Faricimab

AUSTIN, Texas, Sept. 08, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Multiple sclerosis (“MS”) drugs on the market today can slow the disease down, but none of them stop it, and none of them give patients back what they have already lost. Nearly one million people in the United States, and close to 2.9 million worldwide, live with that reality, watching a disease that can gradually erode mobility, vision, and basic bodily control. That gap has just gotten a serious new challenger. Quantum BioPharma Ltd. (NASDAQ: QNTM) (profile) has received FDA clearance to begin a phase 2 trial of Lucid-MS, a patented, first-in-class drug candidate aimed not at calming the immune system but at protecting and potentially repairing the myelin sheath itself. The clearance sets the stage for what would be the first time in history that a drug candidate built on this specific mechanism is tested in people living with the MS disease, a milestone significant enough that it has already drawn a fresh buy rating from Wall Street analysts. This momentum places Quantum BioPharma solidly in a group of leading companies focused on the treatment of serious diseases and areas of significant unmet medical need across vaccines, ophthalmology and neurological disease, including Sanofi (NASDAQ: SNY), Roche Holding AG (OTCQX: RHHBY), Biogen Inc. (NASDAQ: BIIB) and Clene Inc. (NASDAQ: CLNN). Research indicates that MS affects an estimated one million people in the United States and approximately 2.9 million people worldwide. The FDA's clearance of Quantum BioPharma's Investigational New Drug (“IND”) application marks a genuinely rare moment in MS research.In addition to the upcoming phase 2 drug trial, Quantum BioPharma has spent more than a year building a parallel research partnership with scientists at Massachusetts General Hospital (“MGH”) and Harvard Medical School. Lucid-MS, also known by its research designation Lucid-21-302, is built around a different theory of how to target MS progression. Clinical milestones matter to patients, but they also move markets, and Quantum BioPharma has recently drawn fresh attention from Wall Street analysts. Click here to view the custom infographic of the Quantum BioPharma editorial. A Disease That Takes Away Control Research indicates that MS affects an estimated one million people in the United States and approximately 2.9 million people worldwide. The disease occurs when a person's own immune system attacks myelin, the protective coating around nerve fibers that allows the brain to communicate with the rest of the body. Most people are diagnosed in their twenties or thirties, and women are affected roughly twice as often as men. Living with MS often means facing an unpredictable erosion of physical ability. Symptoms include fatigue, vision loss, numbness, and problems with balance and coordination. Over time many patients gradually lose fine motor control, mobility, and even bladder and bowel function. In addition, many people with MS end up managing a complicated mix of medications just to control symptoms alongside their core treatment, adding another daily burden on top of the disease itself. Nearly every currently approved MS therapy works by suppressing or modulating the immune system rather than directly protecting nerve tissue. Interferons, glatiramer acetate and newer monoclonal antibodies can reduce the frequency of relapses, and