SHANGHAI

上海

,

，

May 30, 2025

2025年5月30日

/PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that Albipagrastim alfa for Injection (trade name: MAILISHENG, R&D code: 8MW0511) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing approval by National Medical Products Administration (NMPA).

/PRNewswire/ -- 全产业链创新驱动型生物医药企业迈威生物（688062.SH）宣布，其全资子公司泰康生物开发的注射用阿尔法白介素刺激蛋白（商品名：MAILISHENG，研发代号：8MW0511）已正式获得中国国家药品监督管理局（NMPA）的上市批准。

MAILISHENG is Mabwell's first commercialized innovative drug, and is the first launched novel granulocyte colony-stimulating factor (G-CSF) developed with albumin long-acting fusion technology in .

MAILISHENG是迈威生物首个商业化创新药，也是首个采用白蛋白长效融合技术研发的新型粒细胞集落刺激因子（G-CSF）。

China

中国

.

。

Albipagrastim alfa for Injection is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

注射用Albipagrastim alfa用于降低接受与临床显著的发热性中性粒细胞减少症相关的骨髓抑制性抗癌药物治疗的非髓系恶性肿瘤成年患者感染（表现为发热性中性粒细胞减少症）的发生率。

Albipagrastim alfa is a new generation of long-acting G-CSF (highly active modified cytokine) with intellectual property rights of Mabwell, which was developed with albumin fusion platform technology by fusing highly active recombinant G-CSF with human serum albumin (HSA). The modification increases the molecular weight, significantly inhibits the elimination pathway mediated by G-CSF receptor and prolongs the half-life of the drug in vivo, which improves the treatment adherence by reducing the frequency of administration in clinical practice.

阿尔比帕格拉司亭阿尔法是一种新一代长效G-CSF（高活性修饰细胞因子），拥有迈博威的知识产权。该药物采用白蛋白融合平台技术，将高活性重组G-CSF与人血清白蛋白（HSA）融合开发而成。这种修饰增加了分子量，显著抑制了由G-CSF受体介导的清除途径，延长了药物在体内的半衰期，通过减少临床用药频率提高了治疗依从性。

Compared to PEG-G-CSF, Albipagrastim alfa uses HSA as its natural carrier protein via a Pichia pastoris expression system. This approach offers a simpler production process and superior product homogeneity..

与PEG-G-CSF相比，Albipagrastim alfa通过毕赤酵母表达系统使用HSA作为其天然载体蛋白。这种方法提供了更简单的生产过程和更优越的产品同质性。

Mabwell previously presented results from a Phase III clinical study of 8MW0511 at the European Society for Medical Oncology (ESMO) annual meeting in 2023, and the full manuscript was published in

迈威生物之前在 2023 年欧洲肿瘤内科学会 (ESMO) 年会上展示了 8MW0511 的 III 期临床研究结果，完整手稿已发表在

May 2025

2025年5月

in Breast Cancer Research. 496 patients with breast cancer were enrolled and randomized into the study (8MW0511, n=331, control group, n=165). The result of study showed that 8MW0511 was clinically effective, non-inferior to the positive control. It is able to reduce the incidence of grade 4 neutropenia, significantly shorten the duration of grade 4 neutropenia and lower the incidence of Febrile Neutropenia (FN).

在乳腺癌研究中，496名乳腺癌患者被纳入并随机分配到研究中（8MW0511组，n=331，对照组，n=165）。研究表明，8MW0511具有临床疗效，不劣于阳性对照组。它能够减少4级中性粒细胞减少症的发生率，显著缩短4级中性粒细胞减少症的持续时间，并降低发热性中性粒细胞减少症（FN）的发生率。

The overall safety profile is similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans. The 8MW0511 group was superior to the control group in terms of the incidence of grade 4 neutropenia in cycle 1-4 of chemotherapy, the duration of grade 4 neutropenia, and the incidence of febrile neutropenia.

整体安全性与阳性对照组相似，这表明在人体中具有可控的安全性和良好的耐受性。在化疗的第1-4周期间，8MW0511组在4级中性粒细胞减少症的发生率、4级中性粒细胞减少症的持续时间以及发热性中性粒细胞减少症的发生率方面均优于对照组。

Compared with the control group, the Absolute Risk Reduction (ARR) of grade 4 neutropenia was 3.1%, 7.0%, 4.2%, and 2.8%, while the Relative Risk Reduction (RRR) of grade 4 neutropenia was 15.6%, 68.4%, 58.3% in the 8MW0511 group during the cycle 1-4 of chemotherapy. RRR of FN was 42.0% [1]. The results of this study suggest that 8MW0511 has clinical advantages over the positive control drug, and safety advantages as a long-acting molecule using natural human proteins..

