Legend Biotech Corp (LEGN) 2020 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Legend Biotech Reports Fourth Quarter 2020 Financial Results. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

女士們，先生們，感謝您的支持，歡迎閱讀傳奇生物科技報告 2020 年第四季度財務業績。 （操作員說明）請注意，今天的會議正在錄製中。 （操作員說明）

I would now like to hand the conference to your speaker today, Jessie Yeung. Please go ahead, ma'am.

我現在想把今天的會議交給你的演講者，Jessie Yeung。請繼續，女士。

Good morning, everyone. I hope everyone is safe and healthy. Welcome to Legend Biotech's Fourth Quarter and Full Year 2020 Earnings Conference Call. This is Jessie Yeung, Head of Corporate Finance and Investor Relations for Legend Biotech.

大家，早安。我希望每個人都安全健康。歡迎來到傳奇生物 2020 年第四季度和全年收益電話會議。我是傳奇生物公司財務和投資者關係主管 Jessie Yeung。

Joining me on today's call is Ying Huang, Chief Executive Officer and Chief Financial Officer for Legend Biotech. I few logistics before we get into the details. This review is being made available via webcast accessible through the Investor Relations section of the Legend Biotech website.

今天和我一起參加電話會議的是傳奇生物的首席執行官兼首席財務官黃英。在我們進入細節之前，我很少物流。本次審查通過網絡廣播提供，可通過 Legend Biotech 網站的投資者關係部分訪問。

Please note that today's presentation includes forward-looking statements. We encourage you to review the cautionary statement regarding such statements in today's presentation as well as the company's prospectus filed with the SEC on June 8, which identifies certain factors that may cause the company's actual results to differ materially from those projected should one more or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect. Actual results may vary materially from those described in this presentation. Legend Biotech specifically disclaims any obligation to update any forward-looking statements.

請注意，今天的演示文稿包括前瞻性陳述。我們鼓勵您查看今天的演示文稿中關於此類聲明的警告聲明以及公司於 6 月 8 日向美國證券交易委員會提交的招股說明書，其中確定了某些可能導致公司實際結果與預期產生重大差異的因素，如果一個或多個這些風險或不確定性中的一部分會成為現實，或者基礎假設是否被證明是不正確的。實際結果可能與本演示文稿中描述的結果大不相同。傳奇生物特別不承擔更新任何前瞻性陳述的義務。

Moving to today's agenda. We will be starting with opening remarks, followed by the financial results. Then we will do a quick review of the ASH 2020 data before we end today's call with a Q&A session.

轉到今天的議程。我們將從開場白開始，然後是財務結果。然後，在我們以問答環節結束今天的電話會議之前，我們將對 ASH 2020 數據進行快速回顧。

I would now like to turn the conference call to Ying.

我現在想把電話會議轉給英。

Thank you, Jessie, and good morning, everyone. Welcome to our fourth quarter and 2020 results earnings call. So before I start, I would like to thank everyone, and hope everyone is safe and healthy.

謝謝你，傑西，大家早上好。歡迎參加我們的第四季度和 2020 年業績電話會議。所以在開始之前，我要感謝大家，希望大家都平安健康。

Let me begin today's call by reminding what we do here and why we do what we do here at Legend, it is to serve the patients. Our team at Legend Biotech works tirelessly to bring innovative therapies to patients living with debilitating diseases. I am extremely proud to be a part of this team and grateful for this effort.

讓我通過提醒我們在這裡所做的事情以及為什麼我們在 Legend 做我們所做的事情來開始今天的電話會議，那就是為患者服務。我們傳奇生物科技的團隊孜孜不倦地工作，為患有衰弱疾病的患者帶來創新療法。我非常自豪能成為這個團隊的一員，並感謝我的努力。

Within the fourth quarter of 2020, we achieved critical milestones. At the recent ASH 2020 conference, our collaboration partner, J&J, and Legend, shared exciting results from combined Phase Ib and Phase II CARTITUDE-1 study of cilta-cel and investigational BCMA-targeted CAR-T therapy.

