2026.10.08 | GP | Pharma | Livzon IL-17A/F for Ankylosing Spondylitis

Primary:

1513:HK

Viewpoint:

KOL - Physician

Moderator: Kate Han (KH)

Yu Xue (YX), Chief Physician in the Department of Rheumatology and Immunology - Huashan Hospital Fudan University

SUMMARY

Overview

The discussion assessed a Phase 3 trial of a domestically developed dual IL-17A/F inhibitor for active ankylosing spondylitis after inadequate response to conventional therapy. It covered patient representativeness, efficacy, safety, dosing convenience, and competitive positioning against established IL-17A and IL-17A/F biologics.

Current treatment generally begins with NSAIDs, followed by biologics when response is inadequate. IL-17A inhibitors are frequently selected as first-line biologic therapy. The trial population broadly resembled routine moderate-to-severe patients, although prior exposure to TNF inhibitors was unclear.

Key Insights

The expert ranked efficacy in the upper-middle range among approved biologics but cautioned that cross-trial comparisons are not definitive. ASAS40 is now the key efficacy benchmark, while ASAS20 represents a less demanding response threshold. The increase in response through week 52 was considered typical for biologics and indicative of durable efficacy. Responses commonly plateau around this point. Dual IL-17A/F inhibition is theoretically preferable to IL-17A inhibition alone, but meaningful clinical superiority remains unproven. Pricing and reimbursement will likely matter more than mechanistic differentiation. At price parity, the dual inhibitor should have an opportunity; a substantial premium could erase its practical advantage. Injection-site reactions may negatively affect patient experience, depending on severity and need for treatment. The absence of new inflammatory bowel disease was encouraging but insufficient to establish long-term gastrointestinal safety.

Clinical Data

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Measure

Enrolment

Reported result

Interpretation

323 patients

Population was broadly representative of clinical practice

Disease duration

About 6 years

Not usually a strict trial requirement

HLA-B27 positivity

Baseline BASDAI

Median BASFI

87%

Consistent with the target population

5.5

Indicates active disease

About 4.7

Reflects moderate-to-severe functional impairment

Week 16 ASAS20

62.1% vs 34.2% placebo

Supportive efficacy endpoint

Week 16 ASAS40

45.4% vs 19.4% placebo

Within the expected range for biologics

Week 16 low disease activity

61.5% vs 27.8% placebo

Considered a clinically worthwhile result

Week 52 ASAS40

66.2%

Suggests sustained and deepening response

Week 16 ASQoL change

1.3 points

Supplementary patient-reported benefit

Week 52 BASDAI change

3.2-point reduction

Supports improved disease activity

Overall adverse events

71.4% vs 62.3% placebo

No new safety signal identified

Serious adverse events

1.2% vs 2.5% placebo

Comparable with other studies

Discontinuation

2.2%

Low treatment withdrawal rate

Injection-site reactions

10.9%

Considered relatively common

Advanced fused disease excluded

Under 1% of real-world patients

Exclusion was clinically appropriate

Dosing

Subcutaneous every 4 weeks; no loading dose

Comparable in convenience to existing options

Competitive Landscape

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Therapy class

Advantages

Limitations and positioning

Established IL-17A inhibitors

Familiar, widely available, and competitively priced

Primary competitive threat

Existing dual IL-17A/F inhibitor

Strong theoretical mechanism and favorable efficacy

Uptake constrained by price, reimbursement, and crowded competition

Investigational dual inhibitor

Monthly dosing and potential mechanistic advantage

Success depends heavily on reimbursement and price parity; clinical differentiation remains uncertain

KH: We’ll officially get started now. I’m Kate, an analyst at Guidepoint. Today’s interview will focus on the potential of Livzon’s Lecankitug to treat ankylosing spondylitis (AS) by targeting both IL-17A and IL-17F. Before we begin, could you briefly introduce your professional background?

YX: I work at a tertiary Class A hospital. I started working in 2001, so I have 25 years of work experience.

KH: Approximately how many patients do you see in a typical week, and what proportion of them have AS?

YX: Around 15%.

