MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) announced that, on May 24, 2024, our partner, Akeso Inc. (Akeso, HKEX Code: 9926.HK), received marketing authorization in China from the National Medical Products Administration (NMPA). The approval is based on the positive dataset associated with HARMONi-A, a single region, multi-center, Phase III study conducted in China sponsored by Akeso with data generated and analyzed by Akeso..

迈阿密--（商业新闻短讯）--Summit Therapeutics Inc.（纳斯达克代码：SMMT）（“Summit”，“我们”或“公司”）宣布，2024年5月24日，我们的合作伙伴Akeso Inc.（Akeso，香港交易所代码：9926。HK）获得了国家医疗产品管理局（NMPA）在中国的上市授权。该批准基于与HARMONi-A相关的积极数据集，HARMONi-A是由Akeso赞助的在中国进行的单区域、多中心三期研究，数据由Akeso生成和分析。。

HARMONi-A evaluated ivonescimab combined with platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI) against placebo plus platinum-doublet chemotherapy.

HARMONi-A评估了ivonescimab联合铂类双联化疗治疗表皮生长因子受体（EGFR）突变，局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者，这些患者在用EGFR酪氨酸激酶抑制剂（TKI）治疗后进展，对抗安慰剂加铂类双联化疗。

This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials. The Phase III HARMONi-A study provides further evidence supporting the differentiated mechanism of action of ivonescimab, a PD-1 / VEGF bispecific antibody evidencing cooperative binding characteristics..

这是一个临床环境，患者群体中的PD-1单克隆抗体先前在III期全球临床试验中未成功。III期HARMONi-A研究提供了进一步的证据支持ivonescimab的分化作用机制，ivonescimab是一种PD-1/VEGF双特异性抗体，具有协同结合特性。。

This data and trial are separate and distinct from the Phase III HARMONi-2 trial in locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS >1%), which was covered in a separate announcement. For clarity, the data in this release is with respect to the HARMONi-A trial..

该数据和试验与局部晚期或转移性非小细胞肺癌的III期HARMONi-2试验是分开的，其肿瘤具有阳性PD-L1表达（PD-L1 TPS>1%），这在单独的公告中有所涵盖。为清楚起见，本版本中的数据与HARMONi-A试验有关。。

Clinically Meaningful Efficacy

具有临床意义的疗效

Progression free survival (PFS), the primary endpoint of the study, was significantly improved in the ivonescimab plus chemotherapy arm (HR 0.46; 95% CI: 0.34 – 0.62; p<0.001), representing a 54% reduction in the risk of disease progression compared to chemotherapy. Median PFS for ivonescimab plus chemotherapy was 7.1 months (95% CI: 5.9 – 8.7), as compared to 4.8 months (95% CI: 4.2 – 5.6) for placebo plus chemotherapy.

该研究的主要终点无进展生存期（PFS）在ivonescimab加化疗组中显着改善（HR 0.46；95%CI:0.34-0.62；p<0.001），与化疗相比，疾病进展风险降低了54%。ivonescimab联合化疗的中位PFS为7.1个月（95%CI:5.9-8.7），而安慰剂联合化疗的中位PFS为4.8个月（95%CI:4.2-5.6）。

In addition, for the subgroup of patients receiving a 3rd generation TKI (e.g., osimertinib or other locally approved 3rd generation TKIs), patients experienced a reduced risk of disease progression of 52% (HR: 0.48; 95% CI: 0.35 – 0.66). The PFS benefit was demonstrated across all clinical subgroups..

此外，对于接受第三代TKI（例如osimertinib或其他当地批准的第三代TKI）的患者亚组，患者的疾病进展风险降低了52%（HR:0.48；95%CI:0.35-0.66）。PFS的益处已在所有临床亚组中得到证实。。

While not yet mature, overall survival (OS) analyses performed on request of the NMPA trended positively for ivonescimab plus chemotherapy vs. chemotherapy alone: after 10.2 months of median follow-up, the hazard ratio (HR) was 0.72 (95% CI: 0.48 – 1.09). An additional analysis performed after approximately 17.6 months of median follow-up showed a hazard ratio of 0.80 (95% CI: 0.59 – 1.08).

