Azercabtagene Zapreleucel

Second quarter 2026 total global revenue of approximately $240 million, including BRIUMVI U.S. net product revenue of approximately $228 million Raises full year 2026 total global revenue target to approximately $950 million and raises full year 2026 BRIUMVI U.S. net product revenue target to approximately $890 - 905 million Conference call to be held today, Monday, August 3, 2026, at 8:30 AM ET NEW YORK, Aug. 03, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the second quarter of 2026, along with recent company developments and provided an update on 2026 financial guidance. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, “The second quarter of 2026 was another strong quarter for TG Therapeutics. BRIUMVI delivered another outstanding commercial quarter, exceeding our expectations once again and putting us on track to exit 2026 at an approximately $1 billion annualized U.S. BRIUMVI revenue run rate. Mr. Weiss continued, “Beyond our commercial performance, we continued to expand the long-term opportunity for BRIUMVI with positive Phase 3 ENHANCE results supporting a simplified initiation regimen, encouraging progress in our subcutaneous BRIUMVI program, advancement into myasthenia gravis and schizophrenia, and continued momentum across our azer-cel cell therapy platform. As BRIUMVI continues to grow, it is becoming the foundation of a broader company focused on advancing innovative therapies for immune-mediated diseases. The progress we made this quarter reinforces our confidence in our strategy and our ability to create long-term value for both patients and shareholders.” Recent Highlights & Developments BRIUMVI ® (ublituximab-xiiy) Commercialization BRIUMVI U.S. net product revenue of $227.7 million for the second quarter 2026, representing approximately a 64% increase over the same period last year Total global revenue of $240.3 million for the second quarter 2026 Subcutaneous BRIUMVI Announced positive pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability data from a Phase 1 clinical trial evaluating a subcutaneous formulation of ublituximab (the active agent in BRIUMVI) as compared to IV BRIUMVI Subcutaneous BRIUMVI demonstrated mean bioavailability of greater than 60% relative to IV administration in the Phase 1 trial PK modeling and simulation informed by the Phase 1 bioavailability data support the quarterly subcutaneous dosing regimen that is being evaluated in the fully enrolled Phase 3 trial Top-line Phase 3 data is expected year-end 2026 or early 2027 Positive Topline Phase 3 ENHANCE Data Announced positive topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI in adults with RMS The ENHANCE trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI initiation infusion dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion. BRIUMVI in Myasthenia Gravis Announced positive topline phase 1 data for subcutaneous BRIUMVI in patients with myasthenia gravis (MG) Initiated a potentially registration-directed randomized phase 2 clinical trial evaluating IV BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG BRIUMVI in Schizophrenia Initiated a Phase 2 clinical trial evaluating BRIUMVI in adults with treatment-resistant schizophrenia 2026 Financial Guidance Update Raises full year 2026 target total global revenue to approximately $950 million Raises full year 2026 target BRIUMVI U.S. net product revenue to approximately $890 - $905 million Full year 2026 target operating expense, defined as R&D and SG&A, of approximately $350 - $400 million excluding non-cash compensation, in addition