Porustobart

iStock, ismagilov Venture capital continued to flow into biopharma in the third quarter, though experts pointed out that investors remained selective, preferring to put their money behind advanced and derisked assets, as well as AI-driven drugmakers. Venture capital funding into biopharma companies topped $16 billion in the first half of the year, and the money continued to flow into the industry in the third quarter. But it continues to be a story of haves and have nots, experts say. “We’re seeing more capital being deployed even as overall deal activity remains constrained,” Dan Greaney, executive director of Life Sciences, Innovation Economy at J.P. Morgan, told BioSpace in an email interview. Money is “tending to flow toward later-stage, more de-risked assets, resulting in a small number of companies to receive larger amounts of capital.” Proximal Ventures’ Sahir Raoof agreed. While biopharma is currently enjoying a “stronger financing environment,” the true picture is more nuanced. “The amount of money being raised doesn’t tell the story of how broadly that money is available,” he told BioSpace over email. “Capital is concentrated.” Venture capital 5 largest VC rounds of H1 2026 Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace . July 8, 2026 · 9 min read · Tristan Manalac Read more Jim Polson, senior managing director at FTI Consulting, pointed to AdvanCell’s $315 million raise this quarter and Encoded’s $275 million as signs of “continued investor interest in more advanced, increasingly de-risked programs with clear paths to meaningful clinical milestones.” AdvanCell is pushing its lead radiopharma asset into Phase 3, while Encoded is also moving into pivotal development for its gene upregulation therapy for Dravet syndrome. Another funding pattern that carried from the first half of the year to Q3 is the “growing investment in companies explicitly mentioning the use of AI and computational approaches to discover and develop medicines,” Raoof added. He highlighted several of this year’s biggest rounds so far that have involved a focus on AI: Isomorphic Labs’ mammoth $2.1 billion series B , Parabilis Medicines’ $305 million series F and NewLimit’s $435 million series C . Raoof also pointed to Enveda, which uses a proprietary machine learning engine to unveil the therapeutic potential of molecules that already exist in nature. Enveda closed one of this quarter’s largest VC rounds. Here, BioSpace takes a closer look at Enveda, AdvanCell and the other companies that raised Q3’s largest venture rounds. Chai Discovery Date: July 14 Round: Series C Raise: $400 million Topping the Q3 VC leaderboard is Chai Discovery, which in July commanded a $400 million round to further advance its AI models intended to accelerate preclinical drug discovery. The series C push, which included contributions from