虽然尚未成熟，但根据NMPA的要求进行的总体生存（OS）分析显示，依伐单抗联合化疗与单纯化疗相比，总体生存（OS）呈阳性趋势：中位随访10.2个月后，风险比（HR）为0.72（95%CI:0.48-1.09）。中位随访约17.6个月后进行的另一项分析显示，风险比为0.80（95%CI:0.59-1.08）。

Both overall survival curves appear to demonstrate clear separation between the two arms of the trial and show a trend in improvement of survival towards ivonescimab plus chemotherapy..

两条总生存曲线似乎都表明试验的两个部分之间存在明显的分离，并显示出改善ivonescimab加化疗生存率的趋势。。

Overall response rate (ORR) was 50.6% (95% CI: 42.6% – 58.6%) for those receiving ivonescimab plus chemotherapy vs. 35.4% (95% CI: 28.0% - 43.3%) for those receiving chemotherapy alone. Ivonescimab plus chemotherapy usage resulted in a disease control rate (DCR) – those who either responded or were considered to have stable disease under RECIST 1.1 criteria – of 93.1% (95% CI: 88.0% - 96.5%) vs.

接受ivonescimab联合化疗的患者的总有效率（ORR）为50.6%（95%CI:42.6%–58.6%），而单独接受化疗的患者的总有效率（ORR）为35.4%（95%CI:28.0%–43.3%）。依伐昔单抗联合化疗的使用导致疾病控制率（DCR）为93.1%（95%可信区间：88.0%〜96.5%），而根据RECIST 1.1标准，疾病控制率（DCR）为93.1%（95%可信区间：88.0%〜96.5%）。

83.2% (95% CI: 76.5% - 88.6%) for those receiving placebo plus chemotherapy..

接受安慰剂加化疗的患者为83.2%（95%CI:76.5%〜88.6%）。。

HARMONi-A (n=322)

HARMONi-A（n=322）

Ivonescimab + Chemo (n=161)

Ivonescimab+Chemo（n=161）

Placebo + Chemo (n=161)

安慰剂+化疗（n=161）

Median PFS

中位PFS

7.1 months

7.1个月

(95% CI: 5.9 – 8.7)

（95%置信区间：5.9-8.7）

4.8 months

4.8个月

(95% CI: 4.2 – 5.6)

（95%置信区间：4.2-5.6）

PFS HR

PFS人力资源

0.46

0.46

(95% CI: 0.34 – 0.62)

（95%置信区间：0.34-0.62）

ORR

ORR

50.6%

50.6%

(95% CI: 42.6% – 58.6%)

（95%置信区间：42.6%-58.6%）

35.4%

35.4%

(95% CI: 28.0% – 43.3%)

（95%置信区间：28.0%-43.3%）

DCR

DCR

93.1%

93.1%

(95% CI: 88.0% – 96.5%)

（95%置信区间：88.0%-96.5%）

83.2%

83.2%

(95% CI: 76.5% – 88.6%)

（95%置信区间：76.5%-88.6%）

Median OS (at 10.2 months mFU)

中位OS（10.2个月mFU）

Not reached

未达到

(95% CI: 14.3 – NE)

（95%置信区间：14.3–NE）

14.3 months

14.3个月

(95% CI: 11.2 – NE)

（95%置信区间：11.2–NE）

OS HR (10.2 months mFU)

OS HR（10.2个月mFU）

0.72

0.72

(95% CI: 0.48 – 1.09)

（95%置信区间：0.48-1.09）

Median OS (at 17.6 months mFU)

中位OS（17.6个月mFU）

17.1 months

17.1个月

(95% CI: 14.6 – NE)

（95%置信区间：14.6–NE）

14.5 months

14.5个月

(95% CI: 12.8 – 18.1)

（95%置信区间：12.8-18.1）

OS HR (17.6 months mFU)

操作系统人力资源（17.6个月mFU）

0.80

0.80

(95% CI: 0.59 – 1.08)

（95%置信区间：0.59-1.08）

mFU = median follow-up; NE = not estimable; mFU is 7.89 months unless otherwise noted above

mFU=中位随访；NE=不可估计；除非另有说明，mFU为7.89个月

Manageable Safety Profile

可管理的安全概况

Ivonescimab demonstrated an acceptable and manageable safety profile. The most common treatment related adverse events (TRAEs), both all grades and Grade 3 or higher, were hematological, laboratory count-based events: white blood cell count decreases, anemia, neutrophil count decreases, and platelet count decreases.

