Qilu Network Lightning News June 25, 25, guided by the Shandong Provincial Department of Industry and Information Technology, Science and Technology Department, yantai municipal bureau of industry and information technology, science and technology bureau, market supervision bureau, Yantai MacBayrie to undertake the biomedical industry new format construction site promotion and antibody drug innovation and entrepreneurship community member conference was held in Yantai. Macbury's role as a undertaker has once again attracted attention.
Macbury stands on the "C position" of the new format of the province's biomedical industry
As the first professional biological drug research and development and production service (CDMO) company in Shandong and the second in China to obtain a drug production license for bioengineering products, MacBerry stands on the "C position" of the new format of the province's biomedical industry.
It is revealed that Macbria has more than 50,000 square meters of production facilities, including 12 antibody drug research and development production lines, the maximum reactor size is 2,000 liters, which can simultaneously carry out the commercial production of multiple antibody drugs; the coupling scale of ADC (antibody drug conjugates) drugs reaches 150 liters, which is currently the largest in Asia; it is the second biomedical CDMO company in the industry with its own antibody and ADC preparation line, which truly realizes the full chain service capability of ADC drugs from early development to commercial production. It can help customers greatly accelerate the progress of drug listing and seize market opportunities.
Shimai Pharmaceutical is one of Thermas's beneficiary customers. On August 4, 2020, its DNV3 project was approved for clinical trials by the State Food and Drug Administration. Xiao Zuoxiang, Chairman of Shimai Pharmaceutical, said: "McBrielas completed the CMC work of the DNV3 project on schedule and with high quality, especially in the use of Macbury's medium with independent intellectual property rights and Fed batch mode, the product reached a high expression capacity of 8.1g/l, which significantly reduced the production cost. ”
Run out of CDMO acceleration
When presiding over the keynote speech of the conference, Maberia Chairman Fang Jianmin said that Macberian ran out of the CDMO track acceleration with first-class equipment, excellent technical strength, perfect quality system and experienced team.
Chairman of Mabury Fang Jianmin
Macbury President Li Xinfang
In his keynote speech, Li Xinfang, President of Macbria, said: "The Macbria team has accumulated rich experience and has undertaken nearly 60 comprehensive projects, of which more than 20 projects have obtained FDA, NMPA, TGA clinical trial approvals, many customers have used the samples provided by Macbury to carry out Phase II clinical trials in the United States and Australia, and dozens of projects are carrying out clinical trials in China, effectively promoting the research and development and listing of a number of biological new drugs at home and abroad." "Dr. Li Xinfang has worked for the world's first company to engage in the development of ADC new drugs for more than ten years, participated in the process characterization and commercialization of several monoclonal antibody and ADC projects, and presided over more than a dozen antibody and ADC new drug research and development projects (all of which declared IND in the United States and Europe).
It is understood that Yantai Macbriam International Biomedicine was established in 2013, and currently has three R&D and production bases in Yantai, Shanghai and San Diego (USA), which can provide global customers with one-stop services for monoclonal antibodies, double antibodies, fusion proteins, ADC drugs and other biological macromolecules from research and development, production to clinical and marketing declaration. In 2018 and 2020, Macbria has completed series A and B rounds of financing, raising 900 million yuan. In 2020, the company signed more than 30 comprehensive projects, with contract signings increasing by more than 60% year-on-year and sales revenue increasing by more than 50% year-on-year.
Lightning News reporter Liu Yuliang Yantai reported