GC Pharma, a major Korean biopharmaceutical company, is facing a further delay in winning U.S. approval on its blood derivatives IVIS-SN as it recently received a second Complete Response Letter (CRL) notification from the U.S. FDA.
The company completed the submission of supplementary data in March 2018 after receiving the first CRL notice in November 2016. GC Pharma is to discuss the resumption of approval scheduling with the FDA this month. In light of the past cases of Celltrion and Daewoong Pharm, GC Pharma will have to resubmit supplementary data within 90 days of the second CRL notice. Approval is to take at least six months after the resubmission of supplementary data, meaning that U.S. approval on IVIG-SN could come as early as the second quarter of 2019.
Yet according to NH Investment & Securities, while Celltrion’s case involved a cGMP issue and Daewoong Pharm’s case was about a supplementary data issue, GC Pharma’s situation concerns a manufacturing process. The reason why it took more than one year to submit the first set of supplementary data (following the November 2016 CRL notice) was that a pilot batch had to be newly manufactured. Thus, if the second CRL notice also necessitates additional batch production, approval may again be delayed for another one year. If so, the start of operations at the firm’s new Canadian blood derivatives production plant, which was completed in October 2017, could be further disrupted.
As a result, NH Investment & Securities advises investors to adopt a conservative approach towards GC Pharma’s shares until the FDA’s supplementary data requirements are set and guidelines for the approval schedule are drawn.