Zai Lab Ltd (ZLAB) 2024 Q3 法說會逐字稿

Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab’s third quarter 2024 financial results conference call. (Operator Instructions) As a reminder, today’s call is being recorded.

女士們、先生們，大家好。感謝您的耐心等待，歡迎參加再鼎醫藥 2024 年第三季財務業績電話會議。（操作員說明）謹此提醒，今天的通話正在錄音。

It is now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of Investor Relations. Please go ahead.

現在我很高興請投資者關係資深副總裁 Christine Chiou 發言。請繼續。

Thank you, operator. Hello, everyone and welcome to Zai Lab’s third quarter 2024 earnings call.

謝謝你，接線生。大家好，歡迎參加再鼎醫藥 2024 年第三季財報電話會議。

Today's call will be led by Dr. Samantha Du, Zai Lab's Founder, CEO, and Chairperson. She will be joined by Josh Smiley, President and Chief Operating Officer; Dr. Rafael Amado, President and Head of Global Research and Development; and Dr. Yajing Chen, Chief Financial Officer. Jonathan Wang, our Chief Business Officer, will also be available to answer questions during the Q&A portion of the call.

今天的電話會議將由再鼎醫藥創辦人、執行長兼董事長杜杜博士主持。總裁兼營運長 Josh Smiley 也將加入她的行列； Rafael Amado 博士，總裁兼全球研發主管；陳亞靜博士，財務長。我們的首席商務長 Jonathan Wang 也將在電話問答部分回答問題。

As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings. We will also refer to adjusted loss from operations, which is a non-GAAP financial measure. Please refer to our earnings release furnished with the SEC on November 12, 2024, for additional information on this non-GAAP financial disclosure.

提醒一下，在今天的電話會議中，我們將根據我們目前的預期做出某些前瞻性聲明。這些陳述受到許多風險和不確定性的影響，可能會因為多種因素（包括我們在 SEC 文件中討論的因素）而導致實際結果與我們的預期有重大差異。我們也將提及調整後的營運虧損，這是一項非公認會計準則財務指標。請參閱我們於 2024 年 11 月 12 日向 SEC 提供的收益報告，以了解有關此非 GAAP 財務揭露的更多資訊。

At this time, it is my pleasure to turn the call over to Dr. Samantha Du.

此時，我很高興將電話轉給杜博士。

Thank you, Christine, and welcome everyone.

謝謝克里斯汀，歡迎大家。

This has been a tremendous year for Zai Lab, as we continue to execute our three key strategic priorities: driving revenue growth, expanding our global pipeline, and enhancing operational efficiency.

對於再鼎醫藥來說，今年是重要的一年，我們繼續執行三個關鍵策略重點：推動收入成長、擴大全球產品線和提高營運效率。

Starting with revenue growth. Total net product revenue for the third quarter grew 47% year over year. Our commercial business in China is growing rapidly, with VYVGART on track to become one of our potential blockbuster products. Later this year, we expect to launch multiple new products and indications, which will further grow our top-line.

從收入成長開始。第三季產品淨收入總額年增 47%。我們在中國的商業業務正在快速成長，VYVGART 有望成為我們潛在的重磅產品之一。今年晚些時候，我們預計將推出多種新產品和適應症，這將進一步增加我們的營收。

Turning to our pipeline. We made significant advancements in our global pipeline. Recently, we presented data from ZL-1310, a potential best-in-class DLL3-targeted ADC, in extensive stage small cell lung cancer. We also recently introduced our internally discovered IL-13/IL-31 bispecific antibody for atopic dermatitis and other immunologic diseases.

轉向我們的管道。我們在全球管道方面取得了重大進展。最近，我們展示了 ZL-1310（一種潛在的同類最佳 DLL3 靶向 ADC）在廣泛期小細胞肺癌中的數據。我們最近也推出了我們內部發現的針對異位性皮膚炎和其他免疫性疾病的IL-13/IL-31雙特異性抗體。

Additionally, we added ZL-6301, a preclinical ROR1 ADC, which we plan to advance into Phase 1 next year. By expanding our global portfolio, we are not only addressing pressing healthcare needs worldwide but also reinforcing Zai Lab’s role as an innovator in the industry. We also made substantial progress in our late-stage regional pipeline, keeping us on course for at least five potential approvals over the next one, two years. This includes KarXT, which we expect to submit to the NMPA in early 2025 and bemarituzumab where enrolment has now completed in both pivotal studies. These two products, which we believe both have blockbuster potentials, hold significant promise for patients, and providers alike.

此外，我們還增加了 ZL-6301，一種臨床前 ROR1 ADC，我們計劃明年將其推進到第一階段。透過擴大我們的全球產品組合，我們不僅可以滿足全球緊迫的醫療保健需求，還可以加強再鼎醫藥作為行業創新者的地位。我們還在後期區域管道方面取得了實質進展，使我們有望在未來一兩年內獲得至少五個潛在批准。其中包括 KarXT（我們預計將於 2025 年初向 NMPA 提交）和 bemarituzumab（兩項關鍵研究現已完成入組）。我們相信這兩種產品都具有巨大的潛力，為患者和醫療服務提供者帶來了巨大的希望。

Lastly, we are operating with increased efficiency and productivity throughout the organization. As a result of our efforts, we achieved a 40% improvement in net loss in the third quarter compared to the same period in the previous year.

最後，我們整個組織的營運效率和生產力都在提高。經過我們的努力，我們第三季的淨虧損比去年同期減少了40%。

I am thrilled about the progress we have made, and I want to emphasize that we are well-positioned to create substantial value for our business over the next few years. Thank you all for your continued support of our mission. I look forward to providing further updates in the coming year.

我對我們所取得的進步感到興奮，我想強調的是，我們處於有利位置，可以在未來幾年為我們的業務創造巨大價值。感謝大家對我們使命的持續支持。我期待在來年提供進一步的更新。

And now, I will pass the call over to Josh. Josh?

現在，我將把電話轉給喬許。喬許？

Thank you, Samantha, and thank you everyone for joining the call today.

謝謝薩曼莎，也謝謝大家今天加入電話會議。

This quarter, we made great progress across our business, demonstrating strong financial performance and excellent execution across several pipeline programs. Our third quarter net product revenue grew 47% year-over-year to $101.8 million, led by the successful launch and robust uptake of VYVGART, and also supported by increased sales for ZEJULA and NUZYRA.

本季度，我們的業務取得了巨大進展，在多個管道項目中展現了強勁的財務業績和出色的執行力。我們第三季的產品淨收入年增 47%，達到 1.018 億美元，這得益於 VYVGART 的成功推出和強勁的採用，同時 ZEJULA 和 NUZYRA 銷售額的成長也為我們提供了支持。

Starting with VYVGART. The launch has performed exceptionally well across all measures, and we are on a clear path to exceed $80 million in sales, which is in line with our full-year sales guidance. This would make VYVGART’s launch in gMG one of the strongest ever for an immunology product in China. This achievement is driven by our team’s ability to execute a strategic launch across the entire value chain.

從 VYVGART 開始。此次發佈在所有指標上都表現出色，我們的銷售額預計將超過 8000 萬美元，這符合我們的全年銷售指導。這將使 VYVGART 的 gMG 上市成為中國有史以來最強勁的免疫學產品之一。這項成就得益於我們團隊在整個價值鏈上執行策略發布的能力。

We start with hospitals, our primary channel for expanding patient access. I’m pleased to share that we’ve successfully achieved listings at all of our targeted top priority hospitals for the year, covering approximately 65% of gMG market potential. Now, we are targeting the next wave of hospitals and enhancing supplemental insurance access to offer additional support for the patient community.

