Second domestic PD-1 pricing announcement

On February 22, Cinda biology announced that cindilimab injection (trade name: Dabusu) was officially launched into the domestic market More than ten days later, Dabusu's pricing was officially announced It is understood that the final price of cindilimab is 7838 yuan / 100mg (piece) At the same time, a person familiar with the situation said that the third party will launch the "care · you" new member program for comfortable enjoyment After purchasing three cycles of cindilimab, it will obtain two cycles of products According to the preliminary estimation, the treatment cost of patients is about 13900 per month and 167000 per year According to another report, China pharmaceutical innovation promotion association will work with Cinda biopharmaceutical (Suzhou) Co., Ltd to jointly carry out the "dabeshu ® patient assistance project of China pharmaceutical innovation promotion association" Eligible patients from poverty-stricken households with minimum living insurance and registered cards in mainland China can donate free drugs The specific assistance implementation plan will be announced on the official website of China pharmaceutical innovation promotion association in the near future On December 27, 2018, cindilimab was officially approved by the State Drug Administration for marketing, and it is used to treat relapsed or refractory classic Hodgkin's lymphoma after at least second-line system chemotherapy, which is also the first PD-1 monoclonal antibody for Hodgkin's lymphoma indications The approval of cindilimab is based on a study called orient-1, which is a multicenter, phase II registered study to evaluate the efficacy and safety of cindilimab in relapsed or refractory classical Hodgkin's lymphoma (R / R CHL) 96 patients with relapsed or refractory CHL have been enrolled in the study, which is the largest number of relapsed or refractory CHL in China so far The results of 24-week analysis of 96 patients assessed by irrc showed that: the objective response rate (ORR) was 79.2%, and the disease control rate (DCR) was 97.9%, which reached the preset statistical goal; the analysis population divided according to different criteria showed similar objective response rate; the median response duration had not been achieved, and most of the patients were still in continuous disease response; no response occurred during the study There is no unexpected safety problem There is no death event The safety features are similar to similar products In addition, according to the information previously disclosed in the Hong Kong stock prospectus of Cinda biology, the affinity of cindilimab to the target is 10 times and 50 times of that of pabolizumab and navulizumab respectively, and at the same time, it occupies more available PD-1 binding sites than navulizumab at a given drug concentration It is worth noting that cindilimab injection is also promoting the research and development of other indications There are more than 20 clinical trials, including first-line non squamous non-small cell lung cancer, first-line squamous cell lung cancer, second-line squamous cell lung cancer, EGFR TKI treatment failure of EGFR mutation positive non-small cell lung cancer, first-line gastric cancer, first-line liver cancer, first-line esophageal cancer, second-line esophageal cancer, etc The phase IB clinical data of cindilimab in the first-line treatment of lung cancer have shown that the objective remission rate of cindilimab + pemetrexed / cisplatin is 68.4% for non squamous non-small cell lung cancer and 64.7% for squamous non-small cell lung cancer Up to now, in addition to the above-mentioned cindilimab, PD-1 monoclonal antibody approved for marketing in China market also includes opdivo from Bristol Myers Squibb, keytruda from mosadong and tuoyi from Junshi biology Its pricing and drug donation assistance programs are as follows: indications of opdivo: On June 15, 2018, it was approved by the State Food and Drug Administration for the second-line treatment of adult epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative, disease progression or intolerable local advanced or metastatic non-small cell lung cancer (NSCLC) after previous platinum containing chemotherapy Price: in mainland China, the price is 9260 yuan (100mg / 10ml) and 4591 yuan (40mg / 10ml) According to 3mg / kg intravenous injection once every two weeks, one 100mg / 10ml and two 40mg / 10ml should be used at a time For adult patients with 60kg body weight, it costs 18442 yuan at a time and 36884 yuan twice a month (58868 yuan in Hong Kong) For the adult patients with 50kg body weight, each of 100mg and 40mg specifications costs 13851 yuan for one medication and 27702 yuan for one month Charity assistance program: it is aimed at mainland adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are suitable for EGFR gene mutation negative and anaplastic lymphoma kinase (ALK) negative, who have previously received chemotherapy with platinum containing program and whose disease progression or intolerability is local advanced or metastatic Specifically, it can be divided into low-income patients and low-income patients, among which low-income patients refer to those who are diagnosed in accordance with medicine by designated medical institutions After the standard low-income group patients are approved by the project office of China Cancer Foundation, they can apply for assistance drugs in each cycle according to the project requirements and processes, and get up to four cycles of drug assistance The assistance program in each cycle refers to that after six consecutive treatments of odivo (the single dose of odivo is 3mg / kg, once every two weeks, and it needs to be completed in three months Cheng) can continue to benefit from the treatment of odevo without any disease progression after the assessment of the designated physician, and can not tolerate side effects After the approval of the PMO, free drug assistance for up to 7 subsequent treatments can be obtained Keytruda indications: approved by the State Food and Drug Administration on July 25, 2018, for the treatment of locally advanced or metastatic melanoma patients with disease progression after first-line treatment Price: the retail price in mainland China is 17918 yuan / 100mg For patients with 50kg or less, they need to use drugs 17 times a year, and the cost is about 300000 yuan Charity assistance program: For the low-income patients, if they meet the medical conditions and corresponding economic conditions, the China primary health care foundation can assist keytruda with a maximum dosage of no more than 24 months, that is to say, the low-income patients can use it free of charge; for the low-income patients (the patients confirmed to meet the catastrophic medical expenses), if they meet the medical conditions and corresponding economic conditions, after three courses of self use The China primary health care foundation can provide assistance for three courses of treatment For every three courses of treatment that follow-up patients use by themselves, the foundation can continue to provide assistance for three courses of treatment for a cumulative period of no more than 24 months (keytruda was included in Shenzhen medical insurance in November 2018) tuoyi indication: on December 17, 2018, it was conditionally approved by the State Food and Drug Administration for the treatment of unresectable or metastatic melanoma patients who had previously received systemic treatment failure Price: the price is 7200 yuan / 240mg (piece), 30 yuan / Mg, and the annual treatment cost is 187200 yuan Charity assistance program: Beijing Bethune Public Welfare Foundation launched the "benefit accompanied - Bethune tuoyi public welfare donation project" nationwide to provide drug assistance for melanoma patients who have family difficulties or are unable to receive continuous and effective treatment due to poverty caused by illness According to the program, eligible patients can receive four cycles of drug assistance after using four cycles of tuoyi According to preliminary estimation, if the plan can cover one year or longer treatment cycle, the actual annual drug burden of patients is about 93600 yuan.