The product – known as as 'Jin'ge,' or "golden spear" in English – was launched this week and is the first non-branded version of Pfizer’s blockbuster erectile dysfunction tablet brough to market in China following the loss of patent protection in May.
GBPH said (here in Mandarin) it will sell one pack of Jin’ge for 48 yuan ($7.80) - which is 60% lower than the price Pfizer charges for Viagra in China – and signalled its desire to capture a share of the country’s erectile dysfunction drug market.
According to the China Daily the other difference from Viagra is that Jinge will be available as red, green, orange and pink pills.
QbD and development
GBPH said it produced its pill using the quality by design (QbD) concept, adding that it developed its own synthesis routes for the active pharmaceutical ingredient (API) in compliance with guidance in the US and European Pharmacopoeias.
The firm also sought advice from Nobel Prizer winner Ferid Murad, whose work on nitric oxide was key to the development of Viagra.
Local regulators were also involved according to GBPH, which said: “The Chinese Food and Drug Administration (CFDA) conducted a series of studies in regard to substance, the content, the dissolution behaviour [which it concluded were] consistent with the original research product.”
According to IMS Health, Pfizer’s blue pill generates $163m in sales in China and – in urban centres where data is available – holds nearly 60% of the country’s ED market ahead of Eli Lilly, whose drug Cialis has a 35% share, and Bayer’s Levitra which has the rest.