Ivonescimab表现出可接受和可管理的安全性。所有级别和3级或更高级别的最常见的治疗相关不良事件（TRAEs）是血液学，实验室计数为基础的事件：白细胞计数减少，贫血，中性粒细胞计数减少，血小板计数减少。

There were nine patients (5.6%) who discontinued ivonescimab due to TRAEs compared to four patients (2.5%) who discontinued placebo due to TRAEs. Grade 3 or higher immune-related adverse events occurred in 6.2% of patients receiving ivonescimab plus chemotherapy and 2.5% of patients receiving placebo plus chemotherapy.

有9名患者（5.6%）因TRAEs停用了ivonescimab，而4名患者（2.5%）因TRAEs停用了安慰剂。接受ivonescimab加化疗的患者中有6.2%发生3级或更高的免疫相关不良事件，接受安慰剂加化疗的患者中有2.5%发生3级或更高的免疫相关不良事件。

Grade 3 or higher VEGF-related adverse events between the two arms were similar (3.1% vs. 2.5%, respectively); there were no Grade 3 bleeding or arterial thrombotic events in the ivonescimab plus chemotherapy arm. No TRAEs resulted in the death of a patient in either arm in this Phase III study..

两组之间的3级或更高VEGF相关不良事件相似（分别为3.1%和2.5%）；ivonescimab加化疗组没有3级出血或动脉血栓形成事件。在这项III期研究中，没有TRAEs导致任何一只手臂的患者死亡。。

HARMONi-A (n=322)

HARMONi-A（n=322）

Ivonescimab + Chemo (n=161)

Ivonescimab+Chemo（n=161）

Placebo + Chemo (n=161)

安慰剂+化疗（n=161）

TRAE Gr 3+

带来GR 3+

54.0%

54.0%

42.9%

42.9%

TRAE Gr 3+ Immune-related

TRAE Gr 3+免疫相关

6.2%

6.2%

2.5%

2.5%

TRAE Gr 3+ VEGF-related

TRAE Gr 3+VEGF相关

3.1%

3.1%

2.5%

2.5%

Gr 3+ TRAEs with >10% Incidence:

Gr 3+TRAE，发生率>10%：

Gr 3+ WBC Count Decrease

Gr 3+白细胞计数减少

19.9%

19.9%

16.8%

16.8%

Gr 3+ Anemia

Gr 3+贫血

13.7%

13.7%

12.4%

12.4%

Gr 3+ Neutrophil Count Decrease

Gr 3+中性粒细胞计数减少

29.8%

29.8%

19.3%

19.3%

Gr 3+ Platelet Count Decrease

Gr 3+血小板计数减少

16.1%

16.1%

11.8%

11.8%

“After yesterday’s announcement regarding the HARMONi-2 trial, these results from HARMONi-A – including its strong efficacy, across subgroups, and its differentiated, manageable safety profile – and the associated approval of ivonescimab in China further validates the benefits that ivonescimab has the potential to bring to patients around the globe,” stated Robert W.

Robert W.表示：“在昨天宣布HARMONi-2试验后，HARMONi-A的这些结果-包括其强大的疗效，跨亚组，以及其差异化，可控的安全性-以及在中国对ivonescimab的相关批准-进一步验证了ivonescimab有可能为全球患者带来的益处。”。

Duggan, Chairman and Chief Executive Officer of Summit..

Summit董事长兼首席执行官Duggan。。

“We are excited to continue to develop ivonescimab with appropriate, accelerated pace and with the intent to make a significant difference for those patients who may benefit most from new, innovative therapies in lung cancer and other solid tumors,” added Dr. Maky Zanganeh, Chief Executive Officer and President of Summit..

Summit首席执行官兼总裁Maky Zanganeh博士补充道：“我们很高兴继续以适当、加快的速度开发ivonescimab，旨在为那些可能从肺癌和其他实体瘤的新的创新疗法中受益最多的患者带来重大改变。”。。

Summit Therapeutics continues to enroll in the HARMONi clinical trial, a multi-regional Phase III study evaluating ivonescimab plus platinum-doublet chemotherapy vs. placebo plus platinum-doublet chemotherapy with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI.

