信达生物与劲方医药关于GFH925(KRAS G12C抑制剂)达成全球战略合作

2021-09-02 信达生物 信达生物

2021年9月2日,美国旧金山和中国苏州——信达生物制药集团(香港联交所股票代码:01801),一家致力于研发、生产和销售用于治疗肿瘤、代谢疾病、自身免疫等重大疾病的创新药物的

2021年9月2日,美国旧金山和中国苏州——信达生物制药集团(香港联交所股票代码:01801),一家致力于研发、生产和销售用于治疗肿瘤、代谢疾病、自身免疫等重大疾病的创新药物的生物制药公司,与劲方医药科技(上海)有限公司(“劲方医药”),一家开发肿瘤和免疫领域的领先疗法的临床阶段生物技术公司,宣布达成全球独家授权协议,信达生物将作为独家合作伙获得劲方医药一款靶向常见于肺癌和其他实体瘤致癌驱动基因KRAS G12C的候选药物——GFH925(KRAS G12C抑制剂)在中国(包括中国大陆、香港、澳门及台湾)的开发和商业化权利,并拥有全球开发和商业化权益的选择权

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劲方医药自主研发的GFH925最近已获得国家药品监督管理局(NMPA)的临床试验批准。临床前实验数据显示,GFH925拥有潜在同类最佳的活性,可有效抑制多种携带KRAS G12C突变的肿瘤细胞系生长,有利于加速临床上的有效性验证。其他临床前试验也展现了与其他疗法的联用潜力。

根据协议,信达生物将负责GFH925在中国的临床开发及商业化,并保留全球开发和商业化权益的选择权。待该候选药物获批上市后,信达生物将利用其经验丰富的商业化团队以及广阔的全国商业渠道覆盖推广GFH925。劲方医药负责该药物在临床研究阶段和商业化阶段的药物生产供应。

根据协议,信达生物将支付劲方医药2,200万美元首付款以及累计不超过5,000万美元的全球开发支持费用。如果信达生物行使全球权益的选择权,取决于达到若干全球开发、注册及销售里程碑进展,劲方医药将有资格获得来自信达生物累计不超过2.4亿美元的里程碑付款,以及基于中国和全球范围内GFH925的年度销售净额的梯度特许权使用费。

信达生物总裁刘勇军博士表示:“劲方医药拥有丰富的药物开发经验和原创型大、小分子新药管线。我们很高兴与劲方医药达成此次战略合作。信达生物深耕抗肿瘤领域,已拥有20个处于临床不同阶段的雄厚的抗肿瘤管线、业内领先的临床开发和注册专业化团队、广阔的商业渠道覆盖及逾2000人的商业化团队。KRAS突变是肺癌和实体瘤的一个重要致癌驱动基因。信达生物在肺癌等领域里布局广泛,GFH925可以在单药和联合治疗(例如与PD-1联合用药)等方向进行临床探索,进一步完善我们在大瘤种领域的全面覆盖。双方合作可以发挥信达在临床开发和商业化的协同效应,加速GFH925的开发和上市。同时,KRAS抑制剂在全球具有广阔的市场潜力,信达生物拥有全球开发和商业化的选择性权益,我们期待与劲方合力促进GFH925的开发,尽快惠及广大中国及全球患者。”

劲方医药CEO兰炯博士表示:“劲方医药很高兴宣布公司首个对外授权项目的合作协议。RAS蛋白曾经是著名的‘不可成药’靶点,而劲方针对KRAS G12C突变靶点立项时,全球尚无同类药物进入临床试验,彰显了劲方‘全球新’管线的前瞻性战略。因此,此次合作不仅基于对GFH925(一种潜在的同类最佳KRAS/G12C抑制剂)的认可,也是对劲方内部自主创新能力的认可。作为行业领先的生物制药企业,信达生物在抗肿瘤药物领域拥有丰富、成功的药物开发和商业化经验。我们很高兴与同样致力于加速新药研发、聚焦未满足临床需求的信达生物达成战略合作,我们拥有共同的创新文化和高效的研发体系,期待此次项目合作在全球范围内惠及国内外患者。”

