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PD-1 antibody drug sells 32 billion pounds of drugs annually, and China is listed.
Medical Network June 19th, China's first monoclonal antibody targeting PD-1 - Navulitis Monoclonal Antibody Injection is approved for registration in China.
On June 15, the State Food and Drug Administration issued an announcement to approve the registration application for the import of Navulitis monoclonal antibody injection injection from Bristol-Myers Squibb.
â–Opdivo monoclonal antibody annual sales of 4.948 billion US dollars
The mechanism of action of PD-1/PD-L1 inhibitors is to help T cells restore activity, recognize and destroy cancer cells by blocking the connection of PD1 to PD-L1.
As everyone knows, Opdivo is the first PD-1/PD-L1 drug approved by Bristol-Myers Squibb.
In July 2014, Bristol-Myers Squibb's PD-1 monoclonal antibody Opdivo was approved for sale in Japan for the treatment of advanced melanoma, the world's first anti-PD-1 drug listed in the same year. It was approved for listing in the US in December.
Opdivo has been approved for melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin's lymphoma, head and neck cancer squamous cell carcinoma, urothelial carcinoma, and MSI-H/dMMR metastatic colon cancer. treatment. Opdivo's sales in 2015-2016 were US$982 million and US$3.774 billion, respectively, with a growth rate of 284.3%.
In addition, according to Xinkang industry, the sales of PD-1 monoclonal antibody Opdivo in 2017 was 4.948 billion US dollars, ranking 13th in the global drug sales list.
In addition, according to Xinkang's forecast, Opdivo's total sales will reach 43.3 billion US dollars in the next five years, ranking second in the best-selling anti-tumor drugs.
â–4 additional anti-PD-1/PD-L1 mAb drugs
Five anti-PD-1 or PD-L1 monoclonal antibodies have been marketed worldwide, and PD-1-targeted monoclonal antibody drugs include Opdivo, including Merck's Pabolizumab injection ( Pembrolizumab, trade name Keytruda), and the monoclonal antibody drugs targeting PD-L1 are Tecentriq (Atezolizumab), Bavencio (Avelumab) and Imfinzi (Durvalumab).
1.Keytruda
Merck's Keytruda was approved by the US FDA in September 2014. It is the first US-listed PD-1 monoclonal antibody that inhibits the PD-1 pathway and activates human T cells to kill tumor cells. Keytruda has been approved for the treatment of melanoma, non-small cell lung cancer, head and neck cancer squamous cell carcinoma, classic Hodgkin's lymphoma, locally advanced or metastatic urothelial carcinoma, and MSI-H/dMMR solid tumors. a disease. Keytruda's sales for 2015-2016 were US$566 million and US$1,402 million, respectively, with a growth rate of 147.7%.
2.Tecentrip (atezolizumab )
Roche's Tecentrip (atezolizumab) was approved by the FDA in May 2016 for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) and second-line treatment of non-small cell lung cancer (NSCLC). Tecentriq is the first PD-L1 immunotherapy antibody drug by blocking the interaction of the PD-1/PD-L1 pathway and helping the body's immune system fight cancer cells. Tecentrip is priced at $125,000 a month, with a four-month sales of $77 million and a sales revenue of 157 million Swiss francs in 2016.
3.Bavencio (avelumab )
Bavencio (avelumab), a PD-L1 antibody developed by Merck and Pfizer in Germany, was approved by the US FDA in March 2017 for the treatment of a rare skin cancer, Merck Cell Carcinoma (MCC). This is the first PD-1 drug for MCC.
4.Imfinzi (durvalumab )
AstraZeneca's Imfinzi (durvalumab) is a human monoclonal antibody that directly targets PD-L1 and blocks PD-L1 interaction with PD-1 and CD80 on T cells. The drug was approved by the US FDA in May 2017 for the treatment of patients with advanced or metastatic urothelial carcinoma and patients with locally advanced, unresectable non-small cell lung cancer (NSCLC).
On November 2, 2017, Bristol-Myers Squibb submitted the drug listing application (JXSS1700015) to the Drug Testing Center (CDE) and was accepted by the company, making Opdivo the first immunotherapy PD in China. 1/PD-L1 class of drugs.
Three months after Bristol-Myers Squibb submitted the Opdivo listing application, in February 2018, Merck PD-1 monoclonal antibody Keytruda also submitted a listing application (JXSS1800002) and was accepted by CDE.