与对照组相比，8MW0511组在化疗第1-4周期间，4级中性粒细胞减少的绝对风险降低（ARR）分别为3.1%、7.0%、4.2%和2.8%，相对风险降低（RRR）分别为15.6%、68.4%和58.3%，发热性中性粒细胞减少（FN）的RRR为42.0%[1]。本研究结果表明，8MW0511相较于阳性对照药具有临床优势，并且作为一种使用天然人类蛋白的长效分子，具备安全性优势。

The phase III clinical trial of 8MW0511 also included a chemotherapy regimen of TAC (docetaxel, doxorubicin, and cyclophosphamide), which has a high risk of FN. Stratified analysis showed that comparing to the control group, the incidence of grade 4 neutropenia in the 8MW0511 group was slightly lower during the first cycle of chemotherapy, and significantly lower during cycle 2-4 of chemotherapy..

8MW0511的III期临床试验还包括一个TAC（多西他赛、阿霉素和环磷酰胺）化疗方案，该方案有较高的FN风险。分层分析显示，与对照组相比，8MW0511组在第一个化疗周期中4级中性粒细胞减少的发生率略低，在第2-4周期中显著降低。

[1] Absolute Risk Reduction (ARR): the absolute difference in the percentage of patients who did not develop grade 4 neutropenia in the test group versus the control group. Relative Risk Reduction (RRR): the relative degree to which the risk of developing grade 4 neutropenia was reduced in the test group compared to the control group..

[1] 绝对风险降低 (ARR)：试验组与对照组中未发生 4 级中性粒细胞减少症的患者百分比的绝对差异。相对风险降低 (RRR)：试验组相对于对照组，发生 4 级中性粒细胞减少症的风险降低的相对程度。

About Neutropenia

关于中性粒细胞减少症

Neutropenia is a relatively common hematologic toxicity caused by chemotherapy with cytotoxic drugs, with studies showing that 65.5% of patients treated with chemotherapeutic agents such as paclitaxel, adriamycin, and cyclophosphamide experience a grade 3 or 4 decrease in their neutrophil counts. Febrile neutropenia (FN), as a clinical complication of chemotherapy, commonly results in prolonged hospitalization, increased use of broad-spectrum antibiotics and cost of therapy, reduction of chemotherapeutic agents or delayed chemotherapy, and ultimately affecting the efficacy of antitumor therapy.

中性粒细胞减少症是细胞毒性药物化疗引起的一种较为常见的血液学毒性，研究表明，65.5%接受紫杉醇、阿霉素和环磷酰胺等化疗药物治疗的患者会出现3级或4级中性粒细胞计数下降。发热性中性粒细胞减少症（FN）作为化疗的临床并发症，常导致住院时间延长、广谱抗生素使用增加、治疗费用上升、化疗药物减量或化疗延迟，最终影响抗肿瘤治疗的疗效。

In more serious cases, it may lead to sepsis syndrome, infectious shock, and even death. Therefore, preventing or treating neutropenia and reducing the incidence of FN are fundamental to ensure adequate or dose-intensive chemotherapy..

在更严重的情况下，它可能导致败血症综合征、感染性休克甚至死亡。因此，预防或治疗中性粒细胞减少症并降低FN的发生率是确保足够或剂量密集化疗的基础。

Globally, more than 50% of new cancer cases require chemotherapy. The number of new tumor cases in 2025 is expected to be at 5.03 million (J Natl Cancer Cent. 2024,4(1)), and the number of patients who will require the first course of chemotherapy each year from 2018 to 2040 will increase from 9.8 million (corresponding to about 50 million chemotherapy cycles) to 15 million (corresponding to about 75 million chemotherapy cycles), i.e.

全球超过50%的新发癌症患者需要接受化疗。预计2025年新发肿瘤病例将达到503万例（J Natl Cancer Cent. 2024,4(1)），而从2018年至2040年，每年需要进行第一疗程化疗的患者数量将从980万例（对应约5000万次化疗周期）增加到1500万例（对应约7500万次化疗周期），即：

an increase of 53%, according to an article published in the journal The Lancet Oncology. .

根据《柳叶刀肿瘤学》杂志发表的一篇文章，增加了53%。

By 2040, m

到2040年，m

ore than 57.7% of cancer patients worldwide are expected to require chemotherapy. In addition, with the in-depth development of basic, translational and clinical oncology research, more individualized oncology treatment, and emergence of new antitumor therapeutics, drugs for the prevention or treatment of neutropenia hold great promise for application..

