A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis

Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Over the last twenty years, several disease-modifying therapies with variable benefit/risk profiles have been introduced leading to dramatic changes in the prognosis of MS.
First, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability.
More recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis.
Anti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes.
Taking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.

开始日期2025-09-01

申办/合作机构

University Hospital of Montpellier

NCT05344469

/ RecruitingN/A

A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) and Oral Treatments (Teriflunomide, Dimethyl Fumarate and Diroximel Fumarate) in Patients With Relapsing Multiple Sclerosis [AIOLOS]

This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany.
Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses.

开始日期2022-05-10

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT05688436

/ RecruitingN/A

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage makes it difficult for the brain and spinal cord to function and send messages throughout the body. MS can be a progressive disease, which means it may get worse over time. In relapsing forms of MS (RMS), new symptoms may happen, and existing symptoms may get better or worse over time. DRF is an approved drug that is used to treat people with RMS.
This is known as an "observational" study, which collects health information about study participants without changing their medical care. The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are:
* Those who took DRF during their pregnancy
* Those who took other drugs for RMS during their pregnancy, but not DRF
* Those who did not take any drugs for RMS during their pregnancy
The main question researchers want to learn about in this study is:
• How many participants' babies were born with major congenital malformations (MCMs)? MCMs are problems with how a baby's body forms before birth.
Researchers will also learn more about:
* Loss of the baby before 20 weeks of pregnancy
* Loss of the baby at and after 20 weeks of pregnancy
* How many babies are born early (at or before 37 weeks)
* How many babies are small for their age while in the participant's uterus
* How many babies are born with any sign of life
This study will be done as follows:
* Participants with RMS can join this study if they become pregnant from 29th October 2019 to 31st July 2030. Information will start being collected when the participant decides to join the study.
* The participants' medical records will be reviewed 2 times during the study - once when the study is halfway done, and one at the end of the study.
* Each participant will be in the study until the end of their pregnancy. Each baby will be in the study for up to 1 year after birth.
* The study is planned to end by 30th April 2031.

开始日期2021-09-24

申办/合作机构

Biogen, Inc.

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1,915

项与醋酸格拉默相关的文献（医药）

2026-05-01·Multiple Sclerosis and Related Disorders

Real-world evaluation of the transition between originator and follow-on glatiramer acetate in people with multiple sclerosis: the “GA transition” study

Article

作者: Rasia, Sarah ; Annovazzi, Pietro ; Schiavetti, Irene ; Lus, Giacomo ; Cavalla, Paola ; Pasquali, Livia ; Laroni, Alice ; Sormani, Maria Pia ; La Gioia, Sara ; Carbone, Alessio ; Caleri, Francesca ; Di Sapio, Alessia ; Giovannini, Beatrice ; Signoriello, Elisabetta ; Pozzato, Mattia ; Cordioli, Cinzia ; Zecca, Chiara ; Torri Clerici, Valentina

INTRODUCTION AND OBJECTIVE:

The introduction of follow-on formulations of glatiramer acetate (GA) has raised questions regarding their equivalence to the originator in real-world practice. This study aimed to evaluate the clinical effectiveness and safety of switching from originator GA to its follow-on product, Copemyl® (CO), in people with multiple sclerosis (MS).

METHODS:

A multicenter, retrospective observational study was conducted, including patients with MS treated for at least two years with GA followed by at least two years with CO. The primary outcome was the annualized relapse rate (ARR), whereas secondary outcomes included disability progression assessed by the Expanded Disability Status Scale (EDSS), MRI activity, and adverse events (AEs).

RESULTS:

A total of 138 patients were included. The ARR was very low and comparable across treatments (GA: 0.028; CO: 0.019), with a mean paired difference of -0.009 (95 % CI -0.028 to 0.010; p = 0.38), falling within the predefined equivalence margin. Disability progression over six months occurred in 6.0 % of GA and 7.3 % of CO periods (HR 1.53; 95 % CI 0.74-3.16; p = 0.26). No significant difference was found in MRI activity (52.2 % vs 60.1 %, p = 0.14). Safety profiles were comparable, with mostly mild to moderate AEs; four serious AEs occurred under CO, two of them possibly treatment-related.

CONCLUSIONS:

Switching from originator GA to CO did not influence clinical outcomes or safety. These findings support the therapeutic equivalence of the two formulations in real-world clinical practice, by supporting previous evidence from randomized trials.

2026-05-01·Multiple Sclerosis and Related Disorders

The comparative efficacy of cladribine tablets versus alternative disease-modifying treatments for relapsing-remitting multiple sclerosis: Updated meta-regression estimates by patient subgroup

Review

作者: Maheshwari, Vikalp ; J, Saipriya ; Harty, Gerard T ; Jones, Michelle

BACKGROUND:

A previously published meta-regression compared cladribine tablets with key disease-modifying treatments (DMTs) for patients with relapsing-remitting multiple sclerosis (RRMS). This analysis updates and extends that work by evaluating the relative efficacy of cladribine tablets versus approved DMTs in specific RRMS subgroups, including high disease activity (HDA) and sub-optimal therapy (SOT).