KH: I would like to use the clinical trial of Lecankitug to understand the current treatment landscape and interpret the data. I will start with the enrolled population and baseline characteristics: the study included 323 patients with inadequate response to conventional treatment, with characteristics including age, disease duration of approximately 6 years, an HLA-B27 positivity rate of 87%, and a BASDAI score of 5.5. How should this population be understood? I hope to use these characteristics to assess the current standard of care, whether the patients’ disease activity is high or low, and how these features may influence the results.

YX: Most clinical trials nowadays target a similar patient population. However, this is the first AS clinical trial I’ve participated in where the disease duration was specified this way. In fact, there is no strict requirement regarding disease duration for AS trials. Other than that, the enrolled patients are quite similar to the patients we see in clinical practice.

KH: The patients had relatively high disease activity at baseline and impaired physical function, with a median BASFI score of approximately 4.7, according to the report. How should we interpret these characteristics?

YX: These are patients with moderate-to-severe spondylitis, meaning they still experience pain and restricted mobility that affect their daily lives. These are indicators we use to assess disease activity.

KH: The study enrolled patients who had an inadequate response to conventional treatment. Could the types of conventional treatments they had previously received, or their treatment history more broadly, affect how we interpret the results for this drug? Or how should we understand this?

YX: Generally, regardless of which version of the ankylosing spondylitis guidelines we refer to, including the latest guidelines, biologics are not recommended as first-line treatment. We still use NSAIDs first. If patients do not respond well to NSAIDs, we initiate biologic therapy. In the AS guidelines, including those outside China, many patients

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choose IL-17A monoclonal antibodies as their first-line biologic. I’m not entirely sure whether this trial included patients who had previously responded inadequately to TNF inhibitors. Some studies include a certain proportion of patients with an inadequate response to TNF inhibitors.

KH: The study also included patients with comorbidities. For example, 3.1% to 4.3% of patients had anterior uveitis, 0.6% to 1.2% had psoriasis, and some had inflammatory bowel disease. How should we understand the potential impact of these comorbidities?

YX: These are all common comorbid manifestations we see in clinical practice, and the proportions reported are generally consistent with what we encounter in routine clinical care. However, compared with studies targeting IL-17A alone, this study may have included more patients with these comorbidities, because earlier studies of IL-17A inhibitors would exclude this group of patients.

KH: The study excluded patients with ankylosis of the entire spine or complete bilateral sacroiliac joint fusion. What proportion of patients encountered in real-world clinical practice might be excluded by these criteria, or how should we interpret this?

YX: Probably less than 1%. These patients are already at the most advanced stage of the disease, and there is essentially no further therapeutic benefit to be gained for the affected joints because they have completely fused. This includes patients with grade 4 sacroiliitis, in whom the sacroiliac joints are also completely fused. Such patients have been excluded from previous trials of these biologics as well, so the exclusion criteria are consistent with those used in earlier clinical studies. In clinical practice, we generally do not advocate further biologic treatment for this group of patients either. Management is primarily symptomatic.

KH: The Phase 3 clinical trial lasted 52 weeks. The drug is administered by subcutaneous injection every four weeks, with no loading dose. How should we assess the convenience of this dosing regimen, and how might it affect patient adherence?

YX: This dosing regimen is reasonable. The drug is administered once a month, which is also the dosing frequency for most IL-17 inhibitors currently available. Some also require a loading dose. This regimen is broadly comparable to existing treatments and does not create any major additional inconvenience.

KH: Regarding efficacy, the study reported results at week 16, with an ASAS40 response rate of 45.4%, an ASAS20 response rate of 62.1%, and an ASAS50 response rate of 53.4%. How should we interpret these results in terms of the magnitude and depth of clinical benefit for patients?

YX: Nowadays, the ASAS40 response is generally the main efficacy target. Going back 10 or 15 years, ASAS20 was more commonly used, but it is now considered only a starting point. With the increasing number of biologics available, the expectations are higher, with a greater emphasis on deeper responses. ASAS40 is now the most commonly used endpoint. Is it 67%?

KH: The ASAS40 response rate is 45%.

