有分析数据表明，EGFR突变在亚洲患者群体中更为普遍。据估计，亚洲非小细胞肺癌患者的EGFR突 变率为40%至50%，而欧美人群的这一比例仅为10%至15%。 两家公司去年称，依沃西在中国的一项头对头试验中的结果甚至与默沙东目前的PD-1销量冠军"帕博利 珠单抗"Keytruda（K药）表现相当。 中国本土创新药企的研发成果正在越来越多地吸引跨国制药巨头的关注。2024年大型跨国药企引进的创 新药候选分子大约有31%来自中国，而2019年这一数字还为零。 在芝加哥召开的美国临床肿瘤学会（ASCO）年会上，来自中国的创新药企集中亮相，超过70项研究入 选口头报告，其中双抗药和ADC药物研究进展备受关注。 康方生物与合作伙伴Summit Therapeutics在ASCO期间发布了PD-1/VEGF 双特异性抗体依沃西 （ivonescimab）的首个全球3期临床试验结果。数据显示，该药物可将既往接受过治疗的表皮生长因子 受体（EGFR）突变非鳞状非小细胞肺癌 (NSCLC) 患者的疾病进展或死亡风险降低48%。根据此前的一 项中国3期临床数据，该药物将患者的疾病进展或死亡风险降低了54%。 其他亮相ASCO的中 ...

乐普生物科技公告，自主研发的候选药物MRG003(一种表皮生长因子受体靶向创新型抗体药物偶联物 (ADC)候选药物，用于治疗复发性或转移性鼻咽癌(R/M NPC))的关键注册性临床研究结果于2025年美国 临床肿瘤学会(ASCO)年会上以"重磅研究摘要(LBA)"形式公布，并于会上作口头报告。截至2024年6月 30日，MRG003组的客观缓解率(ORR)为30.2%，化疗组为11.5%(95%CI:7.0%,30.5%,P=0.0025)。 MRG003组的无进展生存期(PFS)显著改善(HR=0.63,95%CI:0.43,0.91,P=0.0146)，中位PFS为5.8个月。截 至2024年12月30日的期中分析中，两组患者的中位生存期(OS)分别为17.1个月和12个月 (HR=0.73,95%CI:0.48,1.12)。 ...

映恩生物成立于2020年，用5年时间就走过其他创新药企10 年的发展历程，目前是ADC（抗体偶联药物）赛道上的明星创 新药企。不乏有人用"中国版的第一三共"来定义映恩生物，朱 忠远认为这个定义并不准确，虽然映恩生物选择的是ADC赛 道，但他想带领映恩生物走上国际舞台，成为全球药企。 作者：瞿依贤 封图：图虫创意 上市首日涨超110%、暗盘交易涨超80%、国际配售获13.52倍超额认购、港股18A生物科技板块 最大融资额……2025年4月中旬，映恩生物（09606.HK）在港股IPO，创下港股18A生物科技板 块多项纪录。 上市当天，医药行业不少创始人、高管、投资人都更新朋友圈表示祝贺——行业里无IPO久矣，更 别提不破发还大涨的IPO。 2021年年中，在诸多因素的影响下，国内创新药企在二级市场开始走下坡路，IPO也彻底进入冰 封期，募资金额大滑坡。2022年至今成功上市的21家18A企业，募资中位数只有3.73亿元，甚至 有多家企业低于2亿元，超过10亿元的只有1家。"低开高走"的认购后，4月15日，映恩生物登陆 港交所，募资2.1亿美元，成为难得一见的行业盛事。这次IPO共引入15名基石投资者，均为头部 ...

ATLANTA, May 30, 2025 (GLOBE NEWSWIRE) -- Gray Media announced today that the Radio Television Digital News Association (RTDNA) awarded a combined 81 regional Edward R. Murrow awards for excellence in journalism to 38 of Gray’s local stations, led by 9 separate awards to WMTV in Madison, Wisconsin and 8 to WVUE in New Orleans, Louisiana. Among the highest honors: Four awards for Overall Excellence — the highest honor bestowed — to KTUU in Anchorage, Alaska; WVLT in Knoxville, Tennessee; WPTA in Fort Wayne, ...

LNCB74 is in a Phase 1, open-label, first-in-human study that will include dose escalation, safety, and biomarker backfills and randomized dose expansion/optimizationThe study is currently enrolling in dose escalationPoster to be presented June 2, 2025, 1:30 pm-4:30 pm CT BELTSVILLE, Md., May 29, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, together ...

