
Monoclonal Antibody Drug Research, Development, and Production


Recently, the National Medical Products Administration announced that Bevacizumab Injection – Anbeiyou, developed by Hualan Genetic, has been approved for marketing in China. The drug’s market entry is expected to provide more treatment options for cancer patients. Thus far, the number of projects supported by the Independent Review Committee (IRC) services provided by Taimei Medical Technology's Independent Review Center and subsequently approved has reached 33.

Source of the image: National Medical Products Administration
As an innovative drug widely used in the treatment of various cancers, bevacizumab's indications cover metastatic colorectal cancer, advanced, metastatic or recurrent non-small cell lung cancer, recurrent glioblastoma, hepatocellular carcinoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, and cervical cancer.
The Independent Review Center (IRC) of Taimei Medical Technology undertook the independent efficacy assessment work supporting the approval-related research this time. Relying on rich experience in independent efficacy assessment, a sound quality management system, an efficient digital collaboration system, and high-quality service with rapid response, the project results were delivered on schedule with high quality, assisting in product approval and receiving positive feedback from the sponsor.
Taimei Medical Technology sincerely congratulates its partner on their achievements and looks forward to Hualan Genetic continuing its success and creating further brilliance!
About Taimei Medical Technology Independent Review Center (IRC)
The Independent Review Center (IRC) of Taimei Medical Technology, relying on its self-developed eImage system, supports remote image review and evaluation, full online operation management for projects, and has a professional medical and project operation team as well as abundant resources of senior imaging medicine/image review experts both domestically and internationally. This ensures efficient, compliant, and accurate blind independent central image review, reduces review bias, improves the accuracy and reliability of review results, accelerates the trial process and approval, and lowers costs.
To date, the TMED Independent Review Center has accumulated experience in over 370 projects, served more than 150 sponsors, collaborated with over 700 research centers, and reviewed more than 430 million images.
In addition to common tumor types, IRC services are available in multiple fields such as the central nervous system, digestive system, cardiovascular system, and musculoskeletal system.
Supports multiple types of examination technologies such as CT, MRI, ultrasound, bone scan, and PET;
Covering more than 70 indications and 60 evaluation criteria;
With project experience in multiple countries (US, Australia, Japan), multiple tumor types, and multiple stages;
Subjected to more than 80 inspections by the national authority and external audits, with no critical findings.




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