Suzetrigine

Seven years ago, when Johnson & Johnson brought a new, ketamine-based depression treatment to market, there were relatively few specialized psychiatry clinics that had the space, staff and expertise necessary to administer the drug.Catherine Owen-Adams, a former president in J&Js Janssen division, described the landscape as very underdeveloped and requiring a huge investment when Spravato launched. But that investment appears to have paid off. Spravato printed more than $1 billion in the first half of this year. And there are now thousands of so-called interventional psychiatry clinics across the U.S.Those clinics may soon serve as the test beds for a wave of psychedelic therapies speeding toward the market. The most advanced among them is COMP360, a synthetic form of a hallucination-inducing compound found in certain mushroom species. The drugs developer, U.K.-based Compass Pathways, has been gradually submitting an approval application with U.S. regulators, and expects to complete the filing sometime in the fourth quarter.Compass CEO Kabir Nath and Chief Patient Officer Steve Levine recently spoke with BioPharma Dive about how their launch plans are progressing and the helpful precedent Spravato has set. They also offered thoughts on the competitive landscape with other psychedelics biotechs, and whether COMP360 might run into the same sales obstacles as a couple other new nervous system medicines.The following conversation has been edited and condensed for clarity.BIOPHARMA DIVE: How are you going to roll out COMP360? Is there adequate infrastructure from a healthcare setting perspective? Your drug is administered over a six- to eight-hour observation period. Its hard to imagine that at most doctors offices, which are so strapped for time and resources.LEVINE: If we were counting on the places where the bulk of antidepressants are written, which is in primary care, then you're exactly right. Those are overrun, busy, few-minute visit clinical situations where yes, this would not fit.In 2019, when Spravato launched, there were just a small handful of interventional psychiatry clinics that could handle in-office multi-hour observation. Fast forward to today, there are about 8,500. And within those 8,500, there's a lot of capacity.There's capacity for at least two reasons. Number one: they're not there to be Spravato clinics; they're there to be interventional psychiatry practices, and they're anticipating approvals to come. And so they've built capacity ahead. Number two: Spravato is a tough treatment to sign up for. It's 25- to 50 day-long treatments per year. No, it doesn't take the entire day; it's about a three-hour visit. But for a patient, a day is a day.So the infrastructure is ready and waiting. The same clinical staff will