The first bidding!2022 Medical Insurance negotiations: Hengrui, Baiji Duo medicine entered the bureau, Pfizer or positive PK with Albervi

After half a year of the seventh batch of national mining, the seventh batch of national mining was underway in Nanjing, and a "big bargain" about generic drugs was staged again.

*For details, view → latest! The seventh batch of national collection results first look at: the maximum decrease of 97%, the influenza magic medicine is 1 yuan/piece; foreign companies continue to "lie down" ...

On the other side, the annual "big test" of innovative medicines is also starting. Earlier this month, 2022 National Medical Insurance and Drug Negotiations officially launched the declaration. No accidents. After experiencing expert review (August), negotiation/bidding (September to October), the results will be announced in November. Essence

In terms of rules, the biggest difference between national talks and previous years is:

1. Application materials: For the first time, you need to join the product PPT and clearly fill in the five types of information: security, effectiveness, economy, innovation, and fairness; these contents will be related to the price reduction basis for the company's negotiations in the future. mainly include:

Related varieties from January 1st to June this year; the sales amount of the Chinese market;

Compared with drugs in the directory in the directory, the economic advantages and lack of economy are inadequate;

2. During the negotiation stage: For non -unique medicines of the drug directory, the bidding model is adopted for the first time, and the minimum quotation is used for medical insurance payment standards.

The above new rules mean that price competition has become an important basis for finalists. Similar to the fate of the brutal bidding of generic drugs, it seems that it must also come to the "non -exclusive and large sales" innovative drug species. This year's medical insurance negotiations can be described as full of attention.

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1. For "malicious bidding", the state talks also take preventive measures: If the enterprise quotation is 70%lower than the willingness to pay for medical insurance, medical insurance will bottom out at 70%.

2. The willingness to pay for medical insurance: It is mainly dependent on the organizer of the medical insurance party to estimate the evaluation of the general -purpose drug.

Import, domestic new drugs are still 4: 6

According to statistics, more than 50 innovative drugs participating in the negotiations for the first time this year may reach more than 50 models, setting the highest record since the negotiation of new medical insurance. in:

There are more than 30 domestic new medicines, accounting for about 60%

About 20 imported medicines, accounting for about 40%

In 2021, medical insurance negotiations were successful in 63%of domestic drugs, and it is expected that 2022 will continue this trend.

Imported new drugs: Pfizer and Bayer's number of new drugs ranked in the top two, Pfizer may be positive with Albervi

About 24 innovative medicines for multinational pharmaceutical companies have obtained "qualifications", of which:

Pfizer led in foreign companies, with 5 new medicines, including PAXLOVID, which has attracted much attention.

Bayer second, 3 models;

Nuohua and GSK each;

Anjin, Anjin/Xiehe fermented Kirin, Mitsubishi Pharmaceutical, Sanofi, Merhado, Xinji, Albervi, Lilly/Cinda, Takeda Pharmaceutical, Shi Weiya, Casey Pharmaceutical.

It is worth noting that Pfizer's Abuqitinib and Albervi's Potaminib is a direct competitive product. Under the new regulations, it may face direct price competition:

One is a JAK inhibitor;

Both have indications for medium -weight characteristic dermatitis;

The former retail price is 3150 yuan/box (specification: 100mg*14 tablets), and the current retail price is 6315 yuan/box (specification: 15mg*28 pieces).

Judging from the three imported JAK inhibitors incorporated into the medical insurance category B, the average price reduction is about 65%. I wonder if it will break through this number during the November negotiations?

Other varieties that focus on also include Bayer's oral NTRK inhibitor Larotinib. This is the world's first "broad -spectrum anticancer drug". According to the official announcement, adults' annual costs were US $ 39,3600 (nearly 2.6 million yuan) Essence

Clinical data shows that the 17 kinds of physical tumors are effective, the objective relief rate is about 75%, and the complete relief rate is about 22%;

According to the data released by the American Clinical Oncology Society in 2022, the objective relief rate of Larotinib the objective relief rate of children's physical tumor patients with NTRK gene fusion is as high as 84%, and there is no unexpected adverse reaction event.