OpenAI and other big names, valued Chai at $3.8 billion. Chai develops machine learning models that take into account biological structure and function to generate new molecules from scratch, the company said in the July news release. This approach aims to do away with the traditional trial-and-error approach to drug discovery and could open up disease targets that had previously been difficult to address. Chai’s latest model is called Chai-3, which the biotech claims “materially improves” the success rates of generated antibodies over previous versions of the model. This platform has won Chai many Big Pharma customers, including Eli Lilly, which in January brought the biotech on to create a purpose-built AI model exclusively for the pharma’s use. Financial details of the deal were not announced. Bristol Myers Squibb , Pfizer , Novartis and argenx have also lined up to work with Chai, each leveraging the biotech’s AI platform for de novo drug discovery. Chai’s impressive fundraising round, led by Index Ventures, Kleiner Perkins, Sequioa Capital and Dimension, comes as tech money floods into biopharma , spurred by the rise of AI. The biggest symbol of this trend is Alphabet’s Isomorphic Labs, which in May raised $2.1 billion in series B money—the second-largest VC round in the industry’s history. Artificial intelligence With tech backing, AI biotechs force biopharma into ‘fail-fast’ drug development AI is quickly becoming a central force in drug development, from powering pharma engines to permanently rewiring the capital markets. August 12, 2026 · 6 min read · Tristan Manalac Read more AdvanCell Date: July 16 Round: Series D Raise: $315 million Just days behind Chai is AdvanCell, which landed a $315 series D windfall that could help the Sydney- and Boston-based biotech break into one of the hottest modality markets in biopharma. AdvanCell is developing targeted alpha radiotherapies for cancer. The company’s lead asset is ADVC001, a lead-212–based candidate designed to target the PSMA protein for the treatment of metastatic prostate cancer. ADVC001 is currently in a Phase 1b/2a study for this indication, with topline data expected in 2029. AdvanCell hopes to use the fundraising proceeds to advance the asset into late-stage development. The series D will also allow the biotech to boost its U.S. manufacturing capabilities, supporting a better supply of the lead-212 isotope—largely in preparation for Phase 3 studies of the asset as well as future commercial demand. The new funding will also accelerate AdvanCell’s pipeline of targeted alpha candidates, the company said. Ally Bridge Group and Alpha Wave co-led AdvanCell’s series D, with participation from big names across the industry, including Bain Capital Life Sciences, Eli Lilly and Sanofi Ventures. Currently, the radiopharma space is dominated by Novartis , which