Kuva Labs, Inc.

全球医疗行业每日重点资讯 文 | 苏丁 企业动态 科塞尔医疗科技(苏州)有限公司与美敦力（上海）管理有限公司战略合作签约仪式举行。双方正式建立深度战略伙伴关系，围绕科塞尔子公司米新医疗科技（苏州）有限公司核心产品Seledora冠状动脉棘突球囊扩张导管开启深度协同。对科塞尔而言，借助美敦力的完善体系，可快速提升Seledora棘突球囊的可及度，加速本土医疗成果的商业化落地与临床转化；对美敦力而言，整合不同优势，以期更快响应中国临床的变化、更好的完善整体解决方案。 箕星药业有限公司宣布已成功完成D1轮融资，募集资金高达2.87亿美元。本轮融资资金将主要用于推进其在研管线CX11的开发。CX11是一款具有独特优势的口服小分子GLP-1 RA，目前由箕星在美国开展一项其治疗肥胖及超重患者的2期临床试验，并由合作方闻泰医药在中国开展一项3期临床试验。此外，募集资金还将用于推进其它心血管代谢项目，包括针对急性缺血性脑卒中和高血压的管线开发 复星医药拟分拆所属子公司复星安特金至香港联交所主板上市。本次分拆完成后，复星医药的股权结构不会因此发生重大变化，且预计仍将维持对复星安特金的控制权。通过本次分拆，复星安特金将作为复星医药下属疫苗业务平台实现独立上市，借助香港资本市场拓宽融资渠道、增强资金实力，并完善激励机制，有利于其持续强化在疫苗领域的综合竞争力、品牌知名度和市场影响力。 科兴宣布，已正式获得纳斯达克听证委员会批准，将继续维持在纳斯达克全球市场的上市地位。根据听证委员会的决定，科兴控股需在2026年5月11日或之前完成截至2024年12月31日的年度财务报告及截至2025年第二季度的中期财务报告的报送工作。目前，公司已聘请众华会计师事务所作为外部注册会计师事务所独立开展审计工作，双方正协同推进相关审计与申报流程。 上海市药品监督管理局公布1月19日最新中药材GAP基地延伸检查结果，上海和黄药业有限公司与上海金蟾药业科技有限公司共同建设的蟾酥生产基地正式通过延伸检查，成为上海首个动物药材GAP基地。 被称为“医生版ChatGPT”的初创公司OpenEvidence完成新一轮融资，估值达到120亿美元。公司宣布，由Thrive Capital和DST领投的2.5亿美元融资已关闭。不到一年时间，OpenEvidence从包括谷歌风投、英伟达、Kleiner Perkins、David Sacks的Craft Ventures和Mayo Clinic等投资者那里筹集了7亿美元。 OpenAI启动与盖茨基金会合作的试点项目“Horizon 1000”计划，旨在支持非洲国家（首站卢旺达）的医疗领军者推进人工智能在健康领域的应用。盖茨基金会与OpenAI将共同投入5000万美元资金、技术及专业支持，力争在2028年前覆盖1000家基层医疗机构及其周边社区。 癌症成像公司Kuva Labs通过收购实体肿瘤生物技术公司Lisata Therapeutics，扩大其业务范围。Kuva的最大收获是certepetide，Lisata的环肽药物，该公司一直在多种二期临床研究中评估该药物，用于胰导管腺癌、胆管癌和阑尾癌。 雅培(Abbott)公布2025年第四季度和全年业绩。第四季度净销售额114.59亿美元，上年同期109.74亿美元。季度净利润17.76亿美元，上年同期92.29亿美元。其中，营养业务销售额19.4亿美元，诊断业务销售额24.57亿美元，制药业务销售额13.82亿美元，医疗器械销售额56.75亿美元。全年总销售额443.28亿美元，上年为419.5亿美元。全年净利润65.24亿美元，上年为134.02亿美元。其中，营养业务销售额84.51亿美元，诊断业务销售额89.37亿美元，制药业务销售额55.36亿美元，医疗器械销售额313.87亿美元。 产业动态 Janux Therapeutics与百时美施贵宝（Bristol Myers Squibb）达成合作并签署全球独家许可协议。双方将共同开发一款尚未披露细节的全新肿瘤激活型治疗药物，该药物靶向一种已验证的实体瘤抗原，并在多种人类癌症类型中表达。在此次合作中，Janux将负责完成从早期研究到IND申报前的临床前开发工作；百时美施贵宝将承担后续的临床开发及全球商业化职责。Janux有望获得最高达5000万美元的首付款及近期里程碑付款，并在研发、监管及商业化阶段累计获得最高约8亿美元的里程碑款项。 第一三共宣布，优赫得（注射用德曲妥珠单抗）正式获得中国国家药品监督管理局（NMPA）批准，单药用于治疗既往接受过一种含曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性成人胃或胃食管结合部腺癌患者。该适应症是德曲妥珠单抗在华获批的第六个适应症，也是HER2阳性胃癌相关的第二个适应症。此次获批，标志着德曲妥珠单抗成为中国首个且唯一获批用于该类患者二线治疗的靶向抗体偶联药物（ADC）。 阿斯利康的英飞凡（度伐利尤单抗）在中国正式获批，与卡铂和紫杉醇联合用于错配修复缺陷（dMMR）的原发晚期或复发性子宫内膜癌成人患者的一线治疗，随后以本品单药维持治疗。 艾伯维宣布利生奇珠单抗（risankizumab，商品名：喜开悦）在华获批第二项适应症，用于治疗对传统治疗或生物制剂治疗应答不足、失应答或不耐受的中重度活动性溃疡性结肠炎（UC）成年患者。 英矽智能（Insilico Medicine）用于炎症及神经退行性疾病治疗的口服NLRP3抑制剂ISM8969临床试验新药（IND）申请获得美国食品药品监督管理局（FDA）批准，用于帕金森病治疗。ISM8969是一款英矽智能Pharma.AI平台赋能开发的创新口服候选药物。为加速ISM8969的全球开发，英矽智能已与衡泰生物达成共同开发合作协议。双方各持有该项目50%的全球权益，同时英矽智能有权获得最高逾5亿港币的预付款和里程碑付款。 天隆科技自主研发的百日咳杆菌核酸检测试剂盒（荧光PCR法）获国家药品监督管理局注册批准，正式上市。 印度特伦甘纳邦政府在达沃斯举办的2026年世界经济论坛上，正式发布其《2026-2030年新一代生命科学政策》。该政策明确提出，到2030年跻身全球五大生命科学集群的宏大目标，并计划吸引250亿美元投资，创造50万高质量就业岗位，并加深与全球生命科学价值链的融合。一项专门设立的生命科学创新基金，规模可扩展至100亿印度卢比（约合1亿美元），将催化早期及成长阶段创新，支持深度科技企业。 联系美通社 +86-10-5953 9500 info@prnasia.com

