Neladalkib

● 药闻快报 ▲关注药财社 聚焦医药界▲ 1 汇伦医药递表港交所 核心品种支撑九亿营收 上海汇伦医药近日正式递交香港IPO招股书，拟在港股主板挂牌上市。 作为一家深耕免疫炎症及肿瘤领域的“仿创结合”型药企，汇伦医药在2023年至2025年间分别实现营收9.85亿元、6.86亿元及6.86亿元。 公司目前主要依赖成熟产品贡献现金流，核心独家品种包括用于治疗急性肺损伤的西维来司他钠以及肿瘤药物左亚叶酸。 在财务结构上，公司维持了较高的销售与研发投入，三年累计研发开支超6.4亿元。 目前，公司多项在研创新药管线取得进展，其中DPP1抑制剂预计于2026年第二季度完成IIa期临床，PDE4B候选分子正处于一期临床阶段，另有针对疼痛治疗的Nav1.8分子计划于2026年开启IIb期试验。 汇伦医药由拥有二十余年行业经验的秦继红博士领衔，此前已获得贵阳生物医药产投、康橙资本等多家机构注资。 本次IPO募集资金将主要用于推进创新药临床研发及提升现有产品的市场渗透率。 2 吉利德50亿美元收购Tubulis 强化ADC药物版图 吉利德科学（Gilead Sciences）今日正式宣布，已与抗体偶联药物领域的新锐生物技术公司Tubulis达成最终收购协议。 根据披露的财务条款，吉利德将支付31.5亿美元的现金首付款，并根据后续预设的研发及商业化里程碑进展支付最高18.5亿美元的额外款项，该笔交易总价值高达约50亿美元。 此次战略并购的核心目的在于整合Tubulis自主研发的新一代ADC技术平台及多元化在研管线，旨在利用其更具精准度的载荷递送技术，解决肿瘤临床治疗中尚未满足的巨大需求，并进一步优化患者的长期生存获益。 重点管线方面，核心产品TUB-040作为靶向NaPi2b的拓扑异构酶I抑制剂，目前正针对铂耐药卵巢癌及非小细胞肺癌开展1b/2期临床研究；另一款靶向5T4抗原的药物TUB-030也已在多种实体瘤中初显临床活性。 交易完成后，Tubulis将转型为吉利德内部专属的ADC研发中心。 此举不仅显著增强了吉利德在创新药领域的竞争优势，更标志着其在全球肿瘤精准医疗版图上的深度布局，未来该平台的临床产出与商业转化前景备受行业及资本市场瞩目。 3 FDA受理Nuvalent抗癌新药申请 聚焦耐药肺癌 Nuvalent公司近日宣布，美国食品药品监督管理局已受理其在研小分子抑制剂neladalkib的新药上市申请。 该药物属于具有高度选择性且具备脑部穿透能力的ALK抑制剂，专门针对既往接受过酪氨酸激酶抑制剂治疗的晚期ALK阳性非小细胞肺癌患者。 此次申请的核心依据源于全球注册性ALKOVE-1临床试验数据，研究结果显示，neladalkib在TKI经治患者中表现出显著的总体疗效，特别是在颅内应答方面取得了关键进展。 技术层面，neladalkib旨在克服现有第一至三代ALK抑制剂产生的耐药性，包括G1202R等复合突变，并能有效穿透中枢神经系统以改善脑转移患者的预后。 此前，该疗法已凭借其在耐药机制上的突破性表现，相继获得FDA授予的突破性疗法认定与孤儿药资格。 此项申请的受理标志着该领域治疗方案的进一步迭代，为多线治疗失败的晚期肺癌患者提供了新的临床选择。 — END — 撰稿：柏佳 | 编辑：leon | 校对：木子 | 审核：金良 投稿与开白联系：13921180988 约稿与商务合作：13951680222 声明：本文数据及信息均来自公开信息，包括不限于上市公司公告、各省证监局官网、交易所官网，各大新闻媒体网站等，数据或信息如有遗漏，欢迎更正，并以公司最终披露为准。本文不构成任何的投资建议。

Nuvalent submitted a New Drug Application (NDA) to the US FDA on for neladalkib, an investigational ALK-selective tyrosine kinase inhibitor, seeking approval in patients with TKI pre-treated advanced ALK-positive non-small cell lung cancer. The filing marks the first NDA submission for neladalkib and represents Nuvalent’s initial regulatory filing with the agency. The company said the submission was completed in under four years from first clinical trial initiation, a timeline the company highlighted alongside the drug’s breakthrough therapy designation, which the FDA granted for patients with locally advanced or metastatic ALK-positive NSCLC previously treated with two or more ALK TKIs. Neladalkib has also received orphan drug designation for ALK-positive NSCLC. The NDA is an application for neladalkib in the TKI pre-treated advanced ALK-positive NSCLC population, the company said. The application draws on data from the ALKOVE-1 trial (NCT05384626), a global, first-in-human Phase I/II study enrolling patients with advanced ALK-positive NSCLC and other solid tumors. The Phase I portion evaluated safety, tolerability, pharmacokinetics, and established a recommended Phase II dose of 150 mg once daily. The Phase II portion is a global, single-arm, open-label study designed with registrational intent in TKI pre-treated patients with advanced ALK-positive NSCLC. Topline pivotal data disclosed in November 2025 showed that neladalkib achieved an objective response