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收回海外权益 宜明昂科战略纠偏打开新空间
Zhi Tong Cai Jing· 2026-01-07 00:36
综合来看,此次权益回收让宜明昂科重新掌握重要资产(IMM2510、IMM27M与)主导权,叠加IMM01、 IMM0306管线在肿瘤和自免领域的差异化布局,公司后续临床进展和BD合作值得期待。 此外,本次同时收回的还有IMM27M(CLTA-4 ADCC+)的海外权益。因为安全性原因,CTLA-4在相当一 段时间内并未受到太多关注,但2025年的诺贝尔生理学或医学奖将CTLA-4靶点重新带回公众视野。近 期BioNTech/OncoC4公布的Gotistobart(新一代CTLA-4抗体)数据较对照组也显示出显著的阳性结果,且 OS曲线有非常典型的拖尾效应。宜明昂科同时拥有VEGF/PD-L1和CTLA-4,未来在联用方面潜力巨 大。而CLTA-4作为单抗进行联用,在剂量和给药频次方面将拥有更多灵活性,从而降低其安全风险。 宜明昂科另一核心看点是CD47系列管线。其中,基石产品IMM01(sirpα-Fc融合蛋白)针对慢性粒单核细 胞白血病(CMML)的III期临床积极推进中,预计今年之内进行III期中期分析,基于前期积累的大量积极 疗效和安全性数据,有望填补CD47领域的空白。此外,基于IMM01开发的髓细 ...
Oruka Therapeutics (NASDAQ:ORKA) Stock Price Up 4.3% – Time to Buy?
Defense World· 2026-01-02 08:38
Core Insights - Oruka Therapeutics has received mixed ratings from analysts, with Guggenheim initiating coverage with a "buy" rating and a target price of $60.00, while HC Wainwright lowered their target from $45.00 to $40.00, maintaining a "buy" rating [1] - The average target price for Oruka Therapeutics is $48.88, with one analyst rating it as a Strong Buy, seven as Buy, and one as Sell [1] - The company's stock has shown a recent increase of 4.1%, with a market cap of $1.47 billion and a P/E ratio of -15.95 [2] Financial Performance - Oruka Therapeutics reported earnings per share of ($0.55) for the last quarter, slightly beating analysts' expectations of ($0.56) [3] - Analysts project an earnings per share of -$3.41 for the current fiscal year [3] Insider Activity - Insider Joana Goncalves sold 7,000 shares at an average price of $30.61, totaling $214,270, which represents an 82.18% decrease in her ownership [4] Institutional Holdings - Institutional investors have increased their stakes in Oruka Therapeutics, with Woodline Partners LP boosting its stake by 46.9% and Fairmount Funds Management LLC increasing its holdings by 9.9% [5] - Institutional investors and hedge funds collectively own 56.44% of the company's stock [5] Company Overview - Oruka Therapeutics is a clinical-stage biopharmaceutical company focused on developing peptide-based therapies for oncology, utilizing a proprietary stapled peptide platform [7] - The lead candidate, ONCT-01, is currently in Phase 1 clinical trials for advanced solid tumors, assessing safety and preliminary efficacy [7]
康辰药业:KC1086 项目获得 FDA 批准开展临床试验
Ge Long Hui· 2025-12-24 09:37
KAT6 属于 MYST 家族组蛋白乙酰化酶,在调节转录、发育、造血细胞分化、细胞周期进程和有丝分裂 方面发挥关键作用。研究发现,KAT6 在乳腺癌、卵巢癌、宫颈癌、肺腺癌、结肠和直肠腺癌和髓母细 胞瘤等多种肿瘤类型中异常高表达,对肿瘤的发生、发展和不良预后密切相关。抑制KAT6 可以有效抑 制肿瘤细胞或者肿瘤的生长,对于逆转肿瘤耐药和肿瘤治疗等方面具有潜在的临床应用价值。 KC1086 在多种小鼠移植瘤 CDX/PDX 模型中展现出优异的体内药效:在ER+/HER2-的乳腺癌药效模型 中, KC1086 的抑瘤率可超过90%,在其他实体瘤药效模型中显示出类似的效果。 KC1086 项目 2025 年 6 月底获得国家药品监督管理局临床试验默示许可,开展针对晚期实体肿瘤患者 的首次人体临床研究;2025 年8 月,完成首例受试者入组。目前,临床试验正在有序推进中。 格隆汇12月24日丨康辰药业(603590.SH)公布,近日,公司获得美国食品药品监督管理局(FDA)签发的 《临床研究继续进行通知书》(Study May Proceed),公司申报的 KC1086 片临床试验申请正式获得 FDA 许可。 KC1 ...