research confirms these drugs help many relapsing patients. But that same research shows the approach has real limits, since roughly one-half of patients on injectable immunomodulatory therapies stop taking them within the first year, and progressive forms of the disease remain especially hard to treat. Even large, well-funded competitors are still searching for something better. Several major pharmaceutical companies have advanced new MS candidates through late-stage trials in recent years only to see mixed or disappointing results, including recent failures in the broader field of myelin repair. That track record underscores how difficult it remains to develop a therapy that changes the disease's underlying course rather than just its symptoms. For patients, that means the wait for something that restores lost function, rather than merely slowing its loss, continues. A Historic First Human MS Test of a New Approach The FDA's clearance of Quantum BioPharma's Investigational New Drug (“IND”) application marks a genuinely rare moment in MS research. According to the company, the IND submission ran approximately 15,000 pages and includes a comprehensive package of pharmacology, toxicology and manufacturing data. With that clearance now secured, Quantum BioPharma can move directly into a randomized, double-blind, placebo-controlled phase 2 trial testing Lucid-MS in people suffering with MS. What makes this trial historic is the mechanism being tested on human patients with MS for the first time. Lucid-MS is a novel, first-in-class, non-covalent inhibitor of an enzyme called peptidyl arginine deiminase 2, or PAD2, that works by targeting demyelination rather than by suppressing the immune system. No FDA-approved MS therapy currently on the market has demonstrated the ability to prevent or reverse demyelination, and the broader field of remyelinating drug candidates has faced repeated setbacks. Quantum BioPharma's own CEO called the clearance a defining moment for the company. “FDA clearance to proceed with our Lucid-MS phase 2 trial is a transformative moment for Quantum and the result of years of dedicated scientific research,” stated Zeeshan Saeed, in the SEC filing. That filing also frames the trial within a global MS therapeutics market anticipated to reach approximately $38.62 billion by 2030. If Lucid-MS demonstrates in human patients what it has shown in preclinical models, the implications extend well beyond one company's pipeline. It would mark the first time a drug candidate targeting demyelination directly, rather than the immune system broadly, has shown in controlled human testing that it might help patients regain lost bodily control. That would represent a meaningfully different category of MS treatment than anything currently available to patients today. A Groundbreaking MS Imaging Collaboration In addition to the upcoming phase 2 drug trial, Quantum BioPharma has spent more than a year building a parallel research partnership with scientists at Massachusetts General Hospital (“MGH”) and Harvard Medical School. The focus of the research is solving a different but related problem: how to actually see demyelination happening in a living patient's brain. The collaboration centers on a novel PET imaging tracer called [¹⁸F]3F4AP. The tracer was developed by Dr. Pedro Brugarolas, an investigator in the Department of Radiology at MGH and assistant professor at