METHODS:

Updated systematic literature reviews identified clinical trials evaluating cladribine tablets and other DMTs in RRMS. Baseline-risk-adjusted meta-regressions were conducted. Outcomes included 6-month confirmed disability progression (6 M-CDP) and annualised relapse rate (ARR).

RESULTS:

Fifty-four clinical trials assessing cladribine tablets plus 19 additional DMTs contributed to the meta-regressions. Results showed significant overlap in the hazard ratio credible intervals, with no therapy statistically dominating in terms of efficacy. At the point-estimate level in the HDA population, for 6 M-CDP, cladribine tablets were predicted to be more efficacious than placebo, fingolimod, alemtuzumab, glatiramer acetate, teriflunomide, ozanimod, interferon beta-1a, ocrelizumab, dimethyl fumarate, and ponesimod; comparable estimates were observed versus ofatumumab. For ARR, cladribine tablets were predicted to be more efficacious than placebo, dimethyl fumarate, glatiramer acetate, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, and teriflunomide, as well as fingolimod, ozanimod, and ponesimod; comparable estimates were observed versus ocrelizumab.

CONCLUSIONS:

Updated meta-regressions demonstrate that cladribine tablets have comparable relative efficacy to other high-efficacy therapies in HDA and SOT patient subgroups. For disability progression outcomes, cladribine tablets showed similar efficacy to ofatumumab; for relapse reduction, cladribine tablets were comparable to ocrelizumab. Cladribine tablets also consistently outperformed most platform therapies across all analyzed subgroups.

2026-02-01·Multiple Sclerosis Journal

GA Depot, a long-acting glatiramer acetate, vs placebo in patients with relapsing multiple sclerosis: A randomized phase 3 clinical trial

Article

作者: Bleich Kimelman, Nadav ; Danon, Uri ; Rubnov, Shai ; Karni, Arnon ; Kolb, Hadar ; Zivadinov, Robert ; Bar-Or, Amit ; Popper, Laura ; Marom, Ehud ; Boyko, Alexey ; Miller, Aaron ; Berger, Joseph R ; Cohen, Jeffrey A

Background::

GA Depot is a long-acting glatiramer acetate (GA)-based formulation designed to provide significantly extended dosing intervals compared to currently available GA formulations.

Objective::

To assess GA Depot efficacy, safety, and tolerability compared to placebo in patients with relapsing multiple sclerosis (RMS).

Methods::

A 52-week multi-center, double-blind, placebo-controlled phase 3 trial in RMS. Patients aged 18–55 with an Expanded Disability Status Scale (EDSS) score ⩽ 5.5 were enrolled and randomized (1:1) to intramuscular (IM) GA Depot 40 mg or matching placebo every 4 weeks. The primary endpoint was annualized relapse rate (ARR) at 52 weeks.

Results::

A total of 1016 patients were treated with GA Depot ( n = 508) or placebo ( n = 508). Adjusted ARR was lower in patients treated with GA Depot compared to placebo (0.18, 95% confidence interval [CI] = 0.14 to 0.3 vs 0.26, 95% CI = 0.21 to 0.32, 30.1% relative risk reduction, p = 0.0066). GA Depot significantly reduced the number of contrast-enhancing lesions ( p = 0.0083). The most common adverse events were injection site reactions (46.1% with GA Depot vs 28.7% with placebo), primarily mild and self-limited.

Conclusion::

GA Depot effectively reduced clinical and radiological activity compared to placebo in RMS patients, recapitulating the favorable profile of subcutaneous GA products with significantly less frequent injections.

Trial Registration::

ClinicalTrials.gov Identifier: NCT04121221 ( https://clinicaltrials.gov/study/NCT04121221 ).

284

项与醋酸格拉默相关的新闻（医药）

2026-04-16

·GlobeNewswire-Health Care

Mapi Pharma to Present Efficacy (EDSS) Data from Glatiramer Acetate Depot Long-Acting Injection Studies in Relapsing Forms of Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS) at AAN 2026

