At the beginning of the new year, a new round of competition has been launched among domestic PD-1 enterprises.
In the past two days, BeiGene (BGNE. NS, 06160. HK, 688235. SH) and Junshi Biotechnology (01877. HK, 688180. SH) have announced that their PD-1 anti-cancer drug has been approved with new indications in China.
From the approved situation, there are different strengths.
Among them, the indication for the approval of the BeiGene PD-1 inhibitor tirelizumab is to be used as a monotherapy for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients. At this point, 12 indications for tirizumab have been approved in China, becoming the domestically produced PD-1 inhibitor with the highest number of approved indications. Among them, all 11 indications have been included in the national medical insurance drug catalog, and it is also the PD-1 inhibitor with the highest number of approved indications included in the national medical insurance drug catalog.
Junshi Biological's PD-1 inhibitor, Treprizumab, has been approved for perioperative treatment of resectable non-small cell lung cancer. This is the seventh indication approved for Treprizumab in China and the first and second globally approved perioperative therapy for lung cancer in China.
As the first cancer immunotherapy approved for market, PD-1 checkpoint inhibitors have led the revolution in cancer treatment. Unlike surgery, radiotherapy, chemotherapy, and targeted drugs, PD-1 inhibitors themselves do not directly kill tumor cells, but attack tumors by activating the patient's own immune system. The function of PD-1 inhibitors is to block the inhibition of T cells by tumor cells, enabling the normal functioning of T cells in the human body, continuously identifying and clearing tumor cells.
In theory, PD-1 is adapted to multiple types of cancer, hence it is known as the "broad-spectrum anti-cancer miracle drug". It is precisely because of its broad-spectrum anti-cancer effect that it has attracted a large number of domestic and foreign enterprises to enter it. Since June 2018, as of now, the number of PD-1 monoclonal antibodies approved for market in China has reached 11, of which 9 are domestically produced, making the industry highly competitive.
In the first three quarters of 2023, BeiGene PD-1 achieved sales of approximately 409 million US dollars; Junshi Biological PD-1 achieved sales of approximately 668 million yuan.
In order to compete for a larger market share, domestic PD-1 pharmaceutical companies are still competing to expand their indications, such as breaking through into large cancer strains.
BeiGene PD-1 has been approved for the treatment of liver cancer, which is a common high incidence malignant tumor in China.
In 2020, there were approximately 410000 new cases of liver cancer in China, accounting for about half of the global total; The number of deaths is about 391000, making it the second leading cause of cancer death in China. 70% -80% of liver cancer patients are already in the middle and late stages of diagnosis, losing the opportunity for surgery or other local treatments. The clinical prognosis is poor, and the 5-year survival rate is only 12.1%. More treatment methods are urgently needed to improve patient survival.
Wang Lai, senior vice president of Baekje Shenzhou and global head of research and development, said: "The incidence rate of liver cancer in China has continued to rise in recent years, and there is a large unmet clinical demand. This approval is another breakthrough in the field of liver cancer for tirelizumab, enriching the first-line treatment options for patients with advanced liver cancer."
For example, expanding towards the treatment of early-stage tumors.
Junshi Biotechnology stated that the approval of the new perioperative indications for Treprizumab for lung cancer marks the official expansion of the treatment population of this drug from late stage to early stage cancer patients.
The perioperative period refers to the entire time period from the start of surgical treatment to the end of surgical treatment for patients. According to the research data of China National Cancer Registration Center, among the five major cancers (lung cancer, gastric cancer, esophageal cancer, colorectal cancer, and female breast cancer) in China, 56.5% of the patients were diagnosed in the second or third stage of cancer, which is the cancer stage where the target group of post-operative adjuvant perioperative treatment is concentrated. With the increasing awareness of cancer prevention and the popularization of early screening for cancer, it is expected that the target group will continue to grow, and there is great market potential in the future.
An insider from Junshi Biotechnology told First Financial reporters that unlike chemotherapy and targeted therapy, PD-1's unique characteristics and safety determine its ability to be used for a long time. If it can be intervened in the early stages of the disease, it can prolong the patient's total survival time and quality of life before the immune system is disrupted, and improve the therapeutic effect. Therefore, the potential number of patients in the field of postoperative adjuvant/perioperative care is higher, the medication cycle is longer, and due to the large number of patients and long follow-up time required for clinical research to prove its efficacy, there are fewer varieties of this indication developed in similar products. With the approval of more indications and the increasing advantage of prospective layout in multi indication perioperative clinical research, the sales revenue of the company's PD-1 in the domestic market still has great potential for growth.