Pralsetinib

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。PART 01周报概述随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵医药数据统计，新药申请与审批获批频繁，显示出医药创新领域的活跃态势。本文将深入分析2025年7月7日至2025年7月13日期间，国内外新药申请、临床试验批准、仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。PART 02国内51款新药IND获批根据摩熵医药数据库统计，2025年7月7日至7月13日期间共有122个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号95个，进口药品受理号27个。本周共计51款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药20款，生物药29款，中药2款。本周获批临床创新药/改良型新药部分信息速览（不含补充申请）注：完整数据可识别“文末”二维码下载查看PART 03本周全球TOP10创新药研发进展在全球创新药研发领域，7月7日，星汉德生物（SCG）宣布，中国国家药品监督管理局药品审评中心（CDE）批准其乙肝病毒（HBV）特异性T细胞受体（TCR）工程化T细胞治疗——SCG101V新药1/2期临床试验（IND）申请，用于治疗慢性乙型肝炎。医学研究表明，健康成年人体内天然存在由T细胞受体（TCR）介导的特异性免疫应答，是清除HBV感染的关键机制。基于这个科学洞见，星汉德生物筛选出特异性靶向乙肝表面抗原的高亲力、高活性天然TCR，并通过T细胞工程改造重塑患者免疫系统。由此开发了其针对慢性乙肝的创新细胞治疗管线SCG101V。SCG101V由特异性TCR介导，选择性识别和靶向感染HBV的肝细胞，通过多重机制，清除cccDNA并消除病毒储存库和整合片段，并建立保护性免疫记忆。一旦病毒储存库被彻底消除，HBV就没有反弹的途径。临床数据显示，SCG101V展现出"一针治愈"的治疗潜力：通过单次给药，即可同时根除乙肝cccDNA和乙肝表面抗原，有望成为慢性乙型肝炎功能性治愈的治疗手段。截图来源：摩熵医药-全球药物研发数据库7月8日，中国国家药监局药品审评中心（CDE）官网公示，百济神州申报的注射用塔拉妥单抗拟纳入优先审评，拟定适应症为：用于既往接受过至少2线治疗（包括含铂化疗）失败的广泛期小细胞肺癌（ES-SCLC）成人患者的治疗。公开资料显示，塔拉妥单抗（tarlatamab）是一款DLL3/CD3双特异性T细胞衔接器（BiTE）。今年5月，百济神州宣布其与安进公司（Amgen）在中国联合开展的注射用塔拉妥单抗2期临床研究DeLLphi-307已取得积极结果。该研究旨在评估塔拉妥单抗用于治疗既往接受过至少二线治疗（包括含铂化疗）失败的广泛期小细胞肺癌中国患者的疗效、安全性以及耐受性，其主要研究终点为客观缓解率（ORR）。近年来，免疫治疗在SCLC领域获得突破，为患者带来了新的选择。塔拉妥单抗是一款由安进公司研发的创新靶向免疫疗法，能够同时结合肿瘤细胞上的DLL3蛋白和T细胞上的CD3蛋白，进而激活T细胞来杀伤表达DLL3蛋白的肿瘤细胞。本周全球TOP10创新药研发进展截图来源：摩熵咨询周报PART 04本周全球TOP10临床试验结果本周全球TOP10临床结果中，7月7日，天境生物公布了其双特异性抗体givastomig的1b期联合治疗试验的积极数据。Givastomig是一种靶向Claudin 18.2（CLDN18.2）阳性肿瘤细胞的双特异性抗体，在表达Claudin 18.2的肿瘤微环境中通过4-1BB信号通路有条件地激活T细胞。该药由天境生物牵头与ABL Bio公司共同开发，两方平等共享除大中华区和韩国以外的全球权益。目前，givastomig正被开发用于一线治疗转移性胃癌，并具有在其他实体瘤中进一步拓展的潜力。截至2025年5月15日的数据，17例Claudin 18.2阳性晚期转移性胃癌患者接受了不同剂量的givastomig联合nivolumab和mFOLFOX6作为一线治疗。数据显示，在所有剂量组中确认的ORR为71%（12/17），DCR达100%。在选定用于剂量扩展的两个剂量组（8 mg/kg和12 mg/kg）中，ORR为83%（10/12）。值得注意的是，即使在PD-L1或CLDN18.2表达水平较低的患者中也观察到了缓解。17名患者中有8名仍在接受治疗，截至数据截止日期，最长的治疗持续时间为13.3个月。安全性方面，联合疗法的耐受性良好，未出现3级或以上的恶心呕吐事件，仅有一例3级治疗相关不良事件（肝酶升高）。截图来源：摩熵医药-全球药物研发数据库7月9日，微芯生物发布公告，其自主研发的西达本胺针对一线治疗弥漫大B细胞淋巴瘤（DLBCL）关键性III期临床试验（DEB研究）已于近日获得最终结果的顶线分析数据，试验组无事件生存期（EFS）显著优于对照组，达成研究主要终点。西达本胺是微芯生物独家发现的全新机制新分子实体药物，是全球首个亚型选择性组蛋白去乙酰化酶（HDAC）抑制剂，属于表观遗传调控剂类药物。DEB研究是一项随机、双盲、安慰剂对照、多中心确证性III期临床试验，旨在评估西达本胺联合R-CHOP（抗CD20利妥昔单抗、环磷酰胺、阿霉素、长春新碱、强的松）对比R-CHOP在既往未经治疗的MYC/BCL2双表达DLBCL受试者中的有效性和安全性。近日，该试验已于研究方案规定的最后一例在组受试者随访到36个月时完成，并进行顶线分析。此次顶线分析进一步证实，西达本胺联合方案可为初治MYC和BCL2双表达DLBCL患者带来显著且可持续的无事件生存期获益，且安全性良好。本周全球TOP10积极/失败临床结果 截图来源：摩熵咨询周报PART 0539款品种过评，浙江易泽达和华海药业领跑根据摩熵医药数据库统计，2025年7月7日至7月13日期间共有138项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号125项（包括化药3类，4类，5.2类），新注册分类临床申请受理号4项（包括化药3类，4类），一致性评价申请9项。本周4个品种通过一致性评价（按受理号计4项），本周35个品种视同通过一致性评价（按受理号计40项）。本周有3项生物类似物注册申报动态，分别是石药集团的注射用奥马珠单抗、石药集团的仑卡奈单抗注射液以及齐鲁制药的QL-2106注射液。本周过评/视同过评品种主要为心血管系统药物，过评/视同过评产品剂型主要为注射剂。截图来源：摩熵咨询周报本周盐酸尼卡地平注射液等多个品种过评/视同过评受理号数量多达2个，同时盐酸尼卡地平注射液也是本周过评/视同过评企业最多的品种为2家。本周过评/视同过评企业共有37家，其中浙江易泽达医药科技有限公司、浙江华海药业股份有限公司和天津力生制药股份有限公司企业过评/视同过评品种数最多，达2种。截图来源：摩熵咨询周报本周有注射用水溶性维生素和普拉替尼胶囊2个品种为首次过评/视同过评。本周首次过评/视同过评品种截图来源：摩熵咨询周报本周有盐酸尼卡地平注射液、盐酸尼卡地平注射液2个品种的过评/视同过评达7家企业。本周过评/视同过评达7家企业品种截图来源：摩熵咨询周报摩熵咨询本期完整周报识别二维码领取下载END本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-2025052024年医药企业综合实力排行榜-202505中国带状疱疹疫苗行业分析报告-2025052023H2-2024H1中国药品分析报告-202504数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025032024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-202501小分子化药白皮书（上）-2025012024年中国医疗健康投融资全景洞察报告-2025012024年医保谈判及市场分析报告-202501近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

