Leading domestic small-molecule innovative drug company: Established in 2017, Dizhe Pharmaceutical is an innovative biomedical company with global competitiveness, focusing on research, development and commercialization of innovative treatments in the field of malignant tumors and immune diseases. The company has established a highly innovative and market-potential small molecule product pipeline portfolio. All products enjoy complete global benefits and adopt a model of simultaneous global development. The company focuses on major diseases such as malignant tumors and hematomas. Many indications for 6 products are already in the global clinical stage, and many candidate innovative drugs are in the pre-clinical research stage.
Suvortinib is a potential BIC variety for EGFR Ex20InS NSCLC: the third-generation EGFR-TKI that has been approved is mainly effective against EGFR 19del, L858R, and T790M drug resistance mutations, but the therapeutic effect on patients with EX20INs is not obvious, and there are still unmet treatment needs in this field. According to ASCO's official website in 2023, the overall ORR data for patients treated with suvortinib 3L was 60.8%, and the ORR was 48.5% for patients with brain metastases, and the ORR was 54.3% in international multi-center EX20INs backline treatment data; the overall ORR data for EGFR EX20INs patients treated with 1L of suvortinib was 78.6%, which is significantly higher than the rest of comparable peers, and the efficacy data advantage is obvious; TEAE is mainly grade 1-2, and clinical safety is relatively controllable. There are currently no suitable drugs for EGFR patients who are resistant to third-generation TKI drugs. Among 37 patients who have received median 5-line treatment, MPFs were 5.8 months and MDor was 6.5 months, showing certain efficacy. Based on our estimates, domestic sales of suvortinib are expected to reach about 3 billion yuan in 2033, and sales of 1.8 billion yuan in the US in 2033.
Golisitinib's differentiated layout of PTCL indications is superior to existing treatments: considering that JAK inhibitors compete fiercely in the field of self-immunity, the company's golisitinib has differentiated PTCL indications for hematoma. Golixitinib's blood safety is slightly superior to the rest of the varieties under study, and the efficacy data is no worse than the rest of the varieties under study. The MdOR assessed by IRC lasts 20.7 months, surpassing existing treatments, and can bring more lasting clinical benefits to patients. As of August 31, 2023, MPFs were 5.6 months, and MoS was greater than 15 months. Based on our estimates, it is estimated that in 2033, the domestic sales value of golisitinib for PTCL indications will exceed 1 billion yuan, and the US sales value will be close to 900 million yuan.
Profit forecast: Considering the high level of innovation of the company's products, we expect the company's revenue from 2024-2026 to be 4.58, 10.49, and 1,646 billion yuan, respectively, corresponding to net profit attributable to mother of -7.49, -4.27, and 0.17 billion yuan. The company is an innovative biomedical enterprise that is expected to achieve break-even in 2026 and gradually become profitable in the future. First coverage, giving the company a “buy” rating.
Risk warning: 1. Product sales fall short of expectations; 2. Risk of product clinical failure; 3. Risk of changes in core technology or core sales personnel; 4. Risk of product shipping progress falling short of expectations; 5. Risk of changes in industry policies.