Na’an T320: The Breakthrough Battle of Shanxi’s Biomedical Industry

山西纳安生物科技股份有限公司（纳安）自主研发的T320抗癌新药近日获得中国临床试验批件，成为山西省首个获批的生物大分子一类新药，标志着山西在生物医药领域实现“零的突破”。这一成果不仅推动了山西从“煤都”向“药谷”的转型，也为内陆省份以科技创新驱动产业升级提供了范例。

The T320 anti-cancer new drug independently developed by Shanxi Na’an Biological Technology Co., Ltd. (Na’an) has recently obtained clinical trial approval in China, becoming the first approved biomacromolecule first-class new drug in Shanxi Province, marking Shanxi’s breakthrough in the field of biomedicine. This achievement not only promotes Shanxi’s transformation from a “coal capital” to a “medicine valley”, but also provides an example for inland provinces to drive industrial upgrading through technological innovation.

山西近年来在“经济转型”战略下，将生物医药产业作为重点发展方向。纳安T320的成功得益于地方政策的大力支持，包括山西综改示范区提供的免费场地、资金支持及配套服务。2023年，本土煤焦巨头森泽能源和万马投资通过战略合作注入资金，加速了T320的临床试验进程。同年，山西现代医药产业链营收突破306亿元，T320的全球同步开发（中、美、澳三地临床）更是打破了山西生物药“零出口”的历史。

In recent years, Shanxi has made the biopharmaceutical industry a key development direction under the “economic transformation” strategy. The success of Na’an T320 is attributed to the strong support of local policies, including free venues, financial support, and supporting services provided by Shanxi Comprehensive Reform Demonstration Zone. In 2023, local coal and coke giants Senze Energy and Wanma Investment injected funds through strategic cooperation to accelerate the clinical trial process of T320. In the same year, the revenue of Shanxi’s modern pharmaceutical industry chain exceeded 30.6 billion yuan, and the global synchronous development of T320 (clinical trials in China, the United States, and Australia) broke the history of Shanxi’s “zero export” of biopharmaceuticals.

T320所属的纳安生物科技股份有限公司业已取得多项国际认定：2024年5月30日，获批美国FDA治疗胰腺癌适应症的孤儿药（ODD）资格认定；同年11月4日，又获得澳大利亚卫生部所属的澳大利亚药品管理局（简称TGA）的临床试验准入；12月5日，正式获批美国FDA的新药临床试验许可。这一系列的资格、许可认定是T320研发历程中的重要里程碑。

T320 belongs to Na’an Biological Technology Co., Ltd., which has obtained several international certifications: on May 30, 2024, it was approved by the US FDA as an Orphan Drug Designation (ODD) for pancreatic cancer indications; On November 4th of the same year, it obtained clinical trial access from the Therapeutic Goods Administration (TGA) under the Australian Government Department of Health and Aged Care; On December 5th, it was officially approved for clinical trials by the US FDA. The series of qualifications and licensing certifications are important milestones in the development process of T320.

纳安的崛起离不开创始人渠志灿博士的“山西情结”。2018年，渠志灿放弃海外优渥条件，带领团队返乡创业，通过Bio-Lattix核心技术平台突破ADC药物研发瓶颈，实现了靶向组织因子（TF）的精准治疗设计。临床前数据显示，T320在胰腺癌动物模型中抑瘤率超90%，并已布局多种实体瘤适应症。