monitor patients having our treatment as are in these centers today. It's a team-based model. There's a multidisciplinary team: medical assistants, technicians, nurses, sometimes therapists. A single prescriber on site that could be a psychiatrist, but it could also be a nurse practitioner, a physician's assistant. And there's multiple rooms operating simultaneously, having multiple different treatments, and our treatment is drag and drop. It slots directly into the way these centers operate today.Yes, it's a longer period of observation, but that's also why we did the work we did a few years ago to put the reimbursement framework in place for these sites, so that regardless of how long somebody's in the chair, they'll be reimbursed for every one of those hours, and actually at a rate we expect to be higher than what they're being paid for Spravato today.NATH: When we say we're going to be the first to launch, we're kind of first and half, because we are tapping into an existing infrastructure. And then on our side, we have built the commercial team already.We've gone from 20 people in commercial at the beginning of the year to about 100 now. We'll continue to expand, but the final piece of that, which is the actual field-facing teams, those well only hire subject to approval. As a small biotech, it doesn't make sense to make that investment just in case there's a [rejection] or a delay or something.Would you say this would have been possible to launch, or at least launch independently, if Spravato hadn't come first?NATH: It's a great counterfactual. It would certainly have been harder, and it would have been probably a much slower ramp.That said we are planning to go slow to go fast, by which I mean we are going to be really managing the earliest patients with kid gloves. We're putting a significant team in place, because it's clearly critical that the patient experience, both subjectively, but also the provider on site from a reimbursement [standpoint] and everything else, is really good for the first few treatments. That's the way to get this whole field off to a good start.We are expecting to do a quite contained, carefully managed launch. There will be things that we haven't thought about. That's just the reality of a launch. And then scale rapidly thereafter.Adherence is a huge issue with mood and with psychiatry indications. Is the efficacy component of your drug the main characteristic you think will keep patients adherent?Compass Pathways Chief Patient Officer Steve LevinePermission granted by Compass PathwaysLEVINE: If we think about what makes adherence difficult with existing antidepressants I can be very sympathetic to that. These are difficult treatments to stick with. If it's traditional SSRIs where you have to take a pill every day or