Performance: The company released its annual report on April 9, 2024. In 2023, revenue was 128 million yuan, technical service revenue was 85.5953 million yuan, pharmaceutical sales revenue was 42.09 million yuan, R&D investment was 836 million yuan, and net loss to mother was 1,053 million yuan. The main reason is that Junmai Kang and Milishu have been on the market for a short time, and the company has maintained a high investment in R&D. The company has 10 innovative drugs, 4 biosimilar drugs in clinical practice, 3 marketed varieties, 1 NDA stage, and 3 phase III varieties. The company has the ability to develop and industrialize antibodies, ADCs and recombinant protein drugs. By the end of '23, the company had 1,491 employees, including 398 technical R&D personnel.
Multiple ADC data were published, and the value of the platform was highlighted.
9MW2821 (Nectin-4 ADC) has entered phase 3, and multiple indication data have been published; a) UC urothelial cancer single agent ORR: 62.2%, DCR: 91.9%, median PFS of 6.7 months, and the first patient enrollment in phase 3 clinical trials has been completed; patients with advanced or metastatic urothelial cancer treated with PD-1 have completed the first phase 1 clinical enrollment.
b) CC cervical cancer: 37 patients who have previously received platinum-containing dual-agent chemotherapy with or without bevacizumab ORR: 40.54%, DCR: 89.19%, including 26 Nectin-4 3+ patients ORR: 50% and DCR: 92.31%;
c) EC esophageal cancer: ORR: 30%, DCR: 73.3% for 30 patients treated with monotherapy with previous platinum-containing chemotherapy and PD- (L) 1 inhibitors for which the efficacy can be assessed.
Clinical trials of 9MW2921 (novel Trop-2 ADC) and 7MW3711 (novel B7-H3 ADC) began in July 2023, and are in the phase I/II clinical study enrollment stage.
Innovative drug pipelines are rich, and multiple differentiated varieties are double reported by China and the US. A number of innovative varieties reported by China and the US, such as IL-33, IL-11, and TMPRSS6, are in the clinical phase. Among them, TMPRSS6 antibody (9MW3011) granted rights outside of Greater China and Southeast Asia to DISC MEDICINE in January 2023, with a total transaction total of up to 412.5 million US dollars. In later pipelines, the third-generation long-acting G-CSF 8MW0511 has been declared for listing;
Commercialization continues to advance, and 9MW0321 has been approved. Junmai Kang fully resumed commercial supply at the end of the first quarter of 2023, and shipped 16,6921 bottles in 2023; 173 hospitals were admitted, covering 1,316 pharmacies. According to the supplementary agreement signed in April 2024, Junshikang will no longer be Junmaikang's MAH, and Junshi Biotech will directly transfer the marketing license holder of Junmaikang to Maiwei Biotech. Milesu was approved for listing at the end of March 2023. The first batch of commercial shipments was completed on April 25, and 8,4474 units were shipped in 2023; completed tendering and registration in 28 provinces; completed provincial health insurance connections in 29 provinces; and admitted 605 hospitals, covering 2,061 pharmacies.
9MW0321 desumab (120mg) (a biosimilar of Agave) was approved by the CDE for marketing on March 29, 2024, and is indicated for giant cell tumors of bone.
Profit forecast. We believe that the company's ADC platform capabilities have been fully verified, and the value will be further highlighted with the continuous development of indications and overseas clinical promotion. We expect the company's 24-26 revenue to be 244, 10.42, and 2,244 billion yuan. Maintain a “buy” rating.
Risk warning: sales falling short of expectations, clinical development progress falling short of expectations, risk of policy changes, etc.