BL-M07D1

English Jeff (Host):All right, thank you everyone. We will go to our next presentation given the timing. Nice to meet you all, and thank you for joining the J.P. Morgan Healthcare Conference. I'm Jeff, based in Hong Kong, the Senior Director in the China Healthcare team. We are very happy and honored to welcome our next presenting company,Sichuan Biokin Pharmaceutical Company. The company is listed in Asia and is an integrated pharmaceutical company spanning capabilities from early-stage research to development, with a focus on oncology. Today, we have the honor of having the CEO of SystImmune,Dr. Jie D'Elia, presenting the company. So Jie, over to you. Jie D'Elia (CEO, SystImmune/Biokin):Thank you, Jeff, and thank you to the J.P. Morgan Healthcare Conference for the invitation. My name is Jie D'Elia, and I am the CEO of SystImmune. SystImmune is the US subsidiary of Biokin Pharmaceutical. I will be presenting on behalf of Biokin. Let's start with Biokin's evolution. Biokin was founded about 30 years ago, in the mid-90s, initially as a generic company. Over the last 30 years, it has evolved into an innovation-driven leading biopharmaceutical company with a first-in-class and best-in-class pipeline. In 2023, Biokin was listed on the Shanghai Stock Exchange. Subsequently, later that year, Biokin entered into a strategic partnership with Bristol Myers Squibb to co-developIzalontamab, a first-in-class bispecific antibody. Since then, we have made significant progress in the development of Izalontamab as well as our wholly owned pipeline. In 2025 alone, we achieved a number of exciting clinical milestones, including the initiation of three pivotal global registration trials and three new Phase 3 trials in China. We also saw the first positive Phase 3 readout of Izalontamab in a controlled randomized trial in China, and I will share that data later in this presentation. In addition, we are very well capitalized. We have raised about 500 million US dollars through an A-share private placement. Additionally, we achieved a clinical milestone payment from our partner Bristol Myers Squibb in the amount of 250 million dollars. Another highlight of our pipeline progress is the initiation of two new INDs, including one for aradiopharmaceuticalproduct. I'm sure you have heard a lot about "China speed" and China innovation. Biokin and SystImmune are best positioned to take advantage of the best of both the China and US innovation ecosystems. We operate a fully integrated biopharma model with teams established in the United States as well as in China. In the US, we focus on innovation, leveraging novel biology concepts to develop novel therapeutics through hit generation and hit-to-lead optimization. Once the lead candidate is identified, our Biokin China team engages in rapid preclinical and process development. The team in China then files the IND and conducts first-in-human studies to generate initial safety data, as well as continued data generation across multiple tumors to establish proof of concept. This data from China enables the US team, where we have over 70 people in our clinical development organization, to quickly engage in an accelerated global development pathway and launch pivotal or registration-enabling trials. This fully integrated, seamless collaboration between the US and China teams has enabled us to advance our pipeline very quickly. Our long-term vision is to build SystImmune and Biokin into a multinational company with global capabilities and scale. We have already established capabilities in global discovery innovation and a global clinical development team. We are in the process of building manufacturing and supply chains both in and outside of China to ensure