occurrences
Recently, the company released its 2023 annual report. Revenue in 2023 was 128 million, up 361% year over year.
Net loss was 1,053 billion yuan, up 10.3% year-on-year.
The ADC IDDC platform technology is perfect, and the early clinical data for multiple indications of 9MW2821 (NECTIN-4 ADC) is excellent
Maiwei Biotech's ADC technology platform uses fixed-point coupling technology with interchain disulfide bonds to achieve fixed-point coupling with a DAR value of 4. Compared with traditional random coupling, the overall drug has better uniformity, lower killing, and a wider treatment window. Currently, the company Nectin-4 ADC 9MW2821 has the highest clinical research progress in urothelial cancer indications in the world. At present, 9MW2811 has read early data for 3 indications, all of which have performed excellently.
1) Cervical cancer. The ORR for patients (N=37) who had previously received platinum-containing dual-drug chemotherapy with or without bevacizumab was 40.54%, and the DCR was 89.19%. Among them, the Nectin-43+ subgroup (N=26) had an ORR of 50% and a DCR of 92.31%. The ORR for the subgroup (N=21) treated with platinum-containing dual-drug chemotherapy and an immune checkpoint inhibitor was 38.10% and DCR 85.71%.
2) Urothelial carcinoma. The patients had ORR and DCR of 62.2% and 91.9%, respectively, and PFS 6.7 months.
3) Esophageal squamous cell carcinoma, the ORR for patients who have previously received platinum-containing chemotherapy and PD- (L) 1 inhibitors as a single agent for evaluable curative efficacy (N=30) was 30% and DCR was 73.3%.
A number of clinical trials have been conducted on 9MW2811. Among them, the indications for using a single drug for UC 2/3L treatment have entered phase III clinical stage, indications for combined PD-1 for UC 1L treatment have entered the clinical stage, and CC and ESCC have entered phase II clinical phase. In addition to 9MW2811, the company's other two ADCs have also entered the clinical phase, 9MW2921 (TROP2 ADC) and 7MW3711 (B7-H3 ADC), respectively.
Domestic acceptance of biosimilar drugs has exceeded expectations. Overseas orders have accumulated more than 13 million US dollars, and Milisu (bone loss indication) is marketed in March 2023, and (giant cell tumor) Maiwejian was launched in April 2024. Among them, the 2024 new medical insurance catalogue broadened the scope of desumab indications to cover osteoporosis in all postmenopausal women, which is beneficial to the sales volume of Melisu. In 2023, Melisu has completed admission to 605 hospitals, and Junmaikang (adalimumab) has completed admission to 173 hospitals.
In addition, the company is actively expanding the overseas incremental market, with a total contract amount of over US$137.15 million. Formal agreements have been signed in 12 countries for antibiotics similar to desulimumab; formal agreements have been signed in 13 countries; and abercip has been signed in 1 country.
Profit Forecasts and Investment Ratings
Considering that R&D expenses from 2024 to 2026 and some pharmaceuticals are still in the early stages of marketing, we adjusted the company's 2024 and 2025 revenue from RMB 814 and RMB 1,365 million to RMB 311 million and RMB 893 million respectively; estimated revenue of 2026 was RMB 1,344 million; and estimated net profit to mother for 2024 and 2025 was adjusted from -790 million yuan and -559 million yuan to -915 million yuan and -655 million yuan; the estimated net profit for 2026 is- RMB 160 million. Maintain a “buy” rating.
Risk warning: Sales volume falls short of expectations, R&D progress falls short of expectations, risk of policy changes