Recently, the Henan Provincial Health Insurance Bureau announced the results of the proposed selection of the 19 provinces (regions, corps) drug alliance centralized belt procurement.

it is understood that through the procedures of enterprise decryption quotation, price negotiation, price correction, resurrection quotation, etc., 24 centralized purchase varieties have successfully produced the results of the proposed selection, and 151 product specifications of 105 enterprises are proposed to be selected, with an average drop of 60.6.

A reporter from China Business News noted that some of the injection products to be selected, including vitamin K1 injection, urokinase injection, and mannitol injection, have been included in the list of shortage drugs; human tetanus that was included in the collection for the first time Immunoglobulin injection has problems such as high cost and limited production capacity.

In order to understand the impact of the alliance's collection on the above-mentioned shortage of drug manufacturers, the reporter wrote to Beite Pharmaceuticals and Hualan Bio (002007.SZ) for interviews. The relevant person in charge of media relations of Beite Pharmaceutical said that the results of the 19-province alliance's centralized selection have been publicized by the government. Relevant information should be subject to the contents of the publicity. Other information cannot be answered for the time being. Hualan Biology has not yet responded to the question of the interview letter.

only 2 varieties A

It is understood that this collection is organized by Henan, Shanxi, Inner Mongolia, Liaoning, Jilin, Heilongjiang, Anhui, Jiangxi, Hunan, Guangxi, Hainan, Guizhou, Yunnan, Tibet, Shaanxi, Qinghai, Ningxia, Xinjiang, Xinjiang Production and Construction Corps, etc. Nineteen provinces (regions, corps) formed an inter-provincial alliance to carry out centralized drug procurement on behalf of the medical institutions in the above-mentioned regions.

judging from the results of the proposed selection, there are 77 product regulations to be selected in the comprehensive review, and 51 product regulations to be selected in the comprehensive review. There are 15 product regulations to be selected through price correction, and only 4 product regulations to be selected through resurrection mechanism.

although the 19-province alliance's centralized purchasing is similar to the previous centralized purchasing, the grouping rules no longer enter groups a and B according to the purchase volume, but enter group a according to the quality level, including reference preparations, over-evaluated generic drugs, newly registered classified new category 3/4 drugs, varieties included in the "China listed drug catalogue" and other products enter group B.

the results of the proposed selection show that only two varieties in group a are to be selected, namely nitroglycerin injection (1ml:5mg) declared by Shanxi kangbao biological products co., ltd. and potassium magnesium aspartate injection (0.85g:0.114g:42mg) declared by national medicine holding and distribution center co., ltd. all of which have obtained the qualification of the proposed selection through negotiation.

among the results of the proposed selection, sodium bicarbonate is the most popular variety, with a total of 26 product specifications selected, while multivitamin (12), potassium magnesium aspartate glucose and deslanoside are all selected with only one product specification.

according to the procurement rules, if the quotation for oral dosage forms is not higher than 0.1 yuan and the quotation for injections (including powders) is not higher than 1.0 yuan, the qualification for candidate selection can be obtained without being restricted by the maximum amount to be selected, conditional candidate selection, etc.

Among the 51 product specifications that are preferred for comprehensive evaluation, inosine injection (0.1g) of Xinhua Pharmaceutical (000756.SZ), potassium magnesium aspartate injection (0.86mg:0.114g:42mg) of Rongsheng Pharmaceutical Co., Ltd. of Guoyao Group are all quoted in 1 yuan, while injection formulations of many other enterprises are quoted in 0.99 yuan and 0.98 yuan.

In addition, human tetanus immunoglobulin injection, which was included in the collection for the first time, and vitamin K1 injection, urokinase injection, mannitol injection and other products that were once included in the shortage drug list have also attracted much attention.

according to the 2022 annual report of siren biology (688163.SH), human tetanus immunoglobulin (HTIG) is directly extracted from the plasma of immunized healthy people, which has the advantages of good curative effect, almost no allergy and no skin test. the price of each one is about 300 yuan. However, due to the constraints of the "Administrative Measures for Plasma Collection Stations" and other regulations and the influence of government control, the source of human plasma is limited, and the preparation process of HTIG is relatively complex, and there are some ethical disputes on the immunization of plasma donors, which lead to the limited production of HTIG.