owns the FDA-approved Lutathera, indicated for gastroenteropancreatic neuroendocrine tumors, and the prostate cancer therapy Pluvicto. Both of these products use the beta-emitter lutetium-177. The pharma is also developing a radiopharma therapy based on actinium-225, which belongs to the more powerful alpha-emitter class . AdvanCell’s lead-212 isotope is also an alpha-emitting particle but has a much shorter half-life than actinium-225. This could enable a better safety profile, as is hinted at in the Phase 1b dose-escalation portion of AdvanCell’s Phase 1/2 TheraPb trial , which found no dose-limiting toxicities or treatment-related serious adverse events. Radiopharmaceuticals Radiopharma Powerhouses Push Frontiers With New Indications, Innovation At the intersection of radiation and precision, Novartis, Bayer, AstraZeneca and more hope to cash in on a radiopharmaceuticals market that could top $16 billion by 2033. May 12, 2025 · 9 min read · Tristan Manalac Read more Enveda Date: Sept. 23 Round: Series E Raise: $311 million Hopping on the AI train is Enveda, which late last month collected $311 million in its series E round to advance a trio of drug candidates, including an “ exercise in a tablet ” asset for obesity. Enveda has now raised more than $845 million since its inception. This investigational oral weight loss therapy, called ENV-308, showed “exceptional” gastrointestinal safety in a Phase 1 study that included 88 healthy adults, the company announced in August without providing specific data. Enveda is also working on ENV-294, an oral drug candidate that in July lowered disease severity in a Phase 1 atopic dermatitis study. ENV-294 is also being tested for asthma . Then there’s ENV-6946, a TL1A+ pathway blocker being studied for inflammatory bowel disease. Enveda plans to use the series E proceeds to advance its three clinical-stage assets into later-stage testing and explore their potential in other indications, the company said last month, noting that new trials are set to start in the coming months. In addition, Enveda will use its fresh capital to continue developing its proprietary PRISM platform , an AI-powered engine that predicts the structures and therapeutic potential of existing molecules. Enveda currently has 14 development candidates, produced through PRISM, in preclinical development. Enveda’s series E was led by Catalio Capital Management, with participation from T. Rowe Price Investment Management, Durable Capital Partners and Lightspeed. Venture capital AI drug hunter Enveda raises $311M for late-stage obesity, inflammatory disease push Tech darling Enveda has raised a total of $845 million in the past six years. The latest funding round is intended to pave the way for an IPO someday. September 23, 2026 · 1 min read · Annalee Armstrong Read more Encoded Therapeutics Date: Sept. 9 