Huahai Pharmaceutical's PIV patent challenge succeeded, and preparations ushered in the "Golden Era" of export!

Recently, Huahai pharmaceutical announced that the 7.5mg anda of paroxetine capsule submitted by Prinston has been approved Paroxetine capsules were developed by noven and listed in the United States in 2013 At present, only patented products are sold on the market in the United States, while this product has not been listed in China According to relevant data, the sales volume of paroxetine capsule in the U.S market in 2016 was about US $25 million It is understood that paroxetine capsule is used to treat vasomotor symptoms (VMS) in moderate to severe menopausal women VMS, commonly known as "hot flashes", although not life-threatening, but disturbing, can cause discomfort, sleep disorders and other symptoms Paroxetine capsule is the only FDA approved non hormone drug for the treatment of menopausal women VMS It is a selective serotonin reabsorption inhibitor (SSRI), which is a generic drug of Paxil, a drug owned by GSK Paxil was approved on December 29, 1992, and reached a sales peak of 2.06 billion pounds in 2002 However, Paxil began to face generic competition in 2003 Global sales of GSK's paroxetine fell to £ 206 million in 2016, according to minenet Figure: 2009-2016 global sales of GSK paroxetine (£ 100 million) (data source: performance database of MNE), the first successful generic drug challenged by patent in China Paroxetine capsule is one of many andas in Huahai pharmaceutical industry, but this anda is enough to make a small feat in the history of Chinese pharmaceutical export, because it is the first successful generic drug challenged by PIV patent in China Huahai pharmaceutical has officially won the Anda this time, which is a complete victory over its competitor Actavis Before that, paroxetine capsule was mainly imitated by two companies, Huahai and atweis, both of which were qualified for the first imitations However, the approval path of patent challenge of the two companies was quite different Atvis got the Anda number first, while Huahai knew the court's decision first On June 20, 2017, paroxetine capsule of atvis officially obtained the Anda number (207139) issued by FDA, but its patent challenge lawsuit is still in progress, and there is no judgment result Huahai obtained the judgment result on June 14, and now officially obtained the Anda number, it can be listed directly without risk The challenge of paroxetine capsule patent and the success of Anda are of double significance to Huahai pharmaceutical industry On the one hand, the patent challenge has successfully proved that Huahai pharmaceutical has established a good patent litigation system At present, Huahai pharmaceutical has 100 research projects of generic drugs, involving 40 patent challenges, of which 25 products have the first chance to be imitated and listed The subsequent varieties can learn from the experience of paroxetine capsule On the other hand, according to the current conformity assessment policy of generic drugs, drugs produced and listed in the same production line in China and approved for listing in the EU, the United States and Japan are deemed to have passed the conformity assessment after being reviewed by the State Food and Drug Administration and inspected on the production site In other words, Huahai pharmaceutical can take the development strategy of "export to domestic sales" to seize the market As a leading enterprise for domestic pharmaceutical enterprises to expand international market, Huahai pharmaceutical started its internationalization strategy in 2004 and applied for anda number in the United States Up to now, in addition to the four products approved this year, Huahai pharmaceutical has 43 products with anda number (25 of which have been listed in the United States) It is expected that the number of approved anda this year is expected to exceed that of 2016, and the ever-growing product mix of pharmaceutical exports will contribute to the growth of performance Table: in 2017, the Anda document number semi annual report of Huahai pharmaceutical revealed that the net profit increased by 14.12% year on year, and Huahai pharmaceutical continued to accelerate the pace of industrial transformation and upgrading, promote the strategy of preparation globalization, and improve and optimize the two industrial chains of preparation and API Now it has formed a series of products with cardiovascular, cerebrovascular, nervous system and antiviral as the leading products The main products are losartan potassium tablets, paroxetine hydrochloride tablets, donepezil tablets, ropinirol tablets, lamotrigine sustained-release tablets, doxycycline sustained-release tablets, duloxetine enteric sol capsule, etc According to the data disclosed in the semi annual report, in the first half of the year, Huahai pharmaceutical achieved a revenue of 2.35 billion yuan, a year-on-year increase of 18.53%; a total profit of 326 million yuan, a year-on-year increase of 13.69%; and a net profit of 295 million yuan, a year-on-year increase of 14.12%, attributable to shareholders of listed companies With the accelerated process of domestic drug approval, Huahai pharmaceutical has continuously expanded its domestic sales team and channels in recent years In the past, the domestic sales of Huahai pharmaceutical industry was mainly agency, but now it needs to switch to self-supporting team mode, which is in the period of sales adjustment and cost input, so the cost growth is relatively fast In the first half of 2017, sales expense, management expense and financial expense totaled 957 million, accounting for 40.72% of revenue During the reporting period, Huahai pharmaceutical still increased its R & D efforts In clinical research, we will work with Enze medical and Taiwan Jiasheng to build phase I clinical research center and bioequivalence (be) test center, which is the largest in Zhejiang Province and meets the international mainstream market standards such as Europe, America and Japan In addition, the research on new biological drugs and similar drugs has been steadily promoted, among which the recombinant human vascular endothelial growth factor receptor antibody fusion protein eye injection (for macular degeneration) has obtained clinical approval Conclusion in recent years, Chinese pharmaceutical products seem to usher in the golden age of going to sea The representative enterprises such as Huahai and Hengrui are also stepping into more difficult varieties step by step It can be predicted that in the future, more pharmaceutical companies will launch PIV patent challenges with high technology content to the original pharmaceutical research enterprises.