Harvard Medical School, with Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and associate professor of Neurology at Harvard Medical School, serving as co-investigator. In June 2025, the first person with MS was scanned using a newly installed combined PET-MR scanner at MGH, allowing researchers to capture PET and MRI data simultaneously with improved precision.By August 2025, the collaboration had already produced peer-reviewed results. Findings published in the European Journal of Nuclear Medicine and Molecular Imaging and funded by the National Institutes of Health showed that [18F]3F4AP had excellent properties for imaging the human brain and could detect differences across lesions that were not visible on conventional MRI. The study reached a key midpoint milestone in May 2026, with Brugarolas noting that the ability to directly quantify demyelinated lesions with intact axons represents an important unmet need in MS research. If fully validated, this imaging approach could eventually give researchers a far more direct and quantitative way to measure myelin loss and repair than MRI alone currently allows. That matters well beyond Quantum BioPharma's own research and development, since a reliable biomarker for demyelination could help evaluate any future therapy aimed at protecting or restoring myelin, not just Lucid-MS. For now, the imaging study and the phase 2 drug trial run on separate, parallel tracks, with Quantum BioPharma also working with a global contract research organization with CNS and MS trial experience, to support the drug trial's site-selection and start-up activities. The Science Behind Lucid-MS Lucid-MS, also known by its research designation Lucid-21-302, is built around a different theory of how to target MS progression. Rather than treating the immune system as the primary target, the compound is designed to act on PAD2, an enzyme expressed in the central nervous system that catalyzes a chemical process called citrullination of myelin proteins. That citrullination process is believed to contribute directly to the breakdown of myelin, making PAD2 inhibition a plausible way to interrupt disease progression at its source. The compound is a patented new chemical entity that has been studied for more than 11 years, with underlying research published in peer-reviewed journals including the “Journal of Medicinal Chemistry” and the “Proceedings of the National Academy of Sciences.” In preclinical animal models, the company reports that Lucid-MS accelerated functional recovery, preserved myelin and reduced axonal degradation, all without suppressing the immune system, distinguishing its proposed mechanism from nearly every currently marketed MS drug. That non-immunomodulatory profile is central to the company's scientific pitch. Because Lucid-MS is not designed to broadly dampen immune activity, the goal is to avoid the infection risk and other systemic side effects that can accompany immunosuppressive MS therapies, while directly addressing the demyelination process believed to drive long-term disability. The compound is also designed for potential oral administration with a comparatively simple dosing regimen, which could offer a meaningful convenience advantage over injectable or infused competitors if it succeeds in later-stage trials. Before reaching this point, Lucid-MS completed phase 1 clinical trials in healthy human volunteers, with the