我們從醫院開始，這是我們擴大病患覆蓋範圍的主要管道。我很高興地告訴大家，我們已成功在今年所有目標重點醫院上市，涵蓋了約 65% 的通用MG 市場潛力。現在，我們的目標是下一波醫院，並加強補充保險的覆蓋範圍，為患者群體提供額外的支持。

Next, we place a core emphasis on physicians where our scientific and data-driven strategies have proven effective. Physician awareness of the FcRn mechanism and the antibody-driven nature of gMG is growing. VYVGART’s brand awareness and adoption have increased each quarter, and, according to a third-party analysis by BenHealth, VYVGART is now the leading top-of-mind biologic therapy for gMG, alongside IVIg. Nearly 2,000 healthcare professionals in China have now prescribed VYVGART, with a growing percentage, now at 40%, being repeat prescribers. This is a significant achievement, given the early stage of the launch.

接下來，我們將核心重點放在醫生身上，我們的科學和數據驅動策略已被證明是有效的。醫生對 FcRn 機制和 gMG 抗體驅動性質的認識不斷增強。VYVGART 的品牌知名度和採用率每季都在提高，根據 BenHealth 的第三方分析，VYVGART 現在與 IVIg 一起成為 gMG 的領先首選生物療法。目前，中國有近 2,000 名醫療保健專業人員開出了 VYVGART 處方，其中重複處方者的比例不斷增加，目前已達到 40%。鑑於發布的早期階段，這是一項重大成就。

Lastly, patients. Approximately 10,000 patients have now been treated with VYVGART since launch, and while it is an exceptional number, it is still just a fraction of the 170,000 patients living with gMG in China. New patients continue to be added at a steady pace, and in the third quarter, we saw a substantial increase in the number of patients initiating treatment in the maintenance setting, whereas previously, it was predominantly acute patients.

最後，患者。自推出以來，已有約 10,000 名患者接受了 VYVGART 治療，儘管這個數字非常驚人，但仍只是中國 17 萬名 gMG 患者的一小部分。新患者持續穩定增加，在第三季度，我們看到在維持治療中開始治療的患者數量大幅增加，而之前主要是急性患者。

Additionally, we are also seeing a significant increase in the number of repeat patients. Based on our estimates, of the patients who initiated treatment with VYVGART in June, approximately one-third have already returned for a repeat cycle. Physicians are beginning to realize the value of long-term treatment with VYVGART for their patients.

此外，我們也發現重複患者的數量顯著增加。根據我們的估計，在 6 月開始接受 VYVGART 治療的患者中，大約三分之一已經返回進行重複週期。醫生開始意識到 VYVGART 長期治療對其患者的價值。

Over time, we believe patients should average five cycles of VYVGART each year, as was seen in the ADAPT clinical trials. What we also saw from the ADAPT+ trial, was the distribution of patients based on the number of weeks that passed between the last infusion of the previous cycle and the first infusion of the subsequent cycle. Around 36% of patients waited less than six weeks, 37% waited nine weeks or more, and the rest fell somewhere in between.

隨著時間的推移，我們認為患者每年平均應接受五個週期的 VYVGART，如 ADAPT 臨床試驗中所見。我們也從 ADAPT+ 試驗中看到，患者的分佈是根據上一個週期的最後一次輸注與下一個週期的第一次輸注之間經過的周數進行的。約 36% 的患者等待時間少於六週，37% 等待九週或更長時間，其餘患者則介於兩者之間。

Now, while it is still too early to make any comments on the distribution in the real-world setting in China, based on current trends and the positive feedback from physicians, we are excited by the strong momentum thus far.

現在，雖然對中國現實環境中的分佈做出任何評論還為時過早，但根據當前趨勢和醫生的積極反饋，我們對迄今為止的強勁勢頭感到興奮。

We also expect additional tailwinds for launch including an anticipated update of the national gMG guidelines towards the end of this year, or early next year, which are expected to include VYVGART as an increasingly important treatment option for gMG.

我們也預計推出將帶來更多有利因素，包括預計在今年年底或明年初更新國家 gMG 指南，其中預計將 VYVGART 作為 gMG 日益重要的治療選擇。

We also plan to launch VYVGART Hytrulo, the subcutaneous formulation of efgartigimod, in gMG by the end of the year. The shorter administration time of 30 to 90 seconds, as well as the possibility of self-administration, provides a significantly more convenient alternative to the IV formulation, and will help drive further uptake.

我們還計劃在今年年底推出 VYVGART Hytrulo，這是 efgartigimod 的皮下注射劑型，用於 gMG。30 至 90 秒的更短給藥時間以及自我給藥的可能性，為靜脈注射製劑提供了一種明顯更方便的替代方案，並將有助於推動進一步的吸收。

Demand for VYVGART is robust and growing, and we believe we are on our way to establishing a new standard of care for gMG patients to achieve better disease management.

對 VYVGART 的需求強勁且不斷增長，我們相信我們正在為 gMG 患者建立新的護理標準，以實現更好的疾病管理。

I’m also pleased to announce that earlier this week, the NMPA approved the supplemental Biologics License Application, for VYVGART Hytrulo for the treatment of adult patients with CIDP, only six months after the sBLA acceptance earlier this year. CIDP is a disease that affects 50,000 patients in China. There are no approved therapies for CIDP in China, and we will be working to launch in this indication as soon as possible.

我還很高興地宣布，本週早些時候，NMPA 批准了 VYVGART Hytrulo 用於治療成年 CIDP 患者的補充生物製劑許可申請，​​距離今年早些時候接受 sBLA 僅六個月。CIDP是一種影響中國5萬名患者的疾病。CIDP在中國尚無核准的療法，我們將努力盡快推出該適應症。

Our VYVGART team is exemplary, with best-in-class support for our physicians, patients, and other key stakeholders, and this provides us with strong footing as we look to execute on the launch of Hytrulo for gMG and CIDP.

我們的 VYVGART 團隊堪稱典範，為我們的醫生、患者和其他主要利益相關者提供一流的支持，這為我們尋求推出用於 gMG 和 CIDP 的 Hytrulo 奠定了堅實的基礎。

There are multiple additional opportunities for VYVGART, including the prefilled syringe, which we expect to submit to the NMPA next year, and new indications, all of which Rafael will cover in his remarks. These opportunities will help us realize the great promise of VYVGART, which we believe can exceed $1billion in annual sales in China, and importantly, improve patient lives.

VYVGART 還有多種其他機會，包括我們預計明年向 NMPA 提交的預充式註射器，以及 Rafael 將在演講中涵蓋的所有新適應症。這些機會將幫助我們實現 VYVGART 的偉大承諾，我們相信 VYVGART 在中國的年銷售額將超過 10 億美元，更重要的是，改善病患的生活。

Now looking at our other commercial products. ZEJULA continues to be the leading PARP inhibitor for ovarian cancer in hospital sales in China. We are seeing continued share uptake driven by increasing penetration in first-line BRCAmut patients. For Nuzyra, we continue to promote ongoing access and support for patients who rely on this important treatment.

現在來看看我們的其他商業產品。則樂繼續成為中國醫院銷售中卵巢癌PARP抑制劑的領導者。我們看到一線 BRCAmut 患者滲透率的提高推動了市場份額的持續成長。對於 Nuzyra，我們繼續促進對依賴這種重要治療的患者的持續獲取和支持。

In addition to VYVGART Hytrulo, we are also preparing for two additional launch opportunities. Augtyro in ROS1-positive non-small cell lung cancer, which comprises between 2% and 3% of the nearly 700,000 new cases of non-small cell lung cancer per year in China. And Xacduro, in Hospital-Acquired and Ventilator-Associated Pneumonia caused by Acinetobacter Baumannii infections, of which there are approximately 300,000 cases in China each year.