maybe multiple pills, first of all, that's just hard to remember and keep up with. I forget my vitamins all the time.You might forget accidentally on purpose if you also have side effects from that drug sexual side effects and weight gain and gastrointestinal side effects and so on. So not exactly a party.In terms of adherence with COMP360, sure efficacy. But also, with an in-office treatment, at least to a first dose, adherence is 100%. You know the person has taken the capsule; they're right there. Then, potentially, it is extremely infrequent thereafter. We think this is going to be a one- to four-time per year treatment. That alone makes this much easier for patients.What we're seeing in our trials is that to the extent that people have any adverse events or side effects, the vast majority are mild to moderate. They're happening on the day of administration, as we would expect. They're transient. They resolve typically by the next day, so you're not constantly taking a medication and having to remember to take it and to live with the incumbent side effects. But on top of that, we're also trying to be really thoughtful about what barriers or burdens could there be for patients. We're also thinking about providers, and we're very interested in making this as easy as possible from an affordability standpoint, from an access standpoint, and just the treatment experience.Wall Street seems to view this emerging class of psychedelics biotechs more as teammates than rivals. But theres a push and pull here. Positive data from any company further validates the field, yet these drugs may potentially compete with each other. How do you navigate that push and pull?NATH: The number of patients who need new options is absolutely vast. That's the case for [treatment-resistant depression]. It's the case, frankly, for [major depressive disorder]. There is a huge amount of need for novel options, at a time when traditional approaches are, by and large, failing to meet the mark and even if they do, are subject to all the same questions around adherence, side effect profile and so on.That maybe sounds a bit Pollyannaish, as if there's room for all of us. But actually, there probably really is. Several SSRIs got to several billion dollars. Several antipsychotics got to several billion dollars. And these are much better drugs than any of those were.This is the big challenge in psychiatry: we still can't tell you who's going to respond to COMP360. I wish I could tell you who are going to be the 40% who have a clinically meaningful response to a second dose, and who are the 60% who can't. That's the same for every one of these others. So ultimately, in the real world, there will be polypharmacy not, I hope, in the sense of taking two of these on the same day, but there