Summit Therapeutics继续参加HARMONi临床试验，这是一项多区域III期研究，评估ivonescimab加铂双联化疗与安慰剂加铂双联化疗与EGFR突变，局部晚期或转移性非鳞状NSCLC的疗效，第三代EGFR TKI治疗后进展。

HARMONi will analyze patients enrolled in North America, China, and Europe. HARMONi intends to include all patients from the HARMONi-A trial who previously received a 3rd generation TKI – representing approximately 276 patients (85%) of the HARMONi-A trial. The planned total enrollment for the Phase III multi-regional HARMONi trial is approximately 420 patients, which Summit intends to complete enrolling during the second half of 2024..

HARMONi将分析北美、中国和欧洲的患者。HARMONi计划纳入HARMONi-A试验中所有先前接受过第三代TKI的患者，约占HARMONi-A试验的276名患者（85%）。第三阶段多区域HARMONi试验的计划总登记人数约为420名患者，Summit计划在2024年下半年完成登记。。

HARMONi-A data was presented by Dr. Li Zhang, Sun Yat-Sen University Cancer Center, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

HARMONi-A数据由中山大学癌症中心的Li Zhang博士在伊利诺伊州芝加哥举行的2024年美国临床肿瘤学会（ASCO）年会上发表。

In addition to the HARMONi-A oral presentation, there will be a poster featuring Phase II clinical trial data for ivonescimab in combination with chemotherapy in front-line biliary tract cancer presented on Saturday, June 1, 2024.

除了HARMONi-A口头报告外，2024年6月1日（星期六）还将发布一张海报，展示ivonescimab联合一线胆道癌化疗的II期临床试验数据。

Conference Call

电话会议

Summit Therapeutics Inc. will host a conference call to discuss recent updates related to ivonescimab, including data released at ASCO, on Monday June 3, 2024, before the market opens.

Summit Therapeutics Inc.将于2024年6月3日（周一）在市场开放前召开电话会议，讨论与ivonescimab相关的最新更新，包括ASCO发布的数据。

Summit will host a live webcast of the conference call at 8:00am ET, which will be accessible through our website www.smmttx.com, and can also be accessed via the following link: https://events.q4inc.com/attendee/130822402.

Summit将于美国东部时间上午8:00主持电话会议的在线直播，可通过我们的网站www.smmttx.com访问，也可通过以下链接访问：https://events.q4inc.com/attendee/130822402.

The dial-in information for US attendees is toll-free at (800) 715-9871. Additionally, all attendees may access through the toll number, (646) 307-1963. The Conference ID is 4259251.

美国与会者的拨入信息可拨打（800）715-9871免费电话。此外，所有与会者都可以通过收费电话号码（646）307-1963访问。会议ID为4259251。

An archived edition of the webcast will be available on our website later in the day on Monday.

周一晚些时候，我们的网站将提供网络广播的存档版本。

About the ASCO 2024 Data

关于ASCO 2024数据

Presentation Title: Ivonescimab combined with chemotherapy in patients with EGFR-mutant non-squamous NSCLC who progressed on EGFR TKI treatment (HARMONi-A): A randomized, double-blind, multi-center, phase 3 trial

介绍标题：依伐昔单抗联合化疗治疗EGFR突变型非鳞状NSCLC患者EGFR TKI治疗进展（HARMONi-A）：一项随机、双盲、多中心的3期临床试验

ASCO Abstract No.: 8508

ASCO摘要编号：8508

Session Date & Time: Friday, May 31 at 4:57pm CT

会议日期和时间：5月31日星期五下午4:57

Poster Title: The safety and efficacy of ivonescimab in combination with chemotherapy as first-line treatment for advanced biliary tract cancer

海报标题：ivonescimab联合化疗作为晚期胆道癌一线治疗的安全性和有效性

ASCO Abstract No.: 4095

ASCO摘要编号：4095

Session Date & Time: Saturday, June 1 at 1:30pm CT

会议日期和时间：美国东部时间6月1日星期六下午1:30

About Ivonescimab

Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.

Ivonescimab在Summit的许可证地区，美国，加拿大，欧洲和日本被称为SMT112，在中国和澳大利亚被称为AK112，是一种新型的，潜在的一流研究性双特异性抗体，它通过阻断PD-1结合了免疫治疗的作用，具有与阻断VEGF相关的抗血管生成作用。

Ivonescimab displays unique cooperative binding to each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF..

当存在PD-1和VEGF时，Ivonescimab以更高的亲和力显示出与其每个预期靶标的独特协同结合。。

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro.1 This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue.

