The latest price of domestic PD-1 is exposed!

In 2022, the competition among PD-(L)1 enterprises is expected to be more intense
.

By Linan

At the beginning of 2022, Junshi Bio and Xinda Bio in the domestic PD-1 "Four Little Dragons" will inevitably attract attention
.

On the evening of January 4, 2022, Junshi Bio announced that the company terminated the promotion cooperation with AstraZeneca Pharmaceuticals and took back the promotion rights of toripalimab injection agreed in the original agreement
.

The "cooperation" between the two parties has only lasted for 10 months.
At the end of February 2021, Junshi will have the exclusive right to promote Tuoyi in the field of urological oncology that has been approved for marketing in mainland China (approved in April 2021), And the exclusive promotion rights for all approved indications in non-core urban areas are granted to AstraZeneca
.

He will continue to be responsible for the promotion of other approved indications in the core urban area except for the indications in the field of urological oncology

Although Junshi Bio said in the announcement, the main reason is that the company's commercialization team has gradually matured, and more indications of toripalimab injection have been successfully included in the latest version of the National Medical Insurance List, so it chose to terminate the promotion
.

However, Junshi's stock market volatility appears to reflect industry doubts about its PD-1 sales performance

On the other hand, in the first three trading days of 2022, Innovent's share price has fallen by nearly 20%
.

At noon on January 5, Innovent Bio also announced an announcement saying: Concerned about the recent abnormal fluctuations in stock price and trading volume, the company hereby clarifies that all business operations are normal, and it is accelerating its transformation into a global biopharmaceutical company

On December 17, 2021, a report of "tightening FDA approval" also caused Innovent to plummet by more than 14% intraday
.

US FDA expert Dr.

Innovent's domestic clinical-based sintilimab is applying to the FDA for listing
.

If FDA approval is tightened, the process of PD-1 "going overseas" will be affected more or less
.

From a general perspective, the recent decline in the stock prices of innovative pharmaceutical companies is not unrelated to the shift of market funds from innovative drugs to the traditional Chinese medicine sector and the panic selling caused by the continuous decline

The latest medical insurance price of domestic PD-1 is exposed, and the price will drop again

The latest medical insurance price of domestic PD-1 is exposed, and the price will drop again

In 2019, Cinda's sintilimab successfully entered the medical insurance catalog with a decrease of 64%, and the annual cost was reduced from 280,000 yuan to 96,700 yuan per year; in 2020, three models of Junshi, Hengrui and BeiGene PD-1 is all included in the medical insurance with an average decrease of 78%, and the annual treatment cost is directly reduced to 50,000 yuan per year
.

Around Double Eleven in 2021, a new round of medical insurance negotiations will start, and PD-1 companies are mainly shortlisted negotiations for new indications
.

Among them, Cinda's sintilimab added 3 indications of "first-line squamous non-small cell lung cancer (NSCLC) + first-line non-squamous NSCLC + first-line liver cancer", and BeiGene's tislelizumab added "first-line NSCLC" There are 3 indications for squamous NSCLC + first-line non-squamous NSCLC + second-line liver cancer, Hengrui’s camrelizumab has added 2 indications of “first-line + third-line nasopharyngeal cancer”, and Junshi’s toripalizumab has added "Third-line nasopharyngeal carcinoma + second-line urothelial carcinoma" has 2 indications

Before the medical insurance negotiation, there was an analysis in the industry that the new indications of PD-1 of Cinda and BeiGene were all major indications, so the price reduction would be more positive, while the PD-1 of Junshi and Hengrui 1 The new additions are mainly small indications, and there is less pressure to reduce prices
.

On December 3, the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2021)" was officially released
.

The new PD-1 indications of Cinda, Junshi and BeiGene have all entered, but the two new indications of nasopharyngeal cancer of Hengrui's PD-1 this year have not entered

The four indications of Hengrui's camrelizumab for injection that entered the medical insurance list last year remain unchanged
.

Regarding the new indications that have not entered this time, Hengrui said in an interview with the media that the price of camrelizumab had just dropped sharply in March this year.

On January 1, 2022, the new version of the medical insurance catalogue was implemented, and then the medical insurance price of domestic PD-1 was also exposed
.

