舒沃替尼纳入CSCO 指南，有望持续放量基于中国注册临床研究“悟空6”（WU-KONG6）的积极结果，舒沃哲（通用名：舒沃替尼片）于2023 年8 月在国内获批上市，是目前全球唯一获批且可及的靶向EGFR Exon20ins NSCLC 的小分子酪氨酸激酶抑制剂。2024 年4 月，舒沃哲获《CSCO 非小细胞肺癌诊疗指南（2024 版）》I 级推荐，是该指南中针对经EGFRExon20ins NSCLC 的唯一I 级推荐方案。舒沃哲首个全球注册临床“悟空1B”已达主要研究终点，非亚裔患者占比超过40%，初步分析结果获2024 年美国临床肿瘤学会（ASCO）大会口头报告，为舒沃哲在美国、欧盟等海外NDA 的申报提供重要依据。一线治疗EGFR Exon20ins NSCLC 的全球多中心III 期临床研究“悟空28”也在顺利开展中。Incidents:
On August 29, 2024, Dizhe Pharmaceutical released its 2024 semi-annual report. It achieved operating income of 0.204 billion yuan in the first half of the year (no revenue for the same period in 2023), net profit attributable to shareholders of listed companies was -0.345 billion yuan (year-on-year loss reduction), and net profit attributable to shareholders of listed companies after deduction was -0.381 billion yuan (year-on-year loss reduction).
Investment highlights:
Suvortinib is included in the CSCO guidelines and is expected to continue to be released based on the positive results of the Chinese registered clinical study “Wukong 6” (WU-KONG6). Suvortinib (generic name: suvortinib tablets) was approved and marketed domestically in August 2023. It is currently the only approved and accessible small-molecule tyrosine kinase inhibitor targeting EGFR Exon20InS NSCLC in the world. In April 2024, Schwarzer received the Level I recommendation of the “CSCO Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer (2024 Edition)”, which is the only Level I recommendation for EGfrexon20InS NSCLC in this guideline. Schwarzhe's first globally registered clinical trial, “Wukong 1B”, has reached the main research end, accounting for more than 40% of non-Asian patients. The preliminary analysis results were presented orally at the 2024 American Society of Clinical Oncology (ASCO) conference, providing an important basis for Schwarzer's NDA application in the US, the European Union, etc. The global multi-center phase III clinical study “Goku 28” for first-line treatment of EGFR Exon20InS NSCLC is also being successfully carried out.
Golixitinib was approved for marketing, and the rest of the pipeline progressed rapidly. On June 18, 2024, the company Gaorizhe (generic name: golisitinib capsules) was approved by the National Drug Administration (NMPA). The single drug is suitable for adult patients with recurrent or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least first-line systematic treatment in the past. 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.
DZD8586 can simultaneously block BTK-dependent and independent BCR signaling pathways, effectively inhibit the growth of various B-NHL subtype cells, and has the ability to completely penetrate the blood-brain barrier, which is expected to overcome the drug resistance problem of existing BTK inhibitors. Currently, DZD8586 is undergoing phase I/II clinical trials of r/r B-NHL globally. Preliminary findings suggest encouraging pharmacokinetic (PK) characteristics, safety, and antitumor activity. DZD6008 is a small molecule targeted inhibitor for advanced lung cancer independently developed by the company. In April 2024, the company was approved to conduct phase I clinical research on DZD6008 in China.
Profit forecasts and investment ratings estimate that in 2024-2026, the company's revenue will be 0.471, 1.049, and 1.646 billion yuan, and net profit to mother will be -0.768, -0.422, and -0.024 billion yuan. As pipeline products continue to be marketed and indications continue to expand, revenue growth is expected to accelerate and maintain 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.
