(CNTB) 2022 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to Connect Biopharma First Half 2022 Financial Results Conference Call.

美好的一天，謝謝你的支持。歡迎參加 Connect Biopharma 2022 年上半年財務業績電話會議。

(Operator Instructions)

（操作員說明）

I would now like to hand the conference over to your speaker for today, [Ina McGinnis]. You may begin.

我現在想將會議交給您今天的發言人 [Ina McGinnis]。你可以開始了。

Thank you, operator. Today's call will be hosted by Connect Co-Founder and CEO, Dr. Zheng Wei; Chief Medical Officer, Dr. Chin Lee; and CFO, Steven Chan. Today's call is being webcast, and the replay will be available on the IR section of the company's website for 12 months.

謝謝你，運營商。今天的電話會議將由 Connect 聯合創始人兼首席執行官鄭偉博士主持；首席醫療官 Chin Lee 博士；首席財務官 Steven Chan。今天的電話會議正在網上直播，重播將在公司網站的 IR 部分提供 12 個月。

Following our prepared remarks, we'll open up the call to Q&A. Before we begin, let me remind you that during today's call, management will make various forward-looking statements. Investors are cautioned that these forward-looking statements are based on current expectations, and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward-looking statements.

在我們準備好的評論之後，我們將打開問答環節。在我們開始之前，讓我提醒您，在今天的電話會議上，管理層將做出各種前瞻性陳述。請投資者註意，這些前瞻性陳述是基於當前的預期，並受到可能導致實際結果或結果與我們的前瞻性陳述所表明的結果大不相同的風險和不確定性的影響。

Please read the safe harbor statement contained in the press release we issued earlier today as well as those contained in Connect Biopharma's registration statement on Form F-1 for a more complete discussion of the risks and uncertainties.

請閱讀我們今天早些時候發布的新聞稿中包含的安全港聲明以及 Connect Biopharma 在 F-1 表上的註冊聲明中包含的聲明，以更完整地討論風險和不確定性。

Now I'd like to turn the call over to Wei. Wei?

現在我想把電話轉給魏。偉？

Thank you, Ina, and good day to all of those joining us today on this call and webcast.

謝謝你，Ina，祝今天加入我們電話會議和網絡廣播的所有人美好的一天。

I plan to talk about the clinical progress we have made over the last 6 months, starting with our lead clinical candidate, CBP-201. Turning to our trials to treat adult patients with moderate to severe atopic dermatitis, or AD.

我打算談談我們在過去 6 個月取得的臨床進展，首先是我們的主要臨床候選藥物 CBP-201。轉向我們治療患有中度至重度特應性皮炎或 AD 的成年患者的試驗。

In the Phase IIb global CBP-201 trial, we reported 16-week data that met the primary and key secondary endpoints of the trial with favorable safety data. Additional analysis demonstrate a potentially competitive therapeutic profile for CBP-201 300 milligram administered every 2 weeks or every 4 weeks.

在 IIb 期全球 CBP-201 試驗中，我們報告了 16 週的數據，這些數據滿足試驗的主要和關鍵次要終點，並具有良好的安全性數據。額外的分析表明，每 2 週或每 4 週給藥一次的 CBP-201 300 毫克具有潛在的競爭性治療效果。

In the ongoing pivotal China-only trial for CBP-201 in AD, we received feedback from China's Center for Drug Evaluation, or CDE, that led us to review the data from the first 255 patients already enrolled in our Stage 1 16-week treatment period, and if positive, review this data in a pre-BLA meeting with the CDE. This is particularly good news as this would potentially accelerate the timeline to BLA submission of CBP-201 in China.

在正在進行的 CBP-201 治療 AD 的關鍵性中國試驗中，我們收到了來自中國藥物審評中心 (CDE) 的反饋，這促使我們審查了已經入組我們第 1 階段 16 周治療的首批 255 名患者的數據如果是，則在與 CDE 的 BLA 前會議中審查此數據。這是一個特別好的消息，因為這可能會加快 BLA 在中國提交 CBP-201 的時間。

As a result, we plan to report the topline data next month, in October, potentially 8 months earlier than originally planned, if positive and having positive results from the stage 2 36-week data readout, we could be in a position to file a new drug application in 2024 and a potential NDA approval in China as early as 2025.

因此，我們計劃在下個月（即 10 月）報告頂線數據，可能比原計劃提前 8 個月，如果積極並且從第 2 階段 36 週數據讀出中獲得積極結果，我們可以提交一份報告2024 年的新藥申請和最早在 2025 年在中國獲得 NDA 批准的可能性。

It's our goal to use this potentially positive results from this PRC specific trial to start handling discussions. We also plan to enroll our first patient in the company's global CBP-201 Phase III study in moderate to severe AD by the end of 2022.

我們的目標是利用這個 PRC 特定試驗的潛在積極結果來開始處理討論。我們還計劃在 2022 年底之前將我們的第一位患者納入公司針對中度至重度 AD 的全球 CBP-201 III 期研究。

We also see great potential for CBP-201 in the treatment of patients with severe asthma with type 2 inflammation, and anticipate complete full enrollment in the first half of 2023. This is 6 months later than previously anticipated. We will also then plan to report the Phase II topline result of CBP-201 in asthma in the second half of 2023 versus first half of 2023 as previously indicated.

我們還看到 CBP-201 在治療伴有 2 型炎症的嚴重哮喘患者方面的巨大潛力，預計 2023 年上半年完成全面入組。這比之前預期晚了 6 個月。我們還將計劃在 2023 年下半年與 2023 年上半年報告 CBP-201治療哮喘的 II 期頂線結果，如前所述。

Turning to CBP-307. CBP-307 is a proprietary oral drug candidate under development to treat ulcerative colitis, a disease that onsets early in adulthood and lasts a lifetime. Despite the available treatment, UC patients continue to suffer with unmet need, while new ones join the ranks in increasing numbers as the disease grow in incidence and regional prevalence. In May, we reported 12-week topline data in a global Phase II trial in moderate to severe UC.

轉向 CBP-307。 CBP-307是一種正在開發的專有口服候選藥物，用於治療潰瘍性結腸炎，這是一種在成年早期發病並持續一生的疾病。儘管有可用的治療方法，但 UC 患者的需求仍未得到滿足，而隨著疾病發病率和區域流行率的增加，新患者的數量也在不斷增加。 5 月，我們報告了一項針對中度至重度 UC 的全球 II 期試驗的 12 週頂線數據。

I think it's important to take some time recapping the status of CBP-307, outlining the partner opportunity and why 307 presents a compelling partnering opportunity. CBP-307 has a proven mechanism of action operating within a well-validated disease pathway demonstrated to be clinically effective against UC. Pharmacodynamics and pharmacokinetics show that CBP-307 hits its target and does so rapidly. In addition, CBP-307 has a higher affinity for binding to Sphingosine 1-phosphate receptor 1 or S1P1. The targeted signaling pathway implicated in ulcerative colitis disease cascade than the other 2 drugs in S1P1 modulator class. Biomarker analysis also shows that CBP-307 reduces the level of circulating lymphocytes in the blood. The downstream and desired effect of hitting this target to meaningful disease mitigated levels of less than 800 cells per microliter.

