Two new hepatitis B projects of guangshengtang failed to be approved

In April 2014, China Securities Regulatory Commission disclosed the prospectus of Fujian guangshengtang Pharmaceutical Co., Ltd (hereinafter referred to as "guangshengtang") This enterprise, which specializes in the use of hepatitis B drugs, has three first-line drugs in the field of hepatitis B treatment However, the two new drugs (entecavir dispersible tablets and pantoprazole sodium enteric coated capsules) mentioned in the prospectus are not approved now Just last month, two failed notices of new drug approval were sent to guangshengtang from the national drug examination center, one of which is of great significance to the company's deep work in the field of hepatitis B drug use, and many enterprises have been approved Industry insiders pointed out that the failure of approval of mature varieties exposed the weakness of guangshengtang's R & D ability and government affairs ability Under the background of the aging of existing varieties and the weakening of competitiveness, it is very important for the company to succeed in applying for new varieties Two new drugs to be approved have failed Guangshengtang mentioned in the prospectus that entecavir dispersible tablets and pantoprazole sodium enteric coated capsules are in the period of approval In April this year, guangshengtang has received the review and approval documents of entecavir dispersible tablets and pantoprazole sodium enteric coated capsules The result is "it is recommended to maintain the original approval conclusion", which means that the approval is failed Industry insiders pointed out that these two new drugs are mature varieties produced by many pharmaceutical companies, and the technical threshold is not high This is not guangshengtang's first failure As early as June 2013, guangshengtang failed in the approval of the above two new drugs Soon after, guangshengtang applied for review of pantoprazole sodium enteric coated capsules and entecavir dispersible tablets, the specific stages of application were production and clinical In the prospectus, guangshengtang only mentioned that the review of pantoprazole sodium enteric coated capsules was more likely to fail, but the risk of entecavir dispersible tablets, a more core variety, was hidden later As an enterprise focusing on hepatitis B drugs, entecavir dispersible tablets are the mainstream varieties and dosage forms in the field of hepatitis B treatment Compared with the current main variety of the company - capsule, the absorption is faster, the price is higher, and the competition pattern is better Pharmaceutical companies have rich dosage forms, and will have more advantages in participating in provincial bidding For the failure of the approval of the two new drugs again, guangshengtang told the big wisdom News Agency: "the company has always adhered to a scientific and rigorous attitude to carry out the research and development of new drugs As for the specific reasons for the failure of the two drugs, it is recommended to consult the relevant government departments The company has made a prompt on R & D risk " "There are many reasons why the application for new drugs has been rejected," a researcher from a pharmaceutical company told the big smart news agency But if several enterprises have been approved for production, the ability of the dead pharmaceutical enterprises in R & D and government affairs is questionable " It is worth mentioning that as a small pharmaceutical enterprise, guangshengtang's R & D investment is not stingy From 2011 to 2013, guangshengtang's R & D investment was 9.9152 million yuan, 14.9658 million yuan and 15.555 million yuan, respectively, accounting for 9.44%, 11.90% and 8.73% of the current operating revenue, higher than the industry average of 5% to 7% of the R & D investment In addition, tenofovir dipivoxil maleate capsule and tenofovir dipivoxil maleate have entered the status of application for production approval in March 2014 As a new type of nucleotide reverse transcriptase inhibitor, tenofovir dipivoxil has a sales volume of more than US $1 billion, which has surpassed that of adefovir dipivoxil The market has gradually surpassed the first-line drugs such as lamivudine and telbivudine Guangshengtang, which takes hepatitis B medicine as the core, whether tenofovir's future research and development can win the laurel will directly affect the company's future growth to a large extent The renewal of core varieties is imminent, and the market competition is intensifying The main varieties of guangshengtang include agandine (adefovir dipivoxil), heganding (lamivudine) and engendine (entecavir capsule) The total sales revenue from 2011 to 2013 accounted for 97.30%, 98.71% and 99.36% of the operating revenue of the same period respectively At present, there is not a kind of effective medicine which can remove hepatitis B virus quickly and directly in the world There are two kinds of effective antiviral drugs: nucleoside and interferon Big wisdom news agency learned from the industry that guangshengtang's main three drugs are nucleoside, which has the disadvantages of high drug resistance rate and rapid replacement of new and old drugs According to the time sequence of listing, in 1999, lamidine opened a new era of nucleoside analogues in the treatment of chronic hepatitis B in China Adefovir dipivoxil of GlaxoSmithKline and entecavir of Bristol Myers Squibb entered China successively at the end of 2005 The change of sales proportion of gst-3 medicine can also clearly reflect the change of medicine "acting for talented people" From 2011 to 2013, the proportion of adefovir dipivoxil in the company's gross profit decreased from 84.9% to 48.71%, while the proportion of entecavir increased from the blank in 2011 to 31.19% in 2013 For adefovir dipivoxil, pharmaceutical companies are ready to update it The senior of Shuanglu pharmaceutical industry once said that it will take 4-5 years for adefovir dipivoxil to develop its drug resistance, which has been considered as an antiviral drug with a long life cycle The future growth of the drug may only be 1-2 years, and it needs to be renewed For the life cycle of three main varieties, guangshengtang said, "there is no direct correlation between drug life cycle and drug resistance In addition, entecavir and tenofovir are low resistance drugs We actively explore but do not predict the future development of pharmaceutical science and technology In addition, it is worth noting that since 2010, guangshengtang has adopted the direct sales mode in Beijing and Shanghai In order to strive for customers to expand the market, it has adopted the sales policy of "goods before payment" From 2013, the company began to gradually develop direct selling mode in some areas of Zhejiang Province, and adopted the collection policy of "goods first, payment later" This is the company's extraordinary move to expand the national market, but also exposed the company's competitive disadvantage outside the base market of Fujian A Shenzhen drug agent said that for prescription drugs, the supplier is relatively strong, and there is little phenomenon of first delivery and then payment, especially for hepatitis B prescription drugs The reason is usually that the market competition is fierce and the supplier is in a weak position Industry insiders pointed out that the market competition of hepatitis B drugs is fierce Compared with domestic and foreign giants, such as GlaxoSmithKline, Novartis, Zhengda Tianqing and other brand pharmaceutical enterprises, the competitiveness of GST is not outstanding At present, its market share is also small In 2012, the company's sales accounted for only 4.13% of the market share of antiviral hepatitis B drugs in China