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After a year, she has not been forgotten
.
In November last year, as a representative of the super payer, Director Zhang Jinni negotiated with pharmaceutical companies after an hour and a half and eight rounds of bargaining, "so humble, really difficult", 700,000 injections of nocinaxen sodium injection, finally dropped to 33,000 yuan
.
In this public video, the target of the price reduction carefully chose a foreign company, but the domestic pharmaceutical industry was still deeply shocked
.
When it comes to medical insurance negotiations, what kind of soul bargaining scene will be released this year?
However, there was an innovative drug that was completely forgotten, and until Yuheng Group was ruled bankrupt, we remembered the fate
of Yuheng Biotechnology (a shareholding company of Yuheng Pharmaceutical) and the 6th domestic PD-1 sepalimab.
This year, 3 domestic PD-1/PD-L1 models are eligible to participate in the 2022 medical insurance negotiations but do not participate, and 10 exclusive innovative drugs directly abandon medical insurance negotiations, the highest
number in history.
01 PD-1 looks down on life and death
01 PD-1 looks down on life and deathThere is a precedent
for refusing to cut prices into health insurance.
As the world's most famous PD-1, Merck K drug (pembrolizumab) has not been included in medical insurance, and the annual cost of charitable drug donation is about 325,000 yuan
.
In contrast, some pharmaceutical analysts expect that after medical insurance negotiations in 2022, the annual treatment cost of domestic PD-1 monoclonal antibody will be reduced to less than
30,000 yuan.
In 2021, pembrolizumab sales in the sample hospitals still increased by 59%.
In the first half of 2022, the sales of PD-1 monoclonal antibody in the sample hospitals, pembrolizumab > carrelizumab, > tirelizumab, > sindilimab
.
Among the PD-1 in the medical insurance system, BeiGene's tislelizumab may be the only one to buck the trend, with sales in the Chinese market reaching 879 million yuan in Q3 this year, an increase of 26.
7% month-on-month, and has achieved three consecutive quarters of growth
this year.
Innovent Cindilimab Q3 sales were approximately RMB550 million, while Junshi Biologics had sales of Teripulimab Q3 of approximately RMB218 million
.
Medicare is meaningless
to the life and death of PD-1.
Domestic PD-1/PD-L1 eligible to participate in the 2022 medical insurance negotiations but not participated in them include, Akeso/Chia Tai Tianqing Pine Amplimumab (39,000 yuan/two years), CStone Pharmaceuticals sugemalimab (9.
9
10,000 yuan/year), Yuheng Biologic Cypalimab (158,000 yuan/year).
Akeso's paiampelimab was approved for listing in August 2021, with the lowest unit price of PD-1, with the sales ability of Chia Tai Tianqing, with sales revenue of 212 million yuan in 2021 and sales revenue of 297 million yuan in the first half of this year, an increase of 40% from the previous month, and there is no need
to enter medical insurance.
Yuheng Biologics commissioned WuXi Biologics to develop separimab, and Akeso PD-1 was approved for marketing in the same month, but it could not be saved by entering medical insurance
.
Sepalimab entered DTP pharmacy, priced at 3,300 yuan / piece, with a cumulative shipment of more than 10,000 units in 2021, sales of less than 100 million yuan, this year's sales data is not disclosed, but Yuheng Pharmaceutical's sales revenue of anti-tumor drugs in the first half of this year was 109 million yuan, down 1.
3%
year-on-year.
The sixth domestic PD-1 has no sense of existence, which is the inevitable result of the homogenization of pipelines in the early stage of
innovative drug development.
And Yuheng Pharmaceutical is also stormy, hovering on the profit and loss line
.
The controlling shareholder, Yuheng Group, was ruled bankrupt
by the Harbin Intermediate Court on November 10.
Zhu Jiman and his wife, the actual controllers of Yuheng Group, became the richest people in Heilongjiang Province with 10.
5 billion yuan in 2018, and saw him rise high
.
Since Yuheng Pharmaceutical went public in 2010, Zhu Jiman has spent a total of 12.
9 billion yuan on 27 mergers and acquisitions
.
Whenever the news of the merger and acquisition came, the stock price of Yuheng Pharmaceutical rose
.
As a sequel of crazy mergers and acquisitions, in 2019, Yuheng Pharmaceutical lost 2.
662 billion yuan and provided for goodwill impairment provisions of 2.
615 billion yuan
.
When sepalimab was approved, Zhu Jiman, who was in trouble, also thanked his partner WuXi Biologics for the help of its technology enablement platform
.
Sepalimab is the first Chinese market commercialization project enabled by WuXi Biologics, but I did not expect such a fate
.
