亚盛医药2026年摩根大通医疗保健会议演讲实录 （问答）

$亚盛医药-B(06855)$ $亚盛医药(AAPG)$
【Q1：战略定位与投资者沟通】

中文（主持人）：谢谢杨博士。欢迎首次登上会议主舞台。亚盛去年纳斯达克IPO后表现强劲。从战略角度，你认为现在处于什么位置？我观察到美国投资者尚未充分了解你们的故事，你们如何吸引投资者？如何从流动性角度保持强势地位？

英文（Host）：Thank you, Dr. Yang. Thank you so much for joining us. Welcome. Let's start the Q&A. For those who are in the audience, if you have any questions, feel free to raise your hand. And for those joining us virtually, you can also submit questions on the portal. Dr. Yang, first time on the main track at the conference, so welcome. Ascentage had been such a strong performer last year out of the NASDAQ IPO. How do you think about where you stand today from a strategic standpoint? I think part of the observation that we see is that U.S. investors haven't gotten to fully know the story, right? So how do you think about getting traction with investors? How do you think about maintaining your strong position also from a liquidity standpoint as well?

中文（杨大钧）：谢谢Brian，这是个很好的问题。首先，通过纳斯达克上市，去年我们有机会参与美欧的许多会议、电话会和投资者/分析师 presentation。但更重要的是，我们下月将符合F-3资格（美国存托凭证增发规则），会尽一切努力通过ATM（ at-the-market offering）等许多其他方式吸引美欧投资者。能与投资者更多参与、沟通、互动，并为他们提供购买亚盛股票的途径，这非常重要。

英文（Yang）：Thank you, Brian. Really good question. Okay. So that's a very important question. First, I think by listing on NASDAQ, we really have the opportunity in the last year to participate in many meetings and the calls, presentations with investors and analysts in U.S. and European countries. But I think more importantly, we will be F-3 eligible next month. We will do everything we can to attract the investors in U.S. and European countries through like ATM, many other approaches. I think that's very important to be able to have more participation, communication, interaction with investors and also have the ways for them to purchase Ascentage stock.

【Q2：BTK降解剂项目详情】

中文（主持人）：好的。我们先聊个新话题。过去我们做了很多奥雷巴替尼和Lisaftoclax的工作。上周你们宣布BTK降解剂获FDA IND批准。能告诉我们这个项目的情况吗？从宏观角度讲，它如何融入你们的管线？尤其是现在你们有奥雷巴替尼和Lisaftoclax处于关键研究阶段。

英文（Host）：Great. Well, let's start off with something new. I think we've done a lot of work in the past on Olverembatinib and Lisaftoclax. Last week, you announced that there is an IND clearance for a BTK degrader by the FDA. How much can you tell us about the program? Can you talk about just a big picture, how does that fit in, especially now that you have late-stage Olverembatinib and also Lisaftoclax in the pivotal studies?

中文（杨大钧）：好问题。我认为BTK降解剂首先展示了我们的研发能力——我们设计这个项目，不到一年就进入了PTC（preclinical toxicology committee，临床前毒理委员会），从PTC到提交IND约7-8个月，30天内获得FDA的IND批准。这是公开信息：CD（中国国家药监局）已将我们的项目放在网站上，开始计时。现在CD可以在14个工作日内批准IND。这是我们第一次将真正的新型降解剂带入临床。但更重要的是，BTK降解剂在临床项目中的意义：第一，它能覆盖所有共价、非共价或突变的BTK抑制剂耐药——这非常重要；第二，它能让我们与Bcl-2抑制剂（尤其是Lisaftoclax）联合使用；第三，未来在淋巴瘤中可能展现更多潜力。打个比方，就像陆军、海军、空军协同作战，靶向血液恶性肿瘤的3大谱系：淋巴、髓系、淋巴瘤，而我们拥有所有这些口服活性靶向小分子药物。

英文（Yang）：Great question. I think the BTK degrader first demonstrated our R&D capabilities. We entered -- designed that program and then getting the PTC in less than a year. And from PTC to getting the -- filing the IND about 7, 8 months and received the IND clearance within 30 days through the FDA. And we're looking for -- this is public information that CD already put on the website, starting the clock. Nowadays, CD can be getting IND cleared by 14 days, 14 working days. I think this is the first time for us to getting the true novel degrader into the clinic. But more importantly, I think with the BTK degrader, first, in terms of clinical program, they will take care of all these inhibitors covalent, non-covalent or mutation or not. That's very important, right? Second, this will allow us to have a combination with our Bcl-2 inhibitors, especially. And also, more importantly, we will demonstrate probably more potential moving forward in the lymphoma. So always using this as the analogy of having Army, the Navy and the Air Force working together to target 3 lineages of heme malignancies, lymphoid, myeloid and lymphoma. And then we have all these 3 orally active targeted small molecule drugs.

【Q3：BTK降解剂Phase I设计】

中文（主持人）：回到BTK降解剂的Phase I设计。我们应该如何理解这个Phase I？关于剂量递增能透露多少？假设从现在起一年后，我们应该关注第一个Phase I数据切割的哪些方面？

英文（Host）：That's a Chinese saying. Maybe just go back to the Phase I setup for this BTK degrader. How should we think about this Phase I -- how much can you tell about the dose escalation of the Phase I? And I guess, let's say, down the line a year from where we stand, what should we be focusing on from the first Phase I data cut?