我認為花一些時間回顧 CBP-307 的狀態、概述合作機會以及為什麼 307 提供了一個引人注目的合作機會很重要。 CBP-307 具有經過驗證的作用機制，在經過充分驗證的疾病途徑中發揮作用，證明對 UC 具有臨床療效。藥效學和藥代動力學表明，CBP-307 可以快速擊中目標。此外，CBP-307 對結合鞘氨醇 1-磷酸受體 1 或 S1P1 具有更高的親和力。與 S1P1 調節劑類中的其他 2 種藥物相比，與潰瘍性結腸炎疾病級聯有關的靶向信號通路。生物標誌物分析還表明，CBP-307 降低了血液中循環淋巴細胞的水平。將這一目標擊中有意義的疾病的下游和預期效果減輕了低於每微升 800 個細胞的水平。

This level of lymphocyte reduction is stronger than (inaudible) and the effect on set is faster than that observed for (inaudible). Moreover, CBP-307 significantly reduced the level of (inaudible) patients, a reliable biomarker correlated with UC disease severity.

這種淋巴細胞減少水平強於（聽不清）並且對現場的影響比觀察到的（聽不清）更快。此外，CBP-307 顯著降低了（聽不清）患者的水平，這是一種與 UC 疾病嚴重程度相關的可靠生物標誌物。

This is why we think CBP-307 will interest partners. CBP-307 demonstrated a statistically significant clinical remission rate at a higher dose. And while this was a secondary endpoint in this trial, clinical remission based on the adapted Mayo score is currently the regulatory endpoint in UC registrational files. And it was the primary endpoint for (inaudible), the only approved drug in this class.

這就是為什麼我們認為 CBP-307 會引起合作夥伴的興趣。 CBP-307 在較高劑量下表現出具有統計學意義的臨床緩解率。雖然這是該試驗的次要終點，但基於改編梅奧評分的臨床緩解目前是 UC 註冊文件中的監管終點。它是（聽不清）的主要終點，是此類中唯一獲得批准的藥物。

Given all of this, any potential CBP-307 partner will be able to enter the UC therapeutic space with a Phase III-ready candidate that has the potential to provide a new and clinically attractive treatment option to patients.

鑑於所有這些，任何潛在的 CBP-307 合作夥伴都將能夠進入 UC 治療領域，進入 III 期準備好的候選人有可能為患者提供一種新的和具有臨床吸引力的治療選擇。

With that recap of highlights and a short review of the state of CBP-307, let me now turn the call over to Chin to discuss in more detail our lead candidate, CBP-201. Chin?

通過對重點的回顧和對 CBP-307 狀態的簡短回顧，現在讓我將電話轉給 Chin 來更詳細地討論我們的主要候選人 CBP-201。下巴？

Thanks, Wei.

謝謝，魏。

I'm going to talk more about plans for our lead drug candidate, CBP-201 in AD and specifically the trial designs for our planned global Phase III program. And then I'll recap the news we just reported our earliest clinical drug candidate, CBP-174.

我將更多地討論我們的主要候選藥物 CBP-201 在 AD 中的計劃，特別是我們計劃的全球 III 期項目的試驗設計。然後我將回顧一下我們剛剛報導的我們最早的臨床候選藥物 CBP-174 的消息。

We've made a lot of progress this year on our CBP-201 AD program. Notably, we had a successful end of Phase II meeting with FDA, and our team has worked diligently on a robust Phase III program, and we are now looking forward to enrolling the first patient into our initial registrational trial before end of this year.

今年我們在 CBP-201 AD 計劃上取得了很大進展。值得注意的是，我們成功結束了與 FDA 的 II 期會議，我們的團隊一直在努力開展強大的 III 期計劃，我們現在期待著在今年年底之前讓第一位患者參加我們的初始註冊試驗。

The first global Phase III study is part of a larger registrational program comprising 4 controlled clinical trials and a separate open-label extension study for patients with moderate to severe AD. Of the 4 controlled trials, 3 of them will evaluate patients through 52 weeks of treatment.

第一項全球 III 期研究是一項更大的註冊計劃的一部分，該計劃包括 4 項對照臨床試驗和一項針對中度至重度 AD 患者的單獨開放標籤擴展研究。在 4 項對照試驗中，其中 3 項將通過 52 週的治療評估患者。

In these trials, patients will receive 300 milligrams of CBP-201 every 2 weeks for the first 16 weeks of treatment. Thereafter, over the remaining 36 weeks, patients who are deemed to be responders will be re-randomized into 1 of 3 groups. Some will remain on the 300-milligram dose given every 2 weeks. Some will step down to 300-milligram dose given every 4 weeks, and others will receive placebo. In 2 of these 52-week studies, we will compare CBP-201 to placebo during the first 16 weeks of each study.

在這些試驗中，患者將在治療的前 16 週內每 2 週接受一次 300 毫克的 CBP-201。此後，在剩餘的 36 週內，被視為有反應的患者將被重新隨機分配到 3 組中的 1 組。有些人將繼續服用每 2 週一次的 300 毫克劑量。有些人會減少到每 4 週服用 300 毫克的劑量，而其他人會接受安慰劑。在這些為期 52 週的研究中的 2 項中，我們將在每項研究的前 16 週內將 CBP-201 與安慰劑進行比較。

The fourth control trial will be 16 weeks in duration, and it's designed to assess the 300-milligram dose of CBP-201 given every 2 weeks as compared to placebo in patients using background topical agents such as corticosteroids.

第四個對照試驗將持續 16 週，旨在評估每 2 週給予 300 毫克劑量的 CBP-201 與使用皮質類固醇等背景局部藥物的患者的安慰劑相比。

Our Phase III program is designed to clearly show how well our 300-milligram dose given every 2 weeks performs against placebo in the first 16 weeks of treatment. The Phase III data set will also provide evidence on CBP-201's ability to maintain clinical improvement in patients who stepped down to a more convenient treatment regimen of 300-milligram given every 4 weeks for long-term use, which is part of our overarching goal of demonstrating the potential differentiated therapeutic benefits of CBP-201 for patients with AD.

我們的 III 期計劃旨在清楚地顯示我們每 2 週給予 300 毫克劑量與安慰劑相比在治療的前 16 週內的效果如何。 III 期數據集還將提供證據，證明 CBP-201 能夠在長期使用每 4 週一次更方便的 300 毫克治療方案的患者中維持臨床改善，這是我們總體目標的一部分證明 CBP-201 對 AD 患者的潛在差異化治療益處。

Now I would like to turn your attention to our early-stage clinical drug candidate, CBP-174, which is being studied to treat chronic pruritus or itching associated with allergic and inflammatory skin conditions including AD. CBP-174 is a highly selective, perfectly acting H3R antagonist for oral administration. As you likely saw on August 30, we reported topline results from our Phase I trial designed to evaluate safety, tolerability and pharmacokinetics, or PK, in healthy adults.

