Belrestotug

来源：制药网 近日，海创药业宣布：拟暂停募投项目"创新药研发项目"HP501子项目后续的研发推进。HP501是海创药业自主研发的小分子化学创新药，为尿酸盐阴离子转运体1(UrateAnionTransporter1，URAT1)抑制剂。截至今年6月30日，该项目已投入募集资金8111.25万元。 对于按下“暂停键”的原因，海创药业解释称，国内已有药企针对URAT1靶点的产品获批上市，并有多项围绕该靶点的Ⅲ期临床研究正在进行。故公司预计，未来URAT1靶点的竞争将较为激烈。公司评估后决定不再将资金投入至HP501项目中。 实际上，近期以来，药企研发管线叫停的消息屡见不鲜。除了国内药企以外，一些国际大型药企如阿斯利康、GSK、默沙东等也在积极做“减法”。 例如阿斯利康7月29日在上半年财报中披露，将终止AZD5851(GPC3CAR-T)、AZD6422(CLDN18.2CAR-T)和NT-125(TCR-T)的I期临床开发，以及zibotentan+dapagliflozin用于肝硬化、Ultomiris(瑞利珠单抗)用于狼疮性肾炎的II期临床开发。此次终止原因是细胞治疗领域存在研发周期长、制造流程繁琐、成本难控、标准化水平低等问题，公司经权衡后决定重新分配资源，集中投入更具可行性与回报潜力的细胞治疗项目。肝硬化适应症终止可能与临床数据未达预期或战略调整有关，公司更聚焦肿瘤和心血管领域的核心管线。 GSK 7月30日发布2025年H1财报，终止项目中包含两项III期临床，具体包括： TIGIT单抗belrestotug用于非小细胞肺癌和ibrexafungerp用于侵入性念珠菌感染的III期临床。今年5月13日，由于GALAXIESLung-201研究未达成主要终点，GSK决定终止belrestotug开发项目并终止与iTeos的合作。此前，葛兰素史克(GSK)向iTeos公司支付6.25亿美元预付款，获得belrestotug的权益。在该药物|期临床试验失败后，这家生物技术公司原本计划逐步停止运营，但最终于本月早些时候接受了ConcentraBiosciences的收购要约。同时，葛兰素史克(GSK)已终止代号为GSK3437949的佐剂重组蛋白疟疾疫苗II期研发项目。这一决定是基于制药部门近期宣布将重点转向第二代多阶段疟疾疫苗的战略调整。此外，抗生素sanfetrinem的口服前药sanfetrinemcilexetil也已从公司1I期研发管线中移除。 罗氏7月24日发布2025年上半年业绩报告，同步更新了研发管线进展。报告显示，2025年上半年，罗氏共削减7个临床项目，其中备受关注的TIGIT单抗RG6058(tiragolumab)仅剩的两项III期临床均被终止。自2022年起，该产品III期研究就不顺利：2024年，其在转移性非鳞状非小细胞肺癌II/III期研究中，无法与对照组拉开疗效差距；同年，该产品联合PD-L1抗体治疗局部复发性或转移性非小细胞肺癌的III期临床也未达到总生存期(OS)主要终点。2025年，其联合Tecentriq用于一线治疗不可切除的III期非小细胞肺癌，以及联合Tecentriq和Avastin用于一线治疗肝细胞癌的两项III期临床，均未达到无进展生存期(PFS)主要终点。 诺华7月17日公布第二季度财报，宣布停止Ianalumab在化脓性汗腺炎(一种导致皮肤摩擦区域形成疼痛肿块的疾病)适应症上的开发，因Ianalumab未能达到诺华预设的疗效阈值，。 默沙东也在近日公布2025第二季业绩，同时提到多个II期和III期临床管线被终止，其中包括MK-1308(CTLA-4单抗)针对非小细胞肺癌的II期研究、MK-1022(HER3-ADC)针对非小细胞肺癌的III期研究，以及MK-7902(仑伐替尼)针对食管癌的III期研究。 此外，赛诺菲、强生等也有在近期宣布终止一些在研项目，原因包括药物上市前景黯淡、疗效不足等。 业内认为，药企研发管线的叫停潮，揭示了新药研发领域的高风险与不确定性。这既是市场竞争激烈化、研发回报预期改变的结果，也反映出药企对研发资源的重新审视与合理配置。在这场研发管线的“断舍离”中，药企需要更加审慎地选择研发方向，聚焦真正具有临床价值与市场潜力的项目。只有这样，才能在激烈的市场竞争中，提高研发成功率，为患者带来更多有效的创新药物，实现可持续发展。 免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。 8月27-29日 敬请期待 第十届「MMC医学市场年会」 点击 阅读原文 了解更多

iStock, zhuweiyi49 After a slow 2024, the biotech shell company Concentra Biosciences is back, offering to buy four biotechs in the past month and seven so far this year. The busiest buyer in biotech right now happens to be the most mysterious. Concentra Biosciences, the biotech buyout specter run by Tang Capital, has ramped up its dealmaking after taking things slow over 2024. The shell company, which is run by mysterious investor Kevin Tang, has made bids to buy four biotechs over the past month and seven so far this year. Not all have been successful, with company boards popping the classic poison pill defense to ward off the unwanted advances. Acelyrin and Pliant fought off offers from Concentra in March. Kronos Bio accepted a similar offer in May worth about $34.8 million. This month, Cargo Therapeutics accepted a $200 million buyout, as did iTeos . Concentra does not hold on to these companies long. The intention is to close them, sell off the assets, return some cash to shareholders and reap whatever cash is left over. It’s a unique strategy in the biotech world but one that has plenty of fodder as the markets continue to batter the industry . The action this year mirrors Concentra’s bustling 2023, when six offers were made. Just two were ultimately successful, however. The company earned a reputation that year as a biotech dark horse—swooping in with an offer for a struggling company as the walls closed in, with a plan of shutting it down and reaping the benefits. Concentra’s pace is breakneck, with so many deals coming it’s hard to keep up with what has been successful and what ultimately failed. Kevin Tang did not return a request for comment as of publication, but recent regulatory documents filed from the slew of offers provide a window