On December 27, 2018, Cinda Bio's PD-1 antibody drug “Sendril Monoclonal Antibody Injection†was officially approved by the National Drug Administration (NMPA) for recurrence or refractory treatment with at least second-line system chemotherapy. Treatment of sexual classic Hodgkin's lymphoma. It is understood that the Xindili monoclonal antibody injection is jointly developed by Cinda Bio and Eli Lilly, the international trademark Tyvyt, the Chinese name Da Boshu. This is the second domestically produced PD-1 antibody drug listed after Junshi Pharmaceutical's "Trepril Monoclonal Antibody Injection", which is considered to be popular. Cinda Bio was first submitted in December 2017, and then the application was withdrawn at the end of February 2018, and the application was resubmitted on April 16, 2018. Junshi Pharmaceutical's earliest application for listing was in March 2018. Due to the withdrawal of the first application, the reporting rate of Xinda Pharmaceutical has been slightly delayed, but the final approval time is only 10 days away from Junshi Pharmaceutical. BMS, Merck, Junshi, Cinda, domestic and foreign companies competing in the same field In addition to Cinda and Junshi, BMS Opdivo and Merck East Keytruda have entered China in succession a few months ago, and their prices are even lower than in the United States. It is understood that Opdivo is approved for the treatment of epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase (ALK)-negative, previously undergoing platinum-based chemotherapy after disease progression or intolerable local advanced or metastatic Adult non-small cell lung cancer (NSCLC). The approved indication for Keytruda is locally advanced or metastatic melanoma. The retail price in China is 17918 yuan/100mg, and the annual treatment cost is 304606 yuan, which is only 54% of the US market price. For low-income patients, The PAP program grants 3+3 (3 courses for 3 courses), and the minimum annual cost of treatment for patients is 161,262 yuan; for patients with low-income, they can use 24 months for free. The official retail price of Opdivo is recommended to be 100mg/10ml 9260 yuan; 40mg/10ml 4591 yuan. If you calculate by 60kg (3mg/kg, once every two weeks), you need to use one 100mg/10ml and two 40mg/10ml, a total of 18442 yuan per two, a total of 36884 yuan a month; 50kg patients cost about 13851 yuan Every two weeks, a total of 27,702 yuan a month. The two companies, Junshi and Xinda, have not yet disclosed the drug pricing rules, but Yu Dechao, chairman of Cinda Bio, mentioned in an interview: “Our focus is on producing high-end biopharmaceuticals that Chinese people can afford. Now because of specific drugs It hasn't come out yet, it's hard to say how much, but the initial plan is that the patient's cost should not exceed 100,000 a year." Fierce competition Throughout the history of medical development, no drug has been as popular in the world as PD-1/PD-L1. In the past history, there have not been so many companies that have focused on one target. From Bristol-Myers Squibb to AstraZeneca to these innovative pharmaceutical companies in China, the world has invested hundreds of billions of research and development costs on this drug. But this also makes players in the market have to face unprecedented fierce competition. In foreign countries, BMS, Merck, Roche, and Pfizer are in the world; domestic, Hengrui, Cinda, Junshi, and Baekje Shenzhou are also rushing to win the lead. BMS holds Opdivo and scores six indications for melanoma, non-small cell lung cancer, renal cell carcinoma, classic Hodgkin's lymphoma, head and neck cancer, and bladder cancer; Merck holds Keytruda, in melanoma, non-small cells The market for lung cancer, head and neck cancer, and urothelial cancer also has a very high voice; Roche Tecentriq is the first PD-L1 antibody approved by the FDA, and has now won two indications for non-small cell lung cancer and bladder cancer. Pfizer, a PD-L1 antibody developed by Pfizer and Merck, is the only PD-1/PD-L1 drug approved for the treatment of a rare skin cancer, Merkel Cell Carcinoma (MCC). Among them, BMS Opdivo's 2015 sales of 942 million US dollars, 2017 sales of 4.948 billion US dollars, is expected to peak sales of 9.59 billion US dollars in the next five years; Merck East Keytruda 2015 sales of 566 million The US dollar, with sales of 3.809 billion US dollars in 2017, is expected to reach a peak of 9.88 billion US dollars in the next five years. Among domestic enterprises, in addition to Junshi and Cinda have been approved for listing, Hengrui Medicine is in the declaration stage, and PD-1 of Baekje China has now been included in the priority review. How are domestic and foreign companies selling? It is understood that the cooperation between Cinda and Eli Lilly includes the research and development, production, quality control and sales of drugs, and its production line has reached the international level. According to the report of the drug Rubik's Cube, the existing production capacity of Xindili monoclonal antibody injection injection is 3 1000 liters, and there are 6 3000 liters in the commissioning. It is the largest and international standard PD--completed among domestic PD-1 manufacturers. 1 production plant. At the same time, Cinda Pharmaceuticals also stressed that Cinda Bio will continue to adhere to the professional academic promotion route. Junshi has established his own sales team, most of whom are from multinational pharmaceutical companies. They will focus on the three major operators of Sinopharm, Shanghai Pharmaceutical and China Resources, with hundreds of hospitals and DTP pharmacies supplemented by local quality operators. Both BMS and Merck's two foreign companies have wisely handed over the general agent to Shanghai Pharmaceutical, a local company with commercial experience, so as not to be unacceptable in the sales process. According to Shanghai Pharmaceutical's third-quarter earnings report, Shanghai Pharmaceutical's distribution revenues on Opdivo and Keytruda reached 190 million yuan and 150 million yuan respectively. As a result of catching up with the approval of imported drugs, Junshi and Xincheng reached the first batch of local innovative enterprises competing with giant pharmaceutical companies. Not only that, Opdivo and Keytruda have played a "friendship price" in the sales price, which makes it more difficult for the local pharmaceutical companies to compete in the market. However, the arterial network is more optimistic about this: First, the current indications for Opdivo and Keytruda in China are non-small cell lung cancer and advanced melanoma, respectively, and there is no direct competition between Cinda, Hengrui and Baekje Shenzhou (the indications for Junshi are after systemic treatment failure). There is a certain correlation between unresectable or metastatic melanoma). This gives local companies a buffer. Secondly, although Opdivo and Keytruda have given Chinese patients a “friendship priceâ€, there may be competitive pressures from local companies behind their friendship prices. The low price strategy may narrow the price space of imported drugs and domestic drugs, but from the previous reports of Junshi and Cinda, the price advantage still exists. According to research firm GlobalData, the global market for cancer immunotherapy will reach about $14 billion in 2019; in 2024, the market will expand to $34 billion. Among them, the number of immunological checkpoint drugs is the largest, and only about five PD-1/PD-L1 monoclonal antibodies have been marketed and sold worldwide. Despite a slight lag, Junshi and Cinda are very likely to become powerful competitors, and opportunities will be reserved for those who take medicine seriously. 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