Ozanimod Hydrochloride

The positive FDA feedback allows for: A novel Phase 2 RHB-204[1] study, planned to be the first ever clinical study in a specifically defined Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease (CD) patient population Groundbreaking approach testing MAP as a root cause of CD, supporting RHB-204 as a potential paradigm-shifting therapy treating both the suspected cause of Crohn's disease and its symptoms RedHill has initiated two new collaborations with leading academic centers utilizing cutting-edge rapid and accurate MAP detection diagnostics – the lack of which has previously been a major barrier to advancing the Company's novel anti-MAP Crohn's disease program Innovative design enables a smaller sample size allowing for lower study costs and faster time to completion Funding for this ground-breaking program expected to be non-dilutive; Grant application submitted and discussions ongoing for additional non-dilutive financing Patent protected through 2041, orally-administered RHB-204, a next-generation optimized formulation of RedHill's RHB-104 designed to further enhance tolerability, safety and patient adherence, is supported by positive RHB-104[2] Phase 3 safety and efficacy results, which delivered a statistically significant 64% improvement in efficacy[3] Expected transferal of pediatric orphan drug designation to RHB-204 as well as potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher The multibillion-dollar Crohn's disease market is expected to expand significantly, with sales in the key markets growing from $13.6 billion in 2024 to over $19 billion in 2033[4], presenting significant commercial potential for new, paradigm changing, FDA-approved therapies RALEIGH, N.C. and TEL AVIV, Israel, July 21, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received positive feedback from the U.S. Food and Drug Administration (FDA), following a scheduled Type C meeting, in which the FDA provided guidance on the pathway to approval for the Company's potentially groundbreaking RHB-204 Crohn's disease (CD) development program. The positive FDA feedback allows for the planned RHB-204 Phase 2 study to be the first ever clinical trial in Crohn's disease to test a specifically defined population of Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) CD patients. Testing MAP as a root cause of Crohn's, this groundbreaking approach could potentially make RHB-204, if approved, a paradigm-shifting new therapy treating both the suspected cause of the disease and its symptoms. A major hurdle in previous clinical studies for new therapies directed at MAP has been the ability to rapidly and accurately detect MAP – one of the slowest growing bacteria on the planet. The Company is collaborating with two leading academic centers for the provision of cutting-edge MAP detection diagnostics, supporting the study's novel design and the potential future commercial application of RHB-204. The Phase 2 study is expected to have primary endpoints of mucosal remission (considered by FDA as a new gold standard in efficacy evaluation in Crohn's disease), correlated with MAP status and clinical remission, per FDA guidance. These endpoints are supported by the positive RHB-104 Phase 3 study safety and efficacy results. The endpoints and expected use of imaging and cutting-edge MAP detection methods to correlate mucosal healing with MAP infection eradication, enable a potentially smaller sample size allowing for