Axial Spondyloarthritis

本文系基于公开资料撰写，仅作为信息交流之用，不构成任何投资建议。自免药物，全球第二大药物市场。过去几年，大批药企涌入肿瘤赛道，诞生出了PD-1、ADC等爆款抗肿瘤药物，但深耕自免领域的玩家却并不多，很多细分自免赛道都是待开发的空白。较大的自免药物需求与市场极低的关注度之间，悄然形成了一种极为明显的预期差。当然，自免赛道的低迷预期不会迅速反转，只有当布局企业逐渐做出一些成绩，才会逐渐吸引更多的资本入局研发，这是一个缓慢的“填坑”过程。近期，中国资本市场中又多了一个自免赛道“填坑”人。01三大核心管线荃信生物是一家专注聚焦于自免疾病的生物科技公司。这是一家十分年轻的公司，拥有8款在研生物制剂，适应症涵盖皮肤、风湿、呼吸道、消化道四大领域。从在线管线数据观测，荃信生物是目前本土自免生物制剂布局最多的三家公司之一。图：国内自免领域生物制剂研发一览，来源：招股书当然，这项数据仅统计的是自免领域生物制剂的研发情况，并不包含小分子药物，同时也没有考量管线进度情况，因此存在失真的可能性。进一步聚焦荃信生物在研管线，虽然拥有8大管线，但多数管线仅处于临床早期，真正到达临床后期的实则只有三条管线：QX001S、QX002N、QX005N。也就是说，荃信生物未来几年的商业化预期，完全取决于这三条管线的兑现情况，充满较高不确定性。图：荃信生物在研管线一览，来源：招股书（1）QX001SQX001S是荃信生物临床进度最快的管线，其已经处于上市申请阶段，预计将于今年四季度获批，有望成为荃信生物第一款上市药物。同时，QX001S也是国内进度最快的乌司奴单抗（Stelara）生物类似药，百奥泰、新诺威的乌司奴单抗生物类似药则都处于临床三期。图：乌司奴单抗生物类似药研发一览，来源：锦缎研究院2018-2023的六年间，乌司奴单抗的全球营收额由51.56亿美元飙升至108亿美元，六年累计营收488.81亿美元，跻身全球药物销售额前十。作为国内进度最快的乌司奴单抗生物类似药，QX001S有望享受到国产替代红利。但在出海方面，安进和Alvotech的生物类似药已经先后在欧美获批，因此QX001S出海难度较大。（2）QX005NQX005N是一款靶向IL-4Rα的单抗创新药。在这个赛道中，赛诺菲的度普利尤单抗（Dupixent）是绝对龙头，2023年销售额已经成长至117亿美元。与大多数爆款类似，度普利尤单抗的业绩增长也是建立在适应症不断扩张的基础上，截止目前其已经在全球获批5大适应症，并有3个适应症即将获批。度普利尤单抗的成功吸引了大批药企入局IL-4Rα靶点。仅以国内市场为考量，康诺亚、智翔金泰、三生国健、荃信生物、恒瑞医药、康乃德生物、康方生物都是这一赛道的有力竞争者。图：国内IL-4Rα单抗研发格局，来源：锦缎研究院荃信生物QX005N有三大适应症进入临床二期，分别是特异性皮炎、结节性痒疹、慢性鼻窦炎伴鼻息肉。这其中，特异性皮炎和慢性鼻窦炎伴鼻息肉适应症布局药企较多，荃信生物进度并不算快；但在结节性痒疹适应症上，QX005N是除度普利尤单抗外进度最快的公司。（3）QX002NQX002N是一款靶向IL-17A的单抗创新药。这个赛道的竞争远比IL-4Rα靶点更加激烈，诺华的司库奇尤单抗（Cosentyx）为龙头产品，礼来、安进、UCB的药物也已获批上市。IL-17A同样是一个适应症广泛的靶点，涵盖斑块状银屑病、中轴性脊柱关节炎、强直性脊柱炎、狼疮性肾病等风湿类疾病。目前国内已经有三款海外IL-17A单抗获批，国内最接近上市的为智翔金泰和恒瑞医药。图：国内IL-17A单抗研发格局，来源：锦缎研究院荃信生物的QX002N仅在强直性脊柱炎适应症进度较快，但这一适应症上，诺华、礼来的产品已经获批，恒瑞医药、UCB、丽珠医药、康方生物的产品同样进入到临床三期。从这不难看出，QX002N差异化做的并不好，很可能遭遇较为严峻的竞争。02深度绑定华东医药荃信生物创始人为裘霁宛，他是名副其实的“华东系”。裘霁宛在1993年毕业后，就加入九源基因负责新药研发，而九源基因正是华东医药前董事长李邦良所创建。在九源基因工作11年后，裘霁宛离职创业，并得到华东医药的鼎力相助。在荃信生物2020年的B+轮融资中，华东医药以3.7亿元高调注资，一跃成为荃信生物第二大股东。本次IPO之前，华东医药依然是荃信生物的第二大股东，持续比例高达17.09%。作为基石投资者，华东医药也参与认购了荃信生物本次IPO发行的股份，合计认购约500万美元价值的股份。图：荃信生物IPO前股权结构，来源：公司招股书除股权投资外，华东医药还是荃信生物重要的合作伙伴。荃信生物临床进度最快的QX001S的国内商业化权益就被授权给了华东医药，合计从华东医药收取5000万美元付款，以及未来QX001S在国内一半的税前利润。从一款乌司奴单抗生物类似药的定位看，QX001S的核心价值还是在于国产替代，虽然荃信生物依然拥有QX001S的海外权益，但在海外市场已经有生物类似药获批的前提下，QX001S想要出海并不容易。基于此，荃信生物未来几年的业绩表现，就要看华东医药能把QX001S带到怎样高度了。对于荃信生物来说，深度绑定华东医药是一种优势，可以借助华东成熟的销售渠道迅速推广药物，也免去了自建销售团队所面临的亏损问题。03核心价值：国产替代详细剖析了荃信生物管线资产后，它的核心价值定位已经逐渐清晰，那就是国产替代。无论是即将上市的QX001S，还是正处于临床后期的QX002N和QX005N，他们本质对标的都是海外爆款创新药。QX001S对标乌司奴单抗（108亿美元），QX002N对标司库奇尤单抗（49.8亿美元），QX005N对标度普利尤单抗（117亿美元）。这些品牌药有着较强销售预期，国内尚且没有实现国产替代的产品。荃信生物要做的就是争取率先实现国产替代，并吃到由此带来的红利。当然，荃信生物的药物是可以出海的，只不过难度比较大而已。随着荃信生物的发展，它未来或将布局更多具备FIC或者BIC潜质的产品，但它们显然不是现阶段投资者应该考虑的事情。路要一步一步地走，管线研发要一款一款的来。国产替代型创新药，虽然没有FIC或者BIC产品商业价值大，但却是我国制药产业发展的必经之路。