除了 VYVGART Hytrulo 之外，我們還準備另外兩個發布機會。Augtyro 治療 ROS1 陽性非小細胞肺癌，中國每年新增近 70 萬例非小細胞肺癌，佔 2% 至 3%。Xacduro是由鮑曼不動桿菌感染引起的醫院獲得性和呼吸器相關肺炎，中國每年約有30萬例病例。

Looking ahead, our late-stage regional pipeline is progressing nicely, and by 2026, we could see the launch of KarXT in schizophrenia, and bemarituzumab in gastric cancer following closely behind. Both of these are substantial market opportunities, each of which represents at least $1 billion in peak potential. Furthermore, we expect to submit a BLA to the NMPA for Tivdak in cervical cancer during the first half of next year, with plans to leverage our established Zejula sales force for its launch.

展望未來，我們的後期區域管道進展順利，到 2026 年，我們可以看到治療精神分裂症的 KarXT 上市，緊隨其後的是治療胃癌的 bemarituzumab。這兩個都是巨大的市場機會，每個都代表著至少 10 億美元的峰值潛力。此外，我們預計在明年上半年向 NMPA 提交 Tivdak 治療子宮頸癌的 BLA，並計劃利用我們現有的 Zejula 銷售團隊來推動其上市。

We are on track to deliver significant topline growth, and in parallel, we are also focused on driving efficient operations and financial discipline. Through our ongoing efforts on enhancing commercial efficiency, optimizing resource allocation, and increasing productivity throughout the entire organization, our net loss in the third quarter declined 40% year over year. We are on track to reach profitability by the end of 2025, and a cash position of $716 million at the end of the third quarter allows us to prepare for the next phase of growth for Zai Lab as we drive both revenues and profitability.

我們預計將實現顯著的營收成長，同時，我們也專注於推動高效營運和財務紀律。透過我們持續努力提高整個組織的商業效率、優化資源配置和提高生產力，我們第三季的淨虧損年減了 40%。我們預計在 2025 年底實現盈利，第三季度末的現金頭寸為 7.16 億美元，使我們能夠為再鼎醫藥的下一階段增長做好準備，同時推動收入和盈利能力。

In summary, our execution this quarter reinforces Zai Lab’s commitment to our strategic goals. With a strong product portfolio, expanding global pipeline, and targeted commercial efforts, we are well-positioned to drive continued growth. We look forward to building on this momentum in the coming quarters.

總之，我們本季的執行強化了再鼎醫藥對我們策略目標的承諾。憑藉強大的產品組合、不斷擴大的全球產品線以及有針對性的商業努力，我們已做好充分準備來推動持續成長。我們期待在未來幾季繼續保持這一勢頭。

And with that, I will pass the call to Rafael.

接下來，我會將電話轉給拉斐爾。

Thank you, Josh. As Samantha highlighted, this quarter we made significant progress in advancing our pipeline, especially on a global scale with ZL-1310, an investigational DLL3-targeted ADC. We are very excited by the preliminary clinical activity from the dose-escalation portion of the ongoing, Phase 1 study of ZL-1310 in patients with recurrent small cell lung cancer, which we presented at the EORTC-NCI-AACR, or ENA symposium in Barcelona, Spain.

謝謝你，喬許。正如 Samantha 所強調的那樣，本季度我們在推進產品線方面取得了重大進展，特別是在全球範圍內，ZL-1310（一種研究性 DLL3 目標 ADC）在全球範圍內取得了重大進展。我們對正在進行的 ZL-1310 在復發性小細胞肺癌患者中的 1 期研究的劑量遞增部分的初步臨床活動感到非常興奮，我們在 EORTC-NCI-AACR 或 ENA 研討會上介紹了該研究。巴塞隆納。

ZL-1310 showed a robust 74% objective response rate across all dose levels in patients with at least one post-treatment evaluation. While it is premature to assess durability, the response rate is the highest observed to date in second line and beyond in extensive-stage small cell lung cancer, and among the highest with an ADC in any disease. The results also showed a 100% objective response rate in patients with brain metastases, with all six patients achieving a partial response.

在至少一次治療後評估的患者中，ZL-1310 在所有劑量水準上均顯示 74% 的穩健客觀緩解率。雖然評估耐久性還為時過早，但迄今為止在二線及以後的廣泛期小細胞肺癌中觀察到的緩解率是最高的，並且是任何疾病中 ADC 的最高緩解率之一。結果也顯示，腦轉移患者的客觀緩解率為 100%，所有 6 名患者均達到部分緩解。

One patient with prior IMDELLTRA failure achieved a partial response with a 67% tumor reduction. Additionally, ZL-1310 demonstrated a good safety profile at all therapeutic dose levels, being well tolerated with the majority of treatment emergent adverse events, or TEAEs, being of Grade 1 or 2. Only 20% of patients had a TEAEs deemed related to ZL-1310, and there had been no adverse events leading to study drug discontinuations.

一名先前 IMDELLTRA 失敗的患者取得了部分緩解，腫瘤縮小了 67%。此外，ZL-1310 在所有治療劑量水平下均表現出良好的安全性，對大多數 1 級或 2 級治療中出現的不良事件 (TEAE) 具有良好的耐受性。只有 20% 的患者出現與 ZL-1310 相關的 TEAE，且沒有導致研究藥物中止的不良事件。

Small cell lung cancer is a highly aggressive disease affecting around 372,000 patients worldwide, including over 100,000 patients in the US and Europe. The mortality rate is high, with a five-year survival rate at just 5% to 10%, highlighting the critical need for treatments against this aggressive, fast-growing neoplasm.

小細胞肺癌是一種高度侵襲性的疾病，影響全球約 372,000 名患者，其中包括美國和歐洲的超過 10 萬名患者。死亡率很高，五年存活率僅為 5% 至 10%，凸顯了對這種侵襲性、快速生長的腫瘤進行治療的迫切需求。

With ZL-1310’s early data demonstrating its best-in-class potential, we have a great opportunity to significantly improve outcomes for patients with small cell lung cancer, and we will work to rapidly accelerate the development of this asset. To date, we have moved ZL-1310 swiftly into dose optimization for monotherapy, and into dose escalation in combination with atezolizumab and atezolizumab plus chemotherapy in the ongoing global Phase 1 study for patients with extensive stage SCLC who had received prior platinum based therapy. DLL3 is also highly expressed in other neuroendocrine tumors, and we will start a global study next year to explore ZL-1310 in these indications.

ZL-1310 的早期數據證明了其同類最佳的潛力，我們有很好的機會顯著改善小細胞肺癌患者的治療結果，我們將努力迅速加速這項資產的發展。迄今為止，我們已迅速將ZL-1310 轉移到單藥治療的劑量優化，並在正在進行的針對先前接受過鉑類治療的廣泛期SCLC 患者的全球1 期研究中與atezolizumab 和atezolizumab 加化療聯合進行劑量遞增。DLL3在其他神經內分泌腫瘤中也高表達，我們將於明年啟動一項全球研究，探索ZL-1310在這些適應症中的作用。

In immunology, we presented pre-clinical data of ZL-1503 at the European Academy of Dermatology and Venerology Congress, or EADV, this year. This is an IL-13/IL-31 bi-specific antibody internally discovered by Zai, which we aim to develop in atopic dermatitis and other inflammatory and pruritic conditions. We continue to see promising results of this bi-specific in preclinical models, and we expect to share more details at a medical conference in 2025.

