Sunshine Guojian PD-1 Specific Combination Therapy Global Rights Authorized to Syndromune Company in the United States
Grant of Global Rights to Kelin Source for the Development and Commercialization of Antibody Coupled Drugs (ADC) with Sunshine Guojian Yinitoumab
On December 2021, SIGO Shanghai, an independent CDMO operation platform wholly-owned by Sunshine Guojian, was officially launched to provide customers with one-stop and full-process CDMO services.
Cipterbin (Inetetamab for Injection), the first innovative anti-HER2 monoclonal antibody independently developed in China, has been approved by the National Medical Products Administration.
The humanized anti-CD25 monoclonal antibody drug Xenopax developed independently by the company has been granted the GMP certificate by the NMPA, and it will be used to prevent acute rejection after kidney transplantation.
The 6 x 5,000L antibody drug production line was certified by the new GMP and put into production.
The company was renamed as Sunshine Guojian Pharmaceuticals (Shanghai) Co., Ltd.
Construction of the 6 x 5,000L antibody drug production line in compliance with EU standards in China was completed.
The 2 x 3,000L antibody drug production line in compliance with EU standards in China was certified by the new GMP and put into production.
The “National Engineering Research Center of Antibody Medicine” was established, which was led by the company and approved by the National Development and Reform Commission.
The first all-human antibody drug in China, YISAIPU, was approved to be on the market, which was the first tumor necrosis factor (TNF-α) inhibitor in the field of rheumatism in China, marking a Chinese company has for the first time penetrated into fully human therapeutic antibody drugs.
The 3 x 750L antibody drug production line with GMP certification was put into production in China.
The Shanghai CP Guojian Pharmaceutical Co., Ltd. was founded.