412 million, 1.621 billion... Will domestic PD-1s sell well in 2021?

Following the release of 2021 financial reports by major multinational pharmaceutical companies, domestic pharmaceutical companies have also gathered to hand over their 2021 transcripts.
PD-1 is a popular product currently on the market.
It has also attracted industry attention
.

With the recent approval of Henlius' PD-1 slulimumab (trade name: Hans-like), the number of PD-1 products on the domestic market has risen to nine.
Except for two imported products, the others are domestically produced.
, including slulimumab, the other six are toripalimab (trade name: Tuoyi) from Junshi Bio, and sintilimab (trade name: Daboshu) from Innovent ), Hengrui Medicine's camrelizumab (trade name: Erica), BeiGene's tislelizumab (trade name: Baizean), and AceBio's piamprilumab (trade name: Aniko), and Yuheng Pharmaceutical's sepalimab (trade name: Yuduo)
.

Among them, four products have entered the medical insurance catalog

PD-1 performance PK of each company

PD-1 performance PK of each company

Toripalimab: If only in terms of sales performance, Junshi's toripalimab has not performed well.
According to its annual report, in 2021, the annual sales revenue of toripalimab will be It is only 412 million yuan, a drop of nearly 60% compared to the sales of 1.
003 billion in 2020.
This is also the year with the lowest annual sales since Tuoyi was approved at the end of 2018.
Its sales performance in the first year of listing was 778 million.

.

Toripalimab:

When evaluating the sales performance of PD-1 in the annual report, Junshi Bio said that although the sales volume in 2021 has increased, it has failed to achieve "price-for-volume", resulting in negative growth in sales revenue
.

For this situation, Junshi Biology mentioned multiple reasons
.

First, after the official implementation of the 2020 National Medical Insurance Catalogue in March 2021, the product terminal pricing of toripalimab will drop by more than 60% compared to the initial pricing in 2020

It is also worth noting that the "going overseas" of toripalimab will be reviewed this month.
It is reported that the US FDA has accepted toripalimab combined with gemcitabine/cisplatin as a late recurrence or metastatic nasopharyngeal Biologics License Application (BLA) for first-line treatment of cancer patients and as a single agent for second-line and above treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing therapy
.

The FDA granted Priority Review designation for this BLA and does not plan to schedule an Advisory Committee meeting, with a proposed Prescription Drug User Fee Act (PDUFA) target review date of April 30, 2022

Sintilimab : Compared with Toripalimab’s sales of over 400 million, the performance of sintilimab is excellent, although Innovent Bio did not directly disclose the sintilimab in its 2021 annual report.
However, according to the quarterly report of Innovent Bio, the sales of sintilimab should exceed 3 billion in 2021, and the sales last year were 2.
49 billion.
Since its listing, its cumulative sales revenue has exceeded 6.
4 billion.
In terms of indications, 4 indications have been approved, covering major cancers such as lung cancer and liver cancer.
At the same time, three indications including esophageal squamous cell carcinoma have been submitted for marketing applications
.

Sintilimab:

However, because of its "going overseas", sintilimab has been a little disturbing recently.
On the evening of March 24, Innovent announced that the company had received a US FDA investigation on sintilimab combined with pemetrexed and platinum-based chemotherapy.
The complete response letter to the New Drug Application (BLA) for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), the FDA said in the response letter that it has completed the review of the BLA, but failed to approve the application, This is consistent with the results of the Oncology Drugs Advisory Committee (ODAC) meeting held in February
.

Although this result was expected, it still caused the share price of Innovent to drop for a while.

Tislelizumab: As one of BeiGene's leading products, Tislelizumab will contribute US$255.
1 million in sales revenue in 2021, or approximately RMB 1.
621 billion, a year-on-year increase compared to 1.
12 billion last year over 40%
.

