Bambusa Therapeutics, Inc.

The IPO queue welcomed two new additions Friday, with Bambusa Therapeutics and Aspen Neuroscience each filing to go public. They join City Therapeutics and Iambic Therapeutics, which are hoping to raise $175 million and $150 million, respectively, as well as targeted degrader developer Lycia Therapeutics (see – Vital Signs: AI fatigue in the IPO marketplace).Aspen is lining up for its IPO less than a year after raising a $115-million series C to support its induced-pluripotent stem cell (iPSC) therapy for Parkinson's disease (PD), sasineprocel (ANPD001). The autologous, one-time treatment — derived from skin fibroblasts which are converted into iPSCs and then differentiated into dopaminergic neuron precursor cells (DANPCs) — is designed to replace a patient's lost dopamine neurons.  The biotech is testing two dose levels of sasineprocel in the Phase I/IIa ASPIRO study involving patients with mid-stage to moderately advanced PD. As of the Aug. 18 data cutoff, 15 patients have been dosed, though Aspen is now enrolling three to six patients in a new cohort specific to genetic PD. In March, the company shared 12-month data from ASPIRO demonstrating "numerical improvements" in good "ON" time of 2.1 to 2.4 hours in the low- and high-dose cohorts, respectively. Additionally, low-dose patients improved MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III "OFF" scores by an average 15.5 points, translating to a 35.8% reduction in motor symptom severity; patients in the high-dose arm improved by an average 13.5 points, or a 29.6% reduction. More long-term data from ASPIRO are due in the first half of 2028, while dosing in a Phase III trial of sasineprocel is expected to start in the second half of 2027. Aspen is also developing a microglia programme for paediatric leukodystrophies comprising autologous, gene-corrected microglia precursor cells converted from patient-derived iPSCs. It's slated to start IND-enabling studies in the second half of 2027.Bambusa's I&I aspirationsBambusa is developing long-acting bispecific antibodies for immunology and inflammation (I&I). It joins the IPO queue more than a year and a half after raising a $90-million series A to back its I&I ambitions. Its lead candidate, BBT001, was designed with half-life extension technology to address both inflammation and chronic itch — the hallmark symptoms of atopic dermatitis (AD) — by targeting IL-4Rα and IL-31. Babmusa is running a global Phase I trial evaluating both intravenous (IV) and subcutaneous (SC) formulations of BBT001 for moderate-to-severe AD. Next year, the biotech plans to report 12-week data from treatment-naïve and biological-experienced cohorts. A Phase IIb dose-ranging study of the SC formulation is expected to launch by the end of 2026In China, Bambusa is running a Phase I/Ib study of BBT001 in AD, as well as a Phase IIa trial for chronic spontaneous urticaria.The company's second candidate, BBT002, targets IL-4Rα and IL-5 to treat respiratory and allergic diseases. A global Phase I trial is underway in chronic obstructive pulmonary disease (COPD), while in China, Bambusa has a Phase I/IIa study ongoing for COPD and a Phase IIa chronic rhinosinusitis with nasal polyps (CRSwNP) trial. Topline data for the IV formulation of BBT002 in COPD and CRSwNP are due in the first half of 2027. A Phase IIa study is evaluating a SC version in patients with asthma, and Bambusa plans to start a Phase IIb dose-ranging trial of the formulation in a respiratory indication next year. The biotech's bispecific portfolio also includes two preclinical programmes. BBT00, directed against TL1A and IL-23p19, is slated to start clinical testing for inflammatory bowel diseases by year end, while BBT004 is designed for dual B-cell depletion to treat autoantibody-driven autoimmune diseases, expected to enter the clinic in 2027.

