A large number of varieties, over-consistency evaluation (attached list)

According to the incomplete statistics of Saibailan on April 15th, as of April 12, there were 228 articles with consistent evaluation; among them, there were 13 conformity evaluations of 3 articles, and ammonia benzenesulfonate There have been 8 over-rated companies for the tablets and tenofovir disoproxil fumarate tablets.

Cephalexin capsule

Recently (April 10), Kelun Pharmaceutical issued an announcement, and its subsidiary Hunan Kelun Pharmaceutical recently obtained the “Approval of Drug Supplementary Application” for the chemical “Cefoperzin Capsule” approved by the State Drug Administration.

It is understood that Kelun Pharmaceutical is the first enterprise in China to pass the consistency evaluation. Up to now, the company has invested Rs 7.3 million in research and development on the cephalosporin capsule consistency evaluation project.

Cephalexin capsules are mainly used for the treatment of acute tonsillitis, angina, sinusitis, bronchitis, pneumonia and other respiratory infections, otitis media, urinary tract infections and skin and soft tissue infections caused by sensitive bacteria; this time, cephalexin capsules The three specifications of 0.125g, 0.25g and 0.5g passed the consistency evaluation.

The data show that cephalexin capsule belongs to the first generation cephalosporin, and it is mainly used for the treatment of mild infection caused by sensitive bacteria. Cephalexin has the advantages of good oral absorption, low toxicity, and broad spectrum of antibacterial activity. It is recommended as a first-line medication by the 2018NICE/PHE Guide: Antibiotics for catheter-related urinary tract infections.

At the same time, the 2015 edition of the Guiding Principles for the Clinical Application of Antimicrobial Agents recommends that the first-generation cephalosporins should be selected for acute bacterial respiratory infections, urinary tract infections, and skin and soft tissue infections. Cephalexin capsules have entered the National Basic Drug List and the National Health Insurance Class A Catalog. According to the statistics of Mine Net, the sales in China in 2017 was about 186 million yuan.

According to the data from the intranet, in 2017, China's urban public hospitals , county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) terminals, sales of cephalexin nearly 300 million yuan. Among them, capsules account for more than 60% of the market.

(Source: Minenet)

Cypress Blue searched for the "cephalosporin" in the official website of the Food and Drug Administration. There were 741 approvals. It can be seen that the market competition of cephalexin is quite fierce.

In the brand competition pattern, Shandong Luoxin Pharmaceutical has the largest market share, accounting for 33.96%; North China Pharmaceutical Hebei Huamin Pharmaceuticals 16.74%, Shanghai Hyundai Pharmaceuticals 9.97%, second and third; Hunan Kelun Pharmaceutical Only 5.59% of the market share.

(Source: Minenet)

We all know that the big killer of consistency evaluation is to purchase quantity. Therefore, Cologne Pharmaceuticals is the first to comment. If it enters the pilot of quantity procurement, it may quickly change its market share.

Previously, Guohai Securities had analyzed: the procurement of quantity will be an opportunity for pharmaceutical companies to rapidly change the competitive landscape. In the previous trial of procurement in Shanghai, 63% of the winning bidders had no sales in Shanghai. After winning the bid, In the future, it will have a market share of more than 50% of the drug in Shanghai, and will eventually occupy the entire market share.

Tenofovir disoproxil fumarate tablets

On April 10, Haisike issued an announcement. Its wholly-owned subsidiary recently received the Drug Registration Approval issued by the State Drug Administration, and the company's product specification of tenofovir disoproxil tablets of 300 mg. Pass the consistency evaluation.

It is understood that the company invested about 12.16 million yuan in the research and development of tenofovir disoproxil fumarate tablets.

The data show that tenofovir disoproxil fumarate tablets are the first nucleotide analogues to treat AIDS, inhibiting viral replication by blocking reverse transcriptase involved in HIV replication. Clinical studies have shown that its antiviral effect and low incidence of drug resistance can inhibit the replication of hepatitis B virus by interfering with the function of hepatitis B virus DNA polymerase in human body, and it has broad application prospects in the treatment of chronic hepatitis B.

The market pattern of this variety is relatively stable: except for the tenofovir disoproxil fumarate tablets (trade name “Wei Rui De”) produced by Gilead Pharmaceuticals. In addition, Chengdu Bite Pharmaceutical Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd., Anhui Baker Biopharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd., Hangzhou Supor Nanyang Pharmaceutical Co., Ltd., Shijiazhuang Longze Pharmaceutical Co., Ltd., Anhui An A total of 9 domestic enterprises of Kehengyi Pharmaceutical Co., Ltd., GlaxoSmithKline (Tianjin) Co., Ltd. and Sichuan Haisike Pharmaceutical Co., Ltd. obtained the production approval of the drug.

According to IMS data, the global sales of tenofovir disoproxil fumarate tablets in 2017 was 1.52 billion US dollars; according to the intranet data, the domestic sales of this variety in 2017 was 620 million yuan. The variety of Chengdu Bite Pharmaceutical Co., Ltd. was selected from the 4+7 city drug procurement in 2018, with a median price of 17.72 yuan/box (specification: 300mg*10 pieces/plate*3 board).

Sodium bicarbonate tablets

On the same day, Haiwang Biological announced that its holding subsidiary had recently received the “Approval of Drug Supplementation” issued by the State Food and Drug Administration for “Sodium Bicarbonate Tablets 0.5g”, which was evaluated by the consistency of quality and efficacy of generic drugs. .

It is reported that Haiwang Bio is the first to pass the consistency evaluation of this variety. At present, there is still an acceptance number for approval, and the status display has been sent.

The data show that "sodium bicarbonate tablets" is used to alleviate stomach pain, heartburn (heartburn) and acid reflux caused by hyperacidity. It has entered the 2017 National Class A medical insurance catalogue and the 2018 National Basic Drug List. In 2018, Haiwang Fuyao's sales of the drug was approximately RMB 12 million.

Coincidentally, according to the medical information service company through the seven latitudes and five Kangke data, Hunan Hansen Pharmaceutical and Yuanda Pharmaceutical's sodium bicarbonate tablets have also been approved in recent days, showing a "sent" status.

(Source: Seven latitudes and five Kangke)

Isoniazid tablets

On April 9, Shanghai Fosun Pharma announced that its controlling subsidiary, Shenyang Hongqi, had received the “Approval for Drug Supplementation” issued by the State Food and Drug Administration for isoniazid tablets. The 0.1g product of the drug passed the generic drug. Consistency evaluation.

It is understood that at this stage, Shanghai Fosun Pharma has invested a total of RMB 4.9 million in research and development for the consistency evaluation of the drug.

The data show that the drug is mainly used in combination with other anti-tuberculosis drugs and is suitable for the treatment of various types of tuberculosis. In 2018, Shenyang Hongqi’s sales of the drug in China was approximately RMB 29.09 million.

As of the announcement date, the isoniazid tablets that have been listed in China include the isoniazi tablets of Hangzhou Minsheng Pharmaceutical Co., Ltd. and the isoniazid tablets of Chengdu Jinhua Pharmaceutical Co., Ltd. According to the latest data from IQVIA CHPA, in 2018, the sales of isoniazid in China was approximately RMB 94.46 million.

According to the incomplete statistics of Cypress Blue, as of today (April 12), there are 228 articles with consistent evaluation; among them, there are 13 articles with consistent conformity evaluation, among which amlodipine besylate tablets, There have been 8 over-rated companies for tenofovir disoproxil fumarate tablets.