Acetaminophen

作者 | 凯西责编 | 遥望01美国将对药品征收关税？据央视新闻消息，当地时间4月8日，美国总统特朗普发表讲话称，美国将对药品征收关税，并于4月9日生效。特朗普在讲话中称：制药企业的大部分产品都在美国销售，若加税落地，他们将不得不从中国及全球其他地区撤离，并在美国本土设厂。受关税消息影响，4月9日，A股、港股生物医药类上市公司股价集体大跌。回顾2018年以来的美国对华医药关税政策，涉及的以医用耗材为主，多数原料药、制剂产品被排除在外。特朗普这一表态引发业内猜测，药品可能失去关税豁免权。截至目前，白宫网站指出，一些商品将不受“对等关税”的约束，包括：已经受到第232条关税约束的钢铝制品、汽车和汽车零部件，以及未来可能受到第232条关税约束的商品；铜、药品、半导体、木制品、黄金；在美国无法获得的能源和其他某些矿物等。《豁免此次从价税商品附录》显示，超过90%的医药产品（包括化药制剂、疫苗、抗体等生物制品）以及维生素类、氨基酸类等大宗原料药仍被纳入豁免清单，仅布洛芬、去甲伪麻黄碱等少数原料药未获豁免。在前期工作基础上，中国医药保健品进出口商会对照中国海关税则号梳理了豁免的医药产品及其相关税号：不过，白宫网站消息称，特朗普拥有“修改权限”，可以视情况提高或者降低关税。02一旦落地可能产生哪些影响？我国是全球最大的原料药生产国和出口国，据中国医药保健品进出口商会数据，2024年我国医药保健品进出口额合计1993.76亿美元，其中出口额1079.64亿美元，进口额914.12亿美元。在我国出口的产品中，体量最大的是西药类，达1064.52亿美元，其中原料药538.07亿美元，西成药297.76亿美元，生化药228.69亿美元；其次是医疗器械类（845.54亿美元），其中医院诊断与治疗占比最大（502.99亿美元），其次是一次性耗材（145.19亿美元），保健康复用品（116.40亿美元），医用敷料（45.44亿美元），口腔设备与材料（35.52亿美元）。从国别来看，多年来美国一直位居我国出口最大规模的单一市场，同时，美国也是我国医药产品第一大进口市场。具体来看，2024年，我国对美国的医药贸易出口额为190.47亿美元，其中医疗器械类达117.58亿美元，西药达64.25亿美元，中药8.7亿美元；至于中国从美国进口的医药商品总额达150.57亿美元，医疗器械类达85.24亿美元，西药类为63.33亿美元，中成药为2.02亿美元。虽然中国对美国在医药贸易中处于顺差地位，但是差距约39.9亿美元，不算太大，且从商品附加值的角度考虑，美国出口的产品附加值更高。印度和美国是我国原料药出口的前两大市场。根据美国官方披露的数据，美国80%的原料药依赖进口，主要来源于我国与印度。美国市场95%的布洛芬、91%的氢羟肾上腺皮质素、70%的对乙酰氨基酚，以及40%以上的青霉素和肝素原料药均依赖我国。不少业内人士认为，美国对我国医药市场的依赖短期内难以改变。相关专家指出，如果美国想摆脱原料药主要依赖我国的局面，在遵循市场规律的基础上，发展美国本土生产体系至少需要10年的时间。此外，美国“药荒”频发，往往寻求从我国紧急进口药品加以解决。今年3月4日，美国药典（USP）发布了其首份易短缺药物清单（Vulnerable Medicines List，简称VML），该清单详细列出了截至2024年10月可能面临供应中断风险的100种药物——其中，49种为慢性病治疗所需，51种则用于急性护理，涉及氯化钠注射液、葡萄糖注射液、肝素钠注射液、异丙酚注射乳剂和盐酸利多卡因注射液、甲氨蝶呤注射液等。中邮证券在一份研究报告中也指出，美国约30%的药品原料依赖中国进口，若既有关税持续，可能导致美国药企成本上升，进而推动其寻求替代来源(如印度)。但印度70%原料药依赖中国，短期内难以替代，中国仍具议价权。中国化学制药工业协会在《2020年中国化学制药行业经济运行报告》中也曾指出，美国的医药市场发展比较成熟，在过去数十年内，已将低附加值、会造成较大污染的原料药生产转移到其他新兴市场。中国是美国主要的原料采购国之一。短期内，中美贸易摩擦会造成出口订单总量下降。但长期来看，这种影响还会反过来转嫁到美国本土医药企业身上，原料药价格上升，制剂产品价格也会水涨船高。至于中药类产品（2024年数据显示，在出口比例上，植物提取物占56.9%，中药材及饮片占22.7%，保健品为12.4%，中成药仅7.5%——主要出口产品为片仔癀、清凉油、安宫牛黄丸、六味地黄丸等经典品种），进出口国家主要集中在亚洲，预计受关税冲突影响有限。03部分细分领域或有利好？据中国医药保健品进出口商会的数据，长期以来，我国医药产品外贸出口主要由医疗器械和原料药产品驱动，而部分国产化率依旧偏低的产品，例如诊断试剂、高值耗材、高端医疗装备及其关键零部件，仍然是我国医疗器械的主要进口品类，如弥补生理缺陷、残疾用器具，缝合用针，血管支架，心脏起搏器，手术机器人等。多家券商指出，如果关税冲突升级，可能加速高端医疗器械国产替代。此外，中国医药保健品进出口商会数据显示，生化药是我国进口医药产品的主要类别，免疫制品、人用疫苗、血液制品和抗血清等三类仍为生化药品主要进口产品，进口所占比重分别为49.26%、25.94%和14.15%从资本市场的反应来看，4月7日，全球股市巨震，A股、港股大量医药上市公司股价下跌，然而也有个别股票不跌反涨——以卫光生物、派林生物、博雅生物、天坛生物为代表的血制品概念股拉升。有券商指出，在生物医药领域，关税反制措施将利好国产替代进程加速。全球供应链的重构并非一蹴而就。中国医药保健品进出口商会对外合作部张小会在《中国医药报》发表的一篇文章就指出，在原料药和制剂产品的产业链环节，中美两国形成了较强的互补关系。在产业分工上，美国医药产业注重创新，专注于创新药研发、高端医疗器械生产以及全球市场拓展，位居产业链高端环节，能够创造高附加值的产品和服务。我国侧重生产制造，在原料药生产、仿制药制造以及药品大规模生产上具有优势，能够为美国医药企业提供生产制造方面的支持。在市场规模上，目前我国已成为仅次于美国的全球第二大医药市场，对于跨国药企的吸引力不减；且我国还是全球第一大原料药生产国、仿制药大国、中低端医疗器械主要生产国，医药创新总体实力居第二位，供应链完备、稳定且韧性强，药械产品国产替代水平日渐提高，面对关税冲突，虽然难免受到影响，但是相信压力可控。数据来源：中国医药保健品进出口商会；参考文章：《稳中有变，在变局中探寻新机遇 ——未来四年特朗普新任期内中美医药合作走势分析》，作者单位：中国医药保健品进出口商会对外合作部 张小会，原载于《中国医药报》2024年11月14日3版。END内容沟通：郑瑶（13810174402）

NEW YORK, April 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2025 annual meeting. Links to each presentation are included below. Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, "We were pleased to share three presentations yesterday which we believe demonstrate our continued commitment to improving the patient experience and understanding the long term and real-world profile of BRIUMVI.” Mr. Weiss continued, “The results of the retrospective ENAMOR survey, which includes data from approximately 400 individuals across 21 MS centers who have been treated with BRIUMVI in the real-world setting, showed a favorable tolerability profile, including a lower rate of infusion related reactions at the first BRIUMVI dose than was observed in the ULTIMATE Phase 3 trials. Interestingly, approximately 90% of surveyed patients were given acetaminophen as a pre-medication in this real-world setting, whereas it was excluded as a