在 2020 年第四季度，我們實現了重要的里程碑。在最近的 ASH 2020 會議上，我們的合作夥伴 J&J 和 Legend 分享了 Ib 期和 II 期 CARTITUDE-1 cilta-cel 和研究性 BCMA 靶向 CAR-T 療法聯合研究的令人興奮的結果。

The data continued to show a very high overall response rate. Specifically, 97% of patients achieved a response. More importantly, 67% of patients achieved a stringent complete response at a median follow-up of 12.4 months.

數據繼續顯示出非常高的總體響應率。具體來說，97% 的患者取得了反應。更重要的是，67% 的患者在中位隨訪 12.4 個月時達到了嚴格的完全緩解。

Also, in December 2020, we initiated rolling submission of BLA or Biologics License Application to the U.S. FDA for cilta-cel. This submission is based on results from the pivotal Phase Ib Phase II CARTITUDE-1 study that evaluated the efficacy and safety of cilta-cel in the treatment of patients with relapsed and/or refractory multiple myeloma. We also announced the U.S. FDA-cleared the IND application for LB1901, which is Legend Biotech's investigational autologous CAR-T targeting CD4 for the treatment of T-cell lymphoma.

此外，在 2020 年 12 月，我們開始向美國 FDA 滾動提交 BLA 或生物製品許可申請，以獲得 cilta-cel。本次提交是基於關鍵的 Ib 期 II 期 CARTITUDE-1 研究的結果，該研究評估了 cilta-cel 在治療復發和/或難治性多發性骨髓瘤患者中的療效和安全性。我們還宣布了美國 FDA 批准的 LB1901 的 IND 申請，這是 Legend Biotech 的研究性自體 CAR-T 靶向 CD4，用於治療 T 細胞淋巴瘤。

Given that a substantial portion of patients with peripheral T-cell lymphoma and also cutaneous T-cell lymphoma experience relapse even with the current treatment options, there remains a high unmet medical need for these patients. With this IND clearance, we're planning to initiate a Phase I first-in-human study for LB1901 in United States.

鑑於大部分外周 T 細胞淋巴瘤和皮膚 T 細胞淋巴瘤患者即使使用當前的治療方案也會復發，因此這些患者仍有很高的未滿足的醫療需求。有了這個 IND 許可，我們計劃在美國啟動 LB1901 的 I 期首次人體研究。

Lastly we also achieved the designation of accelerated assessment in Europe for the treatment of relapsed and refractory myeloma for cilta-cel. The CHMP or Committee for Medicinal Products for Human Use in European Medicine Agency accepted the request from Janssen, our collaborative partner for this assessment, which means instead of the 210 evaluation days for the evaluation process by EMA, this accelerated assessment usually takes 150 evaluation days.

最後，我們還獲得了歐洲加速評估的指定用於 cilta-cel 治療復發和難治性骨髓瘤。 CHMP 或歐洲藥品管理局人用醫藥產品委員會接受了我們的合作夥伴楊森（Janssen）對該評估的請求，這意味著該加速評估通常需要 150 個評估日，而不是 EMA 評估過程的 210 個評估日.

Now let's turn over to the financial results from 2020 and also fourth quarter 2020. Our net loss under IFRS accounting standards in 2020 was about $303 million. This compared to a loss of $133 million in 2019. Loss per share for 2020 was $1.28 compared to $0.66 loss per share for 2019. And these results were driven mostly by larger teams and also a higher number of clinical trials as well as a higher number of clinical trial patients in our CARTITUDE program as well as the CARTIFAN program in China.

現在讓我們看看 2020 年和 2020 年第四季度的財務業績。根據 IFRS 會計準則，我們 2020 年的淨虧損約為 3.03 億美元。相比之下，2019 年的虧損為 1.33 億美元。2020 年的每股虧損為 1.28 美元，而 2019 年的每股虧損為 0.66 美元。這些結果主要是由更大的團隊、更多的臨床試驗以及更多的數字推動的我們的 CARTITUDE 項目以及中國的 CARTIFAN 項目中的臨床試驗患者數量。

In terms of quarter-over-quarter comparison, in the fourth quarter of 2020, our net loss was about $58 million and that compared to the $64 million loss in the fourth quarter of 2019. Loss per share for the fourth quarter of 2020 was $0.22 compared to $0.32 loss per share in the Q4 of 2019.

