The 2021 national talks are on the spot: a variety of PD-(L)1 confrontation BMSs are absent; CAR-T has not appeared in ADC, small molecule inhibitors are hotly talked...

Text: Linan haon slowly

On November 9, 2021, a new round of medical insurance negotiations kicked off in Beijing

The first day of negotiation mainly came from drugs used in the fields of anesthesia, respiratory, anti-infection, and antiviral.

The foreign-funded companies participating on the day mainly included AstraZeneca, Roche, Merck, Merck, Novartis, Takeda, Eli Lilly, etc.

1.

At around 8:50, the staff of the Medical Insurance Bureau began to call for admission, and the atmosphere on the scene became extremely tense

Before the opening of the morning, Cinda and other PD-(L) negotiators were waiting

At present, the four domestically produced PD-1s are all included in the medical insurance catalog, and this negotiation will be a contest between their new indications

The preliminary review list of the 2021 version of the medical insurance catalog was announced, and all domestic PD-1s were included in the preliminary review list

According to the on-site report team of Sina Pharmaceuticals, AstraZeneca, BeiGene, etc.

After the morning session, there was news from the industry that the negotiated price of Baekje and Cinda PD-1 was about 30,000 to 40,000 (Cinda: 3.

Although the final results of the negotiations have not yet been released, the share prices of domestic PD-1 companies Hengrui, Junshi, Cinda, and BeiGene have soared after the medical insurance negotiations in the morning.

In 2019, Cinda’s Sintilimab successfully entered the medical insurance catalog with a 64% decrease.

Previously, Huachuang Securities analyzed that due to the excessive supply of domestic PD-(L)1 monoclonal antibodies, it is expected that after 2 to 3 rounds of medical insurance negotiations, the annual cost of PD-1 products may drop to the range of 20,000 to 30,000 yuan.

2.

In addition to PD-(L)1, which has received much attention, new small-molecule inhibitor drugs are also the focus of this medical insurance negotiation
.

According to statistics from Guosheng Securities, Ensatinib, Vometinib, Sofantinib, Servotinib, Pratinib and Donafenib are all shortlisted in the negotiation of small molecules ALK-TKI
.
Betta Pharmaceuticals' Ensatinib was shortlisted for the first time, and Roche's Aletinib will expire on December 31, 2021.
This time it will participate in the renewal negotiations
.

As for PARP inhibitors, olaparib added BRCA-mutated prostate cancer indications to participate in the national talks; niraparib added ovarian cancer, fallopian tube cancer, and primary peritoneal cancer first-line maintenance treatment to participate in the negotiation; Hengrui's fluazole Pali and BeiGene Pamipali entered the primary list for the first time
.

In terms of BTK inhibitors, the three approved indications of AbbVie/Johnson & Johnson’s product ibrutinib have all entered the medical insurance list and are still within the validity period of the agreement; in this national talk, Nuocheng Jianhua’s ibrutinib participated for the first time.
Jeshenzhou Zebutinib's new indication for adults with Fahrenheit's macroglobulinemia will also participate in the negotiation
.

In the third-generation EGFR-TKI, Osimertinib has participated in the negotiation for the adjuvant treatment of EGFR-sensitive mutant non-small cell lung cancer for the new indication;

For the first time, Iris' new approved product, vomitinib, participated in the competition
.

Iris takes a group photo after the conclusion of medical insurance negotiations on behalf of the company

Guosheng Securities said that in the import substitution market, new domestic small molecule inhibitor drugs are unstoppable
.
Fluzoparib, Pamipalil, Obrutinib, Ensatinib, and Vometinib are actively entering the game to compete for overseas varieties markets
.
If it enters the medical insurance catalog this time, domestic products will further expand the market
.

3.
Concentrated foreign capital admission, BMS absent

Starting at 14:00 in the afternoon, the negotiations were mainly focused on foreign-funded companies.
The first batch of people calling into the venue were Merck, Eli Lilly, and AstraZeneca.
Merck sent three female generals.
The outside world speculated that it might be its PD-1 product
.

