Original title: INNOVENT BIO (01801) liver cancer reached the main end line, showing the first-class clinical executive power source: CITIC Construction Investment
Event
According to the company's announcement, the first-line clinical phase III study (ORIENT-32) analysis of Dabeshu (Cindilizumab) combined with Daclitazumab (bevacizumab) in the first-line clinical phase of advanced liver cancer showed that the progression-free survival (PFS) and overall survival (OS) were significantly longer than those in the control group, reaching the predetermined end point of efficacy. It is also the first PD-1 combination therapy in the world to reach the main end point of clinical phase III.
Comment
The time to reach the finish line is slightly longer than expected, which once again reflects the company's first-class clinical execution.
The first line of liver cancer of the company reached the main clinical end point, and the time was slightly higher than expected. Liver cancer is the fourth largest cancer in China, which does not meet the clinical needs. According to ClinicalTrials data, the ORIENT-32 study of the company's first-line clinical trial of liver cancer started in February 2019 and required 566 people to be enrolled, and the destination was announced in September 2020. The test group was composed of Xindirizumab and Dayoutong (bevacizumab analogue), and the control group was sorafenib. The analysis reached the main clinical end point during the trial period, indicating that Xindirizumab combined with Dayoutong regimen was more effective than sorafinib. The trial took only 19 months to complete the group and reached the main clinical end point. after the efficient completion of the first-line clinical of lung cancer, the first-line test of liver cancer once again demonstrated the company's first-class clinical execution.
The first-line indications for liver cancer are expected to be NDA by the end of the year, consolidating the company's advantage in large indications
We expect that INNOVENT BIO's first-line indications for liver cancer will be submitted for listing at the end of the year, and the company's advantage in PD-1 indications will be further consolidated. At present, the first-line clinical guidelines for liver cancer are still based on small molecular targeted drugs, and the immunotherapy regimen is only Roche's atrizumab combined with bevacizumab. From the side-by-side data, the immune combined antivascular regimen has higher objective response rate (ORR) and greater survival advantage (PFS, OS), and is expected to become a new standard for first-line treatment of liver cancer. INNOVENT BIO's "PD-1+ Beevar" regimen is the first domestic immunization regimen to reach the clinical end point of first-line indications for liver cancer, and it is also the first PD-1 regimen in the world to reach the first-line clinical end point for liver cancer. INNOVENT BIO's PD-1 non-scale NSCLC first-line and squamous NSCLC first-line two major indications have been submitted for listing in April 2020 and August 2020 respectively, among the top three in China. Considering that the combination of Sindilizumab and Beevar is expected to be the first to report production, the advantage of PD-1 in large indications will be further consolidated.
Da Boshu and Da you enter the international market through cooperation and have great long-term sales potential.
The company's PD-1 Dabeshu and bevacizumab similar drugs Dayu have entered the international market through international cooperation and are expected to have good long-term sales potential. Among them, Da Boshu has reached a cooperation with Eli Lilly and Co Pharmaceutical, and Eli Lilly and Co has obtained an exclusive license outside China to promote Cindilizumab to North America, Europe and other regions. INNOVENT BIO will receive a cumulative payment of more than US $1 billion (including a down payment of US $200 million and a development and sales milestone payment of US $825 million). In addition, INNOVENT BIO will receive a double-digit percentage of net sales commission. We expect Xindirizumab to be commercialized in the United States in 2022-2023.
Dayu entered into a partnership with Coherus, a leading US bioanalogue drug company, and Coherus paid INNOVENT BIO a down payment of US $5 million and a milestone fee of US $45 million for the commercialization of IBI305. Based on IBI305's future sales, Coherus will also pay INNOVENT BIO's double-digit percentage of net sales income. Coherus plans to submit an application for a biological product license to FDA from the end of 2020 to the beginning of 2021, and sales are expected to begin in the second half of 2021 to the first half of 2022.
Profit forecast and valuation
It is estimated that from 2020 to 2022, the company's revenue will be 2.45 billion yuan, 3.57 billion yuan and 7.51 billion yuan respectively. Break even in 2023. Using DCF valuation, the reasonable market capitalization of the company is HK $101.3 billion, corresponding to the target price of HK $75.50. Consider the company's comprehensive advantages in clinical, R & D, commercialization, as well as the long-term strategic layout, give the buy rating.