Huajin Securities - Nordland Biotech (430047) Company Update Report: NL003 Enters Review Phase, Product Pipeline Nearing Commercial Harvest

(Source: Research Report Tiger)

▌Ophthalmic drugs continue to inject momentum, fueling the innovative pipeline

In the first half of 2025, the company achieved revenue of 0.37 billion yuan, a year-on-year increase of 1.47%; the net profit attributable to parent company was -0.2 billion yuan. The company currently does not have any new drugs on the market, and ophthalmic drugs, as the core source of income, continue to fund new drug research and development. As of the 2025 semi-annual report, the company and its secondary subsidiary Hui En Lan De have a total of 8 registered eye drop products, with 3 GMP-certified/inspected production lines built (single-dose, multi-dose, and rinsing agents), covering indications such as antibacterial, anti-allergy, dry eye syndrome, and glaucoma.

▌Heavyweight innovative drug registration is proceeding steadily, NL003 is about to enter the harvest period. The new drug registration and marketing application for the ulcer indication of NL003 is currently proceeding steadily. The company received a notification for supplementary materials in April and had submitted the supplementary materials before the semi-annual report. At the same time, the registration application process for the rest pain indication has also been initiated. In addition, the company has started a long-term follow-up study for subjects in Phase III clinical trials and is actively preparing for post-marketing real-world research to strengthen evidence-based medical support through subsequent studies.

▌Commercialization process continues, the company's innovative drug commercialization is about to officially begin

In the first half of 2025, the commercialization of Cedominje Injection has carried out activities such as the formulation of commercialization strategies, organizational setup, and relevant market research. Currently, market research, academic promotion, channel expansion, access research, and innovative payment solutions are being comprehensively implemented according to plan. In addition, the construction of the company’s biopharmaceutical production base is proceeding in an orderly manner. The process design for all process equipment in the bulk solution workshop has been completed, and production and assembly are currently underway. The mechanical and electrical work, as well as the purification project for the bulk solution workshop, are being implemented as planned.

▌Profit Forecast

The company's revenue for 2025-2027 is projected to be RMB 0.88 billion, RMB 1.85 billion, and RMB 3.71 billion, respectively, with EPS of -RMB 0.19, -RMB 0.01, and RMB 0.30. The current share price corresponds to PE ratios of -124.9, -2615.8, and 76.9 times, respectively. We maintain a "Buy" investment rating.

▌Risk Warning

Risk of R&D failure, clinical trial progress falling short of expectations, market competition risks, market promotion falling short of expectations, risk of additional share issuance progress not meeting expectations, industry policy and government regulation risks