Expected hierarchy of newly approved drugs market in 2015

Source: the backlog in the review of pharmaceutical economic news 2016-03-16 has always been one of the most troubling issues for CFDA According to public data, the backlog of reviews at the peak of 2014 exceeded 30000 Low level repeated declaration is undoubtedly the primary factor leading to a large number of reviews Drug approval is one of the core competitiveness of pharmaceutical enterprises, and enterprises are generally keen to increase the number of drug approval in their hands For example, for listed pharmaceutical companies, any information that obtains clinical approval or production approval will be disclosed in a timely manner At present, there are more than 6000 pharmaceutical factories and drug R & D institutions in China If each company only applies for one piece per year, CFDA will also receive more than 6000 applications According to the review report of CDE in 2014 (peak year of review backlog), the number of new declaration manufacturers in 2014 exceeded 100 for 8 chemical drugs, including esomeprazole and atorvastatin CFDA is also looking for solutions to the problem Since the second half of 2015, CFDA has greatly strengthened the inspection of clinical trials, and a large number of clinical applications have been withdrawn or rejected On the other hand, the information publicity has been strengthened to guide enterprises to rationally carry out new drug research and development At the beginning of 2016, the official released the application and approval information in 2015 in a timely manner After the information is made public, it can make each applicant more clear about the application status and reduce repeated investment At the same time, data disclosure can also reduce the operation of dark box and ensure the transparency of information [part I] overview of approved drugs in 2015 according to the statistics of CFDA in 2015, there are 342 kinds of drugs approved in the whole year, and the number of declared drugs has been decreasing for the third year since 2013 However, in terms of classification, the number of traditional Chinese medicines that have been suppressed in the past few years seems to be elated, and the number of approved drugs has tripled; in addition, the number of approved biological drugs has also increased The reduction of more than 100 approved drugs is undoubtedly due to the "contribution" of chemical drugs In 2015, the number of approved chemical drugs decreased by 180 The sharp drop in the number of approved chemicals is closely related to the withdrawal of a large number of varieties in the second half of the year Although the number of approved traditional Chinese medicine has increased significantly, many varieties have been approved by the same manufacturer A large number of imitated traditional Chinese medicines have been approved in a centralized way, undoubtedly benefiting from the centralized evaluation system in 2015 The national TCM plan released at the beginning of 2016 is undoubtedly exciting for the TCM industry, but the R & D bottleneck of traditional Chinese medicine still restricts the development of traditional Chinese medicine, and class 1 new drugs and even class 5 and 6 new drugs are still hard to find Compared with traditional Chinese medicine and chemical medicine, biological medicine still plays a small and refined role - the number of approved drugs is small, but there are many excellent ones Among the 342 newly approved varieties, 203 were approved, including 75 traditional Chinese medicine, 111 chemical medicine and 17 biological medicine, after excluding the APIs and non therapeutic drugs and combining different specifications of the same variety from the same manufacturer Traditional Chinese medicine: the number of approvals has increased greatly 75 newly approved traditional Chinese medicines including 26 varieties need to be paid attention to when applying for clustering, most of which are declared varieties For example, Diyu Shengbai capsule comes from 10 manufacturers; gushongbao tablet / pill comes from 8 manufacturers; Tiaojing Quban tablet / pill comes from 8 manufacturers; rupishu tablet comes from 13 manufacturers Compared with generic drugs and simple modifier drugs, it is more difficult to get approval of new Chinese medicine However, in 2015, the number of new drugs approved for traditional Chinese medicine increased significantly, with a total of 6 Three varieties were approved, including Tribulus terrestris capsule of Changbaishan pharmaceutical, Danlu capsule of Suzhong, huaiqin ointment of Shandong zhongdaqianfang, Jianghuang Tongluo capsule of Hebei Medical University Pharmaceutical Factory, Wuwei Kushen enteric coated capsule of Beijing Zhonghui, and Shouhui defecation capsule of Lunan Houpu Tribulus terrestris capsule is worth looking forward to as five new drugs Chemical medicine: there is a lack of bright spots in domestic varieties Of 111 chemical medicine varieties that are imported heavily, 12 are the exclusive varieties for multinational enterprises to enter China for the first time Among them, Pfizer's axitini, patheon's abitrone, Servier's ivabradine and other varieties have made outstanding achievements abroad, and the Chinese market is also worth looking forward to In addition to the original drugs, most of the remaining varieties are generic drugs However, unlike traditional Chinese medicine, it seems that the centralized review has not been "tied up" with chemical drugs Only Flupentixol, fasudil hydrochloride, palonosetron and clindamycin phosphate for injection have been approved by three manufacturers respectively, while most of the other generic drugs have only been approved by one or two manufacturers Among the varieties declared in China, there are also some newly listed varieties in China, including omeprazole sodium bicarbonate of Xiamen Encheng, parenteral nutrition injection (25) and arginine glutamic acid injection of HISCO, and oprenon injection of Hebei aierhaitai In addition, Huabang's tazarotene betamethasone cream is the only approved domestic class a new drug in 2015 Biopharmaceutics: Six first-time varieties, 17 of which are independently developed by vaccines, including albumin, influenza vaccine, rabies vaccine and other drugs produced by multiple enterprises, as well as six first-time varieties entering China