Female handshake. Flat design. Two business women in green and yellow clothes against the blue background of the metropolis shake hands iStock, Yevhenii Lavrentiev Some of the most high-pro in recent years have involved women-fronted biotechs. BioSpace reviews five of the most notable here. Over the past few years, biopharma has witnessed many big-ticket takeovers, with some of the industry’s largest players dumping serious money to snap up an emerging company and its promising pipeline or platform. These deals garner a lot of attention from analysts and the community at large—the transaction value, the assets at the heart of the agreement, the strategy behind the buyout—but typically very little fanfare is given to the people who made these acquisitions possible in the first place. But many of the biggest and most impactful takeovers in recent years had women at the forefront. The biggest deal of 2025 so far, for instance, involves a woman-led biopharma, as does one of the highest-pro in the field of obesity. Company leaders are often unsung heroes of these big transactions, working for years to build up a biotech to be an attractive acquisition target, and then spending a few hectic months hammering out a deal that appropriately values the company. Considering the decline of women in leadership positions across the industry, BioSpace is taking this chance to give women leaders their due, compiling five of the biggest biotech exits led, orchestrated and made possible by women. Sharon Mates Founder, Chairman, CEO, Intra-Cellular Therapies since 2002 Buyer: Johnson & Johnson Deal Value: $14.6 billion Intra-Cellular Therapies has the distinction of being the target of this year’s largest M&A deal so far—a $14.6 billion buyout by healthcare powerhouse Johnson & Johnson. Taking the biotech to that moment is Sharon Mates, who founded the New Jersey–based company in 2002 and serves as its CEO and board chairwoman. Under Mates’ leadership, Intra-Cellular hit several big milestones over the course of its lifespan, not least of which was securing an FDA approval for the atypical antipsychotic drug Caplyta in December 2019 for schizophrenia, and then again in December 2021 for bipolar depression. During the biotech’s third-quarter 2024 earnings call, after years of demurring when asked by analysts to provide a sales forecast for Caplyta, Mates finally gave in, projecting that the drug would grow to be a $5 billion opportunity for the company over the next 10 years. “We kept getting asked,” Mates told BioPharma Dive in November 2024. “So we said, ‘Okay, why not tell you? Here it is.’” In 2024, Caplyta surged 47% year-on-year to bring in $680.5 million. Aside from Caplyta, Mates also oversaw Intra-Cellular’s initial public offering in March 2015, raising $130 million . The company has since grown considerably. In late 2024, before news of the J&J acquisition had broken, Intra-Cellular had a market cap of nearly $7 billion . This value has since doubled, with the company worth more than $14 billion as of July 2025. Kate Haviland President, CEO, Blueprint Medicines since 2022 Buyer: Sanofi Deal Value: $9.5 billion Since being appointed as Blueprint Medicines’ chief executive in January 2022 , Kate Haviland has helped the kinase inhibitor Ayvakit—the biotech’s only current approved product—move closer toward realizing its true potential. Ayvakit was first approved in January 2020 for gastrointestinal stromal