supply stability. Looking to 2026, we expect the first commercial launch of Izalontamab in China. In anticipation of that, we have established a China commercial team. In the next few years, we will look to establish a US commercial team as Izalontamab advances towards approval later in this decade. We believe we have the critical success factors to enable this long-term vision. We have a very exciting pipeline with 17 clinical-stage programs, supported by a global oncology leader, Bristol Myers Squibb. We also have access to capital markets as we continue to explore a potential IPO in Hong Kong. We are very well capitalized, thanks to approximately $1.5 billion in dilutive and non-dilutive financing raised since 2024. Additionally, as mentioned, we are exploring a Hong Kong IPO to raise about $500 million, which would bring our cash position to over $2 billion. Furthermore, we have received a committed credit facility from Chinese banks amounting to $3 billion, which we can deploy towards global clinical development. This means we have aggregate available funds of $5 billion to draw upon to advance our pipeline, grow our company, and ultimately become a leading biopharmaceutical multinational with global capabilities. Here is a brief overview of our pipeline. We have 17 clinical-stage compounds derived from three innovative platforms: our leading ADC platform with a Topo-1 payload (as well as next-generation novel payloads), our T-cell engager platform with four clinical-stage assets, and our recently initiatedradioligandtherapy platform. The first program from the latter has entered the clinic in China, and we expect to bring that program to the US in the near term. In the US, we currently have six assets in clinical development and two additional programs in IND preparation. By the end of the year, we should have at least eight clinical programs in development, and we expect to launch at least one or two global registrational trials this year. Now let's look at the recent development of Izalontamab, our lead asset. This is a first-in-class bispecific ADC targeting EGFR and HER3, developed in strategic collaboration with Bristol Myers Squibb. As of now, Izalontamab has initiated 13 registration-enabling trials in China and globally. We have dosed over 5,000 patients. This program has received Breakthrough Therapy Designation from the FDA in EGFR-mutant non-small cell lung cancer (NSCLC) and seven additional Breakthrough Designations from the Chinese NMPA in other tumor types. This allows us to seek accelerated regulatory pathways when feasible and maintain close communication with regulatory agencies in both China and the US. Last year, we reported two positive Phase 3 readouts in China. I will share the first one: Izalontamab as monotherapy versus chemotherapy in heavily pre-treated metastatic nasopharyngeal carcinoma patients. This is a China trial, and we have already submitted the BLA for approval. In this randomized controlled study, we saw a response rate of 54% with Izalontamab treatment compared to 27% in the chemotherapy arm. The median duration of response was 8.5 months for Izalontamab versus 4.8 months with chemotherapy. This result led to clinically meaningful improvement in progression-free survival (PFS). As you can see, patients treated with Izalontamab demonstrated a median PFS of 8.4 months compared to only 4.3 months for chemotherapy-treated patients. That is an improvement of over four months in median progression-free survival, with a hazard ratio of 0.44. This gives us great confidence that Izalontamab demonstrates clinically meaningful improvement over chemotherapy in a randomized controlled study, bolstering our confidence in its continued development across