Domestic anti -epilepsy drug market welcoming bureau: chain reaction caused by error caused by the effective period of product product products?

The 21st Century Business Herald reporter Zhu Ping intern Li Jiaying reported that recently, the State Drug Administration decided to suspend the suspension of multinational pharmaceutical companies. Sales and use, and investigate and deal with related issues in accordance with the law. Each imported port drug supervision and management department suspended the distribution of import customs clearance vouchers of the product.

The incident subsequently triggered a chain reaction. Ugly Biyi injection is canceled in the Yangtze River Delta (Shanghai -Zhejiang and Anhui) alliance regional drug collection qualifications. On September 1st, the Procurement Working Group of the Yangtze River Delta (Shanghai -Zhejiang and Anhui) announced the determination of the company with the time of substitutes. Puli Pharmaceutical and Jichuan Pharmaceuticals were replaced by Shanghai and Zhejiang Province.

Regarding the handling of the State Drug Administration, the 21st Century Economic Herald reporter obtained an excellent time ratio stated that the exemplary solution of the Zuo Yican injection was caused by an error caused by the validity logo. The National Drug Administration found that the validity period of the batch product label of the batch of the drug was not consistent with the validity period of the registration approval in a recent non -on -site inspection.

Since being approved in 2017, it has been 5 years in the Chinese market for Zuo Yiraistein injection, and has occupied a large market share for a long time. According to data from the PDB database sample hospital, in 2021, the sales of anti -epilepsy drugs for sample hospitals were 1.498 billion yuan, and the amount of drug purchases in public hospitals across the country was about 503 million yuan. In 2021, the sales of a thick solution sample hospital for injection in Zuo Yican were 31.78 million yuan, accounting for 2.1%of the entire sample hospital epilepsy drugs for epilepsy drugs. However, with the continuous entry of local pharmaceutical companies, the market competition is very fierce. At present, more than 10 pharmaceutical companies have been approved to be listed. Especially after this incident, will it cause a larger "Domino" effect? Will its market advantageous position be further weakened? How will the subsequent best time?

The qualification qualification in the collection is canceled

On August 22, the website of the State Drug Administration issued an announcement on the suspension of imports, sales, and use of Belgian pharmaceutical companies. The State Drug Administration made this decision based on the recent results of a non -on -site inspection overseas. The inspection found that Zuo Yiracatin injected a thick solution (import registration certificate number: H20170341, specifications 5ml: 500mg, and the product name Kai Pulan). The validity period of the batch of products was inconsistent with the validity period of the registration approval. According to the State Drug Administration, the latest issuance date of the Zuo Yili Siraistein injection of Zuo Yitatan is April 20, 2022, and the deadline for validity is April 19, 2027.

Zuo Yiraistein is a well -known antiepileptic drug that was listed in the United States in the form of tablets in the form of tablets in 1999. In 2006, Zuo Yiracan was listed in China, and the product was named Kai Pulan. From the perspective of dosage type, Zuo Yican not only has a thick solution for injection, but also oral dosage forms such as tablets and oral solutions. Zuo Yiracatin injection is suitable for the treatment of partial seizures (accompanied or non -secondary comprehensive seizures) for adults and children over 4 years of age, and can be replaced by patients who cannot apply oral preparations for the time being.

In order to ensure the safety of the public's medication, according to the relevant provisions of the "Drug Administration Law of the People's Republic of China", the State Drug Administration has decided that from August 22, when suspending the excellence, Biraistein injection in Zuora Sitan is imported and sold in China. And use and investigate related issues in accordance with the law. Each imported port drug supervision and management department suspended the distribution of import customs clearance vouchers of the product.

