\u3000\u3000 Betta Pharmaceuticals Co.Ltd(300558) (300558)
Events
On January 14, 2022, the company announced that the company's voronib combined with everolimus was intended to be used to treat patients with advanced renal cell carcinoma (RCC) who had failed to receive anti vascular tyrosine kinase inhibitor treatment in the past, and the NDA was accepted by nmpa.
Comments
Voronib tablet is the original drug of the fourth paragraph accepted by the company's listing application, or fills the gap of domestic innovative drugs for renal cancer. (1) Voronib is a new generation of multi-target kinase inhibitors with new chemical structure, such as VEGFR and PDGFR. The accepted indications are the second-line treatment of advanced renal cell carcinoma. In addition, the indications under research also include chronic age-related macular disease, non-small cell lung cancer and advanced solid tumor. (2) The phase II / III clinical results of voronibu combined with everolimus in the treatment of renal cell carcinoma showed that the PFS of the combined group vs everolimus single drug group was 10 months vs 6.5 months 4 months, Orr was 24.8% vs 8.5% 3%, DCR was 84.2% vs 74.3% The curative effect of the combined group was significantly better than that of the single drug group. (3) At present, five kinase inhibitors targeting VEGFR and PDGFR and used to treat RCC are listed in the world, including sorafenib, sunitinib, pezopanib, axitinib and renvatinib; There is no domestic innovative drug for renal cancer approved in China, and voronib is expected to become the first domestic class 1 new drug for the treatment of renal cancer. (4) Renal cell carcinoma is the most common tumor in China. According to the official account of Betta Pharmaceuticals Co.Ltd(300558) , Globocan2020 estimated that the incidence of renal cell cancer in the world is 431 thousand and 179 thousand. China has 73000 new cases and 43000 deaths every year. (5) Betta Pharmaceuticals Co.Ltd(300558) the global interests of voronib are respectively owned by its wholly-owned subsidiary kanangi medical technology (all indications, China), its holding subsidiary equinox (Ophthalmology, overseas) and its holding subsidiary xcoveryholdings, Inc (cancer, overseas).
The comprehensive layout of single drug and combination therapy in the field of cancer, self-research and strategic cooperation. In the first three quarters of 2021, the company invested 600 million yuan in R & D and submitted 7 clinical applications including popular targets such as EGFR / CMET and krasg12c; Ektinib sold 1.574 billion yuan, the first domestic ALK inhibitor ensatinib sold 120 million yuan, and the indications for first-line treatment of NSCLC have been accepted; After the new bevacizumab was approved in November, 6 new indications were accepted.
Investment advice and valuation
We maintain the profit forecast: it is estimated that the company's revenue in 2021 / 22 / 23 will be RMB 24.48/31.42/4.151 billion, and the net profit attributable to the parent company will be RMB 460/6.12/796 million; The current share price, corresponding to PE in 2021 / 22 / 23, is 69 / 52 / 40 times, maintaining the "buy" rating.
Risk tips
Increased competition, lower than expected sales of new products after listing, excessive price reduction in medical insurance negotiation and other risks.
