Haihe Biopharma Co., Ltd. (hereby referred to as “Haihe Biopharma” or the “Company”) today announced that the main results of the paclitaxel oral solution and Lucitanib (AL3810) were both presented in the oral section of 2024 Chinese Society of Clinical Oncology (CSCO) Annual Meeting.

海河生物制药有限公司（以下简称“海河生物制药”或“公司”）今天宣布，紫杉醇口服液和Lucitanib（AL3810）的主要结果均发表在2024年中国临床肿瘤学会（CSCO）年会的口腔部分。

Study 1: An open-label, multicenter, randomized, non-inferior Phase III trial comparing the efficacy and safety of paclitaxel oral solution (RMX3001DHP107) versus paclitaxel injection (Taxol) in second-line treatment of patients with advanced gastric cancer

研究1：一项开放标签，多中心，随机，非劣效III期临床试验，比较紫杉醇口服液（RMX3001DHP107）与紫杉醇注射液（紫杉醇）在晚期胃癌患者二线治疗中的疗效和安全性

The Paclitaxel Oral Solution (RMX3001) in gastric cancer (GC) has been approved by the National Medical Products Administration- (NMPA) in Sep 19, 2024. The NPMA approval is based on positive results from an open-label, randomized, multi-center phase III study (CTR20190050) led by leading PI Professor Jin Li's team and Professor Shukui Qin's team in China, which was conducted at 53 centers in China and confirmed the efficacy of RMX3001 once again. .

紫杉醇口服液（RMX3001）治疗胃癌（GC）已于2024年9月19日获得国家医药产品管理局（NMPA）的批准。NPMA的批准是基于一项开放标签，随机，多中心的III期研究（CTR20190050）的积极结果，该研究由PI教授Jin Li的团队和中国的Shukui Qin教授的团队领导，该研究在中国的53个中心进行，并再次证实了RMX3001的疗效。。。

Between April 22, 2019, and January 31, 2022 (data cut-off date), 536 patients with unresectable or recurrent or metastatic gastric cancer progressed after fluoropyrimidine- or fluoropyrimidine plus platinum-based first-line therapy were randomly allocated to paclitaxel oral solution (n=268) or paclitaxel injection (n=268) group with median follow-up of 13.4 months and 12.6 months respectively. .

在2019年4月22日至2022年1月31日（数据截止日期）期间，536例不可切除或复发或转移性胃癌患者在氟嘧啶或氟嘧啶加铂类一线治疗后进展，随机分配到紫杉醇口服溶液（n=268）或紫杉醇注射（n=268）组，中位随访时间分别为13.4个月和12.6个月。。。

Median progression-free survival assessed by BIRC was 3.02 months (95% confidence interval [CI]: 2.69, 3.71) in the oral group and 2.89 months (95% CI: 2.53, 3.48) in the injection group, demonstrating non-inferiority conclusion (HR 0.894, 95% CI: 0.719, 1.112, p=0.311). Median overall survival (as of February 15, 2023) was 9.13 months (95% CI: 7.72, 10.97) in the oral group and 6.54 months (95% CI: 5.75, 7.26) in the injection group, showing superiority with an absolute 2.59-month survival improvement (HR 0.770, 95.5% CI: 0.635, 0.934, p=0.006).

BIRC评估的中位无进展生存期口服组为3.02个月（95%置信区间[CI]:2.69,3.71），注射组为2.89个月（95%CI:2.53,3.48），表明非劣效性结论（HR 0.894,95%CI:0.719,1.112，p=0.311）。口服组和注射组的中位总生存期（截至2023年2月15日）分别为9.13个月（95%CI:7.72,10.97）和6.54个月（95%CI:5.75,7.26），显示出优势，绝对生存期改善了2.59个月（HR 0.770,95.5%CI:0.635,0.934，p=0.006）。

Paclitaxel oral solution was clinically manageable. The most common grade 3 or higher treatment-related adverse events were neutrophil count decreased, white blood cell count decreased and anemia. Paclitaxel oral solution displayed improved safety profile with lower incidence in alopecia, neuropathy peripheral, fatigue, musculoskeletal and connective tissue disorders, hypersensitivity reactions than paclitaxel injection. .

紫杉醇口服溶液在临床上是可控的。最常见的3级或更高级别的治疗相关不良事件是中性粒细胞计数减少，白细胞计数减少和贫血。紫杉醇口服溶液显示出改善的安全性，与紫杉醇注射液相比，脱发，周围神经病，疲劳，肌肉骨骼和结缔组织疾病，超敏反应的发生率更低。。。

Study 2: A randomized , double-blind , placebo-controlled , multicenter Phase II clinical study to evaluate the efficacy and safety of Lucitanib (AL3810) in patients with advanced recurrent or metastatic thymic carcinoma who have failed at least one line of chemotherapy (study number: AL3810-202 )

研究2：一项随机，双盲，安慰剂对照，多中心的II期临床研究，用于评估Lucitanib（AL3810）对至少一种化疗失败的晚期复发或转移性胸腺癌患者的疗效和安全性（研究编号：AL3810-202）

