PD-1 Half A Year Report: K Drug Greatly Exceeds O Drug, Indications "Fight" Fiercely

With the financial results of Baiji Shenzhou announced in the second quarter of 2020 on August 7, most of the six PD-1 mAb drugs listed in China have announced the sales situation in the first half of 2020. From the perspective of foreign investment, the stronger the imported "k-drugs" are, and more than half of the imported "o-drugs" are discarded; several local PD-1 drugs have different performances depending on different advantages, such as strong sales or medical insurance. From the perspective of the future competition pattern, each family is competing to give their own PD-1 drugs more indications to gain favorable effect.

PD-1 / L1 is a "net star" in the global biopharmaceutical industry in recent years, but it is no longer a "newcomer". The new trends in the early stage of research and development and the commercialization competition in the later stage are becoming increasingly intense.

According to iqvia data, the global sales of anti-PD-1 antibody in 2019 will be about US $18.809 billion. In 2018, the global sales of anti-PD-1 antibody were about US $14.17 billion. In the long run, companies are fighting for product competitiveness and subsequent commercialization capabilities, including new indications, drug quality, production capacity, channels, sales teams and medical insurance, all of which are the focus of competition.

Domestic PD-1 billion

According to the financial results of Baiji Shenzhou in the first and second quarters of 2020, in March 2020, its PD-1 drug tirelizumab injection was commercialized in China for the treatment of patients with classical Hodgkin's lymphoma (CHL) who received at least second-line systemic chemotherapy.

In the first quarter, the revenue of tiralizumab was US $20.53 million, including the amount used for distributors to create inventory; in the second quarter, the revenue of products in China was 29.42 million US dollars, with an accumulated revenue of 49.95 million US dollars in the first half of the year, about 348 million yuan.

In terms of indications, tirelizumab has been approved for two indications in China. In addition to Hodgkin's lymphoma, the other is a patient with urothelial carcinoma. At present, the indications of NSCLC and HCC have been accepted by nmpa of SFDA.

In the first half of 2020, the total sales of dixinli reached RMB 0.5 billion, which was about RMB 0.2 billion in the first half of 2020. At the end of 2019, sindilimab was listed in the new version of the national health insurance catalogue, becoming the only PD-1 inhibitor to enter the national health insurance list, with a price drop of more than 60%, which has more guarantee in sales. In the new indications, Cinda has also deployed non-small cell lung cancer.

Junshi bio has not released the second quarter revenue of its PD-1 drug, treprilimab. This is the first domestic PD-1 product approved in China. It was launched on December 17, 2018. The indication is unresectable or metastatic melanoma after previous systemic treatment failure. In 2019, the sales volume of treprizumab was 774 million yuan; in the first quarter of 2020, Junshi bio had a revenue of 172 million yuan. Considering that tripril was the only drug on the market, the revenue accounted for 99.999%, which was about equal to the sales volume of treprilimab in the first quarter.

Jun Shi has designed the indications for NPC and urothelial carcinoma for PD-1, and is conducting phase III clinical trials for multiple indications including melanoma, nasopharyngeal carcinoma, esophageal cancer, triple negative breast cancer and non-small cell lung cancer.

As a "big brother in medicine" in China, Hengrui's PD-1 drug, carrilezumab, was not the first to be approved, but it has the most indications at present. On June 19, two new indications of the PD-1 drug of Hengrui Pharmaceutical Co., Ltd. were officially approved by the State Food and drug administration. They were single drug second-line treatment of advanced esophageal squamous cell carcinoma and combination of pemetrexed and carboplatin in the first-line treatment of advanced or metastatic non-small-cell lung cancer.

This is a new field that Hengrui has won following the approval on March 6 of this year for "the treatment of patients with advanced hepatocellular carcinoma who have previously received sorafenib treatment and / or oxaliplatin containing systemic chemotherapy".

Hengrui did not disclose the sales of carrilizumab in the semi annual report, but with its strong sales system, the industry expects that its sales volume may be the highest among the four domestic manufacturers.