to approximately $100 million in expenses associated with the subcutaneous BRIUMVI manufacturing costs and secondary manufacturer start-up costs 2026 Remaining Development Pipeline Anticipated Milestones Present full results from the Phase 3 ENHANCE trial combining Day 1 and Day 15 doses of IV BRIUMVI Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026 Announce topline Phase 3 data for subcutaneous BRIUMVI year-end 2026/first quarter 2027 Financial Results for Second Quarter 2026 Product Revenue, net : Product revenue, net was $235.8 million and $437.1 million for the three and six months ended June 30, 2026, respectively, compared to $138.8 million and $258.5 million for the three and six months ended June 30, 2025, respectively. Product revenue, net consists primarily of net product sales of BRIUMVI in the United States, which totaled $227.7 million and $422.5 million during the three and six months ended June 30, 2026. Also included in product revenue, net for the three and six months ended June 30, 2026 are sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $8.1 million and $14.6 million, respectively. License, milestone, royalty and other revenue : License, milestone, royalty and other revenue was approximately $4.5 million and $8.1 million for the three and six months ended June 30, 2026, respectively, compared to approximately $2.3 million and $3.5 million for the three and six months ended June 30, 2025. License, milestone, royalty and other revenue for the three and six months ended June 30, 2026 is predominantly comprised of $3.6 million and $6.3 million, respectively, of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm, and $0.9 million and $1.8 million, respectively, of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement. R&D Expenses : Total research and development (R&D) expense was approximately $95.3 million and $143.7 million for the three and six months ended June 30, 2026, compared to $31.8 million and $78.1 million for the three and six months ended June 30, 2025. During the three and six months ended June 30, 2026 we incurred approximately $54.6 million and $58.8 million, respectively related to subcutaneous manufacturing and secondary manufacturer expenses. The period over period increase in R&D was also attributable to higher clinical trial-related expenses associated with our development pipeline during the period. SG&A Expenses : Total selling, general and administrative (SG&A) expense was approximately $82.1 million and $170.3 million for the three and six months ended June 30, 2026, compared to $55.6 million and $105.9 million for the three and six months ended June 30, 2025. The increase in selling, general and administrative costs during the three and six months ended June 30, 2026 was primarily due to an increase in marketing and media spend, and personnel costs associated with the commercialization of BRIUMVI. Net income: Net income was $7.8 million and $27.6 million for the three and six months ended June 30, 2026, respectively, compared to net income of $28.2 million and $33.2 million for the three and six months ended June 30, 2025. Cash Position and Financial Guidance : Cash, cash equivalents and investment securities were $612.3 million as of June 30, 2026. We anticipate that our cash, cash equivalents and investment securities as of June 30, 2026, combined with the projected revenues from BRIUMVI, will be sufficient to fund our business based on our current operating plan. CONFERENCE CALL INFORMATION The Company will host a conference call today, August 3, 2026, at 8:30 AM ET, to discuss