How to dig the "virgin land" market with the help of priority approval of "fast lane" 7 varieties?

The priority review and approval procedure for excellent contents has opened a "convenient door" for the rapid marketing of drugs According to the 2016 drug review report, a total of 7 varieties (excluding APIs) have been approved for marketing So, why do these seven varieties get this preferential treatment? Can they take the lead in the "virgin land" market in the corresponding fields in the future? The reform of drug review and approval is being carried out vigorously, and the "encouraging innovation" achieved remarkable results in more than one year With the implementation of the priority review and approval measures, as of the end of last year, a total of 193 drug registration applications have been included in the "fast track" of priority review According to the 2016 annual drug review report issued by the drug review center of the State Food and Drug Administration on March 17, among the priority approval registration applications that have been approved, a total of 7 varieties have been recommended for listing 1 priority approval for children's drug use is favored In 2016, according to the opinions on solving the backlog of drug registration applications and implementing priority review and approval issued by the General Administration, 12 batches of 193 registration applications were included in the priority review process Figure 1: registration applications included in the priority review process As can be seen from Figure 1, there are 17 applications for children's drugs in the priority review process, accounting for 9% The shortage of children's drug use is not only a problem that arouses widespread concern of the society, but also a problem that national government departments and pharmaceutical industry need to overcome together The shortage of children's medicines is mainly lack of special and applicable dosage forms for children, which is also a global problem In order to solve the drug shortage of children, China has taken a variety of comprehensive incentives, and priority evaluation is one of them In addition, of the 57 priority review registration applications that have completed the review, 11 are recommended to be approved for listing (including 2 API registration applications) Table 1: application list of priority approval and registration that has been approved and recommended for listing It can be seen from table 1 that in the application list of priority approval and registration that has been approved and recommended for listing, there are 7 drugs in total (except for APIs, and there are 3 acceptance numbers for topiramab injection), 4 drugs for children, more than half of which are recommended for import 2 Children's drug use: it is urgently needed in clinic and contains market space It is suggested that the four children's drugs approved for import and production are respectively: trodzumab injection, concentrated solution for levetiracetam injection, megestat capsule and caffeine citrate injection, all of which are urgently needed in clinic Tobuzumab injection tobuzumab is a recombinant humanized monoclonal antibody against human interleukin-6 (IL-6) In March 2013, yamelob was approved as the first indication rheumatoid arthritis (RA) in China, which was used to treat moderate and severe active type with poor response, mainly for adult patients The indication of this increase of the drug is applicable to the treatment of systemic juvenile idiopathic arthritis (sJIA), which is mainly used in paediatric patients It provides the first treatment drug with clear efficacy and safety for paediatric patients in China, and solves the problem of clinical long-term no drug available Figure 2: the sales of topuzumab injection in China's public medical institutions in recent years (unit: 10000 yuan) According to the database of minenet, since its listing in 2013, the sales of topuzumab injection in China's public medical institutions (China's urban public hospitals, county-level public hospitals, urban community centers, township hospitals) have been growing steadily, reaching 16.19 million yuan in 2015 Roche said that with the increase of indications, tuozhumab injection, as the only approved biological agent for the treatment of systemic juvenile idiopathic arthritis in China, will meet the market demand of 15000 children Levetiracetam, a concentrated solution for injection, is regarded as the "gold standard" for the treatment of epilepsy It was first listed in the form of tablets in the United States in 1999, and was initially used for partial seizures in adults Subsequently, its solution, injection and sustained-release tablets were also listed successively It is recommended to approve the import of the concentrated solution for injection of levetiracetam produced by Belgium youshibi pharmaceutical company (Belgium United Chemical), which is suitable for children with epilepsy Figure 3: Sales of levetiracetam in public medical institutions in China in recent years (unit: 10000 yuan) According to the database of minenet, the sales of levetiracetam (tablets and solutions) in public medical institutions in China reached 546 million yuan in 2015 At the same time, levetiracetam solution is exclusively owned by Belgium United Chemical Co., Ltd., and the launched concentrated solution for injection has a huge market space in children with epilepsy Megestat capsule megestat capsule is a glucose ceramide synthetase inhibitor produced by actalon The product was recognized by the European drug administration as an orphan drug for the treatment of C-type Niemann peak disease in 2006 Type C Niemann peak disease is due to the genetic defects of lysosomal proteins involved in