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On January 8, the four-day 2022 national health insurance negotiations came to an end
.
The representatives of the companies present today are still waiting for a number of blockbuster new drugs in the field of oncology and rare diseases, as well as the much-anticipated Pfizer new crown drug Paxlovid, which has completed negotiations
.
It is understood that negotiators from Tasly, Haosen, Junshi Biotechnology and other enterprises waited in front of the National People's Congress Conference Center early
.
It is worth noting that in this national talks, the red sea of PD-1 is still crowded
.
According to the 2022 National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalogue Adjustment of the List of Declared Drugs that Passed the Form Review (hereinafter referred to as the "List"), not only were BeiGene, Hengrui Pharmaceutical, Innovent Biologics and Junshi Biologics four senior "players" shortlisted, but also new competitors entered the game, and the smell of gunsmoke became stronger
。
What is more interesting is that the latest official release of the National Health Insurance Administration's "The Head of the Department of Pharmaceutical Administration of the National Medical Insurance Administration Introduces the Participation of New Crown Treatment Drugs in the Negotiation of the 2022 Medical Insurance Drug Catalog" said that this year, three new crown treatment drugs, azvudine tablets, nematevir tablets/ritonavir tablets combination packaging (hereinafter referred to as "Paxlovid"), and lung cleansing and detoxification granules, participated in the negotiations through the
procedures of self-declaration, formal review, and expert review by enterprises.
Among them, the negotiation of azvudine tablets and lung cleansing and detoxification granules was successful, and Paxlovid was unsuccessful
due to the high quotation of the manufacturer Pfizer Investment Co.
, Ltd.
Looking at the situation on the ground in the past few days, the national medical insurance negotiations have been much
mild.
This reflects that China's medical insurance negotiations have moved towards a mature and stable situation, and the price regulation of drugs is meticulous and reasonable, effectively improving the burden of drugs and ultimately benefiting patients
.
The negotiation efficiency of proprietary Chinese medicines is high
On the fourth day, negotiators
from traditional Chinese medicine enterprises such as Tasly appeared at the scene of the national medical insurance negotiation.
It can be seen that this morning intensive negotiations on proprietary Chinese medicines were carried out
.
According to the reporter of the new media center of "Medical Economic News", the enterprises participating in the negotiations today are relatively smooth, and the negotiations are going very quickly
.
According to the List, in the past few days, Yili Pharmaceutical, Yiling Pharmaceutical, Tasly, Yangtze River, Jianmin Group, Taiji Group, Kangyuan Pharmaceutical, and Sunway Pharmaceutical have all brought a variety of exclusive products in various fields to participate in the negotiations
.
Taking Tasly as an example, Peony Antispasmodic Granules was approved
as a Class 6.
1 pediatric new drug in traditional Chinese medicine in December 2019.
It is composed of 11 flavors of traditional Chinese medicine such as white peony, tribulus terrestris, hook vine and Ganoderma lucidum, which has the effect of calming liver yang, stopping spasms, clearing fire and phlegm, and is used in traditional Chinese medicine to distinguish tic-tourette syndrome (Tourette syndrome)
caused by hepatic hyperwind movement and phlegm and fire internal disturbance 。
From the perspective of treatment categories, proprietary Chinese medicines in this negotiation also include drugs for diabetes, rheumatic diseases, cardiovascular and cerebrovascular diseases, liver diseases, gastric drugs (gastritis, ulcers) and other chronic diseases; There are also breast hyperplasia drugs, women's menopausal drugs, pediatric drugs and other different patient groups; As well as antipyretic and detoxifying drugs, cough and expectorant asthma medication, throat medication and other products
for respiratory diseases.
It also includes other classes of medications, such as antidepressants, burns, and dental medications
.
As a treasure of traditional medicine in China, the state has vigorously encouraged the innovation of traditional Chinese medicine in recent years, and issued a number of support policies for the research and development of traditional Chinese medicine, and the vitality and potential of traditional Chinese medicine innovation have been continuously released
.
At the same time, medical insurance negotiations, as an important catalyst for the increase in the volume of proprietary Chinese medicines, are an important part
of the R&D and commercialization of new Chinese medicines.
Chinese patients have enjoyed to the greatest extent the dividends
of greatly increasing the research and development momentum of new Chinese medicine drugs and improving the quality of new Chinese medicines.
In 2022, the medical insurance catalogue will adjust the off-list proprietary Chinese medicines that have passed the formal review
In 2022, the medical insurance catalogue adjusts the proprietary Chinese medicines in the catalogue that have passed the formal review
Image data source: National Health Insurance Administration, Minai.
com
PD-1 finale appearance
This morning, Junshi Biologics took teripulimab to participate in the negotiation
of new indications.
