The whole body uses the anti infective medicine 34 to have evaluated, Kelun, the East sunlight, the Chinese sea snatches the opportunity! Top 20 sales exposure

In recent years, with the promotion of "anti drug restriction order", the market growth of systemic anti infective drugs has slowed down, and the implementation of policies such as consistency evaluation and volume procurement has made the market competition more and more fierce According to the data of mienei.com, the sales volume of systemic anti infective drugs for public hospitals in key provinces and cities reached 35.947 billion yuan in 2018, with injection accounting for nearly 80% of the market share, and the annual sales of four of the top 20 products exceeded 1 billion yuan At present, a total of 34 products have passed or deemed to have passed the consistency evaluation Pharmaceutical enterprises "cluster" in 6 products, such as tenofovir dipivoxil fumarate tablets and cefuroxime ester tablets Sichuan Kelun Pharmaceutical Co., Ltd., Guangdong dongyangguang Pharmaceutical Co., Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd and Chengdu Beite Pharmaceutical Co., Ltd have the most reviewed product specifications It is worth noting that only 2 injections have been evaluated, and 25 injection consistency evaluation supplementary applications are in the review and approval (in the drug Audit Center) Market growth slows down, 4 top 20 products become billion clubs Figure 1: Sales of systemic anti infective drugs in public hospitals of key provinces and cities (unit: 10000 yuan) (source: terminal competition pattern of public hospitals in key provinces and cities of mienei.com) According to the data of mienei.com, in recent years, the growth rate of anti infective drugs for general use in public hospitals in key provinces and cities has slowed down, with the sales volume exceeding 30 billion yuan and reaching 35.947 billion yuan in 2018 Table 1: the total sales volume of top 20 (unit: 10000 yuan) (source: the terminal competition pattern of public hospitals in key provinces and cities of mienei.com) products of systemic anti infective drugs for public hospitals in key provinces and cities is 16.494 billion yuan, accounting for more than 45% of the total sales volume of systemic anti infective drugs Among them, the sales of meropenem for injection, cefoperazone sodium and Sulbactam Sodium for injection (2:1) and entecavir dispersible tablets all exceeded 1 billion yuan Among the top 20 products, 17 are injections except for entecavir dispersible tablets, entecavir tablets and voriconazole tablets 34 products have been evaluated: Kelun, dongyangguang, Huahai Preemptive opportunity Table 2: systemic anti infective drugs that have been evaluated at present (source: medchina drug evaluation database 2.0 of minenet) As of June 17, 34 products of systemic anti infective drugs have passed or deemed to pass the consistency evaluation, among which only one enterprise has passed the evaluation of 20 products, such as levofloxacin tablets, cefdini capsules, oseltamivir phosphate capsules, azithromycin tablets, azithromycin for injection, etc Fig 2: 4 or more enterprises (source: minenet database) from the perspective of the number of enterprises that have been evaluated, the enterprises with the largest number of "cluster" are tenofovir dipivoxil fumarate tablets, cefuroxime ester tablets, entecavir dispersible tablets / capsules, Amoxicillin Capsules and isoniazid tablets Among them, there are up to 9 tenofovir dipivoxil fumarate tablets, including Qilu pharmaceutical, Zhengda Tianqing pharmaceutical, Sichuan hisico pharmaceutical, etc In addition, Sichuan Kelun Pharmaceutical Co., Ltd., Guangdong dongyangguang Pharmaceutical Co., Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd and Chengdu Beite Pharmaceutical Co., Ltd have the most product specifications Injection accounts for nearly 80% of the market, only 2 products have been evaluated! 25 of them swarmed in Figure 3: in 2018, the pattern of general use of anti sensitive chemicals in public hospitals of key provinces and cities (source: terminal competition pattern of public hospitals in key provinces and cities of mienei.com) from the perspective of general use of anti sensitive chemicals, injection, tablet, capsule, powder, granule, etc., while the total proportion of injection and tablet is more than 90% Among them, injection accounts for the largest proportion, up to 77.71%, and the sales volume is nearly 28 billion yuan Figure 4: distribution of dosage forms of over evaluated products (source: minenet database) From the distribution of dosage forms of over evaluated products, although the sales of injections are unique, the over evaluated products are the least, only azithromycin for injection and cefazolin / sodium chloride injection for injection In fact, the over evaluation of injections is not ideal Compared with oral preparations, injections (excluding sustained-release preparations, suspensions, oils, liposomes and other special preparations) do not need to be tested in consistency evaluation, which saves time However, the requirements in prescription technology, excipients, packaging, process control and other aspects are relatively strict, so it is difficult to pass the consistency evaluation 。 Table 3: review of supplementary application for conformity assessment of systemic anti infective injection (source: meed China drug review database 2.0), currently, there are 25 supplementary application for conformity assessment of injection in the review and approval (in the drug review center), of which only one enterprise applies for 16 products The largest number of pharmaceutical enterprises "cluster" is ceftriaxone sodium for injection, involving 14 acceptance numbers and 4 enterprises, namely Sinopharm (Shijiazhuang), Hunan Kelun pharmaceutical, Qilu pharmaceutical and Shanghai Shangyao Xinya pharmaceutical Source: data statistics of the meter net database as of June 17, 2019