Investment Rating - Buy rating, first coverage [5] Core Views - The company is a leading domestic Biopharma player with validated commercialization capabilities, transitioning from Biotech to Biopharma [2] - The company is expanding its innovative drug business from oncology to non-oncology fields, including autoimmune, metabolic, and ophthalmic diseases [2] - In oncology, the company is enriching its late-stage pipeline through self-development and BD collaborations, building an "I/O+ADC" product cluster [2] - Multiple oncology pipeline products are expected to release early PoC data in 2024, further validating the company's R&D capabilities [2] - The company has several non-oncology products in late-stage clinical trials or NDA review, which are expected to provide new growth drivers in the long term [2] Company Overview - Founded in 2011, the company focuses on the R&D, production, and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic, and ophthalmic diseases [3] - The company has over 30 innovative drug candidates, with 10 products already commercialized, 4 under NDA review, and 4 in Phase III or key clinical trials [3] - In 2023, the company achieved total revenue of RMB 6.206 billion (+36.2% YoY), with product revenue of RMB 5.728 billion (+38.4% YoY) [3] - The core product, Sintilimab (PD-1 monoclonal antibody), generated sales of USD 393 million in 2023 [3] Oncology Pipeline - The company's oncology strategy revolves around "I/O+ADC," with Sintilimab as the anchor product, approved for seven indications across five major cancer types [3] - The company is enriching its late-stage oncology pipeline through BD collaborations, such as the KRAS G12C inhibitor fulzerasib and the ROS1 inhibitor taletrectinib, both of which have submitted NDAs [3] - The company is actively building ADC and bispecific antibody/fusion protein technology platforms, with several PoC products entering clinical trials [3] - Early clinical data for self-developed products such as IBI343 (Claudin18.2 ADC), IBI389 (Claudin18.2/CD3 bispecific antibody), and IBI363 (PD-1/IL-2) were presented at ASCO and ESMO 2024, showing promising potential [3] Non-Oncology Pipeline - The company is strategically expanding into non-oncology fields, including metabolic, autoimmune, and ophthalmic diseases, which are expected to become new growth drivers [4] - IBI362, a next-generation GLP-1/GCGR dual-target drug, is the fastest progressing domestic weight-loss drug, with an NDA submitted in February 2024 for the treatment of adult overweight or obesity [4] - Tafolecimab, the first domestically developed PCSK9 monoclonal antibody, has shown stronger affinity and longer dosing intervals compared to competitors [4] - IBI112, targeting psoriasis, is expected to become the first domestic IL-23p19 monoclonal antibody, with global sales of its counterparts exceeding USD 10 billion in 2023 [4] - IBI311, targeting thyroid eye disease, has submitted the first domestic NDA for the IGF-1R target, with Tepezza generating USD 1.966 billion in global sales in 2022 [4] Financial Projections - The company is expected to achieve revenues of RMB 7.929 billion, RMB 10.567 billion, and RMB 13.167 billion in 2024, 2025, and 2026, respectively [6] - Net profit is projected to be -RMB 573 million, RMB 364 million, and RMB 1.368 billion in 2024, 2025, and 2026, respectively [6] - EPS is expected to be -RMB 0.35, RMB 0.22, and RMB 0.84 in 2024, 2025, and 2026, respectively [6] Leadership and Shareholding - The company's leadership team has deep industry and academic backgrounds, with founder Dr. Yu Dechao holding 5.42% of the shares [12] - Temasek is the largest shareholder with a 5.52% stake, followed by The Capital Group with 6.06% [12] Commercialization and R&D - The company has 10 commercialized products, with Sintilimab sales rebounding to USD 393 million in 2023 after a decline in 2022 due to price reductions after inclusion in the national reimbursement list [15] - The company's R&D expenses have increased from RMB 1.295 billion in 2019 to RMB 2.871 billion in 2022, with over 1,500 R&D personnel [21] - The company's R&D focus includes FIC and BIC drugs in oncology, autoimmune diseases, and ophthalmology [21]
信达生物：国内Biopharma领航者，肿瘤与非肿瘤双管齐下