Round: Series F Raise: $275 million Precision medicine developer Encoded Therapeutics makes the cut for this list with its $275 million series F round early last month, which the company plans to use to take its lead asset into pivotal development. Encoded is working on ETX101, an investigational gene upregulation therapy that the biotech is positioning as a one-time therapy for Dravet syndrome, a rare epileptic encephalopathy caused by mutations in the SCN1A gene. ETX101, which is delivered directly into the brain, boosts the expression of SCN1A . The asset is in the Phase 1/2 POLARIS study, which last month showed a strong reduction in monthly countable seizures. The series F money will help drive pivotal development for ETX101. Encoded also plans to use the proceeds to build up another asset, dubbed ETX391, for a 2027 regulatory filing seeking permission to start clinical testing. Aside from advancing its pipeline, part of the series F haul will also go toward scaling up manufacturing capabilities, Encoded said. Encoded’s fundraising push was co-led by GV (Google Ventures) and an undisclosed healthcare fund. Other institutional investors to participate included Illumina Ventures, RTW Investments and ARCH Venture Partners. Funding Encoded raises $275M series F for Dravet syndrome gene therapy Encoded Therapeutics’ lead asset ETX101 is a gene therapy being tested for Dravet syndrome. Phase 1/2 data showed substantial reductions in seizures. September 10, 2026 · 2 min read · Tristan Manalac Read more Solstice Oncology Date: Sept. 9 Round: Series A Raise: $225 million Capping off this list is Solstice Oncology, which had the biggest biopharma launch in Q3, netting $225 million for its series A round in early September. Solstice will use the money to bankroll the development of porustobart, an anti-CTLA-4 antibody that the startup licensed from China’s Harbour BioMed for $105 million, covering a $50 million upfront payment, $5 million in near-term commitments and $50 million in Solstice equity. The Boston-based biotech also put up to $1.1 billion on the line in development, regulatory and commercial milestones. Solstice plans to combine porustobart with Merck’s mega-blockbuster PD-1 drug Keytruda. The FDA has given the go-ahead for the regimen to be tested in a Phase 2 study for neoadjuvant advanced colon cancer and another undisclosed disease, with data slated for the back half of 2027. A Phase 2 study conducted by Harbour showed that porustobart, when used alongside BeOne Medicines’ PD-1 inhibitor Tevimbra, elicited a 30% objective response rate as a late-line option in patients with microsatellite-stable metastatic colorectal cancer without liver metastases, Solstice said in September . Solstice’s series A was led by RA Capital Management, with participation from Forbion, Canaan Partners and other backers. Venture capital Solstice rises with $225M to develop next-gen CTLA-4 drug from China Solstice Oncology, founded in February, is emerging from stealth having already secured an investigational new drug application from the FDA for a Phase 2 trial of a CTLA-4 antibody purchased from China’s Harbour BioMed. September 9, 2026 · 2 min read · Annalee Armstrong Read more

