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Entering the new era of medical insurance, domestic PD-1 ushered in a new round of commercial competition, who can be better?
With the release of the third quarterly report of various pharmaceutical companies, the performance of domestic PD-1 products has gradually
surfaced.
From the perspective of specific sales, there is still a large gap
between various companies.
BeiGene's tirelizub sales reached 2.
179 billion yuan in the first three quarters of China, and is currently in a leading position; according to the financial report of Xinda Biologics' partner Eli Lilly, the total sales of Cindilimab in the first three quarters were about 1.
631 billion yuan; in contrast, China's first successfully listed domestic PD-1 monoclonal antibody, Junshi Biologics' teripulimab, did not maintain a first-mover advantage, with a total sales of 516 million yuan
in the first three quarters.
As the "cornerstone" of tumor immunotherapy, the domestic PD-(L)1 field has always been the "red sea" of tumor market competition, and it is also an important focus
of annual medical insurance negotiations.
For the PD-1 monoclonal antibody "domestic tigers" of Innovent Biologics, Hengrui Pharmaceutical, BeiGene, and Junshi Biologics, which have long been included in medical insurance, the highlight of this year's medical insurance negotiations is to see the competition
for new indications into medical insurance.
A new batch of "players" were shortlisted for the first time, including 3 PD-(L)1 products from Akeso, Henlius and Corning Jerry to participate in the 2022 medical insurance negotiations
.
It is foreseeable that as PD-(L)1 companies enter medical insurance one after another, the market competition will become more and more fierce
in the future.
Since November, domestic PD-1 companies have handed over their report cards for the first three quarters of this year, and some are happy and some are sad
.
On the crowded PD-1 track in China, the running is slower, but there are still companies that can get good profits
.
BeiGene's product revenue in the first three quarters was RMB6.
069 billion, a year-on-year increase of 114.
6
%.
It is particularly noteworthy that BeiGene's core self-developed product, PD-1 tislelizumab, continued to increase in the
third quarter.
In the third quarter, the sales of tislelizumab in the Chinese market reached 879 million yuan, compared with 498 million yuan
in the same period last year.
3 consecutive quarters of growth
.
BeiGene said sales growth was driven by new approved indications this year, driving market penetration and market share, while expanded reimbursement coverage in the medical insurance catalogue led to more new patient demand
.
As the seventh PD-1 listed in China, tislelizumab is the latecomer and successfully "overtaking on a corner", which is expected to further bring broader commercialization potential
.
It is reported that BeiGene's tislelizumab has 9 indications
.
At present, all 5 eligible approved indications for relapsed/refractory classic Hodgkin lymphoma, second-line urothelial carcinoma, first-line non-squamous non-small cell lung cancer (NSCLC), first-line squamous NSCLC and second- or third-line hepatocellular carcinoma (HCC) have all entered the national medical insurance drug list
.
This year, 4 new indications were added to medical insurance: second/third line for advanced lung cancer, second-line esophageal squamous cell carcinoma, first-line nasopharyngeal carcinoma, and second-line MSI-H
/dMMR solid tumor.
In the industry's view, the expansion of indications can bring about an increase in market share, which determines the competitive advantage
of products to a certain extent.
In the future, whoever can expand more indications and has a more reasonable price will be able to seize market share
.
Innovent achieved total product revenue of more than RMB1.
1 billion in the third quarter of 2022, and its product portfolio showed both sequential growth in volume and revenue
.
Among them, sales of sindilimab increased sequentially
due to two newly approved indications (first-line gastric cancer and first-line esophageal cancer).
In the first three quarters, the total sales of Cindilimab were about 1.
66 billion yuan
.
From the current situation, it is difficult to achieve last year's sales of 2.
8 billion yuan
.
In the first three quarters, Hengrui Pharmaceutical achieved operating income of 15.
945 billion yuan, but the sales figures of carrelizumab are still secret
.
According to public information, carrelizumab was officially launched in 2019, and the price was not reduced in 2020, 19,800 / bottle, and 306,900 bottles
were sold.
In 2021, the price was reduced by 85%, and the sales volume reached 1.
4143 million bottles, or about 4.
141 billion yuan
.
As for sales in 2022, it is unknown at the moment
.
In addition, carrelizumab medical insurance this year added 4 indications: nasopharyngeal carcinoma third-line and above, nasopharyngeal carcinoma first-line, esophageal cancer first-line and squamous non-small cell lung cancer first-line
.
In addition, Hengrui Pharmaceutical needs to negotiate a renewal this year
.
As China's first successfully marketed domestic PD-1 monoclonal antibody, Junshi Biologics' teripulimab has a first-mover advantage, but sales have not been raised
.