在環比比較方面，2020 年第四季度，我們的淨虧損約為 5800 萬美元，而 2019 年第四季度為 6400 萬美元。2020 年第四季度每股虧損為 0.22 美元相比之下，2019 年第四季度每股虧損 0.32 美元。

In the next slide, as you can see, we continued to push forward with a robust pipeline of next-generation cell therapies besides the BCMA program, for which we're conducting the CARTITUDE-1 in the U.S., the CARTITUDE-2 5 cohort Phase II trial globally and also the ongoing Phase III randomized active controlled CARTITUDE-4 Phase III trials. In China, we're conducting the pivotal Phase II trial, CARTIFAN-1.

如您所見，在下一張幻燈片中，除了 BCMA 計劃之外，我們繼續推進強大的下一代細胞療法管道，為此我們正在美國開展 CARTITUDE-1、CARTITUDE-2 5 隊列全球 II 期試驗以及正在進行的 III 期隨機主動對照 CARTITUDE-4 III 期試驗。在中國，我們正在進行關鍵的 II 期試驗 CARTIFAN-1。

Besides the BCMA program, we're continuing to conduct the Phase I first-in-human studies, IIT studies, in China. This includes a dual targeting CD19, CD22, auto CAR-T for non-Hodgkin's lymphoma. A dual targeting CD33, CLL1 auto CAR-T for acute leukemia and also a CD4 targeting T-cell lymphoma program.

除了 BCMA 計劃外，我們還將繼續在中國開展第一階段的人體研究，即 IIT 研究。這包括針對非霍奇金淋巴瘤的雙重靶向 CD19、CD22、自動 CAR-T。一種針對急性白血病的雙重靶向 CD33、CLL1 自動 CAR-T 以及針對 CD4 的 T 細胞淋巴瘤計劃。

In the field of allo or allogeneic CAR-T, we're conducting 2 active Phase I studies. The first one is a CD20 targeting allogeneic CAR-T for non-Hodgkin's lymphoma. The second one is a (inaudible) BCMA targeting T-cell program for the treatment of myeloma.

在同種異體或同種異體 CAR-T 領域，我們正在進行 2 項活躍的 I 期研究。第一個是針對非霍奇金淋巴瘤的同種異體 CAR-T 的 CD20。第二個是（聽不清）BCMA 靶向 T 細胞程序，用於治療骨髓瘤。

In the solid tumor field, we're conducting a study for Claudin 18.2 targeting auto CAR-T for gastric cancer and pancreatic cancer. In addition, we recently started a Phase I study for a mesothelin targeting auto CAR-T for ovarian cancer.

在實體瘤領域，我們正在進行一項針對胃癌和胰腺癌的自動 CAR-T 靶向 Claudin 18.2 的研究。此外，我們最近開始了一項針對卵巢癌自動 CAR-T 的間皮素的 I 期研究。

Now I'd like to take a moment to highlight some of the clinical data from the CARTITUDE-1 study that was presented recently at the ASH 2020 conference. As you can see from this slide, the data continues to show a very high overall response rate, specifically, 94 out of the 97 patients enrolled achieved a response. More importantly, 67% of those patients achieved a stringent complete response at the median follow-up of 12.4 months with the data cut. The median progression-free survival has not been reached yet.

現在我想花一點時間來強調一下最近在 ASH 2020 會議上提出的 CARTITUDE-1 研究的一些臨床數據。正如您從這張幻燈片中看到的那樣，數據繼續顯示出非常高的總體反應率，具體而言，97 名患者中有 94 名獲得了反應。更重要的是，這些患者中有 67% 在中位隨訪 12.4 個月時達到了嚴格的完全緩解，數據被削減。尚未達到中位無進展生存期。

This study also demonstrated a manageable safety profile for cilta-cel at the recommended Phase II dose, which is 0.75 million cells per kilogram body weight. Given that these patients were heavily pretreated, in fact, the median life of prior therapy was 6, we believe these results are really excellent.

該研究還展示了 cilta-cel 在推薦的 II 期劑量下的可控安全性，即每公斤體重 75 萬個細胞。鑑於這些患者接受過大量預處理，事實上，之前治療的中位壽命為 6 歲，我們相信這些結果非常好。

As we look into the rest of 2021 and also into 2022, I would like to discuss the near-term target for the company. In the first half of 2021, we're working with our collaboration partner, Janssen Pharmaceuticals, to potentially file the MA application with EMA for cilta-cel. As I just previously mentioned, recently, the EMA accepted a request from Janssen on accelerated assessment for the marketing application for cilta-cel. We're also planning to file BLA in China, pending discussion with CDE for cilta-cel in the second half of this year. In the United States, which is the most important market for cilta-cel, we're targeting FDA approval by end of 2021.