YX: That is generally within the expected range. Previously, ASAS30 response rates were around 70% to 80%, roughly 70%, while ASAS40 response rates were around 50%. For higher-level response endpoints, I think these results are broadly comparable. There may be some numerical differences in indirect comparisons across studies, but these cannot be considered definitive results. Overall, the results are in a similar range.

KH: So ASAS40 is now the primary and more important efficacy measure.

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YX: Yes.

KH: The rate of low disease activity was 61.5%. How should we interpret the significance of this result?

YX: This is also a secondary endpoint in clinical trials. Our primary clinical goal is to achieve disease remission, which is of course the ideal outcome. If remission cannot be achieved, low disease activity is also a treatment target we pursue. If a substantial proportion of patients can achieve low disease activity, that is an acceptable outcome in clinical practice and represents a fairly good result.

KH: Compared with other biologics currently approved for the treatment of ankylosing spondylitis, where would this result rank in terms of efficacy?

YX: I would say it is in the upper-middle range. However, there is still a considerable gap between clinical trial results and real-world outcomes. Clinical trials have strict patient selection criteria, the medication is provided free of charge, and patient adherence is generally better.

KH: We just discussed the ASAS40 response rate at week 16. After 52 weeks of treatment, the ASAS40 response rate increased to 66.2%. How should we interpret this week-52 result, and what is the significance of the change in response rate from week 16 to week 52?

YX: This pattern has also been observed in other clinical trials. Generally, with longer treatment duration, response rates tend to be higher than those observed at the week-16 primary endpoint, as more patients achieve the expected treatment endpoints. The response curve usually continues to rise over time. However, by week 52, the data have generally reached a plateau. Even after two years of follow-up, the response rate may remain around the same level rather than continuing to increase. Some patients may even lose their response, which is also quite normal. Overall, a response rate approaching 70% is a reasonable result and suggests that the treatment can maintain its efficacy over an extended period.

KH: So, generally speaking, 52 weeks is the standard.

YX: Some studies include an open-label extension phase to extend the observation period and further assess long- term safety. I would expect this trial to have a subsequent extension phase as well, if the data have not yet been published.

KH: Next, I’d like to discuss improvements in functional outcomes. The study reported a 1.3-point improvement in ASQoL at week 16, and at week 52, the continuous-treatment group showed a 3.2-point reduction in BASDAI. How should we interpret these changes in functional outcome scores? What magnitude of improvement would generally be considered a relatively good result, and how should we understand the practical clinical significance?

YX: These are functional outcome measures. Could you clarify which specific measures you mentioned?

KH: One is ASQoL.

YX: That is a quality-of-life measure.

KH: Correct, quality of life, and another measure is BASDAI.

YX: These measures fall under what we generally call patient-reported outcomes, along with other functional assessment scales. They are also important in clinical practice. However, when it comes to drug approval, the primary endpoints are generally the most important, while these measures are usually secondary endpoints. They help us

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assess whether improvements in patient-reported outcomes accompany better control of disease activity, serving as supplementary measures for reference.

KH: How much do these functional outcome measures affect patients’ subjective experience, and how should we interpret their significance?

YX: They mainly cover several aspects, including physical functioning and psychological well-being. The assessments are divided into different domains and include very detailed questions. For example, they assess whether patients experience pain at night, whether their condition affects their ability to do household chores or participate in social activities, and whether it causes them to miss work. Overall, these measures provide a comprehensive assessment of a patient’s condition rather than focusing solely on the disease itself. They are more concerned with the overall impact the disease has on the person.

KH: The study also reported safety outcomes at week 52. The overall adverse event rate was 71.4% in the treatment group versus 62.3% in the placebo group, while the serious adverse event rates were 1.2% and 2.5%, respectively. How should we interpret these adverse event rates? The study also reported a treatment discontinuation rate of 2.2%. How should we assess the overall safety profile?

YX: How do these rates compare with placebo?

KH: Are you referring to the discontinuation rate?

YX: No, I mean the serious adverse events.

KH: The serious adverse event rate was 1.2% in the treatment group versus 2.5% in the placebo group.