On the same day, the Timeby said that the incident was caused by the effective identification error on the four specific batch packages of Zuo Yiracan injection. You Ji Bi launched an investigation as soon as he received the results of the inspection, and has completed the active recall of the approval. At present, he is actively cooperating with the regulatory authorities and the overseas factories involved in the incident to take targeted rectification measures. It is expected to restore the supply of the drug in the Chinese market as soon as possible. In addition, You Jibi also stated that the four specific batch products of the Zuo Yican injection in the incident were involved in the validity period of registered approval in China on August 24 this year.

This incident quickly caused market response. On August 24, the Shandong Provincial Public Resources Trading Platform announced the suspension of the submitted product of Zuo Yicatin in Zuo Yicatin in the transaction. At the same time, as a collection of bidding products, Zuo Yiraistein's injection of a solution with a strong solution was canceled. On August 29th, the Procurement Working Group of the Yangtze River Delta (Shanghai -Zhejiang and Anhui) announced the cancellation of the eligibility of the long triangle (Shanghai -Zhejiang and Anhui) alliance in the area of ​​drug collection in the regional drug collection. The substitute process will be based on the relevant terms of the "Yangtze River Delta (Shanghai-Zhejiang and Anhui) Alliance Regional Pharmaceutical Procurement Documents (CSJ-YD2022-1)". And Shanghai.

In addition, Zuo Yican injection is also the third batch of drugs. The drug was the first time that the national collection was included in the dosage form. Therefore, the procurement cycle set by the Medical Insurance Bureau was one year, and one year later, it was renewed by various places according to the implementation situation. In this collection, the highest effective declaration price of Zuo Yican injection was 340 yuan per bottle, and the contented time was 85 yuan per bottle, ranking third and a decrease of 75%. The selected supply area is Beijing, Tianjin, Hunan, Shanghai, Heilongjiang, Guizhou, and Shaanxi. After the first year of procurement period expires, the renewal is completed in some provinces and cities. Except for excellence, Chongqing St. Huaxi Pharmaceutical, Hainan Puli Pharmaceutical and Hebei Renhe Yikang Pharmaceutical won the bid. Among the three companies, the supply companies that are superior to the time -off superiority will be generated. According to the "National Pharmaceutical Concentrated Procurement Documents (GY-YD2019-2)", during the procurement cycle, the election companies cannot be supplied, so that when the agreement cannot continue to be fulfilled, the supply enterprise determined from other selected companies in the same variety.

The market ushered in changes

In China, epilepsy has become the second largest common disease in neurosciences second only to headaches, and the World Health Organization (WHO) has also included epilepsy into one of the five key nerves and mental illness in the world's key prevention and treatment. WHO data shows that there are about 50 million patients in the world, of which 40 million are in developing countries. In China, there are more than 10 million patients with epilepsy, of which 6 million patients still have attacks every year. The domestic anti -epilepsy drug market has a broad prospect with the overall market size exceeding 5 billion. According to data from PDB database sample hospitals, in 2021, the sales of antiepileptic drugs in sample hospitals were 1.498 billion yuan, and the amount of drug purchases in public hospitals across the country was about 50.03 billion yuan.

The domestic anti -epilepsy drug market is highly concentrated. The "2021-2025 global anti-epilepsy drug industry in-depth market research and key regional research report" released by the Xinshijie Industry Research Center shows that the top five of the Chinese types of antiepileptic drugs are currently on the market. Rastein, Okasiping, Prorbarin, and Ramoline, the total market proportion of these five drugs accounted for more than 85%. In the case of high market concentration, Zuo Yilacatin can still firmly grasp the first three positions.

PDB data shows that in the first quarter of 2022, Zuo Yican's sales in sample hospitals exceeded 76 million yuan, accounting for 20.19%of the sales amount of antiepileptic drugs. Among them, the total sales amount of the thick solution used in Zuo Yicatin was about 13.27 million yuan, accounting for 17.4%of the entire Zuo Yican sales.