这可以区分ivonescimab，因为与体内正常组织相比，肿瘤组织和肿瘤微环境（TME）中PD-1和VEGF的表达（存在）可能更高。Ivonescimab的四价结构（四个结合位点）在肿瘤微环境中具有更高的亲和力（多重结合相互作用的累积强度），在体外VEGF存在下对PD-1的结合亲和力增加了18倍以上，并且在体外PD-1存在下对VEGF的结合亲和力增加了4倍以上。这种四价结构是该分子的有意新颖设计，并将这两个靶标转化为具有协同结合特性的单一双特异性抗体，有可能将Ivonescimab导向肿瘤组织与健康组织。

The intent of this design, together with a half-life of 6 to 7 days,1 is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets..

该设计的目的是，除了与这些目标相关的副作用和安全性概况外，还有6至7天的半衰期1，以改善先前确定的疗效阈值。。

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials, HARMONi and HARMONi-3..

Ivonescimab由Akeso Inc.（香港交易所代码：9926.HK）发现，目前正在进行多个III期临床试验。在全球临床研究中，已有1600多名患者接受了ivonescimab治疗。Summit已开始在非小细胞肺癌（NSCLC）中开发ivonescimab的临床开发，并于2023年开始参加两项III期临床试验HARMONi和HARMONi-3。。

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)..

HARMONi是一项III期临床试验，旨在评估ivonescimab联合化疗与安慰剂加化疗相比，对EGFR突变，局部晚期或转移性非鳞状非小细胞肺癌患者进行治疗后，用第三代EGFR TKI（例如osimertinib）治疗进展。。

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.

HARMONi-3是一项III期临床试验，旨在评估ivonescimab联合化疗与pembrolizumab联合化疗治疗一线转移性鳞状NSCLC患者的疗效。

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024.

Ivonescimab是一种研究性疗法，未经Summit许可区域（包括美国和欧洲）的任何监管机构批准。Ivonescimab于2024年5月被批准在中国上市。

About Lung Cancer

关于肺癌

Lung cancer is believed to impact approximately 600,000 people across the United States, United Kingdom, Spain, France, Italy, Germany, and Japan.2 NSCLC is the most prevalent type of lung cancer and represents approximately 80% to 85% of all incidences.3 Among patients with non-squamous NSCLC, approximately 15% have EGFR-sensitizing mutations in the United States and Europe.4 Patients with squamous histology represent approximately 25% to 30% of NSCLC patients.5.

据信，肺癌在美国，英国，西班牙，法国，意大利，德国和日本约有60万人受到影响[2]。NSCLC是最常见的肺癌类型，约占所有发病率的80%〜85%[3]。在非鳞状NSCLC患者中，约15%在美国和欧洲有EGFR致敏突变[4]。鳞状组织学患者约占NSCLC患者的25%〜30%。

About Summit Therapeutics

关于Summit Therapeutics

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs..

Summit Therapeutics Inc.是一家生物制药肿瘤公司，专注于患者，医生，护理人员和社会友好药物疗法的发现，开发和商业化，旨在改善生活质量，延长潜在寿命，并解决严重未满足的医疗需求。。

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol 'SMMT'). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.

Summit成立于2003年，我们的股票在纳斯达克全球市场（代号“SMMT”）上市。我们的总部位于佛罗里达州的迈阿密，在加利福尼亚州的门洛帕克和英国的牛津都设有办事处。

For more information, please visit https://www.smmttx.com and follow us on X @summitplc.

有关更多信息，请访问https://www.smmttx.com并在X@summitplc上关注我们。

Summit Forward-looking Statements

峰会前瞻性声明

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected use proceeds and uses thereof, and other statements containing the words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'would,' and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.

本新闻稿中关于公司未来预期、计划和前景的任何声明，包括但不限于关于公司候选产品的临床和临床前开发、与Akeso Inc.合作的进入和行动、公司的预期支出和现金跑道、公司候选产品的治疗潜力、公司候选产品的潜在商业化、临床试验数据的启动、完成和可用性的声明、潜在的上市批准申请提交、潜在的收购、关于先前在市场股权发售计划（“ATM计划”）中披露的声明、预期使用收益和用途，以及其他包含“预期”、“相信”字样的声明“继续”、“可能”、“估计”、“预期”、“打算”、“可能”、“计划”、“潜力”、“预测”、“项目”、“应该”、“目标”、“会”，“和类似表述，构成1995年《私人证券诉讼改革法案》含义内的前瞻性陈述。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and t.

