Recently, the first batch of diclofenac and other drugs purchased by Guangdong alliance have completed online quotation. This centralized purchase includes varieties of market concern such as growth hormone and recombinant coagulation factor 8.
this is also the first gathering of growth hormone alliance in China . According to the results of the proposed selection announced by Guangdong pharmaceutical trading center that night, in the centralized procurement of the alliance of 11 provinces in Guangdong, no enterprise won the bid for the growth hormone water needle because the enterprise abandoned the bid or did not quote.
At the same time, four Chinese enterprises have launched fierce competition around growth hormone powder injection. Finally, kinsay Pharmaceutical Co., Ltd., a subsidiary of Changchun High And New Technology Industries (Group) Inc(000661) ( Changchun High And New Technology Industries (Group) Inc(000661) . SZ), and Shanghai United Saier Bioengineering Co., Ltd. were qualified for the proposed selection, and the prices of products corresponding to multiple specifications were reduced by about 50% and 30% respectively Anhui Anke Biotechnology (Group)Co.Ltd(300009) ( Anhui Anke Biotechnology (Group)Co.Ltd(300009) . SZ) and Zhongshan Weiming Haiji biomedical Co., Ltd. are the proposed candidate enterprises, and the proposed candidate products are reduced by 10% – 20%.
As the market generally believed that the price system of growth hormone water needle was not affected by the centralized purchase of the alliance, and the favorable water needle sales accounted for a large proportion of Changchun High And New Technology Industries (Group) Inc(000661) , the company’s share price rose for two consecutive trading days on the 10th and 11th. While Anhui Anke Biotechnology (Group)Co.Ltd(300009) which accounted for a large proportion of powder injection sales, its share price was depressed because Changchun High And New Technology Industries (Group) Inc(000661) took the lead in the powder injection bidding.
At the same time, in terms of recombinant human coagulation factor VIII, which is expensive and has a heavy burden on patients’ treatment, two foreign enterprises of baxalta and Novo Nordisk in Switzerland “unexpectedly” cut prices by more than 30% to obtain the qualification of the proposed selection, while the local enterprise Sinocelltech Group Limited(688520) ( Sinocelltech Group Limited(688520) . SH) is not on the list of the proposed enterprises.
growth hormone centralized collection: water injection abandonment standard, powder injection fierce battle
The 11 provinces (autonomous regions) participating in the centralized collection of Guangdong alliance are: Guangdong, Shanxi, Jiangxi, Henan, Guangxi, Hainan, Guizhou, Qinghai, Ningxia, Xinjiang and Xinjiang production and Construction Corps. It is also the first alliance to incorporate growth hormone into the centralized collection.
Growth hormone can be divided into three dosage forms: powder injection, water injection and long-term water injection. Among them, water needle is the mainstream dosage form in China, with a market share of about 60%; Powder injection dosage forms account for about 38%, and long-acting dosage forms account for only 1%.
In terms of price, long-term water acupuncture is the most expensive, with an annual treatment cost of more than 200000; Powder injection and water injection are about 25000 yuan / year and 50000 yuan / year respectively.
In terms of market competition pattern, at present, there are only three enterprises in China: Kinsey pharmaceutical, Anhui Anke Biotechnology (Group)Co.Ltd(300009) , Novo Nordisk, among which Kinsey pharmaceutical has the first market share; The competition in powder injection is more intense. There are 6 or 7 production enterprises, Anhui Anke Biotechnology (Group)Co.Ltd(300009) as the leader of powder injection. In 2020, the sample hospital has the first market share (the amount accounts for 44% and the quantity accounts for 41%), and Kinsey pharmaceutical has the third market share (the amount accounts for 15% and the quantity accounts for 22%); The long-acting dosage form is the exclusive dosage form of Changchun High And New Technology Industries (Group) Inc(000661) but Anhui Anke Biotechnology (Group)Co.Ltd(300009) has also completed phase III clinical treatment. At present, the production line is being transformed and ready to apply for production.
According to the document issued by Guangdong provincial drug trading center on February 23, a total of 174 varieties and 1613 products meet the application conditions.
Among the recombinant human growth hormone varieties, 13 product specifications were successfully declared. Among them, the enterprises applying for powder injection dosage forms (human growth hormone for injection) include Changchun High And New Technology Industries (Group) Inc(000661) subsidiary kinsay pharmaceutical, Anhui Anke Biotechnology (Group)Co.Ltd(300009) , Zhongshan Weiming Haiji and Shanghai United cel; The most concerned water injection type (recombinant human growth hormone injection) in the industry is only declared by Novo Nordisk, a multinational enterprise, and Changchun High And New Technology Industries (Group) Inc(000661) , Anhui Anke Biotechnology (Group)Co.Ltd(300009) both abandoned the bid.
Therefore, before the official quotation on March 10, the focus of the market mainly focused on: 1. How will Novo Nordisk water needle quote and whether its quotation will affect the existing market pattern?; 2. How will the four enterprises of powder injection bid? How will the price of powder injection be reduced
How will Novo Nordisk water needle quote? According to the reporter of kechuangban daily, on the day of online quotation on March 10, many varieties did not participate in the quotation, and Novo Nordisk growth hormone water needle is suspected to be among them.
