Bio-Thera is a science-driven, innovative global biopharmaceutical company based in Guangzhou, China. Guided by “Innovation for Life” and discoveries in modern bioscience, we develop next-generation innovative medicines and biosimilars for cancer, autoimmune, cardiovascular, ophthalmic and other serious diseases.

The company was listed on the Shanghai Stock Exchange STAR Market in February 2020 under stock code 688177. Patients’ well-being is our foremost value.

Through innovative research, we strive to provide safe, effective and affordable medicines that address unmet treatment needs.

As a leader in global antibody drug development, Bio-Thera has advanced multiple medicines to approval. BETAGRIN? (bevifibatide citrate) is approved in China.

Adalimumab (UK brand: QLETLI?; Chinese brand: 格乐立?) is approved in China and the United Kingdom. Tocilizumab (US brand: TOFIDENCE?; Chinese brand: 施瑞立?) is approved in China, the United States, the European Union, Switzerland and the United Kingdom.

Bevacizumab (US and EU brand: Avzivi?; Chinese brand: POBEVCY?; Brazilian brand: Bevyx?) is approved in China, the United States, the European Union and Brazil. Ustekinumab (US brand: STARJEMZA?; European brand: USYMRO?; Chinese brands: 艾沙力? and 喜沙立?) is approved in China, the United States, the European Union and the United Kingdom.

TOFIDENCE? became the first monoclonal antibody developed and manufactured by a Chinese pharmaceutical company to receive US FDA marketing approval. Several additional candidates are in late-stage clinical trials.

In oncology, the company focuses on immunotherapies for the post-PD-1 era and targeted antibody–drug conjugates (ADCs). Bio-Thera puts patients’ well-being first, pursuing innovative research to provide safe, effective and affordable medicines for unmet treatment needs.

Our management team brings extensive experience in drug discovery, manufacturing and commercialization. Under its scientific and technical leadership, Bio-Thera has overcome key technical challenges and built a broad pipeline in oncology, autoimmune, cardiovascular and ophthalmic diseases.

Our manufacturing base meets the quality management system standards of China’s NMPA, the US FDA, the European EMA and Brazil’s ANVISA. Our highly qualified, multidisciplinary team includes experts with international backgrounds and extensive experience in drug development and pharmaceutical management.

Core technical team members have been recognized by the National Major Talent Program, Guangdong’s first group of Leading Science and Technology Talent, Guangzhou’s Leading Innovation and Entrepreneurship Talent, Guangzhou Outstanding Experts, Guangzhou Development Zone Leading Science and Technology Talent, Huangpu District Outstanding Talent, Guangdong’s Pearl River Talent Program for Leading Innovation and Entrepreneurship Teams, Huangpu District Elite Talent, and Guangzhou’s Industrial Development and Innovation Talent Program for urgently needed specialists.

The company’s Antibody Industrial Park in Yonghe Development Zone, Guangzhou, covers approximately 40,000 square meters. Total completed and operational capacity is 66,500 L: six 6,000 L stainless-steel bioreactors with two downstream purification lines; four 4,000 L and two 3,500 L stainless-steel bioreactors; and three 2,000 L and three 500 L single-use bioreactors, each group with associated downstream purification lines.

Additional facilities include a 200 L ADC conjugation reactor with an isolator system and purification line; an integrated vial washing, drying, filling and sealing line for sterile injections; a prefilled syringe filling line; a lyophilized formulation line; a high-speed prefilled syringe line with an intelligent isolator; and a high-speed vial line. Construction of the Yonghe Innovation Industrial Base is accelerating, with 72,000 L of additional monoclonal antibody capacity planned.

On completion, the company’s total capacity will rank among the leading biopharmaceutical manufacturers in China. The base will support innovative medicines and biosimilars planned for launch over the following five years, reinforce manufacturing cost advantages and support expansion in domestic and overseas markets.