang, Guanglin ; Yang, Na ; Dai, Guangxiu

Spleen tyrosine kinase (Syk) is an intracellular tyrosine kinase involved in the signal transduction in immune cells mainly. Its aberrant regulation is associated with diversified allergic disorders, autoimmune diseases and B cell malignancies. Therefore, inhibition of Syk is considered a reasonable approach to treat autoimmune/inflammatory diseases and B cell malignancies. Here we described the preclinical characterization of sovleplenib, a novel, highly potent and selective, oral Syk inhibitor, in several rodent autoimmune disease models. Sovleplenib potently inhibited Syk activity in a recombinant enzymatic assay and Syk-dependent cellular functions in various immune cell lines and human whole blood in vitro. Furthermore, sovleplenib, by oral administration, demonstrated strong in vivo efficacies in murine models of immune thrombocytopenia (ITP), autoimmune hemolytic anemia (AIHA), and chronic graft-versus-host disease (cGVHD), and a rat model of collagen induced arthritis (CIA) respectively, in a dose-dependent manner. Collectively, these results clearly supported sovleplenib as a therapeutic agent in the treatment of autoimmune diseases. Sovleplenib is being globally developed for ITP (Phase III, NCT05029635, Phase Ib/II, NCT03951623), wAIHA (Phase II/III, NCT05535933) and B-cell lymphoma (Phase I, NCT02857998, NCT03779113). SIGNIFICANCE STATEMENT: Syk is a key mediator of signaling pathways downstream of a wide array of receptors important for immune functions, including the B cell receptor, immunoglobulin receptors bearing Fc receptors. Inhibition of Syk could provide a novel therapeutic approach for autoimmune diseases and hematologic malignancies. The manuscript describes the preclinical pharmacology characterization of sovleplenib, a novel Syk inhibitor, in enzymatic and cellular assays in vitro and several murine autoimmune disease models in vivo.

2023-06-01·The Lancet. Haematology

Sovleplenib (HMPL-523), a novel Syk inhibitor, for patients with primary immune thrombocytopenia in China: a randomised, double-blind, placebo-controlled, phase 1b/2 study.

Article

作者: Zhou, Hu ; Leng, Yun ; Yin, Hongyan ; Su, Weiguo ; Yang, Renchi ; Ding, Bingjie ; Yin, Jie ; Shi, Haiyan ; Gong, Yuping ; Chen, Wenming ; Luo, Chengwei ; Liu, Xiaofan ; Wang, Jian ; Mei, Heng ; Hu, Yu ; Li, Junmin ; Li, Yan ; Fan, Songhua ; Chen, Keyan ; Ji, Dexiang ; Gu, Chengyuan ; Huang, Ruibin ; Sun, Huiping

BACKGROUND:

Spleen tyrosine kinase (Syk) inhibitor is a treatment option for primary immune thrombocytopenia. We aimed to evaluate the safety, tolerability, pharmacokinetics, preliminary activity, and recommended phase 2 dose of sovleplenib in patients with primary immune thrombocytopenia.

METHODS:

This randomised, double-blind, placebo-controlled, phase 1b/2 study was conducted at nine hospitals in China. Eligible patients were aged 18-75 years, had an ECOG performance score of 0-1, had primary immune thrombocytopenia for more than 6 months, and did not respond or relapsed after previous first-line treatment or had poor response or postoperative relapse after a splenectomy. Dose-escalation (100 mg, 200 mg, or 300 mg given orally once a day) and dose-expansion phases (recommended phase 2 dose) each consisted of an 8-week, double-blind, placebo-controlled period in which patients were randomly assigned (3:1) to receive sovleplenib or placebo with an interactive web response system followed by a 16-week, open-label period with sovleplenib. Patients, investigators, and the sponsor were masked to treatment allocation during the first 8 weeks. The main efficacy endpoint was the proportion of patients whose platelet count reached 30 × 10⁹ platelets per L or higher and was double of the baseline at two consecutive visits during 0-8 weeks without rescue therapy. Efficacy was evaluated by intention-to-treat. This study is registered with ClinicalTrials.gov, NCT03951623.

FINDINGS:

Between May 30, 2019, and April 22, 2021, 62 patients were assessed for eligibility and 45 (73%) were randomly assigned. Patients received at least one dose of the study drug during the 8-week double-blind period (placebo [n=11] and sovleplenib 100 mg [n=6], 200 mg [n=6], 300 mg [n=16], and 400 mg [n=6]; this group was added following the observation of no protocol-specified safety events at the previous doses). All participants were Asian; 18 (40%) of 45 were male and 27 (60%) were female. The median age was 40·0 years (IQR 33·0-50·0). Ten (29%) of 34 patients in sovleplenib groups versus five (45%) of 11 in the placebo group received concomitant anti-primary immune thrombocytopenia therapy. The recommended phase 2 dose was determined as 300 mg once a day. The proportion of patients who met the main efficacy endpoint were three (50%; 95% CI 12-88) in the 100 mg group, three (50%; 12-88) in the 200 mg group, ten (63%; 35-85) in the 300 mg group, and two (33%; 4-78) in the 400 mg group compared with one (9%; 0-41) in the placebo group. The overall response rate in the 300 mg group was 80% (16 of 20 who received continuous sovleplenib plus those who crossed over from placebo) and the durable response rate was 31% (11-59; five of 16) in the continuous sovleplenib 300 mg and 75% (19-99; three of four) crossed from placebo to sovleplenib during 0-24 weeks. During the 28-day safety evaluation period, two grade 2 or worse treatment-related treatment-emergent adverse events occurred in the sovleplenib groups (hypertriglyceridaemia and anaemia). During 0-8 weeks, the most frequent treatment-emergent adverse events were an increase in blood lactate dehydrogenase, haematuria, and urinary tract infection (seven [21%] of 34 in sovleplenib groups vs one [9%] of 11 in the placebo group); and occult blood-positive and hyperuricaemia (four [12%] vs three [27%] for each). No fatal treatment-emergent adverse events were recorded.

INTERPRETATION:

Sovleplenib was well tolerated, and the recommended phase 2 dose showed a promising durable response in patients with primary immune thrombocytopenia, which provides evidence for future investigations. A phase 3 trial is ongoing (NCT05029635) to confirm the efficacy and safety of sovleplenib in patients with primary immune thrombocytopenia.

FUNDING:

HUTCHMED.

Journal of Xenobiotics

Safety and Efficacy of Tyrosine Kinase Inhibitors in Immune Thrombocytopenic Purpura: A Systematic Review of Clinical Trials

Review

作者: Rengarajan, Harish Kumar ; Dhanesar, Gurneel ; Maroules, Michael ; Anwar, Muhammad Yasir ; Hamza, Mohammad ; Ali, Muhammad Ashar ; Aiman, Wajeeha ; Zafar, Maha ; Omar, Zainab

Immune thrombocytopenic purpura (ITP) is an acquired antibody or cell-mediated platelet damage or decreased platelet production. Steroids, IV immunoglobulins (IVIG), and Rho-anti-D antibodies are the commonly used initial treatments for ITP. However, many ITP patients either do not respond or do not maintain a response to initial therapy. Splenectomy, rituximab, and thrombomimetics are the commonly used second-line treatment. More treatment options include tyrosine kinases inhibitors (TKI), including spleen tyrosine kinase (Syk) and Bruton’s tyrosine kinase (BTK) inhibitors. This review aims to assess the safety and efficacy of TKIs. Methods: Literature was searched on PubMed, Embase, WOS, and clinicaltrials.gov using keywords, “tyrosine kinase” and “idiopathic thrombocytopenic purpura”. PRISMA guidelines were followed. Results: In total, 4 clinical trials were included with 255 adult patients with relapsed/refractory ITP. In all, 101 (39.6%) patients were treated with fostamatinib, 60 (23%) patients with rilzabrutinib, and 34 (13%) with HMPL-523. Patients treated with fostamatinib achieved a stable response (SR) and overall response (OR) in 18/101 (17.8%) and 43/101 (42.5%) of the patients, respectively, while SR and OR were achieved in 1/49 (2%) and 7/49 (14%) of the patients, respectively, in the placebo group. Patients treated with HMPL-523 (300 mg dose expansion) achieved an SR and OR in 5/20 (25%) and 11/20 (55%) of the patients, respectively, while SR and OR were achieved in 1/11 (9%) of the patients treated with the placebo. Patients treated with rilzabrutinib achieved an SR in 17/60 (28%) patients. Dizziness (1%), hypertension (2%), diarrhea (1%), and neutropenia (1%) were serious adverse events in fostamatinib patients. Rilzabrutinib or HMPL-523 patients did not require a dose reduction due to drug-related adverse effects. Conclusions: Rilzabrutinib, fostamatinib, and HMPL-523 were safe and effective in the treatment of relapsed/refractory ITP.

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2024-05-02

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合计814亿太惊人！33家企业研发投入超10亿，恒瑞、石药强势领跑，人福、天士力涨幅明显