Poster scheduled for presentation on Tuesday, April 21, 8:00 AM - 9:00 AM CDTNESS ZIONA, Israel, April 16, 2026 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on introducing innovative long-acting depot injectable treatments, will present efficacy data from GA Depot clinical studies in patients with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) at the American Academy of Neurology (AAN) Annual Meeting 2026, to take place April 18-22, 2026, in Chicago IL. Mapi’s Glatiramer Acetate Depot (GA Depot) is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone®) for treating multiple sclerosis (MS), a chronic inflammatory, demyelinating disease characterized by neurological disability accumulation over time. GA Depot was clinically evaluated for RMS which is characterized by inflammatory attacks (relapses) on the central nervous system, causing new or worsening neurological symptoms followed by partial or full recovery and PPMS which is characterized by continued worsening neurologic function from the onset of symptoms, without early relapses or remissions. EDSS (Expanded Disability Status Scale) assessments were collected from two prospective GA Depot clinical studies: an up to three year, open-label, Phase IIa study in PPMS patients (n=30), and a one-year, double-blind, placebo-controlled, pivotal Phase III study in RMS patients (n=1,016 of which n=508 were in the active arm). GA Depot is administered intramuscularly (IM) once every 28 days for both indications at different dosages. In the above studies in PPMS and RMS, GA Depot showed EDSS stabilization, irrespective of baseline EDSS scores. These EDSS findings suggest GA Depot’s potential in slowing disability progression, reinforcing its role in MS management. GA Depot is in a final review process in Germany for the RMS indication and is planned to start a global Phase III study for PPMS. Mapi received the Israeli Ministry of Health’s GMP (Good Manufacturing Practice) approval, enabling commercial launch in RMS in 2027 in Germany and in EU countries and initiation of marketing early 2028. Ehud Marom, Chairman and Chief Executive Officer, Mapi Pharma, said, “We are very excited to share these positive results for GA Depot in the treatment of MS, where there are significant unmet medical needs. The data we are presenting this week at AAN demonstrate that GA Depot can significantly impact disease progression and we believe that this product, once approved, has the potential to transform the treatment landscape for MS. We look forward to further evaluating GA Depot in the clinic in the PPMS indication and are currently seeking a co-marketing partner for GA Depot for the RMS indication in the EU.” The GA Depot data will be featured in a poster GA Depot (long-acting IM glatiramer acetate) and its impact on EDSS in Relapsing forms of Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS) on Tuesday, April 21, 8:00 AM - 9:00 AM CDT (Poster Neighborhood 19 P7: Multiple Sclerosis: Clinical Trials 1, McCormick Place West, Hall F). Company management will be available for one-on-one meetings during the conference to discuss potential joint development collaborations. Interested parties should contact Mapi directly. About Mapi Pharma Mapi Pharma (Mapi) is a clinical stage pharmaceutical company, engaged in development of high barrier-to-entry and high added-value life cycle management ("LCM") products and AB Rated Depot injectable products that target large markets that include complex active pharmaceutical ingredients ("APIs") and formulations. Mapi is developing depot long-acting injections for the anti-psychotic Cariprazine and for the GLP-1’s, Semaglutide and Tirzepatide for diabetes and weight management as well as a generic AB rated version for Naltrexone (Vivitrol®). The Company is also marketing its own generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) in specific geographic markets. Mapi is built on strong chemical and pharmaceutical R&D and clinical development capabilities and a deep understanding of the global market and of regulatory needs. Mapi is a global company with a dedicated long-acting depot R&D laboratory and aseptic depot manufacturing and a Fill & Finish for injectable Finished Dosage Forms. Mapi has strong IP positions, numerous granted patent applications for APIs and mainly formulations. For more information, please visit www.mapi-pharma.com Contacts: Alex MogleVice President, Corporate DevelopmentMapi Pharma+972 52 6080297alex@mapi-pharma.com Brian RitchieManaging DirectorLifeSci Advisors, LLCbritchie@lifesciadvisors.com

