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迪哲医药(688192):销售收入强劲增长 亏损收窄趋势明显

Digel Pharmaceutical (688192): Strong growth in sales revenue, obvious narrowing of losses

東北證券 ·  Aug 30

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Recently, the company released its semi-annual report. In the first half of 2024, the company's revenue was 0.204 billion yuan (+123% YoY), net profit attributable to mother was 0.345 billion yuan, and net profit not attributable to mother was 0.381 billion yuan.

Comment:

Sales revenue is growing strongly, and losses are narrowing significantly. In the first half of 2024, the company's sales revenue exceeded 0.2 billion yuan, achieving a month-on-month increase of more than 50% for two consecutive quarters, mainly due to the core product Schwarzer? Strong sales performance, based on an integrated business strategy and efficient execution, the company promoted the rapid increase and rapid growth of products in the self-funded market. Schwarzer in ten months? , Gao Ruizhe? Two global FIC/BIC innovative drugs have been approved for launch and are expected to be included in the national health insurance catalogue. Differential innovation in the field of lung cancer and hematoma promotes the vigorous development of the product pipeline, and it is expected that the two products will continue to contribute to revenue growth. Thanks to increased revenue, the company's net loss to mother fell for 3 consecutive quarters, falling 33% in the first half of 2024 compared to the same period last year. Sales revenue is growing strongly, and losses are narrowing significantly.

Schwarzhe? Covering all EGFR Exon20InS NSCLC treatments, the differentiation advantages are remarkable. The core product Schwarzer? It was approved for domestic marketing in August 2023. It is the only small molecule TKI approved and can target EGFR Exon20InS NSCLC in the world, and has been included in the “CSCO Non-small Cell Lung Cancer Diagnosis and Treatment Guidelines (2024 Edition)” only Level I recommendation. Schwarzhe? The globally registered clinical study “Goku 1B” for second-line treatment of EGfrexon20INs NSCLC reached the main study end point, accounting for more than 40% of non-Asian patients. The preliminary analysis results were presented orally by 2024 ASCO, providing an important basis for overseas NDAs such as the US and the European Union; compared with the phase I clinical study “Goku 28,” which is a first-line treatment with platinum-containing dual-drug chemotherapy, is being actively promoted in 16 countries and regions in America, Europe, and Asia. Schwarzhe? It is the only drug in the world that has been certified as a “breakthrough therapy” by the FDA for the full line treatment of EGFR Exon20InS NSCLC, with significant differentiation advantages.

Ko Rui-chul? It was approved in June to break the “no innovative drug in the world for ten years” dilemma in the PTCL field. As the world's first and only highly selective JAK1 inhibitor to treat PTCL, Gao Ruizhe was approved for domestic marketing in June 2024, and was first launched within 2 days of receiving a drug registration certificate. Based on a globally registered clinical study, the “JACKPOT8B section” (JACKPOT8B) was approved for marketing in China through priority review. With a new mechanism of action, the single drug has broken through the bottleneck of r/r PTCL treatment, showing longer survival, deep relief, and overall benefits. It will further explore treatment potential, expand indications to the field of solid tumors and autoimmune diseases, and is expected to achieve dosage.

Profit forecast and investment advice: The company focuses on research and development in the field of anti-tumor drugs, and has a broad market space.

We expect the company to achieve revenue of 0.551/1.111/1.678 billion yuan in 24-26, with earnings per share of -2.02/-1.32/-0.44 yuan. This is the first coverage, giving the company a “buy” rating.

Risk warning: risk of R&D falling short of expectations, risk of sales falling short of expectations, policy risk, etc.

The translation is provided by third-party software.


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