精彩内容踏入5月，上市医药企业2023年业绩报告基本披露完毕。据不完全统计，A股及港股上市医药企业中，研发投入超10亿元的有33家，合计超过814亿元，百济神州、恒瑞医药、复星医药高居前三。其中，10家企业研发投入涨逾20%，华东医药、人福医药、天士力等持续加码；研发投入占营业收入比重超30%的企业有10家，和黄医药、信立泰、信达生物等潜力十足。研发投入超10亿元的A股及港股上市医药企业注：汇率以4月30日计；统计字段含研发投入、研发费用、研发支出、研发成本等；手工整理，如有疏漏，欢迎指正！33家企业研发投入超过10亿元。百济神州、恒瑞医药、复星医药、石药集团、中国生物制药、迈瑞医疗、金斯瑞生物、上海医药、华润医药、长春高新、信达生物、和黄医药、豪森药业13家超过20亿元，百济神州以128.54亿元强势领跑。半数以上企业研发投入呈正增长，石药集团、豪森药业、长春高新、华东医药、人福医药、天士力、荣昌生物、神州细胞等10家同比涨逾20%。17家超百亿营收企业中，10家研发投入占营收比重超过10%，其中百济神州、恒瑞医药、豪森药业超过20%。百济神州、恒瑞、石药......13家企业研发投入超20亿元研发投入向来是衡量企业技术实力的核心维度，在以研发为本的创新药行业尤其如此。与海外MNC相比，国内药企虽在研发支出上尚存一定差距，但伴随近年利好创新药研发政策的密集出台，其奋起直追的势头十分强劲。在A股及港股上市医药企业中，2023年研发投入超20亿元的达到13家。作为国内“研发巨头”的百济神州，近年来研发投入一直遥遥领先其他药企，2022年首次突破百亿元（110.34亿元）大关后，2023年再度增长至128.54亿元，占营业收入比重的72.33%。回顾2023年，百济神州创新药板块成绩斐然，不仅收获首个国产超10亿美元分子泽布替尼（销售额超13亿美元，约合91.38亿元），以及PD-1畅销药替雷利珠单抗（销售额达5.37亿美元，约合38亿元），同时还拥有多达60余个在研创新药项目。预计自2024年起，百济神州每年还能推动10款以上新的分子药物进入临床研究阶段。近五年百济神州研发投入（单位：亿元）来源：公司年报素有“创新药一哥”之称的恒瑞医药，近年来锚定创新引领高质量发展，2023年累计研发投入61.5亿元，占营收比重的26.95%；此外，创新药收入首破百亿元（106.37亿元），同比增长22.1%，占营收比重的46.61%。在高强度研发投入的加持下，恒瑞研发成果加速兑现。米内网数据显示，目前公司已有14款自研创新药（13款1类新药）、2款合作引进1类新药、以及6款2类改良型新药在国内获批上市，多款1类新药已申报上市，包括瑞卡西单抗（长效PCSK9单抗）、艾玛昔替尼（JAK1抑制剂）、夫那奇珠单抗（IL-17A单抗）、HR20013（NK-1/5-HT3抑制剂）、法米替尼（酪氨酸激酶抑制剂）等；此外，还有90多款自主创新产品正在临床开发中，近300项临床试验在国内外开展。创新研发是石药集团未来发展的重要引擎，近年来公司持续加大研发投入，2023年研发费用达48.3亿元，同比增长21%，约占成药业务收入18.8%。截至报告期末，石药集团拥有在研创新药项目130余个，其中大分子40余个、小分子40余个、新型制剂30余个等，公司预计未来5年将有近50个创新药及新型制剂申报上市。2023年以来，石药集团新药研发喜讯频传：1类新药谷美替尼片、纳鲁索拜单抗注射液获批上市；1类新药普卢格列汀片、恩朗苏拜单抗注射液以及3.3类新药奥马珠单抗生物类似药申报上市；SYH2053注射液、SYH2038片、SYS6011、注射用NBL-028、JMT203注射液、SYH2051片、SYS6010、NBL-020注射液等1类新药首次获批临床。复星医药持续推进创新转型，研发投入稳步增长。报告期内，公司累计研发投入共计59.37亿元，占营业收入比重的14.34%；其中，制药业务的研发投入高达51.72亿元，同比增幅1.47%。年报显示，2023年复星共有6个创新药的8项适应症获批上市，包括公司1类新药斯鲁利单抗注射液（广泛期小细胞肺癌、食管鳞状细胞癌）、阿基仑赛注射液（大B细胞淋巴瘤）等；4款独家商业化产品获批上市，其中国产首款钾离子竞争性酸阻滞剂盐酸凯普拉生片、长效重组人粒细胞集落刺激因子拓培非格司亭注射液两款产品已纳入2023版国家医保目录。截至报告期末，复星主要在研创新药、生物类似药项目超过70项，其中5个产品共7项适应症已进入上市前审批阶段。华东、人福、天士力......10家企业研发投入涨逾20%从研发投入增速上看，华东医药、人福医药、天士力、康缘药业、豪森药业、长春高新、荣昌生物等10家企业均涨逾20%。致力于开发高质创新药、特色仿制药的人福医药，2023年公司研发投入再创新高，为15.41亿元，同比增长35.92%，是近五年增速最高的一年。