临床结果临床2期临床3期

2026-04-16

·同写意

一场万亿“灰市”的转正风暴

同写意主办的首届"大国新药"全球会议将于2026年7月22日-24日在国家会展中心（上海）举办。会议对标J.P.摩根大会，构建"中国创新—全球转化—上海交易"模式，彰显中国新药大国地位，推动中国创新引领全球健康产业发展。前段时间，美国卫生与公众服务部部长小罗伯特肯尼迪在播客中公开称，自己是多肽的“铁杆粉丝”，并透露FDA正在讨论将此前被列入“第2类”禁止调配名单的十多种多肽重新纳入“第1类”，允许持有效处方的药房再次进行调配。这位HHS部长甚至直言，拜登政府时期的禁令“于法无据”。一石激起千层浪。BPC-157、MOTS-c、Ipamorelin、AOD-9604——这些以字母和数字命名、此前游走于监管灰色地带的多肽，一夜之间成为合法配制药房和功能医学诊所热议的焦点。若政策最终落地，需求将从海外灰市渠道向合规调配体系回流。这只是一个引子。在肯尼迪的播客表态背后，一场横跨中美、波及数万亿美元市场的多肽产业变局正在加速演进。一个值得追问的问题是：当美国开始为新兴多肽“松绑”时，中国药企在哪里？ TONACEA 01 膨胀的“灰色市场” 肯尼迪推动监管转向的逻辑其实不难理解：禁令从未真正消灭需求，只是将它推向了监管的盲区。近五年来，未批准多肽类产品的在线广告、电商上架和社交媒体内容呈爆发式增长。仅2025年一年，美国Google Trends上“peptides”的搜索热度已正式超越“Ozempic”，多肽从专业圈层走向了大众视野。这些数字背后，是一个绕开FDA的庞大灰色市场。 BPC-157、AOD-9604、MOTS-c、TB-500、Tesamorelin等十多种未批准多肽，以“研究用化学品”“实验室试剂”甚至“日化产品”的名义，堂而皇之地出现在亚马逊等主流电商平台，社交媒体成为催化剂。 BPC-157虽缺乏高质量的已发表临床试验数据，却在再生医学诊所和职业运动员圈层中被广泛使用；MOTS-c被生物黑客视为“运动模拟剂”；Pep19在60天的临床试验中实现了17%的内脏脂肪减少且不影响瘦体重。据英国《金融时报》今年1月的调查，约有1000家中国供应商正通过即时通讯软件和在线平台，向西方消费者直接出口未经监管的多肽产品，用于护肤、减重和增肌。更令人不安的是，患者甚至可以在网上买到仍处于III期临床试验阶段的实验性药物。礼来的三重激动剂retatrutide和诺和诺德的CagriSema——前者尚未完成临床、后者仍在FDA审评中——在灰色市场上均已可以轻松下单。灰市的繁荣，本质上是正规渠道无法满足需求的直接映射，而需求本身并非凭空而来。运动恢复、代谢健康、认知增强、抗衰老等长期被主流制药业忽视的适应症领域，正在多肽的催化下从“隐性需求”变成“显性市场”。 TONACEA 02 跟随者的红利将目光转向中国。过去五年，中国多肽产业经历了从“荒原”到“红海”的剧烈转变，但这一转变几乎完全围绕着一个分子展开：司美格鲁肽。 2026年3月，诺和诺德司美格鲁肽的核心化合物专利在中国正式到期，打开了本土仿制药上市的法律窗口。据国家药监局公开信息，截至目前，华东医药（九源基因）、丽珠集团、齐鲁制药等至少10家本土药企已提交司美格鲁肽仿制药上市申请，另有超11家企业的仿制药品处于Ⅲ期临床阶段。行业预测，2026年第三季度将有首批本土仿制药获批，到2028年国内上市的仿制药数量或将达到20款。原研方诺和诺德已提前开启防御性降价，降糖版司美格鲁肽注射液在电商平台上的价格较纳入医保前降幅超过70%。与此同时，一批更具创新野心的中国药企正在尝试以差异化布局破局。 ● 信达生物的玛仕度肽作为全球首个获批的GCGR/GLP-1双靶点激动剂，48周最高减重14.8%； ● 恒瑞医药的HRS9531（GLP-1R/GIPR双靶点）Ⅲ期数据显示48周最高减重19.2%，已于2025年9月提交上市申请； ● 华东医药的GLP-1R/GIPR激动剂HDM1005直接启动了与玛仕度肽的“头对头”III期研究。 ● 质肽生物GLP-1月制剂佐维格鲁肽（ZT002）注射液已进入减重III期临床，同时其GLP-1/FGF21双靶点激动剂已在澳洲开展I期临床。2026年3月，质肽生物刚刚完成超5亿元C轮融资。但问题也随之浮现。几乎所有中国药企的多肽研发管线都高度集中于代谢疾病赛道，尤其是GLP-1及其衍生物。当美国的功能医学诊所正在大胆尝试BPC-157用于运动恢复、MOTS-c用于代谢优化、Semax用于认知增强时，中国药企在这些“非主流”多肽上的布局几乎为零。