公司简介

上海复宏汉霖生物技术股份有限公司(以下简称复宏汉霖)由上海复星医药(集团)与美国科学家团队于2009年12月合资组建,公司主要致力于应用前沿技术进行单克隆抗体生物类似药、生物改良药以及创新单抗的研发及产业化。公司注册资金为3.5亿人民币,目前累计投入约4亿多人民币用于单抗药物的前期研发。
目前复宏汉霖正在开发的产品主要覆盖肿瘤、自身免疫性疾病等领域,公司研发团队核心人员具有国外大型医药企业多个单抗药物的前期研发以及单抗药物产业化经验。公司以全球联动整合创新为产品开发理念,在中国上海、美国加州和台北均设有研发实验室,配备了单抗药物前期研发所需的符合国际化标准的各项仪器设备,其中上海实验室总面积约4,300㎡,现已完成单克隆抗体药物开发平台的建设。
复宏汉霖总部位于上海市漕河泾高新技术开发区,公司已于2015年底完成了符合国际GMP标准、采用国际先进的一次性生物反应器等设备的、国内领先、国际先进的抗体药物中试以及产业化生产基地的建设。截至目前,公司团队已完成8个产品、13项适应症IND申报的高效研发,位于国内同行业领先地位。其中6 个产品已经全部获得CFDA的11项适应症的临床批件。值得瞩目的是,复宏汉霖的第一个创新型生物改良型单抗HLX07已获三地临床批准,分别是中国大陆、台湾和美国,成功实现了研发产品的国际化战略,并已在台湾开展临床一期研究。复宏汉霖第一个品种HLX01 “重组人鼠嵌合抗CD20单克隆抗体注射液” 的非霍奇金淋巴瘤淋巴瘤适应症,以及第二个品种HLX02“重组抗HER2人源化单克隆抗体”的乳腺癌适应症,目前均处于三期临床研究阶段。第一个品种HLX01的第二个适应症以及第三个品种HLX03“重组抗TNFα全人单克隆抗体注射液”、第四个品种“重组抗VEGF人源化单克隆抗体注射液”均处于临床一期研究阶段。
展望未来,复宏汉霖人将始终以“持续创新,卓越运营;以优质生物药,造福全球病患”为使命,不断探索发展,专注提供质高价优的生物药,积极打造成全球最受景仰的创新型生物医药公司。

Shanghai Henlius Biotech,Inc. is a joint venture company formed by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Henlius Biopharmaceuticals Co., Ltd. in December 2009. The company focuses on the development, production and commercialization of mAbbiosimilar drugs, bio-betters and novel mAbs using cutting-edge technology. Registered in Shanghai Zhangjiang, we have so far invested over 400 million RMB in the early development of monoclonal antibody drugs.
Products currently in development cover a variety of therapeutic areas including oncology and autoimmune diseases. Our R%26D management team has extensive experience in the development and commercialization of a range of monoclonal antibody drugs in such leading international pharmaceutical and biotech companies as Genentech, Amgen, BMS and Eli Lilly. The concept of our drug development lies in global integrative innovation, and we have 3 R%26D laboratories located in China (Shanghai), the US (California) and Taiwan (Taipei).
Henlius is headquartered in the Shanghai Caohejing High-Technology Park. The total area of our Shanghai R%26D laboratory is about 4,300m2, incorporating established development platforms of monoclonal antibody drugs. The company has completed the construction of a GMP standard facility with a 12,000 liter capacity, which adopted advanced disposable bioreactors based on the existing manufacturing facilities, ensuring the position of Henlius as a leading domestic antibody therapeutic testing and production site based in China.
In the eight years since its foundation, Henlius has been a leader in antibody drug development in China, completing the IND submissions of 8 product candidates with 13 indications. The most advanced product in our pipeline, the 'Recombinant Murine/Human Chimeric Anti-CD20 Monoclonal Antibody Injection', and the second product HLX02 ‘Recombinant Humanized Anti-Her2 Monoclonal Antibody Injection’ have both entered the Phase III study.
Looking forward, Henlius will continue to pursue technical innovation and operation excellence in drug discovery and development to improve patients’ lives by timely providing them with quality and affordable protein therapeutics,and strive to be the most admired biotech company in the world.

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