预计全球超过57.7%的癌症患者需要接受化疗。此外，随着基础、转化和临床肿瘤学研究的深入发展，更多个性化的肿瘤治疗方案以及新型抗肿瘤药物的出现，用于预防或治疗中性粒细胞减少症的药物展现出广阔的应用前景。

About Mabwell

关于迈威生物

Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established.

迈威生物 (688062.SH) 是一家全产业链布局的创新型生物医药公司。我们致力于提供更有效、可及的治疗和创新药物，以满足全球医疗需求。自 2017 年起，建立了覆盖靶点发现、早期发现、成药性研究、临床前研究、临床研究和生产转化的先进研发体系。

Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, .

基于世界级、最前沿的研发引擎，迈威生物已拥有 16 项处于不同研发阶段的管线产品，包括 12 个创新药候选产品和 4 个生物类似药候选产品。我们专注于肿瘤、免疫、骨骼、眼科、血液及感染等治疗领域。

4 products have been approved

4种产品已获批

and commercialized, 1 product filed for pre-NDA meeting,

并且商业化，1种产品已提交pre-NDA会议申请，

2 products are in pivotal trials

2种产品处于关键试验阶段

. We have also undertaken 1 national major scientific and technological special project for 'Significant New Drugs Development', 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit.

我们还承担了 1 项“重大新药创制”国家科技重大专项，2 项国家重点研发计划项目，以及多项省市级科技创新项目。迈威生物的泰州工厂拥有符合中国国家药品监督管理局（NMPA）、美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）监管要求的国际 GMP 标准的自主生产能力，并已通过欧盟 QP 审计。

The large-scale manufacturing base in .

大规模制造基地在 。

Shanghai

上海

and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is 'Explore Life, Benefit Health' and our vision is 'Innovation, from ideas to reality'. For more information, please visit

位于台州的ADC商业化生产基地正在建设中。我们的使命是“探索生命，造福健康”，我们的愿景是“创新，从理念到现实”。欲了解更多信息，请访问

www.mabwell.com/en

www.mabwell.com/zh

.

。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature.

本新闻稿包含前瞻性陈述，包括但不限于我们产品候选物的潜在安全性、有效性、监管审查或批准和商业成功，以及与公司产品开发、临床研究、临床和监管里程碑及时间表、市场机会、竞争地位、可能或假设的运营结果、业务战略、潜在增长机会及其他具有预测性质的陈述。

'Forward-looking statements' are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, 'expect,' 'anticipate,' 'intend,' 'plan,' 'believe,' 'estimate,' 'potential,' 'predict,' 'project,' 'should,' 'would,' and similar expressions and the negatives of those terms..

“前瞻性声明”并非历史事实，而是涉及诸多风险和不确定性，可能导致实际结果与前瞻性声明中明示或暗示的任何未来结果存在重大差异。这些声明可以通过使用前瞻性表述来识别，包括但不限于“预期”、“预计”、“打算”、“计划”、“相信”、“估计”、“潜在”、“预测”、“展望”、“应该”、“会”以及类似表述和这些术语的否定形式。

Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel.

前瞻性声明基于公司当前的预期和假设。前瞻性声明受多种风险、不确定性和其他因素的影响，其中许多因素超出公司的控制范围，包括但不限于：环境；政治；经济；社会；立法；我们对公司产品候选物的依赖，其中大多数仍处于临床前或不同阶段的临床开发中；我们对第三方供应商的依赖，如合同研究组织和合同制造组织；临床测试固有的不确定性；我们完成产品候选物所需临床试验并获得监管机构批准的能力；我们保护知识产权的能力；新冠疫情的潜在影响；任何高管或关键人员的流失。

In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results..

如果这些风险或不确定性中的一个或多个恶化，或者任何假设不正确，实际结果可能与所述结果严重不符。

The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

公司告诫所有人士不要过分依赖任何此类前瞻性声明，这些声明仅截至本新闻稿发布之日有效。公司不承担任何义务，除非法律及适用的证券管理机构规则特别要求，公开更新或修改任何此类声明以反映任何预期变化或事件、条件、或情况的变化，或可能影响实际结果与前瞻性声明中所述结果产生差异的可能性。

All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement..

本新闻稿中的所有前瞻性描述、数据和假设均适用于本声明。

SOURCE Mabwell

来源：Mabwell

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