鼎康生物与Humanigen签订COVID-19治疗性抗体的商业化生产制造服务协议

(美国当地时间:2021年5月17日)Humanigen,Inc.(纳斯达克股票代码:HGEN)(“Humanigen”)位于美国加利福尼亚州,是一家临床阶段的生物制药公司,致力于通过其领先的候选药物lenzilumab™预防和治疗称为“细胞因子风暴”的免疫过激反应。今日与世界领先的合同开发和制造组织(CDMO)Chime Biologics(以下简称“鼎康生物”)宣布签订商业化生产制造服务协议,生产Humanigen的lenzilumab原液(Drug Substance)和成品(Drug Product)。该产品在通过监管审批及上市申请后,将在美国以外的地区(包括欧洲,英国,印度和巴西)进行商业销售。

“随着最近公布的lenzilumab LIVE-AIR 3期临床试验结果的公布,我们很高兴与鼎康生物建立合作伙伴关系,以帮助我们预期的lenzilumab商业生产,”Humanigen首席执行官Cameron Durrant,MD,MBA说,“在进行围绕质量,技术能力,供应链和成本效益的竞标过程之后,我们选择了鼎康生物作为首个海外的CDMO合作伙伴,作为lenzilumab美国以外市场的供应商”。

根据协议条款,鼎康生物将使用业界先进的模块化一次性生物制药工厂KuBio(Cytiva)。公司的细胞培养产能为24,000升,并计划扩展至140,000升。鼎康生物承诺每年为Humanigen生产锁定至少56,000升产能。相关技术转移工作已经开始,计划在2022年提供商业化产品。

鼎康生物首席执行官曾宪放博士说,“我们很高兴被Humanigen选为lenzilumab在美国以外的CDMO的商业化合作伙伴。自2013年以来,鼎康生物已开发和生产了30多种产品,并通过其最新一代的模块化一次性工厂供应至20多个国家。我们为质量,合规性,生物工艺方面的专业知识和成本效益方面的成绩而感到自豪,并非常期待在这一重要项目中支持Humanigen。”

关于鼎康生物

鼎康生物是一家总部位于湖北武汉的世界级CDMO公司,坚持以客户为中心,以及时、经济和高质量为服务导向。鼎康生物可提供一站式的综合解决方案,支持从早期药物开发到后期临床研究和商业化cGMP生产,以满足快速发展的生物制药行业的动态需求。我们承诺通过技术和生产创新,使全球所有患者都能负担得起具有国际标准的生物药物,提高治疗水平以改善人类健康。

鼎康生物获得了湖北省药品监督管理局颁发的药品生产许可证,通过了ISO14001:2015 和ISO45001:2018认证,拥有最先进的设备、世界一流的专家团队以及国际标准的管理体系,追求卓越,诚信为本。鼎康生物在中国东湖新技术开发区光谷生物城拥有世界上第一个GE KuBio模块工厂。在不久的将来,鼎康生物总产能将超过140,000L。

关于Humanigen,Inc.

Humanigen,Inc.通过其前沿的创新性GM-CSF靶点中和技术与基因敲除平台开发用于癌症和传染病的临床和临床前产品组合疗法,目前专注于开发的lenzilumab,可用于住院低氧COVID-19患者。Humanigen近期宣布启动一项将用于上市注册申报的随机多中心二期临床试验,以评估lenzilumab联合所有市售CD19 CAR-T用于治疗弥漫性大B细胞淋巴瘤的疗效和安全性。

Humanigen还致力于创建新一代组合基因编辑CAR-T疗法有望提高疗效,与此同时采用GM-CSF基因敲除技术来控制毒性。并且,Humanigen也正在开发具自主知识产权的首创新药产品组合。其中EphA3-CAR-T用于多种实体癌,EMR1-CAR-T用于多种嗜酸性粒细胞疾病。此外,Humanigen还在探索其GM-CSF中和技术(通过使用lenzilumab作为中和抗体或通过GM-CSF基因敲除)联合其他CAR-T,双特异性抗体或自然杀伤(NK)T细胞招募的免疫疗法的有效性,以打破疗效与毒性的不一致,包括预防和/或治疗正在接受异体造血干细胞(HSCT)治疗的移植物抗宿主病(GvHD)患者。有关更多信息,请访问www.humanigen.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements, including, without limitation, statements regarding the volume and timeline for Chime’s production of commercial lenzilumab product, as well as statements regarding Humanigen’s beliefs relating to the technologies in Humanigen’s current pipeline.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the company’s lack of profitability and potential need for additional capital to grow its business; its dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the “Risk Factors” sections and elsewhere in Humanigen’s periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. The company undertakes no obligation to revise or update any forward-looking statements made in this presentation to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.