中文（杨大钧）：第一个问题是，Phase I是典型的剂量递增、安全性、PK（药代动力学），可能还有一些疗效。我认为我们的团队能同时与美国和中国合作（FDA和CD批准），这是一个真正的全球首份Phase I方案——一个方案同时获FDA和CD批准，所以我们可以同时入组患者，不需要重复剂量部分。第二，Phase I通常是“全人群”入组，但我们会尽量纳入那些可能单药获益的患者（如某些淋巴瘤、CLL患者）。然后我们会快速推进：要么针对某一适应症开展单药注册试验，要么很快与我们的Bcl-2抑制剂联合。

英文（Yang）：I think the first one -- I mean, Phase I is a typical dose escalation, safety, PK and potentially some efficacy. I think in this case, one benefit for especially our team being able to work both the U.S. and China with the FDA and the CD clearance. This is really truly the first Phase I global protocol, okay? It's one protocol cleared by FDA and the CD, so we can enroll the patients simultaneously. Don't need to repeat, right, the dose part. I think the second, of course, the Phase I typically is all-comers, but we will try to enroll more those potentially benefit with a single agent as well, some of the lymphomas, the CLL. But then we will really move quickly either monotherapy for a certain indication, registration trial or very quickly into the combination with our Bcl-2 inhibitor.

【Q4：美国商业化准备（Lisaftoclax）】

中文（主持人）：好的。快速转向美国商业化准备。你们有多个全球研究正在开展（奥雷巴替尼和Lisaftoclax）。商业化问题更多指向Lisaftoclax，对吧？你们在美国的商业化准备处于什么阶段？目前有什么安排？如何看待2026和2027年接近商业化里程碑的节奏？

英文（Host）：Okay. Maybe just quickly on turning into commercial preparation for the U.S. You have multiple global -- studies are ongoing across Olverembatinib and Lisaftoclax. I mean, I think the commercial question is really leaning on more towards the Lisaftoclax compound, right? So where do you stand in terms of preparation for a commercial launch here? What is currently in place? And how do you think about your 2026 and 2027 as you kind of approach that commercial milestone?

中文（杨大钧）：好问题。我认为2026和2027年将是亚盛成为全球商业化阶段公司的转折点。我们有4项注册试验正在进行，其中一些有望在2027年申报NDA。第一款产品奥雷巴替尼的商业化将有合作伙伴武田的帮助。第二款产品Lisaftoclax，很多商业化专家告诉我，需要至少提前24个月准备——所以我们正在努力寻找美国的商业化负责人（CCO），希望明年组建团队，为美国商业化做准备。当然，同时我们也开放、灵活，愿意出售或合作。

英文（Yang）：Great question. I think 2026 and 2027 will be a turning point for Ascentage to be the global commercial stage company. I think with the 4 registration trials ongoing, some of them, we're looking for the NDA filing in 2027. The first one, Olverembatinib, our commercialization will be helped by our partner, Takeda. The second one, Lisaftoclax, I was told by many experts in the commercialization says you need to be at least minimum 24 months in advance to be ready, right? So I think we are actually in the effort to looking for the Head of Commercialization, CCO in U.S. And then hopefully, we can bring up the team, be ready for commercialization in U.S. next year. But of course, at the same time, we are open, flexible and willing to sell, to partner.

【Q5：管线优先级与“最爱的孩子”】

中文（主持人）：转向更广泛的投资组合问题。你们有7个临床资产，2个中国获批产品。如何考虑优先级？我知道大家对BTK降解剂很兴奋，投资者应该关注它吗？这个问题更像“你最爱的孩子是谁”？如何考虑优先级，我们应该重点关注哪些方向？

英文（Host）：And just turning to -- any questions from the audience? And just turning to the broader portfolio. You have 7 assets in the clinic, 2 approved products in China. How do you think about prioritizing? I know that there's a lot of excitement around BTK degrader. Is that where you think investors should focus on? I guess this question is more of who is your favorite child? How do you think about prioritizing and where we should do more work on?

中文（杨大钧）：好问题。首先，我们财务状况强劲——我们的CFO和财务负责人都在这里，我们有足够的资金支持所有研发项目至2027年。当然，我们需要优先级排序，不能同时进行所有事情。但有两点需要注意：第一，注册试验（尤其是针对一线患者、主要终点 readout 相对较快的试验）是重点——所以我总是告诉团队，今年的核心是“聚焦执行”（入组、入组、入组）；第二，要为NDA申报和商业化做准备——我们不能迟到。同时，我们也想把BTK降解剂、EED/PRC2抑制剂（肿瘤+贫血）往前推，但对所有潜在合作持开放态度（不仅是后期项目，还有令人兴奋的新靶点）。正如ASH演讲和本次会议所示，有几家同行公司的Phase I数据表现不错。

英文（Yang）：Great question. I think, first, we are financially strong. Our budget -- our CFO and the Head of Finance are here. We have sufficient funding to support all the R&D programs through 2027. Of course, we do need to prioritize. We cannot do everything at the same time. But I think the 2 things will be that the -- for registration trial, okay, especially to the first line and relatively quick readout in terms of the primary endpoint, that's where we need to focus. That's why I always tell the team this year is the focus on execution, right, the enrollment, enrollment, enrollment. Second is to be ready for the NDA filing and commercialization, right? We don't want to be late, right? At the same time, we also want to bring the BTK degrader forward, the EED or PRC2 inhibitor in both anemia and oncology. But at the same time, we are open for all the potential partnership, not just the late-stage program, but also those exciting new targets. As you can see from both the ASH presentation and this conference, there are several peers who are doing quite well with their Phase I data.