我们的跟随策略在“司美格鲁肽仿制”上表现出色，但在“下一个GLP-1是什么”的问题上，仍然缺乏前瞻性的答案。 TONACEA 03 被低估的底层能力不过，将中国多肽产业仅仅描述为“跟随者”并不公允。在上游供应链和中游CDMO环节，中国企业已经建立起全球性的竞争力。据弗若斯特沙利文数据，全球多肽类药物市场规模已从2018年的607亿美元增长至2023年的895亿美元，预计到2032年将进一步增长至2612亿美元。国内市场方面，预计2030年国内多肽CDMO规模将达185亿元。在这其中，GLP-1类药物“功不可没”。药明康德的TIDES业务2025年收入113.7亿元、同比暴增96%，其多肽固相合成反应釜总体积已突破10万升。凯莱英的化学大分子CDMO业务去年增速约124%，多肽固相反应合成产能从4.5万升向2026年底6.9万升快速扩张。泰德医药在2023年已是全球第三大专注于多肽的CRDMO，海外收入占比近八成，管线包括9个GLP-1新分子项目和超过330个CDMO项目。诺泰生物在长链多肽领域实现单批次超10公斤的行业领先产量；圣诺生物以“API+制剂”一体化模式精准卡位GLP-1赛道。 Know-how、成本控制、人力资源、产能基建、交付效率和可靠性——只要具备任一方面，即有全球竞争力，而中国头部CXO全部具备。在全球约65%的多肽原料药生产采用外包模式的背景下，中国企业的产能优势有望在GLP-1全球产能争夺中占据主导地位。上述之外，中国多肽药企的出海步伐也在明显加速。翰宇药业的GLP-1利拉鲁肽注射液在2024年获美国FDA首仿批准上市；今年2月，其醋酸格拉替雷注射液再获FDA批准，用于治疗多发性硬化症。3月，前沿生物的FB4001（特立帕肽注射液仿制药）零缺陷通过FDA批准前现场检查，进入发补研究阶段。中晟全肽在2026年初相继与诺华、礼来达成合作，其中与诺华就一款自主研发的多肽资产达成全球独家授权协议，拿下5000万美元首付款，创下湖南创新药授权出海的新纪录。值得关注的是，出海的多肽品种正在从传统仿制药向更复杂的领域延伸，大环肽赛道成为2026年的一大亮点。 3月18日，强生的口服大环肽Icotrokinra获FDA批准上市，标志着整个口服大环肽赛道完成了从“平台验证”到“产品商业化”的关键跃迁。中国大环肽领军企业元思生肽紧随其后完成1.5亿美元B轮融资，此前已与阿斯利康达成34亿美元的大环肽平台合作。从GLP-1到口服大环肽，中国多肽企业正在从“仿制出海”走向“技术出海”。但与此同时，中国企业在出海过程中面临的挑战也在升级。关税叠加压力、生物技术领域的出口管制趋向，以及中美监管体系的根本性差异，都要求企业从“产品出口”思维转向“全球能力建设”思维。泰德医药在上市募资中已明确将部分资金用于扩大美国本地产能，以规避潜在的政策风险。本土化产能布局正在成为出海战略的新标配。 — 结语 — 当西方开始在政策层面为“非主流”多肽松绑时，中国药企的反应还不够快。不可否认，中国药企在GLP-1上的快速跟进、在CDMO上的产能扩张、在出海上的加速突破，都值得肯定。但问题在于，这些成就几乎全部围绕着一个已经被验证的分子和赛道展开。真正的产业前瞻力，体现在能否在“主流”之外看到“边缘”，在“边缘”之中发现“未来”。 BPC-157、MOTS-c、Semax、大环肽——这些多肽今天在美国仍处于监管灰色地带或技术验证阶段，但它们所瞄准的运动恢复、代谢优化、认知增强、口服给药等临床需求，是全球性的。当FDA为这些多肽打开合法配制药房的大门时，需求将进入一个被监管认可的正规渠道。到那时，谁能提供安全、合规、成本可控的产品，谁就能占据先机。肯尼迪在播客中提到，“这些多肽应该回到合规供应商的手中”。这些“合规供应商”中，有多少会来自中国？参考文章： 1、Will RFK Jr.’s peptide push bolster the gray market for obesity drugs?；pharmavoice 2、减重降糖药市场竞争升级；北京日报 3、多肽CDMO实力对比：药明康德、凯莱英、九洲药业、诺泰生物、圣诺生物、泰德医药；药事纵横 4、Peptide buzz climbs as influencer hype drives demand online；eMarketer 《大国新药》栏目介绍《大国新药》专题栏目由同写意出品，聚焦中国新药崛起的核心逻辑，研讨创新药全球化战略，致力于构建可持续发展的中国创新药生态。栏目记录全球化浪潮中的中国故事，见证从跟跑到领跑的关键突破，解读国家战略，追踪前瞻技术，在标杆事件与案例复盘中，彰显中国医药的大国担当。

