Shanghai Henlius Obtained Second Monoclonal Antibody Drug Approval
On 28 April, Shanghai Henlius Biotech Company Limited (“Shanghai Henlius”), a corporation controlled by Fosun Pharmaceutical, officially received the second clinical trial approval issued by China Food and Drug Administration for the recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection under Shanghai Henlius, which has been developed specifically for indications for rheumatoid arthritis.
As a research and development platform of Fosun Pharmaceutical for macromolecular generic biopharmaceutical drug, Shanghai Henlius has been adhering to the R&D principles of prioritizing efficacy and efficiency by upholding international standards and implementing its R&D strategy of developing biological macromolecular drugs over the past 5 years. This approval is the second one granted to Shanghai Henlius for the clinical application for monoclonal antibody drug since its inception.
It is known that Shanghai Henlius has by far completed the registrations of clinical applications for five categories of monoclonal antibodies and seven types of indications, in addition to seven innovative monoclonal antibodies in the pipeline of R&D product line. All products of Shanghai Henlius currently under development are in fact the achievements of its in-house and multinational R&D team, and the various world-class R&D platforms for monoclonal antibodies covering a full spectrum of relevant technologies established by Shanghai Henlius set ground for such achievements. These platforms range from phage display libraries, antibody engineering, bispecific antibody platform, internal and external pharmacodynamics evaluation systems to development for the methodologies of quality analysis and structure validation, process development for products and pilot production in line with GMP standards.
As always, independent innovation remains the driving force for corporate development at Fosun Pharmaceutical. The company continues to focus on its innovative R&D while optimizing its innovative R&D system for medicine that integrates imitation and innovation. Meanwhile, Fosun Pharmaceutical is highly supportive of innovative R&D and committed to launching new products by constantly increasing investment in the “4+1” R&D platform. The company is a national-level enterprise technology center with highly efficient international R&D teams in Shanghai, Chongqing and the US.
As a research and development platform of Fosun Pharmaceutical for macromolecular generic biopharmaceutical drug, Shanghai Henlius has been adhering to the R&D principles of prioritizing efficacy and efficiency by upholding international standards and implementing its R&D strategy of developing biological macromolecular drugs over the past 5 years. This approval is the second one granted to Shanghai Henlius for the clinical application for monoclonal antibody drug since its inception.
It is known that Shanghai Henlius has by far completed the registrations of clinical applications for five categories of monoclonal antibodies and seven types of indications, in addition to seven innovative monoclonal antibodies in the pipeline of R&D product line. All products of Shanghai Henlius currently under development are in fact the achievements of its in-house and multinational R&D team, and the various world-class R&D platforms for monoclonal antibodies covering a full spectrum of relevant technologies established by Shanghai Henlius set ground for such achievements. These platforms range from phage display libraries, antibody engineering, bispecific antibody platform, internal and external pharmacodynamics evaluation systems to development for the methodologies of quality analysis and structure validation, process development for products and pilot production in line with GMP standards.
As always, independent innovation remains the driving force for corporate development at Fosun Pharmaceutical. The company continues to focus on its innovative R&D while optimizing its innovative R&D system for medicine that integrates imitation and innovation. Meanwhile, Fosun Pharmaceutical is highly supportive of innovative R&D and committed to launching new products by constantly increasing investment in the “4+1” R&D platform. The company is a national-level enterprise technology center with highly efficient international R&D teams in Shanghai, Chongqing and the US.