The Zhitong Finance App learned that Guotai Junan released a research report stating that it maintained the Conoa-B (02162) “gain” rating and raised the 2024 revenue forecast by 0.197 billion yuan (originally 0.156 billion yuan) to maintain the 2025-2026 revenue forecast of 0.526/1.441 billion yuan, considering the early commercialization of CM310. CM310 (supuximab, trade name: Kang Yueda) for moderate to severe AD indications for adults was approved and marketed by the CDE on September 12. It became the first IL-4R monoclonal antibody approved in China and the second in the world, filling the gap in the field of domestically produced AD biologics.

Guotai Junan's main views are as follows:

CM310 is the first domestically produced IL-4R monoclonal antibody with excellent efficacy and good safety.

Phase III clinical data showed that the response rate for EASI-75 in 16 weeks of CM310 was 66.9%, the response rate for EASI-75 at 52 weeks was 92.5%, and the response rate for EASI-90 was 77.1%. In terms of continuous relief of itching, the response rate of 52w PP-NRS with single medication decreased by ≥4 compared to baseline by 67.3%. Furthermore, CM310 can effectively reduce the risk of recurrence. The 52-week recurrence rate and 8-week discontinuation rate were 0.9%, showing good safety and tolerability.

The market space is large and the competitive pattern is good, and the commercialization team of nearly 200 people is expected to rapidly promote sales.

The target drug Dupixent achieved global sales of $0.251 billion in the first year of marketing (2017). Since then, multiple indications have been approved, and rapid growth was achieved in 2023 and 2024H1. Global sales were $11.589 billion (+33%) and $6.66 billion (+27.1%), respectively. Currently, there is still a lot of unsatisfied space in the domestic AD market, and only Dapituo IL-4R is on sale, and the competitive pattern was good after the CM310 was launched. As of 2024.7, the company's commercialization team is close to 200 people. It is expected to actively seize the first-mover advantage, rapidly promote sales and seize market share, and is expected to expand rapidly. In addition, two other indications for CM310 have also been submitted for NDA. (Allergic rhinitis 2024.4, CRSWnP2024.6 submitted and included in priority review and approval) are all expected to be approved for listing in 2025, further increasing the peak of product sales in the future.

R&D capabilities were gradually recognized, and pipelines and external licensing continued to be expanded.

CMG901 was authorized to AZ in 2023. It is currently developing multiple indications such as stage II 1L pancreatic cancer, 1L gastric cancer, and stage III post-line gastric cancer, making it one of the fastest CLDN18.2 ADCs in the world. CM369 and CM355 have reached a commercial cooperation with Nuochengjianhua. CM310 and CM326 are authorized stone medicines for asthma and COPD indications. The free product CM512 & CD536 authorized Belenos Biosciences on 2024.7. Continued pipeline expansion and external licensing, R&D capabilities are gradually being recognized by the outside world, and the reserve capacity is strong.

Risk warning: Clinical progress falls short of expectations, commercialization falls short of expectations, policy risks.