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诺诚健华(688428)深度研究报告:肿瘤产品适应症稳步拓展 自免开启第二成长曲线

Nuocheng Jianhua (688428) In-depth Research Report: Oncology Product Indications Are Steadily Expanding Self-Expecting and Starting a Second Growth Curve

華創證券 ·  Jun 27

The hematoma layout is comprehensive, and the expansion of indications drives sales growth. Nuochengjianhua has deployed 6 products in the field of hematoma, covering all segments of myeloma, leukemia and non-Hodgkin lymphoma. Obutinib, a BTK inhibitor that has already been marketed, is expected to increase significantly as the exclusive domestic indication r/R MZL is approved and included in medical insurance. The company will also submit marketing applications for new indications of obutinib for first-line CLL/SLL treatment in China and r/r MCL marketing applications in the US to further expand commercialization space within the year. The first domestic marketing application for CD19 monoclonal tamxitumab combined with lenalidomide to treat r/R DLBCL has been accepted by the CDE and included in priority review.

Start the company's second growth curve without fear. The number of people suffering from spontaneous diseases is huge. The number of people who are free from self-immunization worldwide is expected to reach more than 500 million, and the number of people who are free from self-immunization in China is about 80 million. The self-care market has become the third-largest market after tumors and infections. With leading small molecule research and development capabilities, Nuochengjianhua lays out a variety of differentiated small molecule drugs in the field of self-defense, which is expected to start the company's second growth curve. Research on the BTK inhibitor obutinib to treat primary immune thrombocytopenia has progressed to phase III, and the treatment of systemic lupus erythematosus and multiple sclerosis is in clinical phase II. In the JAK/TYK2 signaling pathway, the company deployed the TYK2/JAK1 inhibitor ICP-332 and the allosteric inhibitor ICP-488. Positive phase II data for ICP-332 treatment of atopic dermatitis have been read, showing best-in-class potential, and phase III clinical studies will commence this year. ICP-488 highly selective targeting TYK2 has begun a phase II clinical study on psoriasis, and the data is expected to be read out by the end of this year. The company's differentiated layout of the oral IL-17 small molecule drug ICP-923 has shown excellent efficacy in preclinical studies, and is expected to compete with injectable IL-17 biologics based on ease of administration.

The solid tumor layout is a me-better variety, and it is expected that the first product will be put into production soon. The company has deployed five candidate products in the field of solid tumors, including ICP-192, a more selective Pan-FGFR inhibitor, ICP-723, a potentially better second-generation TRK inhibitor, and ICP-189, a SHP2 inhibitor. Among them, ICP-723 treatment of NTRK fusion positive tumors and ICP-192 treatment of cholangioma have entered the registered phase II clinical trial, and the company is expected to submit an ICP-723 marketing application by the end of the year.

Investment advice: First coverage, giving the company a “recommended” rating. We expect the company's revenue for 2024-2026 to be $9.11, $1,405, and $1,734 million, respectively, and net profit to mother of -6.14 billion yuan, -6.24 billion yuan, and -399 million yuan.

According to the innovative drug product pipeline valuation method (cash flow discount method based on risk adjustment), the company was valued at 20.571 billion yuan, and the corresponding target price was 11.7 billion yuan.

Risk warning: Clinical progress falls short of expectations, commercialization progress falls short of expectations, and changes in the competitive landscape.

The translation is provided by third-party software.


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