will clearly be sequencing.The nature of the experience is clearly going to be key. Psilocybin is relatively speaking a benign, not physically challenging experience for patients. That is not true of some of the other psychedelic assets that are moving forward.I'm not going to pretend that we're sitting back and saying it's going to be great [and] we're all going to do incredibly well. But, when we come to market, the incumbent is Spravato. We are very clearly, very positively differentiated versus Spravato. To be clear, that doesn't mean we're trying to counter-detail J&J or go up against Spravato. There are 100,000 patients on Spravato, which leaves almost 4 million patients taking nothing, and again, that's our approach to providers. This is incremental business for you. We're not asking you to choose between Spravato and COMP360 for a patient.Weve seen other novel nervous system drugs Bristol Myers schizophrenia medication Cobenfy, Vertexs non-opioid pain pill Journavx recently come to market for enormous patient populations. Those are two large companies, and so far sales of those drugs have not impressed investors. Do those examples give you pause at all, do you see those as an apples and oranges comparison?NATH: It's a complete apples and oranges from my perspective.Having run Otsuka[s North American business] for many years, including a big schizophrenia business, the idea of a [twice-daily] drug that needs to [be taken on an empty stomach] was always going to be pretty challenging. Other than BMS, and obviously some early investors in Karuna, I don't think anyone else ever [thought] that was going to be anything other than tough.We have the advantage that we're not BMS, so we're not expected to have the product on the shelf the next day and in every retail pharmacy the next day. We're expected to launch this like a biotech, and we're going to launch it like a biotech.LEVINE: Although this will be a new class, in some ways, there isn't that novelty element. We've never had a problem with people having questions or concerns about these drugs working. We never get questions about whether the studies will be positive, whether these drugs actually are clinically effective.We get lots of questions about how they'll be delivered, because a lot of people just don't understand the infrastructure and the actual commercialization. But, rightly or wrongly, from fairly early on, people have just assumed and accepted these drugs work, as opposed to an unfamiliar mechanism where there's a big educational hill to climb, along with the logistical burdens that really made the Karuna drug tough to sell. '

