The world's first subcutaneous injection and the first domestically produced PD-L1 will be approved soon!

On November 4th, the official website of NMPA showed that the recombinant humanized PD-L1 single domain was co-operated by Corning Jerry (9966.

Its indications are microsatellite unstable (MSI-H) colorectal cancer, gastric cancer, and advanced solid tumors with mismatch repair defects (dMMR) that have failed the previous standard treatments

▲Source: NMPA official website

Envolimab is expected to become China's first domestically produced PD-L1 inhibitor, and it is also the world's first subcutaneously injected PD-(L)1 inhibitor

If envolimab is officially approved, China will have 11 PD-(L)1 models

In addition, there are still many PD-(L)1s waiting in line for approval.

And the new round of national health insurance talks strikes, to what extent will PD-(L)1 be involved? Will the fight be as fierce as 2020, and it will become the focus of attention

01 Domestic 11 models of PD-(L)1 and their indications

If envolimab is approved for marketing in the near future, my country's approved 1PD-(L)1 will reach 11, among which:

6 domestically produced PD-1;

2 imported PD-1;

2 imported PD-L1;

1 domestically produced PD-L1

From the perspective of PD-1, the approved indications for the 8 PD-1 inhibitors that have been marketed in China range from 1 to 8

Imported Pembrolizumab and Nivolumab have been approved in China for 8 and 5 indications respectively;

The domestically produced carrelizumab has also been approved for 6 indications, which is currently the most approved variety for domestically produced PD-1;

Followed by BeiGene (6160.

Sintilizumab and Teriplizumab also have 4 and 3 indications, respectively

In addition, Hanlius (2696.

From the perspective of PD-L1, with the listing of Envolimab, there will be 3 models in China:

The newly approved indications for envolimab are microsatellite unstable (MSI-H) colorectal cancer, gastric cancer, and advanced solid tumors with mismatch repair defects (dMMR) that have failed the previous standard treatments

The first domestically approved AstraZeneca PD-L1 inhibitor duvalizumab currently has two domestic indications, namely: 1) patients with unresectable and stage III non-small cell lung cancer; 2) small cell lung cancer (SCLC)

Then there are 4 indications for Roche Atelizumab approved in China: 1) Combination chemotherapy for first-line treatment of advanced and metastatic extensive stage small cell lung cancer; 2) Combination of bevacizumab for first-line treatment of advanced unresectable liver Cell carcinoma

In addition, CStone-B (2616.

02 PD-(L)1 price competition is fierce

Will medicine be universal in the future?

Initially, when pembrolizumab (keytruda) was launched in China, the annual cost reached 300,000 yuan, and many patients could only "hope and sigh".

PD-1 aspect:

In 2019, Sintilimab (1801.
HK)'s Sintilimab successfully entered the medical insurance list with a 64% drop.
The annual cost of Sintilimab was reduced from 280,000 yuan before negotiation to 96,700 yuan per year
.

In 2020, Hengrui Medicine (600276.
SH), BeiGene (6160.
HK) and Junshi Bio (1877.
hk; 688180.
SH) will be included in the medical insurance with an average 78% reduction, and the annual treatment cost will be directly reduced to the lowest.
To about 50,000 yuan/year
.

In this case, Cinda Biotech has further launched a drug donation program
.
According to the new drug donation program, eligible patients only need to pay for 7 cycles to enjoy 2 years of use rights.
The overall cost is 39,800 yuan, and the annual treatment cost is less than 20,000 yuan
.
The price of domestically produced PD-1 has been refreshed again
.

In August 2021, Kangfang Bio-B(9926.
HK)/Zhengda Tianqing’s PD-1 Paimrizumab was approved for the market, and its price is 4875 yuan/100mg each, and the free drug plan is to buy 4 Two free medicines and another 4 free medicines are given until progress is made.
The capped treatment cost for two years is 39,000 yuan
.
The pricing strategy directly refers to Cinda's lowest price of Sintilimab
.