tumors with certain mutations, and then again in June 2021 for systemic mastocytosis. Under Haviland’s leadership, Blueprint successfully expanded Ayvakit’s label again in May 2023, making the drug the first-ever approved therapy for indolent systemic mastocytosis. Ayvakit sales under Haviland jumped from $110.9 million in 2022 to $204.2 million in 2023 , representing more than 80% year-on-year growth. Last year, Ayvakit revenues more than doubled to $478.9 million . The biggest Ayvakit milestone, however, came in June this year, when Sanofi dropped $9.5 billion to acquire Blueprint—a deal centered on the asset and its potential for substantial long-term growth, Brian Foard, Sanofi’s head of specialty care, said in an analyst call at the time. Ayvakit’s story is “just getting started,” he said. As Blueprint CEO, Haviland also showed that she can pick a biotech up after a fall. In February 2023, Blueprint lost a powerhouse partner after Roche terminated a July 2020 agreement over the lung cancer drug Gavreto. Just a year later, however, Haviland helped find a new home for Gavreto, this time with Rigel Pharmaceuticals, which pledged nearly $120 million for the deal , plus tiered royalties. Before taking Blueprint’s helm, Haviland played a critical role in keeping the biotech going. From January 2019 to April 2022, she served as chief operating officer, and before that, as chief business officer from January 2016 to January 2019. In both of these roles, Haviland had a heavy hand in forming and executing the biotech’s business and capital strategy. Heather Turner President, CEO, Carmot Therapeutics since 2023 Buyer: Roche Deal Value: $2.7 billion Heather Turner’s tenure as the head of Carmot Therapeutics might have been short—running from January 2023 to June 2024, according to her LinkedIn page —but it was arguably the most impactful period in the biotech’s life. Under Turner’s leadership, Carmot’s pipeline of potentially best-in-class obesity assets grabbed the attention of Roche, which in December 2023 dropped $2.7 billion upfront , along with the promise of $400 million in milestone payments, to acquire the biotech. The deal, which closed in January 2024 , has proven very fruitful for Roche, with Carmot’s early-stage GLP-1/GIP receptor dual agonist significantly lowering body weight versus placebo in a May 2024 Phase Ib readout. A few months later, in July of that year, Carmot’s pipeline again delivered for Roche, with an oral GLP-1 analog eliciting a 6.1% placebo-adjusted reduction in body weight. Before taking Carmot’s top executive seat, Turner briefly served as the biotech’s chief operations officer from September 2022 to January 2023, another short but impactful stint. In early January 2023, alongside Turner’s promotion to CEO, Carmot announced that it was spinning off a new company based on its proprietary discovery platform for oncology and immune indications. Turner’s post-Carmot trajectory has likewise been impressive. In November 2024, she was appointed into the board of directors of Terns Pharmaceuticals, leveraging her experience with Carmot to help the California biotech advance novel therapies for obesity and other metabolic conditions, alongside cancer. Turner is also now serving as CEO of LB Pharmaceuticals , a New York company looking to distinguish itself in the schizophrenia space. Laura Shawver President, CEO, Capstan Therapeutics since 2022 Buyer: AbbVie Deal Value: $2.1 billion Laura Shawver has been