积极推动新药研发的人福医药，目前有20余款新药已进入临床研究阶段，其中2款1类新药（含新增适应症）进入Ⅲ期临床，6个1类新药进入Ⅱ期临床，5个1类新药进入Ⅰ期临床；包括1.1类中药新药复方薏薢颗粒和改良新药HZ-J001乳膏，于日前相继启动了痛风非急性期高尿酸血症（湿浊瘀阻证）的Ⅱ期临床研究和特应性皮炎的Ⅰ期临床试验。人福医药部分处于Ⅰ期临床及以上阶段的在研新药注：不含新增适应症来源：公司年报、米内网中国临床试验数据库作为国内现代创新中药龙头之一，天士力坚持守正创新与自我革新，不断加大研发创新力度，2023年公司研发投入13.15亿元，同比增长29.49%，占公司营业收入比重的15.17%，占医药工业收入比重的17.73%。年报显示，天士力2023年研发管线高效推进，通过“四位一体”的研发模式拥有涵盖98款在研产品的研发管线，包含41款1类创新药，36款正处于临床试验阶段，其中26款进入Ⅱ期或Ⅲ期临床；2款中药3.1类新药（古代经典名方中药复方制剂）枇杷清肺饮颗粒和温经汤颗粒报产在审，9款创新中药处于Ⅲ期临床阶段。近年来，华东医药稳步推进创新转型，建立起以中美华东为核心的创新研发生态版图。2023年公司在医药工业上的研发投入（不含股权投资）共计22.93亿元，其中研发支出为16亿元，同比增长33.74%，占医药工业营收比例为13.10%。统计截至2023年，华东医药创新产品管线已超过60项，其中有6款创新产品有望于2024年迎来商业化成果，包括自免赛道用于冷吡啉相关周期性综合征的注射用利纳西普，抗肿瘤赛道用于卵巢癌的ADC创新药索米妥昔单抗注射液等。米内网数据显示，2022年中国三大终端六大市场（统计范围详见本文末）抗肿瘤和免疫调节剂合计销售额突破2100亿元，2023年上半年超过1100亿元，预计全年将再创新高。近年来中国三大终端六大市场抗肿瘤和免疫调节剂销售趋势（单位：万元）来源：米内网格局数据库和黄、信达、信立泰......10家企业研发投入占营收比重超30%提高研发投入占营收比重，对增强企业创新能力、促进公司未来发展及提升公司品牌形象等有着重要且积极的意义。据不完全统计，2023年研发投入在10亿元以上，且占营收比重超过30%的企业至少有10家，除包含信立泰等老牌药企外，更多以和黄医药、信达生物、君实生物等Biopharma企业为主。作为一家稳健上进的创新药企业，和黄医药2023年研发投入达到21.86亿元，占营收比重的36.04%。相较于2022年，公司研发费用上有所减少，其主要原因是多项大型注册试验已陆续完成，且海外授权合作方面，相关合作方承担主要开发费用。2023年，是和黄医药取得多项里程碑式突破的一年。如公司核心产品呋喹替尼海外权益于去年1月授权给武田后，同年11月便获FDA批准上市。财报显示，在美上市不到两个月，呋喹替尼便收获约1510万美元（约1.1亿元）的销售收入；其2023年在中国市场的收入为1.08亿美元（约7.8亿元），同比增长15%。此外，公司1类新药索乐匹尼布（免疫性血小板减少症）的上市申请已获NMPA受理，并纳入突破性疗法品种和优先审评品种名单。2023年是信达生物“新十年发展”中实现重要转折的一年，在坚持科学高效的研发战略，以及合理配置多元化产品资源的指导方针下，公司研发投入（22.28亿元）与2022年相比虽有所下降，但其研发投入占营业收入的比重仍达35.9%，创新驱动高质量发展的决心不动摇。米内网数据显示，目前信达生物已有10款产品获批上市，包括7款创新药和3款生物类似药；在研产品方面，有40余款新药（1类新药占比超90%）在国内处于申请临床及以上阶段，覆盖单抗、多抗、免疫细胞因子、融合蛋白、抗体偶联药物、细胞治疗等药物形式，涉及肿瘤、眼科、消化代谢、自身免疫等多个治疗领域，其中玛仕度肽（IBI362）、福泽雷塞（IBI351）、他雷替尼（IBI344）等9款新药处于NDA或Ⅲ期临床阶段，上市可期。信达生物国内处于NDA或Ⅲ期临床的新药注：含联合开发及申报品种来源：米内网综合数据库作为一家创新驱动型医药企业，信立泰近年研发投入与营业收入之比整体呈上升趋势。2023年公司研发投入达到10.47亿元，创下其历史新高，占营业收入的31.13%。从研发管线布局上看，信立泰目前有多个创新药处于NDA或Ⅲ期临床阶段。其中，SAL0107、SAL067（苯甲酸复格列汀）、S086（高血压适应症）、SAL0108等新品已申报NDA；SAL056（长效特立帕肽）、S086（慢性心衰适应症）、SAL003、SAL0130等均已步入Ⅲ期临床。此外，公司中美双报的创新药JK07（SAL007）已获批在美国开展Ⅱ期临床试验（慢性心衰适应症），并计划在美国、中国、加拿大等多地开展国际多中心临床试验；在GLP-1靶点研究上，SAL0112拟用于糖尿病和肥胖适应症的项目已进入Ⅰ期临床。来源：米内网数据库、东方财富网等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。统计日期截至4月30日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