On August 30, 2021, Yuheng Pharmaceutical (002437.
SZ) / WuXi Biologics (02269.
HK) PD-1 Sepalizumab was approved for listing.
According to public information, Yuheng Bio-PD-1 single The price is about 3,300 yuan, and its specific treatment plan and annual comprehensive treatment cost have not yet disclosed information
.

PD-L1 aspect:

In March 2021, AstraZeneca's dovalizumab (commonly known as "I drug") assistance program was upgraded again.
The assistance program was changed from the original "first round 2+2, second round 2+4, and third round 4+12).
", upgrade to the "first round 2+2, follow-up 4+X" mode
.
It is reported that according to the normal price of a patient weighing 50kg, the treatment cost of "I drug" is about 36,176 yuan/month.
Under the new drug donation policy, the annual treatment cost of "I drug" is about 145,000 yuan/year
.

In addition, Roche’s atelizumab (commonly known as “T medicine”)’s charity donation program is also updated_buy 2 get 3 free, and patients who are eligible for ateliizumab charity donation will receive 2 times at their own expense.
After tilizumab treatment, up to 3 follow-up drug assistance can be obtained
.
And this plan is in circulation, that is, after receiving the donated medicine, the patient will receive atilizumab treatment twice again at his own expense, and can get up to 3 times of donated medicine.
Under the new donation policy, "T medicine" The lowest annual treatment cost is about 131,200 per year
.

The pricing of the first domestically approved PD-L1 Envolimab has not yet been announced
.

It is worth noting that after the national medical insurance negotiations in 2019, PD-1 officially entered the era of 100,000 per year
.
After the national medical insurance negotiations in 2020, the cost of treatment for PD-1 year has been drastically reduced to an era of about 50,000 yuan/year
.

Now, the 2021 medical insurance negotiations are imminent.
According to the "2021 National Medical Insurance Drug Catalogue Adjustments Passed the Preliminary Formal Review of the List of Nominated Drugs" announced by the National Medical Insurance Administration in July this year, Junshi Bio, Cinda Bio, BeiGene, Hengrui Pharmaceutical products are included
.

With the PD-(L)1 competition so fierce, there are different opinions on the future market prospects of PD-(L)1
.

Huachuang Securities pointed out that due to the excessive supply of domestic PD-(L)1 monoclonal antibody, it is expected that after two to three rounds of medical insurance negotiations, the cost of PD-1 products may drop to the range of 20,000 to 30,000 yuan
.
At that time, due to rigid production costs and depreciation, as well as high sales expense ratios of various companies, PD-1/L1 monoclonal antibodies may gradually become generalized, and the net sales margin may be less than 20%
.

Soochow Securities said that it is expected that Cinda’s PD 1-year treatment cost will be reduced to about 35,000 yuan after this negotiation, and the more conservative expectation is 32,000, which is less likely to be less than 30,000
.
The PD1 monoclonal antibody of Hengrui and BeiGene will likely reduce the annual treatment cost to about 35,000 yuan to cope with competition
.
Due to Junshi's early stainless steel production capacity and cost advantages, it is expected that the price of its PD1 monoclonal antibody may drop below 30,000
.

It is worth noting that for the current price war of PD-(L)1 so fierce, the company representative said that after PD-(L)1 products are regarded as cornerstone drugs, the application of single drugs and combination drugs in different indications , As well as the development of new tumor immune products may directly lead to the expansion of this market again, so that the market still has some room for imagination, but life is not so easy
.

Sina Pharmaceuticals will continue to pay attention to the scene and situation of the medical insurance negotiations in 2021
.

Reference materials:

Medical Rubik's Cube "PD-1/PD-L1 National Medical Insurance Negotiation Outlook in 2021: Cost or Breakdown of 40,000/year"

The price of cabbage reappeared in China Times' "Magical Tumor Drug": Yuheng Bio-PD-1 is 3,300 yuan a piece, or the new round of medical insurance negotiations will reduce the annual cost to 30,000-40,000 yuan? 》

Yaozhi.
com "Domestic PD-1 indications competition, a new round of medical insurance national talks about price cuts strikes, who will be the big winner? 》