The company's subsidiary, xinlitai, with a capital increase of RMB 550 million, began to fight back?

Source: Xinkangjie 2017-12-08 medical network December 8 news "recently, xinlitai released a notice to increase its own capital of RMB 550 million to Suzhou Jinmeng Biotechnology Co., Ltd., with its equity increased from 58.60% to 84.27%, further accelerating the development of biopharmaceuticals and the transformation of achievements In the past 17 years, xinlitai has a clear strategy, focusing on cardiovascular and cerebrovascular drugs and antibiotics In recent years, the strategy of "developing biopharmaceutical sector" has been put forward in the annual report for many times Now, xinlitai has invested another 550 million yuan in the subsidiaries of biopharmaceutical sector What signals have been released? " Troika Taijia: 18 days ahead, 20 billion achievements Since its listing in 2000, clopidogrel (trade name: Taijia ®) has brought more than 20 billion yuan of sales revenue to xinlitai According to CMH data of Zhongkang, in 2016, only one product of Taijia accounted for 58% of xinlitai's terminal sales It can be said that xinlitai is a "magic medicine" that has been around the world "20 billion in 18 days" comes from its generic drug Taijia The original drug clopidogrel was patented in France in 1990, while China amended the patent law in 1992 to recognize the overseas drugs that obtained invention patents after 1993 The overseas patent drugs from 1986 to 1993 need to apply for administrative protection from the Chinese government alone On September 1, 2000, 18 days before Sanofi obtained administrative protection in China, xinlitai obtained the production approval of clopidogrel, thus obtaining the exclusive production right of 8 years Sanofi applied for administrative protection until May 2012, which lasted for 12 years, and the domestic market was divided by Tredegar and Plavix After the patent expires in 2012, more and more enterprises enter the office to eat the "fat meat" Xinkangjie inquired on CFDA's official website and found that up to December 6, 2017, there were 67 domestic enterprises applying for approval of clopidogrel generic drugs The market is worried that "Taijia" cannot be parried in the fierce competition and its position is not guaranteed According to the financial report, from 2009 to 2016, xinlitai's revenue increased from RMB 850 million to RMB 3.833 billion, an increase of 4.5 times; its net profit increased from RMB 216 million to RMB 1.396 billion, an increase of 6.5 times But in 2016, PE was only about 19 times, the lowest level in history Performance is growing, but valuations continue to decline Unexpectedly, a document made the plot reversed In August 2015, the State Council issued a document to open the curtain of "consistency evaluation", requiring the quality consistency evaluation of chemical generic oral solid preparations in the national essential drug catalog approved before October 1, 2007 to be completed by the end of 2018 As of December 6, 2017, through the inquiry of CDE official website, we can see that Taijia is in the process of conformity evaluation queuing review It is worth noting that in the list of priority reviews published on June 1, 2017, clopidogrel from Eurasia was shortlisted In case of no accident, Ouyi will take the first clopidogrel to pass the consistency evaluation However, in the short term, it is hard to shake the market position that xinlitai has consolidated for many years Tegrilol: Launch patent challenge and lose the best trial Tegrilol is the most powerful competitor of clopidogrel Tegrarol is a commonly used antiplatelet drug in clinic, which has obvious advantages in clinical mechanism and is the next generation of clopidogrel In 2016, tegrillo's global sales reached $839 million The original manufacturer of tigrillo is AstraZeneca, whose patent in China expires in May 2019 Xinlitai tries to obtain the qualification of early listing through the patent challenge On April 27, 2017 and June 22, 2017, the company respectively challenged the compound patent and crystal patent, and obtained the quick report At present, the intermediate patent challenge is steadily advancing   CDE official website shows that more than 30 enterprises have applied for clinical trials and generic production of tegrerolo Sinopharm group, Nanjing Youke and xinlitai have successively submitted generic applications Xinlitai has applied in accordance with category 3 + 4 After being put on record, it has taken the lead in conducting and completing bioequivalence experiments, and submitted its first listing application on March 9, 2017 Sinopharm group and Nanjing Youke have applied on March 23 and 5, respectively Application filed on 11 On November 22, 2017, CDE announced the list of priority review procedures to be included, and tigrillo of xinlitai was successfully shortlisted, but on December 6, Xinkang community found that tigrillo of xinlitai had disappeared from the list by querying CDE official website At present, tegrilol tablets are in line for review and approval The serial number of xinlitai is 213 (4105 at the time of submission), the number of Shiyao group is 224, and the number of Nanjing Youke is 256, ranking the first in tegrilol approval team Rivaroxaban: in phase be, the original research drug of rivaroxaban is Bayer's bairituo, with global sales of 4 billion US dollars in 2016, ranking 40 in the top 100 global drug sales In 2009, rivaroxaban was listed in China, with a patent period up to 2020 As an exclusive product, the sales volume of bairituo continues to rise after it is listed in China By the end of November 2017, about 20 domestic enterprises are applying for registration of generic drugs of rivaroxaban, among which 6 enterprises, including xinlitai, Zhengda Tianqing, Sichuan Kelun, are in the be test stage Two legs: R & D + acquisition in 2008, xinlitai bought bevaludine for injection from PLA General Hospital and Hebei Yuansen pharmaceutical, and obtained the exclusive production approval of bevaludine (teganine ®) in 2010 to replace heparin However, because the price is tens of times higher than heparin, and it is not included in the medical insurance catalog, the performance of teganin has not met expectations In 2012, xinlitai purchased alisartan ester, a new class 1.1 drug of Shanghai Ellis, with a total of 810 million yuan Alisartan ester was listed in 2013 under the trade name of sinritan, with patent protection period up to 2026 In 2017, alisartan ester was listed in the medical insurance catalogue, which was beneficial to the large quantity of sinostat But because the base is too small, the profit contribution to the enterprise is limited in the short term Xinlitai said to the outside world that it is confident that xinlitan ® can quickly enter the heavyweight products with annual sales of one billion, change the status quo of xinlitai's unique medicine, and comprehensively improve the valuation In 2014, xinlitai purchased fugliptin benzoate from Chongqing fuchuang pharmaceutical R & D Co., Ltd., a subsidiary of Fosun, for RMB 25 million Vogliptin benzoate, an inhibitor of DPP4, is one of the most concerned branches in the field of oral diabetes At present, DPP4 inhibitors that have entered the Chinese market include jienuwei and jienuoda of mosadong, anlize of AstraZeneca, nihina of Takeda, otanning of Lilly, etc There are 42 DPP4 drugs in clinical trials, and xinlitai is carrying out phase II and phase III clinical trials Other competitors include hausen, Sihuan pharmaceutical, Kelun pharmaceutical, LVYE pharmaceutical, etc In 2014, through the acquisition of Chengdu Jinkai Biotechnology Co., Ltd and Suzhou Jinmeng Biotechnology Co., Ltd., xinlitai established a new and innovative platform for the production and research of biological drugs, and introduced products such as recombinant human parathyroid hormone and recombinant keratinocyte growth factor On December 5, 2017, xinlitai released an announcement to increase its own capital of RMB 550 million to Suzhou Jinmeng Biotechnology Co., Ltd to further accelerate the development of biological drugs and the transformation of achievements In addition to purchasing varieties, since 2014, xinlitai has significantly increased R & D investment, consciously stepped up product storage, and formed product echelon in high-end innovative drugs and biological drugs