在免疫學方面，我們今年在歐洲皮膚病學和性病學會大會（EADV）上展示了 ZL-1503 的臨床前數據。這是 Zai 內部發現的一種 IL-13/IL-31 雙特異性抗體，我們的目標是開髮用於治療異位性皮膚炎和其他發炎和搔癢病症。我們繼續看到這種雙特異性在臨床前模型中取得的有希望的結果，我們預計在 2025 年的醫學會議上分享更多細節。

We expect to submit an IND Application to the FDA next year. In oncology, we are planning to initiate a global Phase 1 study in solid tumors next year for ZL-6301, a next-generation ROR1 ADC program. We will leverage our strong capabilities to develop these assets as quickly as possible and we anticipate continuing to expand the internal pipeline and progress other undisclosed global products into IND enabling and IND submission stages next year.

我們預計明年向 FDA 提交 IND 申請。在腫瘤學方面，我們計劃明年啟動下一代 ROR1 ADC 計畫 ZL-6301 的全球實體腫瘤 1 期研究。我們將利用我們強大的能力盡快開發這些資產，我們預計明年將繼續擴大內部管道，並將其他未公開的全球產品推進到 IND 啟用和 IND 提交階段。

Now, moving to our key late-stage programs. Starting with neuroscience, last month we announced positive topline results from the Phase 3 bridging study evaluating the safety and efficacy of KarXT in schizophrenia in China. KarXT demonstrated a statistically significant 9.2-point reduction in PANSS total score from baseline at Week 5 compared to placebo, with a p value of 0.0014. The trial also met all secondary endpoints, demonstrating statistically significant reductions in positive and negative symptoms of schizophrenia, as measured by the PANSS positive subscale, PANSS negative subscale, and PANSS negative Marder factor score.

現在，轉向我們的關鍵後期專案。從神經科學開始，上個月我們宣布了評估 KarXT 在中國精神分裂症中的安全性和有效性的 3 期橋接研究的積極結果。與安慰劑相比，KarXT 在第 5 週的 PANSS 總分較基線顯著降低了 9.2 分，p 值為 0.0014。該試驗還達到了所有次要終點，透過 PANSS 陽性子量表、PANSS 陰性子量表和 PANSS 陰性 Marder 因子評分來衡量，精神分裂症的陽性和陰性症狀在統計學上顯著減少。

KarXT showed no unexpected safety signals. These data followed the US approval of KarXT, announced by our partner Bristol Myers Squibb in September. Notably, the United States Prescribing Information of KarXT, or COBENFY, does not list atypical antipsychotic class warnings, and precautions and does not have a boxed warning. In China, we will move swiftly to submit an NDA for KarXT, this first-in-class central nervous system muscarinic agonist in schizophrenia, in early 2025.

KarXT 沒有顯示出意外的安全性訊號。這些數據是在我們的合作夥伴百時美施貴寶 (Bristol Myers Squibb) 於 9 月宣布美國批准 KarXT 後獲得的。值得注意的是，KarXT 或 COBENFY 的美國處方資訊沒有列出非典型抗精神病藥物類別警告和注意事項，也沒有黑框警告。在中國，我們將迅速採取行動，於 2025 年初提交 KarXT 的新藥上市申請（KarXT），這是一種治療精神分裂症的一流中樞神經系統毒蕈鹼激動劑。

Moving to oncology, we are making good progress with bemarituzumab. And last month, we, along with our partner Amgen, completed patient enrolment in the FORTITUDE-102 study for bemarituzumab in combination with chemotherapy and a checkpoint inhibitor as a first-line treatment for FGFR2b-positive gastric cancer, months ahead of schedule. Now, we await results for both pivotal studies, starting with FORTITUDE-101, which we expect in the next few months.

轉向腫瘤學，我們在 bemarituzumab 方面取得了良好進展。上個月，我們與合作夥伴安進(Amgen) 一起完成了FORTITUDE-102 研究的患者入組，該研究將bemarituzumab 聯合化療和檢查點抑製劑作為FGFR2b 陽性胃癌的一線治療方法，比計劃提前了幾個月。現在，我們正在等待兩項關鍵研究的結果，從 FORTITUDE-101 開始，我們預計將在未來幾個月內完成。

Next, with our immunology franchise. As Josh mentioned, we are excited about the recent NMPA approval of VYVGART Hytrulo, the subcutaneous formulation of efgartigimod, for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy, or CIDP. This approval brings a much-needed novel treatment option to patients suffering with this progressive and debilitating neurological disease.

接下來是我們的免疫學專營權。正如 Josh 所提到的，我們對 NMPA 最近批准 VYVGART Hytrulo（efgartigimod 的皮下製劑）用於治療患有慢性發炎性脫髓鞘性多發性神經病變（CIDP）的成年患者感到興奮。這項批准為患有這種進行性和衰弱性神經系統疾病的患者帶來了急需的新型治療選擇。

The NMPA approval is based on the ADHERE study, which we enrolled patients from Greater China. Treatment response in these participants was consistent with global study outcomes. Subgroup analysis of Chinese participants demonstrated a 69% reduction in the risk of relapse with VYVGART Hytrulo compared to placebo.

NMPA 的批准是基於 ADHERE 研究，我們招募了來自大中華區的患者。這些參與者的治療反應與全球研究結果一致。對中國參與者的亞組分析表明，與安慰劑相比，VYVGART Hytrulo 的復發風險降低了 69%。

Additionally, 78% of Chinese participants treated in the open-label period of the study demonstrated evidence of clinical improvement, further confirming the role of IgG auto-antibodies in the underlying biology of CIDP. The favorable safety and tolerability profile of VYVGART Hytrulo weekly dosing in the Chinese patient cohort was consistent with that of global participants. We appreciate the NMPA for their thorough assessment and recognition of the therapy’s differentiated profile and the large unmet patient medical need in China.

此外，在研究的開放標籤期接受治療的中國參與者中有 78% 表現出臨床改善的證據，進一步證實了 IgG 自體抗體在 CIDP 基礎生物學中的作用。中國患者群組中 VYVGART Hytrulo 每週給藥的良好安全性和耐受性與全球參與者一致。我們感謝國家藥品監督管理局對該療法的差異化特徵以及中國大量未滿足的患者醫療需求的全面評估和認可。

Beyond gMG and CIDP, we continue to work with argenx to explore the potential to treat other IgG-mediated autoimmune indications, including Thyroid Eye Disease, or TED, myositis, seronegative gMG, ocular MG, and Sjogren’s disease. We plan to participate in the global registrational studies for these indications, and we are initiating enrolment in these studies in China starting this month.

除了 gMG 和 CIDP 之外，我們繼續與 argenx 合作，探索治療其他 IgG 介導的自體免疫適應症的潛力，包括甲狀腺眼疾 (TED)、肌炎、血清陰性 gMG、眼部 MG 和乾燥症。我們計劃參與這些適應症的全球註冊研究，並從本月開始在中國開始招募這些研究。

I am excited about the great progress we are making with our regional and global pipelines, both in terms of the potential of the products to change medical care, and the speed and quality with which we are executing both in discovery and development. I look forward to providing updates at our next earnings call.

我對我們在區域和全球管道方面取得的巨大進展感到興奮，無論是在產品改變醫療保健的潛力方面，還是在我們在發現和開發方面執行的速度和品質方面。我期待在下一次財報電話會議上提供最新資訊。

And now, Yajing will give an overview of our financial results. Yajing?

現在，雅靜將概述我們的財務表現。雅靜？

Thank you, Rafael. Now, I will discuss our third quarter 2024 financial results compared to the prior year period.

