Events:
The company issued a performance announcement for 2021, with an operating income of 1.6825 billion yuan, a year-on-year increase of + 186.3%, and a total loss of 984.1 million yuan, a decrease of 9.4 million yuan over the previous year.
Comments:
Four McAb similar drugs are available and commercialized to Biopharma: by the end of 2021, Fuhong Hanlin has four McAb similar drug products on the market in China and one in Europe, with a total of 12 indications approved, benefiting more than 170000 patients worldwide. In terms of products:
Triton Monoclonal Antibody (Hanquyou / Zercepac): domestic sales revenue 868 million yuan, year-on-year + 692.7%; overseas sales revenue 62.2 million yuan, licensing and R & D service income 30.2 million yuan (Accord 11 million yuan + Intas 19.2 million yuan). In 2021, the new domestic 60mg specification was approved to be listed, so that it can be flexibly combined with the 150mg specification. In terms of internationalization, it has been successfully listed in nearly 20 European countries and regions, including the United Kingdom, Germany, France, Switzerland and Spain, and the new 60mg and 420mg specifications have also been approved in the European Union. The biological product license application (BLA) for the product in the United States is expected to be submitted in 2022. Rituximab (Hanlikang): 542.5 million yuan in sales revenue and 10.4 million yuan in licensing revenue based on the profit-sharing arrangement agreed with partner Jiangsu Fosun. At present, Hanlikang has been approved for the treatment of non-Hodgkin's lymphoma, chronic lymphoblastic leukemia and rheumatoid arthritis that has not been approved in China. It is the most approved rituximab in China.
Adamu Monoclonal Antibody (Handayuan): based on the profit-sharing arrangement agreed with partner Jiangsu Wanbang to obtain sales revenue of 21.8 million yuan and licensing income of 1 million yuan
Bevacizumab (Hanbeitai): approved by the State Drug Administration in December 2021 for the treatment of metastatic colorectal cancer and advanced, metastatic or recurrent non-small cell lung cancer. Fuhong Hanlin is responsible for the sales and promotion of the product in China, and will actively promote its medical insurance access, bidding and hospital access in 2022.
We are about to enter the stage of innovation-driven growth and promote the global R & D layout: the company has invested 1.7637 billion yuan in R & D in 2021, 12 clinical trials have made important progress, and 6 products and 1 combination therapy have been approved worldwide. More than 20 clinical trials have been carried out simultaneously in China, the European Union, the United States, Australia, the Philippines and Turkey. The R & D progress of some key projects are as follows:
Srullizumab: the first application for registration of highly microsatellite unstable (MSI-H) solid tumors (NDA) is expected to be approved in the first half of 2022; NDA for locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) was also contracted by CDE in 2021.09. The company plans to complete the formation of a sales team of about 200 people in 2022Q3. ASTRUM-005, a phase III study of Seruriumab combined with chemotherapy for SCLC, reached its primary end point overall survival time (OS) in 2021.12. The company plans to submit an application for registration of this indication in China and the European Union in 2022, which is expected to become the first anti-PD-1 monoclonal antibody for first-line treatment of SCLC in the world.
Double antibodies: potential first-in-class double antibodies HLX301 (innovative PD-L1 × TIGIT double antibodies) and HLX35 (innovative 4-1BB × EGFR antibodies) completed the first subject administration in a phase I clinical trial in Australia
Ophthalmic preparation product HLX04-O: optimize the prescription, specification and production process on the basis of Hanbeitai, and have been approved to conduct clinical trials in China, Australia, the United States, the European Union and Singapore.
Innovative HER2 monoclonal antibody HLX22: phase II clinical study combined with Hanquyou in the treatment of HER2 positive gastric cancer patients will also complete the first recipient administration in 2021.
Introduction of innovative product HLX208 (BRAF V600E inhibitor): the first recipient administration has been completed in patients with BRAF V600E mutant adult Langerhans histiocytosis (LCH) and Erdheim-Chester disease (ECD).
Speed up capacity expansion and remove the bottleneck of commercialization: the company has always attached great importance to the construction of an integrated production platform to provide a solid guarantee for the commercialization of products. The company has a total commercial production capacity of 24000 liters, which is expected to reach 48000 litres in 2022 and 144000 litres in 2025. The specific project progress is as follows:
Xuhui Base: the total commercial production capacity will be increased from 20000 liters to 24000 liters in 2021, and the localization research and change of key materials, consumables and equipment will be promoted.
Songjiang base (1): construction capacity of 24000 liters, has been approved for Hanqu excellent production, is expected to be officially put into commercial production in 2022, and plans to complete the GMP verification of the US Food and Drug Administration (FDA) in the first half of 2023.
Songjiang base (2): the total production capacity of the first phase of the project is planned to 96000 liters, which is expected to meet the global commercial production needs of the products. Among them, the first and second phase of the project has a planned production capacity of 36000 liters, which is expected to enter the stage of trial production and process verification in the second half of 2022. The design capacity of the third stage of the first phase of the project is 60000 liters, and it is planned to enter the construction phase of the project in 2022.
Continuous production: in 2021, the company has successfully established China's first continuous clinical production workshop to achieve end-to-end continuous production. The production capacity of single batch is much higher than that of traditional batch production, and the quality is stable and controllable.
Profit forecast, valuation and rating: the company is a star enterprise of antibody drugs in China. With the volume of product sales, it will gradually improve its commercialization ability and become an innovative drug platform with strong comprehensive strength. Considering that the collection of similar biological drugs may cause certain price pressure, the revenue forecast for 2022-2023 is 2.825 trillion yuan (the original forecast is 2.866 trillion yuan, down 1% 2% respectively), and the new forecast income for 2024 is 4.969 billion yuan, an increase of 67.9%, 40.7%, 25.0%, and maintain the "buy" rating.
Risk tips: the risk that the progress of R & D is not as expected; the risk that sales are not as expected; the risk that globalization is not up to expectations.