Eli Lilly China President Ji Liwen leads the negotiation

In addition to domestically produced PD-1 products, how much the imported PD-(L)1 products can be reduced this time has also attracted much attention
.
In the initial review list, two imported PD-1s and one PD-L1 entered, and the three products passed the initial review with a total of 12 indications
.
In the first two rounds of negotiations, Merck’s K drug and BMS O drug did not fall within the satisfactory range of the National Medical Insurance Bureau.
This time I don’t know whether the negotiation will be successful
.

However, the price cuts of domestically produced PD-1 products have also led to a decline in the price of imported PD-(L)1
.
Currently, through adjustments to the drug-giving policy, the first-year price of PD-(L)1 from Merck, Bristol-Myers Squibb, and AstraZeneca has dropped to 140,000, 110,000, and 140,000, respectively
.
Although the imported PD-(L)1 has not yet entered the medical insurance catalog, the price has been cut by at least half compared with the original price
.

Judging from the situation at the scene, AstraZeneca and Merck should have attended the PD-(L)1 product
.
The representative of Merck finished the talk in about half an hour, but Bristol-Myers Squibb did not show up for a long time, and suspected of giving up
.

4.
ADC drugs "emerged"

According to Sina Pharmaceutical's on-site understanding, there will be ADC drugs predicted at the negotiation site on the 11th-Takeda's vebutuximab and Rongchang Biologics' vedictuomab
.

Rongchang biological representative enters the arena

In June 2021, Rongchang Biotech's Vidicuzumab (RC48) was approved for marketing, becoming the first domestically produced ADC drug
.
Vidicuzumab is mainly used to treat locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma)
.

In 2020, Takeda’s verbutuximab was approved in China for the treatment of CD30-positive relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) and relapsed or refractory classic Hodgkin’s lymphoma ( cHL) Adult patients.
In April 2021, Takeda’s Verbutuximab was approved for a new indication for the treatment of CD30-positive primary cutaneous anaplastic large cell lymphoma (pcALCL) that has previously received systemic treatment.
) Or adult patients with mycosis fungoides (MF)
.

Tianfeng Securities pointed out that at present, only Hengrui Medicine's apatinib and vedixituzumab have been approved for third-line treatment indications for locally advanced or metastatic gastric cancer
.
Enmetrastuzumab, which is the same HER2 target ADC drug as vedicitumumab, is still close to 600,000 yuan (not the same indication) after considering charity donations
.
Vidicuzumab is the first domestically approved ADC drug.
The annualized cost for gastric cancer indications after the donation is about 340,000
.

After this round of negotiations, I don't know how much ADC drugs will fall in price
.

5.
Postscript

On the morning of the 10th, Bian Xin, President of Roche China, personally led the team.
The products Roche will participate in the negotiation are expected to be iimerizumab injection, otuzumab injection, risporan oral solution powder, and mabaloxavir Slices
.

Luo's Bianxin brings people into the venue

AstraZeneca and Xi'an Janssen were also the busiest companies on that day, with admission in the morning and afternoon
.
Among them, the varieties that Xi'an Janssen will participate in the negotiation are expected to be apatamide, daratumomab injection, and uznumab injection
.

In addition, foreign companies and varieties involved in the negotiations on the 10th included Chia Tai Tianqing’s pomalidomide capsules; Takeda’s measartan potassium tablets; Eli Lilly’s abbexili tablets and ichizumab injections; Bayer Dalostamide tablets; Eisai's eribulin mesylate injection; Pfizer's dacotinib tablets, Criborol ointment, clofenazole acid soft capsules, ceftazidime avibactam sodium for injection, etc.
; Novartis's tumor drug everolimus tablets
.

Among the domestic companies negotiated on the 10th were Chia Tai Tianqing’s pomalidomide capsules, Xinlitai’s recombinant teriparatide for injection (it is reported that there was no difference in renewal), and Suzhou Zejing Bio’s sorafenib tosylate tablets.
, Rongchang Bio's Tetazep, etc.
for injection
.

(Note: The above-mentioned participating companies and varieties of medical insurance negotiations are for reference only.
We will continue to pay attention to the final results of medical insurance negotiations
.
)

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