當我們展望 2021 年剩餘時間和 2022 年時，我想討論一下公司的近期目標。 2021 年上半年，我們正與合作夥伴楊森製藥（Janssen Pharmaceuticals）合作，可能向 EMA 提交 cilta-cel 的 MA 申請。正如我之前提到的，最近，EMA 接受了 Janssen 關於加速評估 cilta-cel 營銷申請的請求。我們還計劃在中國提交 BLA，等待今年下半年與 CDE 討論 cilta-cel。在 cilta-cel 最重要的市場美國，我們的目標是在 2021 年底獲得 FDA 批准。

Lastly, we're planning to initiate the Phase I first-in-human study for LB1901 for the T-cell lymphoma in the United States. Our collaboration partner, Janssen, is also working to file an NDA to the Japan Ministry of Health, Labor and Welfare for cilta-cel in the second half of this year. In 2022, we're expecting the EMA approval for cilta-cel in European Union. We're also expecting the CDE approval of cilta-cel in China.

最後，我們計劃在美國啟動針對 T 細胞淋巴瘤的 LB1901 的 I 期首次人體研究。我們的合作夥伴楊森（Janssen）也在努力在今年下半年向日本厚生勞動省提交 cilta-cel 的 NDA。 2022 年，我們期待 EMA 批准 cilta-cel 在歐盟。我們也期待 cilta-cel 在中國獲得 CDE 的批准。

In terms of the data update for cilta-cel, I'm pleased to announce that Legend Biotech in collaboration with Janssen intend to present updated data from the CARTITUDE-1 and CARTITUDE-2 Phase II studies at major medical conferences in 2021. In addition, Legend Biotech, along with Janssen, anticipates to publish the data from the LEGEND-2 Phase I first-in-human studies in 2021. As a reminder, this Phase I study enrolled a total of 74 patients in the Phase I study. And every patient has completed the required 3-year follow-up as of November of 2020.

關於 cilta-cel 的數據更新，我很高興地宣布，Legend Biotech 與楊森合作，打算在 2021 年的主要醫學會議上展示 CARTITUDE-1 和 CARTITUDE-2 II 期研究的更新數據。此外，Legend Biotech 和 Janssen 預計將在 2021 年公佈 LEGEND-2 I 期首次人體研究的數據。提醒一下，這項 I 期研究在 I 期研究中總共招募了 74 名患者。截至 2020 年 11 月，每位患者均已完成所需的 3 年隨訪。

In the next slide, as you can see, we have a comprehensive clinical development program for cilta-cel in patients with multiple myeloma. In 2020, we initiated a global Phase III study called CARTITUDE-4. We also expanded the multi-cohort Phase II study called CARTITUDE-2. The most recent cohort, cohort E is enrolling patients with newly diagnosed multiple myeloma or first-line myeloma.

如您所見，在下一張幻燈片中，我們有一個針對多發性骨髓瘤患者的 cilta-cel 綜合臨床開發計劃。 2020 年，我們啟動了一項名為 CARTITUDE-4 的全球 III 期研究。我們還擴展了名為 CARTITUDE-2 的多隊列 II 期研究。最近的隊列 E 正在招募新診斷的多發性骨髓瘤或一線骨髓瘤患者。

We intend to present data from CARTITUDE-1 and also CARTITUDE-2 studies at major conference in 2021. And then as I mentioned, we also anticipate to publish in a paper format, the Phase I LEGEND-2 long-term follow-up.

我們打算在 2021 年的主要會議上展示來自 CARTITUDE-1 和 CARTITUDE-2 研究的數據。然後正如我所提到的，我們還預計以論文形式發表 I 期 LEGEND-2 長期後續行動。

With that, Victor, can you please open the Q&A?

有了這個，維克多，你能打開問答嗎？

(Operator Instructions) Our first question will come from the line of Matthew Harrison from Morgan Stanley.

