港股创新药相关指数备受关注，阶段收益亮眼，成为2025年上半年最靓的仔。 2025年，调整三、四年之久的板块——国产创新药，在出海业务加持下，迎来DeepSeek时刻。 既然登上了全球竞争舞台，那么国产创新药的发展和投资，当然就离不开这些洋词汇： 国产创新药BD收入放量，License-out授权交易金额创新高，试水New-Co合作模式，在ASCO国际会议大放异彩，ADC前沿项目完成FIC突破，加速进入 NDA审批环节…… 这些洋词汇分别意味着什么？我们分门别类，一次性梳理明白。 创新药出海 01 什么BD交易？License-out又是什么？ BD（Business Development），也就是商务拓展； License-out，也就是"对外授权"，属于BD交易的一种重要形式。 "License-out"出海授权模式：国产创新药为了分摊风险和补充现金流，以合作分工的商业模式，把海外的权益用首付款、里程碑、销售分成的方式授权给 跨国药企，在各个阶段获得分成收入。 这种模式在近年来的全球医药市场中逐渐兴起，尤其是在中国创新药领域表现尤为突出。 相比授权给MNC（Multi National Company指 ...

Press Release Nicox Announces Last Patient Completes the NCX 470 Denali Phase 3 Clinical Trial Results expected mid-August to mid-September 2025 New Drug Application (NDA) submission in the U.S. targeted for H1 2026 June 30, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the last patient has completed the Denali Phase 3 trial, evaluating the efficacy and safety of NCX 470, its lead comp ...

- The U.S. Food and Drug Administration (FDA) identified deficiencies at a third-party manufacturing vendor - FDA to provide final decision by PDUFA action date of June 28, 2025 LOS ALTOS, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY or the “Company”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced an update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in pa ...

– 446 participants completed the brilaroxazine long-term open-label extension (OLE) trial with 156 completing one-year and 301 completing six months of treatment – – Full data set from RECOVER OLE highlighting clinical response, safety, efficacy, adherence, and biomarker data expected in Q2 2025 – – Registrational Phase 3 RECOVER-2 trial initiation for brilaroxazine expected mid-2025 – CUPERTINO, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “ ...

Mineralys Therapeutics (MLYS) Q1 2025 Earnings Call May 12, 2025 04:30 PM ET Speaker0 Good afternoon, ladies and gentlemen, and welcome to the Minauralis First Quarter twenty twenty five Earnings Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press 0 for the operator. This call is being recorded on Monday, 05/12/2025. I would now like to turn ...

● XORTX will focus on key steps to advance a NDA filing for Gout indication ● CALGARY, Alberta, April 30, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, is pleased to announce it has received responses from the US Food and Drug Administration (the “FDA”) and clarified key steps for a new drug applicati ...

Core Insights - Grace Therapeutics, Inc. is advancing GTx-104, a novel injectable formulation of nimodipine for IV infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) [1][6] - The company has received positive feedback from the FDA regarding the Phase 3 STRIVE-ON safety trial and plans to submit a New Drug Application (NDA) in Q2 2025 [2][3] Company Overview - Grace Therapeutics is a late-stage biopharma company focused on addressing rare and orphan diseases with innovative drug delivery technologies [9] - The lead clinical asset, GTx-104, has received Orphan Drug Designation from the FDA, providing seven years of marketing exclusivity post-launch in the U.S. [9] Clinical Trial Insights - The STRIVE-ON trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, meeting its primary endpoint with a 19% reduction in clinically significant hypotension incidents [4] - GTx-104 demonstrated higher relative dose intensity (RDI) with 54% of patients achieving RDI of 95% or higher compared to 8% for oral nimodipine [4] - The trial also showed improved functional outcomes at 90 days, with 29% more patients on GTx-104 achieving favorable results [4] Product Details - GTx-104 utilizes unique nanoparticle technology for aqueous formulation, facilitating IV infusion and potentially eliminating the need for nasogastric tube administration [6][7] - The product aims to lower food effects, drug-to-drug interactions, and dosing errors while better managing hypotension in aSAH patients [8] Market Context - aSAH accounts for about 5% of all strokes, with an estimated 42,500 U.S. hospital-treated patients annually, indicating a significant unmet medical need [5]