Heavy! Domestic application for the fourth indication of O drug
Release date: 2020-01-07 Views: 0
Recently, the 4th indication of the O medicine of BMS was declared for marketing. The O medicine was the first PD-1 monoclonal antibody to be marketed in China. At present, two indications have been approved, namely second-line treatment of non-small cell lung cancer (NSCLC). And squamous cell carcinoma of the head and neck.
Two indications approved, two indications declared for listing
Bristol-Myers Bristol-Myers Squibb (BMS) 's PD-1 monoclonal antibody, Nivolumab (brand name: Odivo / Opdivo, referred to as O drug), was the first PD-1 monoclonal antibody to be marketed in China in 2018. Approved by the NMPA in June, for the treatment of epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase (ALK) -negative disease, prior disease progression or intolerable local advanced stage after platinum-containing chemotherapy Adult patients with metastatic non-small cell lung cancer (NSCLC); approved for the second indication in September 2019 for the treatment of disease progression and tumor PD-L1 expression (defined as Patients with relapsed or metastatic head and neck squamous cell carcinoma (SCCHN) in tumor cells expressing PD-L1 (≥1% and ≥2%).
As of now, there are two indications for O drug approved in China. In addition, two indications have been declared for marketing, but the specific indications have not been disclosed. Since there are multiple indications for O drug in clinical phase III, these two There are multiple possibilities for this indication, including small cell cancer, gastric cancer, kidney cancer, esophageal cancer, liver cancer, etc.
There are many clinical trials of O-medicine in clinical stages Ⅱ and Ⅲ. The following table shows the main clinical trials of O-medicine currently in China.
(Source: Drug clinical trial registration and information disclosure platform)
6 PD-1, 1 PD-L1 listed domestically
As of now, there are a total of six PD-1s and one PD-L1 is listed domestically, of which four are domestically produced PD-1s. Among them, Pembrolizumab (Pembrolizumab, trade name: Keytruda, referred to as K drug) has been approved for the most indications, up to 4, and 3 belong to non-small cell lung cancer (NSCLC), which can be said to be preemptive This is the strategic height of domestic lung cancer. Of the domestic PD-1 monoclonal antibodies, except for the approved indication of teripril monoclonal antibody (trade name: Tuoyi) is second-line treatment of melanoma, the other three first indications are all third-line treatment of classic Hodgkin lymphoma . In addition, Tislelizumab's second indication-second-line treatment of urothelial cancer has been submitted for marketing applications. Carrelizumab has three indications for marketing applications, namely hepatocellular carcinoma and esophageal squamous cell carcinoma. As well as non-squamous NSCLC combined with chemotherapy, it is the most frequently reported indication among domestic PD-1.
Domestic listed and declared PD-1 / L1 monoclonal antibodies
(Source: CDE, statistics as of 2020.1.6)
Domestic sales of each PD-1 monoclonal antibody exceeded 100 million
In the first half of 2019, the sales of Treprilzumab was about 310 million yuan (more than 4 months of sales); the sales of Xindilizumab was 330 million yuan (mostly 4 months of sales); Karelizumab Sales in the third quarter of 2019 are expected to be approximately 500 million yuan (sales for more than 2 months).
(Source: the company's official website)
In addition, only Xindililimumab has entered the new national health insurance category B directory in 2019.
(From public information)
Frost & Sullivan predicts global sales will increase to $ 78.9 billion by 2030. Therefore, PD-1 monoclonal antibody sales will continue to increase in the future.
Global PD-1 / L1 monoclonal antibody market size will continue to increase
(Source: Frost & Sullivan)
- Basic introduction of Heilongjiang Hexiang Pharmaceutical Co., Ltd.
- How to contact Bermuda Medical (Shanghai) Regenerative Medicine Technology Co., Ltd.
- Shandong Dongfang Huiyi Health Industry Co., Ltd.
- Brief introduction of Zaozhuang Yinhai Pharmaceutical Co., Ltd.
- Contact information of Shandong Dongfang Huiyi Health Industry Co., Ltd.
- Introduction of Bermoudi (Shanghai) Regenerative Medicine Technology Co., Ltd.
- 开始了！ 1. It's started! 6 illegal actions at designated drug stores
- 有望中美申报上市！ 2. China and the United States are expected to apply for listing! Yifan Pharmaceutical's Class 1 new drug F-627 Phase III clinical success in China
- 『医药头条君』新药研发如何越来越好？ 3. How is the research and development of new drugs in "Medical Headlines" getting better and better? 2019 CDE chemical drug review report
- 2019年全球十大热门生物技术盘点 4. Inventory of the world's top ten hot biotech in 2019
- 重磅！ 5. Heavy! Domestic application for the fourth indication of O drug
- 2019 CDE年度药审报告：589个化药1类申请1045个ANDA 6. 2019 CDE annual drug review report: 589 chemical drugs, Class 1 applications, 1045 ANDA
- 达格列净上市申请获FDA优先审查 7. Dagle's net listing application receives FDA priority review