Summary of Akari Therapeutics Conference Call (May 29, 2025) Company Overview - **Company**: Akari Therapeutics (AKTX) - **Focus**: Development of antibody drug conjugates (ADCs) with novel immuno-oncology payloads aimed at improving cancer treatment outcomes [2][5] Key Points and Arguments Novel Approach to ADCs - Akari is innovating ADCs by using immuno-oncology payloads that differ from traditional cytotoxic agents, aiming to enhance efficacy and safety in cancer treatment [3][5] - The lead asset, AKTX-101, targets TROP-2, a marker on cancer cells, and is conjugated with a novel payload called pH-1 [9][10] Mechanism of Action - The pH-1 payload targets the spliceosome, leading to cancer cell death and priming the immune system to attack similar cancer cells [8][27] - This approach aims to create immunological memory, allowing the immune system to recognize and attack cancer cells upon re-exposure [34] Clinical Development and Safety - Preclinical data shows robust activity for AKTX-101 as a single agent and in combination with checkpoint inhibitors, with favorable safety profiles observed in nonhuman primate studies [10][12] - Akari is advancing its lead ADC into IND-enabling studies to prepare for Phase 1 trials [20] Market Potential and Competitive Landscape - The ADC market is experiencing significant interest, with major pharmaceutical companies investing heavily in this space, indicating a strong opportunity for Akari's differentiated approach [22][23] - Akari's unique payload distinguishes it from competitors, which primarily use microtubule inhibitors or topo-I inhibitors [24][27] Future Directions - Akari plans to explore additional targets for its pH-1 payload, including colon, lung, and prostate cancers, which represent significant unmet medical needs [12][20] - The company is open to partnerships for further development and commercialization of its ADC platform [21][36] Additional Important Content - The transition from an inflammation-focused portfolio to oncology was driven by the potential of the pH-1 platform and the strategic direction of the company [39] - Akari's leadership team includes experienced professionals from major pharmaceutical companies, enhancing its capability to execute its vision [14][15][18] Conclusion - Akari Therapeutics is positioned to leverage its innovative ADC platform to address significant challenges in cancer treatment, with a focus on enhancing patient outcomes through novel immuno-oncology strategies [36][37]

Core Viewpoint - The company has received conditional approval from the National Medical Products Administration for its innovative drug, SHR-A1811, which targets HER2 mutations in non-small cell lung cancer (NSCLC) patients, marking a significant advancement in treatment options for this rare mutation type [1][2]. Group 1: Product Approval and Significance - SHR-A1811 is the first antibody-drug conjugate (ADC) approved in China for HER2 mutation NSCLC patients, addressing a critical need as traditional treatments have limited efficacy [1][2]. - The approval is based on the HORIZON-Lung study, which reported a median follow-up of 14.2 months, with an objective response rate (ORR) of 74.5% and a median progression-free survival (mPFS) of 11.5 months [2]. Group 2: Market Context and Competitors - Existing similar products in the market include Kadcyla and Enhertu, with combined global sales projected to reach approximately $6.557 billion in 2024 [3]. - The company has invested around 1.17007 billion yuan in the development of SHR-A1811, indicating a strong commitment to research and development [3]. Group 3: Future Potential and Research - SHR-A1811 is being explored for its potential in first-line treatment for HER2 mutation NSCLC and other cancer types, with eight indications receiving breakthrough therapy designation from the National Medical Products Administration [2].

L3harris Technologies (LHX) FY 2025 Conference May 29, 2025 09:00 AM ET Speaker0 Okay. Good morning. I'm Doug Harned, Bernstein senior global aerospace and defense analyst, and really happy to have with us again Chris Kobacek, chairman and CEO of l three Harris. With us also is Ken Bettingfield, chief financial officer. I think to start, I think I think, Ken, you got a couple things you wanna say, and then we'll go into fireside chat. Speaker1 Yeah. Great. Thanks for having us, Doug. We're excited to be her ...