many additional indications. Based on this data, we submitted the first BLA in China and expect approval later this year. We also have data from Izalontamab tested as a monotherapy in metastatic EGFR-mutant non-small cell lung cancer patients. In a cohort of 50 patients who had been previously treated with TKIs (and were not chemo-naïve), these patients demonstrated a median PFS of 12.5 months. Overall survival was not reached; however, we observed a 12-month OS rate of 80%. This data demonstrated very promising efficacy in EGFR-mutant NSCLC patients and led to the launch of two Phase 3 trials. One is Izalontamab as a monotherapy in EGFR-mutant NSCLC as a second-line treatment. The other is Izalontamab in combination withOsimertinibin the frontline treatment of EGFR-mutant NSCLC patients. Both Phase 3 trials are ongoing in China. Now switching gears to our next exciting pipeline asset, potentially a best-in-class HER2 ADC, which we call "T-bren". This is a wholly owned asset. T-bren has been studied in 14 clinical trials, including six registration-enabling trials in China. The first registration-enabling trial in China is for second-line-plus HER2-positive breast cancer as a monotherapy. We expect a readout later this year, upon which we will make a data-driven decision to file for approval in China. T-bren is also in a Phase 1 dose escalation and expansion study in the United States, and we expect to continue its development both in China and the US. Looking forward, we have many catalysts through 2026. For Izalontamab in China, we expect to receive the first market approval in nasopharyngeal cancer as well as esophageal carcinoma. We also expect to submit regulatory approvals for additional indications of Izalontamab as a monotherapy in EGFR wild-type NSCLC, EGFR-mutant NSCLC, small cell lung cancer, as well as HR-positive/HER2-negative breast cancer and triple-negative breast cancer. These label expansion opportunities will further expand the commercial potential for Izalontamab in China. We also plan to read out data at ASCO and ESMO this year. In addition, we are initiating additional Phase 3 studies of Izalontamab both as a frontline treatment and as a monotherapy in late-line treatment in additional tumors. Globally, in partnership with BMS, we expect to initiate new global registration trials either as monotherapy or in combination with standard of care. In the US, we plan to present the Phase 1 expansion data in EGFR-mutant NSCLC at a major congress. Most excitingly, thanks to the partnership with BMS, we expect to explore the combination of Izalontamab and our PD-L1/VEGF bispecific antibody in multiple indications. This will further expand the opportunities for Izalontamab to bring clinical benefits to patients. Regarding T-bren, as I mentioned earlier, we expect a Phase 3 readout from China studies, which will enable us to submit the first BLA approval in China. We also expect to initiate the first global registration trial for T-bren in a solid tumor indication. The rest of our pipeline continues to advance as well. We expect to have at least three or four pipeline assets advancing into registrational trials in China. For one of those assets, we expect to initiate a global registration trial as well. We will continue to present early clinical data at major congresses to keep our investors and investigators up to date. With that, thank you very much. I really appreciate your interest in Biokin and SystImmune, and I am happy to answer any questions. Jeff:Okay, great. Thank you very much. 中文 Jeff (主持人):好的，谢谢大家。鉴于时间关系，我们将开始下一场演讲。很高兴见到各位，感谢大家参加摩根大通医疗健康大会。我是 Jeff，常驻香港，是中国医疗健康团队的高级总监。我们非常荣幸地欢迎下一家演讲公司——四川百利天恒药业（Sichuan Biokin Pharmaceutical）。这是一家在亚洲上市的综合性制药公司，具备从早期研究到开发的各项能力，并专注于肿瘤学领域。