the Company’s financial results from second quarter of 2026. To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company's website at . An audio recording of the conference call will also be available for a period of 30 days after the call. ABOUT BRIUMVI ® (ublituximab-xiiy) 150 mg/6 mL Injection for IV BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features. A list of authorized specialty distributors can be found at . IMPORTANT SAFETY INFORMATION Contraindications: BRIUMVI is contraindicated in patients with: Active Hepatitis B Virus infection A history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies. If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19 + B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration. Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury. Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit ABOUT BRIUMVI PATIENT SUPPORT in the U.S. BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at ABOUT MULTIPLE SCLEROSIS Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS. 1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS. 1 ABOUT TG THERAPEUTICS TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI ® (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit , and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn . BRIUMVI ® is a registered trademark of TG Therapeutics, Inc. Cautionary Statement This press release contains forward-looking statements that involve a number of risks and uncertainties. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy, and objectives for future operations may constitute forward-looking statements. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward looking statements include but are not limited to statements regarding our plans, business strategies and operations related to the commercialization of BRIUMVI ® (ublituximab-xiiy) for RMS in the United States, or any jurisdictions outside of the United States; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; expectations of future revenue for BRIUMVI, or TG expenses or profit estimates or targets; our ability to execute our share repurchase program; expectations and timing for our clinical trials of subcutaneous ublituximab (the active ingredient in BRIUMVI), and sometimes referred to as subcutaneous BRIUMVI; expectations and timing for our ENHANCE Phase 3 pivotal program to evaluate a consolidated day 1 and day 15 dosing regimen for IV BRIUMVI; and expectations and timing for any of our pipeline products or programs, including Azer-cel or BRIUMVI in MG. Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to commercialize BRIUMVI; the risk that trends in prescriptions are not maintained or that prescriptions are not filled; the failure to obtain and maintain payor coverage; the risk that HCP interest in BRIUMVI will not be sustained; the risk that momentum in sales for BRIUMVI will not be sustained during the course of the year; the risk that the commercialization of BRIUMVI does not continue to exceed expectations; the risk that our BRIUMVI revenue targets will not be achieved; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variations from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for our clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that the Company does not achieve its 2026 development pipeline anticipated milestones or goals in the timeframe projected or at all, including (i) completing a pivotal program for subcutaneous ublituximab, (ii) completing a pivotal program based on data from the ENHANCE trial to consolidate day 1 and day 15 dosing, (iii) enrolling