Insilico strikes co-development deal with Hygtia for CNS drugFDA outlines manufacturing PreCheck roadmapTumour-penetrating peptide drives Lisata takeoutCylembio miss triggers strategic review at IO Biotech Insilico strikes co-development deal with Hygtia for CNS drug Having recently made its long-awaited IPO debut on the Hong Kong Stock Exchange, Insilico Medicine inked a co-development deal with Hygtia Therapeutics for ISM8969 — an oral NLRP3 inhibitor targeting central nervous system (CNS) disorders — discovered using the former's Chemistry42 platform under its Pharma.AI umbrella. "Developing a safe molecule with good blood-brain barrier penetration remains a formidable obstacle for drug developers," said Ren Feng, co-CEO and chief scientific officer of Insilico. "Through our generative AI platform, we have designed a molecule specifically engineered to overcome this barrier." Under the agreement, the partners hold 50% global rights to ISM8969. Insilico will take charge of the asset's IND submission and Phase I trial for Parkinson's disease, while Hygtia will assume responsibility for subsequent global studies, regulatory submissions and commercialisation activities. Insilico is eligible to receive up to $66 million in total, including an initial upfront payment of $10 million alongside milestone payments.FDA outlines manufacturing PreCheck roadmapThe FDA will start accepting applicants on February 1 for PreCheck, a pilot programme designed to make a predictable regulatory pathway for companies to construct drug manufacturing sites in the US.The US regulator revealed the initiative in August as the Trump administration pushed for drugmakers to reshore their manufacturing, or face steep pharmaceutical tariffs. PreCheck's two-part workflow comprises a Facility Readiness Phase to open more communication channels between manufacturers and the FDA during the design, construction and pre-production stages of opening a new facility, while the Application Submission Phase facilitates pre-application meetings with manufacturers so the FDA can provide early feedback on the Chemistry, Manufacturing, and Controls section of an application.According to the FDA's announcement on Wednesday, it will select the pilot's initial cohort of new manufacturing facilities based on whether they align with national product priorities, the phase of facility development, how soon the site can make drug products, and how innovative the facility is.Tumour-penetrating peptide drives Lisata takeoutLisata Therapeutics has agreed to be acquired by privately held Kuva Labs in an all-cash tender offer valued at $4 per share, plus two contingent value rights (CVRs) that could add up to $2 per share if certain milestones are met. The offer represents an 85% premium to Lisata's most recent closing price, rising to roughly 180% if both CVRs pay out.The CVRs are tied to the future of Lisata's lead asset, the targeting agent certepetide (LSTA1), an investigational iRGD cyclic peptide designed to enhance penetration of anticancer drugs into solid tumours. It has been tested in pancreatic cancer. The deal builds on a relationship formed in 2024, when Kuva licensed certepetide for use with its NanoMark imaging platform, aiming to improve tumour detection and treatment monitoring.A $1 CVR payment would be triggered if rights to certepetide in China revert from Qilu Pharmaceutical