company reporting a favorable safety profile and good tolerability in that earlier testing. Dr. Andrzej Chruscinski, VP of Scientific and Clinical Affairs at Quantum, has said the IND submission reflects years of dedicated scientific research characterizing the compound's safety profile. With the FDA clearance now secured, the upcoming phase 2 trial will be the first opportunity to see whether that mechanism, built on more than a decade of laboratory work, actually helps people with progressive MS regain lost function. Wall Street Takes Notice Clinical milestones matter to patients, but they also move markets, and Quantum BioPharma has recently drawn fresh attention from Wall Street analysts. Rodman & Renshaw just initiated coverage of the company with a Buy rating and an $8 price target. The firm's report describes Lucid-MS as a potentially first-in-class, non-immunomodulatory small molecule aimed at addressing neurodegeneration and disability progression in progressive MS, an area where therapeutic options remain limited. Rodman & Renshaw’s $8 price target reflects its valuation of Quantum BioPharma's overall development pipeline, anchored by the newly cleared phase 2 program. This initiation follows earlier unpaid coverage from Kingswood Capital Partners, which set a $45 price target in September 2025 based on a discounted cash flow model assuming successful phase 2 and phase 3 trials and a 2029 commercial launch. New analyst coverage matters for a clinical-stage biopharmaceutical company because it signals that outside experts, with no obligation to be optimistic, see enough evidence in the data to justify a formal recommendation. For a small-cap company preparing to enter a pivotal trial, that kind of third-party validation can help build the visibility and credibility needed to support the stock through a long and expensive testing process. It also gives investors a data point beyond the company's own announcements when weighing the risk and potential reward of the phase 2 program. Collectively, the FDA clearance and phase 2 studies, the Harvard-affiliated imaging collaboration and the new analyst coverage paint a picture of a company methodically building the pieces needed to test a genuinely different approach to multiple sclerosis. Quantum BioPharma is still a clinical-stage company, and like any drug candidate entering human trials, there are no guarantees of success. But few companies ever reach this point: Lucid-MS is now cleared for its first real test in people living with progressive MS, giving the company a genuine chance to show that protecting the myelin sheath directly can succeed where decades of immune-focused treatments have fallen short. Biotech Leaders Advance Next-Generation Therapies Innovation across the biopharmaceutical sector continues to accelerate as companies pursue new approaches to serious diseases and areas of significant unmet medical need. Recent developments spanning infectious-disease prevention, ophthalmology and neurological disease highlight the breadth of work underway. Sanofi (NASDAQ: SNY) announced that the European Commission (“EC”) has approved an extension of the indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age to help protect against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi was previously approved in the EU for use in individuals aged 12 months and older. The expanded indication follows the positive