近日，药明康德子公司合全药业与生物医药高科技公司诺诚健华（香港联交所代码：09969）达成战略合作，携手加快诺诚健华恶性肿瘤及自身免疫性疾病治疗领域一类新药的开发进程。诺诚健华联合创始人、董事长兼CEO崔霁松博士及合全药业原料药业务高级副总裁傅小勇博士等共同出席了签约仪式。
诺诚健华专注于恶性肿瘤及自身免疫性疾病治疗领域的一类新药研制，在这两大领域自主开发了均衡的10多款候选药物，包括一款处于商业化阶段的药物、五款处于临床阶段的候选药物以及多项处于临床前IND准备阶段的候选新药。2020年底，诺诚健华自主研发的1类新药宜诺凯®（奥布替尼片）获得中国国家药品监督管理局（NMPA）批准上市。作为诺诚健华的合作研究开发生产（CDMO）合作伙伴，合全药业参与了奥布替尼的开发和商业化，为该创新药提供了从原料药、固体分散体到片剂以及包装等支持。此次签署战略合作协议，将进一步拓展双方合作的深度和宽度。
根据协议，合全药业将成为诺诚健华首选CDMO合作伙伴，为诺诚健华在研及后续管线产品（包括小分子药物、多肽、寡核苷酸、复杂化学偶联药物等）提供原料药研发及委托生产服务，包括但不限于原料药的工艺开发、生产、分析，以及支持新药申报的注册文件准备等。
合全药业深耕CDMO领域20年，在全球拥有8个研发生产基地，打造了行业领先的一体化CMC研发和生产平台以及符合国际标准的质量体系。此次与诺诚健华深化合作，合全药业将助力其加速药物管线的开发进程。
诺诚健华联合创始人、董事长兼CEO崔霁松博士表示:
我们很高兴和合全药业深化合作，合全药业一直是值得我们信赖的合作伙伴，双方在奥布替尼项目上的合作卓有成效。诺诚健华始终秉承‘科学驱动创新 患者所需为本’的理念，在肿瘤和自身免疫性疾病领域进行了全面布局，目前正在快速推进产品管线，致力于加速研发出更多造福患者的创新药。
合全药业首席执行官陈民章博士表示：
很高兴与诺诚健华扩大合作关系，这也是合全药业持续赋能客户赢得信任、支持客户更多项目的有力体现。期待通过我们的规模优势和创新能力，以及符合国际标准的质量体系，让其创新药早日取得成功，为全球患者带来健康福音。
关于诺诚健华
诺诚健华（香港联交所代码：09969）是一家商业化阶段的生物医药高科技公司，专注于恶性肿瘤及自身免疫性疾病治疗领域的一类新药研制，适用于治疗中国病人高发的淋巴瘤、肝癌、胆管癌、尿路上皮癌等多种恶性肿瘤及自身免疫性疾病。成立于2015年，诺诚健华由拥有丰富新药开发和企业管理经验的崔霁松博士和世界著名结构生物学家施一公院士联合创立。公司在北京、南京、上海、广州、美国新泽西和波士顿均设有分支机构。
诺诚健华打造了强大的自主研发能力，拥有多项国内外专利，在血液瘤、实体瘤和和自身免疫性疾病领域开发了丰富的产品管线。2020年3月23日，诺诚健华在香港联交所成功上市。
关于合全药业
合全药业是药明康德子公司，在全球多地设有研发及生产基地。合全药业服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业致力于为全球合作伙伴提供高效、灵活、高质量的一站式解决方案，以支持包括小分子、寡核苷酸、多肽及各种复杂化学偶联药物的研发与生产。更多信息，请访问公司网站：www.stapharma.com.cn。
WuXi STA Forms Strategic Partnership
with InnoCare
SHANGHAI, CHINA, –STA Pharmaceutical Co., Ltd., a WuXi AppTec Company (WuXi STA)–and InnoCare Pharma Limited (HKEX: 09969), announced the signing of a strategic partnership agreement.
InnoCare Pharma is a commercial-stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. Currently InnoCare has developed a pipeline with over 10 innovative drugs in the field of cancer and autoimmune diseases, including one commercial-stage, five clinical-stage and several preclinical-stage drug candidates. In 2020, InnoCare's BTK inhibitor orelabrutinib was approved for two indications in China. As InnoCare's Contract Development and Manufacturing Organization (CDMO) partner, WuXi STA has supported the development and commercialization of orelabrutinib, providing API, amorphous solid dispersion, tablet manufacturing and packaging for this innovative drug. The signing of this strategic partnership agreement will enhance the partnership between the two companies.
Under the terms of this agreement, WuXi STA will become the preferred CDMO partner for InnoCare's current and future pipeline projects of small molecule, oligonucleotide, peptide and complex chemical conjugate, including but not limited to the API process development, manufacturing, analytical and regulatory filing support.
As a premier CDMO, WuXi STA established an industry leading integrated CMC platform with eight R&D and manufacturing sites globally, as well as a quality and EHS system meeting global standard. Under the strategic partnership agreement, WuXi STA will support InnoCare to accelerate the development of their pipeline drugs.
Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare, said,
We are very happy to enhance our partnership with WuXi STA, who has been our trusted partner for a long time. The collaboration between the two companies on the orelabrutinib project was very successful. InnoCare is committed to our core value of ‘Science Drives Innovation’, and has built up a strong new drug pipeline for the treatment of cancer and autoimmune diseases. We are dedicated to accelerating market entrance of our new drugs for the benefit of global patients.
Dr. Minzhang Chen, CEO of WuXi STA, commented:
We are delighted to expand our partnership with InnoCare, which is another great example of how WuXi STA empowers our partners and earns their trust to support more projects in their pipeline. We are looking forward to leveraging our industry-leading capabilities and expertise, along with our well-established global standard quality system, to help accelerate the development and commercialization of InnoCare’s pipeline drugs to benefit patients around the world.
About InnoCare Pharma
InnoCare Pharma (HKEX:09969) is a commercial-stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare was founded in 2015 by Dr. Jasmine Cui, who has extensive experience in new drug development and business management and the world-renowned structural biologist Dr. Yigong Shi. InnoCare has branches in Beijing, Nanjing, Guangzhou, Shanghai, New Jersey and Boston.
InnoCare has strong in-house innovation capabilities, holding multiple foreign and domestic patents with a rich product pipeline targeting liquid tumors, solid tumors, and autoimmune diseases. On March 23, 2020, InnoCare was successfully listed on Hong Kong Stock Exchange.
About WuXi STA
WuXi STA (stapharma.com), a subsidiary of WuXi AppTec (wuxiapptec.com), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier contract development and manufacturing organization (CDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate.
For more information, please visit: http://www.STApharma.com
热门跟贴