2026-04-10

·知乎专栏

别再盯津药药业！低位+底部+业绩翻倍创新药10大龙头底部起爆

兄弟们！资金又去挖掘了一个方了，其实也不是什么新题材了没错！就是创新药创新药是反复活跃，津药药业4连板，广生堂、艾迪药业、睿智医药20CM涨停，润都股份、昂利康涨停等12股涨停。创新药持续反活跃得到资金的青睐，核心逻辑在行业基本面正在发生拐点。国家药监局最新发布的数据显示，今年前三个月，我国创新药对外授权（BD）交易总额突破600亿美元，已接近2025年全年1357亿美元总额的一半。 BD交易创新高，意味着创新药企的业绩进入释放期。百济神州、荣昌生物、微芯生物等在科创板上市创新药扭亏，就表明创新药企进入业绩兑现中。进一步佐证了行业拐点加速到来。此外，美国癌症研究协会(AACR)年会将于2026年4月17-22日在美国圣地亚哥召开。据报道，今年共有超过100家中国药企亮相AACR，带来近400项研究成果，覆盖当前多个热门靶点，核药、DAC、细胞治疗、mRNA等前沿技术。这将是进一步站上中国创新药企在创新药领域研发的成果和实力，将拿到更多的BD订单。与此同时，创新药持续活跃，核心还是处于底部位置，在2025年8月19日创出新高之后，创新药板块进入调整，指数调整幅度近20%，但相当部分个股调整却超30%,明显具备性价比优势。特别是2025年业绩大增+低位的创新药将是资金重点抱团的标的。经过深度梳理和挖掘，这10家低位+业绩大涨的创新药空头有望成为这波创新药行情的领头羊，现在把这10家公司梳理出来供大家参考。第一家：恒瑞医药核心亮点：公司是根植中国、全球领先的创新型制药企业，“全球制药公司管线规模TOP25”榜单前八，开发的肿瘤药物基本覆盖全球主要癌症类型。创新药：公司创新药集群已进入销售兑现阶段，2025年创新药销售收入163.42亿元，同比增长26.09%，占药品销售收入的比重达58.34%。股价位置：公司股价较2025年高点回撤超30%，基本消化此前一段涨幅，3月27日收出一根长阳K线形成反包，筑底成功，进入右侧交易低吸机会。业绩表现：2025年公司实现营业收入316.29亿元，同比增长13.02%；实现归母净利润77.11亿元，同比增长21.69%；实现扣非归母净利润74.13亿元，同比增长20.00%。第二家：科兴制药核心亮点：公司是国内重组蛋白药物领军企业，公司产品在国内短效注射用人干扰素、人促红素、英夫利西单抗、短效人粒细胞刺激因子等细分领域的市占率领先。创新药：公司聚焦肿瘤、自身免疫等前沿领域，持续加大研发投入，深耕核心技术，肿瘤恶病质治疗药物GB18注射液成功获得中美两国临床试验批准，成为公司创新管线的重要突破。股价位置：公司股价较2025年高点最大回撤达57%，目前股价已经处于底部反转，形成V型反转，右侧交易时点来临。业绩表现：公司全年实现营业总收入15.41亿元，同比增长9.54%；归属于母公司所有者的净利润1.59亿元，同比增长406.47%；扣非归母净利润0.60亿元，同比增长69.36%；第三家：上海宜众核心亮点：公司是抗肿瘤药物研发领先企业创新药：公司是核心产品紫杉醇聚合物胶束是公司该平台首个获批上市的全新一代紫杉醇类创新剂型，也是我国首个作为2.2类创新药批准上市的紫杉醇胶束类产品。股价位置：公司股价较2025年历史高点最大回撤48%，目前右侧已经构筑完成双底形态，后续有望进一步上行。业绩表现：预计公司2025年01-12月归属于母公司所有者的净利润为6000万元至7000万元，同比增长760.18%至903.54%第四家：昭衍新药核心亮点：公司是国内领先的非临床安全性评价机构，具备自有实验猴资源。创新药：公司是国内唯一拥有两个CLP机构的专业化临床前CR○企业,其中苏州昭衍是国内规模最大的药物安全性评价机构,主营药物临床前研究服务与实验动物的繁殖和销售。股价位置：公司股价年初高点最大回撤41%，股价连续4连阳，出现右侧交易机会。业绩表现：公司实现营业总收入16.58亿元，同比下降17.87%；归母净利润2.98亿元，同比增长302.08%。第五家：康辰药业核心亮点：公司是我国血凝酶制剂龙头企业，注射用尖吻蝮蛇血凝酶国家级制造业单项冠军。