Differentiated pipeline layout, based on global innovation Dizhe Pharmaceutical was founded in 2017. It is an innovative biomedical enterprise focusing on research, development and commercialization of innovative treatments in the field of malignant tumors and immune diseases. Most of the company's core team members, including founder Dr. Zhang Xiaolin, are from AstraZeneca's original innovation center. The company adheres to the innovative R&D concept at the source and aims to launch first-in-class drugs (first-in-class) and treatments with breakthrough potential to fill the world's unmet clinical needs. Based on the industry-leading translational science and molecular design and screening technology platform for new drugs, the company has established six globally competitive product pipelines. The two leading products, sulvoritinib and golixitinib, are in critical global clinical trials. Among them, sulvortinib has been approved for marketing in China.
Suvortinib: NSCLC EGFR 20 exon 20 exon is the world's first small-molecule inhibitor for EGFR 20 exon insertion mutations. It is also the only drug in the world that has received “breakthrough therapy certification” from the FDA to treat EGFR exon20ins mutant NSCLC. The preferred indication is non-small cell lung cancer with EGFR exon 20 insertion mutation. In August 2023, suvortinib obtained approval from the NMPA for marketing in China. It is used in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed through platinum-containing chemotherapy or are intolerant to platinum-containing chemotherapy, and tests have confirmed the presence of epidermal growth factor receptor (EGFR) No. 20 exon insertion (exon20InS) mutations. It became the first national innovative drug for advanced NSCLC with EGFR exon20ins. According to the company's announcement, as of the 2024 quarterly report, suvortinib has only been on the market for more than seven months, with cumulative sales revenue of about 173 million yuan, and rapid commercialization.
Goliximitinib: The high-choice JAK1 inhibitor golisitinib with a differentiated layout is a JAK1 inhibitor independently developed by the company. As a new-generation JAK1 high-selective inhibitor, golisitinib is 200-400 times more selective for other members of the JAK family, effectively reducing the drug safety risks caused by widespread JAK inhibition. r/r PTCL, its first declared indication for marketing, was accepted by the NMPA and included in the priority review process. Golisitinib is the world's first and only highly selective JAK1 inhibitor to treat PTCL. It is also the first and only new PTCL drug in China to be “fast-track” by the FDA. The results of a globally registered clinical study of golixitinib showed that after IRC evaluation, patients treated with r/rPTCL on the second line with golisitinib had an ORR of 44.3%, a CR rate of 23.9%, and tumor remission was observed in various common PTCL subtypes. The IRC-assessed MdOR lasts 20.7 months, surpassing existing therapies and providing patients with longer lasting clinical benefits.
Profit forecasting
Considering that the company's two major products, suvoritinib and golixitinib, are in critical global clinical trials, among them, sulvoritinib has been approved for marketing in China. We expect the company's total revenue for 2024-2026 to be 466 million yuan/902 million yuan/1,512 billion yuan, respectively, and the estimated EPS for 2024-2026 will be -1.95/-1.22/ -0.14 yuan, respectively. Using the free cash flow DCF discount valuation method, the company's valuation was 21,473 billion yuan, corresponding to the initial coverage of the stock price of 51.66 yuan, giving the company a “buy” rating.
Risk warning
Pharmaceutical industry policies fall short of expectations, market competition increases risks, product sales and promotion fall short of expectations, and progress in innovative drug research and development falls short of expectations.