July 5th, 2021, the NDA for Pucotenlimab (HX008) of LEPU BIOPHARMA as the second-line treatment for melanoma was formally accepted by the Center for Drug Evaluation (CDE).
Apart from PD-1 drugs in its product pipeline, LEPU BIOPHARMA has also preempted to launch differentiated and competitive antibody-drug conjugates (ADCs) R&D projects of EGFR ADCs, CD20 ADCs and TF ADCs, etc. LEPU BIOPHARMA now boasts ADC technology platform, antibodies finding platform as well as analysis and development platform to provide essential supports and guarantee for continuously developing innovative antibodies and ADC products. Regarding production, LEPU BIOPHARMA is now advancing the phase I construction of its Shanghai biological park. This production facility consists of a 12000 L capacity bio-pharmaceutical production line and supporting laboratories, which will be put into production by the end of 2021.
As for the core management team, Dr. Pu Zhongjie, founder of LEPU BIOPHARMA, has laid down the prospective strategic blueprints and differentiated competitive strategies for the company based on his decades of experiences in bio-pharmaceutical industry. Led by Dr. Pu, members of core management team are all highly qualified in business such as corporate strategy, drug discovery, clinical development, drug administration and registration. Furthermore, LEPU MEDICAL, one of the major shareholders, will play a synergy role in commercializing products of LEPU BIOPHARMA with the help of its well-established R&D and marketing experiences.
In the future, LEPU BIOPHARMA will definitely make a strong presence in China’s antineoplastics market thanks to its innovative product planning and development, established technology platforms, sufficient production supports as well as useful experiences and resources shared by the management team.
Source from PharmNote