Post by icemandios on Feb 2, 2016 16:25:41 GMT
TSRO licensed Varubi to Jiangsu Hengrui Medicine Co., Ltd on July 30, 2015. Varubi was approved by the US FDA on Sept. 5, 2015. And this is important as the press release made a point of stating:
"Rolapitant has not been approved by any regulatory agency."
Since Varubi/Rolapitant had not yet been approved in any country, Hengrui had the opportunity to apply to the China Food and Drug Administration (CFDA), for an expedited approval pathway, called a "Category I New Drug Application," which could potentially shave years off the time to approval. We do not know that Hengrui availed themselves of this option, but they are a significant, global player and it would be logical.
The following article compares and contrasts the two major approval pathways to CFDA approval and give particular attention to the advantage in terms of time to approval afforded by the category 1 process. (See the chart on page 6).
"OPTIMIZING DRUG REGISTRATION IN CHINA: CATEGORY I ROUTE
Category I New Drug Application
Given the limitations of the category III IDL route,
some developers are exploring the alternative—pursu-
ing a category I NDA based on a full development
program in China. The category I NDA is the default
registration pathway for domestically-developed new
drugs. The number of category I NDA approvals is
increasing, according to CFDA reports on annual drug
registration. New drug approvals rose to 10 in 2011,
“marking a significant increase compared to 2009 and
2010.”
According to a February 2013 CFDA report,
the CDE completed first-time review for 47 CTA appli-
cations for category I and II (new route of administra-
tion) drugs in 2012. Final disposition of these applica-
tions made in 2012 has not yet been reported. The
timelines for review look promising (see figure 1); more
than 70% were reviewed in eight months or less.
"Rolapitant has not been approved by any regulatory agency."
Since Varubi/Rolapitant had not yet been approved in any country, Hengrui had the opportunity to apply to the China Food and Drug Administration (CFDA), for an expedited approval pathway, called a "Category I New Drug Application," which could potentially shave years off the time to approval. We do not know that Hengrui availed themselves of this option, but they are a significant, global player and it would be logical.
The following article compares and contrasts the two major approval pathways to CFDA approval and give particular attention to the advantage in terms of time to approval afforded by the category 1 process. (See the chart on page 6).
"OPTIMIZING DRUG REGISTRATION IN CHINA: CATEGORY I ROUTE
Category I New Drug Application
Given the limitations of the category III IDL route,
some developers are exploring the alternative—pursu-
ing a category I NDA based on a full development
program in China. The category I NDA is the default
registration pathway for domestically-developed new
drugs. The number of category I NDA approvals is
increasing, according to CFDA reports on annual drug
registration. New drug approvals rose to 10 in 2011,
“marking a significant increase compared to 2009 and
2010.”
According to a February 2013 CFDA report,
the CDE completed first-time review for 47 CTA appli-
cations for category I and II (new route of administra-
tion) drugs in 2012. Final disposition of these applica-
tions made in 2012 has not yet been reported. The
timelines for review look promising (see figure 1); more
than 70% were reviewed in eight months or less.