Southwest Securities released a research report stating that maintaining the “buy” rating of Cinda Biotech (01801), the estimated revenue for 2024-2026 will be 75.3, 95.3, and 12.23 billion yuan, respectively. It has outstanding R&D capabilities, proven commercialization capabilities, and major products such as Mashidu Peptide are poised to go ahead. The company achieved operating income of 6.21 billion yuan (+36.2%) in 2023, and realized a net profit loss of 1.03 billion yuan to mother. The loss decreased by 52.8% year-on-year.
The main views of Southwest Securities are as follows:
Product revenue grew rapidly, and PD-1 monoclonal antibodies maintained strong sales performance.
Product revenue reached RMB 5.73 billion in 2023, up 38.4% year on year. Among them, Dabershu (Cindilizumab Injection) continues to maintain strong sales performance and a stable market leading position. In addition, the company's other products continue to grow rapidly. The gross profit margin was 81.7%, up 2.1 pp year on year, mainly due to continuous improvement in production efficiency and continuous reduction in production costs.
The company launched two new innovative drugs and a number of new indications, and four NDAs and SNDA were accepted by the NMPA.
Two new innovative drugs were approved for marketing in China in 2023: Focusu (igiorense injection) and Cimpiride (tolecimab injection).
A number of new indications are included in the medical insurance catalogue: all seven approved indications of dabershu have been included in the national medical insurance catalogue. It is also the only PD-1 inhibitor of gastric cancer and EGFR mutant non-squamous NSCLC in the catalogue; the first indication of olebatinib and all new indications for bevacizumab injections, rituximab injections, and adalimumab injections.
Four NDAs and SNDA were accepted by the NMPA: in November 2023 and March 2024, IBI344 (tarretinib) was used to treat adult patients with ROS1-positive locally advanced or metastatic NSCLC who failed ROS1TKI and did not (1L). In November 2023, IBI351 (fluzelecer) was used to treat patients with advanced NSCLC with the KRASG12C mutation who have received at least one systematic treatment. In February 2024, IBI362 (maxidol peptide) was used for long-term weight control in adult obese or overweight patients.
High-quality pipelines are progressing rapidly, and progress in many key varieties is worth looking forward to in 2024.
In 2024, Maxidopeptide is expected to read the results of Phase 3 of DREAMS-1 and DREAMS-2 to support the submission of a second NDA for the treatment of T2D. Pikontibimab is expected to read CLEAR data from the phase 3 clinical trial to support NDA submission. IBI311 (IGF-1R monoclonal antibody) is expected to submit an NDA for thyroid ophthalmology indications. IBI343 will prepare to conduct a phase 3 international multicenter clinical trial to treat 3L gastric cancer. In addition, the company also has several early pipelines with global potential, such as IBI363 (PD-1/IL-2), which has shown encouraging initial efficacy and good safety in IO-resistant or unresponsive tumors; IBI343 (CLDN18.2ADC) pancreatic cancer in PoC studies, IBI389 (CLDN18.2/CD3), and IBI334 (EGFR/B7H3).
Risk warning: R&D progress in the research pipeline falls short of expectations; overseas listing progress or falls short of expectations; risk that future products will not be covered by health insurance.