Hengrui Pharmaceutical (600276) company announcement comments: blockbuster new drug carelizumab was approved for listing and expects rapid volume to drive accelerated growth
The event company announced that Karelizumab for injection has been approved for conditional registration and is suitable for the treatment of patients with classic Hodgkin’s lymphoma who are regenerating or refractory to at least second-line chemotherapy.
Evaluation of Carizolizumab for its excellent clinical efficacy.
Carrelizumab (SHR-1210) is the third domestic PD-1 monoclonal antibody approved. In April 2018, the listing application for Carreizumab injection (CXSS1800009) was redeemed by CDE.
An open-label, single-arm, multicenter Phase 2 study of carolizumab for relapsed or refractory cHL lymphoma in 2018 replaced 75 patients. The results showed that the ORR assessed by IRC reached 84.
8%, CR rate reached 30.
3%; ORR and CR rates evaluated by the researchers were 80 respectively.
3% and 36.
In terms of safety, carelizumab monotherapy in patients with relapsed / refractory cHL is safe and tolerable.
The mechanism of PD-1 / PD-L1 monoclonal antibody immunotherapy and its outstanding clinical manifestations have broad market space.
At present, the imported varieties Opdivo (BMS) and Keytruda (MSD) have been approved for marketing, the domestic varieties Junshi Biological’s tepirilimumab, Cinda’s Xindililimumab have been approved for marketing, and BeiGene’s tirideLizhu has declared production.
In addition, Carrierizumab has received a copy of the CDE for its second indication to market.
Competition for the expansion of indications is more intense.
CDE data show that Hengrui Medicine’s SHR-1210 has performed 34 clinical trials, including more than 10 indications including hepatocellular carcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, melanoma, non-small cell lung cancer, and lymphoma.
In addition, the combination of carelizumab and apatinib for advanced liver cancer has been approved by the FDA.
We believe that the PD-1 field is crowded and the development of differentiated indications will be an important factor in determining the market space.
The first PD-1 monoclonal antibody Tuoyi (Junshi Biological) sold about 79 million yuan in Q1 2019. Although Karelizumab is the fifth domestically listed PD-1 monoclonal antibody, we believe that Hengrui Medicine can have many yearsThe sales ability in the oncology field grabs the main market share.
Earnings forecast: We believe that the launch of blockbuster innovative drugs may drive Hengrui’s performance to a turning point.
We expect the company’s EPS for 2019-2021 to be 1.
Based on the continuous strengthening of the trend of the innovative pharmaceutical industry, the company, as a leader in the innovative pharmaceutical industry, is at an industry-leading level in terms of product pipeline variety and quantity and R & D focus. With reference to comparable company valuations, we believe that it is reasonable to give 50-55 times PE in 19Corresponds to a reasonable value range of 60.
Combined with the 2019 DCF estimate of a reasonable market value of 2928.
60 ppm, corresponding to a target price of 66.
21 yuan, we give 60-month reasonable value range of 60.
21 yuan, corresponding to 50-55 times PE in 19 佛山桑拿网 years, given a “continuous market” rating.
Product sales did not meet expectations; research and development progress did not meet expectations, and generic drugs prices dropped significantly.