No.115 ｜ 2026年9月30日 "短期内，市场是一台投票机；长期里，市场是一台称重机。" ——本杰明·格雷厄姆 正值国庆节前，当恒瑞把一款还停留在Ⅰ期临床的口服减重药卖出26亿美元，当阿斯利康掏出20亿美元去"绑"住康方依沃西的全球权益，市场正在用真金白银，给中国创新药的"重量"投票。今天这日报，值得你在节前静下来从头读到尾。  周三 ｜ 政策与审批动向 本周一个信号越来越清晰：审批端的"前置化、透明化、国际化"，正在和出海BD形成正向螺旋。今天三笔BD（恒瑞、恩华、迪哲）不是孤立事件，而是"研审联动＋临床数据国际化＋授权交易常态化"三条线索共同作用的结果。 今天的角度，我们不看热闹看门道——真正的变量，是审批效率开始直接折算成企业的议价权。当一款Ⅰ期分子能凭"每周一次口服"的差异化拿到诺和26亿美元，说明监管对新机制、新剂型的包容度，正在变成中国药企谈判桌上的硬筹码。政策不再是后台配角，而是前台定价逻辑的一部分。 一、今日三条高热度 · 专业深度研判 🔥 高热度 ① 恒瑞医药：把Ⅰ期口服减重药 HRS-1596 授权诺和，潜在总额最高 26 亿美元 交易结构 3亿美元首付款＋最高23亿美元开发/注册/商业化里程碑＋按净销售额收取销售提成；诺和获大中华区外全球独家权益，预计2026年第四季度交割。资产差异化在于"每周一次口服"的 GLP-1/GIP 双受体激动剂——目前国内外尚无同靶点口服药获批，恒瑞已在中国获批体重管理与2型糖尿病的Ⅰ期临床。 【怎么看】 诺和作为"口服多肽先行者"，这笔交易补强的是下一代口服减重管线，正面迎战礼来 orforglipron。对恒瑞而言，拿到的是首付款＋里程碑＋长期分成的组合拳，代价是临床不确定性与美国 HSR 反垄断审批节奏。 更关键的信号是——中国源头创新的估值锚，正从"国内销售峰值"转向"全球权益分成"。一款Ⅰ期分子能被全球巨头用真金白银定价，本身就是审批包容度与产业能力共振的结果。 出处：恒瑞医药官网公告，2026-09-29；国际金融报／证券日报／每日经济新闻多源交叉核实。 🔥 高热度 ② 阿斯利康 20 亿美元战略入股 Summit，主导依沃西联合疗法全球开发 交易结构 阿斯利康以20亿美元认购 Summit 新发行可转换优先股，折合每股18.36美元（较市价溢价约19%），完成后持股约12%。注意，这不是传统授权——阿斯利康作为临床发起方，主导依沃西（康方全球首创 PD-1/VEGF 双抗）与自家 CLDN18.2 ADC（Sone-Ve）联合治疗多种胃肠道肿瘤的探索，费用共担、各自保留商业化权利。 【怎么看】 这是"Big Pharma 用股权绑定中国双抗"的新范式，与近期 ADARx-艾伯维 PIPE 一脉相承。依沃西自2022年授权 Summit（最高50亿美元）后，再次被国际巨头用资本背书，全球价值被二次确认；对康方是资金＋产业资源的双重加持，也补上了 Summit 海外商业化能力的短板。 真正的观察点，是2026年11月14日 FDA 对依沃西 BLA 的目标审评日期——那才是价值兑现的硬节点。 出处：康方生物公众号，2026-09-29；中国基金报、界面新闻、每日经济新闻交叉核实。 🔥 高热度 ③ 单日"BD出海三连发"：从卖产品，到卖分子、卖平台 交易结构 把今天三笔并列看：恒瑞 HRS-1596（最高26亿美元）、恩华药业睡眠新药授权美国 Somnivera（1050万美元首付＋最高5.07亿美元里程碑＋获 Somnivera 15%股权，对方由 ARCH / F-Prime / Population Health Partners 于2026年8月新设）、迪哲医药收到阿斯利康6亿美元首付款（舒沃哲全球授权8月31日生效）。 【怎么看】 交易结构在升级——股权绑定、分层提成、再许可分成，买方也从单纯 MNC 扩展到"MNC＋专业 Biotech 创建者"。这背后是政策托底（研审联动、出海便利化）、产业能力积累与全球资本再配置的三重共振。 但要清醒：里程碑款附带条件、临床有不确定性、美国对华生物科技投资新规尚未定稿（拟2027年3月出细则），外部摩擦力仍在。今天的繁荣，是把"硬科技"翻译成"全球定价权"的开始，而非终点。 出处：恒瑞/恩华/迪哲三源公告交叉核实，2026-09-29。 二、资讯速递 · 简单专业预测 ④ Solstice Oncology 完成 2.25 亿美元 A 轮（RA Capital 领投，和铂医药伙伴） 肿瘤免疫新锐拿到顶级基金背书，核心候选药普鲁苏拜单抗已推进两项适应症（含微卫星稳定型结肠癌）。（来源：阿斯达克财经，9/30） 点评：接下来看临床读出节奏与新辅助场景的扩展能力。 ⑤ 引航生物完成 4.5 亿元 Pre-IPO 融资（合成生物） 在"非粮生物基材料三年黄金期"叙事下，产业化落地能力才是估值核心。老股东加注＋新股东入局，明显是为上市铺路。（来源：东方财富／证券时报，9/30） 点评：重点盯产能与客户绑定的兑现度。 ⑥ AnaCardio 完成 6250 万欧元 B 轮（Novo Holdings 领投，心衰 AC01） 心衰赛道长期缺好药，AC01 目标2028年前建成三期准备资产。（来源：动脉网／GlobeNewswire，9/30） 点评：Novo Holdings 入局等于现金流＋信誉双保险，关注其在 HFrEF 后期数据中的耐久性表现。 ⑦ Telix 前列腺癌 BiPASS（68Ga-PSMA-PET）获 FDA 快速通道 RDC 龙头在诊断端再下一城，快速通道缩短 NDA 路径，强化"诊疗一体化"护城河。（来源：Pharma Now，9/30） 点评：真正的壁垒仍是同位素稳定供应，这是它和后来者拉开差距的关键。 ⑧ Zealand Pharma 长效胰淀素 petrelintide 二期减重 10.7% 减重进入"长效＋多机制"比拼，10.7% 不错但谈不上碾压。