财报医药出海

2024-04-23

·研发客

我们分析了这些盈利创新公司 | 第一现场

// 这些Biotech盈利主要归因为三大类：产品销售+授权合作、产品销售为主、授权合作为主。2023年，康方生物、复宏汉霖、和铂医药纷纷宣布实现自创立以来的首次年度盈利。此前，贝达药业、微芯生物、艾力斯、上海谊众等均已凭借核心产品上市扭亏为盈，并在2023年保持盈利，和黄医药则在连亏6年后首度盈利。当然，也有由盈转亏的案例。2021年，荣昌生物和百奥泰凭借产品授权合作分别盈利约2.76亿元和8194万元，康希诺则靠新冠疫苗实现约19.14亿元的净利润。2022年之后，三家公司又重回亏损状态。除去早年曾凭借处方药和消费保健品实现盈利的和黄医药，这些Biotech在首次实现盈利时平均成立时间大约12年，大多数已有商业化产品，且首创新药的增长潜力日渐凸显。与此同时，授权合作带来的大额收入也成为公司盈利的一大助力。拓展阅读投资biotech真的赚钱吗？如何实现盈利？在本次统计样本中，康方生物、和黄医药凭借产品销售+授权合作实现盈利；复宏汉霖、艾力斯、上海谊众、贝达药业、微芯生物等以产品销售为主要盈利点；和铂医药则纯靠授权合作扭亏为盈。其中，2023年盈利最多的Biotech当属康方生物。年报显示，该公司2023年总收入达45.26亿元，净利润19.42亿元。根据康方生物年报，其转亏为盈主要原因之一是PD-1/VEGF双抗依沃西部分海外权益许可给Summit公司，该合作共计约29亿元的首付款已在2023年一季度到账。另一大原因要归功于PD-1/CTLA-4双抗卡度尼利销售收入稳步提升，该产品上市不足半年便取得5.46亿元销售收入，2023年更是增长149%至13.58亿元。拓展阅读康方速度和黄医药与康方生物类似。年报显示，该公司2023年总收入为8.38亿美元（折合人民币约60.61亿元），净收益为1.008亿美元（约7.29亿元）。其中超2亿美元来自4款抗肿瘤新药，VEGFR抑制剂呋喹替尼年收入突破1亿美元。和黄医药在年报中表示，其2023年表现出色很大程度上得益于与武田达成呋喹替尼合作的收入。该药已于去年11月在美国获批，为和黄带来3.12亿美元的首付款加里程碑付款。复宏汉霖则与前两家公司不同，其盈利主要源于核心产品持续销量扩大。该公司5款商业化产品的2023年销售收入合计约45.54亿元，同比增长70.2%，占总收入的比重高达84.4%。其中，4款生物类似药占所有产品收入的比例高达74.4%，尤其是抗肿瘤核心产品汉曲优（曲妥珠单抗），2023年全球收入合计已达27.37亿元。PD-1创新药斯鲁利单抗也表现不俗，2023年收入约11.20亿元，同比增长230.2%。拓展阅读复宏汉霖2023年净利润5.46亿元，首次实现全年盈利|新闻稿此外，主要凭借商业化产品实现盈利的，还有艾力斯（甲磺酸伏美替尼片）、上海谊众（注射用紫杉醇聚合物胶束）、贝达药业（盐酸埃克替尼片、盐酸恩沙替尼胶囊等）、微芯生物（西达本胺、西格列他钠）等。这些公司已连续两年以上盈利，尤其艾力斯仅靠一款产品年收入就有近20亿元。纯靠授权合作实现扭亏为盈的代表为和铂医药。该公司自2022年11月开始通过和铂医疗和诺纳生物两大支柱持续推动业务增长，2023年收入增长主要得益于与辉瑞、Cullinan Oncology和科伦博泰的授权合作，涉及靶向人间皮素的ADC、B7H4/4-1BB双抗等产品授权，以及诺纳生物全H2L2转基因Harbour Mice平台的使用。拓展阅读和铂医药：专注细分患者需求，提升行业创新实力持续盈利的关键是？2023年，泽布替尼以13亿美元的全球销售额，成为中国首款“十亿美元分子”。即便如此，百济神州去年仍亏损超67亿元。创新药一枝独秀并不少见，但对一家想要持续盈利的Biotech而言，终究是独木难支。埃克替尼之后，贝达药业一直在寻找新的增长点。