patients into a trial evaluating BRIUMVI in MG or schizophrenia, or (iv) enrolling patients into a trial evaluating azer-cel; the risk that clinical trial data readouts may be delayed due to a number of factors including enrollment, data collection, data maturity or other factors; the risk that the subcutaneous Phase 3 program will not be successful or if successful still will not be approved by the FDA or achieve commercial acceptance; the risk that, if subcutaneous BRIUMVI is approved, the anticipated expansion of the addressable market will not be realized; the risk that the ENHANCE Phase 3 trial will not be successful or if successful will not be approved by the FDA or achieve commercial acceptance; the risk that we will not move forward with the development of BRIUMVI in MG or schizophrenia and azer-cel in progressive MS following preliminary studies; the uncertainties generally inherent in research and development and early stage exploratory programs; the risk that the collaboration with Christina Applegate is not able to be implemented or does not go as planned for regulatory or other reasons; the risk that the platform does not gain traction or ceases to exist; regulatory developments, legislative actions, executive orders, including the imposition of tariffs and policy changes in the U.S. and other jurisdictions; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our other filings with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor Relations Email: ir@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option 4 Media Relations: Email: media@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website. . Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Data monitor p. 236. TG Therapeutics, Inc. Selected Condensed Consolidated Financial Data Statements of Operations Information (in thousands, except share and per share amounts; unaudited): Three months ended Six months ended June 30, June 30, 2026 2025 2026 2025 Revenue: Product revenue, net $ 235,794 $ 138,843 $ 437,102 $ 258,498 License, milestone, royalty and other revenue 4,541 2,305 8,151 3,506 Total revenue $ 240,335 $ 141,148 $ 445,253 $ 262,004 Costs and expenses: Cost of revenue 41,194 18,938 74,704 34,479 Research and development: Stock-based compensation 8,070 4,318 12,945 7,649 Other research and development 87,267 27,464 130,788 70,495 Total research and development 95,337 31,782 143,733 78,144 Selling, general and administrative: Stock-based compensation 19,805 12,044 34,880 23,684 Other selling, general and administrative 62,325 43,541 135,467 82,232 Total selling, general and administrative 82,130 55,585 170,347 105,916 Total costs and expenses 218,661 106,305 388,784 218,539 Operating income 21,674 34,843 56,469 43,465 Other expense (income): Interest expense 16,572 6,716 24,238 13,473 Loss on extinguishment of debt — — 9,153 — Other income (5,132 ) (2,793 ) (7,519 ) (6,396 ) Total other expense 11,440 3,923 25,872 7,077 Net income before taxes $ 10,234 $ 30,920 $ 30,597 $ 36,388 Income tax expense (2,453 ) (2,733 ) (3,039 ) (3,141 ) Net income $ 7,781 $ 28,187 $ 27,558 $ 33,247 Net income per common share: Basic $ 0.05 $ 0.19 $ 0.19 $ 0.23 Diluted $ 0.05 $ 0.17 $ 0.17 $ 0.20 Weighted-average shares of common stock outstanding Basic 141,770,283 146,739,833 143,097,453 146,708,980 Diluted 157,281,850 162,559,404 158,664,407 162,528,551 Condensed Balance Sheet Information (in thousands): June 30, 2026 (Unaudited) December 31, 2025* Cash, cash equivalents and investment securities 612,253 199,511 Total assets 1,639,629 1,063,253 Total equity 604,083 648,020 * Condensed from audited financial statements