現在我想將您的注意力轉移到我們的早期臨床候選藥物 CBP-174 上，該藥物正在研究用於治療與過敏性和炎症性皮膚病症（包括 AD）相關的慢性瘙癢或瘙癢。 CBP-174 是一種具有高選擇性、作用完美的口服 H3R 拮抗劑。正如您在 8 月 30 日看到的那樣，我們報告了第一階段試驗的主要結果，該試驗旨在評估健康成人的安全性、耐受性和藥代動力學或 PK。

I'm pleased to report that CBP-174 administered orally was observed to be safe and well tolerated across 8 dose escalation cohorts evaluated up to a maximum dose of 16 milligrams or placebo in this randomized, double-blind, placebo-controlled single ascending dose study. There were no serious adverse events and reported adverse events were predominantly mild in severity with no dose-limiting toxicities.

我很高興地報告，在隨機、雙盲、安慰劑對照的單次遞增劑量中，觀察到口服 CBP-174 在 8 個劑量遞增隊列中安全且耐受性良好，評估的最大劑量為 16 毫克或安慰劑學習。沒有嚴重的不良事件，報告的不良事件的嚴重程度主要是輕微的，沒有劑量限制性毒性。

The CBP-174 PK profile exhibited rapid absorption with dose proportional increases and exposure followed by linear elimination. This promising first-in-human data represents progress for the development of CBP-174 as a potential novel treatment for pruritus associated with allergic and inflammatory skin conditions, including atopic dermatitis, which affects millions of individuals worldwide.

CBP-174 PK 曲線表現出快速吸收，劑量成比例增加，暴露後線性消除。這一有希望的首次人體數據代表了 CBP-174 的發展取得了進展，作為一種潛在的新療法，可以治療與過敏性和炎症性皮膚病相關的瘙癢症，包括影響全世界數百萬人的特應性皮炎。

This is our first clinical trial for our third clinical stage drug candidate, and we look forward to continuing to evaluate CBP-174 as we work towards improving the quality of life for patients with debilitating dermatologic diseases.

這是我們針對第三臨床階段候選藥物的首次臨床試驗，我們期待在我們努力改善患有衰弱性皮膚病患者的生活質量的同時繼續評估 CBP-174。

And with that, let me turn the call to Steve to cover the financial report.

說到這裡，讓我把電話轉給史蒂夫來報導財務報告。

Thanks, Chin.

謝謝，欽。

Today, we filed our Form 6-K for the 6 months ended June 30, 2022, which contains detailed financial results and is available on the SEC and Connect websites. I'll cover a few key financial metrics starting with our cash position. For all of my remarks, I'll be comparing the 6 months ended June 30, 2022, to the 6 months ended June 30, 2021, unless specified otherwise.

今天，我們提交了截至 2022 年 6 月 30 日的 6 個月的 6-K 表格，其中包含詳細的財務結果，可在 SEC 和 Connect 網站上查閱。我將從我們的現金狀況開始介紹一些關鍵的財務指標。對於我的所有評論，除非另有說明，否則我將比較截至 2022 年 6 月 30 日的 6 個月和截至 2021 年 6 月 30 日的 6 個月。

As of June 30, 2022, cash, cash equivalents, short-term and long-term investments were USD 212.9 million or RMB 1,429.1 million compared to RMB 1,706.9 million at December 31, 2021. The decrease was mainly due to R&D and administrative costs associated with our 3 clinical drug programs.

截至 2022 年 6 月 30 日，現金、現金等價物、短期和長期投資為 2.129 億美元或人民幣 14.291 億元，而 2021 年 12 月 31 日為人民幣 17.069 億元。減少的主要原因是相關的研發和管理費用與我們的 3 個臨床藥物項目。

Our total cash and investments of USD 212.9 million are expected to fund our operations into at least 2024 based on our current operating plan. R&D expenses increased to USD 50.8 million or RMB 340.8 million from RMB 217.8 million. This increase was driven primarily by higher clinical trial-related expenses, including expenses related to advancing CBP-201 for AD in China, the ongoing global Phase II costs for CBP-201 in asthma, our global Phase II trial cost for CBP-307 in UC as well as higher personnel costs for additional R&D headcount.

根據我們目前的運營計劃，預計我們的現金和投資總額為 2.129 億美元，至少可以為我們的運營提供資金到 2024 年。研發費用從人民幣 2.178 億元增加到 5080 萬美元或人民幣 3.408 億元。這一增長主要是由於與臨床試驗相關的費用增加，包括與在中國推進 CBP-201 治療 AD 相關的費用、CBP-201 用於哮喘的持續全球 II 期費用、我們在 2018 年 CBP-307 的全球 II 期試驗費用UC 以及額外研發人員的更高人員成本。

Administrative expenses totaled USD 10.7 million or RMB 71.8 million compared with RMB 48.0 million in the same period in 2021. Admin expenses rose primarily due to higher personnel costs, stock-based compensation expenses, higher professional services and other costs associated with building out a public company infrastructure and supporting clinical trials.

管理費用總計 1,070 萬美元或人民幣 7,180 萬元，而 2021 年同期為人民幣 4,800 萬元。管理費用增加的主要原因是人員成本增加、股權補償費用增加、專業服務費用增加以及與建立公共機構相關的其他成本增加公司基礎設施和支持臨床試驗。

Net loss totaled USD 59.8 million or RMB 401.3 million compared with a net loss of RMB 942.5 million for the 6 months ended June 30, 2021. The net loss in the prior year period was higher due to the recognition of RMB 674.3 million of fair value adjustments on our preferred stock, which were converted to common stock in last year's IPO.

淨虧損總計 5980 萬美元或 4.013 億元人民幣，而截至 2021 年 6 月 30 日止 6 個月的淨虧損為 9.425 億元人民幣。去年同期的淨虧損較高，原因是確認了 6.743 億元人民幣的公允價值對我們的優先股進行調整，這些股票在去年的 IPO 中轉換為普通股。

With that, I'll turn the call over to the operator for instructions and how to participate in the Q&A portion of today's call. Operator?

有了這個，我會將電話轉給接線員以獲取說明以及如何參與今天電話的問答部分。操作員？

(Operator Instructions)

（操作員說明）

Our first question comes from the line of Louise Chen with Cantor Fitzgerald.

我們的第一個問題來自 Louise Chen 和 Cantor Fitzgerald 的台詞。

Congratulations on all the progress this quarter. So I had a few questions for you. First question I had for you is that atopic dermatitis is a crowded development space. So just curious what you think your differentiation will be here?