广东省人民医院终身主任、广东省肺癌研究所名誉所长吴一龙教授表示:“KRAS是最常见的RAS蛋白亚型,在非小细胞肺癌、胰腺癌结直肠癌等癌细胞内突变率很高。临床前数据显示了 GFH925与已经或即将进入临床的竞品有足够的差异化,期待此项临床研究获得积极的安全性、耐受性及疗效数据。我们也将不断探索精准化治疗和潜在组合疗法的应用空间,令更多携带KRAS G12C抑制剂突变的肿瘤患者获益。”

关于GFH925(KRAS G12C抑制剂)

GFH925为劲方医药自主研发、拥有完全知识产权的高效口服新分子实体化合物,通过共价不可逆修饰KRAS G12C蛋白突变体半胱氨酸残基,有效抑制该蛋白介导的GTP/GDP交换从而下调KRAS蛋白活化水平;临床前半胱氨酸选择性测试,也显示了GFH925对于该突变位点的高选择性抑制效力。此外,GFH925抑制KRAS蛋白后可进而抑制下游信号传导通路,有效诱导肿瘤细胞凋亡及细胞周期阻滞,达到抗肿瘤效果。

关于信达生物

“始于信,达于行”,开发出老百姓用得起的高质量生物药,是信达生物的理想和目标。信达生物成立于2011年,致力于开发、生产和销售用于治疗肿瘤、自身免疫、代谢疾病等重大疾病的创新药物。2018年10月31日,信达生物制药在香港联合交易所有限公司主板上市,股票代码:01801。

自成立以来,公司凭借创新成果和国际化的运营模式在众多生物制药公司中脱颖而出。建立起了一条包括26个新药品种的产品链,覆盖肿瘤、代谢疾病、自身免疫等多个疾病领域,其中6个品种入选国家“重大新药创制”专项。公司已有5个产品(信迪利单抗注射液,商品名:达伯舒®,英文商标:TYVYT®;贝伐珠单抗生物类似药,商品名:达攸同®,英文商标:BYVASDA®;阿达木单抗生物类似药,商品名:苏立信®,英文商标:SULINNO®;利妥昔单抗生物类似药,商品名:达伯华®,英文商标:HALPRYZA®;pemigatinib口服抑制剂,商品名:达伯坦®,英文商标:PEMAZYRE®)获得批准上市,1个产品上市申请被NMPA受理,信迪利单抗在美国的上市申请获FDA受理,5个品种进入III期或关键性临床研究,另外还有15个产品已进入临床研究。信迪利单抗已于2019年11月成功进入国家医保目录,成为全国首个,也是当年唯一一个进入国家医保目录的PD-1抑制剂。

 

信达生物已组建了一支具有国际先进水平的高端生物药开发、产业化人才团队,包括众多海归专家,并与美国礼来制药、Adimab、Incyte、MD Anderson 癌症中心和韩国Hanmi等国际合作方达成战略合作。信达生物希望和大家一起努力,提高中国生物制药产业的发展水平,以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站:www.innoventbio.com或公司领英账号www.linkedin.com/company/innovent-biologics/。

 

关于劲方医药

 

劲方医药以未满足的临床需求为出发点,以疾病生物学机理和临床转化医学为核心,深入研究肿瘤信号通路、肿瘤免疫微环境及免疫调节等领域的最新生物学机制,主攻尚无临床验证的创新靶点与适应症,致力于原创型“全球新”药物开发,并拥有全球自主知识产权。

 

劲方医药自2017年成立以来,已建立了涵盖大、小分子药物的技术平台、研发体系及人才梯队,产品管线包含十余个“全球新”项目,并有多个候选药物已进入包括中国、美国、澳大利亚等地在内的全球多中心临床研究阶段。预计未来三到五年,更多研发项目进入后期临床研究的同时,公司也将迈入产业化阶段。

 

 

前瞻性声明

本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时,凡与本公司有关的,目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。

 

这些前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证,会受到风险、不确性及其他因素的影响,有些乃超出本公司的控制范围,难以预计。因此,受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响,实际结果可能会与前瞻性表述所含资料有较大差别。

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    2022-02-07 jklm09
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    2021-09-04 yinhl1978
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    2021-09-04 cathymary
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