生物类似药是和参照药具有相似性的生物用品，在此基础上可以获得“适应症外推”。中国2015 年发布相关指导原则，2020 年起多个生物类似药临床试验指导原则颁布。美国方面FDA 和政府正尝试努力推动生物类似药发展，帮助医疗保健系统减负，生物类似药相关项目自2019 年后保持增长趋势。Investment summary
The company is based in Guangzhou and is committed to the development of innovative drugs and biosimilar drugs. The company was founded in 2003 and listed on the Science and Technology Innovation Board in 2020. It is a global biopharmaceutical enterprise based in Guangzhou based on science and innovation. It is committed to developing a new generation of innovative drugs and biosimilar drugs to meet urgent clinical needs.
The biosimilar market has great potential, and China and the US are in the process of promoting biosimilar regulations and development.
Biosimilars are biological products similar to reference drugs, and “indication extrapolation” can be obtained on this basis. China issued relevant guidelines in 2015, and several biosimilar clinical trial guidelines have been promulgated since 2020. The US FDA and government are trying to promote the development of biosimilar drugs and help reduce the burden on the healthcare system. Biosimilar related projects have maintained a growing trend since 2019.
The company has a rich pipeline. 3 products have been marketed domestically, 1 product has been declared for listing, and several products are in phase III clinical stage. The company's domestically marketed products include 3 biosimilar drugs, Prerecil, and Schrelli. An innovative antithrombotic drug, batifiban, is under application for marketing. At the same time, the company's golimumab and usinumab analogues are in phase III of the world. The product pipeline is rich and progressing smoothly.
Tocilizumab has been officially approved by the FDA for marketing, and bioanalogs are expected to open up a wide range of overseas markets.
The company announced on October 9, 2023 that the company's tocilizumab was approved for marketing by the US FDA in September 2023. It is the first monoclonal antibody drug independently developed and produced by a local Chinese pharmaceutical company and approved for marketing by the US FDA. Overseas rights have previously authorized Biogen, which is expected to open up the international market and contribute overseas revenue.
Laying out a new ADC R&D platform, the product has the best potential in its class. The company currently has a novel ADC technology platform, using shear ligands and topoisomerase I. At the same time, judging from the disclosed phase I data of the FRαADC drug BAT8006, the product initially showed excellent therapeutic effects.
Investment advice
Tocilizumab was successfully approved for marketing by the FDA, making it the first domestically produced monoclonal antibody to receive FDA approval for marketing. The approval also had a landmark effect. The company is about to open up a broad global market for biosimilar drugs. At the same time, the company has a rich pipeline, and several products are undergoing global phase III clinical trials, and there is a certain guarantee of long-term continuous performance growth. The company's new ADC platform has highlights, excellent early clinical trial data, and is worthy of long-term attention. We expect revenue of 2023-2025 to be 745/12.40/2,442 billion yuan, with growth rates of 63.7%, 66.4%, 96.9%, and net profit to mother of -4.58/-3.24/-0.98 billion yuan, corresponding earnings per share of -1.11/-0.78/-0.24 yuan. For the first time covered, we gave a purchase rating.
Risk warning
International relationship risks, future procurement policy risks, risk of product sales falling short of expectations after launch, risk of product development failure and failure to meet expectations, and risk of exchange rate fluctuations.