YX: These results are generally comparable to what we have seen in other studies. In fact, the adverse event rate was lower in the treatment group than in the placebo group. This may be because patients in the placebo group did not receive adequate control of inflammation during the initial treatment period, which could lead to more adverse events. Once inflammation is suppressed and their overall condition improves, the incidence of adverse events may decrease. Overall, there do not appear to be any new safety signals. The reported events are mostly common adverse events. However, I’m not sure how high the incidence of injection-site reactions was. I would expect it to be higher than that with placebo.

KH: The study reported an injection-site reaction rate of 10.9%.

YX: That would be considered a very common adverse reaction. The injection-site reaction rate is somewhat high. I’m not sure whether the study disclosed whether these reactions required medical intervention, whether they worsened directly, or whether they were all mild and self-limiting. These details could affect the patient experience with the treatment.

KH: The study did not report any cases of inflammatory bowel disease (IBD). Is this clinically significant, and how should we interpret this finding?

YX: There has been concern that IL-17A inhibitors targeting IL-17A alone may increase the risk of IBD, although a definitive causal relationship has not been established. As a result, IL-17A inhibitors are generally avoided in patients with pre-existing IBD. However, dual IL-17A/F inhibition may offer better protection in the gut. The absence of new- onset IBD is consistent with expectations, but the observation period is too short to draw firm conclusions. Longer- term follow-up is needed.

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KH: What is your overall impression of this Phase 3 clinical trial? We have seen that several IL-17 inhibitors are already approved for ankylosing spondylitis, including Bimekizumab, an IL-17A/F inhibitor. We would like to understand your overall assessment of these results and how you would position this drug relative to existing IL-17A inhibitors and dual-target IL-17A/F inhibitors, particularly in patients with severe disease.

YX: In theory, dual-target inhibition should be better than single-target inhibition based on the mechanism of action. In addition, real-world clinical use in China and data from previous clinical studies have both shown good results. However, bimekizumab's overall sales in China have been limited by its price, its lack of inclusion in the national reimbursement drug list, and the large number of competing products. The clinical differentiation offered by its distinct mechanism of action is not sufficient to offset the financial burden on patients. In other words, it does not offer good value for money, which is why its use has been limited.

For this product, I’m not sure whether it will eventually be included in the national reimbursement drug list, but that will be a key factor. If it is included and priced competitively with existing IL-17A inhibitors under the reimbursement scheme, physicians will certainly be more inclined to choose a dual-target inhibitor. However, if its price is set significantly higher than that of current IL-17A inhibitors, I think its efficacy advantages could essentially be negligible in terms of actual clinical decision-making.

KH: If the drug is approved, given current use of IL-17A inhibitors and IL-17A/F inhibitors, would this new IL-17A/F inhibitor face intense competition? Or how should we understand its potential market position?

YX: Yes, competition will be intense. Its main competition will come from existing IL-17A inhibitors. Although the mechanism of action differs, it is not yet clear whether these differences will translate into substantial clinical benefits. More clinical experience is needed to determine that, but opportunities to gain such experience may be limited.

KH: So, can we understand this to mean that the market already has a large number of competing products?

YX: Yes. The key is how the product is positioned, particularly its price. If it is priced at the same level as existing IL-17A inhibitors, it should still have a market opportunity.

KH: Those are all the questions we have. Since Livzon's IL-17A/F inhibitor is a domestically developed dual-target IL-17 inhibitor, we wanted to better understand the results of its Phase 3 clinical trial. Thank you very much for helping us interpret the findings. We hope to invite you again for future discussions on related topics. Thank you very much.

YX: You're welcome.

KH: Goodbye.

YX: Bye-bye.

