Sinocelltech Group Limited(688520) recombinant eight factor dose, HPV propulsion, covid-19 vaccine in clinical application

\u3000\u3 Guocheng Mining Co.Ltd(000688) 520 Sinocelltech Group Limited(688520) )

Events

On April 27, 2022, Sinocelltech Group Limited(688520) released the 2021 annual report and the first quarterly report of 2022. In 2021, the company’s revenue, net profit attributable to the parent and net profit deducted from non attributable to the parent were 134 / – 866 / – 863 million yuan respectively; In the first quarter of 2022, the revenue, net profit attributable to the parent and net profit deducted from non attributable to the parent were 155 / – 143 / – 113 million yuan respectively. The performance was better than expected.

Comments

The sales volume of domestic exclusive restructuring eight factors increased rapidly. The first recombinant human coagulation factor VIII product for injection independently developed by the company, angain, was approved to be listed in China on July 24, 2021 and sold for 130 million yuan by the end of 2021. Anjiayin’s quality, stability, production capacity and cost are its three core advantages. The product is the third generation recombinant human coagulation factor 8 product without albumin in process and preparation. 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.

Covid-19 multivalent vaccine is in rapid clinical progress, and there are abundant follow-up pipelines. (1) The company’s covid-19 virus bivalent variant recombinant protein vaccine product sctv01c obtained clinical approval from Chinese and overseas regulatory authorities in November and December 2021, and a number of clinical phase I / II studies have been nearly completed. The clinical application of covid-19 virus 4-valent variant recombinant protein vaccine product sctv01e in many countries is also in progress. (2) Covid-19 neutralizing antibody scta01 completed the clinical phase I study and the clinical application of international multicenter clinical phase II / III during the reporting period and was in the process of enrollment. Subsequently, it obtained the clinical approval of covid-19 neutralizing antibody cocktail combination scta01 + scta01c in December 2021. (3) The company’s sct400 (CD20 antibody), sct630 (adalimumab) and sct510 (bevacizumab) have completed the on-site verification and acceptance of the registration application respectively.

The fixed increase of the 2.2 billion new drug R & D fund-raising and investment plan has been approved, and the recombinant protein and other products with high production barriers have been commercialized one after another, and the 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 be mainly composed of recombinant factor 8 and CD20 monoclonal antibody (on-site verification has been completed), and its Chinese sales CAGR in recent eight 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 2022 / 23 / 24 will be RMB 768 / 15.23 / 2.832 billion, and the net profit attributable to the parent company will be RMB -610 / – 67 / 500 million, maintaining the “buy” rating.

Risk

Risks such as the failure of R & D progress and commercialization process, the failure of fixed increase issuance and the lifting of the ban on restricted shares.

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