In 2008, RemeGen, Ltd. was jointly established by Rongchang and Professor Fang Jianmin. Located at Rongchang Bio-pharmaceutical Industry Park, the company is specialized in the R&D, production and industrialization of biological drugs. The company has brought in the most advanced expendable biological reactor and related purification and preparations equipment, and has European-American and Chinese GMP certified management systems on the production, materials, quality, project and verification, which ensures that the laboratories and production workshops are built and operated strictly according to the requirements of FDA, EMA, and CFDA GMP. At present, the company’s annual output value is up to 5 billion Yuan.
Ever since its inception, RemeGen has developed 8 innovative biological drugs which are in different development phases now, and has gained many important scientific achievements. Thus the company is in the leading position in the industry both at home and abroad. In April 2011, the “Tai’ai”- recombinant human B lymphocyte stimulatorreceptor–antibody fusion protein for injection use, was approved by CFDA to enter the phase of clinical study for the treatment of autoimmunity diseases like systemic lupus erythematosus and rheumatoid arthritis. At present, “Tai’ai” has entered the II and III phase of clinical study, and it has been included in the Key New Drug Development Program of“11th Five-Year Plan” and “12th Five-Year Plan” and gained great support from the government.
In the field of cancer therapy, RemeGenhas developed the new ADC drug RC48 which has been approved by CFDA for clinical study in September 2015. RC48 is the first ADC new drug in China that has been approved by CFDA for clinical trial. RC48 is mainly used for the treatment of Her2 over-expression gastric cancer, lung cancer, breast cancer, ovarian cancer, and bladder cancer. It can cure the cancer through “precision guidance” to the interior of the cancer cells.
RemeGen has built two core technology platforms respectively for the CHO cell expression and the ADC antibody drug conjugates. CHO cell expression platform consists of four modules including pharmaceutical molecules gene cloning, engineering cell strain screening, CHO cell culture in large scale, drug purification, and preparations optimization. Equipped with multiple cell production culture line ranged from 2L to 2000L, the company’s annual output is 250 kg antibody protein under the GMP environment, featuring leading technical capability in domestic market and advanced level in the world.
The “ADC antibody drug conjugates new drug development generic technology platform” features four key technologies, including 1. Large-scale antibody-drug conjugates technology; 2.ADC drug small molecule and adapter large-scale preparation technology; 3.ADC drug analysis and quality control standards; 4.Model system for ADC drug evaluation. The technological platform guarantees the R&D and industrialization of ADC drugs.
Adhering to the talent development strategy of “building a first-class R&D team, and establishing advantageous position with talents”, RemeGentakes the chief scientist Professor Fang Jianmin as the core, who is the specially recruited expert for the “1000 People Plan”, and actively recruits and employs various kinds of technical, R&D and management staff, especially the backbone talents who have profound education background, great academic achievements and international competitiveness in the industry, and industry elites who are highly capable and familiar with domestic markets. The company has established an excellent R&D talent team which knows the international rules, follows the global trend, and is also adapted to the actual Chinese environment and is capable to participate in the market competition in both the domestic and overseas markets.
RemeGen takes “enhancing the quality of life with science” as its holy mission,keeps improving its competitiveness in terms of technology, talents, products, services and management with a global view, and maintains its leading position in the fields of autoimmunity and tumor therapy. The company aims to provide global customers with excellent technologies, products and services through various means, and become China’s most powerful biopharmaceutical company and build “RemeGen” as a unique and strong brand in the biopharmaceutical field in the world.