The rapid release of sulvortinib in 2023&2024Q1 has accelerated, and 2024ASCO will soon release MRCT data for advanced EGFR exon20ins mutant MRCT data with sulvoritinib second-line treatment. Commercialization of golisitinib is imminent, and early pipeline differentiation advantages are strong, and we look forward to commercialization implementation and more data reading and catalysis.
Catalysis: Optimistic about business acceleration and data readout catalysis
Suvortinib: In August 2023, the EGFR exon20ins mutant advanced NSCLC indications that had previously received platinum-containing chemotherapy was approved for domestic marketing. Sales revenue in 2023 reached 91 million yuan, and 2024Q1 revenue reached 81 million yuan (QOQ 58.87%), achieving rapid release. Furthermore, in April 2024, suvortinib was recommended by the “CSCO Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer (2024 Edition)”. Based on excellent clinical data and expert recommendations, we are optimistic about the prospects for rapid dosage of suvortinib sales. Furthermore, according to the company's annual report, the second-line EGFR Exon20InS mutant advanced global registration clinical study (WU-KONG1 Part B) has successfully completed the enrollment of all patients, and overseas new drug marketing applications are being actively prepared. The latest research data will be announced for the first time in the form of an oral report at the 2024 ASCO conference. We look forward to reading out the clinical data.
Golixitinib: In September 2023, the domestic marketing application for golisitinib to treat recurrent refractory peripheral T-cell lymphoma was accepted and included in the priority review process, and commercialization is imminent. There is no standard treatment plan for recurrent refractory peripheral T-cell lymphoma. The competitive pattern is relatively good. Golisitinib ORR is prominent, safety is reliable, and commercialization potential is promising.
DZD8586: DZD8586 is the world's first non-covalent LYN/BTK dual-target inhibitor for B-NHL independently developed by the company, and can completely penetrate the blood-brain barrier. The overall ORR for B-NHL patients who failed multi-line treatment reached 64.7%, showing good anti-tumor activity and safety. Global phase I/II clinical trials are ongoing, and we expect continued clinical progress and more data to be read out.
Profit forecasting and valuation
Considering the company's product launch and promotion pace, and not considering the flexibility of cooperation and licensing, we expect the company's revenue for 2024-2026 to be 4.79 billion yuan, 9.17 billion yuan, and 1,419 million yuan, respectively. The company's pipeline implementation has accelerated, and sulvoritinib continues to be released. Commercialization of golisitinib is imminent. Early pipeline differentiation advantages are strong. We expect more data to be read out and catalyzed to maintain the “buy” rating.
Risk warning
Risks that clinical progress and marketing of new drugs fall short of expectations, risks of sales falling short of expectations due to increased competition, risks of stricter policies, etc.