Emestedastat

国内医药要闻 1. 上半年创新药出海交易额破千亿美元：工信部发布会披露，上半年国内共38款创新药获批上市（其中国产31款），创新药对外技术授权总额超1000亿美元再创新高，全球首个抗丁肝抗体、首款实体瘤CAR-T、首款狂犬病双抗等成果集中落地 。 2. 医保智能监管拦截违规资金129亿元：国家医保局公布，上半年全国定点医药机构事前提醒系统接入率达71%，累计事前提醒5605万人次，拦截违规涉费金额129亿元，从源头管控医保基金跑冒滴漏 。 3. 万泰生物RSV疫苗临床申请获受理：万泰沧海与厦门大学联合研发的冻干重组呼吸道合胞病毒（RSV）疫苗临床试验申请获CDE受理，采用重组蛋白技术路线，面向老年及免疫低下人群，填补国内预防手段空白。 4. 泰诺麦博登陆科创板：全球首款重组抗破伤风毒素全人源单抗企业泰诺麦博7月21日科创板上市，募资约10亿元；核心产品新替妥无需皮试、一针起效，已纳入国家医保。 5. CRO行业景气度触底回升：美迪西发布上半年业绩预告，归母净利润4200万–6300万元实现扭亏为盈，主要受益于全球创新药研发需求回暖、订单增长及降本增效落地 。 6. 科源制药业绩与基药目录双重利好：上半年净利润同比增40%–52%，同时非布司他片、盐酸鲁拉西酮片等4个品种新纳入2026版基药目录，有望加速基层市场放量 。 国际医药要闻 1. 礼来加码致幻剂药物赛道：斥资最高3.8亿美元收购AtaiBeckley，重点布局裸盖菇素相关疗法，探索化疗神经损伤、肿瘤伴随抑郁等适应症，全球药企加速进入精神活性药物研发领域。 2. 司美格鲁肽肾病获益再获真实世界证据：阿联酋真实世界研究显示，司美格鲁肽可显著改善2型糖尿病合并早期慢性肾病患者的血糖与肾功能指标，进一步支撑GLP-1类药物的靶器官保护价值。 3. 默克扩建欧洲生物药检测产能：投资2500万欧元在欧洲新建2000平方米BioReliance检测设施，完善生物药上市放行与质量检测网络，服务全球生物制药客户。 4. 阿尔茨海默病新药居家剂型获批：卫材与BioArctic联合开发的Leqembi（仑卡奈单抗）居家注射剂型获FDA批准，患者可在家自行给药，大幅提升治疗可及性。 5. 澳大利亚新型抗抑郁药二期临床积极：Actinogen公司的emestedastat针对难治性抑郁症二期概念验证试验结果发表，显示出明确的抗抑郁活性，为耐药患者提供新方向。

Ongoing Xanamem (emestedastat) Alzheimer’s disease pivotal trial progresses toward final results in November this yearSYDNEY, July 20, 2026 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) today announces that results from its proof-of-concept trial, entitled “A phase 2 randomised, double-blind, placebo-controlled trial of emestedastat in patients with major depressive disorder (MDD) and cognitive impairment (CI)” have been published as a peer-reviewed article in the British Journal of Psychiatry, a leading international journal in behavioural and psychiatric medicine. The article is available here. A key conclusion from the article is that Xanamem® showed clinically, and at times, statistically significant antidepressant activity and is worthy of further investigation as a novel anti-depressant. Secondly, in contrast to the widely held belief that cognitive impairment improves along with depressive symptoms, improvements in cognition and depression were not correlated. In contrast to effects on depression, there was no demonstrable benefit of Xanamem on cognition. The phase 2a trial was randomized and double-blind, evaluating Xanamem 10mg once daily versus placebo over six weeks in 165 participants, followed by four weeks of blinded follow-up. A distinctive feature of the trial was the enrolment of participants with measurable CI in addition to a current MDD episode. Approximately 80% of participants were receiving background anti-depressant therapy, and the mean number of prior depressive episodes was ten. Anti-depressant benefit compared with placebo in the overall population commenced at the end of six weeks of therapy and was maximal four weeks later during the blinded follow up phase (2.7 MADRS1 points, p < 0.05). A similar benefit was seen in key subgroups, including in the 46% of patients receiving background SSRI2 therapy, who also achieved maximal benefit at the end of four weeks of blinded follow up (4.2 MADRS points, p < 0.05). The timecourse of Xanamem benefit on depression is consistent with the known timeframe of onset and reversal of chronic cortisol-related adverse effects (e.g. when starting or stopping chronic prednisone treatment). Professor Michael Berk AO, academic psychiatrist and co-author, said: “These results are highly encouraging for the Xanamem 10 mg daily dose that is also being used in the Alzheimer’s disease program. The trial demonstrates that the drug penetrates the brain and there is a signal of clinically meaningful activity to improve depressive symptoms in a difficult-to-treat MDD patient population. There remains a significant unmet medical need for therapies such as Xanamem that have a novel mechanism of action and can be safely combined with existing depression treatments.” Alzheimer’s disease program progress towards first pivotal readout in November Actinogen continues to advance its Alzheimer’s disease program supported by a recent positive recommendation from the XanaMIA pivotal trial’s independent Data Monitoring Committee (DMC) on June 17. The DMC reviewed available safety data from all 247 XanaMIA trial participants and concluded that the trial should continue without amendment. Earlier this year the DMC also recommended continuation following a formal interim analysis of unblinded safety and efficacy futility. Topline results from the fully enrolled, randomized phase of the XanaMIA trial of Xanamem 10 mg versus placebo are expected in November this year. The trial enrolled a population with mild to moderate, progressive Alzheimer’s disease. Participants