阳光诺和签署STC008注射液《技术开发合同》
Zhi Tong Cai Jing· 2025-12-24 09:20
STC008为公司自主立项研发的项目,主要用于治疗晚期实体瘤患者的肿瘤恶液质,目前该项目处于I期 临床试验阶段。此次合同的签订预计将对未来业绩产生积极影响,有利于提升公司的盈利能力。 阳光诺和(688621.SH)发布公告,公司与浙江星浩控股合伙企业(有限合伙)(简称"星浩控股")于近期就共 同开发STC008注射液项目事宜达成合作协议并签署相应的《技术开发合同》。根据《技术开发合同》 约定,公司将获得人民币5,000万元首付款及后续里程碑付款,累计总金额为5亿元(含税),以及销售净 额(不含税)8%的销售分成。 ...
493亿!中国市场创新药“销冠”诞生
Xin Lang Cai Jing· 2025-12-22 04:16
药智数据显示,在2016年至2025上半年,国内公立医疗机构创新药销售额排名中(本文所讨论的药物范畴均限定为创新药;即便相关药物专利已过期且已 有仿制药上市,销售额统计仍仅针对其原研创新药),辉瑞(晖致)的阿托伐他汀钙片累计销售额高达492.7亿元,稳居近十年中国创新药市场之首,成 为名副其实的"销量冠军"。 01 "王者逻辑" 图片来源:药智数据 从年度销售走势来看,2016年至2019年是其黄金成长期,销售额从56.12亿元稳步攀升至68.54亿元,2018年更是创下74.05亿元的年度峰值,成为TOP10榜 单中唯一单年销售额突破70亿元的产品,尽显"王者"姿态。2020年,受国家带量采购政策影响,其销售额回落至38.47亿元。但凭借强大的临床刚需支 撑,此后几年(2021-2024年)销售额稳定在43亿—44亿元区间。2025年上半年已实现23.75亿元的销售额,药智数据预测其全年销售额有望突破41亿元, 这也印证了这款产品在政策调整后的市场韧性。 阿托伐他汀钙片(辉瑞)国内公立医疗机构年度销售额 图片来源:药智数据 一款药品能够登上"十年销冠"宝座,绝非偶然,是临床需求、产品优势以及特定的市场环境共 ...
科伦博泰生物-B涨超4% ITGB6等两款候选药于明年一季度开展I/II期单药治疗临床试验
Zhi Tong Cai Jing· 2025-12-11 02:26
天风证券(601162)指出,科伦博泰生物与Crescent合作内容包括分别推进两款候选药物的单药治疗开 发,并共同评估CR-001与SKB105的联用疗法。双方均有权独立开发CR-001的其他联用方案。CR-001是 一款四价双特异性抗体,在临床前研究中显示强大的抗肿瘤活性。 科伦博泰生物-B(06990)涨超4%,截至发稿,涨3.69%,报427.4港元,成交额1831.69万港元。 消息面上,近日,科伦博泰生物和Crescent达成合作,共同开发及商业化新型肿瘤治疗手段(含新型联用 疗法),合作涉及科伦博泰生物的一款靶向整合素β6(ITGB6)并以拓扑异构酶抑制剂为载荷ADC药物 SKB105(CR-003),以及Crescent的一款PD-1xVEGF双特异性抗体CR-001(SKB118)。这两款候选药物正 在开发用于治疗实体瘤,预计于2026年第一季度开展I/II期单药治疗临床试验。 对价方面,科伦博泰生物将从Crescent获得8,000万美元首付款,并有资格获得最高累计12.5亿美元的里 程碑付款,以及基于SKB105净销售额按中个位数至低双位数比例浮动的分级特许权使用费。如Crescent ...
港股异动 | 加科思-B(01167)再涨超11% 近期收到海松资本1.25亿元首付款 公司此...
Xin Lang Cai Jing· 2025-12-10 06:29
来源:智通财经网 消息面上,加科思近日宣布就其订立的增资协议及股权转让协议,已收到海松资本支付的1.25亿元的首 付款。该首付款的到账,进一步充盈了本集团的现金储备,也将为本集团后续创新肿瘤疗法管线研发的 推进提供助力。 据悉,加科思10月份公布,与海松资本及一名产业合作方签署增资及股权转让协议。根据本次协议,海 松资本将以人民币1.25亿元首付款及7500万元里程碑付款收购北京加科思旗下加科瑞康80%的股权。完 成后,北京加科思于加科瑞康持股将降至10%。公告称,该交易符合集团聚焦不同关键细胞通路的肿瘤 方向关键管线产品的战略发展。 加科思-B(01167)再涨超11%,截至发稿,涨10.28%,报8.69港元,成交额7382.33万港元。 ...
