Guotai Junan: Maintains "Buy" rating on KEYMED BIO-B (02162), first domestically produced IL-4R monoclonal antibody Kangyueta approved.

Guotai Junan released a research report stating that it maintains a "hold" rating for KEYMED BIO-B (02162), considering the early commercialization of CM310, and has raised the revenue forecast for 2024 to 197 million yuan (originally 156 million yuan) while maintaining the revenue forecast for 2025-2026 at 526/1,441 million yuan. CM310 (dupilumab, trade name: Kangyueda) received CDE approval for the adult moderate to severe atopic dermatitis indication on September 12, becoming the first domestic and the second global IL-4R monoclonal antibody to be approved, filling a gap in the domestic AD biologics field. Key points from Guotai Junan: CM310 is the first domestic IL-4R monoclonal antibody with excellent efficacy and good safety. Phase III clinical data shows that the EASI-75 response rate of CM310 monotherapy at 16 weeks is 66.9%, and at 52 weeks it reaches 92.5%, with an EASI-90 response rate of 77.1%. In terms of sustained itch relief, the response rate of PP-NRS decreasing 4 from baseline after 52 weeks of monotherapy is 67.3%. In addition, CM310 can effectively reduce the risk of relapse, with 52-week and 8-week discontinuation relapse rates both at 0.9%, demonstrating good safety and tolerability. Large market space, favorable competitive landscape, and a commercial team of nearly 200 people expected to rapidly advance sales. Dupixent, a drug targeting the same pathway, achieved global sales of $251 million in its first year on the market (2017). It continued to gain approval for multiple indications, achieving high growth in 2023 and 2024H1 with global sales of $11.589 billion (+33%) and $6.66 billion (+27.1%), respectively. The domestic AD market still has significant unmet needs, and with only one IL-4R drug on the market, CM310 is in a favorable competitive position. As of July 2024, the company's commercial team has nearly 200 people and is expected to take advantage of the first-mover advantage, rapidly advance sales, and capture market share. In addition, CM310 has submitted NDAs for two other indications (allergic rhinitis submitted in April 2024, CRSwNP submitted in June 2024 and included in the priority review and approval process), both expected to be approved for market in 2025, further increasing the product's sales peak. Research and development capabilities are gradually gaining recognition, with continuous pipeline expansion and external partnerships. CMG901 was licensed to AZ in 2023, currently in multiple Phase II and Phase III indications including 1L pancreatic cancer, 1L gastric cancer, and post-line gastric cancer, making it one of the world's fastest CLDN18.2ADCs. CM369 and CM355 have reached a commercial partnership with INNOCARE. CM310 and CM326's asthma and COPD indications were licensed to Stone Pharmaceuticals. The self-immune products CM512 & CD536 were licenced to Belenos Biosciences in July 2024. Continuously expanding the pipeline and external partnerships, the research and development capabilities are gradually gaining external recognition, with strong backup forces. Risk warning: Clinical progress is slower than expected, commercialization is slower than expected, and policy risks.