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congratulations! tot biopharm’s cdmo partner medilink therapeutics yl202 clinical trial application received default approval from the fda

date time:2022-09-09

recently, tot biopharm’s cdmo partner, medilink therapeutics, announced that its self-developed innovative antibody - drug conjugates (adc) yl202 has received default approval from the fda to conduct clinical trials for the treatment of advanced solid tumors. tot biopharm expressed warm congratulations in this regard.

the approved adc, yl202, is the second product based on medilink therapeutics’s tmalin tech platform and is expected to provide new proof for the completion of clinical proof-of-concept for the tmalin tech platform, providing safer and more effective treatment options for tumor patients worldwide. as a trustworthy cdmo partner, tot biopharm has provided gmp-compliant formulation manufacturing services for yl202 clinical samples.

 

according to rich practical experience and mature technology platform and quality system, tot biopharm provides one-stop cdmo solutions for adc r&d and manufacture. we have accumulated extensive practical experience in the process development of products, especially for the late stage before put into market.

 

tot biopharm has gmp-compliant manufacture workshops for adc, stock solution and formulation, allowing key adc manufacture links to be completed in the same plant. at present, tot biopharm is building two isolator linkage lines in response to higher manufacture demand, one of which is specialized to adc commercial manufacture, equipped with two 20 m2 lyophilizes to deliver faster and more efficient cdmo services.

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