舒沃替尼：突破疗法彰显全球BIC 实力，20ins 市场广阔有待开拓舒沃替尼为高选择性EGFR-TKI，是肺癌领域首个且目前唯一获中美双“突破性疗法认定”的国创新药，首选适应症为EGFR 20 号外显子插入突变非小细胞肺癌，20ins 为非小细胞肺癌EGFR 第三大突变类型占比约10%，舒沃替尼ORR 59.8%显著优于全球同类产品。目前国内NDA 已获优先审评，有望于2023 年中上市；海外注册临床加速推进中，有望于2023 年底提交美国NDA。我们认为该疾病领域仍存在较大未被满足的治疗需求，舒沃替尼凭借优异疗效和可控安全性，有望成为全球有力竞争者。Report summary
The company is an innovation-driven biomedical company based on global competition. It strategically focuses on the field of oncology and immune diseases, and is committed to launching the world's first drugs and breakthrough therapeutics in response to major clinical needs. It has established an ongoing research pipeline with a global competitive advantage. Five small molecule innovative drugs have entered the global clinical stage, and the two leading products, suvotinib and golicitinib, are being promoted at an accelerated pace. We believe that the company's differentiated pipeline layout seizes a first-mover advantage. Combined with the comprehensive promotion of global clinical development and the advance deployment of commercialization teams, various pipelines are expected to accelerate global sales.
Key points of investment
Shuvotinib: Breakthrough therapy highlights the strength of global BIC. The 20ins market is wide to be developed. Shuvotinib is a highly selective EGFR-TKI. It is the first and only nationally innovative drug in the field of lung cancer that has been “certified as a breakthrough therapy” by China and the US. The preferred indication is EGFR exon 20 mutation mutation. 20ins is the third largest mutation type of EGFR in non-small cell lung cancer. 59.8% of suvotinib ORR is significantly superior to similar products worldwide. Currently, the domestic NDA has received priority review and is expected to be listed in mid-2023; overseas clinical registration is being accelerated, and it is expected that the US NDA will be submitted by the end of 2023. We believe that there is still a large unmet treatment demand in the field of this disease. With its excellent efficacy and controllable safety, suvoritinib is expected to become a strong competitor in the world.
Golicitinib: A new generation of high-selection JAK1 inhibitors, opening up new ways to lay out the hematoma field Golicitinib is the world's first and only highly selective JAK1 inhibitor in the field of T-cell lymphoma that has entered the global registered clinical stage. The first indication is for the treatment of recurrent refractory peripheral T-cell lymphoma (r/r PTCL), which is currently in the international multi-center phase II single-arm registration trial stage. There are many subtypes of PTCL and there is no effective treatment. The survival rate of r/r PTCL patients who failed the initial treatment was low, and the ORR of r/r PTCL treated with golicitinib reached 42.9%, far higher than the current standard treatment. Golicitinib received fast track approval from the FDA in 2022 and is expected to be submitted to the US and China NDA in 2023. After marketing, it is expected to successfully open up global market space with excellent curative effects.
Research pipeline reserves are abundant, and Source Innovation Brave “No Man's Land” company has extensive research pipeline reserves. In addition to the above two core products, 3 innovative drugs have entered the global clinical stage, namely DZD8586 (r/r B-NHL, clinical phase I), DZD1516 (advanced HER2-positive breast cancer, clinical phase II proof of concept), and DZD2269 (mCRPC, clinical phase I). The company's equity incentive assessment index combines the company's product milestones and market capitalization growth to achieve deep binding between company development, employee incentives, and shareholder interests, forming a good incentive for speeding up product launch and building its own hematopoietic capacity, demonstrating full confidence in the company's long-term development.
Profit Forecasts and Investment Ratings
We expect the company's revenue for 2023-2025 to be 147/6.23/1,124 million yuan respectively; the net profit of the mother is -885/-3.90/-110 million yuan respectively. Using the DCF valuation method, considering that the company's products are expected to be listed in 2023 and differentiated efficacy advantages, we gave the company a valuation of 28.119 billion yuan in 2023, the corresponding stock price was 68.89 yuan, covered for the first time, and gave it a “buy” rating.
Risk warning: risk of not being profitable; core competitiveness risk; operating risk; financial risk; related estimates have subjective hypothetical risks.