（操作員說明）我們的第一個問題將來自摩根士丹利的 Matthew Harrison。

I guess, 2 for me. Ying, I believe you said your plan is to have the BLA approved in the U.S. by the end of 2021. Can you maybe just comment where in the progress of the rolling submission you guys are on now? And can we be able to meet that time line? I assume you're assuming an accelerated assessment. So if you could comment on that, that would be great.

我想，2對我來說。 Ying，我相信你說過你的計劃是在 2021 年底之前讓 BLA 在美國獲得批准。你能不能評論一下你們現在滾動提交的進度在哪裡？我們能滿足那個時間線嗎？我假設你假設一個加速評估。因此，如果您可以對此發表評論，那就太好了。

And then second, maybe you could just -- we haven't talked about this before, but maybe you could just comment broadly on your expectations around the commercial opportunity in China. And what sort of work you're doing to prepare for that given you're planning to submit sometime later this year?

其次，也許你可以——我們之前沒有討論過這個，但也許你可以廣泛評論你對中國商業機會的期望。鑑於您計劃在今年晚些時候提交，您正在為此做哪些準備工作？

Thank you, Matthew, for the questions. So let me address your first question about the BLA in the United States. So we did say that both J&J and Legend expect the cilta-cel to be approved by FDA by end of this year. So we're expecting to ask FDA for a priority review given our breakthrough definition by the FDA. And as you know, typically after a BLA package has been completed, there's a 2-month acceptance period, following which there is a 6-month review period. So the total is 8 months after we complete the BLA package.

謝謝你，馬修，你的問題。那麼讓我來回答你關於美國 BLA 的第一個問題。所以我們確實說過強生和傳奇都希望 cilta-cel 在今年年底前獲得 FDA 的批准。因此，鑑於 FDA 的突破性定義，我們期待要求 FDA 進行優先審查。如您所知，通常在 BLA 包完成後，有 2 個月的接受期，之後有 6 個月的審查期。所以總共是我們完成 BLA 包後的 8 個月。

So broadly speaking, J&J and Legend have stated that we expect the drug to be approved by end of 2021. Therefore, if you do the math, that means we should expect the BLA package to be completed by end of April. So we're not providing any guidance or provide any clarity on exactly when this is completed. But what we can tell you today is that we're completely on track in terms of the BLA submission here. And again, we stand by the expectation that we expect cilta-cel to be approved and launched by 2021, end of this year.

從廣義上講，強生和聯想表示，我們預計該藥物將在 2021 年底獲得批准。因此，如果你算一算，這意味著我們應該預計 BLA 包將在 4 月底完成。因此，我們沒有提供任何指導，也沒有明確說明何時完成。但是我們今天可以告訴您的是，我們在 BLA 提交方面完全走上了正軌。再一次，我們堅持預期 cilta-cel 將在今年年底的 2021 年獲得批准和推出。

So that's what we'll say about the BLA submission time line. And as a reminder -- yes, go ahead?

這就是我們要說的關於BLA 提交時間線的內容。提醒一下——是的，繼續嗎？

Sorry, I was going to say before you answer the second question, can I just ask a quick follow-up on that. Will you announce when you complete the submission or only when you have acceptance from the FDA?

抱歉，在你回答第二個問題之前我要說的是，我可以快速跟進一下嗎？您會在完成提交時宣布還是僅在獲得 FDA 接受時宣布？

So J&J and Legend are actually discussing the disclosure around the BLA submission and also the BLA acceptance. Unfortunately, I am not at liberty to tell exactly today what our plan is. Suffice to say that you will hear from the partners here about this. Probably the only thing I can say is stay tuned. But you will hear something from J&J and Legend about this.

因此，強生和聯想實際上正在討論圍繞 BLA 提交以及 BLA 接受的披露。不幸的是，我今天不能準確地告訴我們我們的計劃是什麼。我只想說你會從這裡的合作夥伴那裡聽到這件事。可能我唯一能說的就是保持關注。但是您會從強生和傳奇公司那裡聽到一些關於此的信息。

So to address your second question, Matthew, in terms of commercial market, potential in China. I guess, if you look at the current landscape in China, there's no commercial CAR-T therapy yet. If you look at the CDE process, so far 2 product -- or 2 product candidates, namely (inaudible) which is a JV from (inaudible) has been submitted. And right now, it's still being reviewed by CDE. The other one is the (inaudible) product from Wuxi Juno, which is a JV between Wuxi and the Juno Pharmaceutical. And again, that is in the review process. The application has been submitted to CDE.