创新药：公司的产品注射用尖吻蝮蛇血凝酶，商品名为“苏灵”，是国内血凝酶类止血药细分领域唯一的国家一类新药。自主研发的抗癌新药KC1086片正式获得美国食品药品监督管理局（FDA）签发的《临床研究继续进行通知书》，获准在美国开展临床试验。股价位置：公司股价较2025年高点最大回踩50%，量能持续缩量，目前连续收出大阳线，右侧交易机会出现。业绩表现：预计公司2025年01-12月归属于母公司所有者的净利润为14500万元至17500万元，同比增长243%至315%。扣非后净利润1.4亿元至1.7亿元，同比增长350.00%至447.00%。第六家：泰格医药核心亮点：公司是中国领先的临床合同研究机构，2024年，以10.6%的市场份额在中国临床外包服务市场中保持领先地位，并以1.1%的全球市场份额成为全球前十的中国临床外包服务提供商。创新药：公司是国内临床试验CRO企业龙头，累计为客户提供临床研究服务400余项;与肿瘤疾病领域创新药物研发企业海和药物战略合作。股价位置：股价处于历史底部，周线上看，目前处于收敛三角形末端运行，即将面临上破，右侧交易机会已经出现。业绩表现：2025年公司实现营业收入68.3亿元，同比增长3.5%；实现归母净利润8.9亿元，同比增长119.2%第七家：百济神州核心亮点：公司是一家全球领先的肿瘤创新治疗公司，专注于为全世界癌症患者研发创新抗肿瘤药物。创新药：公司自主研发的BTK抑制剂百悦泽®是全球获批适应症最广泛的BTK抑制剂，已在全球75个市场获批。2025年首次实现盈利，主要得益于泽布替尼和替雷利珠单抗以及安进授权产品的销售增长。股价位置：公司股价位置较2025年高点最大回撤近40%，近期连续收出大阳线，叠加消息面催化，底部基本确认，右侧交易机会出现。业绩表现：2025年收入53.43亿美元，同比增长40.2%；净利润2.87亿美元，上年同期净亏损6.45亿美元。第八家：凯莱英核心亮点：公司是全球领先的小分子CDMO供应商创新药：公司为国内多家医药公司提供1.1类新药研发服务;代表性新药项目包含:治疗丙肝,心血管疾病,囊性纤维化等项目。股价位置：公司股价较历史高点深度回撤84%，近期持续拉升，打破了周线上构筑的不规则的双底形态，右侧交易机会出。业绩表现：公司实现营业收入66.70亿元，同比增长14.91%，归母净利润为12.53亿元，同比增长56.09%第九家：翰宇药业核心亮点：国内多肽药物先进企业，全球为数不多具有规模化多肽原料药的企业之一，在利拉鲁肽和格拉替雷等多肽特色原料药产业化方面国际知名。创新药：公司是国内多肽制剂龙头,新药利拉鲁肽及利拉鲁肽注射液、特立帕肽及特立帕肽注射液分别获得临床批件,用于血糖控制等方面;甲磺酸溴隐亭片可用于治疗II型糖尿病,是首个通过美国FDA降糖新药与心血管疾病风险评估的糖尿病药物,是公司首次从规范市场引进的新药项目。股价位置：股价较2025年高点最大回踩近48%，量能持续尾声，调整解决尾声，近两个交易日走出放量大阳线，站上120日均线，底部确定，上行空间打开，右侧交易机会出现。业绩表现：预计公司2025年01-12月归属于上市公司股东的净利润为4000万元至5000万元，同比增长123.03%至128.79%。第十家：昂利康核心亮点：公司已形成化学原料药和化学制剂一体化的产业链，国内最大的alpha酮酸原料药生产厂家，抗雄性激素中间体、植物源胆固醇、植物源维生素D系列行业领先。创新药：公司的研发战略目前正从“有特色的仿制药”逐步转向“有特色的仿制药——改良型新药——创新药”。在创新药布局上，公司将加快推进QHL-1618临床前研发的进程。股价位置：公司股价较2025年高点深度回撤60%，调整过程持续缩量，底部确定，近几个交易日持续收出中阳线，并且放量站上120日均线，右侧交易机会出现。业绩表现：预计公司2025年01-12月归属于上市公司股东的净利润为11000万元至13800万元，同比增长36.93%至71.78%。声明：本文引用官方媒体和网络新闻资料，如有错误，请以最新信息为准。本文绝不构成任何投资建议、引导或承诺，仅供交流探讨，请审慎阅读。市场有风险，投资决策需建立在理性独立思考之上。