substantially lower study costs and faster time to completion. Patent protected until 2041, RHB-204, is a novel next-generation optimized formulation of Phase 3-stage RHB-104, designed to support enhanced tolerability, safety and adherence, with a 40% pill burden reduction, and thus, potentially, better outcomes. The development of RHB-204 is supported by a strong foundation of clinical efficacy and safety data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD, which successfully met its primary and secondary endpoints, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone. The data from this study, published in the peer-reviewed journal, Antibiotics[5], also demonstrated the safety and efficacy of concomitant use of RHB-104 with anti-TNFs, immunomodulators and steroids, suggesting that RHB-204 could be a transformative safe and effective, stand-alone or combination, oral therapy. Up to 40% of CD patients fail to respond to anti-TNF treatment, and over time a similar number of responders lose response and have disease flare-ups[5]. Additionally, many existing treatment options are both expensive and intravenously administered, further increasing the cost burden. Moreover, several of these existing therapies have known safety issues, including Black Box Warnings. A safe and effective orally administered therapy would provide a welcome alternative approach. The CD market is expected to expand significantly over the 2024–2033 forecast period, with sales in the United States, Japan, and five major European markets, growing from $13.6 billion to $19.1 billion at a compound annual growth rate (CAGR) of 3.87%[4]. Funding for this ground-breaking program is expected to be non-dilutive. RedHill is actively pursuing partnering and collaborations for this program, including via an innovation development grant application already submitted and ongoing discussions with non-dilutive external funding sources. RHB-204 is expected to benefit from the transferal of pediatric orphan drug designation from RHB-104 and, where applicable, the Company intends to explore the potential for additional regulatory process designations, such as breakthrough therapy designation and fast track designations that may provide additional exclusivity or potential for priority review vouchers. About Crohn's Disease Crohn's disease (CD) is a form of Inflammatory Bowel Disease (IBD) causing inflammation of digestive tract tissue that can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. CD can be highly debilitating and remains a serious burden for both patients and healthcare systems: destroying quality of life and even leading to life-threatening complications. There is no known cure for Crohn's disease. According to the Cleveland Clinic, experts estimate that more than three-quarters of a million Americans and approximately 6-8 million people globally have Crohn's disease Commonly used FDA-approved therapies in the treatment of CD include: Abbvie's Humira® (adalimumab), Janssen's Remicade® (infliximab) and Stelara® (Ustekinumab), BMS's Zeposia® (ozanimod) and Pfizer's Xeljanz® (tofacitinib). About RHB-204 RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat Mycobacterium avium subspecies paratuberculosis-positive (MAP-positive)-related Crohn's disease. Patent protected until at least 2041, and with an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104), RHB-204 is a next-generation formulation of RHB-104 with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD. Originally developed for the treatment of pulmonary NTM disease caused by MAC, RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. RedHill has protection for RHB-204, and its use in treating pulmonary MAC disease, until 2041. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia, for the treatment of Helicobacter pylori (H. pylori) infection in adults[6], with submission planned for marketing authorization in other territories. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. Government and academic collaborations for development for radiation and chemical exposure indications such as Gastrointestinal-Acute Radiation Syndrome (GI-ARS), a Phase 2 study in prostate cancer in combination with Bayer's darolutamide and a Phase 2/3 program for hospitalized COVID-19 patients; (ii) RHB-204, an all-in-one, fixed-dose, orally administered, combination antibiotic therapy with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacterial (NTM) disease; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to regain and maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. 1. RHB-204 is an investigational new drug, not available for commercial distribution in the United States. 2. RHB-104 is an investigational new drug, not available for commercial distribution in the United States. 3. Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. doi: 10.3390/antibiotics13080694. PMID: 39199994; PMCID: PMC11350828. 4. DataMonitor - Disease Analysis: Crohn's Disease, September 2024. 5. Singh S, George J, Boland BS, Vande Casteele N, Sandborn WJ. Primary Non-Response to Tumor Necrosis Factor Antagonists is Associated with Inferior Response to Second-line Biologics in Patients with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis. J Crohns Colitis. 2018 May 25;12(6):635-643. doi: 10.1093/ecco-jcc/jjy004. PMID: 29370397; PMCID: PMC7189966. 6. Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Category: R&D Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Logo: SOURCE RedHill Biopharma Ltd. 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编者按：多发性硬化（MS）是一种致残性自身免疫性中枢神经系统疾病。过去十多年间，多款新兴疗法获监管机构批准治疗MS，极大改善了患者的生存状况。作为医药和生命科学产业创新的赋能者，药明康德很高兴能为来自合作伙伴的多款MS新药提供赋能支持。但这一领域仍然存在未被满足的临床需求，新药研发面临诸多挑战。当前产业界正在不断寻求新型疗法，致力于为患者带来更安全、有效、便利的治疗选择。药明康德也将持续以一体化、端到端的CRDMO模式为全球合作伙伴提供从研究、开发到生产的全链条服务，助力加速创新疗法的问世，造福病患。今年上半年，多发性硬化（multiple sclerosis，MS）新药研发领域迎来了多项进展。3月，赛诺菲（Sanofi）宣布其BTK抑制剂tolebrutinib的上市申请已获得美国FDA授予优先审评资格，以治疗非复发性继发进展型多发性硬化症（nrSPMS），并延缓成人患者独立于复发活动的残疾进展。若获得批准，tolebrutinib有望成为首款既能治疗nrSPMS，又能减缓残疾累积而不受复发活动影响的脑穿透性BTK抑制剂。行业媒体也将这款疗法列入“2025年有望上市的10款潜在重磅疗法”。 4月，Immunic公司公布了其潜在first-in-class疗法——核受体相关1（Nurr1）激活剂vidofludimus calcium（IMU-838）在进展型多发性硬化症（PMS）患者中开展的2期CALLIPER试验的积极数据。与安慰剂相比，IMU-838将基于扩展残疾状态量表变化的24周确认残疾恶化事件的相对风险降低了20%。5月，罗氏（Roche）与旗下基因泰克（Genentech）也公布其BTK抑制剂fenebrutinib在复发型多发性硬化（RMS）患者中96周的最新研究数据。分析显示，患者在使用该药治疗近两年后的复发率低，脑部无活动性病灶，且功能障碍无进展。此外在细胞疗法领域也有一些进展，例如百时美施贵宝2月公布了其在研CD19靶向CAR-T细胞疗法的最新临床研究数据，该产品在复发缓解型多发性硬化（RRMS）患者中显示出良好的初始安全性。图片来源：123RF新一代疗法涌现，它们如何改变多发性硬化治疗作为一种复杂的神经退行性疾病，MS因较高复发率和高致残率给患者，尤其是青壮年，带来了严重的疾病负担。根据多发性硬化国际联合会（MSIF）2025年4月发布的数据，目前全球超过280万人罹患多发性硬化。过去十年间，有近10款新药获FDA批准治疗MS。这其中主要包括两类新机制药物，即靶向CD20阳性B细胞的单抗药物和S1P受体调节剂。抗CD20单抗如ofatumumab、ocrelizumab等，通过与B细胞表面的CD20结合，达到从血液循环中清除B细胞的效果。而这些细胞在MS患者中对激发自身免疫反应有重要作用。另一类是以ozanimod、siponimod为代表的第二代S1P受体调节剂。S1P是调节淋巴细胞迁移出淋巴结的信号，S1P受体调节剂可降低迁移到中枢神经系统、攻击髓鞘的炎症性淋巴细胞的数量，减轻髓鞘的损伤。第二代S1P受体调节剂能够有选择性地与S1PR1和S1PR5受体亚型结合，在降低血液和淋巴循环中的淋巴细胞数目，减少中枢神经系统的炎症反应的同时，降低可能出现的副作用。