premed as per protocol in the ULTIMATE Phase 3 trials potentially offering a rationale for the lower rate of infusion related reactions observed. We plan to further evaluate the efficacy and tolerability of BRIUMVI in the real world setting through the ENABLE Phase 4 96-week observational study which will enroll approximately 500 patients across approximately 100 MS centers in the United States. Lastly, we were encouraged to see in the presentation by Dr. Steinman, that after five years of BRIUMVI treatment, the frequency of serious infections remained consistent with the ULTIMATE Phase 3 trials and there were no observed cases of PML.” TG PRESENTATIONS: Poster Title: Retrospective Evaluation of Infusion Tolerability: Ublituximab Real-World Observational Survey (ENAMOR) Lead Author: Dr. Ed Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Poster Title: ENABLE: The First Phase 4 Observational Study for Patients with Relapsing MS Treated with Ublituximab in Real World Clinical Setting Lead Author: Dr. Ed Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Poster Title: No Association Between Decreases in Serum Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN) and Serious Infections (SI) with Long-term Ublituximab (UBL) Treatment in Patients with Relapsing Multiple Sclerosis (RMS) Lead Author: Lawrence Steinman, MD, Standford University, Standford, CA The above presentations are also available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm. ABOUT THE ULTIMATE I & II PHASE 3 TRIALS ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248). 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 for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease. A list of authorized specialty distributors can be found at www.briumvi.com. 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): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies 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. A pregnancy test is recommended in females of reproductive potential prior to each infusion. 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. 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 www.briumvi.com. ABOUT BRIUMVI PATIENT SUPPORT 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 www.briumvipatientsupport.com. 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, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit www.tgtherapeutics.com, 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. 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 the results of the ULTIMATE I & II Phase 3 studies, the ENHANCE Phase 3b study, and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II or ENHANCE trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of 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 BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company’s reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical 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 failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements; the uncertainties inherent in research and development; and general political, economic and business conditions, including the risk that the ongoing COVID-19 pandemic could have on the safety profile of BRIUMVI and any of our other drug candidates as well as any government control measures associated with COVID-19 that could have an adverse impact on our research and development plans or commercialization efforts. 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, 2024 and in our other filings with the U.S. Securities and Exchange Commission. 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 www.tgtherapeutics.com. 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: https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p.236.