Blockbuster biological drugs are included in the collection!

On January 19, the Guangdong Provincial Drug Trading Center officially released the "Guangdong Alliance Diclofenac and Other Drugs Centralized Procurement Documents", which opened a new prelude to this year's inter-provincial alliance centralized procurement
.
Compared with the previous draft for comments, the scope of the Guangdong Alliance’s centralized procurement in the official document has been further expanded, covering 276 chemicals and therapeutic biological products in the National Medical Insurance Drug Catalog with high consumption and high purchase amount, including human blood.
Albumin, recombinant human growth hormone, rituximab and other clinically important varieties
.
Affected by this news, the stock price of growth hormone leader Changchun High-tech fell by the limit today
.
In addition to the largest number of varieties in local centralized procurement, the influence of the alliance centralized procurement led by Guangdong, a major traditional medicine province, should not be underestimated
.
The alliance regions participating in this collection of drugs include Guangdong, Shanxi, Jiangxi, Henan, Guangxi, Hainan, Guizhou, Qinghai, Ningxia, Xinjiang, Xinjiang Production and Construction Corps and other 11 provinces (autonomous regions and corps), second only to the previous The 19-province Chinese patent medicine alliance led by Hubei and the 14-province chronic disease drug alliance led by Henan, the double-reporting volume of medical institutions and retail pharmacies also means that the relevant varieties involved have a considerable market size, and a new round of market reshuffle is imminent
.
Centralized collection of blood products and growth hormones for the first time Under the baton of the top level of the country that they should be collected as much as possible, both local and provincial alliances are actively expanding the scope of centralized drug collection
.
As can be seen from the drug procurement list released by Guangdong, the alliance has divided 276 products for centralized collection into two parts: blood products and other drugs, the latter including glucose/sodium chloride/glucose-sodium chloride injection, non-exclusive drugs and Three categories of exclusive drugs that can be combined according to the grouping principle
.
It should be pointed out that this is also the first time that blood products have entered the category of volume procurement
.
Blood products are mainly biologically active preparations prepared from healthy human plasma by biological processes or separation and purification techniques
.
According to data, the market size of blood products in China has shown a growing trend in recent years, reaching 38.
2 billion yuan in 2020
.
According to different functions and structures, blood products can be divided into three categories: albumin, immunoglobulin and coagulation factors
.
Among them, human albumin is the leading variety in the blood product market.
It is mainly used in the clinical treatment of critically ill patients.
The epidemic has further promoted the increase in the use of human albumin
.
According to the statistics of Minet.
com, the two major varieties of human albumin and sodium chloride injection stand side by side on the top 20 product list of terminal chemical drugs in China's public medical institutions in 2020, with sales exceeding 10 billion yuan
.
Currently, Jet Behring occupies the leading position in the albumin market, followed by Hualan Bio, Shanghai RAAS and Boya Bio.
How the market pattern will change after this battle, we will wait and see
.
In the purchase list, recombinant human growth hormone is also listed, which also means that the boots of this blockbuster variety have officially landed
.
As pituitary, hypothalamus and similar drugs, the current competition pattern of recombinant human growth hormone injection in the domestic market is one imported and two domestically produced, corresponding to Novo Nordisk, Changchun Saikin and Anke Bio.
Enterprise
.
According to the data of Minet.
com, the sales of recombinant human growth hormone injection in public medical institutions in China in 2020 will be close to 4 billion yuan, and Changchun Jinsai Pharmaceutical will account for 99.
96%
.
In May last year, as soon as the news that recombinant human growth hormone was about to be included in the centralized procurement came out, the stock prices of Changchun High-tech and Anke Bio, the parent companies of Changchun Jinsai, fell continuously
.
With the official release of the centralized procurement documents today, Changchun Hi-Tech crashed and fell to the limit, and Anke Bio fell 7.
54%
.
After the special national procurement of insulin, the industry has paid more and more attention to the inclusion of biological drugs in the centralized procurement
.