因此，馬修，就商業市場而言，中國的潛力是為了回答你的第二個問題。我想，如果你看看中國目前的情況，還沒有商業化的 CAR-T 療法。如果您查看 CDE 流程，到目前為止，已經提交了 2 個產品或 2 個候選產品，即（聽不清），它是來自（聽不清）的合資企業。目前，它仍在接受 CDE 的審核。另一種是無錫君諾的（聽不清）產品，它是無錫和君諾製藥的合資企業。再次，這是在審查過程中。申請已提交給 CDE。

So given that there is no commercial CAR-T therapy yet in the Chinese market. It's difficult to comment on, for example, pricing and also the coverage from commercial insurance or reimbursement from the health care plans in China. However, if you look at the sheer number of patients, who suffer from myeloma or first-line and beyond myeloma, it's actually a similar or bigger number compared to what we have in the States.

因此，鑑於中國市場上還沒有商業化的 CAR-T 療法。例如，很難評論定價以及商業保險的承保範圍或中國醫療保健計劃的報銷。但是，如果您查看患有骨髓瘤或一線及其他骨髓瘤的患者的絕對數量，與我們在美國的患者相比，它實際上是一個相似或更大的數字。

As you know, in the States, every year, about 14,000 patients unfortunately die from multiple myeloma. And that's the minimal addressable market for us pending the FDA approval. And we believe the size of the patient population in China is actually large. However, since there's no commercial product that's been already approved in the market yet, we have no benchmark to assess that.

如您所知，在美國，每年約有 14,000 名患者不幸死於多發性骨髓瘤。這是我們等待 FDA 批准的最小目標市場。而且我們認為中國的患者人數實際上很大。然而，由於還沒有商業產品已經在市場上獲得批准，我們沒有基準來評估它。

In our opinion, in the first launch phase, this drug is most likely going to be paid through self-pay mechanism, that is out-of-pocket from patients for this. Because right now, there's a ceiling for China national coverage for the drug cost. And we just don't think any CAR-T would come to the market immediately with the national health plan coverage.

我們認為，在首發階段，該藥最有可能通過自費機制支付，即患者為此自掏腰包。因為現在，中國的藥品費用覆蓋率是有上限的。而且我們只是不認為任何 CAR-T 會隨著國家健康計劃的覆蓋而立即上市。

(Operator Instructions) Our next question will come from the line of Biren Amin from Jefferies.

（操作員說明）我們的下一個問題將來自 Jefferies 的 Biren Amin。

Ying, on CARTITUDE-2, I believe you're going to have some data this year. Can you just maybe talk about which cohorts we should expect data in because I think there's about 4 or 5 cohorts in the trial that you guys are investigating. So any color you could provide there would be helpful.

Ying，關於CARTITUDE-2，我相信你今年會有一些數據。你能不能談談我們應該期待哪些隊列數據，因為我認為你們正在調查的試驗中大約有 4 或 5 個隊列。因此，您可以提供的任何顏色都會有所幫助。

Sure. Thanks, Biren, for your question. So as you know, we have already opened 5 cohorts for the CARTITUDE-2 program so far, which is a global trial. And if you look at the patient population we're enrolling because we opened the Cohort A first. So I just want to remind you that in the Cohort A, we were planning to enroll 20 to 30 patients who were treated with 1 to 3 prior lines of therapy and also refractory to Revlimid.

當然。謝謝，比倫，你的問題。如您所知，到目前為止，我們已經為 CARTITUDE-2 計劃開設了 5 個隊列，這是一項全球試驗。如果你看看我們正在招募的患者群體，因為我們首先打開了隊列 A。因此，我只想提醒您，在隊列 A 中，我們計劃招募 20 至 30 名接受過 1 至 3 線治療且對 Revlimid 無效的患者。

So this is essentially the same patient population we're testing in the randomized global Phase III trial called CARTITUDE-4. However, this is a single-arm Phase II study here. So as you can imagine, if we do plan to publish or present any data from the CARTITUDE-2 trial, most likely, it will start with Cohort A. That is the most likely patient population in which we will present data in 2021.