opinion adopted by the Committee for Medicinal Products for Human Use on June 25, 2026. Roche Holding AG (OTCQX: RHHBY) released new two-year data from the phase IIIb/IV SALWEEN study of Vabysmo(R) (faricimab), presented at the 19th Asia-Pacific Vitreo-retina Society (“APVRS”) Congress in Australia. The results showed significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (“PCV”), a severe subtype of neovascular age-related macular degeneration (“nAMD”), the leading cause of vision loss in people over the age of 60. Biogen Inc. (NASDAQ: BIIB) reported that the National Medical Products Administration (“NMPA”) of China has approved the subcutaneous formulation, the anti-amyloid beta (Aβ) protofibril antibody LEQEMBI(R), as an initiation treatment for mild cognitive impairment (“MCI”) due to Alzheimer’s disease (“AD”) or mild AD dementia, collectively referred to as early AD. The application was accepted by the NMPA in January 2026 and was subsequently granted Priority Review designation. Clene Inc. (NASDAQ: CLNN) shared results from new analyses examining clinical outcomes among CNM-Au8(R)-treated patients whose neurofilament light chain (“NfL”) biomarker levels declined or stabilized. These findings will be included in Clene’s planned New Drug Application (“NDA”) seeking accelerated approval and are intended to address the questions raised by the U.S. Food and Drug Administration (“FDA”) during a March 2026 Type C meeting. At that meeting, the FDA acknowledged that NfL, a recognized blood marker of nerve-cell injury, has established prognostic value in amyotrophic lateral sclerosis (“ALS”) and could potentially serve as a reasonably likely surrogate endpoint to support accelerated approval. As established and emerging biopharmaceutical companies continue to advance new medicines and treatment strategies, developments across these diverse therapeutic areas underscore both the breadth of medical need and the opportunity for continued innovation. From disease prevention and vision preservation to new approaches for neurodegenerative disorders, these advances illustrate the range of scientific and regulatory progress taking place across the sector. 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当武田以114亿美元押注一款尚在III期的PD-1/IL-2双抗，当辉瑞一口气与同一家中国公司签下12个早期项目，当一家Biotech在2025年首次盈利、手握302亿现金——信达已经不是十年前那家靠一款PD-1打天下的苏州初创公司了。但百亿美元BD里程碑里有多少能兑现？玛仕度肽在GLP-1价格战中能走多远？2022年FDA拒批的阴影会在IBI363身上重演吗？一、发明三款国家1类新药的人 俞德超2011年在苏州创立信达生物时，已经是全球唯一发明过三个国家1类新药的科学家——安柯瑞（溶瘤病毒）、康柏西普（朗沐®，VEGF受体融合蛋白，至今仍是康弘药业核心产品）和后来的信迪利单抗。中科院分子遗传学博士、UCSF博士后的学术背景，让信达从第一天就瞄准全球first-in-class/best-in-class，而非做仿制药攒现金流。 公司快照 成立时间2011年8月 总部江苏苏州 港股上市2018年10月（1801.HK） 员工数约8,000人（销售3,600+） 获批产品18款 / 12款纳入医保 总产能140,000升（约占中国生物药20%） 现金储备302亿元（2026H1） IPO七年后，信达已从单品Biotech跨越为多产品Pharma——首家纳入恒生指数的创新药生物科技公司，MSCI ESG AAA评级，美国团队近100人为MRCT和FDA申报铺路。二、62亿基石与FDA的14:1 信迪利单抗（达伯舒®/Tyvyt，IBI308）是信达第一款产品，也是与礼来十年绑定的起点。2018年12月获批r/r cHL以来累计拿下10项适应症、8项纳入医保，最新一项为2026年5月联合呋喹替尼二线RCC。 信达不单独披露单品销售，第三方院内采购口径估算2025年约62亿元，仍是产品收入基石。但多轮医保谈判后PD-1年治疗费用从数十万降至数万，价格战让这款明星产品不再是增长引擎。 出海教训 · FDA CRL 2022年2月，FDA肿瘤药物咨询委员会以14:1投票建议不批准信迪利单抗，认为需要补充MRCT数据和OS终点；3月FDA正式发出完整回复函。这是中国PD-1出海的标志性挫折。 信达后续全球化策略彻底转向——IBI363从一开始就采用全球MRCT设计，并引入武田作为Co-Co伙伴分担成本和风险。三、ORR 36.7%，mOS 18.2月 信迪利单抗是过去，IBI363是未来。这款PD-1/IL-2α-biased双抗融合蛋白将PD-1抗体与偏好性IL-2变体融合，阻断免疫抑制的同时选择性激活效应T细胞而非Treg。它是全球首个进入III期的PD-1/IL-2双抗，入组超1,200例，获FDA突破性疗法认定。IO耐药sqNSCLC数据 ASCO 2025公布IO预治疗sqNSCLC数据：3mg/kg组确认ORR 36.7%、DCR 90%、mPFS 9.3月。