The first self-developed anti-PD-1 monoclonal antibody in China — Tuoyi (Treprimumab Injection) was approved by the State Drug Administration on December 17, 2018, and its public clinical data has attracted global attention.
The results of the study showed that the clinical efficacy of teriplizumab monotherapy was significant, reaching the world's leading level.Its objective response rate (ORR) in patients with unresectable or metastatic melanoma who have failed prior systemic therapy 17.3%, disease control rate (DCR) 57.5%, 1-year survival rate 69.3%.Published data from an open-label study of melanoma in clinical trials of the imported product pabolizumab in China are objective response rates 16.7%, disease control rate 38.2%, 1-year survival rate 50.8%.
Because of the high R & D and generation of PD-1 monoclonal antibody products and the absence of independent products in China, patients in China have so far been forced to rely on high imported products, which are often impoverished and overwhelmed by illness.With the broadcast of the popular movie "Medicine God", it is pushing such products to the cusp.Good clinical data performance and the huge demand of Chinese patients have made the pricing of topologies the focus of attention in all sectors of society.
1, on pricing and charity programs
According to the official news of Junshi Bio on January 7, the price of the extension will be set at 7,200 yuan/240 mg (branch), 30 yuan/mg, and the annual cost of treatment 18.720,000 yuan.The price of the imported product of the same indication is 17918 yuan/100mg (branch), 179 yuan/mg, and the annual treatment cost is 609,212 yuan (average weight 60kg).
This pricing has long been available. Junshi management said in an interview with CCTV last week that despite the significant effect of topology, pricing will certainly strive to benefit more patients and may be 1/3 or less of imported products.
In addition, the Bethune Foundation for Public Welfare in Beijing announced the launch of the Bethune Tuoyi Public Welfare Donation Project to provide drug assistance to melanoma patients who are in family difficulties or who are impoverished due to illness and cannot receive sustained and effective treatment in order to benefit more patients.
According to the project protocol officially provided by the Foundation, eligible patients receive 4 cycles of pharmaceutical assistance after using 4 cycles of topologies.According to preliminary estimates, if the plan can cover a period of one year or more, the actual annual medication burden is about 93,600 yuan.
The price of terlizumab is much lower than the pricing of similar imported products, less than one-third of the imported products.
The benefits of Junshi Bio are much lower than the price of PD-1 products in many parts of the world, which greatly alleviates the problem of accessibility of the drug in China, allows more patients to actually benefit, reduces the economic burden, and relieves social pressure.
2. More clinical research data are disclosed, and the efficacy is outstanding
As a novel recombinant humanized anti-PD-1 monoclonal antibody, the affinity and binding stability of teriplizumab to therapeutic targets have reached the international advanced level, demonstrating excellent antitumor efficacy and good safety in vitro and in clinical trials.
In addition to the already approved "King of Cancer" melanoma, the efficacy of terlizumab in other tumors has also been stunning.Such as Hodgkin's lymphoma, early clinical trials showed an effective rate of up to 88%, numerically more than other similar products have been reported in this indication.More than a dozen tumor types such as nasopharyngeal carcinoma, gastric cancer, esophageal cancer, urothelial carcinoma, and alveolar soft tissue sarcoma are also under development.
At the same time, combination therapy with teriplizumab is also being explored.Even in terms of approved indications for melanoma, teriplizumab is constantly refreshing its record.In response to the high incidence of mucosal melanoma in China, a global breakthrough has been made in the combination therapy of teriplizumab and angiogenesis inhibitors, with an early clinical data efficiency of more than 60%.
At present, the research focus in the field of tumor immunotherapy is mainly focused on immune checkpoint inhibitors such as Programmed Death-1 (PD-1) receptors, which are different from traditional chemotherapy and targeted therapies, mainly by overcoming immunosuppression in patients and reactivating patients' own immune cells to kill tumors. It is a brand-new concept of anti-tumor therapy.
The approved topo (teriplizumab injection) is a novel recombinant humanized anti-PD-1 monoclonal antibody developed by Junshi Biological, which can block the binding of PD-L1 on the surface of tumor cells by blocking the PD-1 of T lymphocytes, relieve the immunosuppression of tumor cells on immune cells, and allow immune cells to regain anti-tumor cellular immunity and kill tumor cells.
Melanoma has shown a rapid growth trend in recent years in our country. It is one of the fastest growing malignant tumors in China. There are about 20,000 new cases each year, and the mortality rate is also rising rapidly year by year. It has become one of the diseases that seriously endanger the health of our people.In terms of treatment, melanoma patients who have failed first-line treatment currently lack effective standard treatment options.
Professor Guo Jun, Vice President of Cancer Hospital of Peking University and Secretary General of Chinese Society of Clinical Oncology (CSCO), participated in and led the registered clinical research work of Tuoyi (Treprimumab Injection). He said: "In recent years, immunotherapy has shown surprising results in a variety of cancer treatment areas, making many kinds of cancer patients re-ignited the desire for life, but the high price still makes many Chinese patients deterred.With the approval of the PD-1 monoclonal antibody with independent intellectual property rights in China, the price and charity plan are announced at the same time. Cancer patients in China will receive the most advanced level of immunotherapy in the world at an annual treatment cost of less than 100,000.
The topology of Junshi Bio (teriplizumab injection) is used for the treatment of locally advanced or metastatic melanoma that has previously failed standard therapy, and its approval for marketing not only fills the gap in domestic PD-1 inhibitors, but also gives more Chinese patients the opportunity to obtain internationally advanced levels of cancer immunotherapy.Melanoma is the first indication approved by Tuoyi in China. In the future, indications such as nasopharyngeal carcinoma, non-small cell lung cancer, gastric cancer, esophageal cancer, urothelial carcinoma, and liver cancer will also be applied for listing.At present, these indications are in the clinical research stage.