只有做好了国产替代这件事，我们才能将更多的医保费用留在国内，才能有机会寻求更多创新。实际上，能够将国产替代这件事做好的公司都取得了不错的成绩，如几年前的贝达药业，再比如近期的艾力斯。所以荃信生物只要能够将目前三条核心管线快速顺利孵化上市，填好自免药物这个“大坑”，那么它就已经对得起大多数投资者期待了。· 靶点格局 ·PD-1靶点 | TIGIT靶点 | Claudin18.2靶点GLP-1靶点 | CDK4/6靶点 | CD20靶点 EGFR靶点 | KRAS靶点 | CD47靶点c-MET靶点 | ALK靶点 | BCR-ABL靶点· 产业地图 ·百济神州 | 恒瑞医药 | 君实生物 | 信达生物 再鼎医药 | 复宏汉霖 | 先声药业 | 康方生物药明康德 | 药明生物 | 贝达药业 | 诺诚健华亚盛医药 | 新诺威 | 荣昌生物 | 基石药业诺辉健康 | 迈瑞医疗 | 联影医疗 | 华大智造爱尔眼科 | 时代天使 | 亚虹医药 | 康宁杰瑞绿竹生物 | 讯飞医疗 | 微创医疗 | 福瑞股份京东健康 | 平安好医生 | 晶泰科技 | 英矽智能金斯瑞生物 | 复宏汉霖 | 华东医药 | 云顶新耀

In 2022, Rinvoq was responsible for drumming up the highest spending among pharmas on TV ads, while another AbbVie offering, Skyrizi, took third place. A year later, Skyrizi took the ad-spending throne, while Rinvoq slipped to second place. No run-of-the-mill desk workers here—AbbVie’s trio of “Just Okay” TV commercials for Rinvoq’s arthritis indications focus on individuals performing jobs typically reserved for a quirky lead in a romantic comedy. (Cinematic meet-cutes not pictured.) The latest installment in the campaign began airing earlier this month, per iSpot.tv, and features a mobile pet groomer and a landscape designer with rheumatoid arthritis and psoriatic arthritis, respectively. It follows a spot that hit the small screen late last year and highlighted a hiker and an event planner, and another that debuted in early 2023 and starred a swim coach and a baker—all of whom have either moderate to severe rheumatoid arthritis or psoriatic arthritis. The newest iteration, like its predecessors, starts with each of the stars admitting that they’d told themselves they were “OK” with their arthritis symptoms, before declaring, “Just OK isn’t OK.” As they’re each shown performing their hands-on jobs—with the pet groomer parking his business-on-wheels outside a home to give a dog a bath and the landscaper paving a new pathway in her own backyard—a voice-over notes that Rinvoq may help relieve symptoms like joint pain, stiffness, swelling and fatigue, prevent further joint damage and, in psoriatic arthritis, clear up skin, before offering up a list of potential side effects. The commercial ends with the pet groomer advising viewers who are “done settling” to “take back what’s yours” by talking to their doctors about Rinvoq. The three “Just Okay” ads are only the tip of the iceberg for AbbVie’s efforts to push Rinvoq. Its first arthritis-focused campaign for the JAK inhibitor in early 2020 took a similarly action-packed angle, roping in motorcycle riders, outdoor photographers, anglers and more to inspire viewers to “make it your mission” to