The first domestic PD-1 has been approved for listing! Facing the price test!

On December 17, the State Drug Administration had the conditions to approve the first domestic PD-1 monoclonal antibody - treprizumab injection (trade name: tuoyi) It took 284 days from submitting the listing application to being approved through the priority review This is also an innovative biological product drug independently researched and developed by Chinese enterprises with full independent intellectual property rights, which is used to treat local progress or metastatic melanoma after previous standard treatment failure At present, the competition between PD-1 has entered a white heat After the approval of foreign import drugs opdivo and keytruda for listing in China, as the third one, Junshi biology should not only deal with the PK of the two imported drugs, but also confront the subsequent wave of domestic PD-1 listing It is reported that the ibi308 (sindelimab) of Cinda biology has also completed all the technical review work and entered the administrative approval stage on December 12 Conditional approval It is understood that the current research focus in the field of tumor immunotherapy is mainly focused on the immunosuppressive checkpoint inhibitors such as anti programmed death-1 (PD-1) receptor, which is different from the traditional chemotherapy and targeted treatment, mainly through overcoming the immunosuppression in patients and reactivating their own immune cells to kill tumors, which is a new anti-tumor treatment concept The approved trepril mAb is an all human monoclonal antibody against PD-1 receptor developed by Suzhou Zhonghe biomedical Co., Ltd (a wholly-owned subsidiary of Shanghai Junshi Biomedical Technology Co., Ltd.), which can block the binding of PD-1 of T-lymphocytes with PD-L1 on the surface of tumor cells, release the immunosuppression of tumor cells on immune cells, and Immune cells play the role of anti-tumor cell immunity again and kill tumor cells Data show that melanoma has been increasing rapidly in China in recent years, and it is one of the fastest growing malignant tumors The incidence rate of melanoma is about 20000 cases a year, and the mortality rate has been increasing rapidly year by year It has become one of the diseases that seriously endanger the health of our people In terms of treatment, there is a lack of effective standard treatment for melanoma patients who fail in the first-line treatment The clinical trial results of trepril mAb showed that the objective remission rate, disease control rate and 1-year survival rate of patients with unresectable or metastatic melanoma who had previously received systemic treatment failure were 17.3%, 57.5% and 69.3%, respectively The approval of the drug on the market is of positive significance to the choice of clinical medication for cancer patients in China As the first domestic monoclonal antibody with PD-1 as the target drug approved for marketing in China, trepril mAb has been supported by major national science and technology projects Since the beginning of 2016, clinical research and development of the drug has been started So far, more than 20 clinical trials are in progress, including those in the United States In March 2018, the State Drug Administration officially accepted the application for listing registration of the drug, and included it in the priority review and approval varieties to speed up the review and approval The national drug review center, the drug review and inspection center, the China food and Drug Control Institute and other relevant units work together to actively communicate and guide with the applicant, timely solve the technical problems encountered in the review, give priority to technical review, on-site inspection and laboratory inspection, and based on the validity data of the applicant's completed phase II study of advanced melanoma in China and 7 temporary items According to the safety data of the bed study, the product was approved for listing on December 17 How to price? It is understood that the price of the first domestic PD-1 has not been determined, but Junshi's pricing strategy does need more consideration Data shows that the global sales volume of PD-1 and PD-L1 inhibitors increased from US $1.6 billion in 2015 to US $10.1 billion in 2017, with a compound growth rate of 154.2% It is estimated that the compound annual growth rate will be 29.3% in 2017-2022, and the market size is expected to reach US $78.9 billion in 2030 In the face of broad market prospects, enterprises are actively layout At present, there are six PD-1 / PD-L1 drugs on the market in the world In addition to opdivo (BMS) and keytruda (MSD), there are tecentriq (Roche), imfinzi (AstraZeneca), bavencio (Merck / Pfizer), libtayo (Sanofi and regenerator) In China, in addition to the previously approved opdivo (BMS) and keytruda (MSD), PD-1 / PD-L1 of Cinda, Hengrui and Baiji are also on the way of listing In addition, according to incomplete statistics, there are more than 20 domestic enterprises participating in the competition in the field of PD-1 / PD-L1, which are in different clinical stages In the fierce competition of varieties, in addition to curative effect, price is also an important factor to seize the market Especially in the context of national health insurance negotiation and volume purchase, imported drugs are facing considerable pressure of price reduction According to the official price, the price of drug o is 4591 yuan for 40 mg / 10 ml and 9260 yuan for 100 mg / 10 ml for 60 kg patients, it costs 36884 yuan a month, while in the United States, it costs 66056 yuan The retail price of drug K in China is 17918 yuan / 100mg, and the annual treatment cost is 304606 yuan, only 54% of the market price in the United States Both imported PD-1 models choose the pricing strategy of sacrificing unit price in exchange for potential sales volume Analysts pointed out that both drug O and drug K are listed in China at the lowest price in the world, which shows the expectation of the two companies for the Chinese market, and also infers the fierce competition in the future PD-1 market On the one hand, the promotion of domestic PD-1 R & D forces multinational pharmaceutical companies to lower prices; on the other hand, the low price strategy of imported PD-1 also blocks the price of domestic PD-1, where the price ceiling has been placed I believe that the price setting of domestic PD-1 will be more rational, and then, what will be the attitude of the medical insurance department? Will PD-1 participate in the health insurance price negotiation through dynamic adjustment? It is understood that in November, Shenzhen human resources and Social Security Bureau released the announcement of the review results of 2018 additional selection experts, and drug K (keytruda) was prominently listed According to the Trial Measures of supplementary medical insurance for serious and serious diseases in Shenzhen, the undertaker shall pay 70% of the expenses incurred by the insured in the same social medical insurance year for the use of the drugs in the catalogue of supplementary medical insurance drugs for serious and serious diseases in Shenzhen (the maximum amount of payment shall not exceed 150000 yuan) The competition among all kinds of products has started Who will be ahead? Welcome to discuss actively! Source: medical economics