Capstan Therapeutics’ leader since the company launched in September 2022 . Under her wing the California biotech has gone from a scrappy cell therapy startup to a subsidiary of one of the industry’s biggest players. To kick start Capstan, Shawver had $165 million in series A capital, as well as the backing of several Big Pharma players, including Pfizer, Bayer, Novartis, Eli Lilly and Bristol Myers Squibb. She made the most out of what she was given, building out the biotech’s proprietary in vivo cell engineering platform designed to deliver mRNA or gene editing payloads to address B cell–mediated and plasma cell diseases, among other conditions. In March 2024, Shawver once again hooked Capstan’s high-pro raising $175 million in an oversubscribed series B round. Months later, in November that same year, Capstan delivered promising preclinical data for its lead CAR T candidate CPTX2309, which was able to demonstrate in vivo engineering of CD8-positive cells and elicit B cell depletion in animal models. These achievements culminated in June this year, when AbbVie doled out $2.1 billion in cash to acquire Capstan, a deal that hinged on CPTX2309 and the biotech’s engine. Strategic exits are nothing new for Shawver. She was previously CEO of Snythorx, which in December 2019 was acquired by Sanofi for approximately $2.5 billion . A few years later, in mid-2022 when she was CEO of Silverback Therapeutics, Shawver helped negotiate a reverse merger with ARS Pharmaceuticals as Silverback was reeling from two discontinued assets . Ivana Magovcevic-Liebisch President and CEO, Vigil Neuroscience since 2020 Buyer: Sanofi Deal Value: $470 million Vigil Neuroscience debuted with $50 million in December 2020 with industry veteran Ivana Magovcevic-Liebisch in the top spot, bringing more than two decades’ worth of biopharma leadership experience. In the years since, Magovcevic-Liebisch expanded Vigil’s coffers, raising $90 million through a series B round in August 2021, followed by a $75 million haul in August 2022 through a private placement with existing and new investors. In June 2024, Vigil received another $40 million in strategic investments from Sanofi. Magovcevic-Liebisch and her team used this money to build out the biotech’s pipeline of novel neuro assets that work by activating a brain protein called TREM2 , in turn opening up a novel pathway of addressing nervous system damage. This effort paid off, with an early-stage readout in January 2025 showing that its small-molecule drug candidate VG-3927 demonstrated an encouraging safety profile while also showing strong reductions in soluble TREM2 levels. Vigil has decided to move the asset into mid-stage trials. Vigil stands out in the neuro space as being one of few players that have seen success with TREM2. Since AbbVie and Alector’s AL002 failed a mid-stage study in November 2024, the target has fallen out of favor of investors and analysts. “The failure of ABBV/ALEC’s AL002 in Alzheimer’s disease significantly diminished enthusiasm” for TREM2, Stifel wrote in a May 21 note. Despite this dark cloud over TREM2, Magovcevic-Liebisch was able to leverage VG-3927’s potential to arrive at a $470 million acquisition agreement with Sanofi . The deal, which put a 250% premium on Vigil’s share price, paid particular focus to the small-molecule asset. Sanofi promised a contingent value right conditional on VG-3927’s first sale. If all goes well, the takeover value could reach $600 million.