according to the data of the intranet, up to now, a total of 19 enterprises have obtained the approval documents for human tetanus immunoglobulin. The main production enterprises include Shandong Taibang Biological Products Co., Ltd., Hualan Biology, Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd., Chengdu Rongsheng Pharmaceutical Co., Ltd. Bohui Innovation (300318.SZ) disclosed in its 2022 annual report data that only one batch of tetanus human immunoglobulin was issued in 2021 and 2022 respectively, with 10300 bottles and 18700 bottles respectively.

in this collection, a total of 7 enterprises of tetanus human immunoglobulin injection (2.5ml:250IU) are to be selected, with Guangdong shuanglin biopharmaceutical co., ltd. having the lowest price, and the proposed selection price is 165 yuan. Harbin Pasfico Biopharmaceutical Co., Ltd. has the highest price in the same group with 212.8 yuan.

on August 9, 2022, the general office of the Ministry of industry and information technology and the general office of the national health and Health Commission jointly issued the notice on strengthening the monitoring of the production and reserve of drugs selected from the centralized procurement of drugs organized by the state, which publicized the monitoring varieties and production enterprises of shortage drugs including vitamin K1 injection, urokinase injection and mannitol injection.

Even if the above-mentioned varieties are included in the shortage drug monitoring catalogue, the relevant enterprises still choose to participate in the collection of the 19-province alliance.

for example, urokinase injection (100000 units) has a total of 6 enterprises to be selected, and the lowest quotation is 55.62 yuan. Mannitol injection (250ml:50g, with plastic bottles/glass bottles as the representative packaging materials) is to be selected by a total of 10 enterprises, with the lowest quotation being 2.35 yuan. Vitamin K1 injection (1ml:10mg) is to be selected by a total of 5 enterprises, with the lowest quotation being 3.45 yuan.

Multiple large variety injections included

judging from the list of varieties purchased by the 19-province alliance, 21 of the 24 varieties collected are injections, including inosine injection, oxacillin injection, adenosine cyclophosphate injection, multivitamin (12) injection, dihydroxypropyltheophylline injection, urokinase injection, tetanus immunoglobulin injection, 20% mannitol injection, vitamin K1 injection, etc.

Yao Rong Yun data show that the total sales of the 24 varieties collected by the 19-province alliance in China's hospitals in 2022 will be about 16 billion yuan, of which 20 varieties are over 100 million yuan, 11 varieties are over 0.5 billion yuan, and 6 varieties are over 1 billion yuan.

for example, in-hospital sales of adenosine cyclophosphate injection will reach 1.802 billion yuan in 2022 and inosine injection will reach 1.568 billion yuan in 2022. There are also oxacillin injections, tetanus human immunoglobulin injections, multivitamin (12) injections and urokinase injections, all of which will have in-hospital sales far exceeding 1 billion yuan in 2022.

It is understood that prior to this, adenosine cyclophosphate for injection has been included in five local collection, of which four are multi-provincial drug alliance collection. A total of 4 pharmaceutical companies won the bid, namely Wuxi Kifu Pharmaceutical, Guangdong Jianxin Pharmaceutical, Guangzhou Poinsettia Pharmaceutical and Hainan Huanglong Pharmaceutical. The winning price was 2.65~6.12 yuan.

in this 19-province alliance collection, the highest effective declared price of adenosine cyclophosphate injection (20mg) is 16.81 yuan, with a total of 8 enterprises planning to be selected. Among them, Datong Wuzhoutong Pharmaceutical Co., Ltd. quoted 5.56 yuan, the lowest price in the same group. Wuzhi Tongkang Pharmaceutical Co., Ltd. quoted 8.58 yuan, the highest price among adenosine cyclophosphate injections.

At present, only oxacillin for injection is sold in China, involving 20 production enterprises. In 2022, the drug's sales in China's hospitals increased by 55.48 year-on-year to 1.507 billion billion yuan. In terms of manufacturing enterprises, Sichuan Pharmaceutical Preparation Co., Ltd. and Chengdu Beite Pharmaceutical Co., Ltd. ranked high, with market share of 48.29 and 16.89 respectively.

however, the drug rongyun China drug review database shows that currently no drug company has passed the consistency evaluation for oxacillin for injection. However, since May this year, some pharmaceutical companies have submitted applications for the listing of oxacillin for injection to the Food and Drug Administration with three types of generic drugs. Currently, a total of 8 companies, including Dongyang Xiangsheng Pharmaceutical Technology Co., Ltd., Zhongfu Pharmaceutical Co., Ltd., Kelun Pharmaceutical (002422.SZ) and Fu 'an Pharmaceutical (300194.SZ), are under review and approval.