Generics: "3-1" changes to "4-1", ADD ANOTHER MEMBER TO THE ED MARKET

At present, Jiangsu Tianslidi Yi Pharmaceutical Co., LtdHedara non-opioid 4 generic drugs listing application in the State of NMPA is "certified completed - to be approved", but it is understood that the wholly-owned subsidiary Jiangsu Tianslidi Yi Pharmaceutical signed the "drug registration approval" on hedara non-tablets, which means that the domestic Hedadala non-market will be from the original "1 original research and 3 imitation" situation into a "1 original research"Tadalafi is a long-acting selective diesterase 5 (PDE5) inhibitor developed by Lilly, the trade name "Cialis" (Chialysi), was first approved for the treatment of erectile dysfunction (ED) in men, but was later approved by the FDA for the treatment of pulmonary hypertension (PAH) (2009) and benign prostate hyperplasia (BPH) (2011)Hedarafi was approved by THE EMA in 2002, FDA in 2003 and entered the domestic market in 2005And in June 2007 and January 2008, he successfully approved the "once daily use" dosage form in Europe and the United States, opening a new model of ED treatment: from the traditional model of on-demand use to a more personalized treatment model breakthrough, from "physiological function improvement" to "physical and mental balance" upgradeHowever, he was late to market in China with the "once daily use" dosage, which was not listed in China until 2013as the world's first long-acting PDE5 inhibitor,, he was recommended by medical guidelines from many countries and regions as a first-line treatment drug for ED, and its sales have grown year by year since its launch, making it a heavy product of LillyUntil 2013, however, he had been less than Sidinafi (the commodity name Wan Aico), but since then he has been anti-Sidinai, exploring the reasons, not only because of its fast effect, long duration of effect, absorption is not affected by food, but also because of the introduction of the "once use" dosagein the country, before he Dara non-market belongs to the "1 original research and 3 imitation" situation (see the table below), in which Changchun Haiyue in February 2019 took the lead in taking the first imitation of he Darafi, Nanjing Zhengda Tianqing, Qilu followed closely behindHowever, since the approval of the Tianshi Li Tadala non-film, the domestic Tadaranon market will become "one original research and 4 imitation" situationAnd according to the insight database, Lilly, Qilu, Changchun Haiyue Hedara non-parts of the specifications have been in some areas of the winning bidin addition, in addition to the above-mentioned has been approved by the four domestic enterprises, according to the insight database, there are more than 40 domestic enterprises in the layout of the field, of which more than 30 are tablets, 3 are oral instant film agents, 1 chewing tablets, which can be foreseen in the future in this field of market competition will be more intensein fact, in the domestic approved treatment of ED PDE5 inhibitors, in addition to Hedarafi, there are wideadens and the above mentioned to West Dinafi, which is notable for the west of NafeiThe non-original research manufacturer of Sidina is Pfizer, the commodity name Wan Aike, is often said to be "Viagra", first approved in the United States in 1998, entered the domestic market in 2001, after which almost monopolized the entire domestic ED market, until 2014 Baiyun Shanxi Dina non-generic drug "Golden Go" listing, Wan Ai ke growth rate began to decline, but is still China's ED market (refers to All of China's local cities and cities and above) sales of the largest real-world marketAnd so far, according to the insight database, a number of domestic enterprises have obtained the west of the non-generic drug qualification, more than a dozen enterprises in the listing application, the future competition is also very fierceand the non-original research manufacturer of the wildina is Bayer, the commodity name Alida, entered the market in 2003 Although Alida has the fastest start-up time compared to Van Aico and HeiEr, the post-ipo report card is not bright, with global sales of just 226 million euros ($264 million) in 2015 References: the insight database , CDE, NMPA official website