\u3000\u3000 Sinocelltech Group Limited(688520) (688520)
Events
On January 7, 2022, the company announced that the company’s product recombinant human coagulation factor VIII for injection (trade name: angain) ®， Product Code: sct800) the supplementary application for the proposed new indications for children has been accepted by the State Food and drug administration; After that, it still needs to go through multiple links such as review and approval, and the acquisition time and results of the supplementary application approval are uncertain.
Comments
The reorganization of eight factors was the first in China. Five months after listing, the new indications for children’s medication were accepted, and the commercialization process was accelerated again, which was confirmed by strength. (1) This supplementary application for bleeding control and prevention indications in adults and children with hemophilia A a (congenital coagulation factor VIII deficiency) is mainly based on a multicenter, open and non control, Phase III clinical trial to evaluate the efficacy, safety and pharmacokinetics of recombinant human coagulation factor VIII (sct800) in children with severe hemophilia A (< 12 years old) who have previously received coagulation factor VIII treatment. The results of this clinical trial are in line with expectations, with good hemostatic effect and no unexpected safety problems. It is similar to the efficacy and safety results reported in foreign clinical research literature of imported recombinant coagulation factor VIII. (2) According to the website of the State Food and drug administration, six imported recombinant coagulation factor VIII products have been listed in China, namely Bayer's baikeqi ® And Ke Yueqi ®、 Baite's bainzhi ®、 Ren Jie of Pfizer ®、 Novo Nordisk's noyi ®、 South Korea green cross green Angelica ®， The above five items have obtained the marketing license for children's indications. (3) Quality and its stability, production capacity and cost are the three core advantages of anjiayin. The product is the third generation recombinant human coagulation factor VIII product independently developed by the company, and the process and preparation do not contain albumin. The company has established high-efficiency and stable production engineering cell line, serum-free and protein-free suspension flow addition process, high-efficiency and high specificity downstream purification process with affinity purified antibody as the core step independently developed and produced, finished preparation formula without albumin additive and production line with 4000 liter cell culture scale.
The 2.2 billion new drug R & D fund-raising and investment plan was approved as the first fixed increase on the science and innovation board; Recombinant proteins and other products with high production barriers have been commercialized one after another, and a profit breakthrough is imminent. (1) The company’s fixed growth plan has been approved, and the Chinese and international clinical promotion of heavy products such as recombinant factor 8 and 14 price HPV will be accelerated. (2) We expect that the company’s revenue in the next three years will mainly consist of recombinant factor 8 and CD20 monoclonal antibody (on-site verification has been completed), and its Chinese sales CAGR in recent 8 years is as high as 30% and 16% respectively. It is expected that the company will achieve positive profits by the end of 2023 or 2024 (see our in-depth report for details).
Profit forecast and investment suggestions
We maintain the profit forecast. It is estimated that the company’s revenue in 2021 / 22 / 23 will be 86 / 684 / 1934 million yuan, and the net profit attributable to the parent company will be -934, – 723 and -76 million yuan, maintaining the “buy” rating.
Risk
The R & D progress and commercialization process do not meet expectations, the failure of fixed increase issuance and the lifting of the ban on restricted shares.