祝賀本季度取得的所有進展。所以我有幾個問題要問你。我要問你的第一個問題是特應性皮炎是一個擁擠的發展空間。所以只是好奇你認為你的差異化會在這裡？

And then secondly, for CBP-307, do you think we could hear about a partner before the end of the year? Or is this more of a 2023 or -- if you could give us any sort of timing, that will be helpful. And has there been interest by partners in your discussions? And then lastly, what is the opportunity for CBP-201 in asthma?

其次，對於 CBP-307，您認為我們能在年底前聽到合作夥伴的消息嗎？或者這更像是 2023 年，或者——如果你能給我們任何時間安排，那將會很有幫助。合作夥伴是否對你們的討論感興趣？最後，CBP-201 在哮喘方面的機會是什麼？

Essentially -- thank you for the question, I believe that we have 4 questions here. Let me take a crack on the first questions, and then Chin can address the 307 and the timeline for clinical report. And I can probably also after my answer to the first question, some insight on interest of investors and partners on 307 and then, again, maybe back to Chin on asthma potential.

本質上——謝謝你提出這個問題，我相信我們在這裡有 4 個問題。讓我先回答一下第一個問題，然後 Chin 可以解決 307 和臨床報告的時間表。在回答第一個問題後，我可能還會對投資者和合作夥伴對 307 的興趣有一些了解，然後可能再次回到 Chin 的哮喘潛力。

So with respect to the opportunity of CBP-201 in the AD space, you are absolutely correct that the AD space treatment has evolved quite a bit now since launch of dupilumab. And it is now becoming a more crowded space. But if you'll look at the market opportunity and the number of patients worldwide that can be -- that can benefit from systemic treatments, the opportunity, obviously, is very large, and that's validated by the performance of drugs like dupilumab in the marketplace.

因此，關於 CBP-201 在 AD 空間中的機會，你是絕對正確的，自從推出 dupilumab 以來，AD 空間治療已經有了很大的發展。它現在正變得更加擁擠。但是如果你看看市場機會和全世界可以從系統治療中獲益的患者數量，那麼這個機會顯然是非常大的，而且市場上 dupilumab 等藥物的表現也證實了這一點.

Now when we look at opportunities, obviously, we're looking at this time, we believe that biologics, especially biologics that have significant efficacy and excellent safety profile, is going to continue to be most important and will continue to dominate this space as the market grow. And, obviously, other modalities will have a significant role as well.

現在，當我們看機會時，顯然，我們正在尋找這個時間，我們相信生物製劑，尤其是具有顯著療效和出色安全性的生物製劑，將繼續成為最重要的，並將繼續主導這一領域，因為市場增長。顯然，其他方式也將發揮重要作用。

Now within the IL-4 alpha receptor antibody space represented here by dupilumab, we believe that blocking IL-4 and IL-13 continue to be the most effective way of treating AD as well as other diseases, allergic diseases associated with type 2 inflammation. So if you just look at IL-4Ra antagonist space, obviously, so far dupilumab is the only drug on the market right now.

現在，在 dupilumab 代表的 IL-4 α 受體抗體空間內，我們相信阻斷 IL-4 和 IL-13 仍然是治療 AD 以及其他疾病、與 2 型炎症相關的過敏性疾病的最有效方法。所以如果你只看 IL-4Ra 拮抗劑空間，顯然，到目前為止，dupilumab 是目前市場上唯一的藥物。

Connect is developing a potentially differentiated antibody as a second to the market in this specific class, right? And as we have communicated in the past, dupilumab is good, it's a wonderful drug. But certainly, in terms of its efficacy, in terms of convenience of use, in terms of dosing frequencies, there are clearly opportunities to improve and allow other molecules to come in.

Connect 正在開發一種潛在的差異化抗體，作為該特定類別的第二個市場，對嗎？正如我們過去交流過的那樣，dupilumab 很好，它是一種很棒的藥物。但可以肯定的是，就其功效而言，就使用的便利性而言，就給藥頻率而言，顯然有機會改進並允許其他分子進入。

When we look at CBP-201, it's an entirely different molecule with different binding epitope. And our goal here is to have differentiation in perhaps a number of areas, right? So we have potentially the overall efficacy, and we're going to find out in our future studies. And the other is potentially in the long treatment period of maintenance where -- and Q4W may be an opportunity where it's not available for dupilumab.

當我們觀察 CBP-201 時，它是一種完全不同的分子，具有不同的結合表位。我們的目標可能是在多個領域實現差異化，對吧？所以我們有潛在的整體療效，我們將在未來的研究中找出答案。另一個可能是在維護的長期治療期間——而 Q4W 可能是一個機會，它不適用於 dupilumab。

So to kind of circle back to the question, yes, it is a crowded space. And each of this kind of category have their specific utility to address patients' needs, and we believe that CBP-307 does have a great opportunity if our clinical data support a robust efficacy and potentially dosing (inaudible).

所以回到問題，是的，這是一個擁擠的空間。並且每一類都有其特定的用途來滿足患者的需求，我們相信，如果我們的臨床數據支持強大的療效和潛在的劑量（聽不清），CBP-307 確實有很大的機會。

The -- let me go to the question on CBP-307. We -- as in my opening remarks here, we emphasized that CBP-307, by all the measures that we look at, looked at the totality of our Phase II data, we are quite comfortable that clearly the molecule is working the way it should, especially by the clinical remission rate.

讓我來談談關於 CBP-307 的問題。我們——正如我在這裡的開場白中一樣，我們強調 CBP-307，通過我們所看到的所有措施，查看了我們 II 期數據的整體，我們很高興分子顯然正在按照它應該的方式工作，尤其是臨床緩解率。

And there have been continued interest in CBP-307, and we have been an ongoing discussion. And at this time in point, we don't have anything to update, but we will be happy to do so when we are ready to announce any sort of update on this discussion.

人們一直對 CBP-307 感興趣，我們一直在進行討論。此時此刻，我們沒有任何要更新的內容，但是當我們準備好宣布有關此討論的任何更新時，我們將很樂意這樣做。

Let me ask Chin to address the progress in terms of when our clinical report will come up and also the asthma opportunity for CBP-201. Chin?

讓我請 Chin 談談我們的臨床報告何時出現以及 CBP-201 的哮喘機會方面的進展。下巴？

Yes. Thanks, Wei.

是的。謝謝，魏。

So I think as you heard on the first part of this call, so for the AD program, so we're well underway for the first study looking forward to getting our first patient in the study before the end of this year. And then we'll continue to make positive steps towards the program as we move the AD indication forward. So we're very excited about that.

所以我想正如你在本次電話會議的第一部分聽到的那樣，對於 AD 計劃，我們正在順利進行第一項研究，期待在今年年底之前讓我們的第一位患者參與研究。然後，隨著我們將 AD 指示向前推進，我們將繼續朝著該計劃邁出積極的一步。所以我們對此感到非常興奮。

And then maybe a quick update regarding asthma. So we look forward to getting the results closer to the first half of next year and continue to make progress on that.