Finally, the official results of the proposed selection showed that the growth hormone water needle did not win the bid. This also means that after Changchun High And New Technology Industries (Group) Inc(000661) , Anhui Anke Biotechnology (Group)Co.Ltd(300009) abandoning the bid, Novo Nordisk may choose not to participate in the quotation, or its quotation is invalid (such as the quotation is higher than the limit price, etc.).
Soochow Securities Co.Ltd(601555) pharmaceutical team analyzed that Kinsey pharmaceutical and Anhui Anke Biotechnology (Group)Co.Ltd(300009) gave up the bidding for growth hormone water injection, and Novo Nordisk water injection also failed to win, which means that the price system of water injection has not been affected
“The main reasons are insufficient product competition, relatively low medical insurance expenses, the main market outside the hospital, and the convenience and compliance of patients are significantly different from powder injection.” Soochow medicine explains the reason why growth hormone water needle is not selected by enterprises.
In terms of powder injection, the two enterprises to be selected are Kinsey pharmaceutical and Shanghai United Saier, and Anhui Anke Biotechnology (Group)Co.Ltd(300009) and Zhongshan Weiming Haiji are the enterprises to be selected. From the perspective of product decline, the decline of the proposed powder injection products compared with the highest effective application price is about 30% – 50%, and the decline of the proposed alternative products is between 10% – 20%.
Figure | bid winning situation of centralized collection of growth hormone by the alliance of 11 provinces in Guangdong
According to the rules, the enterprise to be selected refers to the enterprise to be selected in the P2 (second round) bidding, and the corresponding product is the product to be selected; The proposed alternative enterprise refers to the enterprise that participates in P1 (the first round) and P2 bidding at the same time, but fails to win the P2 bidding. The corresponding product is the proposed alternative product. For the enterprises to be selected and the enterprises to be selected, the difference between the two mainly lies in the difference in the pre purchase volume in the first year.
It is worth mentioning that although only 11 provinces (autonomous regions) participated in the alliance’s centralized procurement, insiders in the industry expect that the winning price of this centralized procurement will achieve national linkage, and the prices of water needles and other dosage forms are expected to be adjusted at the same time
recombinant human coagulation factor Ⅷ: foreign enterprises “take the initiative” to reduce prices
In this collection, recombinant human coagulation factor Ⅷ is another popular variety that has attracted more attention.
Public information shows that recombinant human coagulation factor VIII (also known as recombinant coagulation factor VIII) is mainly used to treat hemophilia A a (hemophilia A a). Hemophilia A A is the most common type of hemophilia in clinic, with a large group of patients.
This is a disease caused by the lack of eight factors of coagulation. In order to treat this disease, eight factors must be supplemented in time.
In China, blood coagulation factor VIII is the most commonly used in patients with hemophilia. This kind of products is a kind of blood products, which is mainly extracted from human plasma. However, due to the shortage of human plasma supply, the production capacity is limited. The corresponding manufacturers include Shanghai Raas Blood Products Co.Ltd(002252) ( Shanghai Raas Blood Products Co.Ltd(002252) . SZ), Hualan Biological Engineering Inc(002007) ( Hualan Biological Engineering Inc(002007) . SZ), Shandong Taibang, etc.
In addition, coagulation factor VIII can also be produced by recombination in vitro, that is, recombinant human coagulation factor VIII. In overseas mature markets, blood derived factor 8 drugs have withdrawn from the market, and the treatment demand of hemophilia is mainly met by recombinant factor 8. From the current market demand, China’s hemophilia market in the future will gradually transform into recombinant human coagulation factor VIII as the main drug.
However, the production process of recombinant coagulation factor 8 protein has high technical threshold and difficult production. At present, the supply in the Chinese market mainly comes from imported varieties, and the price is also quite expensive. On July 23, 2021, Sinocelltech Group Limited(688520) independently researched and developed recombinant coagulation factor VIII product – angain was approved for listing, which is the first domestic recombinant coagulation factor VIII product.
According to the document issued by Guangdong provincial drug trading center on February 23, in the first round of centralized procurement, 14 specifications of recombinant human coagulation factor VIII met the application conditions, including Bayer healthcare LLC in the United States, Wyeth Farma S.A. in Spain, baxalta manufacturing s à RL in Switzerland, Novo Nordisk A / S, green cross Corporation and Sinocelltech Group Limited(688520) these six companies.
Finally, baxalta and Novo Nordisk A / S (Novo Nordisk) of Switzerland were qualified to be selected, and the price reduction of products corresponding to several specifications was about 50% and 30% respectively; Bayer company of the United States and Wyeth Farma of Spain are proposed candidates, and the price reduction rate is more than 20% If the enterprise fails to win the bid.
Figure | bid winning of recombinant human coagulation factor VIII collected by the alliance of 11 provinces in Guangdong
Why can foreign companies “counter surpass” domestic brands and vigorously reduce prices in the bidding of recombinant human coagulation factor VIII?
In this regard, some analysts told the reporter of science and Innovation Board daily, this is mainly a “passive response to the low price listing of domestic recombinant coagulation factor 8” . At the same time, it believes that the price reduction of recombinant coagulation factor 8 has limited impact on blood derived coagulation factor 8, because there is still a certain gap between the two prices.