In addition, the other three drugs that have previously entered the medical insurance catalog: carrelizumab for injection (Hengrui Pharmaceutical), tislelizumab (BeiGene), and Cindilimab (Innovent Biologics), have made progress
in the medical insurance negotiations in the past few days.
It is worth mentioning that according to the data analysis of Deppon Securities, Hengrui's carrelizumab sales were the highest in the first three quarters of 2022, followed by BeiGene's tirelizumab, of which tirelizumab achieved sales in
the third quarter.
Overall, if the negotiations go smoothly, with the approval of new indications and the entry into medical insurance, the share of the domestic PD-(L)1 market will continue to expand
.
In addition, this year's PD-(L)1 new entrant, Akeso's bispecific antibody (PD-1/CTLA4) Kadunili, has received a lot of attention
.
The drug was approved for marketing in June 2022 for patients with relapsed or metastatic cervical cancer who had previously failed platinum-containing chemotherapy, and is the first domestic bispecific antibody and the world's first approved PD-1-based bispecific antibody
.
In addition, Henlius PD-1 monoclonal antibody and Corning Jerry/Sidi / Simcere Pharmaceutical's PD-L1 monoclonal antibody participated in this round of negotiations
for the first time.
Looking back at the medical insurance negotiations in the past two years, the price reduction of PD-(L)1 included in the medical insurance catalogue is about
50%.
Some market views believe that the serious involution of PD-1 products has spread around the world, and under the current market pressure of domestic PD-1 products that are difficult to go overseas, whether they can be successfully shortlisted in the medical insurance catalog, "price for market" has a very
significant impact on the commercial competition of products.
With the addition of this "newcomer" to the health care negotiation, the PD-1 Red Sea will continue to churn.
"Non-exclusive varieties" are heavy in their hearts
Prior to the negotiations, Medicare, a large buyer, had new rules
for "simple renewal" and "non-exclusive drug bidding".
The rules are clear that if a drug is included in the drug list through bidding, the lowest of the quotations of each enterprise shall be taken as the payment standard
for the generic drug.
This means that regardless of whether the enterprise product is quoted at a high price or does not participate in the auction, the medical insurance payment will be reimbursed at the lowest quoted enterprise price
.
Good news
for most companies that have ever landed.
However, such happiness is difficult to experience for "non-exclusive varieties" that have not been insured
.
At the same time, compared with the "price reduction" of other varieties, for the 41 "non-exclusive varieties" participating in the negotiation this time, the scene of this national negotiation is still relatively cruel
.
Taking the most competitive variety of memantine hydrochloride sustained-release capsules as an example, a total of 5 enterprises including Zhejiang Jingxin Pharmaceutical, Qingdao BAHEAL Pharmaceutical, Jiangsu Tasly Diyi Pharmaceutical, Chengdu Yuandong Biopharmaceutical, and Fujian Baonuo Pharmaceutical launched fierce bidding, "price competition may be no less than centralized procurement"
.
In addition, Yichang Renfu, the owner of the treatment drug bupropion for depression, will face competition from Shanghai Xuantai
.
Fosapitant for injection also has competition from many companies, including Shandong Luoxin, Jiangsu Haosen, Chia Tai Tianqing and so on
.
Pfizer Paxlovid failed to negotiate
Since the beginning of this medical insurance negotiation, "P drug talk? How to talk? "It has always been a topic
of widespread concern in the market.
Departing from 8:30 a.
m.
to 1:20 p.
m.
on Jan.
7, the high-profile Pfizer could be the company that has taken the longest to negotiate this health care
.
While everyone was speculating about the results of P drugs, on January 8, the National Health Insurance Administration released the negotiation of
new crown treatment drugs that everyone was keenly concerned about.
According to the latest news from the National Health Insurance Administration, the negotiation of the new crown treatment drug Azvudine tablets and lung cleansing and detoxification granules was successful, and Paxlovid failed to succeed
due to the high quotation of the manufacturer Pfizer Investment Co.
, Ltd.
At present, all therapeutic drugs in the "Novel Coronavirus Infection Diagnosis and Treatment Plan (Trial Version 10)", including Paxlovid, azvudine tablets, monoravir capsules, cold and wet granules, etc.
, will be temporarily paid by medical insurance until March 31
, 2023.
At the same time, in order to meet the needs of the treatment of patients infected with new coronavirus infection in various places, local medical insurance departments have recently temporarily included a batch of new crown symptomatic treatment drugs into the payment scope
of local medical insurance in combination with the operation of local medical insurance funds.
In addition, after Azvudine tablets and lung cleansing detoxification granules were included in the national medical insurance drug list after this negotiation, there are more than 600 kinds of drugs in the national medical insurance drug list for the treatment of fever, cough and other new crown symptoms
.