因此，這基本上與我們在名為 CARTITUDE-4 的隨機全球 III 期試驗中測試的患者群體相同。然而，這是一項單臂 II 期研究。因此，您可以想像，如果我們確實計劃發布或展示 CARTITUDE-2 試驗的任何數據，很可能會從 Cohort A 開始。這是我們將在 2021 年展示數據的最有可能的患者群體。

Great. And then maybe on some of your Phase I programs, you've got several programs, the CD19, CD22, CD33, CLL and CD20 allogeneic. Can you just maybe talk about when we could expect data from some of the Phase I studies? Should we expect it this year? Or is it more likely next year?

偉大的。然後也許在你的一些第一階段項目中，你有幾個項目，CD19、CD22、CD33、CLL 和 CD20 同種異體。您能否談談我們何時可以從一些 I 期研究中獲得數據？我們應該期待今年嗎？還是明年更有可能？

Absolutely. Happy to answer that question. So Biren, we do have 6 active Phase I ongoing studies in China for various indications. And depending on which program we're in also different stage. In some programs, we're screening patients, in some programs are opening sites getting through the ethical committee approvals. In some programs, we're actually already dosing patients by now.

絕對地。很高興回答這個問題。所以 Biren，我們在中國確實有 6 項正在進行的 I 期研究，用於各種適應症。並且取決於我們處於哪個程序中的不同階段。在一些項目中，我們正在篩查患者，在一些項目中，我們正在開放通過倫理委員會批准的網站。在某些項目中，我們現在實際上已經在給患者服用。

So given the pace of the enrollment, we're not providing any official guidance. However, I think the earliest possible time for us to report any data from these Phase I programs would be second half towards the end of this year, we should be able to have some data in hand. And that is we should have a reasonable number of patients in terms of data.

所以考慮到招生的速度，我們沒有提供任何官方指導。但是，我認為我們最早報告這些第一階段計劃的任何數據的時間將是今年年底的下半年，我們應該能夠掌握一些數據。也就是說，就數據而言，我們應該有合理數量的患者。

And would these data readout coincide with the IND filing here in the U.S. for these programs?

這些數據讀出是否與這些程序在美國的 IND 文件一致？

Not necessarily, Biren. For example, we're already working on an IND for the Claudin 18.2 targeting auto CAR-T for gastric cancer and pancreatic cancer. Right now, at the same time, we're also conducting a Phase I IIT study in China for this same program in gastric cancer patients, although we don't have much clinical data for that program yet, but we have made a decision to move forward. Given our belief in the scientific rationale for targeting Claudin 18.2 as a treatment for gastric and pancreatic cancer. And also, given the preclinical data we have observed in our lab, we have made a decision to move forward. So we're actually actively preparing for an IND application in the U.S. for that program later this year.

不一定，比倫。例如，我們已經在研究針對胃癌和胰腺癌的自動 CAR-T 的 Claudin 18.2 的 IND。目前，與此同時，我們也在中國針對胃癌患者進行同樣的項目 IIT 研究，雖然我們還沒有該項目的太多臨床數據，但我們已經決定前進。鑑於我們相信將 Claudin 18.2 作為治療胃癌和胰腺癌的科學依據。而且，鑑於我們在實驗室觀察到的臨床前數據，我們已經決定繼續前進。因此，我們實際上正在積極準備今年晚些時候在美國為該項目申請 IND。

And I'm actually not showing any further questions in the queue. I'd like to turn the call over to Ying for any closing remarks.

而且我實際上沒有在隊列中顯示任何進一步的問題。我想把電話轉給 Ying 做任何結束語。

Okay. Great. Again, I just want to thank everyone for dialing in. And thank you very much for your interest in Legend Biotech. And Jessie and I will be standby, if you have any further questions, feel free to contact us through any means. And again, thank you very much, and we look forward to a very productive year in 2021.

好的。偉大的。再次，我只想感謝大家撥入。非常感謝您對 Legend Biotech 的興趣。 Jessie 和我將隨時待命，如果您還有任何問題，請隨時通過任何方式與我們聯繫。再一次，非常感謝你們，我們期待 2021 年是豐收的一年。

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. 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。