今天我们荣幸地邀请到 SystImmune 的 CEOJie D'Elia 博士来介绍公司。Jie，交给你了。 Jie D'Elia (SystImmune/百利天恒 CEO):谢谢 Jeff，也感谢摩根大通医疗健康大会的邀请。我叫 Jie D'Elia，是 SystImmune 的 CEO。SystImmune 是百利天恒的美国子公司。我将代表百利天恒进行演讲。让我们从百利天恒的发展历程开始。百利天恒成立于大约 30 年前，即 90 年代中期，最初是一家仿制药公司。在过去的 30 年里，它已发展成为一家创新驱动的领先生物制药公司，拥有同类首创（first-in-class）和同类最优（best-in-class）的产品管线。2023 年，百利天恒在上海证券交易所上市。随后在同年晚些时候，百利天恒与百时美施贵宝（Bristol Myers Squibb）达成战略合作伙伴关系，共同开发Izalontamab，这是一种同类首创的双特异性抗体。 自那时以来，我们在 Izalontamab 以及全资管线的开发方面取得了巨大进展。仅在 2025 年，我们就实现了多项激动人心的临床里程碑，包括启动了三项关键的全球注册试验和三项在中国的新三期试验。我们还看到了 Izalontamab 在中国一项对照随机三期试验中的首次阳性读出，稍后我将分享这些数据。此外，我们的资金非常充裕。我们通过 A 股私募融资筹集了约 5 亿美元。此外，我们还从合作伙伴百时美施贵宝那里获得了一笔 2.5 亿美元的临床里程碑付款。 我们管线进展的另一个亮点是启动了两项新的 IND（新药临床试验申请），其中包括一项放射性药物产品。我相信大家听过很多关于“中国速度”和中国创新的讨论。百利天恒和 SystImmune 处于最佳位置，能够利用中美两国创新生态系统的优势。我们拥有完全整合的生物制药运营模式，在美国和中国都建立了团队。在美国，我们专注于创新，利用新颖的生物学概念，通过苗头化合物生成和先导化合物优化来开发新型疗法。 一旦确定了先导候选药物，百利天恒中国团队就会进行快速的临床前开发和工艺开发。随后，中国团队将提交 IND 并开展首次人体研究，以生成初步安全性数据，并在多种肿瘤中持续生成数据以建立概念验证。来自中国的数据使我们拥有 70 多名临床开发人员的美国团队能够迅速启动加速的全球开发路径，并开展关键试验或注册支持试验。美中团队之间这种完全整合、无缝的合作使我们能够非常迅速地推进管线。我们的长期愿景是将 SystImmune 和百利天恒打造成为一家具有全球能力和规模的跨国公司。 我们已经建立了全球发现创新能力和全球临床开发团队。我们正在中国国内外建设生产和供应链，以确保供应的稳定性。展望 2026 年，我们预计将在中国首次商业上市 Izalontamab。为此，我们已经建立了中国商业团队。在接下来的几年里，随着 Izalontamab 在本十年后期迈向获批，我们将着手建立美国商业团队。我们相信我们具备实现这一长期愿景的关键成功要素。 我们拥有令人兴奋的管线，包含 17 个临床阶段项目，并得到全球肿瘤学领军企业百时美施贵宝的支持。随着我们继续探索在香港 IPO 的可能性，我们也拥有进入资本市场的渠道。得益于自 2024 年以来筹集的约 15 亿美元的稀释性和非稀释性融资，我们的资金非常充裕。此外，如前所述，我们正在探索在香港 IPO 筹集约 5 亿美元，这将使我们的现金头寸增加到 20 亿美元以上。此外，我们还获得了中国银行提供的 30 亿美元承诺授信额度，可用于全球临床开发。 这意味着我们总共有 50 亿美元的可用资金来推进管线、发展公司，并最终成为一家具有全球能力的领先跨国生物制药公司。以下是我们的管线概览。我们有 17 个临床阶段的化合物，源自三个创新平台：我们领先的 ADC 平台（配备 Topo-1 载荷以及正在开发的下一代新型载荷）、拥有四个临床阶段资产的 T 细胞接合器(TCE)平台，以及最近启动的放射性配体疗法平台。后者的第一个项目已在中国进入临床，我们预计近期将该项目引入美国。 在美国，目前我们有六个处于临床开发阶段的资产，还有两个项目正在进行 IND 准备。到今年年底，我们应该至少有八个临床项目在开发中，并且预计今年将启动至少一到两项全球注册试验。现在让我们看看我们的核心资产 Izalontamab 的最新进展。这是一款靶向 EGFR 和 HER3 的同类首创双特异性 ADC，是与百时美施贵宝战略合作开发的。截至目前，Izalontamab 已在中国和全球启动了 13 项注册支持试验。我们已经给药超过 5000 名患者。该项目已获得 FDA 授予的 EGFR 突变非小细胞肺癌（NSCLC）突破性疗法认定，以及中国国家药品监督管理局（NMPA）在其他肿瘤类型中授予的七项突破性疗法认定。 这使我们能够在可行的情况下寻求加速监管途径，并与中美两国的监管机构保持密切沟通。去年，我们报告了中国两项阳性三期试验结果。我将分享第一项：在经过多线治疗的转移性鼻咽癌患者中，Izalontamab 单药治疗对比化疗的研究。这是一项中国试验，我们已经提交了 BLA（生物制品许可申请）以寻求批准。在这项随机对照研究中，Izalontamab 治疗组的缓解率为 54%，而化疗组为 27%。Izalontamab 的中位缓解持续时间为 8.5 个月，而化疗组为 4.8 个月。这一结果带来了无进展生存期（PFS）具有临床意义的改善。 正如大家所见，接受 Izalontamab 治疗的患者中位 PFS 为 8.4 个月，而化疗患者仅为 4.3 个月。中位无进展生存期改善了超过四个月，风险比为 0.44。这让我们非常有信心，证明 Izalontamab 在随机对照研究中显示出优于化疗的具有临床意义的改善，也增强了我们继续在更多适应症中开发该药物的信心。 基于这些数据，我们提交了中国的首个 BLA，并预计今年晚些时候获得批准。我们还有 Izalontamab 单药治疗转移性 EGFR 突变非小细胞肺癌患者的数据。在一个由 50 名既往接受过 TKI 治疗（非化疗初治）的患者组成的队列中，中位 PFS 达到了 12.5 个月。总生存期尚未达到，但我们观察到 12 个月 OS 率为 80%。该数据展示了在 EGFR 突变 NSCLC 患者中非常有前景的疗效，并促成了两项三期试验的启动。 一项是 Izalontamab 单药二线治疗 EGFR 突变非小细胞肺癌。另一项是 Izalontamab 联合奥希替尼（Osimertinib）一线治疗 EGFR 突变非小细胞肺癌。这两项三期试验均在中国进行中。现在转向我们下一个激动人心的管线资产，可能是同类最优的 HER2 ADC，我们称之为“T-bren”。这是全资资产。T-bren 已在 14 项临床试验中进行了研究，包括中国的六项注册支持试验。中国首个注册支持试验是针对二线及以上 HER2 阳性乳腺癌的单药治疗。我们预计今年晚些时候会有读出，届时我们将基于数据决定是否在中国提交批准申请。 T-bren 也在美国进行一期剂量递增和扩展研究，我们预计将在中国和美国继续其开发。展望未来，到 2026 年我们将迎来许多催化剂。对于中国的 Izalontamab，我们预计将获得鼻咽癌和食管癌的首个上市批准。我们还预计将提交 Izalontamab 单药治疗其他适应症的监管申请，包括 EGFR 野生型非小细胞肺癌、EGFR 突变非小细胞肺癌、小细胞肺癌，以及 HR 阳性/HER2 阴性乳腺癌和三阴性乳腺癌。这些适应症扩展机会将进一步扩大 Izalontamab 在中国的商业潜力。 我们还计划在今年的 ASCO 和 ESMO 上公布数据。此外，我们正在启动更多 Izalontamab 的三期研究，包括作为一线治疗以及作为晚期治疗的单药疗法，覆盖更多肿瘤类型。在全球范围内，通过与 BMS 的合作，我们预计将启动新的全球注册试验，采用单药治疗或与标准疗法联合使用。在美国，我们计划在一个主要会议上展示 EGFR 突变非小细胞肺癌的一期扩展数据。 最令人兴奋的是，得益于与 BMS 的合作关系，我们预计将探索 Izalontamab 与我们的PD-L1/VEGF 双特异性抗体在多种适应症中的联合用药。这将进一步扩大 Izalontamab 为患者带来临床获益的机会。关于 T-bren，正如我之前提到的，我们预计中国研究将有三期读出，这将使我们能够在中国提交 T-bren 的首个 BLA 批准。我们还预计将启动 T-bren 在实体瘤适应症中的首个全球注册试验。 我们的其余管线也在继续推进。我们预计至少有三到四个管线资产将进入中国的注册试验。对于其中一个资产，我们预计也将启动全球注册试验。我们将继续在主要会议上展示早期临床数据，让我们的投资者和研究人员了解最新进展。谢谢大家。非常感谢各位对百利天恒和 SystImmune 的关注，我很乐意回答任何问题。 Jeff:好的，太棒了。非常感谢。