Psilocybin

iStock, ma_rish Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst cautioned, however, that the transaction should not be seen as “supporting a uniform re-rating of every psychedelic developer.” Last week, Eli Lilly became the latest top pharma to buy into the psychedelics craze. Analysts are calling Lilly’s bid to buy AtaiBeckley for up to $3.8 billion the biggest endorsement yet of the sector, which could secure its first-ever approval this year. “Lilly’s pending acquisition of AtaiBeckley is the clearest strategic validation to date of psychedelics and interventional psychiatry as an emerging pharmaceutical category,” H.C. Wainwright analysts wrote in a note to investors Monday morning. With the intended buyout, “Lilly raises the floor, and the bar” for the psychedelics space, the analysts added, and “moves large-cap biopharma participation from partnerships, options, and selective asset acquisitions to outright ownership of a public platform centered on a Phase 3 short-duration psychedelic.” The deal follows AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ bretisilocin, which closed in October 2025. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); H.C. Wainwright cautioned, however, that not all psychedelics biotechs are created equal, and that Big Pharma’s interest in the space will not necessarily be a tide that raises all boats. The Lilly-AtaiBeckley acquisition, the analysts wrote, “should not be interpreted as supporting a uniform re-rating of every psychedelic developer: it raises the strategic floor for differentiated late-stage assets while also raising the bar for clinical maturity, indication selection, intellectual property, treatment duration, durability, and real-world scalability.” AtaiBeckley’s lead asset, BPL-003, is a synthetic form of a psychedelic compound called 5-MeO-DMT being studied for treatment-resistant depression (TRD) and currently in Phase 2 development. BPL-003, which is designed to be delivered via nasal spray, elicited an antidepressant response in 66.7% of patients by the second day in a Phase 2a trial . It is a “differentiated short-duration psychedelic that has shown rapid, meaningful, and durable efficacy” in TRD, Jefferies said in a Thursday note. H.C. Wainwright noted that AbbVie’s interest in Gilgamesh’s bretisilocin also fits this “short-duration” profile. Bretisilocin, a novel, short-acting serotonin 5-HT2A receptor agonist and 5-HT releaser, was in Phase 2 trials for major depressive disorder (MDD) at the time of the acquisition. “Both AbbVie and Lilly paid up for shorter-duration assets, AbbVie . . . for bretisilocin’s compressed psychoactive window, and Lilly for BPL-003’s approximately two-hour in-clinic session, reflecting the strategic value of clinic throughput and a lower episode-of-care burden,” the analysts noted. This isn’t to say that a fast-acting therapeutic is necessarily a home run. “A shorter-duration therapy becomes commercially superior only if it preserves a sufficiently compelling clinical effect while meaningfully reducing the cost and operational burden of delivery,” H.C. Wainwright said. Psychedelics Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeover With the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry. July 16, 2026 · 2 min read · Tristan Manalac Read more While the first indication du jour for the contemporary psychedelics space was post-traumatic stress disorder (PTSD), depression—in particular TRD—has taken center stage since Lykos Therapeutics failed to secure approval for its MDMA-assisted PTSD therapy in August 2024. Compass Pathways’ COMP360—which H.C. Wainwright in its Monday note dubbed “the most clinically and regulatorily advanced [psychedelic] asset”—also targets TRD. The candidate, for which Compass expects to complete a rolling FDA submission in the fourth quarter, demonstrated its durability in a Phase 3 trial earlier this month, as 39% of patients who received two fixed doses of the psilocybin-based drug achieved a clinically meaningful reduction in depression severity by week six, according to a July 7 release . Johnson & Johnson’s esketamine-based nasal spray Spravato is currently on the market for TRD, though the company has previously told BioSpace it does not consider Spravato to be a classic psychedelic. Meanwhile, other psychedelic developers are still pursuing PTSD. Otsuka Pharmaceutical, for example, picked up Transcend Therapeutics and its methylone treatment TSND-201, which is in Phase 3 development for PTSD, for up to $1.2 billion earlier this year. TSND-201 was one of three psychedelics to receive Commissioner’s National Priority Vouchers, intended to radically speed drug reviews, in April. With the broad range of assets covered in recent deals, H.C. Wainwright pointed to continued differentiation in the psychedelics space. “In our view,” the analysts wrote, “this breadth demonstrates that strategic buyers are not waiting for a single mechanism or delivery model to emerge as the definitive winner before acting.”