Domestic innovative drugs that are eligible to participate in the 2022 medical insurance negotiations but are not involved
02 Different fireworks
02 Different fireworksDifferent from the inner roll of PD-1, the 10 exclusive innovative drugs gave up participating in medical insurance negotiations with no competitive confidence, "I am me, fireworks of different colors"
.
After innovative drugs enter the medical insurance catalog, they exchange price for quantity
.
According to the statistics of Essence Securities, the average sales of the 17 drugs transferred to the medical insurance catalog in 2018 were 90 million yuan before the transfer and 310 million yuan after the transfer, while in 2019
The average sales of the 70 drugs transferred to the medical insurance catalogue were 50 million yuan before the transfer and 90 million yuan
after the transfer.
The price paid is an average price reduction of 50~60%, and for exclusive varieties, there may be situations
where the volume and price cannot be balanced.
Seliniso is Antengene's first commercial product and the first + only nuclear output inhibitor (SINE) drug approved for XPO1 targets in China and Asia Pacific, with NMPA conditional approval
in December 2021.
The monthly treatment cost of celiniso tablets in the United States is 22,000 US dollars, and the domestic price is 1/7
of the United States.
Seliniso tablets were officially commercialized in Chinese mainland on May 13 this year, with sales of 54 million yuan in more than a month, and the annual sales target
of 180-200 million yuan is expected to be completed.
The domestically listed Seliniso is imported from the United States and its pricing is relatively moderate, but it still faces greater pressure to reduce prices if it participates in medical insurance negotiations
.
Exclusive products, no pressure
from market-oriented competition.
Antengene will promote the local production of Seliniso, and the Shaoxing plant is in trial operation, and it is expected to participate in medical insurance negotiations
next year or the year after when the cost of drugs is reduced.
CSPC Duvilise Capsules (formerly known as Duensib Capsules) obtained drug registration approval in March this year, becoming the first approved PI3K inhibitor in China and the world's first approved dual inhibitor
of PI3K-δ and PI3K-γ.
Omutivimab is the first rabies monoclonal antibody in China, filling the gap in China's anti-rabies monoclonal antibody drug market, and is also an important symbol
of the transformation of North China Pharmaceutical to biological drugs, which has suffered from centralized procurement.
Yttrium [90Y] resin microspheres, a key tumor intervention product of Grand Pharma, is the first product approved for the treatment of colorectal cancer liver metastases in China, which can efficiently control tumors, and some tumors can be transformed in a reduced stage, thereby creating opportunities
for curative surgery.
Innovent Pemitinib is the first targeted therapy drug approved for cholangiocarcinoma in China, filling the therapeutic gap
in this field.
The incidence of intrahepatic cholangiocarcinoma accounts for about 15~20% of primary liver malignant tumors, and the trend
is increasing.
CStone Pharmaceuticals ivosnib is the world's first potent and selective oral mutant IDH1 (IDH1m+) inhibitor
.
The people can be trusted
Solidegil phosphate is domestically approved for the treatment of locally advanced basal cell carcinoma (Basal Cell
Carcinoma, BCC).
Subi Pharmaceutical's emanimumab is a rare blood disease drug and is the only fully humanized monoclonal antibody approved for the treatment of primary HLH in the world, which will solve the pain point
of no drug available in patients with primary HLH in China.
We should also see that most of the above exclusive varieties are license-in from overseas, and the issue of cost recovery from the perspective of pharmacoeconomics may be one of
the reasons for the reluctance to enter medical insurance for the time being.
One of the focus of this year's health care negotiations is whether exclusive varieties or rare disease drugs can be priced differently
.
Akeso's first domestic dual antibody cardunilimab currently costs about 952,000 yuan per year for treatment, and about 19.
8 after charitable assistance
million
.
If the reduction is limited on the basis of 200,000 yuan, it will reflect the tolerance of the Health Insurance Bureau to exclusive varieties with high innovation content
.
19 rare disease drugs passed the form review, most of which had an annual treatment cost of more than 300,000 yuan, and the β of agacasse for injection and α for injection exceeded 1.
5 million yuan
.
The ceiling of medical insurance negotiations is 300,000 yuan per year, and JW Therapeutics CAR-T took the initiative to declare medical insurance negotiations, which has passed the formal review, can it finally sit at the negotiating table?
If the ceiling can be raised, it will alleviate the pressure of high-priced drugs of about 200,000 yuan, which is a major marginal improvement
to the payment environment for domestic innovative drugs.
Wait and see
.
Some innovative drugs abandon medical insurance and bypass traditional single payers to find living space, which is also an improvement
.
A virtuous ecosystem is always able to provide more choices
.