BeiGene said in the announcement that the demand for new patients brought about by the expansion of medical insurance reimbursement, the further expansion of the sales team, and the increase in the number of drug admissions continued to promote the expansion of Baizean’s market penetration and market share

Tislelizumab:

Tislelizumab is also preparing to “go overseas”.
In 2021, BeiGene submitted its first new drug application for tislelizumab to the FDA for second-line squamous esophageal cancer (ESCC).
The center's Phase 3 trial data has a target date of July 12, 2022 for a decision on the drug's U.
S.
marketing application
.

According to public information, tislelizumab is currently conducting about 50 clinical trials in 35 countries and regions around the world, with more than 9,000 subjects enrolled.

Carrelizumab: Relying on a strong sales force and mature sales channels, Carrelizumab, which won the first domestic PD-1 sales performance last year (its sales performance in 2021 is 4.
89 billion), is due to the fact that Hengrui Medicine's 2021 annual report has not yet been released.
Announced, its sales performance is not known yet, but Hengrui Medicine previously released its financial report for the first half of 2021 that the sales revenue of Carrelizumab due to the difficulty of entering the hospital and the different implementation time of medical insurance in various places negative growth month-on-month
.

Carrelizumab:

Piamprimab: On the last day of March, Kangfang Bio released the first transcript of its PD-1 monoclonal antibody after it was launched.
Piamprimab achieved sales of about 212 million yuan
.

Combined with the CTLA-4 monoclonal antibody licensed to Merck & Co.

Piamprilumab:

In the future, the sales volume of Piamprimab will also depend on the expansion of approved indications
.

In 2021, Kangfang Bio has also successively applied for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer and the third-line treatment of metastatic nasopharyngeal carcinoma with Piamprimab combined with chemotherapy.

Sepalizumab: Since Yuheng Pharmaceutical has not disclosed its 2021 annual report, the sales performance of Sepalizumab is not known yet, but its price of 3,300 yuan per bottle of 120mg (4ml) has refreshed the price of domestic PD-1
.

Sepalizumab:

Slulimumab: Fuhong Henlius' slulimumab has not yet generated sales because it has just been approved
.

Slulimumab:

In terms of imported PD-1 sales performance, Keytruda will top the revenue list of all Merck products with a global revenue of US$17.
186 billion (approximately RMB 109.
3 billion) in 2021, while its competitor Opdivo’s global sales will be US$7.
52 billion (approximately RMB 47.
84 billion).
), the gap between the two is already very obvious
.

As for the sales performance of the approved PD-L1 in 2021, the global sales of AstraZeneca’s durvalumab (trade name: Infineon) were US$2.
412 billion (approximately RMB 15.
35 billion).
The sales of tilizumab (trade name: Taishengqi) were US$3.
58 billion (approximately RMB 22.
78 billion).
The industry's sugelimab (trade name: Zejiemei) should have no sales results due to its approval in November and December 2021, respectively
.

The PD-1/PD-L1 market is becoming increasingly "involutionary"

The PD-1/PD-L1 market is becoming increasingly "involutionary"

With the continuous approval of PD-1/PD-L1 monoclonal antibody products, the "internal volume" faced by market competition will intensify.
According to statistics from Essence Securities, it is estimated that by the end of 2022, there will be a total of 17 PD-1/PD-L1 models.
Monoclonal antibody and 1 PD-1/CTLA-4 double antibody are listed in China, of which 14 domestic PD-1/PD-L1 (including double antibody) are currently in the PD-1 market, and the drugs to be declared later include Jiahe Biogen’s genozumab and Lepu Bio’s pretlimumab, among which Jiahe Biotech’s NDA submission was only 2 months later than Kangfang/Tianqing’s piamplimumab, and it is expected to be approved within this year
.

According to data from Frost & Sullivan, the global PD-1/L1 inhibitor market in 2018 is expected to reach a market size of US$63.
9 billion by 2023
.
In China, the market size of PD-1/L1 inhibitors is expected to reach 66.
4 billion yuan in 2023 and grow to 98.
8 billion yuan in 2030
.
With the internal and external attack, the expansion of old drugs and the launch of new drugs, it remains to be tested by the market which product will grab more share
.