The approval of genizan's glucosidase α for injection under Sanofi has brought good news to the patients with Pompeii disease in China; the recombinant human TNK tissue plasminogen activator for injection by Guangzhou Mingkang biological Co., Ltd has been approved for the first time in China as a class 7 new biological drug, which is a specific drug for acute myocardial infarction Compared with therapeutic biological drugs, China's independent research and development in the field of vaccines was more brilliant in 2015, with a number of new drugs approved, mainly for polio and HFMD Among them, Sabin strain polio inactivated vaccine of Institute of biology of medical college is the first independently developed inactivated polio vaccine in China and the first Sabin strain polio inactivated vaccine in the world In addition, two inactivated vaccines for HFMD enterovirus 71 have also been developed successfully, among which the inactivated vaccine of enterovirus 71 cultured by human diploid cells used in biology of medical college is very worthy of expectation [Part 2] the fate of the four varieties is different The listing of new products is undoubtedly of great significance to pharmaceutical enterprises However, the market expectation of 203 varieties approved in 2015 is very different We can divide them into four categories: Star varieties, growing varieties, competing varieties and sunset varieties It is undoubtedly the dream of new products to enter an unsatisfied market with high clinical demand, or a market with huge market capacity but lack of competitive varieties For example, in 2014, sovaldi, the second largest drug in the world with an annual sales of 10 billion US dollars, entered the field of hepatitis C treatment with a large number of patients, but there was no ideal solution for a long time The treatment plan of pegylated interferon combined with ribavirin was not ideal, sovaldi The entry of hepatitis C has brought hope to a large number of patients, who no longer need to inject interferon for years Entering such a market will undoubtedly get the key to becoming a "star variety" Among the varieties approved in 2015, traditional Chinese medicine lacks such varieties, but there are several varieties of chemical medicine and biological medicine with good opportunities The representative varieties include imported abitrone, the first domestic linezolid and human follicle stimulating hormone, and the inactivated enterovirus 71 vaccine (human diploid cell) independently developed in China Patheon: the incidence rate of the prostate cancer is increasing rapidly The patient's eagerly anticipated China's listing of the company is undoubtedly one of the most clinically marketable drugs in 2015 The drug is the second most common treatment for prostate cancer in Western men China incidence rate of prostate cancer is relatively low, but the incidence rate has increased substantially in recent years Hormone and LHRH analogues are commonly used in the treatment of prostate cancer, but for castrated resistant prostate cancer, the effect of these drugs is not ideal For castrated resistant prostate cancer, the best drug is abitrone Abitrone is an androgen receptor antagonist, which can prolong the survival period of patients with refractory prostate cancer [trend comment] although abitron was approved in Europe and America in 2011, its application progress in China is slow A large number of online posts asking foreign countries to buy the drug reflect the expectation of domestic patients for the drug Considering that only four years after the listing of abitrone, the global annual sales volume has reached 2.2 billion US dollars, the market of the original research drug after being approved in China is worth looking forward to Indications of linezolid: severe drug-resistant bacteria infection enterprise: hausen pharmaceutical circle: the original research drug was out of stock, and the first generic drug is expected in the future Linezolid is one of the last choice for serious drug-resistant bacterial infections It is used in multi drug resistant bacterial infections with vancomycin, norvancomycin and teicoplanin Before the approval of the generic drugs, linezolid tablets and large infusion injections produced by Pfizer and freseniuskabi were only sold in China for a long time, and maintained a rapid growth until 2012 According to PDB data, the sales volume of the drug sample hospital exceeded 220 million yuan However, from 2013 to 2014, sales of linezolid decreased significantly, and the products were in short supply nationwide In 2015, the drug supply problem was solved, and the annual sales volume of sample hospitals is expected to exceed the peak in 2012 [comment on trend] during the period of shortage of linezolid, vancomycin and other competitive products have seen explosive growth However, the sales volume recovered rapidly after the normal sales, indicating a large market demand for linezolid The last nationwide shortage of linezolid had a huge impact on clinical practice Fortunately, the generic linezolid glucose injection of hausen has been approved in April 2015, which is expected to impact the market share of the original research drug at a lower price Indications of human follicle stimulating hormone: Infertility enterprise: Jinsai pharmaceutical circle: opening up the background of "two children", requiring blowout and opening up the "two children" in an all-round way In this context, the need to increase pregnancy opportunities through drug intervention has increased significantly, and the market opportunity of follicle stimulating hormone for infertility and other gynecology and Obstetrics Diseases has been further expanded as a common drug in this field In May 2015, Kinsey's recombinant human follicle stimulating hormone for injection was approved successfully, which belongs to recombinant human follicle stimulating hormone Before that, only one recombinant human follicle stimulating hormone preparation, gonaphene, was originally developed in China Other follicle stimulating hormones were all derived from urinary follicle stimulating hormone extracted from postmenopausal women According to PDB data, in 2014, the sales volume of guonanfen sample hospital reached 260 million yuan, and the sales volume of urofollicle stimulating hormone sample hospital also exceeded 100 million yuan