Investment Rating - The report gives a "Buy" rating for the company with a target price of HKD 58.05 [5] Core Views - The company has a strong R&D engine and commercialization capabilities, aiming for RMB 20 billion in revenue by 2027 [1] - The company has 11 approved products, with product revenue reaching RMB 3.8 billion in H1 2024, a 55% YoY increase [1] - The company is focusing on four key disease areas: oncology, cardiovascular & metabolic, autoimmune, and ophthalmology, with a diversified product pipeline [1] - The company expects to have nearly 20 approved products by 2027, targeting RMB 20 billion in domestic revenue [1] Oncology - The company has 9 approved oncology products, with 1 NDA submitted and 2 in key clinical stages [2] - Sintilimab (PD-1) sales reached RMB 2.75 billion in 2023, a 34% YoY increase, and is expected to maintain growth due to its inclusion in the national reimbursement drug list (NRDL) [2] - The company is developing next-generation IO therapies, including a global first-in-class PD-1/IL-2 bispecific antibody (IBI363), which has shown promising efficacy in Phase I trials [2] - The company is leveraging its "IO+ADC" dual strengths, with IBI343 (CLDN18.2 ADC) showing potential as a best-in-class ADC in gastric and pancreatic cancers [34] Metabolic and Cardiovascular - Mazdutide (GLP-1R/GCGR dual agonist) is the first GLP-1R/GCGR dual agonist to enter Phase III globally, with NDAs submitted for obesity and type 2 diabetes [3] - Mazdutide has shown significant weight loss and glycemic control in clinical trials, with potential to become a leading treatment for obesity and diabetes [44] - Tafolecimab (PCSK9 inhibitor) is the first domestically developed PCSK9 monoclonal antibody approved in China, with potential for inclusion in the NRDL in 2024 [49] Autoimmune and Ophthalmology - The company has a strong pipeline in autoimmune diseases, including IBI112 (IL-23p19 inhibitor) for psoriasis, which has shown best-in-class potential with a 12-week dosing interval [3] - IBI311 (IGF-1R inhibitor) is expected to be the first innovative drug for thyroid eye disease (TED) in China, with NDA submitted [3] Financial Projections - The company is expected to achieve revenues of RMB 8 billion, RMB 11 billion, and RMB 14.7 billion in 2024, 2025, and 2026, respectively, with YoY growth rates of 29%, 37%, and 34% [3] - Net profit is projected to turn positive in 2025, reaching RMB 121 million, and further increase to RMB 1.34 billion in 2026 [3] - The company's DCF valuation suggests a fair value of HKD 58.05 per share, with a market cap of HKD 94.7 billion [3]
信达生物：自主研发已入佳境，四大领域商业化势如破竹