布格替尼片（安伯瑞®，Alunbrig®，Brigatinib，研发代号AP26113）是ARIAD Pharmaceuticals研发的口服小分子ALK酪氨酸激酶抑制剂，单药适用于间变性淋巴瘤激酶(ALK)阳性的局部晚期或转移性的非小细胞肺癌(NSCLC)患者的治疗。 基本信息 靶点：ALK（间变性淋巴瘤激酶），属于口服小分子ALK酪氨酸激酶抑制剂，可穿透血脑屏障，对多种ALK耐药突变有效。 作用机理：布格替尼是口服、可逆的二代ALK酪氨酸激酶抑制剂（TKI），竞争性结合ALK激酶的ATP口袋，阻断激酶磷酸化激活，抑制肿瘤驱动信号，同时具备广谱ALK耐药突变抑制活性、良好血脑屏障穿透能力。 规格：30 mg、90 mg、180 mg。 适应症：单药用ALK阳性局部晚期或转移性非小细胞肺癌（NSCLC）。 用法：导入期7天90mg qd；之后180mg qd，持续给药至疾病进展或不可耐受毒性。 上市情况 美国：2017年4月FDA加速批准（克唑替尼耐药后二线）；2020年5月转为完全批准，拓展一线适应症（ALTA-1L三期）。 中国：2022-03-22，NMPA批准上市（化药5.1类进口原研） 注册与受理信息 临床试验信息 专利情况布格替尼（Brigatinib/Alunbrig®）美国专利信息：专利权人为TAKEDA PHARMACEUTICALS USA INC（武田制药美国公司，原研方为ARIAD Pharmaceuticals，2017年被武田收购）NDA号：208772。 原研武田核心专利：国内布局新用途（EGFR、ROS激酶）、中间体、晶型、组合物。其中晶型专利（CN111888368B）于2035-10-21到期，是保护期最长的核心专利。 国内高校/院所布局：沈阳药科大学（制备方法）、陆军特色医学中心（新用途）、常州工程职院（中间体，已失效）、浙江工业大学（中间体合成）。 国内企业布局：安多辉（反应装置实用新型）、南京艾德凯腾（冻干口崩片，已撤回）、正大天晴（衍生物，授权有权）、成都海杰亚（中间体，已驳回）。 其他药品分享链接如下，欢迎点击查看： Ormeloxifene OTF慢性体重管理的新型药物-Tirzepatide 新型的非阿片类小分子镇痛药-Suzetrigine 奥麦利昔芬口腔薄膜立项调研报告 纳米技术双氯芬酸乳胶剂药学研究 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【药品分享】卢美哌隆胶囊——一种新型的非典型抗精神病药物 【药品分享】奥氟格列隆片——口服非肽类小分子 GLP-1 受体激动剂 【药品分享】苯磺酸克利加巴林胶囊——一种新型的治疗神经病理性疼痛的药物 【药品分享】苯磺酸美洛加巴林片——治疗周围神经病理性疼痛（PNP）的第三代钙离子通道调节剂 【药品分享】Iberdomide胶囊——一款新一代cereblon（CRBN）E3连接酶调节剂（CELMoD）化合物 【药品分享】酒石酸伐尼克兰鼻喷雾剂——一种用于治疗干眼症的西药 【药品分享】赛沃替尼片——中国首个获批的高选择性 MET 酪氨酸激酶抑制剂 【药品分享】盐酸阿夫唑嗪缓释片——一种用于治疗良性前列腺增生（BPH） 的 α1 - 受体阻滞剂 【药品分享】索格列净片——全球首个获批的SGLT1/SGLT2 双重抑制剂 【药品分享】奥吡卡朋胶囊——新一代的儿茶酚-氧位-甲基转移酶抑制剂（COMT） 【药品分享】奎扎替尼片——一种口服高选择性 FLT3 抑制剂 【药品分享】硫酸拉罗替尼胶囊 / 口服溶液——全球首个高选择性口服 TRK 抑制剂 【药品分享】司帕生坦片——成人IgA肾病领域首个非免疫抑制疗法 【药品分享】黄体酮阴道栓剂/阴道缓释凝胶剂——主要用于辅助生殖技术（ART）中的黄体支持 【药品分享】替戈拉生片——首款国产钾离子竞争性酸阻滞剂类药物（P-CAB） 【药品分享】拉坦前列烯酯滴眼剂——一种新型眼科用药 【药品分享】布比卡因脂质体注射液——一种长效局部麻醉药 【药品分享】甲磺酸加诺沙星片——一种喹诺酮类抗菌药 【药品分享】磷酸芦可替尼乳膏——中国首款且唯一获批的白癜风治疗靶向药 【药品分享】甲磺酸洛美他派胶囊——全球唯一口服MTP抑制剂 【药品分享】依达拉奉口服混悬液——肌萎缩侧索硬化症（ALS，渐冻人症）新药 【药品分享】依达拉奉右莰醇舌下片——全球卒中领域首个获FDA突破性疗法认定的舌下脑保护剂 【药品分享】马来酸氟诺替尼片——JAK2/FLT3/CDK6 三靶点抑制剂 【药品分享】普拉替尼胶囊——国内首个获批的高选择性 RET（转染重排）酪氨酸激酶抑制剂 【药品分享】右美托咪定舌下膜——新型 α₂肾上腺素受体激动剂舌下膜剂 【药品分享】卡匹色替片——全球首个获批上市的AKT抑制剂 【药品分享】库莫西利胶囊——全球首个CDK2/4/6抑制剂 【药品分享】赛贝曲司他片——全球首个HAE急性发作口服疗法 【药品分享】KYGEVVI（Doxecitine/Doxribtimine）——全球首款且唯一获批的TK2d针对性治疗药物 【药品分享】Forzinity（Elamipretide）注射剂——全球首个用于治疗Barth综合征的药物 【药品分享】Brinsupri（Brensocatib, 布伦索卡替布）片——全球首个获批上市的二肽基肽酶1（DPP-1）抑制剂 【药品分享】维立西呱片——全球首个心衰适应症的可溶性鸟苷酸环化酶（sGC）刺激剂 【药品分享】盐酸哌罗匹隆片——非典型抗精神病药 【药品分享】盐酸托泊替康胶囊/注射用盐酸托泊替康——经典的拓扑异构酶Ⅰ抑制剂类抗肿瘤药 【药品分享】阿普昔腾坦片——全球首个获批用于难治性高血压的口服双重内皮素受体拮抗剂（ERA） 【药品分享】注射用盐酸依拉环素——全球首个氟环素类抗生素 【药品分享】奥洛格列净胶囊——国内首款抑制SGLT1与SGLT2的1类创新药 【药品分享】盐酸匹米替尼胶囊——国内首个、全球首个获批的腱鞘巨细胞瘤（TGCT）系统性靶向药，高选择性CSF-1R抑制剂 【药品分享】布地奈德肠溶胶囊——全球首个、中国唯一获批用于原发性IgA肾病对因治疗的靶向药物 【药品分享】艾拉莫德片——中国原研、全球首个上市的小分子抗风湿药（csDMARD） 【药品分享】索托克拉片——新一代BCL2抑制剂 【药品分享】利奈昔巴特片——口服、选择性、可逆性回肠胆汁酸转运体（IBAT/ASBT）抑制剂 【药品分享】多替诺雷片——高选择性URAT1抑制剂 【药品分享】瑞普泊肽片——口服GLP‑1/GIP双靶点激动剂 【药品分享】硫酸索西美雷塞片——口服、强效的KRAS G12C共价抑制剂 【药品分享】罗伐昔替尼片——全球首创JAK/ROCK双靶点口服小分子抑制剂 【药品分享】埃诺格鲁肽注射液——全球首个获批上市的cAMP偏向型长效GLP-1受体激动剂 【药品分享】维培那肽注射液——长效GLP-1受体激动剂 【药品分享】普乐司兰钠注射液——全球首个靶向APOC3 mRNA的siRNA降脂药 