1 哈药股份突发！总裁被立案 10月11日，哈药股份发布公告，公司于近日收到相关监察委员会关于公司董事、总裁芦传有的《立案通知书》和《留置通知书》。对于公司董事兼总裁被立案、实施留置，哈药股份表示，公司拥有完善的组织架构和规范的治理体系，严格按照《公司法》《上市公司治理准则》《上海证券交易所股票上市规则》等法律法规、规范性文件及《公司章程》等相关制度规范运作。目前，公司已对相关工作进行了妥善安排，公司董事长、其他董事和其他高级管理人员均正常履职，董事会运作正常，生产经营情况正常，公告事项不会对公司生产经营管理产生重大影响。公开资料显示，哈药集团股份有限公司成立于1991年，位于黑龙江省哈尔滨市，是一家以从事医药制造业为主的企业。1993年6月在上交所上市，是全国医药行业首家上市公司，也是黑龙江省首家上市公司。芦传有出生于1962年，硕士学历，工程师。他曾任哈药集团制药六厂总工程师、常务副厂长、厂长、党委书记，哈药集团三精制药有限公司党委书记、董事长、总经理，哈药集团股份有限公司副总经理、副总裁等职。2025年，芦传有领薪296.68万元。 2 福沃药业完成新一轮融资，武汉高科、武创投、泰格医药联合投资 近日——福沃药业宣布完成新一轮融资。本轮融资由武汉高科国有控股集团有限公司（以下简称“武汉高科”）旗下基金、武汉创新投资集团有限公司（以下简称“武创投”）旗下基金、泰格医药旗下美元投资基金TG Sino-Dragon Fund II L.P.（以下简称“TG Sino-Dragon”）联合投资。 3 阿斯利康：ALXN1850低磷酸酯酶症三期临床失败 10月11日，阿斯利康宣布Efzimfotase alfa（ALXN1850）治疗低磷酸酯酶症（HPP）的三期临床HICKORY顶线数据。相比于安慰剂，ALXN1850治疗组的患者主要终点6分钟行走距离（6MWT）在数字上获得改善，但没有达到统计学显著。具体数据表明，Efzimfotase alfa治疗组6MWT增加了17.05米，p值为0.1675。亚组分析表明，ALXN1850对于儿童期发病的亚组，疗效更加显著。阿斯利康今年流年不利，多项三期临床陆续失败，包括PD-1/CTLA-4双抗一线治疗NSCLC的三期临床、Wainua治疗ATTR-CM的三期临床以及此次ALXN1850治疗HPP三期临床失败等。 4 利太智药宣布完成近5000万元种子轮融资 利太智药是一家AI原生多肽创新药物研发企业，专注于以生成式AI技术开展多肽新药设计。采用“平台+管线”双引擎模式，兼顾短期技术变现与长期价值增长，逐步向AI原生制药公司升级。近日，利太智药宣布完成近5000万元种子轮融资，本轮由讯飞创投、L2F 光源创业者基金及知名产业方联合投资，光源资本担任独家财务顾问。资金将主要用于核心管线研发、算力投入、专利布局、人才招募及日常运营。 5 艾力斯回应海外三期临床研究失败 10月9日，艾力斯向界面新闻回应核心产品伏美替尼海外临床失败称，该FURVENT研究数据有待深入分析，确定后续开发及监管沟通方案。公司认为本次FURVENT研究结果不会影响伏美替尼第三季度及未来的销售，该药目前的销售主要来自EGFR敏感突变一线治疗适应证。艾力斯称，在之后召开的FURVENT研究全球研究者会议上，专家认为伏美替尼对EGFR 20外显子插入突变达到了此前的疗效预期。化疗组经盲态独立中心审评评估的无进展生存期与研究者评估结果存在较大差异，除这一差异外，伏美替尼的其他各项数据表现良好。 6 维立志博PD-L1/4-1BB双抗胆道癌适应症获FDA快速通道资格认定，免疫冷肿瘤治疗价值再获国际监管认可 10月12日，南京维立志博生物科技股份有限公司（以下简称“维立志博”或“公司”，股票代码：9887.HK）宣布，公司核心产品维利信®（LBL-024, 抗PD-L1/4-1BB双特异性抗体）获美国食品药品监督管理局（FDA）快速通道资格认定，用于一线治疗晚期胆道癌（BTC）。这是维利信®继肺外神经内分泌癌（EP-NEC）后获得的第二项FDA快速通道资格。基于维利信®在一线BTC临床研究中展现的亮眼数据，本次快速通道资格认定自递交至获批仅用时9天，FDA同时建议公司尽快就维利信®联合化疗在BTC上的注册计划进行沟通交流，这将有力加速维利信®胆道癌适应症在美国的开发、注册及商业化进程。 7 成立仅两年就冲刺纳斯达克！这家美国药企已融资1.36亿美元，背后涉及百欧恩泰珠海资产 10月9日，Bambusa Therapeutics正式向美国证券交易委员会提交S-1注册声明，申请在纳斯达克全球精选市场上市，拟使用股票代码“BBTX”。这家公司的特别之处在于，它成立于2024年3月，至今只有约两年半时间，却已经完成多轮私募融资，并开始推进IPO。根据招股书，截至2026年6月30日，公司累计通过私募融资获得约1.361亿美元。其投资者包括ATHOS、BVF Partners、KKR旗下平台Dawn Biopharma、INCE Capital以及RA Capital等机构。 本文来自翰米咨询内容团队，欢迎个人转发至朋友圈。 免责声明：翰米咨询内容团队关注医药大健康行业发展动态。本公众号仅用作信息分享，无任何商业用途，转载文章会标注来源和作者，如不希望被转载，请联系我们予以删除。 戳「阅读全文」，查看最新最全的大健康行业资讯

Dive Brief:Aspen Neuroscience could be the first company of its kind to go public in the U.S. if it follows through on newly disclosed plans to join the Nasdaq.Founded in 2018, Aspen hopes to treat Parkinsons disease by taking a patients own cells and reprogramming them so that they eventually become dopamine-producing neurons. Dopamine is essential for fluid body movement, muscle control and coordination. Parkinsons degrades and ultimately destroys cells that produce this