AACR会议财报细胞疗法引进/卖出

100 项与醋酸格拉默相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04318	醋酸格拉默	L03AX13	DB05259

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
多发性硬化症	美国	Teva Pharmaceuticals USA, Inc.	2014-01-28
复发-缓解型多发性硬化	美国	Teva Pharmaceuticals USA, Inc.	1996-12-20

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性多发性硬化	临床3期	美国	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	白俄罗斯	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	波斯尼亚和黑塞哥维那	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	保加利亚	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	爱沙尼亚	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	以色列	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	摩尔多瓦	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	俄罗斯	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	乌克兰	Mapi-Pharma Ltd.	2019-09-19
横纹肌肉瘤	临床3期	美国	Mapi-Pharma Ltd.	2019-09-19

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


P8-6.018 (AAN2024)	临床3期	复发性多发性硬化	-	GA Depot	鹹膚網網築鑰廠糧簾糧(憲淵鹽鑰壓衊積選蓋廠) = 淵夢鹽遞觸夢壓夢糧蓋製繭醖憲顧壓繭鏇製鹹 (夢製艱繭齋襯糧鏇繭壓 ) 更多	积极	2024-04-09
				Copaxone	鹹膚網網築鑰廠糧簾糧(憲淵鹽鑰壓衊積選蓋廠) = 糧鹽獵遞網鏇鏇構範願製繭醖憲顧壓繭鏇製鹹 (夢製艱繭齋襯糧鏇繭壓 ) 更多
S31.010 (AAN2024)	N/A	多发性硬化症	930	Fingolimod	窪積積壓網醖簾齋鑰鏇(網網積構獵築網窪願襯) = 襯構餘壓鹽鏇積廠鑰餘廠鹽壓憲淵願選糧鏇淵 (遞糧遞糧製餘遞遞衊願 )	不佳	2024-04-09
				Natalizumab	窪積積壓網醖簾齋鑰鏇(網網積構獵築網窪願襯) = 鑰鹽範積醖糧鹹淵鹹鑰廠鹽壓憲淵願選糧鏇淵 (遞糧遞糧製餘遞遞衊願 )
GA Depot, Phase 3 (ACTRIMS2024)	临床3期	复发性多发性硬化	763	GA Depot	夢夢觸膚淵繭製繭壓鑰(獵範鏇構餘積遞鏇廠範) = mean percent change 8.34 鹽鬱繭網範鏇艱鹹觸鏇 (遞餘繭鏇醖壓糧鹽顧顧 )	积极	2024-02-29
Phase III Open Label period (ACTRIMS2024)	临床3期	-	821	Glatiramer Acetate Depot	壓鏇糧膚餘構衊製鏇窪(蓋網願積範網網顧憲範) = The most frequent TEAEs reported (≥5% of the subjects in any treatment group), irrespective of the relatedness, were ISRs, pyrexia, influenza-like illness, body temperature increase, and headache 獵網衊鹹夢觸網願簾顧 (糧鬱淵衊鹽築壓築窪膚 ) 更多	积极	2024-02-29
				Placebo
NCT04121221 (ECTRIMS2023)	临床3期	复发性多发性硬化	-	GA Depot	憲鹹願鏇鑰壓鹽衊廠製(糧壓鏇觸餘鏇廠構製膚) = 鹹鹹繭鬱網製艱鹽選鑰餘襯獵夢鑰網窪淵製壓 (夢觸積構構糧範艱窪網 ) 更多	-	2023-09-30
				Copaxone®	憲鹹願鏇鑰壓鹽衊廠製(糧壓鏇觸餘鏇廠構製膚) = 蓋艱憲遞淵膚選餘網選餘襯獵夢鑰網窪淵製壓 (夢觸積構構糧範艱窪網 ) 更多
AAN2022	临床2期	复发-缓解型多发性硬化 anti-GA antibodies	-	GA Depot 80mg	願積廠醖夢齋獵衊顧繭(衊窪鹹遞積願齋蓋夢願) = 簾鏇齋夢淵醖鑰獵鏇獵襯積襯繭構餘襯齋夢鏇 (齋蓋積鑰網鹽鹹遞範窪, +/ ~ 1.13) 更多	积极	2022-05-03
				GA Depot 40mg	願積廠醖夢齋獵衊顧繭(衊窪鹹遞積願齋蓋夢願) = 繭膚壓構觸襯積膚鬱簾襯積襯繭構餘襯齋夢鏇 (齋蓋積鑰網鹽鹹遞範窪, +/ ~ 1.25) 更多
NCT00176592 (BECOME, CTgov)	临床4期	多发性硬化症 \| 复发-缓解型多发性硬化	75	Betaseron (Betaseron)	鹹壓壓壓簾觸鏇憲窪簾(繭壓艱鬱蓋選鑰積醖艱) = 衊膚襯鑰窪簾繭壓糧構廠餘顧鏇蓋齋鏇顧廠衊 (餘鏇蓋鏇壓膚壓窪構觸, 2.76) 更多	-	2021-11-16
				Copaxone (Copaxone)	鹹壓壓壓簾觸鏇憲窪簾(繭壓艱鬱蓋選鑰積醖艱) = 醖觸廠願鬱顧廠衊憲簾廠餘顧鏇蓋齋鏇顧廠衊 (餘鏇蓋鏇壓膚壓窪構觸, 2.46) 更多
NCT00326625 (CTgov)	临床2期	肌萎缩侧索硬化	366	Placebo	壓憲鬱憲壓膚糧廠衊壓(鏇鏇觸簾繭鑰壓製範鹽) = 壓窪艱鏇餘艱構壓夢網齋願遞壓選鏇餘鏇選淵 (鹹艱艱遞鏇網積鑰築構, 0.058) 更多	-	2021-10-20
GA Depot phase IIa (ECTRIMS 12020 \| ECTRIMS 22020 \| AAN2020)	临床2期	原发性进行性多发性硬化	11	GA Depot	積簾鏇齋顧鹹觸積構觸(願鏇窪願廠蓋蓋憲積簾) = stable 鏇觸願衊膚鹽簾憲餘構 (觸膚蓋醖艱膚範鹽衊願 ) 更多	积极	2020-12-07
NCT00211887 (CombiRx, Pubmed \| Neurology)	临床3期	多发性硬化症	959	Interferon-beta-1a	簾構齋餘廠衊繭築鹽鹹(憲願壓築齋遞蓋餘衊積) = After adjustment, anxiety (hazard ratio [HR] 1.25, 95% confidence interval [CI] 1.01-1.55) and dyslipidemia (HR 1.32, 95% CI 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80, 95% CI 0.67-0.97) was associated with a decreased hazard. 選壓膚壓範憲衊醖窪餘 (憲願淵蓋願簾膚鹽鑰齋 )	积极	2020-08-04
				Glatiramer acetate