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益方生物-U(688382)投资价值分析报告:药构出发 面向全球的创新药BIOTECH

Yifang Bio-U (688382) Investment Value Analysis Report: Biotech, an innovative drug targeting the world from the perspective of pharmaceutical composition

光大證券 ·  Feb 20

Biotech is an innovative drug starting from pharmaceutical composition and targeting the world. Established in 2013, Yifang Biotech is an innovative drug research and development enterprise based in China with a global perspective. The company's R&D team has a deep academic background. With in-depth research and understanding of the mechanism of action of the disease, they select potential drug targets, and design drugs to meet clinical needs, starting from the combined conformation of compounds and targets.

Starting from the target, it covers the two major fields of solid tumors and metabolic diseases. The company has independently developed a series of innovative targeted drugs with patent protection, covering the two major fields of solid tumors and metabolic diseases.

Solid tumors: Existing products have been commercialized to target indications with urgent clinical needs.

1) Befotinib: It is a third-representative dermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) used to treat non-small cell lung cancer (NSCLC) with positive EGFR mutations. In May 2023, its second-line treatment was successfully approved for marketing; the NDA for first-line treatment was accepted, and the partner Betta Pharmaceuticals has now been authorized to manufacture, market and sell. As a standard drug for NSCLC treatment, EGFR-TKI currently has three generations. Because it can overcome T790M drug resistance mutations, the inhibitory effect on tumor cells can be greatly enhanced. Therefore, third-generation EGFR-TKI treatment has obvious advantages and broad replacement space; 2) D-1553: is a KRAS G12C inhibitor that can be used to treat various cancers with KRAS G12C mutations, and has been certified as a breakthrough therapy and is in clinical phase II (NSCLC); KRAS is one of the most important targets in cancer treatment. G12C is the most common KRAS mutation, and the number of cases in China is expected to reach 51,000, with many patients; in addition, there are no KRAS in China G12C inhibitors have been approved, and clinical demand is very urgent, and it is expected that approval and marketing will be accelerated; 3) D-0502: It is an oral selective estrogen receptor degrading agent (SERD), which has entered clinical phase III in China. SERD targeted drugs are the main treatment plan for breast cancer patients in China, but currently only one drug, fluvizil, has been approved for marketing. Its intramuscular administration characteristics lead to poor patient compliance and low bioavailability. Therefore, the global market has strong demand for novel oral SERD targeted drugs.

Metabolic diseases: A blue ocean market with advanced R&D progress and a huge target population of patients.

4) D-0120: It is a urate transporter 1 (URAT1) inhibitor used to treat hyperuricemia and gout.

With changes in diet structure, the number of patients with metabolic diseases in China continues to rise. The current treatment plan is mainly febustat and phenbromalone, and safety issues are prominent. Since uric acid excretion is more effective than inhibiting uric acid synthesis, URAT1 targets have great potential. The product has entered Phase IIb in China, and progress is ahead.

Profit forecast, valuation and rating: We estimate that the company's main product sales revenue from 2023 to 2025 will be 1,83/2.90/431 million yuan, respectively; net profit to mother will be -2.89/-1.86/-48 billion yuan, respectively. Using the absolute valuation of the company's pipeline as the main valuation reference, the company was given an overall valuation of 8.9 billion yuan, corresponding to a target price of 15.5 yuan. First coverage, considering the huge potential of the company's technology platform, leading layout ideas, and a “buy” rating.

Risk warning: Risk of R&D progress falling short of expectations; risk of falling prices due to policy changes; risk of increased competition.

The translation is provided by third-party software.


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