Sintilimab 10ml:100mg was reduced from 2843 yuan/bottle to 1080 yuan/bottle, a decrease of 62%
.
The recommended dose is 200 mg administered every 3 weeks until disease progression or unacceptable toxicity
.
Based on this calculation, the cost of sintilimab for one year is 36,720 yuan (before medical insurance reimbursement)
.

Toripalimab 2ml:80mg changed from 906.
08 yuan/piece to 825.
00 yuan/piece; the other 6ml:240mg specification changed from 2100.
97 yuan/piece to 1912.
96 yuan/piece, only a small price reduction compared to before
.
Based on the 6ml:240mg specification, the annual treatment cost is about 33,200 yuan
.

Tislelizumab 10ml: 100mg has changed from 2180 yuan/piece to 1450 yuan, with a price reduction of 33%
.
The annual treatment cost is less than 50,000 yuan
.

The price of camrelizumab this time remains at 2928 yuan (200mg/bottle), the same price as last year
.
The annual treatment cost is about 50,000 yuan
.

On the whole, according to the reimbursement ratio of 70% and 80% of medical insurance (depending on the locality), the annual treatment cost of patients after medical insurance can be less than 10,000 yuan
.
(Comprehensive multi-party information, the above is for reference only)

In order to allow the Guotan drugs to be admitted to the hospital as soon as possible after the price reduction, the National Medical Insurance Bureau and others have launched a "dual channel" policy
.
Recently, an "Urgent Notice of the Office of the National Medical Insurance Administration on Accelerating the Landing of Drugs in the National Medical Insurance Negotiation in 2021" issued by the National Medical Insurance Bureau has flowed out in the industry.
Access, speed up the implementation of the medical insurance reimbursement policy, and promptly include negotiated drugs into the "dual-channel" management.
In principle, the 67 new negotiated drugs that will be added to the catalog in 2021 must be included in the "dual-channel" management of drugs in each province
.

The medical insurance list has become one of the ways for innovative drugs to achieve "commercialization" as soon as possible.
The promotion of the dual-channel policy ensures that the country's drugs can penetrate the last mile of admission, which is beneficial to innovative pharmaceutical companies, especially some pharmaceutical companies that are not yet mature for commercialization
.

With the implementation of the medical insurance catalogue, PD-1 companies in the Red Sea market seem to have sensed the crisis in advance and actively adjusted their sales strategies
.
For example, Junshi Bio and AstraZeneca's "breakup"; at the end of 2021, it is reported that Eli Lilly's PD-1 sales team in China will shrink
.
Eli Lilly said that starting from January 1, 2022, about 15% of the hospital visits that Lilly has been responsible for since 2021 will be transferred to Cinda, and Cinda will be responsible for 100% of the hospital visits for sintilimab in China
.
Eli Lilly and Cinda are expected to re-divide.
.
.

Domestic PD-1 sales in 2021: Junshi has not disclosed, Erica has negative growth

Domestic PD-1 sales in 2021: Junshi has not disclosed, Erica has negative growth

In 2020, the sales of Bristol-Myers Squibb's O drug and Merck's K drug in the imported PD-1 market in the Chinese market will reach 460 million yuan and 2.
41 billion yuan respectively; the import of AstraZeneca's I drug and Roche's drug in PD-L1 will reach 460 million yuan and 2.
41 billion yuan respectively.
The sales of T drugs in the Chinese market were 720 million yuan and 310 million yuan respectively
.

During the same period, domestic PD-1 products, Junshi's Tuoyi, Xinda's Daboshu, Hengrui's Erica, and BeiGene's Baizean, achieved sales of 1.
09 billion yuan and 2.
49 billion yuan respectively in the Chinese market.
yuan, 4.
89 billion yuan, and 1.
12 billion yuan
.

In 2019, Cinda's sintilimab successfully entered the medical insurance catalog with a decrease of 64%, and the annual cost was reduced from 280,000 yuan to 96,700 yuan per year; in 2020, three models of Junshi, Hengrui and BeiGene PD-1 is all included in the medical insurance with an average decrease of 78%, and the annual treatment cost is directly reduced to 50,000 yuan per year
.

On March 1, 2021, the new version of the medical insurance catalogue was officially implemented
.
Different from 2020, only two domestic PD-1 companies, Cinda and BeiGene, have announced clear sales performance in 2021
.