謝謝你，拉斐爾。現在，我將討論我們 2024 年第三季的財務表現與去年同期的比較。

Total net product revenue for the third quarter was $101.8 million, compared to $69.2 million for the same period in 2023, representing 47% y-o-y growth. This increase was primarily driven by increased sales for VYVGART and also supported by increased sales for ZEJULA and NUZYRA.

第三季產品淨收入總額為 1.018 億美元，而 2023 年同期為 6,920 萬美元，年增 47%。這一成長主要是由 VYVGART 銷量增加所推動的，同時也受到 ZEJULA 和 NUZYRA 銷量增加的支持。

Primary drivers of this year-over-year revenue growth included the following: VYVGART net product revenue grew to $27.3 million in the third quarter of 2024, compared to $4.9 million for the same period in 2023, driven by increased sales since its launch in September 2023 and NRDL listing for the treatment of gMG effective January 1, 2024.

營收年增率的主要驅動因素包括： 自 9 月推出以來銷量增加，VYVGART 產品淨收入在 2024 年第三季增至 2,730 萬美元，而 2023 年同期為 490 萬美元2023 年和NRDL 上市治療gMG 於2024年1 月1 日生效。

ZEJULA net product revenue increased 16% to $48.2 million. ZEJULA sales remained strong as it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China.

ZEJULA 產品淨收入成長 16%，達到 4,820 萬美元。則樂的銷售依然強勁，繼續成為中國大陸卵巢癌醫院銷售中領先的 PARP 抑制劑。

NUZYRA net product revenue grew 82% to $10.0 million, driven by the NRDL listings for the IV formulation for the treatment of adults with community-acquired bacterial pneumonia, or CABP, and acute bacterial skin and skin structure infections, or ABSSSI, in the first quarter of 2023 and the oral formulation for these indications in the first quarter of 2024.

NUZYRA 的淨產品收入增長了82%，達到1000 萬美元，這主要得益於用於治療成人社區獲得性細菌性肺炎(CABP) 和急性細菌性皮膚和皮膚結構感染(ABSSSI) 的靜脈製劑的NRDL上市。

Turning now to our expenses. Research and Development expenses were $66.0 million in the third quarter of 2024, compared to $58.8 million for the same period in 2023. This increase was primarily due to increased upfront and milestone fees for our license and collaboration agreements, partially offset by decreased clinical trial expenses and personnel costs as a result of ongoing resource prioritization and efficiency efforts.

現在談談我們的開支。2024 年第三季的研發費用為 6,600 萬美元，而 2023 年同期為 5,880 萬美元。這一增長主要是由於我們的許可和合作協議的預付費用和里程碑費用增加，但由於持續的資源優先排序和效率努力而導致的臨床試驗費用和人員成本的減少部分抵消了這一增長。

Selling, general and administrative expenses were $67.2 million in the third quarter of 2024, compared to $68.6 million for the same period in 2023. This decrease was primarily driven by decreased personnel costs as a result of ongoing resource prioritization and efficiency efforts, partially offset by increased general selling expenses primarily for VYVGART.

2024 年第三季的銷售、一般和管理費用為 6,720 萬美元，而 2023 年同期為 6,860 萬美元。這一下降主要是由於持續的資源優先排序和效率努力導致人員成本下降，部分被主要用於 VYVGART 的一般銷售費用增加所抵消。

Loss from operations in the third quarter of 2024 was $67.9 million, $48.2 million on a non-GAAP basis when adjusted to exclude non-cash expenses including depreciation, amortization, and share-based compensation. Both narrowed by 19% year-over-year. We expect our loss from operations to continue to narrow as a result of growing revenues and ongoing cost and efficiency initiatives.

2024 年第三季的營運虧損為6,790 萬美元，根據非公認會計原則（non-GAAP）計算，經調整以排除包括折舊、攤提和股權激勵在內的非現金費用後，營運虧損為4,820 萬美元。兩者均較去年同期收窄 19%。由於收入的成長以及持續的成本和效率舉措，我們預期營運損失將繼續縮小。

Zai Lab reported a net loss of $41.7 million in the third quarter of 2024, or a loss per ordinary share attributable to common stockholders of $0.04, which improved by 40% year-over-year compared to a net loss of $69.2 million for the same period in 2023, or a loss per ordinary share of $0.07.

再鼎醫藥公佈 2024 年第三季淨虧損 4,170 萬美元，即歸屬於普通股股東的每股普通股虧損 0.04 美元，較去年同期淨虧損 6,920 萬美元年增 40% 2023 年期間，或每股普通股虧損0.07 美元。

We are in a strong financial position, ending the quarter with a cash position of $716.1 million, compared to $730.0 million as of June 30, 2024. Based on our operating plan, and our anticipated revenue growth, we expect to be able to fund our business through profitability, which we expect to achieve by the end of 2025.

我們的財務狀況強勁，本季末現金部位為 7.161 億美元，而截至 2024 年 6 月 30 日為 7.300 億美元。根據我們的營運計劃和預期的收入成長，我們預計能夠透過獲利能力為我們的業務提供資金，預計到 2025 年底實現這一目標。

And with that, I would now like to turn the call back over to the operator to open up lines for questions. Operator?

至此，我現在想將電話轉回給接線員，以開通提問線路。操作員？

(Operator Instructions) Michael Yee, Jefferies.

（操作員說明）Michael Yee，Jefferies。

Congrats on the results and continued execution. We had two questions. The first was just thinking about, they've got growth. Maybe Josh could comment, but you had significant growth in the first quarter, almost doubled in the second quarter and more moderated in the third quarter. Can you just give some color about what would have driven a third quarter growth and how to think about fourth quarter? And does it have to do with the timing of when people are getting the second cycle or how to think about the number of people coming back? Just maybe talk to the sequential growth that we were seeing quarter over quarter and in the fourth quarter.

祝賀結果並繼續執行。我們有兩個問題。第一個只是想，他們已經成長了。也許喬許可以發表評論，但第一季成長顯著，第二季幾乎翻倍，第三季成長放緩。您能否簡單說明一下推動第三季成長的因素以及如何看待第四季？這是否與人們接受第二個週期的時間有關，或與如何考慮回來的人數有關？也許只是談談我們看到的季度環比和第四季的連續成長。

And the second question relates to obviously your great DLL-3 results, which got a lot of attention versus the existing approved [drug]. Can you just remind us what the immediate next steps are and when we would get the next data released there? Thank you.

第二個問題顯然與您出色的 DLL-3 結果有關，與現有批准的結果相比，該結果引起了很多關注[藥物].您能否提醒我們接下來的步驟是什麼以及何時會在那裡發布下一個數據？謝謝。

Okay. Hey Mike. Thank you. It's Josh, I'll take the VYVGART question and then ask Rafael to comment on the next steps with the DLL-3. I think with VYVGART, as I mentioned in the upfront remarks, we're really pleased with the first nine months of this year. I think in Q3, we saw continued trends in terms of about 1,000 new patients being initiated per month and increasingly we're seeing because of the -- where we are in the year and in the launch, we're seeing patients come back for second and third cycles. So really in line with what we would have hoped for and expected.

好的。嘿麥克。謝謝。我是 Josh，我將回答 VYVGART 問題，然後請 Rafael 對 DLL-3 的後續步驟發表評論。我認為，正如我在前面的評論中提到的，對於 VYVGART，我們對今年的前九個月感到非常滿意。我認為在第三季度，我們看到了每月約 1,000 名新患者啟動的持續趨勢，而且我們看到越來越多的人因為我們在今年和啟動過程中的情況，我們看到患者回來接受治療第二個和第三個週期。所以確實符合我們的希望和期望。

I think in terms of the sequential growth at some point, you just -- some of it just becomes a function of the base and where we are in the cycles and otherwise. And we -- I think, I just -- I say are quite pleased with Q3 performance. And I think as we think about Q4, we -- everything we see so far, we're halfway through the quarter in terms of patient metrics and otherwise, it is very encouraging. We continue to see new patients come in at about 1,000 a month and increasingly those patients are being initiated in the maintenance phase of the disease. You'll remember that, we've focused in the second half of this year on really trying to get the patients started in a maintenance setting. These are patients that we consider uncontrolled, which is about 50% of the 170,000 patients in China. And if they're initiated in a maintenance setting, you have a really good chance to get them, on the -- on average like five cycles per year over a calendar year.