议程：

• 活动性AS且NSAID应答不足、HLA-B27阳性率约87%、平均病程约6年的基线特征，在多大程度上反映了真实世界临床AS

人群？

• 第16周ASAS20（62.1% vs 34.2%）、ASAS40（45.4% vs 19.4%，P<0.001）和ASAS50（35.4% vs 14.7%）应答率应

如何解读？

• 所报告的ASDAS-CRP（LDA 61.5% vs 27.8%）和ASDAS-ESR（LDA 53.4% vs 24.1%）改善有何临床意义？
• 安全性特征应如何解读：总体治疗中出现的不良事件（TEAE）发生率为71.4% vs 62.3%，严重不良事件（SAE）发生率

为1.2% vs 2.5%？Kate Han：这边就正式开始了，我是岂珀咨询的分析师Kate，今天的访谈是想聊一聊丽珠的莱康奇塔单抗白介素17A/F在

10/12/2026 at 06:05 AM UTC

强直性脊柱炎治疗中的前景，那么在正式开始访谈之前，邀请我们的专家，请您简单的介绍一下您的专业背景。Yu Xue：我在三甲医院工作，2001年参加工作，工作25年。Kate Han：您一周可能会看诊多少患者，其中强直患者的比例会是怎样呢？Yu Xue：15%吧。Kate Han：我想借莱康奇塔单抗的临床试验，了解目前治疗现状并解读数据。先从入组人群和基线特征谈起：该研究纳入323 例对传统治疗疗效不足的患者，包括年龄、病程约 6 年、HLA-B27 阳性率 87%、BASDAI 5.5。应如何理解这一人群？我希望借此判断当前标准治疗背景、患者疾病活动度高低，以及这些特征可能对结果的影响。Yu Xue：因为现在临床试验大部分也是针对这个的人群，但是好像这个病程，我还是第一次参加的临床试验其实对强直没有一个硬性的病程的要求，其他都跟我们临床上看到的病人差不多。Kate Han：它这个入组时基线疾病活动度较高，功能受损它这边写法叫做中位的BASFI约4.7，该怎样去理解这样的一个特征呢？Yu Xue：这个就是我们讲的中重度脊柱炎的患者，也就是我们一些还是有疼痛、活动障碍，影响到生活，用来判断疾病活动的指标。Kate Han：像这个研究纳入的是传统治疗不足的，那之前接受过这些传统治疗，或者是接受过怎样的传统治疗，可能会对于这个白介素17的A/F这样的药物结果的解读会有影响吗，还是该怎样去理解Yu Xue：一般我们是在强直性脊柱炎无论哪一版指南，最新的指南上面还都不是说一线治疗，我们现在还是非甾体类抗炎药。如果是非甾体抗炎药不好，他们启动生物制剂的治疗，生物制剂现在在指南当中强直性脊柱炎除了国内以外的指南当中，很多患者选择白介17A的单抗是作为一线的生物制剂，那我也不太清楚它这个是不是包含既往有肿瘤坏死因子应答不佳的患者，有些研究它会有一定比例的肿瘤坏死因子应答不佳的患者。Kate Han：它研究中有合并其他的症状的患者，比如说有前葡萄膜炎患者比例是3.1%到4.3%，然后有银屑病患者的比例是0.6到1.2，还有炎症性肠炎，该怎样去理解这些合并症可能的影响呢？Yu Xue：这些合并症也都是我们常规一线合并的一些表现，这些比例也都在临床诊疗当中所见的比例其实也是差不多的。但是既往的话可能它这个是比单白介17A的这个靶点，更多的纳入这样的患者，因为单纯以前白介17A的患者，会把这一群患者给排除掉。Kate Han：它排除了全脊柱强直或双侧骶髂关节完全融合的患者，那排除这些患者，可能会排除到现实临床中多少比例的患者呢，还是该怎样去理解。Yu Xue：1%不到吧，因为这一类患者其实目前已经到了是最晚期的患者了，基本上关节已经没有进一步治疗的价值了，因为已经完全融合了，包括骶髂关节四级的话，也就是骶髂关节也是完全融合了，所以这些都是既往这一类生物制剂全部都排除在外的患者，跟既往临床研究都是保持一致的。这一部分患者在临床上，我们也不太主张再去生物制剂的治疗了，就是主要是对症的一些治疗。Kate Han：它这个临床三期实验持续时间为52周，这个药物给药方式是每4周皮下注射，无需负荷剂量给药方案，这种给药方案它的便利性该怎样去理解呢，可能会怎样影响到患者的一个依从性。Yu Xue：这个给药方案还是可以的，现在的话每个月一次，大部分白介17也是这样的给药，也会给一个负荷剂量，跟现在差不多，没有说带来很大的不便。Kate Han：关于它的有效性的结果，它这边报了一个16周的结果，它的ASAS40的应答率为45.4%，ASAS20的应答率为62.1%，还有ASAS50应答率53.4%，那该怎样去理解这样的一个结果，怎样反映患者获益的幅度和深度。Yu Xue：现在基本上都是要求ASAS40的应答，像最早可能倒退10年、15年，以前20比较多，但是觉得这个ASAS20只是一个最起步的，现在生物制剂越来越多，要求是更高维度，就更深度的一些应答，也就是ASAS40是现在最常用的一个指标，它有67%？Kate Han：40的话是45%。Yu Xue：一般就差不多吧，以前的话30的话百分之七八十，70左右，40的话在50左右，有些更高维度的，我觉得差不多，可能最多也就是一些数值上的一些间接比较的数据上的差异，但这个不能作为最终的一个结果，差不多。Kate Han：现在以40为主，就是为重要的指标。Yu Xue：嗯。Kate Han：低疾病活动率为61.5%，该怎样去看这样的一个指标它变化的意义。Yu Xue：这个也是临床试验当中的一个次要指标，也是可以，我们现在最主要临床就是能够达到疾病的缓解，当然这是最好的目标，如果达不到缓解，达到低疾病活动度也是追求的既往的一些指标，这样将近一定比例的患者能够达到低疾病活动度，临床上也是可以接受的，还是一个不错的结果。Kate Han：那这个指标跟可能目前现在市面上已经获批适应症的强直的这些生物药比，它这个结果的水平应该是可能处在什么样的位置呢？

