\u3000\u3 Guocheng Mining Co.Ltd(000688) 180 Shanghai Junshi Biosciences Co.Ltd(688180) )
Events
On May 17, 2022, the company announced that treprizumab (trade name: tuoyi) ®） A new indication for the combination of paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced / recurrent or distant metastatic esophageal squamous cell carcinoma was approved.
Commentary
The fifth indication was added to the indication of treprizumab, and patients with esophageal squamous cell carcinoma benefited significantly from the first-line treatment. (1) Treprizumab is the first PD-1 approved in China. It was approved as the first indication for melanoma in December 2018 and is still exclusive in China; Later, it was successively approved for nasopharyngeal carcinoma, urothelial carcinoma and esophageal squamous cell carcinoma. (2) Chinese patients with esophageal cancer account for more than half of the world. There are more than 300000 new cases of esophageal cancer in China every year, of which about 90% are esophageal squamous cell carcinoma. Platinum based first-line chemotherapy has limited clinical benefits, with a 5-year survival of less than 20%. There is an unmet need for the treatment of esophageal squamous cell carcinoma. (3) This approval is based on a phase III clinical study of treprizumab combined chemotherapy versus placebo combined chemotherapy, jupiter-06; The results showed that the overall survival (OS) of the treprizumab combined chemotherapy group was significantly improved, the median OS was 17 months vs 11 months, and the risk of disease progression or death was reduced by 42% (HR = 0.58); Orr was 69.3% vs 52.3% respectively 1%（pPD-1’s visit to the United States was postponed, and multiple catalysts for the follow-up of treprizumab were expected. (1) China’s expected catalyst: the indications for non-small cell lung cancer have been accepted in China and are expected to be approved within this year; It is expected that clinical data will be read out this year. (2) Innovation going to sea: the company received a reply letter from FDA on treprizumab nasopharyngeal carcinoma BLA in the United States, requesting a change in the quality control process that the company believes is easier to complete; The on-site verification to be completed is blocked by the travel restrictions related to the novel coronavirus pneumonia epidemic. The company expects to resubmit the BLA before the middle of this year.
R & D investment continues, and constant increase adds more help. The company plans to increase no more than 3.98 billion for innovative drug project research and development and science and technology headquarters and R & D base projects, so as to continuously improve its innovation strength. In terms of innovation pipeline, the company has the global original research target BTLA project, and the phase I clinical results will be published for the first time in asco2022; Vv116, a covid-19 small molecule oral drug, is undergoing phase 3 clinical trials compared with paxlovid, and is expected to become the first domestic covid-19 oral drug approved for emergency use in China.
Profit forecast and investment suggestions
We maintain the company’s profit forecast. It is estimated that the company’s sales revenue in 2022 / 23 / 24 will be 3.15/45.9/7.56 billion yuan, and the net profit will be -285123/866 million yuan. Maintain the “buy” rating.
Risk tips
Risks such as R & D process, sales volume failing to meet expectations after entering medical insurance and lifting the ban on restricted shares.