The inclusion of rituximab in the collection by the Guangdong Alliance has also attracted widespread attention in the industry
.
According to statistics from Minet.
com, in 2020, the market size of rituximab in public medical institutions in China will reach 4.
36 billion yuan
.
Although the original drug company Roche still occupies a major share, with the successive approvals of rituximab biosimilars from Henlius and Innovent, the market competition pattern has changed
.
Some industry insiders pointed out that at present, my country's biological preparations/biosimilars seem to need to accumulate more experience in terms of supply stability and substitution, and do not fully meet the requirements for inclusion in the country.

.
However, as a local exploration, the Guangdong Alliance is first to test the waters for the centralized procurement of biological drugs, and is expected to accumulate certain experience for the formulation of innovative procurement policies suitable for biological products at the national level
.
A number of successful candidates have gradually become a trend.
From the cephalexin contract renewal plan and the national procurement contract renewal with more than ten provinces, the price can be adjusted.
The industry can see Guangdong's innovative exploration of policies and rules for centralized drug procurement
.
However, unlike the industry's judgment that Guangdong is likely to purchase more than 200 varieties in batches, this time the Guangdong Alliance adopts a unified procurement model
.
Due to the huge number of purchased products, Guangdong Alliance grouped them according to different categories of drugs, and differentiated A/B purchase orders except for blood products
.
For example, Guangdong Alliance proposed that, in principle, non-exclusive drugs should be grouped according to the name of the drug in the medical insurance drug catalog (by medical insurance number) and the combined dosage form (based on the "General Principles of Preparations" of the Chinese Pharmacopoeia); contrast agents of different concentrations/drops Ophthalmic preparations, medicines with completely different indications, and medicines limited to children's use distinguish different groups
.
According to the proportion of the total amount of pre-purchase in the first year reported by the public medical institutions corresponding to the actual application regulations of each company of the same variety and group to the total amount of pre-purchase in the first year of the alliance area, the order is in descending order according to the proportion of each company.
Sorting, accumulatively 80% of the enterprises are listed in the A purchase order, and the rest are listed in the B purchase order
.
It is worth noting that the exclusive varieties appearing in this collection document are not the only varieties in the popular sense
.
Guangdong Alliance proposes that as exclusive drugs (including drugs of the same variety with the same person in charge of the enterprise or different companies with direct holding and management relationships) that cannot be combined according to the above principles, the value after rounding up to the integer according to the P0 corresponding to the declared product regulations shall be reserved.
Divided into 3 groups, each bidding group only has purchase order A: ①value≤30 yuan; ②30 yuan<value≤150 yuan; ③value>150 yuan
.
If there are more than 1 company actually applying for the same drug name and combined dosage form, they shall be grouped according to the principle of non-exclusive drug purchase order
.
After the purchase order is formed, Guangdong Alliance sets up the corresponding bidding rules for the companies to be selected and the companies to be selected one by one
.
For example, for other drugs in the non-exclusive drug A purchase order P2 to be selected, Guangdong proposes that one of the following conditions can be included in the proposed selection: (1) If the number of valid quotation companies is less than or equal to 3, according to the "unit" of P2 Comparable price"/average daily cost is sorted in order from low to high, and the enterprise with the lowest "comparable price per unit" is included in the proposed selection
.
(2) If the number of companies with valid quotations is more than 3, they will be sorted according to the "comparable price per unit"/average daily cost of P2 from low to high, and the companies with the top 50% ratio (rounded up and reserved for one digit) are included in the proposed selection range.
If there are more than 24 companies with valid quotations, the top 12 companies will be included in the scope of selection
.
It can be seen that price is still an important determinant of selection eligibility
.
At the same time, Guangdong has also made it clear that the companies to be selected in P2 will obtain 100% of the pre-purchased volume in the first year of the procurement period of the company in the alliance area and gain incremental use
.