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Yu Xue：中上，但其实真正在临床试验当中和真实世界还是有很多的差距的，临床试验筛选也是严格，免费供药，患者依从性也更好一些。Kate Han：它这边刚才聊了一个16周的ASAS40的应答率，治疗持续到52周的时候，它的ASAS40的应答率提高到了66.2%，那这样的一个52周的结果，该怎样去理解呢，以及从16周到52周这样的结果的一个变化的意义该怎样去理解。Yu Xue：这个在其他临床试验当中观察到的其实也是，一般更长的时间会比16周主要终点应答率会更高一些，会有更多的患者达到这种预期的一些终点，一般这个曲线到后面都是往上走，但是到了52周基本上这个数据是一个瓶颈期，可能你观察到两年之后也差不多就这点比例，不会再往上走了，有的甚至会有些丢失，但这也都是很正常的，总体来讲接近70%的比例也是可以的数值，说明它整体的疗效可以维持比较长的一个时间。Kate Han：那一般情况下就是52周。Yu Xue：有些会有开放期，会更加延长观察它长期的一些安全性延长期的研究，这个研究应该后续也有延长期，如果数据还没有公布的话。Kate Han：后面是关于一些功能性指标的一个改善，它这边有一个叫ASQoL改善为1.3分，在16周的时候，52周的时候持续治疗组的BASDAI改善达负的3.2分，那该怎样去看这些功能性指标的改善分数的改变，大概什么样的一个水平可能会是一个相对比较好的结果，以及它的实际意义该怎样去理解。Yu Xue：就是一些功能性的指标，功能性指标反正你讲的刚才具体是哪些指标？Kate Han：这个叫ASQoL。Yu Xue：就是生活指标。Kate Han：对，生活质量，还有一个叫BASDAI。Yu Xue：这些指标也是现在我们叫患者报告结局之类的其他的合并功能型的量表，在临床上现在也很重要，但是作为上市的话最主要的终点可能这些都是作为一些次要终点，来看随着他疾病活动度的控制，相应的一些患者报告是不是有相应的改善，是作为一些次要的参考指标。Kate Han：这些功能指标的话，对于患者的感受上的影响大吗？还是该怎样理解。Yu Xue：主要这么几个方面，有躯体的功能还有心理上的，它分不同的模块，而且它会问一些很细节的问题，量表上都会有，比如说夜间痛还是痛，另外会不会影响生活当中做家务，或者是社交的时间，会不会因此误工，反正是各方面，是一个整体的状况的一个评估，而不单纯针对这个疾病，更多的是去针对这个疾病给你整体这个人带来的影响。Kate Han：它后面报道了安全性，就在52周的时候总体的一个不良事件发生率实验组为71.4%，然后安慰剂组为62.3%，它严重的不良事件发生率分别为1.2%和2.5%，该怎样去理解这样的一个不良事件发生率，后面还报道了一个停药率，一个是为2.2%，该怎样去看它的这个安全性。Yu Xue：那么它跟安慰剂比呢。Kate Han：停药率吗？Yu Xue：不是，就是严重不良事件。Kate Han：严重不良事件实验组为1.2%，安慰剂组为2.5%。Yu Xue：这个其实跟我们其他看到的差不多，反而就是实验组的不良事件会比安慰剂组的小一点，因为安慰剂组在前期没有得到很好炎症控制的时候，反而会增加更多的不良事件，后面抑制住了之后整体状况好了之后，不良事件反而会下降，应该讲也没有发现什么新的信号，就是安全性事件的信号，也都是一些常见的，但不知道注射部位反应大不大，这个应该是百分之多少，应该是会比安慰剂要高的。Kate Han：它这边写注射部位，这个应该是注射部位发生率是10.9%。Yu Xue：那已经算是很常见的了不良反应，它这个注射部位反应还是有点高的，注射部位反应多，我不知道它有没有披露是需要药物干预还是怎么样，会直接加重还是都是轻度的缓解，因为可能会影响患者的使用体验。Kate Han：它这边没有报道IBD病例，这个影响大吗，还是该怎样去理解？Yu Xue：因为既往就是白介17A，单纯A的靶点，可能会增加IBD这样的一个风险，有这样的讲法，但是也并没有这样的归因，所以既往有IBD的一般都避免使用白介17A，但是整体A和F可能在肠道方面有更好的保护作用，但是没有新发的话也就是符合预期，但是观察时间也太短，需要更长期的观察来看。Kate Han：这个临床三期实验给您的总体印象如何，因为我们也看到其实关于强直性脊柱炎目前的有白介素17有比较多上市的，也有一个白介素A/F的比奇珠单抗也是上市的，我们想理解一下可能这个结果给您的整体印象是如何，该怎样在重度白介素17单靶的也好还是双靶点白介素也好，看它的可能的定位。Yu Xue：理论上来讲双靶要比单靶的好，这个是从机制上来讲是这样的，另外就是在中国的一些临床真实世界的应用，包括它之前的一些相应的临床研究的数据，其实也都是很好的，但是比奇珠在中国整体销售量就是因为它的价格问题和没有进医保，而且竞争产品比较多，它的这些机制上的差异化临床上的差异化，不足以来弥补它经济上的这个患者的付出，所以这是性价比不高，你要吃性价比肯定不高，所以用的也不多。