Domestic new medicines: Baiji and Hengrui each three leaders

The Chinese pharmaceutical company is led by Bio Pharma on behalf of Baiji Shenzhou and Big Pharma on behalf of Hengrui Pharmaceutical, with three new drug sprint medical insurance negotiations.

Baiji Shenzhou includes: perfume ivy (multiple osteoma), Dujiezab β (neuroblastoma), and Stecci Ming (rare disease); all three of them come from License-in ;;

Hengrui includes: Darcille (breast cancer), Hengge column (II diabetes), and Revilula (prostate cancer);

In addition, innovative pharmaceutical companies such as Cinda, Junshi, Ding Ding, Microex, Yasheng, Cornerstone Pharmaceutical, Genting Xinyao will also bring their innovative products to participate in medical insurance negotiations.

It can be seen that more and more China Biotech has become the main force of medical insurance negotiations.

Under the new bidding regulations, PD- (L) 12022 country talks forward

PD- (L) 1 has always been the most noticeable highlight of the state talks.

Under the new regulations, this national talks not only have the new PD-(L) 1 company to join the war, but also face the price competition of the same indication, competition may be more intense than ever before.

5 PD- (L) 1 "New Face" join the battle. New and old players may face positive PK

This national talk, the three domestic new PD-1 that did not catch up last year (from Kangfang Biological/Zhengda Tianqing, Yuheng Biological, Fuhong Hanlin), and 2 domestic new PD-L1 /Thinking Di/Xianyin Pharmaceutical and Cornerstone Pharmaceuticals) will join the battle. Earlier negotiations, the average price reduction of PD-1 products of Cinda, Hengrui, Baiji, and Junshi was 75%. Under the new bidding regulations this year, it may promote homogeneous PD- (L) 1 manufacturers to pay more cautiously.

for example,

In the field of second-line MSI-H/DMMR, the field of advanced physical tumors, this year Fuhong Hanlin and Baiji Shenzhou will carry out PK;

In the field of three -line Hodgkin lymphoma, this year Yuheng Biological and Kangfang Biotechnology/Zhengda Tianqing will be PK;

Cinda, Hengrui, Baiji, Junshi, PD- (L) 1 "Old Facial" new indications

Among PD- (L) 1 "Old Face", Cinda, Hengrui, Baiji, and Junshi also have multiple new indications this time to participate in the directory adjustment.

Four major domestic TOP PD-1 new adaptive symptoms medical insurance competition

Baiji Shenzhou is currently the "player" with the most indications on PD-1 arena. As of June 2022, Nine Approval of Ralery Mipidumi has been approved in China to surpass Hengrui Corri Zhuabi Mipido. Become the most approved PD-1 approval in China. in:

5 items have been included in medical insurance

This year, there are 4 new indications and 3 exclusive. The first -line combined chemotherapy nasopharyngeal cancer will face the PK of Hengrui and Junshi.

Junshi Biological's first major adaptive first-line treatment of local advanced or metastatic esophageal squamous albate carcinoma was approved on May 13 this year. Simplica carcinoma accounted for 90%of Chinese esophageal cancer patients). Its PD-1 currently has 5 indications, of which:

3 items have been included in medical insurance

There are two new indications this year, but they are facing competition with the other three.

It is worth noting that, before, Junshi has applied for some small cancer species that are less competitive, such as melanoma, nasopharyngeal cancer, etc., to achieve the "fast listing" of Tripley Mipide, which has also become the first approval of approval. China PD-1. However, the shortcomings of this strategy are becoming more and more obvious. The most intuitive thing is to affect the sales of Tripley Midurate.

Since its official listing, Tripley Mippy has the lowest sales of domestic TOP4 PD-1.

2019, the first year of sales of 775 million yuan;

2020, sales of 1.09 billion yuan;

2021, sales of only 410 million yuan; while Hengrui Pharmaceutical (Karelizab) sales of 4.141 billion yuan, Cinda Bio (Civily Midumi) sales were 3.1 billion yuan, Baiji Shenzhou (Dali Lei Lei Lei Lei Lei Lei Lei Lei Lei Lei Lei Lei Lei Lei Leilei's Li Zhu Ming) sales exceeded 1.6 billion yuan.