然後也許是關於哮喘的快速更新。因此，我們期待在接近明年上半年的時候得到結果，並繼續在這方面取得進展。

And I think, Louise, your question around CBP and asthma, certainly, the line of the response that Wei gave on your -- one of your questions around the AD space, I think asthma is not dissimilar. Obviously, there's many treatments for that. But we believe that we've got potentially a molecule that in 201 -- CBP-201, that can be very competitive once we've generated the totality of data for approval across the different indications we are currently pursuing in AD as well as asthma.

我認為，路易絲，你關於 CBP 和哮喘的問題，當然，魏對你的回答——你關於 AD 空間的問題之一，我認為哮喘沒有什麼不同。顯然，有很多治療方法。但我們相信，我們有可能在 201 中獲得一種分子——CBP-201，一旦我們生成了我們目前在 AD 和哮喘中追求的不同適應症的全部數據以供批准，它就會非常有競爭力.

And I think that in of itself represents opportunity for us with the molecule, not just in AD, but asthma because I think with a molecule like this, we want to pursue indication that will allow us to continue to layer on the different treatment options that physicians will have from CBP-201.

而且我認為這本身就代表了我們使用分子的機會，不僅在 AD 中，而且在哮喘中，因為我認為對於這樣的分子，我們想要尋求指示，這將使我們能夠繼續在不同的治療方案上分層醫生將從 CBP-201 獲得。

Our next question comes from the line of Thomas Smith with SVB Securities.

我們的下一個問題來自 Thomas Smith 與 SVB Securities 的對話。

I guess first on CBP-201. Can you give us any additional color on your regulatory interactions with China CDE? And maybe speak to your level of confidence that positive results from the ongoing study could result in an approvable data set?

我猜首先是 CBP-201。你能給我們更多關於你與中國 CDE 的監管互動的顏色嗎？也許可以談談您對正在進行的研究的積極結果可能會產生可批准的數據集的信心程度？

Thank you, Tom. Thank you for the question.

謝謝你，湯姆。感謝你的提問。

Yes, and I can provide an update here. We did talk about this in our press release. And -- it really is an excellent development for the program, trying to get dropped a proof and make it available to patients in China. As you recall that in our previous discussion, we had planning to enroll more patients in that study in order to satisfy the exposure center.

是的，我可以在這裡提供更新。我們在新聞稿中確實談到了這一點。而且——這真的是該項目的一個很好的發展，它試圖放棄一個證據，讓中國的病人可以使用它。您還記得在我們之前的討論中，我們計劃在該研究中招募更多患者以滿足暴露中心的要求。

And in our discussion with CDE, based on their reply our questions, it certainly appear to us, and we believe, that the CDE want to see the -- how the data set looks like and because we already have a global Phase IIb trial, and on top of that, we built this China pivotal trial, in terms of the designs and the purpose, it's entirely consistent with the pivotal trial.

在我們與 CDE 的討論中，根據他們對我們問題的回答，在我們看來，CDE 顯然希望看到——數據集的樣子，因為我們已經進行了全球 IIb 期試驗，最重要的是，我們建立了這個中國關鍵試驗，在設計和目的上，它與關鍵試驗完全一致。

So -- now we won't be able to provide sort of additional detail, in fact, we -- this is not in-person meeting with the CDE. And so we believe that it will depend on whether or not we hit our endpoint in our pivotal trial in China. And the other thing I should point out is that the ability to very quickly follow up with the pre-BLA meeting, which is what we agreed on with the CDE immediately after the 16-week data, it's a very positive sign.

所以——現在我們無法提供更多的細節，事實上，我們——這不是與 CDE 的面對面會議。因此，我們認為這將取決於我們是否在中國的關鍵試驗中達到了終點。我應該指出的另一件事是能夠非常快速地跟進 BLA 前會議，這是我們在 16 週數據後立即與 CDE 達成一致的，這是一個非常積極的跡象。

It also allow us to have better understanding of what else is needed, whether on our package to be complete, and that will all depend on the pre-BLA meeting that we're going to schedule as soon as we have our data together.

它還使我們能夠更好地了解還需要什麼，我們的包裹是否完整，而這一切都將取決於我們在獲得數據後立即安排的 BLA 前會議。

Okay. Got it. That makes sense. And then you mentioned -- it sounded like in the prepared remarks, potentially using the China pivotal data as the start of potential partnering discussions. Can you just talk about what you'd be looking for in terms of partnership? And I guess, latest thoughts on how you're thinking about commercialization in China versus the U.S. versus Europe versus other regions?

好的。知道了。這就說得通了。然後你提到——聽起來像是在準備好的發言中，可能使用中國關鍵數據作為潛在合作討論的開始。你能談談你在尋找合作夥伴方面的內容嗎？我想，關於您如何看待中國、美國、歐洲和其他地區的商業化的最新想法？

Yes. So on the partnership front, I think we indicated also in previous discussions with investors is that we are open to partnering CBP-201, both in regional deals, China specific -- Greater China specific, for example, as well as global deals.

是的。因此，在合作夥伴關係方面，我認為我們在之前與投資者的討論中也表示，我們願意與 CBP-201 合作，無論是在區域交易、特定於中國——例如特定於大中華區的交易中，還是全球交易中。

Now obviously, our expectation is that the global deal or ex-China deal will take a little bit longer to conduct and to complete. And so that's sort of our objective is that we will have a regional deal first. So just in sort of in terms of the logistics and the realistic timeline for negotiations and partnership discussions, but it -- we will also be interested in ex-China partnership.

現在顯然，我們的預期是全球交易或中國以外的交易將需要更長的時間來進行和完成。因此，我們的目標是首先達成區域協議。因此，就談判和夥伴關係討論的後勤和現實時間表而言，我們也將對中國以外的伙伴關係感興趣。

With respect to commercialization, we certainly are open to working with China pharmaceutical companies -- China-based pharmaceutical companies who may have much more capability in their marketing, especially in immunology space. I think we all come to realize that to be successful in the China market, we do need efficiencies, and building a sales force is not a trivial task.

在商業化方面，我們當然願意與中國製藥公司合作——中國製藥公司可能在營銷方面擁有更強的能力，尤其是在免疫學領域。我想我們都開始意識到要在中國市場取得成功，我們確實需要提高效率，而建立銷售隊伍並非易事。

So if the deal is favorable and they allow us to achieve our goal in terms of getting the drug in approved China as well as generating revenue, connect in a the form of royalty, we are completely open to that as well. And as I said at this moment, we are not able to share any specifics on the progress, we will be very happy to discuss when the time comes.

因此，如果這筆交易是有利的，並且他們允許我們實現我們的目標，即在獲得批准的中國獲得藥物以及產生收入，以特許權使用費的形式連接，我們也完全開放。正如我此時所說，我們無法分享任何進展的細節，我們將非常樂意在適當的時候進行討論。

And -- Yes. Just to add a little bit related to your question, Tom, is -- yes, the -- now that the pivotal trial data is available rather quickly, much earlier than previously anticipated, and so this certainly will become also part of the discussion in our partnership discussions, and we see this as a very positive sign with another set of data available to us.