✓ 研报客AI助手 · 智能报告解读 摩熵咨询 医药行业观察周报（2026.07.06-2026.07.12）总结一、国内创新药/改良型新药申请临床/获批临床/申请上市/获批上市数据分析1.1 总体概况 本周共有100个创新药/改良型新药临床申请/上市申请获CDE承办，其中国产药品78个，进口药品22个。 本周共计113款创新药/改良型新药获得“默示许可”，包括化学药68款，生物药44款，1款中药。 本周无新药获批上市。 1.2 本周获批临床创新药/改良型新药信息速览 QT-019C细胞注射液：用于治疗中重度难治性系统性红斑狼疮，为“现货型”同种异体CAR-T细胞产品，靶向CD19和BCMA，可降低清淋化疗预处理需求。 BW-41012注射液：用于房颤的卒中预防，靶向KLKB1，通过siRNA降解KLKB1 mRNA，具有皮下长效注射、出血风险低等优势。 GLR-2038片：用于晚期乳腺癌，为口服蛋白降解靶向嵌合体药物，靶向ER。 其他获批临床品种：包括治疗多发性骨髓瘤、慢性肾脏病、非小细胞肺癌、系统性红斑狼疮、高脂蛋白(a)症、实体瘤、高脂血症、转移性非小细胞肺癌、IgA肾病、心力衰竭等。 1.3 本周获批上市创新药信息速览 本周无创新药获批上市。 二、国内仿制药/生物类似物申报/审批数据分析2.1 总体概况 本周共有76项仿制药申报上市/申报临床获CDE承办，包括新注册分类上市申请71项，新注册分类临床申请2项，一致性评价申请3项。 本周6个品种通过一致性评价，54个品种视同通过一致性评价。 本周1项生物类似物注册申报动态：特立帕肽注射液由北京博康健基因科技有限公司申报。 2.2 本周通过/视同通过一致性评价全局分析 过评/视同过评品种主要集中在消化系统与代谢领域。 富马酸伏诺拉生片过评/视同过评受理号最多，达6个。 富马酸伏诺拉生片和钠钾镁钙注射用浓溶液过评/视同过评企业最多，均为3家。 苏州中化药品工业有限公司、成都倍特药业股份有限公司、郑州泰丰制药有限公司过评/视同过评品种最多，均为2种。 本周过评/视同过评企业共66家。 2.3 本周首次过评/视同过评、过评/视同过评达7家品种盘点 盐酸埃克替尼片：首次过评，用于多发性神经纤维瘤II型、转移性食管癌、鼻咽癌、转移性胰腺癌、非小细胞肺癌等。 卡铂注射液：过评/视同过评达7家，用于乳腺肿瘤、头颈部肿瘤等。 三、国内医药大健康行业政策法规汇总3.1 本周国内医药大健康行业政策法规速览 2026-07-07：国家药监局发布《关于黄芪片转换为非处方药的公告（2026年第62号）》。 2026-07-08：国家卫生健康委发布《关于开展老年合理用药促进行动（2026—2030年）的通知》。 2026-07-09：国家卫生健康委发布《国家基本药物目录（2026年版）》。 2026-07-10：国家卫生健康委发布《关于加强居民连续用药管理工作的通知》；国家医保局发布第十八批智能监管“两库”规则和知识点。 3.2 重点政策详细说明 国家卫生健康委《国家基本药物目录（2026年版）》： 新版目录共794种药品，其中化学药品和生物制品476种，中成药318种。 相较于2018年版目录，新增药品116种，调出药品5种。 《新版目录》将于2026年9月1日正式施行，覆盖71%的公立医疗机构药品使用量。 强调基本药物的“突出基本、防治必需、保障供应、优先使用、保证质量、降低负担”的功能定位。 四、全球创新药研发概览4.1 本周全球TOP10创新药研发进展 安斯泰来：维恩妥尤单抗在华申报上市，用于肌层浸润性膀胱癌。 歌礼：向美国FDA递交两项治疗肥胖症的IND申请。 Vera Therapeutics：Atacicept在美获批上市，用于治疗IgA肾病。 