rate (ORR) of 31% (95% CI: 26–37) in 253 TKI pre-treated patients treated at the recommended dose, as assessed by blinded independent central review. Responses were durable, with 64% and 53% of responders maintaining benefit at 12 and 18 months, respectively. Subgroup analyses indicated higher response rates in select populations, including patients who were lorlatinib-naïve and those harboring ALK resistance mutations such as G1202R, where response rates reached 68%. Intracranial activity was also observed, with responses reported in patients with brain metastases, supporting the drug’s CNS-penetrant design. Across the broader safety population treated at the recommended dose, adverse events were generally manageable, with dose reductions reported in 17% of patients and discontinuations in 5%. Nuvalent said detailed clinical results supporting the NDA will be presented at a future scientific meeting. The submission enters a treatment landscape shaped by six FDA-approved ALK inhibitors spanning three generations. Lorlatinib (Pfizer’s Lorbrena/Lorviqua) is the only approved third-generation ALK TKI and holds a first-line indication approval for patients previously treated with at least one ALK TKI, but no FDA-approved ALK-targeted therapy is specifically indicated for patients who progress after lorlatinib. Chemotherapy is the standard recourse in that setting. Neladalkib is designed to address this gap through a mechanism that distinguishes it from existing agents: it is engineered to retain activity against tumors carrying treatment-emergent ALK resistance mutations, including compound mutations such as G1202R, which emerge following sequential TKI use and are refractory to all currently approved ALK inhibitors. Lorlatinib itself can select for compound mutations upon progression, and these represent a recognized and clinically significant resistance mechanism with no approved targeted solution. The drug’s CNS penetrance is a second design feature relevant to the clinical context. Brain metastases occur in a substantial proportion of ALK-positive NSCLC patients over the course of disease, and intracranial progression remains a cause of treatment failure even with agents that have demonstrated systemic activity. Neladalkib’s reported intracranial responses in the ALKOVE-1 population are therefore of clinical interest, though the magnitude and durability of those responses await formal data presentation. A third distinguishing characteristic is the drug’s selectivity: neladalkib is designed to avoid inhibition of the tropomyosin receptor kinase family, which shares structural similarity with ALK. Dual ALK/TRK inhibition, as seen with lorlatinib, is associated with CNS adverse events including cognitive effects and mood changes that can affect tolerability and dose continuity. A TRK-sparing profile may reduce this class of toxicity, though clinical confirmation is pending full data disclosure. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website