由于各种重要因素，包括公司在ATM计划下出售普通股的能力，影响资本市场的条件，一般经济，行业或政治条件，包括我们对ivonescimab开发和商业化活动相关基础数据的评估结果，与监管机构（包括食品和药物管理局）的讨论结果，未来临床试验启动固有的不确定性，可用性和t，实际结果可能与此类前瞻性声明所示的结果存在重大差异。

Appendix: Glossary of Critical Terms Contained Herein

附录：此处包含的关键术语表

Affinity – Affinity is the strength of binding of a molecule, such as a protein or antibody, to another molecule, such as a ligand.

亲和力-亲和力是分子（如蛋白质或抗体）与另一分子（如配体）结合的强度。

Avidity – Avidity is the accumulated strength of multiple binding interactions.

亲合力–亲合力是多种结合相互作用的累积强度。

Angiogenesis – Angiogenesis is the development, formation, and maintenance of blood vessel structures. Without sufficient blood flow, tissue may experience hypoxia (insufficient oxygen) or lack of nutrition, which may cause cell death.6

血管生成-血管生成是血管结构的发育，形成和维持。如果没有足够的血流，组织可能会出现缺氧（氧气不足）或缺乏营养，这可能导致细胞死亡

Cooperative binding – Cooperative binding occurs when the number of binding sites on the molecule that can be occupied by a specific ligand (e.g., protein) is impacted by the ligand’s concentration. For example, this can be due to an affinity for the ligand that depends on the amount of ligand bound or the binding strength of the molecule to one ligand based on the concentration of another ligand, increasing the chance of another ligand binding to the compound.7.

协同结合-当分子上可被特定配体（例如蛋白质）占据的结合位点数量受到配体浓度的影响时，就会发生协同结合。例如，这可能是由于对配体的亲和力取决于配体结合的量或基于另一配体浓度的分子与一种配体的结合强度，从而增加了另一种配体与化合物结合的机会。

Immunotherapy – Immunotherapy is a type of treatment, including cancer treatments, that help a person’s immune system fight cancer. Examples include anti-PD-1 therapies.8

免疫疗法-免疫疗法是一种治疗方法，包括癌症治疗，可以帮助人的免疫系统对抗癌症。例子包括抗PD-1疗法

Intracranial - Within the cranium or skull.

颅内-在颅骨或颅骨内。

PD-1 – Programmed cell Death protein 1 is a protein on the surface of T cells and other cells. PD-1 plays a key role in reducing the regulation of ineffective or harmful immune responses and maintaining immune tolerance. However, with respect to cancer tumor cells, PD-1 can act as a stopping mechanism (a brake or checkpoint) by binding to PD-L1 ligands that exist on tumor cells and preventing the T cells from targeting cancerous tumor cells.9.

PD-1程序性细胞死亡蛋白1是T细胞和其他细胞表面的一种蛋白质。PD-1在减少无效或有害免疫反应的调节和维持免疫耐受方面起着关键作用。然而，对于癌肿瘤细胞，PD-1可以通过与肿瘤细胞上存在的PD-L1配体结合并阻止T细胞靶向癌性肿瘤细胞而充当停止机制（刹车或检查点）。

PD-L1 – Programmed cell Death Ligand 1 is expressed by cancerous tumor cells as an adaptive immune mechanism to escape anti-tumor responses, thus believed to suppress the immune system’s response to the presence of cancer cells.10

PD-L1程序性细胞死亡配体1由癌细胞表达，作为逃避抗肿瘤反应的适应性免疫机制，因此被认为可以抑制免疫系统对癌细胞存在的反应

PD-L1 TPS – PD-L1 Tumor Proportion Score represents the percentage of tumor cells that express PD-L1 proteins.

PD-L1 TPS–PD-L1肿瘤比例评分代表表达PD-L1蛋白的肿瘤细胞的百分比。

PFS – Progression-Free Survival.

PFS–无进展生存期。

RANO – Response Assessment in Neuro-Oncology, the standard for assessing the response of a brain or spinal cord tumor to therapy.

RANO–神经肿瘤学中的反应评估，是评估脑或脊髓肿瘤对治疗反应的标准。

SQ-NSCLC – Non-small cell lung cancer tumors of squamous histology.