into the process. In the case of Elevation Oncology , the documents show that Tang took over and removed the executive committee and officers as the deal closed. At iTeos, the deal notes reveal Tang and his company dropping into executives’ DMs to discuss a possible offer after a disappointing clinical trial. A Failure and a Phone Call On May 13, iTeos announced Phase II results from a study testing belrestotug and GSK’s Jemperli in patients with high PD-L1 non-small cell lung cancer. The combo showed clinically meaningful improvements in objective response, which was the main goal, but did not meet the secondary of improving progression-free survival. Therefore, the companies decided to discontinue development of belrestotug altogether. Tang and his company saw the release, and days later, on May 15, disclosed in a Schedule 13G filing (which indicates a passive investment interest) its ownership of nearly 10% of iTeos’ shares. The Tang Capital team reached out to the biotech the next day to discuss the trial results—an unusual step as it’s typically positive results that garner investor interest. A few weeks later, on June 2, an advisor for iTeos contacted Tang Capital to see if the firm might be interested in a potential transaction. Tang’s crew asked for more information, specifically clinical and financial details, to guide the decision. The two parties entered into a confidentiality agreement a few days later. On June 11, the parties met in Boston, with iTeos’ management presenting an overview of the biotech. It took a day for Tang Capital to come up with an offer. Tang and his company offered to buy 100% of iTeos’ equity for $10.25 per share in cash, which represented the projected difference between iTeos’ net cash balance at closing after the discharge of liabilities and the aggregate cash payment that shareholders would receive, namely 3% of $490 million. Shareholders would also be eligible for two contingent value rights (CVRs) if all went well, hinging on cash available at closing and sales of the biotech’s legacy products. The first CVR would give shareholders all of the cash at closing that exceeded $490 million. The second granted them payouts should the iTeos team develop a new company for the legacy assets with a capital raise of at least $20 million. Later that same day, Tang filed a Schedule 13D with the SEC, suggesting an activist position in the company. Over the next few weeks, Tang Capital conducted due diligence. Tang Capital’s proposal was revised on June 26, edging the per-share price up to $10.36. Representatives for iTeos indicated a readiness to proceed with negotiating the transaction. The biotech’s executives suggested that the NewCo CVR be scrapped in favor of a structure that provided shareholders with 80% of the proceeds from the licensing, sale or other disposition of the assets instead. The company believed this simpler structure would provide greater certainty on the execution and timing of the transaction. After Tang Capital’s due diligence, the proposal was revised downward to $10.05 per share payable at closing. Tang’s group agreed to the new CVR proposal. Other negotiations included extending the legacy products CVR term to 10 years after the merger to allow greater certainty that shareholders would receive a payout. The deal was sealed on July 18, with iTeos issuing a press release announcing the transaction. Concentra offered a swift resolution after the clinical data just didn’t pan out for iTeos. Unfortunately, as the industry continues to reel, there could be plenty more companies ripe for similar transactions, meaning Concentra is providing a service uniquely suited to this moment in time for the industry.