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益方生物(688382):重磅产品获批在即 在研管线进度领先

Yifang Biotech (688382): Major products are about to be approved, and research pipelines are leading the way

國金證券 ·  Dec 25, 2022 00:00  · Researches

Investment logic

The company focuses on major diseases such as tumors and metabolic diseases, pays attention to drug targets with a large patient base and unmet treatment needs, and is committed to developing innovative targeted drugs with independent intellectual property rights. At present, the company has no products on the market for sale, and the core products are ahead of the research and development progress in the same target, and revenue is expected to be achieved from 2023.

Beftini is a third-generation EGFR TKI product developed by the company, which has longer mPFS and better brain metastasis efficacy than the same target drug. The second-line indications of befotinib have been submitted for listing, and the first-line indications have completed the reading of key registered clinical data, and it is expected that they will be approved for listing in 2023, becoming the third-generation domestic EGFR approved. Considering the advantage of efficacy data of befotinib and the successful commercialization experience of partner Beda Pharmaceutical in the field of EGFR, it is expected that the sales of beftini will reach a peak of 2.9 billion yuan, which is expected to bring 110 million or 200 million yuan of milestone and sales commission income to the company from 2023 to 2024.

The company has three core products in the late clinical research and development stage, which is expected to be put on the market one after another from 2024 to 2026, bringing sustained growth momentum. Dmur1553 is the first domestic KRAS G12C targeted drug to enter the clinical stage. At present, it has been approved to carry out the key single-arm II phase clinical and included a breakthrough treatment variety. It is expected to be approved in 2024, and the sales peak is expected to exceed 1.1 billion yuan. Oral SERD targeting drug Dmur0502 is aimed at ER positive HER2 negative advanced breast cancer patients to solve the current convenience problem of SERD drug injection. At the same time, compared with other oral SERD products under development, it has been approved to carry out phase III clinical practice, is expected to be approved in 2025, and the sales peak is expected to exceed 1.2 billion yuan. URAT1 inhibitor DMel 0120 is aimed at patients with gout and hyperuricemia. The population is large and existing drugs generally have safety problems. DMY 0120 is currently in the II phase, which is expected to be approved in 2026 and its sales are expected to exceed 1.8 billion yuan in 2031.

Profit forecast and valuation

It is estimated that the company's revenue from 2022 to 2024 will be 0.9 billion yuan and the net profit will be-5.9 million and 7.5 billion yuan respectively. Using the DCF valuation method, we think that the reasonable valuation of the company is 11.94 billion yuan, corresponding to the target price of 20.77 yuan per share, covering for the first time and giving a "buy" rating.

Risk hint

New drug research and development risk, new drug listing approval risk, health insurance negotiation risk, intensified competition or product iteration risk, generic drug and collection risk, patent risk, deregulation risk and so on.

The translation is provided by third-party software.


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