是的。湯姆，只是補充一點與你的問題相關的是——是的，——現在關鍵的試驗數據相當快地可用，比之前預期的要早得多，所以這肯定也會成為討論的一部分我們的伙伴關係討論，我們認為這是一個非常積極的跡象，我們可以使用另一組數據。

I hope this helped.

我希望這有所幫助。

Yes. No, that's very helpful. And then just maybe last question. Just -- when can we expect to hear more on your plans and next steps for future studies with CBP-174?

是的。不，這非常有幫助。然後可能只是最後一個問題。只是——我們什麼時候能聽到更多關於你的計劃和未來 CBP-174 研究的後續步驟？

Yes. And we literally just got the data and are able to present, right? So this first study is truly a typical first-in-human study to allow us to get an understanding of the drug characteristics, right, the safety profile, which is the most important part of this evaluation. And by this study so far, we are happy with the safety profile with the dose level that we have achieved.

是的。我們實際上只是獲得了數據並且能夠呈現，對嗎？因此，第一項研究確實是一項典型的首次人體研究，讓我們了解藥物特性，對，安全性概況，這是本次評估最重要的部分。到目前為止，通過這項研究，我們對我們所達到的劑量水平的安全性感到滿意。

The next step, obviously, require a little bit more kind of deliberation here in terms of how we leverage a next study that will look like -- I think most people think it will look more like a multiple ascending dose, but not just purely a multiple ascending dose in healthy individuals, to be able to think about whether or not we can build certain kind of biomarker or even running the study in patients of, say, skin inflammation.

下一步，很明顯，就我們如何利用下一項研究而言，下一步需要更多的考慮——我認為大多數人認為它看起來更像是多次遞增劑量，而不僅僅是純粹的在健康個體中多次遞增劑量，以便能夠考慮我們是否可以建立某種生物標誌物，甚至可以在皮膚炎症患者中進行研究。

So I -- we're going to have to go back and put our heads together to come up with that plan. So we'll be happy, again, to update when the time comes.

所以我 - 我們將不得不回去並集思廣益以提出該計劃。因此，我們很樂意再次在時機成熟時進行更新。

Yes. And Wei, if I can just add one more point to Tom's good question around CBP-174. The other thing is, Thomas, one of the things that we did in the Phase I single ascending dose study is, we administered the drug using it in a solution. And there may be opportunities for us to think about optimizing the formulation in the next study.

是的。魏，如果我能再補充一點湯姆關於 CBP-174 的好問題。另一件事是，Thomas，我們在第一階段單次遞增劑量研究中所做的一件事是，我們在溶液中使用它來管理藥物。並且我們可能有機會在接下來的研究中考慮優化配方。

And so that's another reason we want to sort of consider some of the details around what that next study will look like in addition to other comments that Wei made that are really excellent points in terms of the things that we want to think through rather than just doing a sort of just a usual typical MAD type of Phase I study.

因此，這也是我們想要考慮一些關於下一項研究的細節的另一個原因，除了 Wei 提出的其他評論之外，這些評論在我們想要思考的事情方面確實是非常好的觀點，而不僅僅是做一種通常的典型 MAD 類型的第一階段研究。

Thank you, Tim. That's another excellent point in here. This type of first-in-human study is to find out some information as quickly as possible. The correct way of hosting the drug, as Chin pointed out, is API in solution. Certainly, it's not the format of the formulation we would like to take to the next study. So -- yes, that's a (inaudible) as well. I hope this is helpful.

謝謝你，蒂姆。這是這裡的另一個優點。這種首次人體研究是為了盡快找出一些信息。正如 Chin 指出的那樣，承載藥物的正確方法是溶液中的 API。當然，這不是我們想在下一次研究中採用的公式格式。所以——是的，這也是（聽不清）。我希望這是有幫助的。

(Operator Instructions)

（操作員說明）

Our next question comes from the line of Kelly Shi with Jefferies.

我們的下一個問題來自 Kelly Shi 與 Jefferies 的對話。

Can you hear me fine?

你能聽到我的聲音嗎？

Kenny -- yes, we can hear you.

肯尼——是的，我們能聽到你的聲音。

Okay. So first of all, could you actually share some color regarding the payback of the end of Phase II meeting with FDA? Do you still plan to enroll more severe AD patients? And how do you implement this strategy into the operation for the global Phase III trial?

好的。因此，首先，您能否就與 FDA 的 II 期會議結束時的回報分享一些顏色？你們還打算招募更多的重症AD患者嗎？您如何將這一戰略實施到全球 III 期試驗的運作中？

Great. Thank you for the questions. And this sounds like a question for Chin. Would you like to take on this question?

偉大的。謝謝你的問題。這聽起來像是給 Chin 的問題。你願意回答這個問題嗎？

Yes. Great question, Kelly.

是的。好問題，凱利。

So as mentioned in the first part of the call, we did have what we believe to be a very successful interaction with FDA. And during that meeting, a lot of time -- most of the discussion was spent on how our Phase III program will look like, and had a lot of discussions around very detailed things, everything from the design of not only the initial treatment, but beyond the primary endpoint in terms of generating more chronic use data in our 52-week study. So that was very informative for us and also had good discussions around the details of who we would take into that chronic long-term study, for example, who -- the definition of responders, even down to the details around -- some of the details around end point and how we would train investigators.

因此，正如電話第一部分所述，我們確實與 FDA 進行了我們認為非常成功的互動。在那次會議上，大部分時間——大部分討論都花在了我們的 III 期計劃會是什麼樣子上，並且圍繞非常詳細的事情進行了很多討論，不僅是初始治療的設計，還有在我們為期 52 週的研究中，在生成更多長期使用數據方面超出了主要終點。因此，這對我們來說非常有用，並且還就我們將把誰納入長期研究的細節進行了很好的討論，例如，誰——響應者的定義，甚至細化到周圍的細節——一些有關終點的詳細信息以及我們將如何培訓調查人員。

So it was a very fruitful conversation around sort of nuts and bolts of our clinical Phase III program. And we did have some other conversations, for example, around patient population about -- for example, including children, younger adolescents. That was something that we know the FDA was favorable in wanting us to pursue. So we got some good feedback on that. And so I think a very fruitful conversation, again, more around the Phase III program. And I would say that the bulk of the conversation was, in fact, going through our different trial designs. I would say about 80% of the call.

