Hengrui Medicine (600276): PD-1 Esophageal Squamous Cell Carcinoma Stage III Outstanding Clinical Outcome Abbitron’s first imitation of the market and continuous promotion of imitation
Investment Highlights Event: On July 9, 2019, the company issued an announcement that Carelizumab is a single-agent second-line treatment of advanced esophageal squamous cell carcinoma in a randomized, open, chemotherapeutic, controlled, multicenter phase III clinical study (hereinafter referred to as the “ESCORT Study””) Reached the primary study endpoint.
The results of the ESCORT study show that for patients with locally advanced or metastatic esophageal squamous cell carcinoma who have failed previous first-line chemotherapy, receiving carelizumab monotherapy versus chemotherapy chosen by the investigator can prolong the overall survival of the patient.
At the same time, the company’s blockbuster abiraterone acetate was recently approved for listing, becoming the first domestic generic drug of this type to be listed.
Carelizumab has reached the main clinical endpoint in the second-line treatment of advanced esophageal squamous cell carcinoma, and its indications have been promoted to enhance product competitiveness.
The ESCORT study is a randomized, open-label, chemotherapeutic drug-controlled, multicenter, phase III clinical study that began enrolling patients in May 2017. Until May 2019, a total of 448 patients were randomized and received study drugs, of which 228 Patients received carelizumab and 220 patients received investigator-selected chemotherapy.
Recently, this study has reached its intended primary study endpoint, namely overall survival.
Studies have shown that for patients with locally advanced or metastatic esophageal squamous cell carcinoma who have failed previous first-line chemotherapy, receiving carrelizumab alone versus chemotherapy chosen by the investigator can prolong the overall survival of the patient.
The population of esophageal squamous cell carcinoma in China is wide.
GLOBOCAN 2018 research shows that there were 57 worldwide in 2018.
20,000 people were newly diagnosed with esophageal cancer and 50 were at the same time.
90,000 people died of esophageal cancer, ranking seventh and sixth among all tumors. Most of them are common in East Asia. Relatively speaking, Europe and the United States are relatively large, while China is a large country with esophageal cancer.
According to the 2018 China Cancer Report, the number of new cases of esophageal cancer is 25.
80,000, the incidence rate ranked sixth, of which 18 were men.
50,000, women 7.
20,000 patients died of esophageal cancer.
30,000 people, ranking fourth, squamous cell carcinoma is more common in Asian and African countries. In developing countries, about 90% of esophageal cancer is squamous cell carcinoma.
Carizolizumab has accelerated clinical progress in PD-1 in esophageal squamous cell carcinoma.
Junshi Trepril started clinical phase 3 on January 31, 2019. The study of Cinda Xindilizumab combined with TP regimen for first-line esophageal squamous cell carcinoma was first announced on November 21, 2018, and BeiGene BGB-Clinical Phase 3 of A317 and chemotherapy as first-line treatment for patients with esophageal cancer include international multicenter trials: a total of 480 people, 240 people in China. It is estimated that Hengrui will accelerate its progress in domestic PD-1 manufacturers.
Carelizumab is well-positioned and leading in major tumor types.
The company’s four major tumor tumors have taken up a lot of energy, and the progress is gratifying. The esophageal squamous cell carcinoma is expected to be declared for listing in the second half of this year. For the liver cancer, the company submitted a new drug application for second-line treatment of hepatocellular carcinoma.Teni’s treatment plan has entered Phase 3 clinically, and in terms of non-small cells, the company’s multiple combined drug regimens are in Phase 3 clinical.
The heavy-duty drug abiraterone acetate has been approved for marketing, and the 杭州养生会所 product competition is good and the market space is large.
On July 5, the results of the drug registration progress inquiry showed that Hengrui Pharmaceutical’s application for the listing of abilitrone acetate has become the first domestic imitation.
The original research manufacturer of Abitron (Zeke) is Johnson & Johnson, which was initially listed in the United States in April 2011. Its indication is prostate cancer. In 2018, it totaled 3.5 billion U.S. dollars.
Zeke was approved for listing in China in 2015.
Prostate cancer in China is the most common genitourinary cancer in men, with an incidence rate of about 9.
8 / 100,000 people, combined with the domestic population base, the market space is large.
The original research quickly nurtured the market, and the company first imitated to promote rapid volume.
In 2017, Abitron entered medical insurance through negotiations, the drug price dropped by 53%, and the shift in medical insurance accelerated the increase in variety. In 2018, Abitron’s PDB was placed at 3.
250 thousand yuan, an increase of 594% in ten years, sales volume was 8.
For domestic manufacturers, in addition to Hengrui being approved for listing, Chengdu Xinyue (2017.
11), Qilu Pharmaceutical (2018.
6), Zhengda Tianqing (2018.
3), Jiangxi Shanxiang (2018.
2) and India’s Reddy (2018.
10) All are declared for listing (the time of declaration is in brackets).
The company is expected to quickly seize the original drug market through the first imitation advantage.
Profit forecast and investment recommendations are based on the company’s stable operating style, certain product lines, and rich R & D pipeline reserves. We estimate the company’s operating income for 2019-2021 to be 225.
3.6 billion, net profit attributable to mother is 52.
08 million yuan, 67.
4.9 billion, 86.
740,000 yuan, an increase of 28 in ten years.
5%, corresponding to the PE of 56X / 44X / 34X, PD-1, pirlotinib, paclitaxel albumin and other heavy products on the market bring sales growth, rich research and development channels for the company’s future development to provide continuous driving force.
As a leader in the industry, the company benefits from the positive effects of the innovative drugs brought by the policy and the increase in industry concentration. Therefore, we maintain the “Buy” rating.
Risks suggest that the company’s drug bidding is lower than expected; the progress of the drug review and approval process is gradually expected; the progress of the R & D pipeline is gradually expected; the preparation export is lower than expected