Text/Forbes China
Before the 2021 medical insurance national talks, the competition of PD-1 has been filled with smoke. In the inner PD-1 track, more and more companies are looking overseas to bring Chinese treatment solutions to the world.
On November 1, Junshi Bio-U (688180.SH) announced that its application for licensing of PD-1 monoclonal antibody-terreprimumab plus gemcitabine/cisplatin as the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal cancer and the two-agent application for second-line and above treatment after platinum-containing treatment of recurrent or metastatic nasopharyngeal cancer has been officially accepted by the FDA.
According to the announcement, the FDA has granted a priority review of the BLA and said that it does not plan to convene an advisory committee meeting to review the BLA, and the proposed prescription drug user fee act (PDUFA) target review date is April 2022.
The individual stock report released by Guosheng Securities Research Institute today believes that this move is expected to fill the gap in the United States that no anti-PD-1 monoclonal antibody has been approved for the treatment of nasopharyngeal cancer, bringing treatment options from China to patients with NASOPHARY in the United States. It has also accumulated valuable experience for the subsequent declaration of more innovative products abroad, and has shown the world the extraordinary strength of research and development of Chinese innovative pharmaceutical enterprises.
Image source: Junshi Bio's official website
Triprprimab is the first domestic monoclonal antibody drug with PD-1 as the target approved for marketing in China, and has carried out more than 30 clinical studies covering more than 15 indications in China, the United States and other countries so far. On December 17, 2018, tripramineab was conditionally approved for marketing by the State Drug Administration ("NMPA") for the treatment of unresectable or metastatic melanoma that has previously failed systemic treatment.
In September 2020, triprizumab was recognized by the FDA as a breakthrough therapy for second-line and higher treatments after platinum-containing therapy for relapsed or metastatic nasopharyngeal carcinoma. Based on this determination, in March 2021, the company officially submitted to the FDA on a rolling basis the BLA for the treatment of recurrent or metastatic nasopharyngeal cancer and obtained a rolling review, and the company became the first domestic anti-PD-1 monoclonal antibody to submit a BLA to the FDA.
In August 2021, triprimizumab plus gemcitabine/cisplatin was recognized by the FDA as a first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma. In September 2021, the Company completed a rolling BLA submission for both of these indications. The formal acceptance and award of priority review was confirmed, shortening the 10-month standard review time to 6 months. For drugs that, upon approval, will significantly improve treatment for serious diseases, the priority review identified as intended to mobilize FDA resources for the evaluation of applications for such drugs. Furthermore, the FDA said it does not plan to hold an advisory board meeting to review the BLA. As of the date of the announcement, no tumor immunotherapy has been approved for the treatment of nasopharyngeal carcinoma in the United States.
The main players of PD1 monoclonal antibody, which account for a high proportion of the domestic market, include Xinda's Xindili monoclonal antibody, BeiGene's Tirelizumab, Hengrui Pharmaceutical's Carellizumab, Junshi's Tripolimab, which is listed earlier domestic PD1, Xindali maclizumab is one of the earliest to enter the medical insurance, after the launch of the "2+2,5+X" drug donation program, the annual treatment cost of Xindili was reduced to 39,800 yuan.
Due to the current vicious competition in the domestic PD-1 market, the price reduction is too fast, and the current price has reached a low level.
The domestic PD-1 market is fiercely competitive, and "going to sea" has become a new path for PD-1 drugs to expand the market.
In addition to Junshi Biotech, at the beginning of 2021, BeiGene and global pharmaceutical giant Novartis reached cooperation and licensing agreements on the development, production and commercialization of its self-developed anti-PD-1 antibody drug terelizumab in many countries, and the down payment of this transaction was US$650 million, which is the highest down payment amount of domestic drug licensing cooperation project to date. Innovent Biologics and Eli Lilly have reached a collaboration in March 2015 to jointly develop and commercialize oncology drugs in China, including the PD-1 monoclonal antibody drug Sindili maclizumab. In April 2020, Hengrui Pharmaceutical licensed Carriizumab to CrystalGenomics (CG) Company in South Korea, which will obtain the exclusive right to develop, register and market The exclusive clinical development, registration and marketing of Carrillizumab in Korea.