我認為，就某個時刻的連續成長而言，其中一些只是成為基礎的函數以及我們在週期中的位置以及其他方面。我們——我想，我只是——我說對第三季的表現非常滿意。我認為，當我們考慮第四季度時，我們——到目前為止我們所看到的一切，就患者指標而言，我們已經過了本季度的一半，否則，這是非常令人鼓舞的。我們繼續看到每月約 1,000 名新患者進來，並且越來越多的患者開始處於疾病的維持階段。您會記得，我們​​今年下半年的重點是真正努力讓患者開始維持治療。這些是我們認為不受控制的患者，約佔中國17萬名患者的50%。如果它們是在維護環境中啟動的，那麼您就有很好的機會獲得它們，平均每年大約有五個週期。

So I think we'll see in the fourth quarter, we should see the continued benefit from new patients coming in and now building cumulative effect of patients coming back for second and third cycles that I mentioned in the comments up front that where we can now look to back to June as an example and look at the patients who initiated then and sort of track them at a high level. And I think what we see is a third have already come back in for a second cycle and we should see more of that in the fourth quarter.

因此，我認為我們將在第四季度看到，我們應該看到新患者的持續受益，現在正在建立第二和第三個週期患者回來的累積效應，我在前面的評論中提到，我們現在可以在哪裡以 6 月為例，看看當時發起的患者，並在高層追蹤他們。我認為我們看到的是三分之一已經回到第二個週期，我們應該在第四季看到更多。

So I think fourth quarter, no reason to not expect continued good patient capture and sequential growth. And I think as we -- we're really thinking now about 2025 and just a reminder, I think if you look at number of patients that will be initiated on VYVGART by the end of the year, we'd expect that to be over 12,000. And if we can get some substantial portion of those patients into the treatment, the maintenance treatment paradigm that we're focused on, I think you have a pretty good base of sales headed into 2025.

因此，我認為第四季度，沒有理由不期望持續良好的患者捕獲和連續增長。我認為，我們現在確實在考慮 2025 年，只是提醒一下，我想，如果你看看年底前將開始接受 VYVGART 治療的患者數量，我們預計這一情況將會結束12,000。如果我們能讓這些患者中的很大一部分接受治療，即我們關注的維持治療模式，我認為到 2025 年，您將擁有相當好的銷售基礎。

Just as an example, if half of those patients are continuing on treatment in a maintenance phase. You're starting with a reservoir of somewhere in the range of $200 million or so of sales, which you look to add patients on top of that's not guidance or anything. But I again, I think it continues to emphasize the good launch uptake that we see and the long term potential.

舉個例子，如果這些患者中有一半在維持階段繼續接受治療。你從銷售額在 2 億美元左右的某個地方開始，你希望在這之上添加患者，這不是指導或任何東西。但我再次認為，它繼續強調了我們所看到的良好的發布採用率和長期潛力。

I think with that, I'll turn it to Rafael to talk about the immediate next steps for DLL-3.

我想，我將把它交給 Rafael，討論 DLL-3 的後續步驟。

Thanks, Josh and thanks, Michael for the question. I think it was about next steps and next data set or update. So since the presentation, we've continued to enrol patients in other dose levels and of course to capture durability, as we talked about and confirmed responses as well as and very short follow up. So it's important for us to continue to see and let the data mature.

謝謝喬希，也謝謝麥可提出的問題。我認為這是關於下一步和下一個數據集或更新。因此，自演講以來，我們繼續以其他劑量水平招募患者，當然也是為了捕捉持久性，正如我們討論和確認的反應以及非常短的隨訪一樣。因此，對我們來說，繼續觀察並讓數據成熟非常重要。

We -- we'll continue also to have all regulatory interactions, but at the same time, we've announced, as I said in the preparatory remarks that we've chosen a couple of doses for dose optimization. So we'll start that limitation as well. And we will decide when we have a meaningful update that may consist of the totality of the dose escalation with confirmatory responses on every patient and a decent follow up across those cohorts and perhaps what we're starting to see in the randomization phase.

我們也將繼續進行所有監管互動，但同時，正如我在準備演講中所說，我們已經宣布，我們已經選擇了幾個劑量來進行劑量優化。所以我們也將開始這個限制。我們將決定何時進行有意義的更新，其中可能包括劑量遞增的總體情況以及對每位患者的確認反應，以及對這些隊列的良好隨訪，以及我們在隨機化階段開始看到的內容。

So we are enrolling very fast and collecting data. And we anticipate that we will make this update sometime in the next year. We haven't committed to a specific time, but it will be whenever we consider that we have a meaningful update. We don't want to present just scanty data set. But given the fact that we're accumulating data fairly fast and that we're making significant progress with this study. It should not be very long from the last presentation. Thank you.

因此，我們的註冊速度非常快並收集數據。我們預計我們將在明年的某個時候進行此更新。我們尚未承諾具體時間，但只要我們認為有有意義的更新，就會確定。我們不想只提供很少的數據集。但考慮到我們正在相當快地累積數據並且我們在這項研究中取得了重大進展。距離上次演示應該不會太久。謝謝。

Yigal Nochomovitz, Citigroup.

伊格爾·諾霍莫維茨，花旗集團。

There was some news yesterday obviously with regard to the schizophrenia market and the [ADBI Data]. Could you comment as to how that may impact your thinking about the CAR T launch, given that change in the competitive landscape? And then more generally just, could you comment on the commercial build out for CAR T as you proceed to launch the product? Thank you.

昨天顯然有一些關於精神分裂症市場和[ADBI 數據]。考慮到競爭格局的變化，您能否評論一下這可能會如何影響您對 CAR T 上市的看法？更一般地說，您能否評論一下在您繼續推出該產品時 CAR T 的商業建設？謝謝。

Thank you, Yigal. It's Josh, I'll cover this. First, we're quite excited about the opportunity for patients and for Zai for RXT. And you've seen the results from the bridging study, which are very much supportive of it in line with the global registration. So we're going to move fast towards the mission and get ready for launch.

謝謝你，伊格爾。我是喬希，我來報道這件事。首先，我們對 RXT 為患者和 Zai 提供的機會感到非常興奮。您已經看到了橋接研究的結果，該結果非常支持它與全球註冊一致。因此，我們將快速完成任務並為發射做好準備。

And I think for launch, I think one of the things that is different about China, I think versus the US is the concentration of opportunity. Then we do see about 500 hospitals across China that comprise more than 50% of the 4 million patient type of opportunity that is resident in China.

我認為對於發布而言，我認為中國與美國的不同之處之一是機會的集中。然後我們確實看到中國約有 500 家醫院，佔中國居民 400 萬患者類型機會的 50% 以上。

So I think we think of this launch in terms of the commercial build out at least initially as closer to the VYVGART type of targeted approach than some of the broader launches, which you may be thinking about. So somewhere in the range of a 200 person sales force that launch should be able to capture much of the opportunity. We see the opportunity here significant as and it's really though -- it's really around educating physicians, getting them to try KarXT versus the historical atypical antipsychotics.