within 12 months, while the second $1 CVR would be paid upon the filing of an NDA or similar registration document by Kuva to commercialise certepetide in any indication in any jurisdiction.Boards at both companies have unanimously approved the proposed acquisition, and the parties expect to sign a definitive agreement by late February.Cylembio miss triggers strategic review at IO BiotechIO Biotech said it will explore strategic alternatives ranging from a merger or asset sale to a potential liquidation or dissolution, following a regulatory setback last year involving its experimental melanoma vaccine Cylembio. The biotech is also considering another round of layoffs and other cost-cutting measures.The review follows a restructuring disclosed in September, when IO Biotech said it would lay off roughly 50% of its workforce after the FDA advised against filing Cylembio for approval. The regulator concluded that a Phase III study testing Cylembio in combination with Merck & Co.'s Keytruda (pembrolizumab) had failed to deliver a statistically strong enough progression-free survival benefit to support a biologics license application. Cylembio, an off-the-shelf therapeutic cancer vaccine built on IO Biotech's T-win platform, is designed to stimulate T-cells against both tumour cells and immune-suppressive cells in the tumour microenvironment. Pavan Kamat and Elizabeth Eaton contributed to this report.

Kuva Labs’ experience of certepetide stretches back to November 2024.\n Cancer imaging company Kuva Labs is expanding its scope via the acquisition of solid tumor biotech Lisata Therapeutics.The big prize for Kuva is certepetide, Lisata’s cyclic peptide drug that the company has been evaluating in a range of phase 2 studies for pancreatic ductal adenocarcinoma, cholangiocarcinoma and appendiceal cancers. The cyclic peptide undergoes a process called protease-mediated cleavage in the tumor, producing a C-end Rule or “CendR” peptide that enables transport across the tumor stroma and improves delivery of anticancer drugs.Kuva’s experience of certepetide stretches back to November 2024, when the company licensed the drug to use with its own NanoMark platform to help create a new class of magnetic resonance imaging agents to detect tumors.Now, Kuva wants to bring certepetide and its owner in-house. Kuva has offered $4 per share of Lisata—an 85% increase on the $2.16 that Lisata’s stock closed at Tuesday.On top of that cash payment, Lisata’s stockholders could be in line for an additional $2 per share should Kuva both resecure the Chinese rights to certepetide from its partner Qilu Pharmaceutical and submit the drug for approval in any country. Lisata was formed in 2022 from the merger of Caladrius Biosciences and Cend Therapeutics. The resulting company was tasked with taking forward Cend’s lead candidate certepetide, which at that point was still known as CEND-1.Certepetide has also attracted interest from the likes of CDMO Catalent, which in October secured the right to evaluate the drug as a potential payload for antibody-drug conjugates.