According to the third quarter report of 2022, Junshi Biologics' teripulimab achieved sales revenue of about 218 million yuan
.
Compared to the other three, the gap is not small
.
At present, teripulimab has been approved for 6 indications in China, and the data of subsequent postoperative adjuvant/perioperative treatment is waiting to be read, and 2 new indications have been added to medical insurance this year, namely the first line of nasopharyngeal carcinoma and the first line
of esophageal squamous cell carcinoma.
According to Frost & Sullivan, the global PD-(L)1 monoclonal antibody market is expected to reach $62.
6 billion
by 2025.
Among them, China's PD-(L)1 market size is expected to reach 51.
9 billion yuan in 2025.
From the perspective of the existing sales scale, there is still market space
.
However, as PD-(L)1 enters medical insurance one after another, market competition will become more and more intense, and a new round of knockout may begin
.
On October 16, the National Health Insurance Administration issued the "Announcement on the Phased Results of Expert Review of Declared Drugs Approved by Formal Review for the Adjustment of the National Medical Insurance Drug Catalogue in 2022", which means that the expert review work has been completed and the 2022 medical insurance negotiations have entered the "countdown"
.
343 drugs passed the formal examination this time, including 183 new varieties of Western medicines and 15 proprietary Chinese medicines; There are 111 renewed varieties of Western medicine and 34 proprietary Chinese medicines in the catalog
.
Through combing, it was found that this round of medical insurance negotiations is still full of highlights
.
From the perspective of indications, anti-tumor and immunomodulators were selected in the preliminary review catalog, with a total of 89.
Looking back at the previous medical insurance negotiations, the competitive landscape of PD-1/L1 drugs has attracted much attention
.
According to the 2022 medical insurance negotiation catalog, the PD-(L)1 drugs owned by multinational pharmaceutical companies do not appear in the list, and the relevant "fight" will be carried out
among domestic pharmaceutical companies.
From "volume" products to "volume" indications, 4 domestic PD-1 products have undergone great changes in the indications pattern after the adjustment of the medical insurance catalog in 2021, and the highlight of this year's medical insurance negotiations is to see the competition
for new indications into medical insurance.
According to statistics, from July 1, 2021 to June 30, 2022, a total of 10 new indications were added to the PD-1 monoclonal antibody "domestic four tigers
".
Among them, BeiGene's tislelizumab added 4 indications, ranking first; Innovent Biologics' Cindilimab, Hengrui Pharmaceutical's carrelizumab and Junshi Biologics' teripulimab each added 2 new indications
.
In addition to the new indications that can participate in the new round of medical insurance negotiations, indications that were not successfully negotiated into medical insurance last year have also become indications
for participating in the new round of medical insurance negotiations.
Hengrui Pharmaceutical's carrelizumab had 2 indications for nasopharyngeal carcinoma that were not included in the 2021 medical insurance catalogue last year, and will participate in this round of medical insurance negotiations together with the 2 new indications
.
Together, the "domestic four tigers" have more than 10 indications of medical insurance to be discussed
.
In the 2022 medical insurance negotiations, in addition to the "four tigers" that occupy half of the domestic PD1 to continue to "roll" indications, there are several new PD-(L)1 players entering the game, including Henlius' PD-1 serplulimab, Corning Jerry/Sidi/Simcere Pharmaceutical's PD-L1 envolimab, and Akeso's PD-1/CTLA-4 dual antibody cardunilimab injection
.
Akeso's paipulimab has only been approved for one indication for Hodgkin lymphoma, but the sales revenue is very objective, achieving revenue of 300 million yuan in the first half of 2022, and the two indications of non-small cell lung cancer and nasopharyngeal cancer have also applied for marketing, and it is expected that the revenue will further grow
after listing.
In March this year, Henlius' PD-1 monoclonal antibody serplulimab was approved for use in unresectable or metastatic highly microsatellite unstable (MSI-H) solid tumors that have failed standard treatment, and is the first domestic "pan-cancer" PD-1
.
By the end of June 2022, the sales revenue will be about 76.
9 million yuan
.
Corning Jerry/Sidi/Simcere Pharmaceutical's envolimab was approved for marketing in November 2021, which is the first approved PD-L1 monoclonal antibody in China and the world's first PD-L1 subcutaneous
injection.
In the first half of 2022, the sales revenue was 54 million yuan
.
What will be the competitive landscape for PD-(L)1 once the newcomers join? Will new entrants successfully shortlist with "bloody" price reductions and accelerate hospital admission through medical insurance to achieve product volume? How much will the price of the "domestic four tigers" PD-1 be reduced after the new indications? The "annual drama" of medical insurance negotiations is about to be staged, and the "Medical Economic News" will continue to pay attention to
the follow-up progress.