In general, medical insurance reimburses a wide range of drugs for the treatment of new coronavirus infection, which can meet the public's drug needs
.
The number one in MNC China personally went into battle
The presence of MNC's "number one" in China shows the importance
they attach to medical insurance negotiations.
According to the "Medical Economics News" new media center on the spotIn addition to Qian Yun, Vice President of Pfizer Global Biopharmaceutical Business Group China, Osram, Vice President and General Manager of AbbVie China Region, Chen Siyuan, Vice President of Bristol-Myers Squibb and General Manager of China and Asia Regional Markets, and Gao Lunbo, Vice President of Merck China Healthcare appeared
。
Health care
negotiation
The varieties that these foreign giants may negotiate include:
AbbVie's two exclusive products, upatinib sustained-release tablets for atopic dermatitis and venetincla tablets for leukemia, with upatinib extended-release tablets being the second generation of selective JAK inhibitors and venetinicil tablets being the first, oral and selective B-cell lymphoma factor-2 (Bcl-2) inhibitor
.
Bristol-Myers Squibb's roctecept for injection
.
As the first innovative drug for the treatment of β-thalassemia in China for more than ten years, roctecept for injection was launched in June 2022; In October 2022, the phase III COMMAND study of injectable roctecept for the first-line treatment of transfusion-dependent myelodysplastic syndrome (MDS) reached the primary endpoint of the interim analysis, further triggering market expectations
.
In addition, Merck's high blood pressure drug bisoprolol amlodipine, which is a single-tablet combination of bisoprolol fumarate and amlodipine besylate, which was approved
in May 2021.
The "drama" of rare disease drugs has been staged one after another
It is said that rare diseases and oncology drugs are the highlight of this medical insurance negotiation, which can be seen from the degree of confidentiality on the spot, originally only the west gate 1 was opened, and on the 7th, the west 1 gate and the west 2 gate can be accessed, and the traces of enterprise representatives are difficult to identify
.
Last year, Biogen became famous for treating spinal muscular atrophy (SMA) nocinaxen sodium was "down" and "dropped", and this year Roche took risprandan to participate in medical insurance negotiations
with risprandan and nocinaxen sodium to treat SMA's rare disease drugs.
Rispram was approved for marketing in China in June 2021, and after the sodium of nocinaxen dropped to more than 30,000 at the end of 2021, Roche chose to actively reduce the price, and in June 2022, the price of rispram was reduced to 14,500 yuan
per bottle.
On this basis, if Roche wants to win the health insurance negotiation, he may have to show "more sincerity"
.
This year, Biogen brought another product, dimethyl fumarate, "World War II" medical insurance negotiations
.
At present, Novartis' fingolimod, Biogen dimethyl fumarate, Bristol-Myers Squibb's ozanimod and other products have made the competition for oral drugs in the MS field increasingly fierce
.
Whether this product can enter the medical insurance catalog will be the key to whether Biogen's product will be rapidly increased in China, and it is also highly anticipated
by patients and the market.
Also noteworthy is BeiGene, where in December 2021, the National Medical Products Administration approved the import registration application for injectable sertuximab, a clinically urgently needed rare disease drug, through a priority review and approval process, as the first and only approved treatment drug for Castleman's disease in China, if it can be included in medical insurance, it will certainly help improve the clinical treatment of
patients with idiopathic multicentric Castleman disease (iMCD) in China 。
In recent years, the country's drug dilemma for patients with rare diseases has been a key focus, and this year's medical insurance negotiations have clearly encouraged the participation of rare disease drugs, and the conditions for their declaration have also been relaxed to rare disease drugs approved before June 30, 2022, and are not limited to approval after 2017
.
In 2017 and 2018, 3 and 2 rare disease drugs were included in the national talks, and more than 6 rare disease drugs were included in the national talks after 2019, including 8 drugs in 2019, 6 in 2020 and 7 in 2021
.
There will be more and more drugs in the rare disease list, which can be seen from the optimistic attitude of many representatives of relevant enterprises at the negotiation site
.
The access and adjustment of the national medical insurance catalogue is a major livelihood project that benefits thousands of households, aiming to improve the level of residents' medication protection and reduce the medical burden
of patients.
Since the establishment of the National Medical Insurance Administration, the medical insurance drug list has been adjusted for four consecutive years, a total of 507 new drugs and good drugs have been included, 391 drugs with uncertain efficacy have been transferred, the total number of drugs in the current version of the medical insurance list has increased to 2860, and the average price of drugs included in medical insurance through negotiation has been reduced by more than 50%, effectively reducing the burden
on patients.
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