Hengrui Pharmaceutical (600276) Opinions on Major Issues: PD-1 Approved for Listing and Sales Expected to Exceed 10 Billion
Core point of view Carelizumab was approved for production, and the indication for approval was r / r cHL. Considering the number and speed of clinical trials in large indications, the advantages of combined use of monoclonal antibodies are obvious, and the company is commercialWith strong capabilities, we expect that Carelizumab’s sales lead will exceed 10 billion.
Carelizumab targeted r / r cHL indications have been approved for production with excellent benefits.
The company announced that its karelizumab for injection has been approved by the NMPA for the “Drug Registration Certificate” and “New Drug Certificate”, and has been approved for “recurrence or refractory classic Hodgkin after at least second-line system chemotherapy””Lymphoma”, Karelizumab has an ORR and CR of 84 for this indication.
3%, excellent benefits.
The domestic PD-1 market is expected to exceed 40 billion.
Since listing in the United States in 2014, PD-1 monoclonal antibodies have been rapidly growing, and global revenue has exceeded 14 billion yuan in 2018. Currently, clinical guidelines are still being subverted, and the 佛山桑拿网 global market will continue to maintain rapid growth.
At present, two domestic imports, Opdivo and Keytruda, and Traplezumab, and Xindililimumab, two domestic PD-1s, have been approved for listing. It is expected that the new indications will be approved and they will gradually replace the national medical insurance.The market size is expected to exceed 40 billion.
Carelizumab is expected to break the corner and overtake, and sales are expected to exceed 10 billion.
Although Carizolizumab is the third domestically approved PD-1, we believe that it is expected to overtake the curve and occupy the largest domestic market share: Carizolizumab leads the number and speed of clinical trials in large indications, Conducted 6, 5, 7, 3 clinical trials in the fields of liver cancer, esophageal cancer, liver cancer, and nasopharyngeal cancer respectively. Currently the second indication is to declare production (expected to be second-line liver cancer), second-line non-small cell lung cancer, esophagusThe second-line cancers are expected to report production within the year; Karelizumab has obvious advantages in combination with the drug. The company has independent small-molecule anti-cancer drugs Apatinib, famitinib and the large-molecule drug bevacizumab, etc., and SHR1210 andThe combination of Apatinib has shown excellent curative effects in the areas of triple negative breast cancer, non-small cell lung cancer, and direct conversion of hemangioma complications. The company has a strong commercialization capability, and the company has a tumor sales team of more than 4,000 people, with a significant numberAbove that, it is expected that they will be responsible for the sales of Carelizumab; in summary, we believe that Carelizumab is expected to occupy more than 25% of the country’s market and sales will exceed 10 billion.
Risk factors: failure of new drug research and development; research and development progress exceeds expectations; drug price risk.
Investment suggestion: The company’s product line under development is comprehensive. The company’s PD-1 has been successfully approved for listing. The space is huge. Pirlotinib, 19K, albumin paclitaxel and other products are gradually increasing in volume. The performance continues to grow. The EPS forecast for 2020/2021 is 1.
86 yuan, maintain “Buy” rating.