但从年报来看，其后续推出的恩沙替尼和贝伐珠单抗并未对业绩做出重要贡献。过去三年，该公司营业收入增速逐年放缓，2022年净利润甚至下降62.04%。对此，资本市场已做出判断，4月23日贝达药业收盘价仅有38.65元/股，较最高峰值跌超75%。拓展阅读埃克替尼之后，贝达还有什么微芯生物凭借核心产品西达本胺，自2016年便扭亏为盈，但直到2021年10月糖尿病新药西格列他钠获批，才打破了该公司单一商业化产品的局面。不过从年报来看，微芯生物这两年营收并未大幅上涨，盈利也没有突破1亿元，股价较巅峰时期跌超83%。要想迈入持续商业化盈利，研发不能停还得会卖药。康方生物推出卡度尼利和派安普利后，仍在全面推进管线开发。其中，肿瘤领域PD-1/VEGF双抗依沃西已递交NDA并获得优先审评，非肿瘤领域还有抗PCSK9单抗伊努西单抗及IL-12/IL-23单抗依若奇单抗均已递交上市申请。和黄医药除了4款已商业化产品，另有10多款肿瘤候选药物正在临床试验阶段，且多款已进入注册申报阶段，比如新型Syk抑制剂索乐匹尼布、FGFR 1/2/3抑制剂HMPL-453、PI3Kδ抑制剂安迪利塞等。拓展阅读和黄医药：最大突破来自海外上市复宏汉霖则继续贯彻“生物类似药和创新药双轮驱动”的战略，在研管线中有抗体、ADC、小分子等16款产品进入临床。该公司计划于2024年递交帕妥珠单抗HLX11、地舒单抗HLX14、抗VEGF单抗HLX04-O等多个产品的上市申请。相比之下，艾力斯、上海谊众可谓走在独木桥上，上市产品单一，在研管线大多处在临床前阶段。谁能成为爆款？从各公司商业化产品来看，市场表现较好的主要是创新程度较高的1类新药。比如贝达药业核心产品埃克替尼。作为中国首款针对EGFR突变的肺癌靶向药，该药自2011年上市后一直是该公司收入及利润的主要来源，截至2023年底累计销售已超过150亿元。不过自从进入国家医保后，埃克替尼不仅降价50%以上，其销量在2023年上半年也开始出现下滑趋势。埃克替尼能辉煌多久尚未可知，但来自新一代肺癌靶向药的冲击已到眼前，艾力斯第三代EGFR-TKI伏美替尼就是其中之一。据艾力斯介绍，伏美替尼具有“脑转强效、疗效优异、安全性佳、治疗窗宽”等特点，已在中国获批用于EGFR敏感突变和T790M突变的非小细胞肺癌患者。它在2021年上市首年便创造2.36亿元的营收，次年进入医保后收入更是翻了三倍以上，到2023年已增长至19.72亿元。同样销售势如破竹的还有康方生物的PD-1/CTLA-4双抗卡度尼利。该药于2022年6月在中国获批单药用于宫颈癌2线/3线治疗，是全球首个获批上市的肿瘤双免疫检查点抑制剂，上市不足半年便收入5.46亿元，2023年更是增长149%至13.58亿元。相较之下，康方生物的PD-1抑制剂派安普利表现不甚理想。该产品2023年销售收入在2.73亿元左右，同比下降56%。国内同靶点产品竞争激烈，来自百济神州、信达生物和复宏汉霖的PD-1抑制剂2023年销售额均在10亿元以上。其中，复宏汉霖的斯鲁利单抗作为第7款国产PD-1抑制剂，尽管2022年3月才“姗姗来迟”，但通过切入MSI-H实体瘤这一相对空白市场和后续差异化的肿瘤布局，2023年销售额已反超君实生物、康方生物和誉衡生物的同类产品。2023年12月，斯鲁利单抗还在印度尼西亚获批，成为首个在东南亚国家获批上市的国产抗PD-1单抗。拓展阅读中国PD-1在新兴市场有机会吗?不过，以生物类似药起家的复宏汉霖，目前最畅销的还是汉曲优。作为中国首个中欧双批单抗药物，汉曲优一经上市就迅速打开海内外市场并逐年放量。2023年该药年收入已超过27亿元，贡献了复宏汉霖营收的半壁江山，同时也成为本次统计样本中销售最多的药品。编辑 | 戴佳凌dai.jialing@PharmaDJ.com 总第2094期访问研发客网站可浏览更多文章www.PharmaDJ.com