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这个产品我不清楚它将来能否进到医保很关键，如果进到医保，它同样能够在价格上能够在医保上去对标现有的白介17A，那肯定会更多的去选择双靶点，如果你这个定价上要比白介17A现在的患者超前超的更多，我觉得它这些疗效上的优势其实也是可以忽略的。Kate Han：那假如说要是获批的话，根据现在目前这个白介17A或者是包括A/F的使用来看，新的白介素17A/F，目前它面临的竞争很强吗，还是该怎样去理解它可能。Yu Xue：强的，最主要就是跟现在白介17A去竞争，虽然你说机制上不一样，但这些不一样也不见得有多大真正的临床的获益，其实要更多的实践才能知道，但你这个实践的机会就很少。Kate Han：就能不能理解市场上产品已经很多了。Yu Xue：对，就关键看它定位了，定到多少钱，如果跟现在白介17A是一样的价格，那它还是有市场的。Kate Han：这边其实也就是这些问题了，因为它等于是丽珠的白介素17A/F是国产双靶点的白介素17的产品，所以想理解一下它目前的临床三期实验结果，非常感谢您帮助我们理解，之后如果有相关话题希望能够再次邀请到您，非常感谢。Yu Xue：好的。Kate Han：再见。Yu Xue：拜拜.

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10/12/2026 at 06:05 AM UTC