【药品分享】玛仕度肽注射液——全球首个GCG/GLP-1双激动剂 【药品分享】瑞米布替尼片——全球首个获批用于CSU的口服靶向药 【药品分享】溴莫尼定噻吗洛尔滴眼液——α₂受体激动剂与非选择性 β 受体阻滞剂组成的复方降眼压药 【药品分享】吡洛西利片——国内首个CDK2/4/6多靶点抑制剂 【药品分享】奥氟格列隆片（Orforglipron） ——中国首个、全球首批上市的口服小分子 GLP-1受体激动剂 【药品分享】Copper Histidine注射液（Zycubo）——全球首个、唯一用于治疗儿童门克斯病（Menkes disease）的铜替代注射剂 【药品分享】依来格列隆片（Elecoglipron）——口服小分子非肽类GLP-1受体激动剂 【药品分享】阿利奈普仑（Aleniglipron）——口服小分子、非肽类、偏向性GLP-1受体激动剂 【药品分享】甲磺酸阿美替尼片——中国首个原研三代EGFR酪氨酸激酶抑制剂（TKI） 【药品分享】甲磺酸达麦利替尼片——口服高选择性c-MET酪氨酸激酶抑制剂 【药品分享】盐酸Acoramidis片——转甲状腺素蛋白（TTR）稳定剂 【药品分享】阿莫西林伏诺拉生胃漂浮片——3D打印胃漂浮片 【药品分享】盐酸伊可白滞素片——全球首创口服IL‑23受体拮抗剂 【药品分享】马来酸吡咯替尼片——中国首个自研的HER1/HER2/HER4不可逆酪氨酸激酶抑制剂（TKI） 【药品分享】本维莫德乳膏——全球首创芳香烃受体（AhR）调节剂（TAMA）类皮肤病外用药 【药品分享】盐酸莫托咪酯注射液——化药1类静脉麻醉新药 【药品分享】注射用罗哌卡因微晶——长效缓释局部麻醉药 【药品分享】盐酸伊立替康脂质体注射液——一款针对吉西他滨治疗失败的转移性胰腺癌的二线标准脂质体化疗药 【药品分享】甲磺酸氟马替尼片——Bcr-Abl酪氨酸激酶选择性抑制剂 【药品分享】注射用阿加糖酶β——国内获批的首个用于治疗法布雷病的药物 【药品分享】甲苯磺酸尼拉帕利胶囊——高选择性PARP1/2抑制剂 【药品分享】帕米帕利胶囊——强效、选择性PARP1/2抑制剂 【药品分享】苯环喹溴铵鼻喷雾剂——选择性M胆碱能受体拮抗剂 【药品分享】注射用拉罗尼酶浓溶液——MPS Ⅰ型的特异性酶替代治疗药物 【药品分享】海博麦布片——国产自主原研的胆固醇吸收抑制剂 【药品分享】盐酸可洛派韦胶囊——直接抗病毒药物（DAA）→ NS5A抑制剂 【药品分享】克拉考特酮乳膏——外用、非甾体、选择性雄激素受体（AR）抑制剂 【药品分享】非卢替尼片——全球首个用于多发性硬化的口服BTK抑制剂 【药品分享】Brenipatide注射液——GLP-1R/GIPR双受体激动剂（继替尔泊肽之后的第二款） 【药品分享】罗赛促红素α注射液——国产首个长效重组促红细胞生成素（EPO）创新药 【药品分享】贝组替凡片——全球首个口服小分子HIF-2α抑制剂 【药品分享】那米司特片——口服选择性PDE4B抑制剂 【药品分享】富马酸立康可泮胶囊——一款针对罕见病PNH的口服补体B因子抑制剂 【药品分享】醋酸索乐匹尼布片——高选择性脾酪氨酸激酶（Syk）抑制剂 【药品分享】甲磺酸艾多替尼片——全球首款专为肺癌脑转移设计的第三代EGFR-TKI 【药品分享】安瑞克芬注射液——全球首个获批镇痛适应症的高选择性外周κ-阿片受体（KOR）激动剂 【药品分享】Difelikefalin注射液——全球首个获批的外周选择性κ-阿片受体（KOR）激动剂 【药品分享】Obefazimod——口服、靶向 CBC、特异性增强miR-124的首创小分子 【药品分享】拉尼兰诺片——口服泛PPAR激动剂 【药品分享】舒洛地特注射液——抗血栓药、血管保护剂 【药品分享】贝普若韦生注射液——反义寡核苷酸（ASO）类乙肝新药 【药品分享】氨酚右敏口服溶液（奥肯能®）——中国内地唯一获批的氨酚右敏口服溶液 【药品分享】佩玛贝特片——新型过氧化物酶体增殖物激活受体α/δ双重激动剂 (PPARα/δ) 【药品分享】盐酸依匹斯汀乳膏——外用第二代非镇静抗组胺抗过敏药膏 【药品分享】注射用双羟萘酸帕瑞肽微球——一款用于治疗肢端肥大症的第二代长效生长抑素类似物（SRL）微球制剂 【药品分享】埃拉菲布拉诺片——治疗原发性胆汁性胆管炎（PBC）的口服靶向新药 【药品分享】泽卢克布仑钠注射液——新一代皮下注射型C5补体抑制剂 【药品分享】依达拉奉右莰醇注射用浓溶液——一款复方神经保护类注射剂 【药品分享】醋酸戈那瑞林注射液——促性腺激素释放激素（GnRH）类药物 【药品分享】甲磺酸贝舒地尔片——全球首个选择性ROCK2激酶抑制剂 【药品分享】伊托法替布软膏——外用JAK抑制剂（JAK1/JAK3） 【药品分享】注射用华卟啉钠——新型肿瘤光动力治疗（PDT）专用光敏剂 【药品分享】优替德隆胶囊——口服埃博霉素类微管抑制剂 【药品分享】艾普美妥司他片——EZH1/2双靶创新药 【药品分享】精氨酸艾曲莫德片——新型选择性鞘氨醇1-磷酸受体（S1P₁）调节剂 【药品分享】磷酸芦可替尼乳膏——全球/国内首款、唯一获批用于非节段型白癜风复色的外用JAK1/JAK2选择性抑制剂 【药品分享】盐酸右哌甲酯缓释胶囊——治疗6岁及以上注意缺陷多动障碍（ADHD）的一线药物 【药品分享】抗菌肽PL-3301口腔凝胶——中国首创的抗菌肽类抗口腔真菌感染药物 【药品分享】Zasocitinib (TAK-279) 胶囊——新一代高选择性口服 TYK2 抑制剂 【药品分享】注射用Abelacimab——一款全人源IgG1单克隆抗体，靶向凝血因子XI（FXI） 【药品分享】Duvakitug注射液——首创性人源化IgG1-λ2单克隆抗体，靶向TL1A（TNFSF15） 【药品分享】醋酸氟轻松/氢醌/维A酸乳膏——治疗中重度黄褐斑疗效明确的外用复方 【药品分享】富马酸伏诺拉生氯化钠注射液——钾离子竞争性酸阻滞剂（P‑CAB）||东阳光药业研发的2.2,2.4类改良新型新药 【药品分享】盐酸阿曲生坦片——诺华研发的高选择性内皮素 A（ETA）受体拮抗剂||中国首个获批用于IgA 肾病的非免疫性口服靶向药 【药品分享】RGT-274-CR胶囊——上海齐鲁锐格医药研发的口服小分子GLP-1受体激动剂 【药品分享】酒石酸西尼必利片——高选择性5-HT₄受体激动剂类胃肠动力药 【药品分享】石杉碱甲控释片——采用双相控释/渗透泵技术的2.2类改良型新药 【药品分享】塞伐艾替尼片——口服、可逆、选择性酪氨酸激酶抑制剂（TKI） 【药品分享】Admilparant片——口服小分子LPA₁受体拮抗剂 【药品分享】瑞拉可兰胶囊——全球首个选择性糖皮质激素受体（GR）拮抗剂 