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五款明星药PD-1欲进2020年国家医保目录,最终花落谁家?

Five star drugs, PD-1, want to enter the 2020 national health insurance catalogue. Who will end up in the end?

富途资讯 ·  Sep 25, 2020 11:23  · Exclusive

Recently, National Healthcare Security Administration issued an announcement on publicizing the "declared Drug list through formal examination through the Adjustment of the National Medical Insurance Drug Catalog in 2020" (referred to as the "declaration list"). The announcement shows that five PD-1 have entered the preliminary examination list. The following is the sales of these five drugs in the first half of 2020:

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In theory, PD-1 inhibitor can treat all cancers.

T cells, known as "human guardians", can recognize human tumor cells and carry out killing attacks. But the tumor cell is more cunning, see that there is a protein on the T cell called PD-1, and then the tumor cell will stick out a PD-L1 protein (the ligand of PD-1). When two small hands (PD-1 and PD-L1) combine, it induces T cell apoptosis, inhibits T cell activation and proliferation, and cancer cells can multiply and survive.

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Photo source: such as medicine, global good medicine

PD-1 inhibitors bind directly to human T cells, so cancer cells cannot bind to human T cells and activate the body's immune system to destroy cancer cells. Therefore, theoretically speaking, PD-1 inhibitors are suitable for many cancers, such as lung cancer, liver cancer, gastric cancer and so on. In addition, PD-1 inhibitors do not produce drug resistance and can be used for a long time.

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Photo: Emory University Cancer Research Institute

Innovative drugs enter the core requirements of health insurance: good efficacy, high safety and low price

The health insurance department hopes to include more innovative drugs in the national health insurance, but China's health insurance funds are limited after all. Therefore, the premise that innovative drugs want to be included in health insurance is that the price is low, the effect is good and the safety is high, and the low price can quickly usher in the growth of sales because of the inclusion of health insurance. Therefore, if PD-1 McAbs, which are not included in health insurance, want to successfully enter the national health insurance catalogue, the most concerned challenge is to negotiate price reduction.

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The first indication approved for INNOVENT BIO's PD-1 inhibitor is relapsed / refractory classical Hodgkin's lymphoma and was selected into the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of lymphoma. In addition, in 2019, INNOVENT BIO reduced the price by about 63% to be included in the national health insurance, becoming the only PD-1 inhibitor to enter the national health insurance. Generally speaking, INNOVENT BIO PD-1 inhibitor is not only effective, but also very cheap.

Note: clinical diagnosis and treatment guidelines are recommended by the system to help clinicians and patients make appropriate treatment according to specific clinical conditions. Simply understand, the guide is the most basic, the most standard, the most standardized scheme. Follow this plan to ensure the effect and reduce the risk.

After INNOVENT BIO's PD-1 inhibitor entered our national health insurance catalogue in 2019, the sales volume of China's PDB sample hospitals accounted for 52% in 2020.

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The top five PD in China-1 who is the most likely to enter the 2020 National Health Insurance catalogue?

China PDThe main battlefields of-1 inhibitors are lung cancer, liver cancer, gastric cancer and rectal cancer.The four major types of cancer in China: the first is lung cancer (related to smoking, 800000 per year), the second is gastric cancer (440000 per year), the third is colorectal cancer (420000 per year), and the fourth is liver cancer (400000 per year related to hepatitis B, hepatitis C and alcohol).

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1) Merck & Co Inc, the best effect and the most expensive

Merck & Co Inc's Pablizumab, from the following approved indications, there is no doubt that all PD-1 drugs are the best, including not only lung and stomach cancer, but also first-line treatment. But its disadvantage is very obvious, the price is very expensive, the cost of each patient is 280000 yuan / year, the price is already the lowest in the world, and the possibility of a substantial price reduction is not high.

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Note: first-line treatment refers to medication after diagnosis; second-line treatment means that patients are resistant to first-line drugs and begin to use second-line drugs; and so on, if second-line treatment fails, third-line treatment, fourth-line treatment and so on will be considered. Therefore, the market space of first-line (1L) drugs is larger than that of second-line (2L) drugs.

2)Bristol-Myers Bristol-Myers Squibb CoThe first approved PD-1 inhibitor in China

Bristol-Myers Bristol-Myers Squibb Co's O drug is the first approved PD-1 inhibitor in China. At present, its indications are mainly those of second-line and third-line treatment. In addition, its price is not only higher than that of domestic drugs, but also no better than domestic drugs.

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3) Hengrui medicine, the number of indications is second only to "K medicine".

As the "first brother of medicine" in China, Hengrui Pharmaceutical's Carrilizumab sold more than 2 billion yuan in the first half of the year, surpassing the domestic sales of Merck & Co Inc's "K medicine" and Bristol-Myers Bristol-Myers Squibb Co's "O medicine" (Opdivo). In addition, Hengrui Medicine has successively won three new indications of liver cancer, non-small cell lung cancer and esophageal squamous cell carcinoma within half a year, and the number of indications is second only to "K drug", but the side effect of its combination is very obvious and the safety is not high.

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4)BeiGene, Ltd.A number of indications have been approved this year

BeiGene, Ltd. 's tiraizumab is a PD-1 drug on the market at the end of 2019. From the sales volume in the first half of 2020, the product did not take the lead in the market. But in terms of indications, Baze'an ®has achieved a lot this year: this year, the State Drug Administration approved applications for listing indications for urothelial cancer, advanced squamous and non-small cell lung cancer, and unresectable hepatocellular carcinoma. The adaptation of PD-1 has not only large domestic indications such as lung cancer and gastric cancer, but also a number of indications for first-line treatment.

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5Junshi creatureA number of small indications were approved

The indication of Junshi organism is melanoma, which has a low incidence in China and lack of direct clinical treatment, which is one of the main reasons for its low sales. In the first half of 2020, the two new indications of Tuoyi submitted by Junshi Biology are recurrent / metastatic nasopharyngeal carcinoma (NPC) and metastatic urothelial cancer (UC), respectively, but they are both small indications in China.

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Summary

According to the comprehensive observation of the safety, indications and efficacy of PD-1 drugs at present, Merck & Co Inc > INNOVENT BIO > BeiGene, Ltd. > Hengrui Medicine > Bristol-Midea Bristol-Myers Squibb Co > Junshi Biology. According to the observation of patients' annual expenses, INNOVENT BIO > Junshi Biology > BeiGene, Ltd. > Bristol-Midea Bristol-Myers Squibb Co > Hengrui Medicine > Merck & Co Inc.

INNOVENT BIO's PD-1 entered the national health insurance catalogue in 2019. The remaining five PD-1 models are now in a tense state of preparation to enter the national health insurance catalogue in 2020. Taken together, BeiGene, Ltd. 's PD-1 is most likely to be included in the national health insurance catalogue in 2020.

Edit / elisa

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