恒瑞11款肿瘤药物纳入2025年新版国家医保目录
Huan Qiu Wang· 2025-12-07 12:51
Core Insights - The National Medical Insurance Drug List for 2025 includes 11 anti-tumor products from Heng Rui Medicine, with 5 innovative drugs newly added to the national insurance directory, enhancing accessibility for patients [1] - Heng Rui's oncology division has developed a differentiated product matrix covering various high-incidence tumors, including immunotherapy and targeted therapy [1][5] Group 1: New Drug Inclusion - Five innovative drugs newly included in the insurance directory are: - Injection of Rukang Trastuzumab (Aivida®) - Injection of Phronolapitan Palonosetron (Ruitanning®) - Malic Acid Famitinib Capsules (Aibite®) - Acetate Abiraterone Tablets (II) (Airiji®) - Liposomal Irinotecan Injection (II) (Yueyouli®) [1][2] - These drugs address long-standing treatment gaps in various cancers, providing improved accessibility and efficacy for patients [1][2] Group 2: Expanded Indications - Three existing drugs in the insurance directory have expanded indications: - Fluorouracil Capsules (Airiyi®) now includes treatment options for breast cancer patients with specific genetic markers - Apatinib Tablets (Aitan®) have new indications for combination therapy - Injection of Carrelizumab (Airika®) is now indicated for recurrent/metastatic cervical cancer [3][4] Group 3: Long-term Drug Continuity - Three key products have successfully renewed their insurance coverage, ensuring continuous access for patients: - Pyrotinib Tablets (Airini®) for HER2-positive breast cancer - Hecoriparib Ethanolamine Tablets (Hengqu®) for immune thrombocytopenia and severe aplastic anemia - Sulfapeginterferon Injection (Aido®) for reducing infection risk in chemotherapy patients [4][5] Group 4: Overall Coverage - Out of 16 innovative drugs launched by Heng Rui, 14 have been included in the national insurance directory, achieving near-complete coverage of innovative results [5] - The company aims to continue focusing on patient needs while expanding its technological platforms and diverse pipeline to meet unmet clinical demands [5]
港股异动 科伦博泰生物-B(06990)涨近3% 与Crescent建立战略合作伙伴关系 共同研发肿瘤治疗手段
Jin Rong Jie· 2025-12-05 05:08
智通财经获悉,科伦博泰生物-B(06990)涨近3%,截至发稿,涨2.54%,报460.4港元,成交6743.33万港 元。 本文源自:智通财经网 此次合作涉及公司一款靶向整合素β6(ITGB6)并以拓扑异构酶抑制剂为载荷的抗体偶联药物 (ADC)SKB105,以及Crescent一款程序性细胞死亡-1(PD-1)x血管内皮生长因子(VEGF)双特异性抗体(双 抗)CR-001。这两款候选药物均正在开发用于治疗实体瘤,预计于2026年第一季度开展1/2期单药治疗临 床试验。 基于此次合作,公司将向Crescent收取8000万美元的首付款,并有资格收取高达12.5亿美元的里程碑付 款,以及基于SKB105净销售额的中个位数至低双位数百分比的分级特许权使用费。 消息面上,12月4日,科伦博泰生物-B发布公告,公司与Crescent Biopharma,Inc.及其全资子公司Crescent Biopharma Operating Company,LLC(连同CrescentBiopharma,Inc.合称"Crescent"或"CrescentBiopharma")已 建立战略合作伙伴关系,共同开发和商业化肿瘤 ...
创胜集团-B:创胜医药于ESMO Asia公布osemitamab三联疗法一线治疗胃或胃食管结合部腺癌的I/II期(Transtar102)更新疗效数据
Zhi Tong Cai Jing· 2025-12-04 23:10
Core Insights - The company announced promising clinical results for osemitamab in combination with nivolumab and CAPOX as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma, presented at the ESMO Asia Congress 2025 [1][2] Group 1: Clinical Trial Results - The updated efficacy analysis from the TranStar102 trial showed a median progression-free survival (mPFS) of 16.6 months and an objective response rate (ORR) of 68% among 26 patients with CLDN18.2 expression ≥40% and PD-L1 CPS known [1] - The median duration of response (mDoR) was reported at 18 months, indicating significant clinical benefits from the treatment [1] - Higher CLDN18.2 expression patients demonstrated better PFS regardless of PD-L1 expression levels, suggesting consistent potential therapeutic benefits [1] Group 2: Safety and Clinical Benefit - The safety profile of osemitamab was consistent with previously reported data from the ASCO 2025 conference, indicating good safety and tolerability [2] - The principal investigator highlighted the consistent clinical benefits across different PD-L1 subgroups, suggesting the treatment could provide significant improvements for advanced gastric or gastroesophageal junction adenocarcinoma patients [2] - The global clinical development executive vice president of the company expressed optimism about the strong clinical benefit signals and the potential of osemitamab to offer substantial benefits to patients in need of more effective treatment options [2]