And in addition to Bristol-Myers Squibb and Merck, domestic PD-1 / PD-L1 antibody drugs in the research of more than 10 companies.
进度 Domestic PD-1/PD-L1 biopharmaceutical progress and pattern analysis
There are more than 10 domestic PD-1/PD-L1 antibody drugs in research, among which the fast-growing enterprises include Hengrui Medicine , Cinda Bio, Baekje Shenzhou and Junshi Biological.
In April 2018, CDE issued the “Publicity of the Application for Registration of Drugs to be included in the Priority Review Procedure (Twenty-eighth Batch)â€, Carrefour (Hen Rui), Treipril Monoclonal (Jun Shi), The three domestic anti-PD-1 antibody drugs of Cindy monoclonal antibody (Cinda) were included in the priority review list.
At present, Cinda's Cinda monoclonal antibody (IBI308) has been reported for listing production. From the perspective of clinical trials, Hengrui's SHR-1210, Cinda's IBI308 and Baekje Shenzhou's BGB-A317 have indications to enter clinical phase III, and Junshi's JS001 has also entered clinical phase II. PD-1 antibody drugs that have entered the late clinical stage in China are expected to be approved for marketing in 2018/2019.
Hengrui Medicine: Benefited from having two indications to enter clinical phase III, and four indications entering clinical phase II. If these six indications are approved, sales are expected to reach 5.2 billion yuan in 2025. PD-1 is the leader in domestic sales.
Cinda Bio: There is one indication that enters clinical phase III, and two indications enter clinical phase II. We predict that its sales will reach 2.6 billion yuan in 2025.
Baekje Shenzhou and Junshi Bio: The progress is close, and the sales in 2025 are all 1.7 billion yuan.
According to Southwest Medical, by 2025, the total sales of PD-1 antibody drugs can reach 13 billion yuan.
Another aspect of the market outlook for the monoclonal antibody market is its high cost of treatment. According to the announcement of the Food and Drug Administration, Navulitis Monoclonal Injection can extend the median overall survival of patients with advanced non-small cell lung cancer for about 3 months.
According to the FDA approved the revised Opdivo dosing regimen in September 2016, patients with non-small cell lung cancer were dosed "240 mg/time, once every 2 weeks" until disease progression or intolerable toxicity.
The Opdivo 240mg specification is priced at approximately $6,500 in the United States and approximately $169,000 (approximately $1.08 million) for a one-year treatment.
Attachment: Announcement of the Food and Drug Administration
Recently, the State Drug Administration approved the import registration application for Nivolumab Injection (English name: Nivolumab Injection) for the treatment of negative for epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK) negative. Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone disease progression after platinum-containing chemotherapy or are intolerable.
At present, research hotspots in the field of tumor immunotherapy mainly focus on inhibitors such as anti-programmed death-1 (PD-1) receptors, which are different from traditional chemotherapy and targeted therapy, mainly by overcoming the body of patients. Immunosuppression, reactivation of the patient's own immune cells to kill the tumor, is a new anti-tumor treatment concept. The approved Navulitis Monoclonal Antibody Injection is a fully human-derived monoclonal antibody against the PD-1 receptor developed by Bristol-Myers Squibb. It can block PD-1 by blocking T lymphocytes. Binding to the surface of tumor cells PD-L1, the immune suppression of immune cells by tumor cells is relieved, and the immune cells re-exist anti-tumor cell immunity to kill tumor cells.
Bristol-Myers Squibb first developed and completed a clinical trial of the drug in patients with advanced non-small cell lung cancer who developed disease after treatment with platinum-containing double-drug chemotherapy, and submitted an application for registration of imported drugs accordingly. The State Drug Administration will speed up the completion of the technical review of this product and the on-site verification of clinical trial data in accordance with the priority review procedure. The import registration of this product will be approved on June 15, 2018.
Lung cancer is a globally high malignant tumor with the highest mortality rate. In recent years, some targeted therapeutic drugs have achieved good results in the field of lung cancer treatment, but for advanced non-small cell lung cancer with no driver gene mutation, chemotherapy is still the main, and the overall survival of patients is usually shorter. The clinical trial data of this product show that compared with the existing second-line standard treatment, this product can extend the median overall survival of patients with advanced non-small cell lung cancer for about 3 months.