因此，這是一場關於我們臨床 III 期計劃的具體細節的非常富有成果的對話。我們確實進行了一些其他對話，例如，圍繞患者群體——例如，包括兒童、青少年。這是我們知道 FDA 贊成我們追求的東西。所以我們得到了一些很好的反饋。因此，我認為一次非常富有成果的對話，再次更多地圍繞第三階段計劃展開。我要說的是，大部分談話實際上是在討論我們不同的試驗設計。我會說大約 80% 的電話。

And then -- in terms of -- you had a question around a sense of getting more severe patients. So this is something that, coming out of our Phase III -- or excuse me, Phase II global study, this is something that is first and foremost in our mind. I should first say that in terms of executing excellence, so far, if the current large trial in China that Wei discussed, that serves as our pivotal trial for potential registration in China, that study, I think, will be a good sort of next step for us to see if we're able to recruit the kind of more severe patients. And so far, based on what we know, that looks to be the case. In terms of replicating that in a Phase III global program, there's going to be inherent challenges there because we'll be going to, obviously, different geographies.

然後 - 就 - 你有一個關於獲得更多嚴重患者的問題。所以這是我們第三階段的結果——或者對不起，第二階段全球研究，這是我們首先考慮的事情。我首先要說的是，就卓越執行而言，到目前為止，如果 Wei 討論的目前在中國進行的大型試驗是我們在中國進行潛在註冊的關鍵試驗，我認為該研究將是下一個很好的選擇一步讓我們看看我們是否能夠招募到那種更嚴重的患者。到目前為止，根據我們所知道的，情況似乎是這樣。就在 III 期全球計劃中復制這一點而言，那裡將存在固有的挑戰，因為顯然我們將前往不同的地區。

But one of the things that we've discussed is trying to balance the operational challenge of trying to enroll patients in a timely fashion versus making sure we get sufficiently active patients at baseline. And one of the things we may do is allow patients who have higher levels of baseline that's been typically required for some subgroup of patients to enroll as part of the entry criteria until we get enough of those more severe patients.

但我們討論的其中一件事是試圖平衡試圖及時招募患者的操作挑戰與確保我們在基線時獲得足夠活躍的患者。我們可能做的一件事是允許具有較高基線水平的患者作為入組標準的一部分，而這些基線水平通常是某些患者亞組所需要的，直到我們獲得足夠多的更嚴重的患者。

But on a whole, we would still allow those patients who have moderate to severe AD as all of the other Phase III trials in the AD space has done. But again, we may have a subgroup that may actually have even a higher level of disease severity so that, overall, we'll have a patient population that will be hopefully more severe than what we had in our Phase II global study.

但總的來說，我們仍然會允許那些患有中度至重度 AD 的患者，就像 AD 領域的所有其他 III 期試驗所做的那樣。但同樣，我們可能有一個亞組實際上可能具有更高的疾病嚴重程度，因此，總體而言，我們的患者群體有望比我們在 II 期全球研究中的患者群體更嚴重。

I also have a follow-up. So on the clinical trials dugout, it was showing that the nasal polyps trial was terminated. Curious, do you plan to resume the program in the future? And what are your thoughts for 201 in terms of indications beyond AD?

我也有跟進。所以在臨床試驗的休息室裡，顯示鼻息肉試驗已經終止。好奇，你打算在未來恢復這個項目嗎？在 AD 以外的適應症方面，您對 201 有何看法？

Chin, do you want to go ahead and also take another question? Yes?

Chin，你想繼續回答另一個問題嗎？是的？

Yes. Absolutely. Yes. So another really good question, Kelly. So we made a very difficult decision to terminate that study and it was -- I think you may be aware, it was not due to any safety issues at all. It was more of an operational issue in terms of enrolling the study during a very challenging period.

是的。絕對地。是的。另一個非常好的問題，凱利。因此，我們做出了一個非常艱難的決定來終止該研究——我想你可能知道，這根本不是因為任何安全問題。就在一個非常具有挑戰性的時期招募研究而言，這更像是一個操作問題。

And I think 2 important factors that weighed in on that study was -- number one, the pandemic that was ongoing at the time as well as the lockdowns in China, but also, secondary, there was also the Ukraine conflict that had an important impact on that study because we had sites in Ukraine that were to start up, and I think people who are experienced in running clinical trials, Ukraine is often a country that serves to enroll a lot of patients in different clinical trials. And so when that conflict beget, it impact their ability to get those sites recruiting patients. So those are 2 key reasons that really impacted our ability to continue to enroll that study. And again, we made a very difficult decision to stop that study.

我認為影響該研究的兩個重要因素是——第一，當時正在發生的大流行病以及中國的封鎖，但其次，烏克蘭衝突也產生了重要影響在那項研究中，因為我們在烏克蘭有一些要啟動的站點，我認為在進行臨床試驗方面經驗豐富的人，烏克蘭通常是一個在不同臨床試驗中招募大量患者的國家。因此，當衝突開始時，它會影響他們讓這些網站招募患者的能力。因此，這些是真正影響我們繼續參加該研究的能力的兩個關鍵原因。再一次，我們做出了一個非常艱難的決定來停止這項研究。

In terms of whether or not we will pursue nasal polyps in the future. maybe I can turn that back to Wei to comment on that. But obviously, I think with dupilumab having shown efficacy there in that indication, I think we know the mechanism should work and our drug would likely work in that indication.

在以後會不會追求鼻息肉方面。或許我可以將其轉回給 Wei 對此發表評論。但很明顯，我認為 dupilumab 已經在該適應症中顯示出療效，我認為我們知道該機制應該起作用並且我們的藥物可能會在該適應症中起作用。

So -- let me turn it over to Wei to see if you want to -- if you could answer the question about would we pursue nasal polyps in the future?

所以 - 讓我把它交給 Wei，看看你是否願意 - 如果你能回答關於我們將來會追求鼻息肉的問題嗎？

Sure, sure. Well, thank you, Kelly, for the question. And thank you, Chin. Yes, so this tie into a kind of a broader question of indications for a drug like CBP-201. And we want to go back to the same thesis of why IL-4Ra antagonists, they're different from IL-13 antibodies for their ability to block a broader disease pathways.

一定一定。好吧，謝謝你，凱利，提出這個問題。謝謝你，Chin。是的，所以這與更廣泛的 CBP-201 等藥物的適應症問題有關。我們想回到為什麼 IL-4Ra 拮抗劑的相同論點，它們不同於 IL-13 抗體，因為它們能夠阻斷更廣泛的疾病途徑。

And if you look at dupilumab, for example, right now, it looks like it's going to be approved for many, many indications in the type 2 pathway. I think we believe CBP's value is going to be significantly increased with additional indications such as asthma, nasal polyps and other studies, other indications as well because these type 2 diseases are very often -- they are kind of comorbidities, and patients suffer from more than one type of type 2 diseases and, therefore, potentially making this class of drug a lot more attractive, right?

例如，如果你現在看看 dupilumab，它看起來將被批准用於 2 型通路中的許多許多適應症。我認為我們相信 CBP 的價值將隨著額外的適應症而顯著增加，例如哮喘、鼻息肉和其他研究，以及其他適應症，因為這些 2 型疾病經常——它們是一種合併症，患者遭受更多比一種 2 型疾病，因此，可能使這類藥物更具吸引力，對吧？

So we're seeing that being played out already. So a nasal polyps will one of the indications that either our partner in the future will pursue and perhaps that's both in China and ex-China as well. But again, that's not something we're going to begin running starting in the next few months, right, but that's certainly in the plan in the future.