molecule. Aspens most advanced therapy known as sasineprocel or ANPD001 has gone through an early-stage clinical trial and is now entering late-stage testing.While other neurology-focused cell therapy developers have gone public, Aspen may be the first built around a treatment specifically targeting Parkinsons. The company has raised approximately $347 million since its inception, and intends to trade under the ticker symbol ASPE.Dive Insight:Like Aspens programs, many cell therapies in development are designed to be one-time treatments made with cells donated from the patient. These medicines have already shown powerful effects in certain cancers as well as early signs that they could be useful against autoimmune conditions like lupus.However, they are also complex, expensive and difficult to make. Aspens production process takes roughly four months. It starts with harvesting a skin sample, which is then sent off to a manufacturing facility where select cells are isolated and grown. They are then engineered into induced pluripotent stem cells, which can become any type of cell.Scientists then, through a highly technical set of procedures, introduce a series of molecules and proteins that effectively guide these cells to become durable, precursor cells that mature into dopamine-producing neurons. The best batches are frozen and shipped back to treatment centers, where theyre surgically implanted into the patient.This intensive process isnt cheap. In 2025, Aspen recorded a net loss of $62 million, and over the first six months of this year that figure reached almost $37 million. Research and development accounts for more than 70% of Aspens operating expenses.In registration documents filed Oct. 9, Aspen noted that, based on its current operating plan, its existing cash, cash equivalents and marketable securities wont be enough to keep operating for another year. Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern, the company wrote. Even with a successful public offering, Aspen believes that it will need substantial additional capital to finance itself.Aspens announcement does come at a time when the window for biotech initial public offerings is more open than its been in years. Two dozen biotechs have gone public so far in 2026, a pace not seen since 2021. Among the new cohort, 16 raised at least $250 million from their offerings, according to BioPharma Dive data.There is also a healthy backlog of drugmakers in the IPO queue, including a pair of immune system specialists Bambusa Therapeutics and Lycia Therapeutics that submitted registration documents this month. Two other biotechs, City Therapeutics and Iambic Therapeutics, are scheduled to price offerings this week as well. '