In an interview with the 21st century economic report, Hengrui pharmaceutical executives said, "during the epidemic period, the normal operation of many hospitals was affected, especially the operation selection or postponement, anesthesia drugs and other surgery related drugs were affected, and the hospital side sales were affected. But on the production side, we have basically returned to normal in February, and now the sales side is basically normal. "

Junshi bio also said that the adjustment of hospital resources, the willingness of patients to see a doctor and the limitation of realistic conditions had a certain impact on its sales volume. In the first half of the year, the sales volume of PD-100 million yuan is not affected by the revenue of each product.

Next step competition

The biggest competitive factor of domestic PD-1 drugs is foreign PD-1.

With the publication of Q2 financial reports, the competition between the world's two major PD-1 drugs, namely, the "K drug" pabolizumab of mosartan and the "O drug" navulizumab of BMS, has become a greater bright spot.

On July 31, MSD released its Q2 financial report for 2020. Due to the impact of the epidemic, its revenue dropped by 8% to 10.872 billion US dollars. In the first half of 2020, its revenue was 22.929 billion US dollars, an increase of 2% year-on-year. In the first half of the year, sales of keytruda increased by US $88 million to US $88 million. Benefited from keyruda and Gardasil / Gardasil 9, the revenue of MSD in China in the second quarter was US $811 million, an increase of 9%. In the first half of the year, the total revenue of China market was 1.657 billion US dollars, an increase of 14%, accounting for 8.1% of the global market. It surpassed Japan and became the third largest market in the world outside the United States and the European Union.

On the contrary, O pharmaceutical is not very optimistic: on August 6, BMS announced its second quarter results. Due to the completion of the acquisition of Xinji, its revenue rose 61% to US $10.129 billion, and its revenue in the first half of the year was $20.91 billion, up 71% year-on-year. But in the first half of the year, revenue fell 6% to $3419 million, well below keyruda.

In terms of indications, drug K has also abandoned drug O. on June 22, mosartan announced that drug K was approved as a new indication for second-line treatment of esophageal squamous cell carcinoma in China, which is also the fifth indication approved by pabolizumab in China. Opdivo has three approved indications in China, including lung cancer, head and neck squamous cell carcinoma and gastric cancer.

According to iqvia data, the sales volume of multinational enterprises in the first quarter of 2020 will reach 50.3 billion yuan, down 13.0% year-on-year; the sales of local enterprises in the first quarter of 2020 will be about 112.7 billion yuan, with a year-on-year decrease of 25.0%. The sales volume of each treatment field decreased significantly in the first quarter. However, due to the expansion of the medical insurance catalogue and the rigid demand for clinical medication, the impact of the epidemic situation on anti-tumor drugs and immunomodulators was relatively small, with a year-on-year growth rate of - 2.9%, reaching 22.7 billion yuan. After the outbreak, the growth can be expected to recover.

PD-1 is not easy to compete with.

The first is the indication. Junshi bio officially landed on the scientific and technological innovation board in July. According to its prospectus, Junshi bio's PD-1 has only been approved as an indication of melanoma, and the number of patients with this indication is small. Among the new melanoma patients in 2019, the corresponding patients are only 2400, and the market scale is small. The PD-1 of BMS, MSD and Hengrui has been approved more than one indication, and has been involved in lung cancer, liver cancer and other indications with a large number of patients.

After the price reduction of l061 yuan, the price of smb-3640 yuan decreased, and the price of smb-3640 yuan decreased, which led to the decrease of the price of pd-361 yuan. At present, the annual treatment costs of PAP for domestic PD-1 products are similar, and they do not have advantages. A new round of "price war" may occur in the future market promotion, distribution access and other aspects of fierce competition.

In addition to many products that are about to enter the market, there are many products that have been approved in the market. According to the statistical analysis data published in the journal Nature, as of August 2019, there are 102 candidate drugs in clinical trials for PD-1 targets worldwide. According to frost Sullivan's report, as of March 31, 2020, there are 26 phase III single drug trials for PD-1 mAbs and 70 phase III combined treatment trials for PD-1 mAbs in China.

?