When the generic drug market is shuffled: the winners who fa

In the generics market, drugs that fail the drug conformity assessment are accelerating their expulsion from the market.

On February 20th, Heilongjiang Provincial Medical Insurance Bureau issued the "Announcement on the Eligibility of Suspension of Unqualified Quality and Efficacy Evaluation of Drugs on the Online Trading of Pharmaceutical Products in Heilongjiang Province in 2019". According to the announcement, in accordance with the "Opinions of the General Office of the State Council on the Evaluation of the Consistency Evaluation of the Quality and Efficacy of Generic Drugs" and the "Implementation Opinions of the General Office of the People's Government of Heilongjiang Province on Reforming and Improving the Supply and Protection Policies for Generic Drugs", Amoxicillin Capsules (0.25G), escitalopram oxalate tablets (10mg), entecavir dispersible tablets (0.5mg), entecavir capsules (0.5mg) and other four drugs of the standard through the quality and efficacy of generic drug evaluation manufacturers reached 3 Home (as of February 15th, 2019), suspending the above product specifications, the quality of the generic drug and the consistency of the efficacy evaluation of the drug manufacturer in the province's centralized drug procurement platform trading qualification.

Among them, entecavir dispersible tablets involve Shandong Lukang Medicine (600789, Diagnostics) Co., Ltd., Entecavir capsules involve Hainan Zhonghe Pharmaceutical Co., Ltd., and escital oxalate tablets involve Xi'an Yangsen Pharmaceutical Co., Ltd. The company has three companies, and Amoxicillin capsules involve more than 70 companies.

2 billion yuan market adjustment

Amoxicillin is a star drug. In the future, with the continuous advancement of consistency evaluation, this drug market is expected to accelerate adjustment.

Kang Enbei (600572, Diagnostics) announced in October 2018 that the holding subsidiary Zhejiang Jinhua Kang Enbei Bio-Pharmaceutical Co., Ltd. received the amoxicillin capsule issued by the State Drug Administration. Hereinafter, the "Approval for Drug Supplementation" is referred to as "the drug", and the drug is evaluated by the consistency of generic drugs, and the specification is 0.25 g.

According to the announcement issued by Kang Enbei, there are currently 241 domestic approvals for amoxicillin capsules and 5 amoxicillin capsules for import approval. The manufacturers with the highest sales have Zhuhai Federal Pharmaceuticals (Hong Kong stocks 03933) Co., Ltd., Shijiazhuang Group (Hong Kong stocks 01093) Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., Kunming Baker Norton Pharmaceutical Co., Ltd., Guangzhou Baiyun Mountain (600332,Medical stock) (Hong Kong stocks 00874) Pharmaceutical Group Co., Ltd., Xiansheng Pharmaceutical Co., Ltd., Harbin Pharmaceutical Group Co., Ltd., etc.

Kang Enbei said that Jinhua Kang Enbei's amoxicillin capsules are conducive to expanding the market share of the drug through the consistency evaluation of generic drugs, and to enhance the market competitiveness, while at the same time carrying out generic drugs for the company's follow-up products. The evaluation work has accumulated valuable experience.

According to the data released by the National Drug Evaluation Center, at present, there are more than three pharmaceutical companies that have passed the consistency evaluation of 0.25g of amoxicillin capsules, namely Hunan Hunan Kelun Pharmaceutical Co., Ltd. and Zhejiang Jinhuakang. Enbe Biopharmaceutical Co., Ltd., Zhuhai Federal Pharmaceutical Co., Ltd. Zhongshan Branch and Shijiazhuang Group. In addition, amoxicillin capsules (specification: 0.5g) produced by Zhonguo Pharmaceutical (Shijiazhuang) Co., Ltd. of the pharmaceutical group were evaluated by the consistency of quality and efficacy of generic drugs.

According to the announcement issued by Kelun Pharmaceutical (002422, Diagnostics), amoxicillin capsules have entered the category A medical insurance and the 2018 national base drug catalogue. In 2017, amoxicillin capsules had sales of about 2.059 billion in China. yuan.

Shuffle Acceleration

Varieties that pass the consistency assessment will be the focus of policy support. According to the information released by the State Food and Drug Administration, the National Essential Drugs List (2018 Edition) was implemented on November 1, 2018 and established a dynamic adjustment mechanism to link with the consistency evaluation. Varieties that have passed the consistency evaluation are prioritized in the catalogue, and varieties that have not passed the consistency assessment will be gradually transferred to the catalogue. For the varieties included in the national essential medicines list, the evaluation time limit requirements are no longer uniformly set.

In addition, the State Food and Drug Administration also pointed out that the service guidance should be strengthened and the consistency evaluation work should be fully promoted. Among them, the establishment of a green channel is mentioned, and the application for consistency evaluation is followed up, and the progress of the review is accelerated. If a company encounters major technical problems in the course of research, it may communicate with the drug evaluation agency in accordance with the relevant provisions of the “Administrative Measures on Communication and Technology Review Communication and Communication”. Further strengthen the guidance of key varieties and key enterprises, organize on-site research and communication, and help enterprises solve difficult problems.

In addition to accelerating the evaluation of conformity, many varieties have also been given support for the varieties that have passed the consistency evaluation. For example, will pass the sameThe varieties of sexual evaluation are directly linked to the net purchase.

In addition, some places have also pulled the varieties that have not passed the consistency evaluation into the suspended procurement list. In addition to Heilongjiang, according to the statistics of the reporters, on January 31, the Public Resource Trading Center of Guangxi Zhuang Autonomous Region issued the Notice of the Guangxi Zhuang Autonomous Region on the Suspension of Partially Unqualified Evaluation of Drug Online Trading Qualifications in 2019; December 19, 2018 The Jiangsu Provincial Public Resource Trading Center issued the "Notice on the Suspension of Procurement of Drugs for the Consensus Evaluation of the Quality and Efficacy of Generic Drugs in Jiangsu Province in 2018". In addition, several provinces such as Liaoning, Hunan, Jiangxi, and Zhejiang have issued documents requesting that products not reviewed will be suspended.

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