财报疫苗生物类似药引进/卖出

2024-04-05

·BioSpace

HUTCHMED Highlights Data to be Presented at AACR Congress 2024

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California. Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of certain types of acute leukemia. Compared with five other menin inhibitors in clinical development, HMPL-506 showed the stronger inhibitory potency in MLL-rearranged and NPM1 mutant leukemia cell line models. Furthermore, HMPL-506 in combination with azacytidine, venetoclax or gilteritinib synergistically improved the anti-tumor effect against MLL-rearranged leukemias both in vitro and in vivo. The investigational drug candidate displayed favorable pharmacokinetic pro high selectivity and low risk of cardiac toxicity. A Phase I study of HMPL-506 is planned for the second half of 2024. Initial preclinical data will also be presented for HMPL-A067 (HMA800067), a novel CD38-targeting antibody-drug conjugate (ADC) in which daratumumab was conjugated with cytotoxic payload Monomethyl auristatin E (MMAE) via a novel linker. It demonstrated significant superior anti-tumor activity to daratumumab, including in several B-cell malignancies models with resistance to daratumumab treatment. Other presentations include preclinical data on the ERK 1/2 inhibitor, HMPL-295; early clinical data on the Syk inhibitor, sovleplenib, in lymphoma patients; additional clinical data from global studies of VEGFR inhibitor, fruquintinib, and MET inhibitor, savolitinib; and several investigator-initiated studies of fruquintinib and VEGFR/CSF-1R/FGFR inhibitor, surufatinib. Details of the presentations are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of MLL-rearranged and NPM1mutant acute leukemia in preclinical models Min Cheng, HUTCHMED, Shanghai, China #2113 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 HMPL-A067 (HMA800067), a novel CD38-targeting antibody-drug conjugate (ADC), demonstrated superior anti-tumor activity to daratumumab in preclinical B-cell malignancies models Yan Xu, HUTCHMED, Shanghai, China #1890 Poster Session (PO.ET01.02 - Antibody-Drug Conjugates and Bispectific Antibodies) Monday, April 8, 2024 Preclinical characterization of HMPL-295, a potent and selective ERK1/2 inhibitor Jia Hu, HUTCHMED, Shanghai, China #1661 Poster Session (PO.MCB03.01 - Cell Signaling Components as Therapeutic Targets) Monday, April 8, 2024 Targeting YAP1/TEAD signaling re-sensitizes MAPK/ERK pathway inhibitors in KRAS-driven cancer cells Xianwen Yang, HUTCHMED, Shanghai, China #1931 Poster Session (PO.ET03.04 - Drug Resistance 2: Ras GTPase) Monday, April 8, 2024 Safety and Efficacy of Sovleplenib (HMPL-523), a Syk Inhibitor, in Patients with Relapsed or Refractory Lymphoma Paolo Strati, The University of Texas MD Anderson Cancer Center, USA #CT144 Poster Session (PO.CT01.03 - Phase 0 and Phase I Clinical Trials) Monday, April 8, 2024 Early carcinoembryonic antigen (CEA) dynamics to predict the efficacy of fruquintinib (F) + best supportive care (BSC) in patients with metastatic colorectal cancer (mCRC) enrolled in FRESCO-2 Stefano Lonardi, Veneto Institute of Oncology IOV-IRCCS Padua, Italy #6408 Poster Session (PO.CL01.10 - Predictive Biomarkers 5) Tuesday, April 9, 2024 Savolitinib (savo) + osimertinib (osi) vs savo + placebo (PBO) in patients (pts) with EGFR-mutated (EGFRm), MET-amplified advanced NSCLC with progression on osi James Chih-Hsin Yang, National Taiwan University Hospital and National Taiwan University Cancer Centre, Taipei, Taiwan #CT251 Poster Session (PO.CL01.10 - Predictive Biomarkers 5) Tuesday, April 9, 2024 INVESTIGATOR-INITIATED STUDIES Enhanced anticancer efficacy via ROS-dependent ferroptosis: synergy between surufatinib and cisplatin in small cell lung cancer Xiaolin Li, First Affiliated Hospital of Nanjing Medical University, Nanjing, China #2122 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 Efficacy and underlying mechanisms of surufatinib in non-small cell lung cancer treatment Yanfang Zheng, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou, China #2126 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 Enhancing Radiosensitivity in Biliary Tract Cancer: The Dual Role of Surufatinib in Tumor Suppression and Macrophage Reprogramming Hong Ma, Wuhan Union Hospital, Wuhan, China #2127 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 Surufatinib treatment in pancreatic cancer: unveiling the role of GPR34 in TAMs and enhancing immunotherapy efficacy Jihui Hao / Song Gao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China #2128 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 Efficacy and Underlying Mechanisms of Surufatinib Combined with PD-1 Monoclonal Antibody and Chemotherapy in Pancreatic Cancer Guanghai Dai / Ru Jia, Chinese PLA General Hospital (CPLAGH), Beijing, China #2129 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 Optimizing the treatment schedule of radiotherapy combined with VEGFR-TKIs and PD-(L) 1 inhibitors in metastatic colorectal cancer Tao Zhang / Zhenyu Lin, Cancer Center, Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China #3827 Poster Session (PO.CL10.04 - Outcome Investigation with Real World Data) Monday, April 8, 2024 Clinical and epidemiological pro neuroendocrine differentiation- A hospital-based retrospective study Susheng Shi / Yaru Wen, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China #4630 Poster Session (PO.ET06.04 - Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes) Tuesday, April 9, 2024 Epidemiological characteristics and treatment strategies of gastric cancer with neuroendocrine differentiation (NED) Jun Zhang, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China #4864 Poster Session (PO.PS01.08 - Descriptive Epidemiology and Statistical and Epidemiological Methodology) Tuesday, April 9, 2024 Initial efficacy of surufatinib plus sintilimab and IBI310 for patients with high-grade advanced-neuroendocrine neoplasm: A multicenter, single arm phase 2 study Lin Shen / Ming Lu, Peking University Cancer Hospital and Institute, Beijing, China #CT266 Poster Session (PO.CT02.02 - Phase II Clinical Trials 2) Tuesday, April 9, 2024 About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067, the further clinical development for fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067, its expectations as to whether any studies on fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067 would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067 for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of nab-paclitaxel, sintilimab, toripalimab, pemetrexed, platinum, etoposide or cisplatin as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon +44 (20) 7886 2500