intracellular lipid transporters The main stage of the disease is late infancy and adolescence In recent years, the number of such children has increased dramatically in China Megestat capsule is approved to be imported this time, which will provide the first effective treatment drug for patients with rare disease C-type Niemann peak disease in China Caffeinated citrate injection caffeinated citrate injection is the only approved drug in the world to treat premature infants with apnea Apnea of premature infants is a potentially crippling and fatal disease In the past medical practice of our country, there is no effective treatment drug In Europe and America, caffeinated citrate has become the first choice in clinical treatment of premature infants with apnea Figure 4: Sales of caffeinated citrate injection in public medical institutions in China in recent years (unit: 10000 yuan) Over the years, caffeinated Citrate Injection's market in China has been exclusively occupied by Alfa vestman pharmaceutical company, the original research manufacturer According to the MI Nei net database, the sales volume of public medical institutions in China reached 34.46 million yuan in 2015 The caffeine citrate injection approved by Chengdu Yuandong Pharmaceutical Co., Ltd is the first generic drug in China, which is expected to reduce the medical cost of patients Gefitinib - the first one billion market gefitinib tablet is the first generation of small molecule tyrosine kinase inhibitor targeting epidermal growth factor receptor in advanced non-small cell lung cancer Compared with traditional chemotherapy, it has better efficacy and safety It is developed and produced exclusively by AstraZeneca Figure 5: Sales of gefitinib in public medical institutions in China in recent years (unit: 10000 yuan) According to minenet advanced database, among the small molecule targeted antitumor drugs for lung cancer treatment, gefitinib produced by AstraZeneca ranked first in terms of sales volume and market share in recent years In 2015, its sales volume in China's public medical institutions reached 1.253 billion yuan This time, as the first generic drug in China, Qilu pharmaceutical's gefitinib (trade name: IRICO) has been approved for marketing, which will effectively improve the accessibility of patients' medication At the same time, it is reported that Qilu pharmaceutical IRICO, under the premise of consistent quality with the original research drug, has a price about 1 / 3 lower than the original research drug after price reduction, and will share a market of more than 1 billion yuan with AstraZeneca 4 Regofinib tablets - "the only" market share Regofinib is a small molecule tyrosine kinase inhibitor developed jointly by Bayer and onyx The imported regofinib tablets approved through the priority review and approval procedure are applicable to the treatment of metastatic colorectal cancer patients who have received chemotherapy based on fluorouracil, oxaliplatin and irinotecan, and who have received or are not suitable for the treatment of anti vascular endothelial growth factor receptor and anti epidermal growth factor receptor drugs (RAS wild type); Patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumors who had previously been treated with imatinib mesylate and sunitinib malate According to relevant data, the sales volume of regofinib in 2015 was US $347 million, up 17% year on year After being approved for marketing in China due to its "significant clinical advantages", the drug is the first small molecule targeted drug for the treatment of advanced colorectal cancer in China, and it is expected to occupy the market with its "unique" advantage in a period of time However, how long regofinib can be "proud of the Jianghu" in the Chinese market deserves attention It is reported that many domestic enterprises have applied for registration according to class 3.1 new drugs, and the competition in the domestic market of regofinib may be quite fierce in the future Kapofungin acetate for injection - the patent expires first The original manufacturer of kapofungin is mosadon, which is suitable for the empirical treatment of neutropenia in adult patients and children patients (three months and more), suspected fungal infection in patients with fever, and invasive Aspergillus that is ineffective or intolerable to other treatments Kapofungin acetate is a semi synthetic β - 1,3-glucan synthesis inhibitor freeze-dried powder developed and marketed by Merck & Co for intravenous injection It is the first echinocandin antifungal agent on the market Figure 6: kapofungin's sales in China's public medical institutions in recent years (unit: 10000 yuan) According to the database of minenet, kapofungin's sales in China's public medical institutions in 2015 has exceeded 1 billion yuan, and before that, the market has been exclusively occupied by the original manufacturer MSD The first generic drug launched by Hengrui pharmaceutical seized the opportunity of patent expiration and was approved for listing through the priority approval process, which is the only one in China at present Hengrui said the move will help promote the product in the domestic market, and kapofungin is expected to enter a rapid growth period and become a new large variety of the company Conclusion as one of the most important tasks in the reform of drug review, the priority review and approval process is of great significance to solve the unmet clinical needs of patients and promote the development of China's pharmaceutical industry Pharmaceutical companies also benefit from the "fast lane" access, so that superior varieties can be quickly produced and listed We are looking forward to whether these products can play their strengths in the market in the future.