【药品分享】盐酸依特卡肽注射液——全球首个、国内唯一获批的静脉注射型拟钙剂 【药品分享】Avacincaptad pegol玻璃体内注射液——全球首批用于AMD继发地图样萎缩（GA）的靶向药物 【药品分享】盐酸达利雷生片——新一代非管制、非苯二氮䓬类抗失眠药物 【药品分享】甲磺酸瑞索利塞片——高选择性PI3Kα小分子靶向抑制剂 || 全球首个获批用于特定卵巢癌的靶向新药 【药品分享】富马酸西他沙星注射液——新型喹诺酮类抗菌药物 【药品分享】Icotrokinra——全球首个获批的口服 IL-23 受体（IL-23R）选择性拮抗多肽 【药品分享】氘可来昔替尼片（Deucravacitinib）——全球首个口服、选择性 TYK2 变构抑制剂 【药品分享】柯美奇拜单抗注射液——鼻用糖皮质激素治疗后症状控制不佳的成人中重度季节性过敏性鼻炎患者的福音 【药品分享】吉诺昔替尼——口服小分子JAK1/TYK2双重抑制剂 【药品分享】洛替拉纳（Lotilaner）——GABA 门控氯离子通道非竞争性拮抗剂 || 兼具兽医驱虫与人用眼科两大用途 【药品分享】CagriSema——由卡格列肽（cagrilintide）2.4 mg与司美格鲁肽（semaglutide）2.4 mg组成的强效减重复方药 【药品分享】苹果酸卡博替尼——口服、多靶点酪氨酸激酶抑制剂（TKI） 【药品分享】迪高替尼（Delgocitinib）——一款外用泛JAK抑制剂 【药品分享】拉氟莫司(Laflunimus)——口服免疫抑制剂 || 兼具免疫抑制与抗炎双重活性 【药品分享】伏昔尼布片——全球首个IDH1/IDH2双重突变抑制剂靶向药 【药品分享】盐酸奥昔布宁片——M受体抗胆碱药 【药品分享】贝泽昔替尼片——国内首款获批的高选择性JAK2单靶点抑制剂 【药品分享】苯甲酸安达艾替尼胶囊——新型小分子酪氨酸激酶不可逆抑制剂（EGFR-TKI） 【药品分享】伏欣奇拜单抗注射液——全人源抗IL‑1β单克隆抗体 || 用于急性痛风性关节炎的1类创新生物药 【药品分享】利多卡因丁卡因乳膏 【药品分享】伐米奇拜单抗注射液——玻璃体内注射用抗IL-6人源化单抗 【药品分享】依赛弗酶α注射液（Efzimfotase alfa 注射液）——第二代重组组织非特异性碱性磷酸酶（TNSALP）酶替代疗法 【药品分享】格达托利西布（Gedatolisib）——first‑in-class 泛 PI3K/mTORC1/2 双重抑制剂 【药品分享】伯瑞替尼肠溶胶囊——中国原研、高选择性c-MET小分子抑制剂 || 首个获批MET扩增NSCLC单药治疗的靶向药 【药品分享】力胜克拉片——中国首个申报上市的原研Bcl-2抑制剂、全球第二款Bcl-2抑制剂 【药品分享】BGM0504注射液——GLP-1/GIP 双受体激动剂 【药品分享】塞利尼索片——全球首个口服选择性核输出蛋白XPO1抑制剂 【药品分享】Seltorexant薄膜包衣片——选择性食欲素2受体（OX2R）高选择性拮抗剂 【药品分享】盐酸埃克替尼片——国内首个自主研发的一代EGFR-TKI 【药品分享】盐酸伊普可泮胶囊——全球首个口服补体B因子抑制剂 【药品分享】恩考芬尼胶囊——靶向BRAF V600突变的口服激酶抑制剂 【药品分享】Enpatoran——口服、选择性TLR7/8小分子抑制剂 【药品分享】硝酸异康唑阴道片——抗真菌外用药物 【药品分享】Zorevunersen注射液——全球独家ASO上调蛋白表达技术 【药品分享】妥拉美替尼胶囊——全球首个针对NRAS突变黑色素瘤的MEK抑制剂 【药品分享】盐酸替那帕诺片——全球首创NHE3抑制剂类新型降磷药物 【药品分享】注射用莱古比星——新型蒽环类抗肿瘤药 【药品分享】优替德隆胶囊——口服埃博霉素类微管抑制剂 【药品分享】伊那利塞片——中国首个PIK3CA突变乳腺癌精准靶向药 【药品分享】呋喹替尼胶囊——中国首个自主研发VEGFR-TKI || VEGFR靶点靶向抗癌药 【药品分享】琥珀酸瑞波西利片——CDK4/6抑制剂 【药品分享】盐酸替那帕诺片——全球首个且唯一获批的肠道磷吸收抑制剂 【药品分享】芬布替尼片——口服、可逆、可透过血脑屏障的BTK抑制剂 【药品分享】炔丙基半胱氨酸胶囊——全球首个进入临床的硫化氢（H₂S）供体I类创新药 【药品分享】Balcinrenone达格列净胶囊——选择性盐皮质激素受体拮抗剂（MRA）+SGLT-2抑制剂 【药品分享】诺拉西班（Nolasiban）分散片——选择性口服催产素受体拮抗剂 || 早产二线/辅助治疗药物 【药品分享】塞多明基注射液——国内首款裸质粒基因治疗药物 【药品分享】鲁兹诺雷钠片——国产首个高选择性URAT1抑制剂 【药品分享】玛伐凯泰胶囊——全球首创、中国唯一获批的心肌肌球蛋白抑制剂 【药品分享】依托芬那酯凝胶——外用非甾体抗炎镇痛药 【药品分享】聚卡波非钙片——国际指南首选容积性缓泻剂 【药品分享】Mezigdomide胶囊——新一代IMiDs/cereblon E3泛素连接酶调节 【药品分享】洛布替尼片——全球首款共价+非共价双机制第四代 BTK 靶向药 【药品分享】奥莱泊肽注射液——PEG修饰长效GLP‑1单靶点激动剂 【药品分享】安瑞曲替尼胶囊 ——国内第二款国产二代NTRK广谱抗癌药 【药品分享】麦格司他胶囊——抑制葡萄糖神经酰胺合成酶的罕见病口服靶向药 【药品分享】乌帕替尼片（Upadacitinib）——选择性JAK1抑制剂 【药品分享】Dordaviprone胶囊——全球首款、目前唯一获批用于 H3 K27M 突变型弥漫性中线胶质瘤（DMG）的靶向药 【药品分享】屈昔多巴胶囊——去甲肾上腺素前体药物  || 帕金森、多系统萎缩、神经源性体位低血压一线对症用药 【药品分享】康特替尼颗粒——第二代ALK多靶点激酶抑制剂 【药品分享】盐酸兰诺可泮片——国产首个获批上市的补体因子B（CFB）抑制剂 【药品分享】Elinzanetant软胶囊——全球首款NK1/NK3双重神经激肽受体拮抗剂 【药品分享】Fosmanogepix注射液——全球首创（First-in-class）Gwt1抑制剂类抗真菌前药 【药品分享】Zorevunersen注射液——反义寡核苷酸药物 【药品分享】宗艾替尼片——高选择性不可逆HER2（ERBB2）酪氨酸激酶抑制剂（TKI） 【药品分享】甲苯磺酸他拉唑帕利胶囊——高选择性PARP抑制剂 【药品分享】Bexicaserin口服溶液——选择性5-HT2C受体激动剂口服液体制剂 【药品分享】醋酸伏诺拉生注射用浓溶液——钾离子竞争性酸阻滞剂（P-CAB） 