Medicilon assisted Zhejiang Bolaatu Medical Technology Co., Ltd on PA1010 tablets with implied permission for clinical trials

2020-03-15

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On March 10, 2020, PA1010 tablets, which are independently developed by Zhejiang Bolaatu Medical Technology Co., Ltd, obtained the implied license for NMPA clinical trials. This is the first new drug declared by Bolaatu. PA1010 is a new class I drug for chronic hepatitis B (CHB).

Zhejiang Bolaatu is a new drug research and development company under the Zhejiang Kangde Pharmaceutical Co., Ltd. Bolaatu is mainly focusing on hepatitis B and their major business is the development of antiviral drugs and asthma drugs.

Medicilon collaborated with Bolaatu in the research and development of PA1010 tablets and completed the related work of API development and quality research to accelerate the development of new drugs for PA1010 tablets.

Medicilon has established a platform for research and development of cGMP APIs and developed the GMP APIs for clinical trials for innovative drug companies. Medicilon vigorously develops new technologies and establishes a safety assessment laboratory in the process of drug substance synthesis, which meets the requirements of regulations and ICH guidelines.

❖ Medicilon’s preparation services

Medicilon's preparation laboratory and workshop area is about 4,000 square meters, with 100 professional R&D teams, of which more than 40% are masters/doctors, and more than 95% are undergraduates. The team has rich experience in successful research and development of innovative drugs, consistency evaluation, and improved new drugs, and experience in China-US dual filing and project management. The Medicilon pharmaceutical preparation R&D team has successfully cooperated with well-known large and medium-sized pharmaceutical companies worldwide, and has accumulated 18 years of experience in the research and application of innovative drugs and generic drugs. We provide one-stop and systematic preparation R&D services covering innovative drugs and generic drugs to meet the needs of customers at different stages of R&D.