• • • • • • • • • 2026.06.10 • • • • • • • • • GSK以106亿美元收购Nuvalent，加码肺癌精准治疗赛道 GSK宣布以106亿美元（每股124美元，溢价40%）全现金收购临床阶段生物制药公司Nuvalent，获得三款聚焦非小细胞肺癌的靶向药物。其中ROS1抑制剂zidesamtinib和ALK抑制剂neladalkib均已获FDA突破性疗法认定，正处于FDA审评中，PDUFA日期分别为2026年9月和11月。这是GSK十年来最大并购交易，预计2027年起贡献营收。 来源：GSK官网 | 2026-06-09 中国NEO脑机接口获NMPA全球首次商业批准，比Neuralink更快 中国NMPA批准NeuraMatrix与清华大学联合开发的NEO脑机接口设备商业化上市，这是全球首次有国家监管机构批准侵入式脑机接口设备的商业销售，比马斯克的Neuralink更早获批。NEO采用半侵入式设计，8个传感器置于硬脑膜而非脑实质，安全性更高。该设备已纳入国家医保，首例植入患者已恢复书写能力。 来源：TNW | IB Times | 2026-06-08 Imviva CTA313获FDA IND批准，CD19/BCMA双靶点异体CAR-T进军自身免疫 Imviva Biotech宣布FDA批准其CTA313（CD19/BCMA双靶点异体CAR-T）的IND申请，用于治疗B细胞介导的自身免疫性疾病，包括SLE、MS和AE。该产品基于公司专有ANSWER™平台，采用创新篮子设计，可同时评估多个适应症的安全性和疗效。 来源：Health Technology Net | 2026-06-09 Imugene Azer-cel获FDA快速通道资格，异体CAR-T治疗血液肿瘤 Imugene宣布其异体CAR-T产品Azer-cel获FDA授予快速通道资格，用于治疗复发或难治性CLL/SLL和MZL。快速通道资格将加快该疗法的开发和审评进程，促进更频繁的FDA沟通。 来源：Middle News | 2026-06-09 OriCell GPC3 CAR-T获NMPA批准进入确证性II期临床 OriCell宣布其GPC3靶向CAR-T疗法获NMPA批准开展确证性II期临床试验，用于治疗晚期肝细胞癌。这是中国细胞治疗领域的又一重要里程碑，标志着该产品向商业化迈出关键一步。 来源：Morningstar/PR Newswire | 2026-06-08 俄罗斯首次利用BMCP技术成功修复声带 俄罗斯谢切诺夫大学临床中心完成全球首例利用个体化生物医学细胞产品（BMCP）修复声带的手术。该技术基于患者自体间充质基质细胞球，通过微创方式经喉部注入损伤区域，无需外部切口。细胞球为三维细胞结构，植入后存活时间更长，持续支持损伤区域再生，最终被患者自身组织替换，恢复声带自然结构和振动功能。首例患者手术成功，恢复进展良好。 来源：Izvestia | 2026-06-09 山东省脐血库脐血NK细胞治疗神经母细胞瘤项目完成818号令备案：全国首例 山东省脐血库与中山大学肿瘤防治中心联合开展的脐血NK细胞治疗高危、复发/难治性神经母细胞瘤I期临床研究项目，正式通过国家卫健委全流程审核，成为818号令实施后全国首个成功备案的脐血NK细胞治疗儿童肿瘤项目（备案号MR-N-44-2026-000004）。中国生物技术发展中心已审批149个项目，仅13个获批，通过率不足10%。临床前研究已发表于OncoImmunology，证实脐血NK细胞联合GD2单抗具有协同抗肿瘤效应。 来源：齐鲁壹点 | 2026-06-09 再鼎医药缇乐获批宫颈癌适应症，中国首款宫颈癌ADC药物 再鼎医药缇乐（维替索妥尤单抗）获NMPA批准用于化疗期间或之后进展的复发或转移性宫颈癌。缇乐是全球首个获FDA批准用于宫颈癌的ADC药物，也是中国首款且目前唯一获批用于宫颈癌的ADC药物。III期研究显示，与化疗相比，死亡风险降低45%。 来源：美通社 | 2026-06-09 复宏汉霖斯鲁利单抗获批胃癌围术期适应症，全球首个胃癌围术期抗PD-1 复宏汉霖斯鲁利单抗注射液新增适应症获NMPA批准，联合奥沙利铂和替吉奥用于PD-L1 CPS≥5的可手术切除胃癌患者的新辅助及术后辅助治疗。该方案是全球首个且目前唯一获批用于胃癌围术期治疗的抗PD-1单抗，实现了术后免疫单药替代传统辅助化疗。 来源：美通社 | 2026-06-09 石药集团GLP-1长效注射液获FDA批准临床，每月给药一次 石药集团宣布其自主研发的GLP-1受体激动剂司美格鲁肽长效注射液（SYH9017）获FDA批准在美国开展临床试验，用于成人超重或肥胖患者的体重管理。该产品为每月给药一次的长效制剂，依托公司长效递送技术平台，皮下注射后可形成凝胶库实现药物长效递送。 来源：PR Newswire | 2026-06-09 Smith+Nephew CORI XT手持机器人完成首批临床病例，含全球首例机器人肩关节置换 Smith+Nephew宣布其下一代CORI XT手持机器人平台在膝盖和肩膀关节置换手术中完成首批临床病例。全球首例机器人肩关节置换手术由杜克健康中心完成，使用CORI SHOULDER系统结合AETOS肩关节系统。CORI XT平台可覆盖从部分到翻修膝关节、髋关节及肩关节。 来源：BioSpace | 2026-06-09 讯飞星火医疗大模型V3.5发布，全国产算力支撑多模态突破 讯飞医疗正式发布基于全国产算力训练的星火医疗大模型V3.5，聚焦临床诊疗与居民健康管理两大刚需场景。三大核心突破：①深度融合医疗语音识别、影像辅诊和医学语义理解的多模态能力，业界首次突破远场多角色语音识别与病历自动生成实用门槛；②率先在国产算力平台实现长文本高效训练，推理吞吐量提升4.5倍；③循证思维链强化学习驱动医疗智能体能力全面升级。据IDC 2026测评，综合实力行业榜首。 来源：上证报 | 2026-06-09 飞利浦2026未来健康指数报告：AI从承诺走向临床实践 飞利浦发布2026未来健康指数美国报告，基于2000+医护人员和20000+患者调研。核心发现：36%医护人员表示AI提升了接诊能力；49%医护人员年节省至少132小时（相当于3个完整工作周）；27%医护人员借助AI发现或预防潜在医疗错误；74%临床医生表示过去一年AI工具使用量增加。报告标志着AI正从概念验证进入规模化临床实践阶段。 来源：Business Wire | 2026-06-09 礼来与AlzeCure达成超10亿美元授权合作，加码阿尔茨海默病 礼来与瑞典AlzeCure Pharma达成授权合作，获得阿尔茨海默病候选药物Alzstatin ACD680全球权益。ACD680为γ-分泌酶调节剂，旨在减少有害淀粉样蛋白Aβ42的产生，同时增加良性Aβ37/Aβ38蛋白。交易首付1000万美元，里程碑总额可能超过10亿美元，另有分层中个位数销售提成。 来源：FierceBiotech | 2026-06-09 三星1.75亿美元投资Element Biosciences，加码基因测序赛道 三星电子向Element Biosciences投资1.75亿美元，参与其扩大后的E轮融资。Element专注于新一代基因测序技术，旗下AVITI测序系统已覆盖40多个国家。本轮融资将支持AVITI Dx和AVITI24等新产品的商业化发布及全球市场扩张。 来源：Reuters/MarketScreener | 2026-06-09 Cartesian与WestGene达成体内CAR-T平台授权，推进自身免疫疾病治疗 Cartesian Therapeutics与中国WestGene Biopharma达成战略许可协议，共同开发体内CAR-T疗法用于自身免疫疾病。该合作结合Cartesian的Descartes-08 mRNA载荷与WestGene的靶向脂质纳米颗粒（tLNP）递送平台，无需体外细胞工程即可在体内生成CAR-T细胞。I期试验计划2026年下半年在全身型重症肌无力患者中启动。 来源：Nasdaq | 2026-06-09 本资讯仅供行业交流参考，不构成任何投资建议或医疗建议。内容来源于公开信息，我们力求准确可靠，但对信息的完整性和准确性不作任何保证。如需专业建议，请咨询相关领域专业人士。 — 2026.06.10 — IDT Frontier · Daily Pulse News