There are limited treatment options once chemotherapy fails for patients with advanced thymic carcinoma. Lucitanib (AL3810) is a novel orally potent tyrosine kinase inhibitor, selectively targeting FGFR1-3, VEGFR1-3 and PDGFRα/β. At this Chinese Society of Clinical Oncology (CSCO) annual meeting, we reported the results of the first randomized, double-blind, placebo-controlled clinical trial (AL3810-202, led by Wentao Fang from Shanghai Chest Hospital and Caicun Zhou from East Hospital Affiliated to Tongji University) evaluating efficacy and safety of Lucitanib in patients with advanced recurrent or metastatic thymic carcinoma who have failed at least first-line of chemotherapy. .

一旦晚期胸腺癌患者化疗失败，治疗选择有限。Lucitanib（AL3810）是一种新型口服强效酪氨酸激酶抑制剂，选择性靶向FGFR1-3，VEGFR1-3和PDGFRα/β。在本次中国临床肿瘤学会（CSCO）年会上，我们报告了第一项随机、双盲、安慰剂对照临床试验（AL3810-202，由上海市胸科医院方文涛和同济大学附属东方医院周蔡村领导）的结果，评估了Lucitanib对至少一线化疗失败的晚期复发或转移性胸腺癌患者的疗效和安全性。。。

A total of 68 patients were enrolled, with 46 in Lucitanib group and 22 in control group. Efficacy Results: Investigator-assessed median PFS was 6.6 months in Lucitanib group and 1.9 months in control group (p=0.0306, HR =0.53). The risk of disease progression or death was reduced by 47%. IRC assessed median PFS was 5.8 months in Lucitanib group and 3.7 months in control group (p=0.1050, HR=0.60).

共纳入68例患者，其中Lucitanib组46例，对照组22例。疗效结果：研究者评估的Lucitanib组中位PFS为6.6个月，对照组为1.9个月（p=0.0306，HR=0.53）。疾病进展或死亡的风险降低了47%。IRC评估的Lucitanib组中位PFS为5.8个月，对照组为3.7个月（p=0.1050，HR=0.60）。

The risk of disease progression or death was reduced by 40%. The results of each subgroup analysis (based on forest plots) were consistent, indicating that the Lucitanib group had PFS benefits. In addition, multiple innovative statistical methods (such as weighted log rank tests, Restricted Mean Survival Time, Bayesian method) were used to conduct further post-hoc sensitivity analysis on the IRC assessed median PFS based on the characteristics of small sample size studies on rare diseases, and the analysis results all supported the main conclusion. .

疾病进展或死亡的风险降低了40%。每个亚组分析的结果（基于森林图）是一致的，表明Lucitanib组具有PFS益处。此外，基于罕见病小样本研究的特点，使用多种创新统计方法（如加权对数秩检验，限制平均生存时间，贝叶斯方法）对IRC评估的中位PFS进行进一步的事后敏感性分析，分析结果均支持主要结论。。。

Safety Results: The most common TRAEs with Lucitanib were proteinuria, hypertension, hypothyroidism and thrombocytopenia. The most common grade 3 TRAEs with Lucitanib were hypertension, proteinuria and thrombocytopenia. No grade 4/5 TRAEs were observed. This study suggests that Lucitanib may have significant clinical benefit and has acceptable safety for patients with advanced recurrent or metastatic thymic carcinoma. .

安全性结果：使用Lucitanib最常见的TRAE是蛋白尿，高血压，甲状腺功能减退症和血小板减少症。Lucitanib最常见的3级TRAE是高血压，蛋白尿和血小板减少症。没有观察到4/5级TRAE。。。。

About Haihe Biopharma Co., Ltd

海河生物制药有限公司简介

Haihe Biopharma Co., Ltd is a global, values-based, R&D driven biopharmaceutical leader headquartered in China with operation centers in the US and Japan, and mainly focuses on innovative anti-tumor therapies. The company has the fully capability of drug discovery, development, manufacturing and commercialization and delivers life-saving therapies to cancer patients in China, even the world widely.

海河生物制药有限公司是一家全球性、基于价值观、研发驱动的生物制药领导者，总部位于中国，运营中心位于美国和日本，主要专注于创新的抗肿瘤疗法。该公司具有完全的药物发现、开发、制造和商业化能力，并为中国乃至全球的癌症患者提供挽救生命的疗法。

As an R&D focused company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed in-house innovator with global perspective management and R&D team. Currently Haihe Biopharma has two approved products (Gumarontinib, Haiyitan®) in China and Japan and paclitaxel oral solution (RMX3001DHP107) in China，including several drug candidates..

作为一家由中国工程院院士领导的专注于研发的公司，海河生物制药是一家致力于内部创新的公司，拥有全球视角的管理和研发团队。目前，海河生物制药在中国和日本有两种批准的产品（Gumarontinib，Haiyitan®），在中国有紫杉醇口服液（RMX3001DHP107），包括几种候选药物。。