Shanghai Junshi Biosciences Co.Ltd(688180) (688180)
Event: November 29, 2021, The company announced that a new indication of treprizumab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma was listed, and the application was approved by the State Drug Administration (nmpa) After (third line treatment) and urothelial carcinoma, treprizumab is the fourth indication approved in China and the first first first-line treatment indication.
Teraprizumab can be used from the back line to the front line in the field of nasopharyngeal carcinoma treatment. As a characteristic cancer species in South China and Southeast Asia, there is still a bottleneck in the clinical treatment of nasopharyngeal carcinoma. For unmet clinical needs, The company developed treprizumab and traditional GP chemotherapy (gemcitabine + cisplatin) combination therapy, writing a new revolution in the treatment of advanced nasopharyngeal carcinoma. In February 2021, treprizumab was approved by nmpa for the treatment of patients with recurrent / metastatic nasopharyngeal carcinoma who had failed to receive second-line or above systematic treatment, and became the first immune checkpoint inhibitor approved for nasopharyngeal carcinoma in the world. The indications for first-line treatment of nasopharyngeal carcinoma were approved this time Prilimumab has realized the penetration application from rear line to front line in the treatment of this indication.
Innovative achievements continue to shine, and international development is just around the corner. Compared with the standard GP regimen, the phase III clinical trial jupiter-02 of treprizumab combined with gemcitabine / cisplatin and placebo combined with gemcitabine / cisplatin for the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma has achieved significant improvements in PFS, OS, Orr and dor. Treprizumab combined with GP regimen is expected to rewrite the first-line treatment standard of recurrent / metastatic nasopharyngeal carcinoma. Jupiter-02 research has won the honor of being recommended by LBA of ASCO conference and the cover of natural medicine for the first time; Treprizumab became the first domestic PD-1 monoclonal antibody to submit a listing application to FDA. FDA did not need to hold an expert meeting to give priority to the evaluation of BLA for first-line, second-line and above treatment indications of nasopharyngeal carcinoma. The date of PDUFA was April 2022.
With extensive coverage and prospective layout, the indications of treprizumab are ushering in the blowout period. At present, treprizumab continues to make efforts in expanding the coverage of indications, actively expanding the scope of applicable population and opening up a broad market space. The forward oriented indication layout truly realizes the “whole line” Application of treprizumab in tumor treatment, which is conducive to the exertion of the advantages of immunotherapy and is in line with the global development trend of tumor immunity. Including lung cancer, liver cancer, esophageal cancer, breast cancer and other first-line, ancillary new adjuvant therapy will be listed in 2021~2024, and the reapril mAb is entering the indications of harvest blowout period.
Profit forecast and investment rating. It is estimated that the company’s revenue from 2021 to 2023 will reach 4.147 billion yuan, 3.382 billion yuan and 4.197 billion yuan respectively, with a year-on-year increase of 160%, – 18.4% and 24.1% respectively; The net profit attributable to the parent company is -72 million yuan, – 173 million yuan and 124 million yuan respectively, and the corresponding EPS is -0.08, -0.19 and 0.14 yuan respectively, maintaining the “buy” rating.
Risk tip: risk of R & D failure; Risk of product price reduction.