SQ-NSCLC–鳞状组织学的非小细胞肺癌肿瘤。

T Cells – T cells are a type of white blood cell that is a component of the immune system that, in general, fights against infection and harmful cells like tumor cells.11

T细胞–T细胞是一种白细胞，是免疫系统的组成部分，通常可以抵抗感染和有害细胞，如肿瘤细胞

Tetravalent – A tetravalent molecule has four binding sites or regions.

四价-四价分子有四个结合位点或区域。

Tumor Microenvironment – The tumor microenvironment is the ecosystem that surrounds a tumor inside the body. It includes immune cells, the extracellular matrix, blood vessels and other cells, like fibroblasts. A tumor and its microenvironment constantly interact and influence each other, either positively or negatively.12.

肿瘤微环境-肿瘤微环境是围绕体内肿瘤的生态系统。它包括免疫细胞、细胞外基质、血管和其他细胞，如成纤维细胞。肿瘤及其微环境不断相互作用并相互影响，无论是正面还是负面。

VEGF – Vascular Endothelial Growth Factor is a signaling protein that promotes angiogenesis.13

VEGF-血管内皮生长因子是一种促进血管生成的信号蛋白

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1 Zhong, et al, SITC 2023

1钟等人，SITC 2023

2 American Cancer Society: www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed April 2024; World Health Organization: International Agency for Research on Cancer, Globocan data by country (UK, Spain, France, Italy, Germany); Japan National Cancer Registry.

2美国癌症协会：www.Cancer.org/Cancer/types/lung-Cancer/about/key-statistics.html。2024年4月访问；世界卫生组织：国际癌症研究机构，按国家分列的Globocan数据（英国，西班牙，法国，意大利，德国）；日本国家癌症登记处。

3 Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiology, Biomarkers & Prevention. (2019).

3 Schabath MB，Cote ML.癌症进展和优先事项：肺癌。癌症流行病学，生物标志物与预防。（2019年）。

4 About EGFR-Positive Lung Cancer | Navigating EGFR (lungevity.org).

4关于EGFR阳性肺癌|导航EGFR（lungevity.org）。

5 Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiology, Biomarkers & Prevention. (2019).

5 Schabath MB，Cote ML。癌症进展和优先事项：肺癌。癌症流行病学，生物标志物与预防。（2019年）。

6 Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105

6涉谷M.血管内皮生长因子（VEGF）及其受体（VEGFR）在血管生成中的信号传导：抗血管生成和促血管生成疗法的关键靶标。基因癌症。2011年12月；2（12）：1097-105

7 Stefan MI, Le Novère N. Cooperative binding. PLoS Comput Biol. 2013;9(6)

7 Stefan MI，Le Novère N.合作绑定。PLoS计算机生物学。2013年；9（6）

8 US National Cancer Institute, a part of the National Institute of Health (NIH). https://www.cancer.gov/about-cancer/treatment/types/immunotherapy. Accessed April 2024.

8美国国家癌症研究所，国家卫生研究所（NIH）的一部分。https://www.cancer.gov/about-cancer/treatment/types/immunotherapy.2024年4月访问。

9 Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

9 Han Y等人。PD-1/PD-L1途径：癌症的最新研究。Am J Cancer Res.2020年3月1日；10（3）：727-742。

10 Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

10 Han Y等人。PD-1/PD-L1途径：癌症的最新研究。Am J Cancer Res.2020年3月1日；10（3）：727-742。

11 Cleveland Clinic. https://my.clevelandclinic.org/health/body/24630-t-cells. Accessed April 2024.

11克利夫兰诊所。https://my.clevelandclinic.org/health/body/24630-t-cells.2024年4月访问。

12 MD Anderson Cancer Center. https://www.mdanderson.org/cancerwise/what-is-the-tumor-microenvironment-3-things-to-know.h00-159460056.html. Accessed April 2024.

12 MD安德森癌症中心。https://www.mdanderson.org/cancerwise/what-is-the-tumor-microenvironment-3-things-to-know.h00-159460056.html.2024年4月访问。

13 Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.

13涉谷M.血管内皮生长因子（VEGF）及其受体（VEGFR）在血管生成中的信号传导：抗血管生成和促血管生成疗法的关键靶标。基因癌症。2011年12月；2（12）：1097-105。