It has been 5 years in the Chinese market for Zuo Yirai Siratan injection. In July 2017, the medicine was approved to be listed in China. Earlier, the medicine had been approved for listing in the European Union and the United States in March and August 2006. In the past five years, Zuo Yiraistein has provided a good income growth in the Chinese market. The financial report shows that according to the regional net sales, the net sales in Europe in the first half of 2022 in Europe and the United States reached 2.255 billion euros, and the net sales of international markets in other times reached 506 million euros. Among them, China became the second largest market in this part with 90 million euros, an increase of 50%year -on -year. During the reporting period, Zuo Yicatin -class drugs contributed a net sales of 380 million euros to the best time, a year -on -year decrease of 21.65%, accounting for 14%of the antiepileptic and immune drugs.

With the suspension of importing, selling and use, the proportion of Yoshi Shi Ziracatin injection may decline in the domestic market. Opportunities for local enterprises may have arrived.

At present, many pharmaceutical companies have been approved to be listed. According to the State Drug Administration, there have been more than 10 imitation drugs for Zuo Yican's injecting in Zuo Yiraistein in China, including Huahai Pharmaceutical, Jichuan Pharmaceutical, Yangzijiang Pharmaceutical, Beijing Fourth Ring Pharmaceutical, Huiyu Pharmaceutical, and Huiyu Pharmaceutical, and Huiyu Pharmaceutical, and Huiyu Pharmaceutical, Huiyu Pharmaceutical, Huiyu Pharmaceutical, Huiyu Pharmaceutical, Huiyu Pharmaceutical, and Huiyu Pharmaceutical, and Huiyu Pharmaceutical, and Huiyu Pharmaceutical, and Huiyu Pharmaceutical, and Huiyu Pharmaceutical, and Huiyu Pharmaceutical, and Huiyu Pharmaceutical, and Huiyu Pharmaceutical. Puli Pharmaceutical and so on. Among them, Puli Pharmaceutical Zuo Yican injection has been approved to be listed in the United States, the Netherlands, Germany, Britain, Spain, and Malaysia.

You Ji Bi is facing the crisis where Zuo Yican's market share is eaten. As of the seventh batch of national pricking, there are 250mg specifications of antiepileptic chemicals, Zuo Yican, 10%(150ml: 15mg) specifications, and injection of 5ml: 500mg specifications for injection.

The 250mg market of Zuo Yi Siratin Film Public Hospital is basically monopolized by Zhejiang Jingxin Pharmaceutical and Zhejiang Polo Kangyu. According to PDB data, in the first quarter of 2022, in the 250mg market of Zuo Yira, the sales of the two Zhejiang pharmaceutical companies in sample hospitals accounted for 92.9%, and the sales amount accounted for 91.8%.

In the Zuo Yican oral solution agent (150ml: 15mg) market, Chongqing St. Huaxi Pharmaceutical and Ye Kai Thai Medicine (Suizhou) have gradually occupied more markets. From the perspective of the sales of enterprises, in the first quarter of 2022, the sales volume of the two bidders in sample hospitals accounted for 94.6%, and the total sales amount accounted for 83.9%.

Zuo Yiracatin injection 5ml: 500mg specifications are included in the third batch of national mining. There are four companies winning the bid.Utah is 85 yuan/branch, Hebei Renhe Yikang Pharmaceutical 98.5 yuan/support.In the first quarter of 2022, the sales volume of four bidders in sample hospitals accounted for 94.2%, and the sales amount accounted for 90.1%.Chengdu Tiantai Mountain Pharmaceutical, which ranked first with 60.7%sales in 2020, was evaluated by the consistency of thick solutions in Zuo Yican injection in March 2022. It was not eligible to participate in the collection in 2020.The proportion of sales fell to 8.8%.Ug time occupies an absolute position in the 500mg specifications, and the proportion of 96.6%has made it ranked first in the sample hospital market with two tablets specifications.

With the deepening of the implementation of the collection of collection, in the case of compact local enterprises, how much space can some dosage markets in Zuo Yican in the public hospital can still be observed.Measures, the 21st Century Economic Herald reporter will continue to pay attention.

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