Therefore, if the adaptation of esophageal cancer adapts to medical insurance will help revenue growth. However, in the face of the pressure of bidding this year, the suspense is quite large.

In addition, on the 29th of last month, the NMPA "Card Point" attached conditions to approve the Kangfang Biological PD-1/CTLA-4 bispecific antibody (Kadinilicabeta injection) to be available for previous acceptance of platinum chemotherapy. Treatment of recurrence or metastatic cervical cancer patients. This also gives this world's first PD-1/CTLA-4 dual resistance to become the first double anti-new drug to enter the national medical insurance.

At present, Merhadon K medicine, BMS O medicine, and Roche and Astraon's PD-1/PD-L1 have no plans to enter the medical insurance.

Can CAR-T and ADC bring new surprises?

In addition to the "Internet celebrity" PD- (L) 1, some new faces of tumor drugs this year are also worthy of attention.

In this term, the number of tumor drugs is nearly half, including 20 domestic and 6 imports, which can be described as a "feast" of tumor drugs.

CAR-T newly added competitors, will the first admission to the medical insurance?

2021 Medical Insurance negotiations, at that time, known as "2 million cure cancer" Fosun Kate CAR-T products Aquelun passed the qualification review, but finally did not participate in the negotiation link. Because as the "unique" product of the Chinese market at that time, Aquelun may not need to fall in worth it.

However, with Yaoming Junuo CAR-T products, Rukiolun joined the war, will the 2022 medical insurance negotiation table appear on the CAR-T product?

Aquelun: China was approved in June 2021, with a retail price of 1.2 million yuan a needle and a revenue of 120 million yuan (5 months) in 2021. As of the end of February 2022, it has been included in the Huimin of 23 provinces and cities. Insurance more than 40 commercial insurance.

Ruki Olun: China was approved in September 2021, with a retail price of 1.29 million yuan a needle. In 2021, it revenue of 31 million yuan (3 months); business insurance.

At present, Ruki Olun is lower than Aquelun, regardless of the people's insurance, commercial insurance coverage and sales. Who can occupy more markets in the future or it will depend on the national medical insurance negotiations.

Can the world's best -selling ADC product, Roche Enmei Monzumabo's three -war medical insurance?

ADC, as a star track in the recent tumor field, has caused a large -scale layout of global enterprises.

Four products in the Chinese market have been approved, from Takeda, Roche, Pfizer, and Rongchang creatures. Among them, only Rongchang Bio -Bio -Bio Aipidae entered medical insurance in 2021. The indication certificate is gastric cancer.

In June 2021, Vidici Mipido was just approved and entered medical insurance in November.

After entering the medical insurance, the price of Vidicus' anti -anti -resistance was reduced from 13,500 yuan/box to 3800 yuan/box.In 2021, with the medical preservation volume, Vidici Mipido revenue was US $ 80 million in less than half a year.In 2022, the Vidy Sicipopi Anti -Anti -Anti -Anti -Agenal Certificate of Urine Cancer Cancer was expected to continue to expand the scope of medical insurance payment.

As the world's best -selling ADC product, in 2020, China has been approved for breast cancer indications for the first time in 2020. Roche has worked hard for Eunmenguszhu to fight for medical insurance.Last year, it did not pass during the preliminary trial. This year, Roche Enmei Monterumab has been reduced from 330,000 yuan per year to medical insurance for medical insurance, with a cumulative decrease of 56%.

Medical insurance negotiations have created conditions for more innovative drugs to enter the hospital market quickly. However, from the game (negotiation) between the providers and the payment party to the game (bidding) between pharmaceutical companies (bidding), innovative drugs seem more difficult.

However, the degree of product innovation and good curative effect are the last word.High -quality innovation products seem to be fearless in the Chinese market with fierce price competition or strict requirements for clinical data.

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