fight the condition. Meanwhile, after securing an FDA green light for Rinvoq’s use in treating atopic dermatitis, AbbVie stuck to the high-octane theme with a 2022 ad for the indication that Fierce Pharma Marketing described at the time as a cross between a ‘90s rave and an Air Force recruitment video. That year, Rinvoq—which is also cleared in ulcerative colitis, Crohn’s disease, ankylosing spondylitis and non-radiographic axial spondyloarthritis—was responsible for drumming up the highest spending among pharmas on TV ads, with nearly $316 million, while another AbbVie offering, Skyrizi, took third place. A year later, for all of 2023, Skyrizi took the ad spending throne, while Rinvoq slipped to second place with a total of $351.1 million. And AbbVie is holding steady atop the direct-to-consumer ad spending pile: Data from iSpot.tv show that the two drugs have remained at the top of the list so far this year, with Skyrizi securing the No. 1 spot in January and Rinvoq reclaiming the throne in February.

A drug review committee for the European Medicines Agency (EMA) recommended approval of UCB’s Bimzelx (bimekizumab) for hidradenitis suppurativa (HS) on Friday, moving the antibody one step closer to clinching its fourth approval in the EU.The dual IL-17A and IL-17F inhibitor is already approved by the EMA to treat plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. Last year, Bimzelx scored a long-awaited FDA approval for psoriasis (see – KOL Views Q&A: Early look at how UCB’s Bimzelx is faring in battle with IL-17s and IL-23s in psoriasis). The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Bimzelx based on two Phase III trials, BE HEARD I and BE HEARD II. The studies enrolled 1014 patients with moderate-to-severe HS to receive a Bimzelx injection either every two weeks, every four weeks, or placebo. At week 16, Bimzelx led to statistically significant and clinically meaningful improvements over placebo as measured by Hidradenitis Suppurativa Clinical Response (HiSCR50), meeting the primary endpoint.If approved, Bimzelx would become the third therapy available for HS patients in the EU, following AbbVie’s Humira (adalimumab) and Novartis’ Cosentyx (secukinumab). More options could be on the horizon, however, as the next generation of HS treatments, which are directed against several new targets, reach late-stage testing. For more, see KOL Views Q&A: Leading dermatologist optimistic about next wave of HS treatments.A greenlight in HS could also help UCB reach its estimated peak sales of at least €4 billion ($4.2 billion) for Bimzelx.