临床1期免疫疗法AACR会议临床2期

100 项与索乐匹尼布相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
特发性血小板减少性紫癜	申请上市	中国更多	和记黄埔医药（上海）有限公司更多
自身免疫性溶血性贫血	临床3期	中国更多	和记黄埔医药（上海）有限公司更多
出血	临床1期	美国更多	和黄医药（中国）有限公司更多
非霍奇金淋巴瘤	临床1期	欧盟更多	和黄医药（中国）有限公司更多
皮肤表现	临床1期	澳大利亚更多	和黄医药（中国）有限公司更多

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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


NCT03779113 (AACR2024) 人工标引	临床1期	淋巴瘤	47	HMPL-523 700 mg QD	觸簾觸獵醖淵憲襯壓鹹(製廠觸衊選製衊繭餘鬱) = 築願構遞廠鏇窪衊鏇範膚獵鏇膚繭鑰願廠鹽鏇 (遞構醖壓餘願廠築積餘 ) 更多	积极	2024-04-05
NCT05029635 (ESLIM-01, Corporate Publications) 人工标引	临床3期	特发性血小板减少性紫癜	188	索乐匹尼布	淵夢鏇壓膚夢願鏇壓製(憲鏇築選窪願繭襯構夢) = 该试验成功达到了其主要终点，即与接受安慰剂治疗的患者相比，接受索乐匹尼布治疗的患者的持续应答率取得了具有临床意义和统计学意义的显著改善。遞醖廠觸艱繭襯獵築憲 (築糧遞夢網製蓋艱築積 ) 达到更多	积极	2023-08-21
				安慰剂
NCT03951623 (Pubmed)	临床1/2期	特发性血小板减少性紫癜一线	45	Sovleplenib 300 mg	壓醖淵願襯糧製鹹鑰鹽(夢糧鬱壓窪積齋製鏇遞) = two grade 2 or worse treatment-related treatment-emergent adverse events occurred in the sovleplenib groups 襯構築醖廠廠願遞齋選 (鏇選選簾窪廠衊積觸糧 ) 更多	积极	2023-04-04
				Placebo
NCT02857998 (GlobeNewswire) 人工标引	临床1期	特发性血小板减少性紫癜	45	HMPL-523	積齋膚構繭遞艱膚憲夢(廠壓觸構觸遞鹽夢遞觸) = No patients discontinued treatment due to treatment-related adverse events 簾簾築蓋糧餘遞鑰鏇觸 (製築廠壓醖襯選獵鏇鑰 ) 更多	积极	2021-12-14
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NCT03779113 (GlobeNewswire) 人工标引	临床1期	淋巴瘤	21	HMPL-523	選醖構鬱構襯齋齋鹹製(鹹廠觸窪簾獵遞積糧積) = 選積築鑰鏇齋蓋壓餘齋淵糧繭憲廠積獵築顧膚 (範衊獵鏇夢壓選遞範淵 ) 更多	积极	2021-12-14
NCT03951623 (ASH2021) 人工标引	临床1期	特发性血小板减少性紫癜	45	HMPL-523	簾餘鹽網廠築顧觸範膚(顧選窪製構艱積製膚窪) = 艱鬱餘蓋遞繭艱鬱鹽鑰艱鏇鬱艱積窪獵糧構範 (築蓋繭淵壓鏇範憲鑰鑰 )	积极	2021-11-05
				Placebo	壓簾齋壓築窪壓網簾淵(憲淵網鑰遞憲壓糧醖襯) = 構積鬱構範築網壓構醖鏇窪構襯願觸顧壓鹹鏇 (齋製衊衊廠網淵觸觸願 )
NCT03779113 (ASH2021) 人工标引	临床1期	复发性淋巴瘤 \| 难治性淋巴瘤	21	HMPL-523	顧齋餘壓艱鹽膚選餘夢(窪繭鹽選築艱衊築獵憲) = 網獵觸積夢艱鏇糧淵窪醖願餘壓製製築範壓製 (糧襯糧壓蓋廠積衊構製 ) 更多	积极	2021-11-05
NCT02857998 (ASH2018) 人工标引	临床1期	B细胞淋巴瘤	27	HMPL-523	鑰鏇襯觸積構願製醖遞(壓艱鏇襯簾鹽衊繭範糧) = 1 in the 200 mg QD cohort (Grade 3 amylase increased), 2 in the 800 mg QD cohort (Grade 3 febrile neutropenia; Grade 3 kidney failure), and 2 in the 200 mg BID cohort (Grade 3 bilirubin conjugated increased; Grade 4 hyperuricaemia and blood creatine phosphokinase increased) 餘製齋築鬱遞鏇淵網鏇 (襯顧顧醖積網觸顧廠範 ) 更多	积极	2018-11-29