Summary of Whitehawk Therapeutics FY Conference Call Company Overview - **Company Name**: Whitehawk Therapeutics - **Background**: Whitehawk Therapeutics was formed from the previous company Adi Biosciences, which commercialized an mTOR inhibitor called Fiaro, generating approximately $25 million in annual sales in the US. The company underwent a transformation by selling Fiaro to a Japanese pharmaceutical company and raised about $250 million to license a portfolio of antibody-drug conjugates (ADCs) for oncology treatments [4][5][6]. Core Points and Arguments - **Focus on Oncology**: Whitehawk is focused on developing a portfolio of ADCs for various cancers, marking its first participation in the ASCO conference as a newly branded entity [4][6]. - **Strategic Partnerships**: The company partnered with WuXi Biologics and Hangzhou DAC to access innovative ADC platforms, paying $44 million upfront for three next-generation ADC assets [10][12]. - **Technology Differentiation**: The ADC platform is differentiated by its targeting approach, linker system, and payload delivery, which are optimized for stability and efficacy [15][16][20]. - **Clinical Development**: Whitehawk plans to bring its ADC portfolio into clinical trials over the next year, with IND filings for three ADCs (HAWK007, MUC16, and SCC6) planned in rapid succession [6][41][42]. Important Insights - **Market Opportunity**: There is significant unmet need in the oncology space, particularly for patients with EGFR wild-type lung cancer, where ADCs have not yet made substantial inroads [28][30]. - **Precedent Data**: The three ADC targets (PTK7, MUC16, and SCC6) have shown promising efficacy signals in previous programs, which were discontinued due to safety concerns with first-generation ADCs [39][40]. - **Potential for Best-in-Class**: Whitehawk believes its next-generation ADCs can outperform existing therapies, with the potential for improved overall response rates and progression-free survival [46][51]. - **Focus on Specific Indications**: The company aims to build on existing data by focusing on specific indications, such as lung and ovarian cancer, rather than a broad approach, to demonstrate efficacy [50][51]. Additional Noteworthy Content - **Clinical Experience**: Early data from Hangzhou DAC's internal programs indicate good tolerability and potency, which supports Whitehawk's investment in this platform [32][33]. - **Payload Variations**: The company is utilizing a proprietary topoisomerase inhibitor payload, which is believed to have a better safety profile compared to existing options [25][26]. - **Future Directions**: Whitehawk is considering expanding its focus to include endometrial cancer due to high expression levels of PTK7 and unmet medical needs in that area [52][53]. This summary encapsulates the key points discussed during the conference call, highlighting Whitehawk Therapeutics' strategic direction, technological innovations, and market opportunities in the oncology sector.

Sutro Biopharma (STRO) FY Conference Summary Company Overview - **Company**: Sutro Biopharma - **Event**: TD Cowen's Sixth Annual Oncology Innovation Summit - **Date**: May 28, 2025 Key Points Strategic Changes - Sutro Biopharma conducted a strategic review to enhance shareholder value, leading to a focus on advancing their second and third generation Antibody-Drug Conjugates (ADCs) pipeline [3][4] - The development of Lavelta has been deprioritized, but insights gained will inform future product design and clinical strategies [4][5] ADC Pipeline Differentiation - Sutro claims to have one of the most powerful ADC technologies, optimizing every component from antibody to linker to payload [8] - The next generation ADCs are designed to target complex biological targets, utilizing both single and dual payloads [8][9] - Dual payload ADCs are expected to overcome resistance seen in single payload ADCs, providing targeted chemotherapy and combination therapy [9][10] Safety and Efficacy - Sutro's platform allows for higher dosing compared to competitors, with a therapeutic index that can be optimized for safety [10][12] - The company has seen significant preclinical data indicating a two to threefold higher pharmacokinetics (PK) compared to competitors, which may translate into better patient outcomes [24][25] - The manufacturing process in cell-free extracts avoids glycosylation, reducing potential toxicity [17][20] STRO-four Development - STRO-four is a tissue factor ADC with a DAR-eight exotecan and proprietary beta glue linker, designed to minimize on-target liabilities [39][40] - Sutro aims to file an Investigational New Drug (IND) application in the second half of 2025, with first-in-human studies expected by year-end [47] - The ADC is anticipated to have 50-fold higher exposure compared to the approved competitor, Tisotumab vedotin, which could lead to improved patient benefits [49][50] Future Programs - STRO-six, another ADC program, targets integrin beta-six and is expected to have a significant commercial opportunity, particularly in lung cancer [53] - The platform's ability to avoid interstitial lung disease (ILD) is highlighted as a critical factor for success in lung cancer treatments [55] Additional Insights - Sutro's approach to selecting payloads and linkers is data-driven, focusing on combinations that enhance therapeutic index while minimizing safety risks [35][36] - The company is exploring the potential for three payload combinations to further enhance treatment efficacy against resistant tumors [34] Conclusion - Sutro Biopharma is positioning itself as a leader in the ADC space with innovative technologies and a focus on safety and efficacy, aiming to address unmet needs in oncology treatments. The upcoming IND filings and clinical trials are critical milestones for the company.