About - Anrate

Fueling Biopharmaceutical Advancements Through Technological Innovative Breakthroughs

Established in August 2014, Tonghua Anrate Biopharmaceutical Co., Ltd. (referred to as Anrate) embarked on a groundbreaking mission as a pioneer in the field of biopharmaceuticals. Under the visionary guidance of national initiatives such as the "the 14th Five-Year Plan" for key national research and development plans, and the "the 12th Five-Year Plan" for major new drug development, Anrate spearheaded projects aimed at revolutionizing the production of therapeutic adjunctive medical proteins. At the forefront of innovation, Anrate assumed leadership roles in key projects such as the "Industrial Demonstration of Therapeutic Adjunctive Medical Proteins such as Albumin" and the "Development of Injection-Grade Recombinant Human Albumin". Recognized for our contributions, Anrate has received commendations from Party and state leaders, along with unwavering support from local governments.
Years of dedicated effort have culminated in the establishment of a comprehensive recombinant protein drug research and development system. This system encompasses gene editing, cell chassis screening and cultivation, product separation and purification, and rigorous detection protocols. By overturning traditional production methodologies, Anrate has achieved remarkable milestones in industrialization scale, production efficiency, and product purity, positioning ourselves as a beacon of innovation on the global stage.
In 2018, we celebrated the successful launch of our first production line, setting a new benchmark with the largest global albumin biopharmaceutical production scale at the time, boasting an annual output of 5 tons. Looking ahead, we are poised for even greater achievements. By 2024, our production base will expand to accommodate a staggering 100-ton capacity, catering to the growing demand for recombinant human albumin raw materials and formulations. In March 2024, we achieved yet another milestone with the completion and licensing of a 50-ton recombinant human albumin

400 acres

Industrial park area

10 items

Global industry leader

200 items

National Patent

Anrate Mission

Dedicated to Human Health and Happiness

Anrate Vision

Enriching Lives with Health and Joy

Anrate core values

Integrity, Innovation, Collaboration, and Value.

Course

2012

Shanghai Anrate Biopharmaceutical Technology Co., Ltd. initiated the national "the 12th Five-Year Plan" major new drug innovation project.

2014

Jointly established Tonghua Anrate Biopharmaceutical Co., Ltd. with Dongbao Industry Group Co., Ltd., focusing on pioneering research in recombinant human albumin.

2015

Undertook a significant scientific and technological research project of Jilin Province's "Double Ten Project".

A new process for ultra-high purity recombinant human albumin was initially established.

Successfully scaled up the process to 50L and 1000L in small-scale experiments.

2016

Successfully scaled up the process to 3000L and 5000L in small-scale experiments, laying the groundwork for large-scale production.

2017

Completed a comprehensive preclinical evaluation of the toxicology, pharmacology, and pharmacodynamics of the recombinant human albumin injection.

2018

Achieved drug registration for the recombinant human albumin injection, marking a milestone as a new category 1 drug in China.

Obtained a drug production license.

2019

Clinical trials were approved by the National Medical Products Administration.

Phase Ia clinical trials were conducted at the First Hospital of Jilin University, and stability studies were completed.

Implemented a comprehensive GMP management system for production.

2020

Phase Ia clinical trials were completed.

Phase Ib clinical trials were completed.

Completed a shareholding reform and renamed to "Tonghua Anrate Biopharmaceutical Co., Ltd."

2021

Phase II clinical trials were initiated at the First Hospital of Jilin University.

2022

Phase II clinical trials were completed, and a Phase III clinical trial launch meeting was held at the First Hospital of Jilin University.

Undertook the national "the 12th Five-Year Plan" key research project "Key Technologies and Applications for Green Biomanufacturing of Medical Proteins".

2023

Signed a contract with Indonesia, and completed on-site audits in Russia.

Phase III clinical trials were conducted domestically.

On-site audits were completed in Russia.

2024

Part A of the first-phase engineering of the Anrate production base obtained a production license, marking a significant milestone in the company's journey towards large-scale production of recombinant human albumin.

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social responsibility

Anruit is an international biotechnology enterprise driven by innovative technology. With the mission of "making contributions to human health and happiness", we are committed to bringing more possibilities to the future biopharmaceutical industry. We firmly believe that only enterprises with a high sense of social responsibility can create more commercial value.

Subsidiary companies