所以我們已經看到了這一點。因此，鼻息肉將成為我們未來合作夥伴追求的跡象之一，也許這在中國和中國以外都是如此。但同樣，這不是我們要在接下來的幾個月開始運行的東西，對吧，但這肯定在未來的計劃中。

(Operator Instructions)

（操作員說明）

Our next question comes from the line of Joe Catanzaro with Piper Sandler.

我們的下一個問題來自 Joe Catanzaro 和 Piper Sandler 的台詞。

Just two quick ones for me. Maybe first one following up on the discussion earlier around the potential for partnership opportunities for CBP-201. Just want to confirm that it is your expectation to launch the global Phase III AD program before year-end, irrespective of whether you have any partnership in place by then?

對我來說只有兩個快速的。也許是第一個跟進之前關於 CBP-201 合作機會潛力的討論的人。只是想確認一下，您希望在年底之前啟動全球 III 期 AD 計劃，無論您是否有任何合作夥伴關係到位？

And then second question around the October readout and how you're thinking about the extent of disclosure in the topline? Should we expect something similar to last November's Phase IIb topline readout? Or would you expect to include some more details like P values or maybe even absolute efficacy metrics?

然後是關於 10 月份讀數的第二個問題，以及您如何考慮頂線的披露程度？我們是否應該期待與去年 11 月的 IIb 期頂線讀數類似的結果？或者您是否希望包含更多細節，例如 P 值或什至絕對功效指標？

Thank you, Joe, for the question. Let me take a kind of stab at the first question first on the potential partnership.

喬，謝謝你提出這個問題。讓我先回答第一個關於潛在夥伴關係的問題。

Yes, so with respect to launch of our Phase III global studies and whether or not by the time we would have a global partner. The assumption right now, obviously, is that we will be able to launch our study given our financial operation at the moment, without securing a global partner by the time we launch. We are talking about only a quarter's time, right? So -- but again, with the new data that we have, that we're going to release. We are going to continue our global discussions and hopefully, in the not-too-distant future, we'll be able to have a good partnership to move the program forward. So that's -- so the part of the question.

是的，關於啟動我們的 III 期全球研究以及到那時我們是否會有全球合作夥伴。顯然，現在的假設是，鑑於我們目前的財務運作，我們將能夠啟動我們的研究，而在我們啟動時無需確保全球合作夥伴。我們談論的只是四分之一的時間，對吧？所以——但是，我們將再次發布我們擁有的新數據。我們將繼續我們的全球討論，並希望在不久的將來，我們能夠建立良好的合作夥伴關係來推動該計劃向前發展。這就是問題的一部分。

Was there another question on the partnership?

關於夥伴關係還有其他問題嗎？

No, I think that covers it. The second question was on sort of the disclosure level on the October readout.

不，我認為這涵蓋了它。第二個問題是關於 10 月份讀數的披露水平。

Yes. And I would like to turn this to Chin to provide some detail.

是的。我想請 Chin 提供一些細節。

Yes. Thanks, Wei. Thanks for the question, Joe. So for the topline readout -- so I think your question is in terms of level of detail relative to, I think you're referring to that original press release we had for our Phase II global AD trial data. Is that correct?

是的。謝謝，魏。謝謝你的問題，喬。因此，對於最重要的讀數——所以我認為你的問題是關於詳細程度的，我認為你指的是我們為我們的 II 期全球 AD 試驗數據發布的原始新聞稿。那是對的嗎？

Yes. That's right.

是的。這是正確的。

Okay. Great. So in terms of maybe just to give you a little bit of context around what we plan to have for the topline, it's going to obviously be the primary endpoint at week 16, which is the ED75. We'll have some key secondary endpoints, IGA, itch, et cetera, along with very topline safety results.

好的。偉大的。因此，也許只是為了給您一些關於我們計劃為頂線提供的背景信息，它顯然是第 16 週的主要終點，即 ED75。我們將有一些關鍵的次要終點、IGA、瘙癢等，以及非常重要的安全結果。

And given that we will have primary and key secondary -- I think one of the things that we took away from the first press release is the desire for external investor community to have that level of granularity you're probably referring to. And so we -- I think at this point, we would look forward to disclosing as much of that information as possible versus something that's more higher level.

鑑於我們將擁有主要和關鍵的次要——我認為我們從第一篇新聞稿中得到的其中一件事是希望外部投資者社區擁有你可能提到的那種粒度級別。所以我們——我認為在這一點上，我們期待盡可能多地披露這些信息，而不是更高級別的信息。

I don't know if that completely answers your question.

我不知道這是否完全回答了你的問題。

Yes, that does. That's helpful.

是的，確實如此。這很有幫助。

(Operator Instructions)

（操作員說明）

I'm showing no further questions in the queue. I would now like to turn the call back over to Zheng Wei for closing remarks.

我不會在隊列中顯示更多問題。我現在想把電話轉回給鄭偉，讓他發表結束語。

Sorry, I just muted myself. Well, thank you, operator.

對不起，我剛剛把自己靜音了。嗯，謝謝接線員。

Looking forward, just in the next several months, we have a number of milestones that we anticipate will help advance our goal of developing T cell-driven therapies to treat inflammatory diseases to improve the lives of patients with chronic inflammation.

展望未來，就在接下來的幾個月裡，我們有許多里程碑，我們預計這些里程碑將有助於推進我們開發 T 細胞驅動療法治療炎症性疾病的目標，從而改善慢性炎症患者的生活。

For CBP-201 in AD, we are on track to report topline data from the Stage 1 16-week treatment period of the China-only pivotal trial in October. We plan to initiate a global Phase III trial before the end of 2022. For CBP-201 in asthma, we anticipate completing enrollment in a global Phase II trial in asthma patients with type 2 inflammation in the first half of 2023. We plan to report topline finding in the second half of 2023.

對於 AD 中的 CBP-201，我們有望在 10 月份報告僅限中國的關鍵試驗的第一階段 16 周治療期的頂線數據。我們計劃在 2022 年底前啟動全球 III 期試驗。對於 CBP-201 治療哮喘，我們預計將在 2023 年上半年完成針對患有 2 型炎症的哮喘患者的全球 II 期試驗的註冊。我們計劃報告2023 年下半年的頂線發現。

Additionally, CBP-307 in UC will complete its Phase II maintenance phase in the second half of 2022.

此外，UC 的 CBP-307 將在 2022 年下半年完成其二期維護階段。

Thank you all for your interest in Connect Biopharma, and I look forward to reporting to you on the progress in the coming weeks and months.

感謝大家對 Connect Biopharma 的關注，我期待著在未來幾周和幾個月內向您報告進展情況。

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

女士們，先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。