正大天晴：TQB3126获批临床，用于晚期乳腺癌。 默沙东：口服PCSK9抑制剂恩利西肽在华申报上市。 凌科药业：JAK抑制剂LNK01004治疗白癜风2期临床研究启动。 艾迪药业：抗HIV复方制剂ADC119获批临床。 正大天晴：TQB3454在华申请上市，用于胆道癌。 赛诺菲：Sarclisa Escena获批上市，用于多发性骨髓瘤。 信立泰：环肽药物SAL0167获批临床，用于高脂血症。 4.2 本周全球TOP7积极/失败临床结果 Tvardi Therapeutics：TTI-109在1期临床试验中显示积极数据，可显著减少STAT3驱动的免疫细胞群。 恒瑞医药：HRS-7535在III期临床试验中取得积极数据，可显著减轻肥胖患者的体重。 科济药业：CAR-T疗法治疗胃癌腹膜转移患者，实现长期疾病控制，且安全性良好。 应世生物：Ifebemtinib联合格索雷塞治疗KRAS G12C突变NSCLC，Ib/II期研究数据积极。 Compass Pathways：psilocybin III期研究数据积极，对难治性抑郁症有显著疗效。 翰森制药：Risvutatug Rezetecan在III期临床试验中达到OS主要终点，用于小细胞肺癌。 诺诚健华：奥布替尼在3期临床试验中达到主要终点，用于慢性淋巴细胞白血病和小淋巴细胞淋巴瘤。 五、总结 本周国内医药行业在创新药、仿制药及政策法规方面均有所进展。创新药方面，多个靶向药物和生物药获批临床，涵盖肿瘤、代谢疾病、自身免疫性疾病等多个领域。仿制药方面，大量品种通过一致性评价，其中富马酸伏诺拉生片和卡铂注射液表现突出。政策法规方面，国家卫健委发布新版基本药物目录，强调药物的可及性和安全性，同时医保局更新智能监管规则，提升监管效率。 全球创新药研发进展活跃，涵盖多种新适应症和新机制药物。安斯泰来、歌礼、Vera Therapeutics等公司在新适应症和新药申请方面取得重要进展，正大天晴、默沙东、赛诺菲等在肿瘤和代谢疾病领域推出重要药物，显示出全球药物研发的多样性和创新性。 总体来看，本周医药行业在研发和监管方面均展现出积极的发展态势，为患者提供更多治疗选择和保障。 ▸ 报告内容 ▸ 点击下方卡片 · 免费获取报告源文件 研报客 YANBAOKE · 智能研报聚合平台 整合全球5000+研究机构 · 汇集500万+专业报告 · 全行业深度覆盖 连接世界顶级智库 · 获取百万中英研报 · 一站式研究解决方案 ✓ 主要服务 📂 报告库：跨行业覆盖 · 智能搜索 · 全文定位 🔄 语言处理：多语种互译 · 原版样式保留 🤝 智能助手：文档问答 · 深度解析 · 专业应答 🔕 订阅推送：关键词订阅 · 实时更新通知 💻 多终端：PC端 · 移动APP · 微信小程序 ✓ 智能特色 🔎 意图识别：精准理解需求 · 高效匹配结果 📡 信息融合：多源交叉验证 · 综合分析输出 🧩 深度理解：超越字面 · 把握语境文化内涵 📐 领域适配：科技 · 商务 · 学术 · 专业术语 💭 对话记忆：上下文连贯 · 多轮交互支持 📖 文档精通：专业研报解读 · 结构化分析 📡 实时更新：最新资讯获取 · 主动推送 ✓ 应用领域 💰 投资决策：券商报告 · 市场研判 · 策略制定 📊 商业洞察：行业扫描 · 趋势追踪 · 竞品分析 🏗️ 产业分析：深度研究 · 价值链梳理 🔮 前瞻研判：发展走向 · 技术路径 · 政策风向 ✓ 产品入口 🌐 PC网页：pc.yanbaoke.cn 📲 移动应用：应用商店搜索「研报客」 💻 客户端：pc.yanbaoke.cn/pc2.html 🗲 微信小程序：搜索「研报客」 ▸ 多格式转换 · 文本提取 · 便捷下载分享 多端数据同步 · 随时随地研读 AI生成内容 · 仅供参考