Betta Pharmaceuticals Co.Ltd(300558) (300558)
event
On December 23, 2021, Betta Pharmaceuticals Co.Ltd(300558) announced that bevacizumab injection (trade name: Betaine) declared by the company ®） The supplementary application to be added for the treatment of patients with recurrent glioblastoma, hepatocellular carcinoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer and cervical cancer has been accepted by nmpa.
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One month after the new approval, six applications for new indications were accepted, and the indications of bevacizumab were fully covered. (1) Bevacizumab of the company is a biological analogue of Avastin, which was just approved for listing in November 2021; four applications and six new indications were accepted one month later. If all applications are approved, Betta Pharmaceuticals Co.Ltd(300558) bevacizumab will become the first domestic bevacizumab with the same multi indication layout as the original Avastin. (see Figure 1 for China's competition pattern) (2) With the expiration of bevacizumab single antigen drug research patent, since 2019, eight pharmaceutical enterprises in China have been approved to list their biological analogues, and one pharmaceutical enterprise's listing application has been accepted (see Figure 2 below for details). Betta Pharmaceuticals Co.Ltd(300558) , catching up from behind; although it was newly approved in 2021, the application for new indications will enable the company to achieve the same breadth of indication coverage as the original research.
The original innovative drugs continue to maintain a strong market position. (1) Ektinib strongly maintained the market position of the next generation egfrtki. Kemena sold 1.574 billion yuan in the first three quarters and nearly 500 million yuan in the third quarter. On June 4, 2021, Kemena's postoperative adjuvant indications were approved, and alternative chemotherapy has become a new adjuvant treatment option for patients with EGFR mutant NSCLC of stage ii-iiia lung cancer, which is expected to continue to grow steadily in the future. (2) Bemena, the first domestic ALK inhibitor, contributed to the increase in sales and is expected to become a first-line treatment drug. In the second quarter of 2021, bemena achieved sales of about 55 million yuan, with a revenue of 65.3 million yuan in the third quarter, an increase of nearly 19% month on month. In July 2021, the indications submitted by the company to bemena NSCLC for first-line treatment were accepted, and it is expected that it will make up for the sales of bemena not in medical insurance to a certain extent in the future Um.
The whole layout of combination therapy in the field of lung cancer, independent innovation + strategic cooperation to promote clinical progress. The company continues to make efforts in the field of lung cancer: in the first three quarters of 2021, the company's R & D investment reached 600 million yuan, accounting for 34.92% of its revenue; Seven clinical applications including popular targets such as EGFR / CMET and krasg12c and the combination of PD-1 and CTLA4 were submitted.
Investment advice and valuation
We maintain the profit forecast: it is expected that the company's revenue will be RMB 24.48/31.42/4.151 billion and the net profit will be RMB 456/602/783 million on 2021 / 22 / 23. Maintain the "buy" rating.
Risk statement
Increased competition, lower than expected sales of new products after listing, excessive price reduction in medical insurance negotiation and other risks.