因此，我認為我們認為這次發布的商業構建至少在最初階段比您可能正在考慮的一些更廣泛的發布更接近 VYVGART 類型的目標方法。因此，在 200 人的銷售隊伍範圍內，該發布應該能夠抓住大部分機會。我們認為這裡的機會很重要，而且確實如此——它實際上是圍繞教育醫生，讓他們嘗試 KarXT 而不是歷史上的非典型抗精神病藥物。

Of course, having less potential competition long term is a good thing for our sales forecast and otherwise, but I think regardless for the first few years, we're -- we were going to be focused on educating positions on the new mechanism and the opportunity here. So that doesn't change, but certainly long term, it provides a more open and broader field for us.

當然，長期潛在競爭較少對我們的銷售預測和其他方面來說是一件好事，但我認為無論在最初幾年，我們都將專注於對新機制和新機制的立場進行教育。 。所以這不會改變，但從長遠來看，它為我們提供了一個更開放、更廣泛的領域。

So we've been consistent, I think in saying that we do see a quite significant opportunity in schizophrenia for KarXT. You certainly don't have to make very significant penetration types of assumptions to get to -- at reasonable per day prices in line with what we see from post our NRDL branded atypical antipsychotics. You don't need to assume very high penetration rates to get to sales numbers that are in the billion dollar range. So we're focused on capturing that opportunity and getting off to a quick start as soon as we can get submitted and approved.

因此，我認為我們確實看到了 KarXT 在精神分裂症治療中存在相當大的機會，這一點我們一直是一致的。當然，您不必做出非常重要的滲透類型假設即可達到合理的每日價格，與我們從國家醫保目錄發布的非典型抗精神病藥物中看到的價格一致。您無需假設非常高的滲透率即可獲得數十億美元的銷售數字。因此，我們專注於抓住這個機會，並在提交並獲得批准後立即開始快速啟動。

And then with regard to the internal discovery efforts, obviously, you have the IL-13, IL-31, which you briefly mentioned, I'm curious, how you're thinking about that one in terms of internal discovery versus potentially partnering that one out. And then also if you have any updates on the topical IL-17, I'm curious how that one's going to evolve as far as the data?

然後關於內部發現工作，顯然，你有 IL-13、IL-31，你簡要地提到過，我很好奇，你如何看待內部發現與潛在合作方面的問題一出。另外，如果您對熱門 IL-17 有任何更新，我很好奇該數據將如何發展？

Okay, great. Thanks. I'll ask Rafael to jump in on that question.

好的，太好了。謝謝。我會請拉斐爾來回答這個問題。

Yeah, thank you. With IL-13/31 is actually a product that will be an IND next year. We're pretty excited about what we're seeing for clinically with this product. It is a by specific its name implies and we presented data in terms of its half-life, which is quite long owing to the special design of two heavy chains per binding site. And also it's quite potent in pre-clinical assets.

是的，謝謝。IL-13/31實際上是明年將進入IND的產品。我們對該產品的臨床效果感到非常興奮。正如其名稱所暗示的那樣，我們提供了其半衰期的數據，由於每個結合位點都有兩條重鏈的特殊設計，半衰期相當長。而且它在臨床前資產方面也非常有效。

And we continue to continue to do these assays over time to look at durability of the clinical effect. So far, we think that it's the right ligand and receptor that we've chosen. We provide an optimal molecule lead for ectopic dermatitis and other inflammatory conditions, like potentially asthma and some eosinophilic disorders as well like [hepatitis] et cetera as well as [aprodic] disorders where there's a long list that.

隨著時間的推移，我們將繼續進行這些測定，以觀察臨床效果的持久性。到目前為止，我們認為這是我們選擇的正確配體和受體。我們為異位性皮膚炎和其他發炎性疾病提供最佳的先導分子，例如潛在的氣喘和一些嗜酸性粒細胞疾病，以及[肝炎]等以及[aprodic]疾病，其中有很長的清單。

So you're right. I mean, this would be a really massive development program if we were to pursue all these indications, obviously, we'll do this in a thoughtful way. And probably starting with atopic dermatitis and seeing how it performs in terms of long half-life potency ability to those long term and ability to obliterate the providers in [AD] and then also affect the biology of the lesion, which is hopefully something that would lead to differentiation with regards to 60 safety and convenience.

所以你是對的。我的意思是，如果我們要追求所有這些跡象，這將是一個非常龐大的開發計劃，顯然，我們會以深思熟慮的方式來做這件事。可能從異位性皮膚炎開始，看看它在長半衰期效力方面的表現如何，以及消除[AD]中提供者的能力，然後也影響病變的生物學，這希望能夠導致60 安全性和便利性方面的差異化。

So those are my comments about these two products with regards to whether or not we will partner. Those are decisions that we haven't really evaluated yet around this product we need more data about this.

以上是我對這兩款產品關於我們是否合作的評論。這些是我們尚未圍繞該產品真正評估的決定，我們需要更多有關此的數據。

The other question was --

另一個問題是--

On the IL-17.

在IL-17上。

Oh, yeah, IL-17. Thanks for that. So, IL-17 is ongoing. It's testing two schedules and two strengths against placebo in a Phase 2 study, five arm trial and it's occurring quite well. At the moment and we are going to start we'll do an interim analysis for futility. And we think we'll have enough patient data at -- sometime early next year.

哦，是的，IL-17。謝謝你。因此，IL-17 正在進行中。它正在二期研究、五組試驗中測試兩種方案和兩種與安慰劑相比的強度，結果進展順利。目前，我們將開始對無效性進行臨時分析。我們認為我們將在明年初的某個時候獲得足夠的患者數據。

So I think the next data milestone, we'll probably just receive the recommendation from the IDMC on this utility analysis. And then after that, if the study continues and it will read out, we anticipate that we will complete a call by the end of the year and then read out subsequently.

因此，我認為下一個資料里程碑，我們可能會收到 IDMC 關於此效用分析的建議。之後，如果研究繼續進行並且將會讀出，我們預計我們將在今年年底之前完成電話會議，然後隨後讀出。

So those are our plans. Whether or not there's a second interim analysis depends on what we are seeing or what the recommendation from the DMC is, but so far our plans are to do futility next year and then to continue if the futility is not met.

這些就是我們的計劃。是否進行第二次中期分析取決於我們所看到的情況或 DMC 的建議，但到目前為止，我們的計劃是明年進行無用的分析，如果沒有達到無用的效果，則繼續進行。

Anupam Rama, JP Morgan.

阿努帕姆‧拉瑪，摩根大通。

Priyanka on for Anupam. We just have a quick question. You guys have been increasingly highlighting the internal pipeline and as you guys move to a more of a global infrastructure for clinical development, how should we think about R&D spend over the next several years?

普里揚卡 (Priyanka) 替補阿努潘 (Anupam)。我們只有一個簡單的問題。你們越來越強調內部管道，隨著你們轉向更多的全球臨床開發基礎設施，我們該如何考慮未來幾年的研發支出？

We'll ask Yajing to cover that, please.

我們會請雅靜來報道這個問題。

Hi, this is Yajing. Thanks for the question. So the on the R&D side, as we have a lot of regional pipeline in development right now. They are approaching to the approval stage. So that's quite significant investment we made already and that's continued to up very quickly. At the same time, the global pipeline is picking up. So we are going to expect to expand and accelerate our global and that position overall R&D spend is going to remain relatively stable with modest growth in the next few years.

嗨，我是雅靜。謝謝你的提問。因此，在研發方面，我們目前有許多區域管道正在開發中。他們正接近批准階段。因此，我們已經進行了相當大的投資，投資持續快速成長。與此同時，全球管道正在加速。因此，我們預計將擴大並加速我們的全球研發支出，整體研發支出將在未來幾年保持相對穩定並適度成長。

Louise Chen, Cantor.