【药品分享】甲苯磺酸依仑司群片——新一代口服选择性雌激素受体降解剂（SERD） 【药品分享】硫酸瑞美吉泮口崩片——CGRP 受体拮抗剂（降钙素基因相关肽）|| 偏头痛靶向特效药 【药品分享】阿托吉泮片——全球首款口服长效CGRP靶点预防偏头痛药物 【药品分享】乌布吉泮片——CGRP受体拮抗剂 || 第二代口服偏头痛急性期药物 【药品分享】扎维吉泮鼻喷雾剂——高选择性CGRP受体拮抗剂  || 全球唯一获批鼻喷CGRP吉泮类急性期药物 【药品分享】培来加南喷雾剂——全球首款上市加南类多肽抗菌药（FIC） 【药品分享】艾沙利酮片——高选择性非甾体醛固酮受体拮抗剂（MRA）  || 全球首个上市的非甾体选择性MR拮抗剂 【药品分享】布美他尼鼻喷雾剂——全球首款、唯一鼻内给药袢利尿剂 【药品分享】注射用盐酸依拉环素——新型全合成氟环素类（四环素衍生物）静脉抗生素 【药品分享】舒瑞基奥仑赛注射液——全球首款实体瘤自体CLDN18.2靶向CAR-T细胞新药 【药品分享】盐酸环喷托酯滴眼液——儿童验光首选短效睫状肌麻痹剂之一 【药品分享】盐酸赛庚啶口服溶液——抗过敏抗组胺药 【药品分享】Rinzimetostat (ORIC-944)——口服选择性 EED别构型PRC2表观遗传抑制剂 【药品分享】Empasiprubart注射用浓溶液——全球首创靶向补体C2人源化IgG1清扫型单克隆抗体 【药品分享】阿更葡糖钠注射液——全球第二款、中国首款自主研发的环糊精类靶向肌松逆转剂 【药品分享】盐酸罗哌卡因缓释溶液——国产自主长效局麻缓释制剂 || 填补国内切口原位长效镇痛空白 【药品分享】Telisotuzumab Adizutecan 注射用粉末——抗c-Met抗体偶联药物（ADC） 【药品分享】L606 (曲前列尼尔脂质体吸入混悬液)——靶向肺动脉高压 【药品分享】佩米替尼片——选择性FGFR1/2/3酪氨酸激酶抑制剂 【药品分享】唑尼沙胺胶囊——磺酰胺类结构 || 广谱抗癫痫药，偏头痛预防 【药品分享】琥珀酸安维吖啶片——双靶点胆碱酯酶抑制剂 【药品分享】布莱昔替尼片（Bleximenib）——口服高选择性Menin-KMT2A相互作用抑制剂 【药品分享】利厄替尼片——第三代EGFR-TKI靶向药 【药品分享】注射用苯磺酸瑞马唑仑——苯二氮䓬类短效静脉镇静/麻醉药 【药品分享】瑞维鲁胺片——国产全新二代雄激素受体抑制剂 【药品分享】塞普替尼胶囊——全球首款高选择性RET靶向药  || 国内唯一拥有12岁以上儿童甲状腺肿瘤完整临床证据的RET抑制剂 【药品分享】注射用和厚朴酚脂质体冻干粉——全球首创小分子脂质体靶向制剂 【药品分享】注射用顺铂聚合物胶束——前沿纳米化疗创新赛道  || 改良型新药-纳米靶向注射制剂 【药品分享】奥普雷顿片——国内首个获批的口服OX2R选择性激动剂 【药品分享】琥珀酸思普可泮片——口服选择性补体B因子（CFB/FB）小分子抑制剂  || 全球首个每日一次口服FB抑制剂 【药品分享】苹果酸法米替尼胶囊——多靶点TKI创新药  || 国内唯一获批用于宫颈癌的口服抗血管TKI 【药品分享】盐酸伊普可泮胶囊 【药品分享】枸橼酸伊沙佐米胶囊——第二代、全球首个口服可逆性蛋白酶体抑制剂 【药品分享】注射用西罗莫司（白蛋白结合型）——mTOR 激酶抑制剂  || 白蛋白纳米粒递送系统 【药品分享】Bleximenib片——Menin抑制剂（KMT2A/Menin 相互作用抑制剂） 【药品分享】Eloralintide注射液——选择性长效胰淀素（Amylin）受体激动剂（AMY1R激动剂） 【药品分享】阿柏西普眼内注射溶液——重组人源VEGF融合蛋白的治疗用生物制品 【药品分享】艾托莫德片——高选择性S1PR1（鞘氨醇‑1‑磷酸受体1）小分子激动剂 【药品分享】GBI268注射液——复方局部镇痛注射剂 【药品分享】Edecesertib片——IRAK‑4小分子激酶抑制剂 【药品分享】阿布昔替尼片——高选择性JAK‑1小分子抑制剂 【药品分享】盐酸阿思尼布片——全球首个且目前唯一基于ABL肉豆蔻酰口袋（STAMP）创新机制的靶向药物 【药品分享】Venglustat——葡萄糖神经酰胺合成酶（GCS/UGCG）抑制剂 【药品分享】塞瑞替尼胶囊——第二代ALK酪氨酸激酶抑制剂（ALK-TKI） 【药品分享】泊那替尼片——第三代BCR-ABL酪氨酸激酶抑制剂（TKI）|| 唯一能够有效抑制BCR‑ABL T315I耐药突变的TKI 【药品分享】盐酸阿那格雷胶囊——PDE3抑制剂 【药品分享】奥雷巴替尼片——国内首个获批可有效抑制T315I突变的三代BCR-ABL抑制剂 【药品分享】比克恩丙诺片——HIV‑1感染单片复方抗病毒药 【药品分享】甲磺酸奥希替尼片——第三代EGFR靶向药 【药品分享】醋酸戈舍瑞林缓释植入剂——促性腺激素释放激素激动剂缓释皮下植入制剂 【药品分享】拉考沙胺缓释胶囊——钠通道调节剂 【药品分享】纳曲酮利培酮植入剂——新的缓释植入剂型 【药品分享】普那布林注射用浓溶液——GEF‑H1（ARHGEF2）激动剂 【药品分享】Petrelintide注射液——长效胰淀素（Amylin）受体激动剂 【药品分享】酒石酸凡瑞格拉替尼片——1类高选择性FGFR口服小分子创新药 【药品分享】醋酸兰瑞肽缓释注射液（预充式）——长效生长抑素类似物（SSA） 【药品分享】吡非尼酮胶囊——多细胞因子通路调节剂 【药品分享】罗替高汀贴片——非麦角类多巴胺受体激动透皮贴剂  || 全球首个经皮吸收的帕金森治疗药物 【药品分享】芦沃美替尼片——高选择性MEK1/2（丝裂原活化蛋白激酶激酶 1/2）抑制剂 【药品分享】硫酸阿托品滴眼液——竞争性 M‑胆碱（毒蕈碱）受体拮抗剂 【药品分享】盐酸恩沙替尼胶囊——国产第二代间变性淋巴瘤激酶(ALK)-酪氨酸激酶抑制剂(TKI)靶向药 【药品分享】富马酸奥赛利定注射液——新型静脉镇痛药物 || G蛋白偏向性μ‑阿片受体激动剂 【药品分享】司美格鲁肽微针贴片——用于2型糖尿病与肥胖体重管理的新剂型药品 【药品分享】甲苯磺酸利特昔替尼胶囊——国内首个获批可用于12–17岁青少年重度斑秃的口服系统治疗药物 【药品分享】艾曲帕米鼻喷雾剂——经鼻给药的速效钙通道阻滞剂 【药品分享】盐酸替扎尼定胶囊——中枢性α2肾上腺素受体激动剂 【药品分享】格贝前列素滴眼液——单分子双功能NO供体型前列腺素前药 【药品分享】盐酸伊司特韦片——全球首个依托DEL结合AI技术成功获批的原创小分子药物 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。