（来源：Pharma Now，9/30） 点评：礼来、诺和的口服压力就在门外，关键看三期制造放大与长期耐受数据。 ⑨ 礼来 Foundayo（orforglipron）间接对比胜口服 semaglutide 口服 GLP-1 战场白热化，orforglipron 52周多1.5%减重、0.3% A1C 改善，巩固礼来口服地位。（来源：Pharma Now／BioPharma Dive，9/30） 点评：恒瑞 HRS-1596 的"每周一次"才是下一代差异点，时间站在更优剂型一边。 ⑩ Egetis Emcitate（tiratricol）获 FDA 批准，MCT8 缺乏症首款疗法 罕见病"首款"商业化体量小，但定价权强、护城河深。（来源：FDA／PharmacyTimes／BioWorld，9/29） 点评：关注患者筛查网络与支付通道搭建——这类药的胜负，七分在诊断、三分在用药。 ⑪ 泰尔茂神经收购 NeoCast 液体栓塞剂（cSDH） 器械并购聚焦神经血管细分赛道，液体栓塞剂补强产品组合。（来源：动脉网／GlobeNewswire，9/30） 点评：看后续整合与国内集采／招标节奏，细分龙头的并购逻辑是"补短板"而非"铺大盘"。 ⑫ MindRank MDR-001 牵手三生大中华商业化，最高 17.5 亿元 AI 设计口服 GLP-1 进入商业化兑现期，三生渠道加持是加分项。（来源：Fineline／flcube，9/30） 点评：关注三期肥胖数据与口服小分子依从性优势的实打实验证。 三、全球政策风向标 🇨🇳 中国（近24h 及政策顺风） • 9月29日，NMPA 批准礼来 Jaypirca（吡托布鲁替尼）一线单药用于 CLL/SLL——非共价 BTK 抑制剂在华完成全病程布局，审评提速信号明确。 • 9月29日，石药集团（CSPC）mRNA 肿瘤疫苗 SYS-6077 获 NMPA 临床许可。 • 政策底色：《药物临床试验质量管理规范（2026修订）》自9月1日起施行（新增"数据治理"章节），叠加"研审联动、出海授权"环境，是今日三笔 BD 的底层顺风。 • 风险面：美国第232条款专利药关税第二阶段已于9月29日生效、财政部对华生物科技投资新规拟2027年3月出细则，仍是中国出海的外部摩擦力。 🇺🇸 美国（近24h） • 9月30日为多项 FDA PDUFA 决议密集到期日：mavacamten 青少年 oHCM、apitegromab（SMA）、brepocitinib（皮肌炎）、rusfertide（真性红细胞增多症）等迎来裁决窗口。 • FDA 持续推进"减少动物试验"现代化路径与 GLP-1 等审评效率改革，长期利好创新药研发成本曲线下移。 🇪🇺 欧洲（近24h 及近周） • 9月29日，EMA 更新"中小企业（SME）先进疗法认证程序"，降低 CGT / ATMP 企业的监管门槛与前期成本。 • 9月 CHCP 会议推荐12款新药＋11项适应症扩展（含 Enhertu 早期 HER2+ 乳腺癌、Ocrevus 扩展至10岁+ 多发性硬化），欧盟审评在"临床价值"导向下提速。 🇯🇵 日本（近期审评提速） • 9月16日，MHLW 集中批准一批新药（礼来 Onswik 周制剂胰岛素、Alexion Klygefa、J&J Icotyde 口服 IL-23R、SK cenobamate 等），日本市场在谨慎中释放准入红利（近周事件，标注日期）。 🇭🇰 香港 • 港交所 18A / 生物科技上市通道保持顺畅，9月多只创新药新股递表／挂牌，制度红利延续，为内地 Biotech 提供"上市—再融资—出海"闭环。 四、互动 今天这份日报看到这里——如果你正做医疗基金 LP 尽调，或手里有创新药标的想聊聊，留言区抽 3 位送 1v1 答疑。 信源核实备注 ① 恒瑞→诺和 HRS-1596：恒瑞医药官网公告（2026-09-29）、国际金融报／证券日报／每日经济新闻多源交叉核实；潜在总额最高26亿美元（3亿首付），大中华外全球权益，预计2026 Q4 交割。 ② 阿斯利康 20 亿美元入股 Summit：康方生物公众号（2026-09-29）、中国基金报、界面新闻、每日经济新闻交叉核实；可转换优先股18.36美元/股、持股约12%、主导依沃西＋Sone-Ve 联合临床。 ③ 中国 BD 出海三连发（范式研判）：以①恒瑞、②恩华药业公告（2026-09-29，睡眠药1050万美元首付＋最高5.07亿美元里程碑＋获 Somnivera 15% 股权，Somnivera 由 ARCH/F-Prime/PHP 于2026-08 创立）、③迪哲医药公告（收 AZ 6亿美元首付，舒沃哲全球授权8/31生效）为样本，三源公告交叉核实。 ④ Solstice 2.25 亿美元 A 轮：阿斯达克财经／AAStocks（2026-09-30）、和铂医药披露；RA Capital 领投，候选药普鲁苏拜单抗。 ⑤ 引航生物 4.5 亿元 Pre-IPO：东方财富／证券时报／证券之星（2026-09-30）；元禾控股等老股东加注，苏创投等新股东入局。 ⑥ AnaCardio 6250 万欧元 B 轮：动脉网／GlobeNewswire（2026-09-30）；Novo Holdings 与 Ljungström 家族办公室领投。 ⑦ Telix BiPASS 快速通道：Pharma Now（2026-09-30）；68Ga-PSMA-PET 前列腺癌活检前影像。 ⑧ Zealand petrelintide 二期：Pharma Now（2026-09-30）；ZUPREME-1 减重10.7%。 ⑨ 礼来 Foundayo 间接对比：Pharma Now／BioPharma Dive（2026-09-30）；orforglipron 52周优于口服 semaglutide。 ⑩ Egetis Emcitate FDA 批准：FDA／PharmacyTimes／BioWorld（2026-09-29）；tiratricol 治疗 MCT8 缺乏症首款。 ⑪ 泰尔茂神经收购 NeoCast：动脉网／GlobeNewswire（2026-09-30）；液体栓塞剂 cSDH。 ⑫ MindRank MDR-001×三生：Fineline／flcube（2026-09-30）；AI 设计口服 GLP-1，大中华商业化最高17.5亿元。 免责声明 本资讯由公开信息整理而成，仅供行业研究与学习交流，不构成任何投资建议、要约或招揽。文中涉及的交易金额、临床数据、监管状态均以来源公告及媒体报道为准，可能存在更新或修正。医药研发与监管具有高度不确定性，相关事项最终以企业或监管机构的正式披露为准。投资者应独立判断并自担风险。版权归整理方所有，未经授权不得转载。 医投磐石 YITOU PANSHI