尽管过去二十年MS治疗取得显著进展，但疾病的高度异质性和血脑屏障的存在，使得现有疗法在长期疾病控制和神经保护方面仍面临挑战。针对这些挑战，研究人员正在探索包括BTK抑制剂、抗体疗法、细胞疗法等在内的新机制创新疗法。公开资料显示，目前全球范围内有数十款新药在临床阶段探索治疗MS的潜力。其中少数几款产品进入3期临床阶段，包括多款脑穿透性BTK抑制剂，CD40L靶向单抗、神经保护转录因子Nurr1激活剂等等。此外，多款细胞疗法也在临床研究中展现出治疗MS的潜力。图片来源：123RFBTK抑制剂在MS的治疗潜力备受关注。现有的MS疗法主要针对外周炎症，它们在穿透中枢神经系统（CNS）的能力方面受到限制，因此开发能够跨越血脑屏障、靶向CNS内炎症的新疗法，成为MS新药开发的未来方向。目前，多款可穿越血脑屏障的BTK抑制剂正在临床阶段探索治疗MS的潜力。以tolebrutinib为例，该产品能够穿过血脑屏障，达到治疗性脑脊液浓度，使其能够调节中枢神经系统内的b淋巴细胞和疾病相关的小胶质细胞。这使得该产品能够靶向导致神经变性和残疾积累的炎症过程来治疗进展性MS。临床3期试验结果表明，与安慰剂相比，tolebrutinib可将非复发性继发进展型多发性硬化（nrSPMS）出现6个月确认残疾进展（CDP）的时间延缓31%。目前，全球还有多款具血脑屏障穿透性的BTK抑制剂正在临床阶段探索治疗MS的潜力。进展较快的产品如诺华（Novartis）在研的BTK抑制剂瑞米布替尼片（remibrutinib）、罗氏在研的BTK抑制剂fenebrutinib、诺诚健华BTK抑制剂奥布替尼等，均已进入治疗MS的3期临床研究阶段。CAR-T细胞疗法也是MS的研发方向之一。据报道，CAR-T疗法的理论优势在于B细胞耗竭更有效，能更好地清除自身反应性B细胞，从而可能诱导缓解，甚至有可能治愈疾病。针对MS，CAR-T疗法还具有直接穿过血脑屏障的优势。例如，Kyverna Therapeutics早前宣布，在两名进展性多发性硬化患者的脑脊液中观察到其所开发的CD19靶向CAR-T疗法KYV-101细胞的存在和扩增，并且在一名患者中观察到鞘内抗体水平的下降，这意味着CAR-T细胞可以靶向中枢神经系统中的CD19阳性B细胞。在穿透血脑屏障方面，研究人员还在探索其他的新方向，比如转铁蛋白受体（TfR）作为一种促进跨越血脑屏障运输的蛋白质，可以优化药物在大脑中的递送。目前针对该靶点的新药已经在其他神经系统疾病中取得积极进展。文献指出，同时靶向TfR和MS治疗靶点（如CD20）有望增强多发性硬化新药的CNS特异性递送。突破血脑屏障限制，加速神经系统疾病新药研发创新多发性硬化是神经系统疾病的类型之一，其治疗药物的研发一直面临诸多挑战。在这一领域，药明康德凭借“一体化、端到端”的CRDMO服务平台，持续为包括多发性硬化在内的神经系统疾病疗法开发提供全方位支持，助力全球合作伙伴加速新药问世。比如在近年来获FDA批准的MS创新疗法中，就有多款得到了药明康德的赋能。在中枢神经系统（CNS）领域，药物研发的成功率显著低于其他治疗领域。数据显示，CNS药物研发的成功率只有8%，不及其他治疗领域药物研发成功率的一半。其中主要原因之一为血脑屏障（Blood to Brain Barrier, BBB）的特性阻碍了药物入脑，影响其在脑中的暴露量。因此，血脑屏障通透性研究对CNS药物的开发具有重要的意义。公开信息显示，药明康德DMPK自2009年起开始进行CNS相关研究，拥有超过15年的临床前CNS药物研发经验，建立了针对CNS药物体外血脑屏障通透性评价的特色且准确性较高的“漏斗”模型。对于主要通过被动扩散入脑的CNS药物，“漏斗”模型的评估准确性为100%。通过完善的体外、体内测试平台，药明康德DMPK能够快速、准确、高效地对CNS药物进行全方位药代动力学相关评价，筛选出具有良好的脑通透性及稳定性的CNS候选药物。根据早前公开信息，该平台已完成包括常规小分子、治疗性蛋白、寡核苷酸等新分子实体类型项目百余项，成功助力全球客户多个CNS药物进入临床阶段。当前，随着BTK抑制剂、细胞疗法等创新疗法的涌现，多发性硬化治疗正迎来新契机。在持续丰富的研发管线推动下，这一曾被视为不可控的慢性疾病，正逐步向可管理可控的长期病况转变，为全球患者带来新的曙光。药明康德将继续以专业能力和规模赋能医药创新，与全球行业伙伴共同助力CNS治疗领域的新突破。参考资料：[1]Robert J. Fox, M.D. Amit Bar-Or, M.D., Anthony Traboulsee, M.D.Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis.April 8, 2025 N Engl J Med 2025;392:1883-1892 DOI: 10.1056/NEJMoa2415988[2]Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis.Retrieved Mar 25,2025.From https://www.news.sanofi.us/2025-03-25-Tolebrutinib-regulatory-submission-accepted-for-priority-review-in-the-US-for-patients-with-multiple-sclerosis[3] Maria Pia Amato, Emilio Portaccio. Multiple sclerosis in 2024: evolving evidence and new hopes.THE LANCET Neurology, Volume 24, Issue 1p17-18 January 2025. DOI: 10.1016/S1474-4422(24)00483-6.[4] Conway SE, Galetta K. Therapeutic advances in multiple sclerosis: Novel therapies (immune checkpoint inhibitors, CAR-T, Anti-CD40L). Neurotherapeutics. 2025 Feb 27:e00558. doi: 10.1016/j.neurot.2025.e00558. Epub ahead of print. [5] 演讲回顾 | 药明康德科学论坛广州站：“漏斗”模型助力CNS药物渗透性评估 from https://mp.weixin.qq.com/s?__biz=MzkzMDE3OTkxNw==&mid=2247557971&idx=2&sn=c8c53b0e0fb3792fb29f4e2c0dfddaba&chksm=c325fffa6a1c6246ad71ca641497e6fa9b62fb4e73ff1adf927ac31c2d4fe5f0fa203fb53a24&poc_token=HBwYO2ijOdEaquwwLznsXEgS1lmDOSVpNVlOFN57[6]多发性硬化国际联合会（MSIF）官网https://www.msif.org/about-ms/what-is-ms/[7] Immunic Announces Vidofludimus Calcium Reduced Risk of Disability Worsening by 30% in Primary Progressive Multiple Sclerosis Patients from Phase 2 CALLIPER Trial.Retrieved Apr 30,2025.From https://ir.imux.com/2025-04-30-Immunic-Announces-Vidofludimus-Calcium-Reduced-Risk-of-Disability-Worsening-by-30-in-Primary-Progressive-Multiple-Sclerosis-Patients-from-Phase-2-CALLIPER-Trial版权说明：本文欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。