Domestic innovative drugs will compete with foreign star products for medical insurance qualification more than 20 drugs will be shortlisted.

With regard to this year's adjustment of the medical insurance catalogue, the original draft of the consultation clearly qualified, two of the drugs eligible for participation must be from January 1, 2015 to December 31, 2019, approved by the State Drug Administration according to the new drug registration application for listing, or due to changes in the adaptation certificate, functional treatment, etc., to the drug regulatory department to supplement the application for approval of the drug.
controversially said the provision was supposed to result in innovative drug companies disqualifying drugs approved by 2020.
relevant businesses and associations to the National Health Insurance Administration to reflect the views.
final document, released yesterday, reflects the NHS's acceptance of the advice and shows the utmost sincerity in extending the approval period for medicines until the date of publication: August 17.
However, it is worth noting that for new drugs included in the scope of the adjustment of the health insurance catalogue, the health insurance bureau document is defined as approved by the State Drug Administration for the listing of new generic drugs, and previously described as approved by the State Drug Administration according to the new drug registration application for listing of drugs, industry analysis of this expression may also lead to different qualifications, new generic drugs also exist in the global new and New China differences, and therefore need to be carefully screened.
same time, the State Drug Administration maintained an efficient review rate in 2020 despite the outbreak, and as of August 17, the State Drug Administration had approved at least 29 new drugs, including 17 imported and 12 domestically produced drugs.
, the performance of multinational pharmaceutical companies is still eye-catching, Roche, Takeda, Sanofi, Concorde fermentation Kirin each have two products approved, the remaining 21 products from 21 enterprises.
the rule change, the negotiating landscape for some innovative drugs will also change.
01 PD-1/L1 pattern more complex Roche's atiliju monoantitor was approved by the State Drug Administration in February this year for the first-line treatment of widespread small cell lung cancer.
after the changes to the health care catalog adjustment rules, Atili Zhu single resistance will receive tickets.
this is the second PD-L1 drug approved in China following the approval of AstraZeneta's PD-L1 drug Imfinzi on December 10, 2019.
addition to 6 PD-1 drugs, the current domestic market of PD-1/L1 drugs reached 8.
, in the first half of this year, many PD-1 products have obtained new adaptation certificates, PD-1/L1 pattern will be more complex.
According to Roche's 2019 financial results, atili-pearl monotherapy includes advanced bladder cancer, advanced lung cancer, initial treatment of non-squamous non-small cell lung cancer (NSCLC), extensive stage small cell lung cancer and PD-L1-positive triple-negative breast cancer.
revenue for this product in 2019 was SFr1,875 million, up 143% year-on-year.
lung cancer is the most PD-1/L1 area of contention, but also can be included in the health insurance reimbursement of a big point of view.
Domestic PD-1, in June this year, Henri Pharmaceuticals' Karelli pearl single anti-combined Pyme segaplatin first-line treatment of advanced or metastatic non-squamous non-small cell lung cancer new adaptive application was officially approved for listing, so that Karelli pearl single resistance officially joined the first-line treatment of lung cancer.
, Xinta Bio's PD-1 has been the first to be included in health insurance.
, the number of PD-1/L1s with lung cancer-related adaptation certificates has reached five, including four imported products and Hengrui's products.
no doubt that the lung cancer adaptation certificate and which PD-1 can enter the 2020 version of the health care catalog is a big look this year.
02 ADC products are expected to be the first to enter the health insurance currently, a total of two ADC drugs on the market in China, and are approved in 2020.
the health-care directory policy changes, this type of drug is expected to be included in health insurance.
Roche's Enmetrotojudan resistance was approved in China in January 2020, mainly used for the treatment gap of HER2-positive early breast cancer patients who still have invasive lesions after receiving the new auxiliary treatment based on yew-type combined querceto-bead monoantigen, and also filled the therapeutic gap of HER2-positive breast cancer patients in China who did not reach pathological complete remission (pCR) after the new auxiliary treatment.
certificate was approved in the United States and the European Union in May 2019 and December 2019, respectively, basically achieving simultaneous approval by China and Europe and the United States.
another drug is Vitoxy monoantigen from Takeda, which was approved slightly later than Enmetro-Bead monoanti.
But the product is still the only antibody-coupled drug to be marketed targeting CD30, the first fda-approved new drug for interdational large cell lymphoma (ALCL) in nearly 40 years, and the first first first-line treatment for classic Hodgkin's lymphoma (cHL) and outer T-cell lymphoma (PTCL).
for patients with multiple types and limited treatment for lymphoma, this product fills a number of gaps.
currently, six adaptation certificates have been approved in the FDA, with a focus on lymphoma.
the six adaptation certificates approved by the FDA together account for about 14 percent of lymphoma patients in China, and for health insurance, the burden of this certificate is lower than for major cancers such as lung cancer.
03 domestic star drugs will be shortlisted for approval in 2020, many of them from local enterprises.
June 3, 2020, Zebtini, a BTK inhibitor in Baiji Shenzhou, was approved for the treatment of adult sleeve lymphoma patients who have received at least one treatment in the past, as well as adult patients with chronic lymphoblastic leukemia/small lymphocytic lymphoma who have received at least one treatment in the past.
as early as November 2019, the FDA has approved Zebtinib to be marketed for the treatment of once-treated patients with set cell lymphoma, becoming the first local research and development of a new cancer drug in China.
It is understood that the first generation of BTK inhibitor Ibtini in 2017 when the domestic market, the price is 48,600 yuan per month, in 2018 after the national health insurance negotiations to reduce the price, for CLL patients, the monthly drug price before reimbursement of 17,010 yuan, and for MCL, due to different dosages, the monthly drug price before reimbursement of about 22,680 yuan.
's initial pricing was close to Ibdini's after the health-care negotiations, while for MCL patients, the monthly treatment cost was less than the $22,680-a-month price that Ibdinie negotiated to cut.
face of lower prices than after the negotiations on health care, the health-care catalog adjustment, Zebtini can enter health care, how much can reduce prices, is also a big point of view.
addition, the world's second third-generation EGFR-TKI innovative drug, the first domestic three-generation EGFR-TKI drug - methylfate ametinib has also been shortlisted for this year's health care negotiations.
of this year, the State Drug Administration approved the listing of Haussen's class 1 innovative drug, amethystine tablet, on condition of approval through the priority review and approval process.
The drug is used in adult patients with local late stage or metastasis non-small cell lung cancer who have tested positive for EGFR T790M mutation during or after treatment of the mesothionine kinase inhibitor (TKI).
and its competition, Teresa from AstraZeneta, is also showing great glides in China, with sales of 1,004 million yuan, up 989.40 percent year-on-year, according to the PDB database.
Amethystini's listing will enrich the three-generation EGFR targeted drug market, but Teresa is currently included in the 2019 version of the health insurance catalog, the price from more than 50,000 yuan to 153,000 boxes.
With the listing of domestic star drugs, some pharmaceutical products have become more abundant, and this also gives the National Health Insurance Administration greater bargaining power, the 2020 health insurance catalog adjustment will also usher in a price competition between enterprises.
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