2025年11月更新随访进一步改善：mPFS 10.1月、mOS 18.2月、24月OS率47.8%。IO耐药人群现有标准治疗ORR通常<20%、mOS 10-12月，IBI363数据极具临床意义。 全球III期MarsLight-11正在进行，是最大近期催化剂。罗氏RG6279等同类竞品尚处早期，信达临床进度全球领先。四、114亿美元：中国BD天花板 2025年10月，信达与武田签署刷新中国创新药对外授权纪录的协议，总额114亿美元，涵盖三个核心资产： 资产 机制 合作模式 权益划分 IBI363 PD-1/IL-2α 全球Co-Co 60/40成本分担，美国60/40利润分成；武田获美国及大中华区以外独家商业化权 IBI343 CLDN18.2 ADC License-out 武田获大中华区以外全球独家权益 IBI3001 EGFR/B7H3 ADC 选择权 武田拥有大中华区以外选择权 12亿美元首付（含1亿美元股权，HK$112.56/股溢价20%）+102亿里程碑。武田还计划在美国建厂生产IBI363——这不是传统License-out的"卖掉就走"，而是Co-Co长期绑定，信达深度参与全球开发并分享美国利润。 这不是终点。2026年5月辉瑞与信达达成105亿美元、12个早期项目合作（4 Co-Co+4外授权+4全球授权），辉瑞首次与中国Biotech做如此规模的早期合作。加上礼来十年7次合作（第7次3.5亿首付/85亿里程碑）、罗氏10亿（IBI3009 DLL3 ADC）、Spero 11亿（IBI355 CD40L），2025年以来BD总额超330亿美元，累计首付超22亿美元。 BD交易总览（2025年以来核心交易） 武田（IBI363+IBI343+IBI3001）114亿美元 辉瑞（12个早期项目）105亿美元 礼来第7次合作85亿美元 罗氏（IBI3009 DLL3 ADC）10亿美元 Spero（IBI355 CD40L）~11亿美元 累计首付款超22亿美元五、18款获批与四个全球首创 玛仕度肽（信尔美，IBI362）是信达与礼来合作的GCG/GLP-1双激动剂，2025年6月成为中国首款该类减重药。GLORY-1（n=610）显示6mg 48周减重14.84%（NEJM），DREAMS-3头对头6mg减重10.3%显著优于司美格鲁肽1mg的6.0%（p<0.0001），9mg高剂量48周减重16.46%已报NDA。但替尔泊肽15mg 72周减重22.5%疗效优势明显，司美格鲁肽专利到期后10+仿制药涌入，玛仕度肽已降价（2mg/2支540→299元），高盛预测2026年40-50亿元但价格战可能压缩。 IBI343（CLDN18.2 ADC）采用TOPO1抑制剂载荷（依喜替康类似物）和Fc沉默设计减少脱靶毒性，是CLDN18.2赛道的差异化亮点。Nature Medicine发表I期数据：胃癌8mg/kg cORR 47.1%，6mg/kg ORR 32.3%、DCR 90.3%、mPFS 5.5月。胃癌III期G-HOPE-001（中日MRCT）进行中，NDA已于2025年11月获CDE受理；胰腺癌III期已启动并获FDA FTD。 IBI311（替妥尤单抗N01）靶向IGF-1R，2025年3月获批TED——中国首款IGF-1R药物、70年来首款TED新药。RESTORE-1突眼应答率85.8% vs 安慰剂3.8%（JAMA Ophthalmology），当年获批当年进医保。 其他获批产品覆盖肿瘤（佩米替尼、奥雷巴替尼、塞普替尼、氟泽雷塞、伊基奥仑赛CAR-T等）、代谢（首个国产PCSK9托莱西单抗）、自免（IL-23p19匹康奇拜单抗）。早期管线中，IBI3003（GPRC5D/BCMA/CD3三抗）末线MM≥360μg/kg ORR 100%并获FDA FTD；IBI324（VEGF/ANG2眼科双抗）头对头法瑞西单抗数据积极；IBI355（第三代CD40L单抗）以约11亿美元授权Spero。六、8.14亿，拐点确认 2024年Non-IFRS净利3.32亿首次转正；2025年历史性突破——IFRS净利8.14亿元，首个完整盈利年，Non-IFRS净利17.2亿，毛利率87.2%。 关键财务数据 2024总收入94.22亿元（+51.8%） 2025总收入130.42亿元（+38.4%） 2025产品收入119亿元（+44.6%） 2025 IFRS净利润8.14亿元（首次年度盈利） 2025研发开支26.24亿元（费率20.1%） 2026H1产品收入超82亿元（+55%） 现金及金融资产302亿元（2026H1） 2026H1产品收入超82亿（+55%），Q2超43亿（+约60%），全年有望接近190亿。现金储备从2024年末102亿跃升至2026年中302亿元，主要来自武田12亿和礼来3.5亿美元首付。8月26日中报业绩会上管理层透露，累计20亿美元BD首付款已可覆盖全年研发支出，302亿现金将主要用于国际化推进。Vision 2030给出的收入预期管理层明确标注"偏保守"，尚未纳入M&A和license-in等外延增长贡献；2030年以后海外收入预计成为主要增长引擎。七、四赛道同时开战 PD-1红海，信迪利单抗靠10项适应症8项医保维持基本盘但增速放缓，百济替雷利珠海外拓展形成压力。GLP-1减重赛道，玛仕度肽14.8%优于司美格鲁肽但不及替尔泊肽22.5%，肝脂肪降低80.2%是差异化亮点，但16% vs 22.5%的差距可能限制峰值。 ADC方面，IBI343在CLDN18.2第一梯队，IBI3009授权罗氏、辉瑞12项目扩展靶点——与科伦博泰深绑默沙东不同，信达ADC策略更多元。PD-1/IL-2赛道IBI363全球最快，武田114亿Co-Co本身就是最强背书。八、330亿是期权不是现金 三大核心风险 1. GLP-1价格战——替尔泊肽在华放量+10+仿制药涌入，玛仕度肽已降价，若9mg未能显著缩窄疗效差距，销售峰值可能低于预期。 2. BD里程碑不确定性——330亿美元总额中绝大部分是里程碑，研发失败或商业化不及预期都可能导致无法兑现；授权费确认时点不均也会造成利润波动。 3. 出海与研发风险——信迪利单抗2022年FDA拒批阴影未消，IBI363作为first-in-class分子III期结果存在不确定性。 截至2026年8月21日，股价HK$102.40，市值约1,785亿港元（~227亿美元），TTM P/E 198倍（盈利初期低基数），2027E P/E约44倍。29位分析师93%强推，均价HK$117.64，大摩最乐观HK$138.5（隐含约35%上行）。 券商 目标价（港元） 日期 摩根士丹利 138.50 2026-08-19 交银国际 118.00 2026-08 花旗 115.00 2026-08 高盛 111.68 2026-08-06 浦银国际 110.00 2026-08 44倍2027E P/E高于传统Pharma（20-30倍）但低于高增长Biotech管线兑现期。定价隐含三个预期：产品收入30%+增速至200亿、IBI363/IBI343全球价值兑现、BD现金流持续。III期成功则仍有上行，玛仕度肽大幅低预期或IBI363不及II期则20-30%回调不意外。结语 信达是中国创新药BD模式的标杆。从2015年礼来5,600万美元买走信迪利单抗海外权益，到2025年武田114亿美元Co-Co下注IBI363，十年间完成了从"被授权方"到"全球共开发伙伴"的身份转换。18款获批、302亿现金、首次年度盈利，构成中国Biotech最扎实的基本面之一。 但330亿BD总额是"期权"而非"现金"，里程碑兑现要靠临床数据一步步验证。IBI363的MarsLight-11 III期是未来2-3年最大单一变量——成功则中国首个肿瘤免疫全球FIC商业化资产落地，失败则武田114亿框架面临重估。从PD-1卷王到百亿美元BD机器，信达证明了一件事：一个能持续产出优质资产、让全球Top Pharma反复开支票的研发引擎，本身就是最深的护城河。