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益方生物(688382):高效原创 全球化布局的BIOTECH新秀

Yi Fang Bio (688382): a BIOTECH rookie with efficient and original global layout

中信證券 ·  Jul 5, 2022 00:00  · Researches

The company focuses on the R & D, production and commercialization of innovative targeted drugs in major diseases such as oncology and metabolic diseases. With excellent independent research and development strength, the company has built a rich portfolio of targeted drug pipelines, including 3 core products in the clinical stage, 1 licensed product and 5 preclinical drug candidates. Core products have been approved to carry out phase II or III clinical trials, and have global intellectual property rights, and the progress of research and development is among the highest in the world or in China. The authorized BPI-D0316 (befotinib mesylate) NDA has been accepted by NMPA, and the research and development progress of the self-developed KRAS G12C inhibitor Dmur1553 ranks first in China. Based on the absolute and relative valuation methods, it is estimated that the long-term fair value range of the company from 6 to 12 months after listing is 15.176 billion ~ 17.562 billion yuan.

Yifang Biology is an innovative biomedical company with global vision and excellent ability of self-research. The company focuses on the R & D, production and commercialization of innovative targeted drugs in major diseases such as oncology and metabolic diseases.

The company continues to pay attention to the drug targets with a large patient base and unmet treatment needs. Three core products in the clinical stage have been approved to conduct phase II or III clinical trials, all of which are independent research and development and have global intellectual property rights, and the progress of research and development is among the highest in the world or in China. The company's core R & D team has an average of more than 20 years of rich experience in leading new drug research and development and team management by multinational pharmaceutical companies, with a reasonable technical knowledge structure and expertise covering all aspects of new drug research and development. to ensure that the company's new drug research and development process continues to move forward efficiently.

Industry analysis: tumor and metabolic drugs continue to develop, and the market scale of targeted drugs is growing rapidly. ① oncology drug market: the oncology drug market is booming. According to Frost Sullivan (quoted from the company's prospectus), it is estimated that by 2030, the global and domestic antineoplastic drug market will reach 482.5 billion US dollars and 683.1 billion yuan respectively, accounting for about 23% of the overall drug market. ② hyperuricemia and gout market: due to changes in people's diet and lifestyle, the number of patients with metabolic diseases such as hyperuricemia and gout is on the rise. in the future, with the introduction of new drugs, the market size will also accelerate. It is expected that the global and domestic gout drug market will reach US $7.7 billion and 10.8 billion yuan respectively in 2030, with a compound growth rate of 14.6% and 29.2% from 2025 to 2030. ③ targeted drug market: affected by the aging population, the improvement of the global economic level, the support of national industrial policies, pharmaceutical enterprises to increase investment in innovative drug research and development and other factors, patients' demand for targeted drugs continues to increase. With the rapid development of the diagnostic industry, the application of targeted drugs will be further promoted. It is expected that the targeted drug market will continue to grow rapidly.

Company analysis: gather major disease areas, leading clinical progress of core products. The company focuses on tumor, metabolic diseases and other major diseases that do not meet the clinical needs, has three independent research and development and global rights and interests of the core products, strong product properties, research and development progress of the global or domestic leader: ① Dmuri 0120 is a new type of URAT1 inhibitor with good safety and uric acid-lowering effect, the preliminary analysis results of IIa phase show good safety and uric acid-lowering effect, and the domestic progress is in the forefront. 2023 is expected to enter the clinical phase III trial. ② Dmur0502 is an oral SERD targeting drug for ER positive and HER2 negative patients. It has been approved to conduct a head-to-head registered III phase clinical trial with standard treatment in ER positive HER2 negative breast cancer patients. ③ Dmur1553 is the first domestic KRAS G12C inhibitor to enter the clinical trial stage, which has been included in the list of breakthrough treatments by CDE. The key single-arm II phase clinical trial has been approved by CDE, and the international multicenter clinical trial has entered the II phase clinical trial. In addition, BPI-D0316 (befotinib mesylate) is the third generation EGFR inhibitor independently developed by the company and authorized by the company. At present, this product NDA has been accepted by NMPA.

Fund-raising analysis: accelerate the promotion of innovative drug research and development, enhance the company's comprehensive competitiveness. The company plans to issue no more than 115 million shares to the public, and the funds raised will be used for: ① new drug research and development projects: investment in clinical trial expenses of Dmur0120, Dmur0502, Dmur1553 and other preclinical products, as well as R & D investment of other preclinical products, which will help the company to provide patients with safe, effective and affordable high-quality drugs through innovative research and development to meet the treatment needs that need to be solved urgently. So as to further improve the core competitiveness of enterprises ② headquarters base construction project: integrates the company's headquarters base, new drug research and development, academic exchange, supporting support and other functions, the completion of the project will further enhance the company's R & D strength in the field of innovative drugs such as anti-tumor and metabolic diseases.

Risk factors: the related risks of biomedical industry companies that intend to adopt the fifth set of listing standards; the related risks of innovative drug R & D enterprises; the risk of product market competition. The risk of the commercialization of the company's products.

Jointly controlled risks. Intellectual property risk and outstanding litigation risk. The third party entrusts R & D risk.

Risk of technology upgrade and product iteration. Risk of loss of core technical personnel. Risks related to pharmaceutical industry policies.

The risk of insufficient working capital. Equity incentive leads to the continuous risk of share payment. The risk of failure of the release. The conclusion of market capitalization obtained by relative valuation method and absolute valuation method has no overlapping risk. The negative impact on the company's earnings forecast and valuation if the earnings forecast hypothesis is not established.

Valuation conclusion. We estimate that the company's revenue from 2022 to 2024 will be 65 million / 213 million / 819 million yuan, and its net profit will be-672 million /-569 million /-120 million yuan respectively. As it is predicted that the company will not be able to break even in the next two years, and the annual profit and risk are relatively predictable, it is recommended to use the DCF valuation method; at the same time, refer to the comparative method of comparable company market capitalization, R & D expenses and so on. Combining the absolute and relative valuation methods, we believe that the overall forward fair value range of the company from 6 to 12 months after listing is 15.176 billion-17.562 billion yuan, and the corresponding R & D expenses account for 1.79% of the market value in 2021. 2.08%.

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