Innovent's financial report for the first half of 2021 shows that the sales of sintilimab in the first half of the year reached 1.
4 billion yuan; in the third quarter, the sales of sintilimab of Innovent Bio were about 800 million yuan
.
According to Eli Lilly, the sales of sintilimab in the first three quarters were about 2.
17 billion yuan, approaching the annual sales of 2020
.

BeiGene’s financial report for the first half of 2021 shows that sales of tislelizumab in the first half of the year were 800 million yuan; in the third quarter, BeiGene’s tislelizumab sales in China totaled US$77 million, with a contract of 490 million RMB, an increase of 54% year-on-year.
Based on this, BeiGene's PD-1 sales in the first three quarters have exceeded the full-year sales in 2020
.

In the first half of 2021, Junshi's operating income increased by 267.
77% year-on-year to 2.
114 billion yuan, but it did not announce the specific sales of toripalimab in the first half of 2021
.
Junshi's performance growth in the first three quarters mainly came from the company's new crown neutralizing antibody ectelvizumab (JS016/LY-CoV016) in cooperation with Eli Lilly
.

Hengrui’s financial report for the first half of 2021 stated that the sales revenue of camrelizumab had a negative month-on-month growth, and the industry speculated that its camrelizumab sales would plummet in the first half of 2021
.

Kangfang Bio/Chia Tai Tianqing’s piamplimumab and Yuheng Pharmaceuticals/WuXi Biologics’ sapalimumab were approved for marketing in August 2021, and there is currently no sales data
.

The sales performance of Junshi PD-1 products in 2021 has become a mystery, which has also intensified speculation that its performance is not optimistic; Hengrui has not chosen to reduce the price again this year to enter the medical insurance catalogue in response to the current sales situation.
.
.
Moreover, it can be What we can see is that both Junshi and Hengrui are constantly seeking new profit growth points
.

On December 21, 2021, the official website of the State Food and Drug Administration showed that CStone's PD-L1 sugelimab injection was approved by the State Food and Drug Administration
.
With the launch of sugelimab, according to previous statistics from Sina Pharmaceuticals, 12 PD-(L)1 models have been listed in China
.
Including 6 domestic PD-1, 2 domestic PD-L1, 2 imported PD-1, 2 imported PD-L1
.
(For details, please refer to: "First-line NSCLC, the 2nd domestic PD-L1 approved! Inventory of 12 domestic PD-(L)1 models")

Among them, the price war for the newly approved PD-(L)1 is still fierce - the PD-1 piamplimumab of Kangfang Bio/Chia Tai Tianqing was approved for marketing, and the capped treatment cost for two years was 39,000 yuan.
In terms of pricing strategy, the price of Sintilimab from Biaoxinda after removing medical insurance; Yuheng Pharmaceutical/WuXi Biologics PD-1 Sepalizumab was approved for marketing.
According to public information, the price is about 3,300 yuan per bottle.
Left and right; the nvolimab injection jointly developed by Sidi Pharmaceutical, Corning Jerry Pharmaceutical and Simcere Pharmaceuticals, the unit price is 5980 yuan/bottle, and the eligible patients are about 72,000/2 years
.
This price is nearly half cheaper than imported PD-L1
.

At present, the domestic PD-1/PD-L1 track is highly competitive.
According to the statistics of Essence Securities, there are currently 5 domestic PD-1/PD-L1 and 1 PD-1/CTLA-4 double antibody in the market review stage.
By the end of 2022, a total of 17 PD-1/PD-L1 monoclonal antibodies and 1 PD-1/CTLA-4 double antibody will be launched in China, of which a total of 14 domestic PD-1/PD-L1 (including double antibody) )
.

Some brokerages have predicted that with the increasing number of domestic PD-(L)1 monoclonal antibodies, it is expected that after 2~3 rounds of medical insurance negotiations, the annual cost of PD-1 products may drop to 20,000 to 30,000 yuan.
interval
.

Medical insurance accelerates the reshuffle of the domestic PD-(L)1 market, and the price is gradually "generalized"; last year, the CDE anti-tumor drug new policy was released to crack down on pseudo-innovative and me-worse drugs; then there were signals from the industry that the FDA's approval was tightened.
The landing will greatly cool down the crowded PD-(L)1 track.
.
.
At the beginning of 2022, Junshi and Cinda have attracted much attention, and it is expected that the contest between PD-(L)1 enterprises will be more intense this year
.