were pre-screened for elevated plasma pTau181 levels and were required to have a Mini-Mental State Examination score between 18 to 26 points. Dr Dana Hilt, the Company’s CMO said: “Depressive symptoms also occur frequently in patients with Alzheimer’s disease. Anti-depressant activity may be a useful feature of Xanamem treatment for Alzheimer’s disease and help to improve well-being and quality of life in these patients. Topline results in November 2026 will include initial evaluation of Xanamem effects on psychiatric symptoms. Xanamem has the potential to be a game-changer for Alzheimer’s disease, given its potential product profile as a safe and effective oral therapy that can significantly slow disease course progression beyond currently approved treatments.” ® Xanamem is a registered trademark of Actinogen Medical Limited1 MADRS: Montgomery-Asberg Depression Rating Scale2 SSRI: Selective Serotonin Reuptake Inhibitors are the commonest class of anti-depressant in use About Actinogen Medical Actinogen Medical (ACW) is an ASX-listed, biotechnology company in the late clinical stages of development for Xanamem® (emestedastat), its novel oral therapy for Alzheimer’s disease and depression. The Company is based in Sydney, Australia with operations and clinical trials in Australia and the US. Xanamem has been studied in eight clinical trials with more than 500 people treated to date and has a promising safety and efficacy profile. ACW’s ongoing clinical trial, XanaMIA, is a phase 2b/3 pivotal trial of 247 participants with mild to moderate Alzheimer’s disease, treated for 36 weeks with Xanamem 10 mg or placebo, followed by an open-label extension phase with active Xanamem 10 mg for completing participants. In January 2026 an Independent DMC conducted an interim analysis of safety and efficacy futility and recommended the trial proceed to completion. The trial is now fully enrolled and will report topline, final results from the randomized phase in November this year. About Xanamem (emestedastat) Xanamem’s novel mechanism of action is to control the level of cortisol in the important areas of the brain through the inhibition of the cortisol synthesis enzyme, 11β-HSD1, without blocking normal production of cortisol by the adrenal glands. Xanamem is a first-in-class, once-a-day pill designed to deliver high levels of brain cortisol control in regions where 11β-HSD1 is highly expressed such as the hippocampus. Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be toxic to brain cells. Elevated cortisol is also associated with depressive symptoms. Xanamem has demonstrated excellent brain target engagement and in human trials has shown potential to slow progression of Alzheimer’s disease and improve depressive symptoms in patients with moderately severe depression. To view Xanamem’s two-minute Mechanism of Action animation, click here. Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global regulatory authority. Xanamem® is a trademark of Actinogen Medical. Disclaimer This announcement and attachments may contain certain “forward-looking statements” that are not historical facts; are based on subjective estimates, assumptions and qualifications; and relate to circumstances and events that have not taken place and may not take place. Such forward looking statements should be considered “at-risk statements” - not to be relied upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business, economic and competitive uncertainties / contingencies and regulatory and clinical development risks, future outcomes and uncertainties) that may lead to actual results being materially different from any forward looking statement or the performance expressed or implied by such forward looking statements. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Actinogen Medical does not undertake any obligation to revise such statements to reflect events or any change in circumstances arising after the date hereof, or to reflect the occurrence of or non-occurrence of any future events. Past performance is not a reliable indicator of future performance. Actinogen Medical does not make any guarantee, representation or warranty as to the likelihood of achievement or reasonableness of any forward-looking statements and there can be no assurance or guarantee that any forward-looking statements will be realized. Dr. Steven Gourlay CEO & Managing Director E: steven.gourlay@actinogen.com.au Investors Will Souter Investor Relations E: will.souter@actinogen.com.au Media George Hazim Media & Public Affairs Australia E: georgehazim@mediaaffairs.com.au