路易絲·陳，康托爾。

Hi team. Congrats on all the progress this quarter. And thank you for taking our questions. This is [Wayon] for Louise.

大家好。恭喜本季取得的所有進展。感謝您回答我們的問題。這是路易絲的[Wayon]。

So we have a quick question. What is the current competitive landscape for DLL-3? Are there any other assets in development? And how should we think about the market opportunity and any type of ballpark potential revenue contributions you can think of? Thank you.

所以我們有一個簡單的問題。DLL-3 目前的競爭格局如何？還有其他資產正在開發中嗎？我們應該如何考慮市場機會以及您能想到的任何類型的潛在收入貢獻？謝謝。

Thanks for the question. I'll ask Rafael to comment on the competitive dynamics and development in small cell lung cancer here. And then I'll come back and talk about how we think about market opportunity. So, Rafael, if you want to give a quick summary here.

謝謝你的提問。我將請 Rafael 對小細胞肺癌的競爭動態和發展發表評論。然後我會回來談談我們如何看待市場機會。那麼，拉斐爾，如果您想在這裡快速總結一下。

Sure. Yeah, it's a very dynamic and evolving field at the moment. You mentioned in development, there are two products approved that continue development, [Larvi mexadine], which is approved for progression of justice platinum chemotherapy or after platinum therapy. And in Delta which is a [decile engager]. [Yellow-3] decile engager, both that were approved based on responses of 35% to 40% with durability 5.3 and nine months.

當然。是的，目前這是一個非常充滿活力且不斷發展的領域。您提到在開發中，有兩個產品已獲準繼續開發，[Larvi mexadine]，已獲批准用於進展正義鉑類化療或鉑類治療後。在達美航空，這是一個[十分參與者]。 [Yellow-3] 十等分接合器，兩者均根據 35% 至 40% 的回應獲得批准，耐用性為 5.3 個月，持續時間為 9 個月。

So those are the standards if you will. Contemporary standards for approval of these two drugs and they both have a post marketing commitments or full approval.

如果你願意的話，這些就是標準。這兩種藥物的當代核准標準均具有上市後承諾或完全批准。

Other drugs are in development. Well, you may know about the ADHD with [Arby's from Rob T] that was actually discontinued because of toxicity. So that's not really in play at the moment. There are other TCL engagers with ligand DLL-3 like the FDI compound as well. And perhaps one that is emerging as a robust product that is YL201 from MediLink, which was presented at [aresmo], the D7H3 ADC. And it had a response rate in small cell lung cancer and stage of 68% close to six months of operational response in about 80 patients.

其他藥物正在開發中。嗯，你可能知道 [Arby's from Rob T] 的注意力不足過動症 (ADHD)，但實際上由於毒性而停產。所以目前這還沒有真正發揮作用。還有其他帶有配體 DLL-3 的 TCL 接合劑，例如 FDI 化合物。MediLink 的 YL201 或許是正在成為一款強大的產品，它在 [aresmo] 上展示了 D7H3 ADC。在約 80 名患者中，其對小細胞肺癌和分期的緩解率接近 6 個月的手術緩解率，達到 68%。

So as you can see, the landscape is thankfully now robust with the number of products both approved and in the process of development. And it's a good thing. We don't think that these products are necessarily cost resistant particularly this engager and ADCs or different targets like D7H3 and DLL-3, that's what's mentioned in the prepared remarks. So the response was at least one response and in delta failure patient with our product with the 1310. So a dynamic landscape. But I think one that there's much need in this disease that remains stronger than me.

正如您所看到的，值得慶幸的是，現在的情況很強勁，獲得批准和正在開發的產品數量不斷增加。這是一件好事。我們認為這些產品不一定具有成本抵抗力，特別是此參與器和 ADC 或 D7H3 和 DLL-3 等不同目標，這就是準備好的評論中提到的內容。因此，對於使用我們的 1310 產品的 Delta 故障患者來說，反應至少是一種反應。所以這是一個動態的景觀。但我認為這種疾病仍然比我更強烈，有很大的需要。

I'll pass it on to you, Josh.

我會把它傳遞給你，喬許。

Thanks, Rafael. And yeah, I think given the unmet need here, we're quite excited about the market opportunity. This is a global asset for us. If we think of patients in the West, it's about 100,000 patients with small cell lung cancer. And if I -- I'll focus my remarks on the US, which is about 40,000 because I think it can give an idea on how we see and think about the market opportunity.

謝謝，拉斐爾。是的，我認為考慮到這裡未滿足的需求，我們對市場機會感到非常興奮。這對我們來說是一項全球資產。如果我們考慮西方的患者，大約有 10 萬名小細胞肺癌患者。如果我——我將把我的評論集中在美國，大約有 40,000 人，因為我認為它可以讓我們了解如何看待和思考市場機會。

I think if we look at pricing in the range and this is just looking at things like tarlatamab now and price per cycle and you can extrapolate across other significant tumors and otherwise, but if we use somewhere between $150,000 per second-line given a number of cycles and maybe $250,000 in first-line again, just very rough numbers. You can get to using 40,000 patients in the US, if 25,000 of them are in first-line, I think you get to, again using a $250,000 type of price. You get to over $5 billion in in sales potential.

我認為，如果我們看看這個範圍內的定價，這只是看看現在的tarlatamab 和每個週期的價格，你可以推斷其他重要的腫瘤和其他情況，但如果我們使用每個二線150,000 美元之間的某個地方，考慮到一些週期和可能再次一線的 250,000 美元，只是一個非常粗略的數字。你可以在美國使用 40,000 名患者，如果其中 25,000 名患者在一線，我認為你可以使用 250,000 美元的價格。您的銷售潛力將超過 50 億美元。

And then in second-line, if you're at 15,000 patients that fewer cycles -- you can get somewhere in the range of $2.5 billion or so. So we do see this as a $7.5 billion total market opportunity in the US alone. As Rafael mentioned, that's -- they're not mutually exclusive opportunities here. We do see that as relevant for how we're thinking about developing DLL-3 and the exciting potential that is -- that involved here, of course, then you can extrapolate out to Europe and China and other markets as well. But we're quite excited and of course, we'll put the investments in speed and execution around getting to the market. So we can begin to tap into that opportunity.

然後在二線，如果你有 15,000 名患者，那麼更少的周期 - 你可以獲得 25 億美元左右的資金。因此，我們確實認為僅在美國就有 75 億美元的總市場機會。正如拉斐爾所提到的，它們在這裡並不是相互排斥的機會。我們確實認為這與我們如何考慮開發 DLL-3 以及這裡所涉及的令人興奮的潛力有關，當然，您也可以推斷到歐洲、中國和其他市場。但我們非常興奮，當然，我們將圍繞進入市場的速度和執行進行投資。所以我們可以開始利用這個機會。

(Operator Instructions) I am showing no further questions at this time. I will now turn the call back over to Zai Lab’s CEO, Samantha Du, for closing remarks.

（操作員說明）我目前沒有提出任何進一步的問題。現在，我將把電話轉回給再鼎醫藥執行長 Samantha Du，讓其致閉幕詞。

Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the fourth quarter of 2024.

謝謝你，接線生。我要感謝大家今天抽空參加我們的電話會議。我們感謝您的支持，並期待在 2024 年第四季後再次向您更新最新消息。

Operator, you may now disconnect this call.

接線員，您現在可以掛斷此呼叫。

Thank you. That does conclude our conference for today. Thank you for participating. You may now disconnect.

謝謝。我們今天的會議到此結束。感謝您的參與。您現在可以斷開連線。