The core product Nectin-4 ADC drug is currently in a leading position in clinical progress in the world, and it has potential as a BIC product with the same target ADC drug. The Nectin-4 ADC has been approved worldwide by Padcev developed by Seagen/Astellas. Its combination K drug for first-line urothelial cancer has proven the efficacy of the Nectin-4 target in urothelial carcinoma, with great potential. The company's core product, 9MW2821 (Nectin-4 ADC), currently leads the world. The disclosed clinical phase II trial data for second-line urothelial cancer is excellent, and adverse reactions are controllable, and has BIC potential; currently, urothelial cancer indication products are undergoing single-drug key phase III clinical trials and phase I/II clinical trials with PD1; the recently disclosed ORR values for stage II esophageal cancer (30 cases) reached 30%, DCR reached 73.3%; the ORR and DCR for patients with cervical cancer (37 cases) were respectively 40.54% and 89.19%. There is great potential for future overseas licensing and product sales volume.
ADC platform technology is gradually being validated, and the next generation of products is worth looking forward to. The new company continues to optimize the ADC R&D platform, and next-generation ADC drugs have better structural uniformity, quality stability, efficacy and tolerability. Subsequent product layouts include Trop2 ADC, B7-H3 ADC, etc. It is expected that many ADC varieties will enter the clinical development stage in the future.
Differentiated layout of innovative drug+biosimilar drug pipelines, and emerging markets are gradually being developed. As for biosimilar drugs, adalimumab and desumab have been approved. In the future, products including long-term brightening and abibasip will gradually be marketed, contributing to the company's cash flow. Domestic sales teams and partners will accelerate product release, and overseas will rely on partners in various countries to continue to promote the global commercialization of products.
Profit forecast and rating: Currently, desulumab (osteoporosis) and adalimumab have been approved for marketing. The next 3 years, including long-acting G-CSF, abacip, and Nectin-4 ADC, are expected to be approved for listing. The profit forecast does not take into account overseas markets and future product licensing revenue. The company's revenue for the year 23 to 25 is estimated to be 127 million yuan/404 million yuan/888 million yuan, respectively. Considering that the company's Nectin-4 ADC has the potential for best-in-class products, high drug certainty and a good competitive pattern, the company's own ADC platform has accumulated deep research and development, and expectations for future innovative drug pipeline values. Covered for the first time, a “gain” rating was given.
Risk warning: The risk that clinical progress of products falls short of expectations, the risk of commercial sales of products falling short of expectations, and the risk of increased competition in the biosimilar collection and price reduction industry.