GTJA released a research report stating that it maintains the 'shareholding' rating for Innocare-B (02162), considering the early commercialization of CM310, and raises the 2024 revenue forecast to 0.197 billion yuan (from the original 0.156 billion yuan) while maintaining the 2025-2026 revenue forecast at 0.526/1.441 billion yuan. CM310 (Dupixent biosimilar, traded as Kan Yueta) for moderate to severe AD in adults was approved for listing by the CDE on September 12, filling the gap in the domestic market and becoming the second globally approved IL-4R monoclonal antibody.

GTJA's main opinions include:

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

Phase III clinical data shows that the CM310 monotherapy achieved a 16-week EASI-75 response rate of 66.9%, with a 52-week EASI-75 response rate reaching 92.5%, and an EASI-90 response rate of 77.1%. In terms of sustained relief from itching, the 52-week monotherapy treatment showed a PP-NRS reduction rate of at least 4, reaching 67.3%. In addition, CM310 effectively reduces the risk of relapse, with 52-week and 8-week discontinuation relapse rates both at 0.9%, demonstrating good safety and tolerability.

Furthermore, CM310 has the potential to significantly reduce the risk of relapse, with 52-week and 8-week discontinuation relapse rates both at 0.9%, demonstrating good safety and tolerability. In addition, CM310 has submitted NDAs for two other indications (allergic rhinitis in April 2024, and CRSwNP in June 2024, both included in priority review and approval), expected to be approved for listing in 2025, further enhancing the peak sales of the product.

There is a large market space, a favorable competitive landscape, and a commercialization team of nearly 200 people expected to rapidly advance sales.

The first year of market availability for Dupixent, a drug with the same target, achieved global sales of 0.251 billion US dollars in 2017. Subsequently, it received approvals for multiple indications, with high-speed growth achieved in 2023 and the first half of 2024, reaching global sales of 11.589 billion US dollars (+33%) and 6.66 billion US dollars (+27.1%) respectively. The domestic AD market still has significant unmet potential, with only one IL-4R drug, and a good competitive landscape is expected after the listing of CM310. As of July 2024, the commercialization team of the company has grown to nearly 200 people and is expected to actively capitalize on the first-mover advantage, rapidly drive sales, and capture market share, with the potential for rapid volume growth. In addition, CM310 has submitted NDAs for two other indications (allergic rhinitis in April 2024, and CRSwNP in June 2024, both included in priority review and approval), expected to be approved for listing in 2025, further enhancing the peak sales of the product.

Research and development capabilities are gradually gaining recognition, continuously expanding the pipeline and external authorizations.

In 2023, CMG901 was licensed to AZ and is currently undergoing Phase II clinical trials for first-line pancreatic cancer, first-line gastric cancer, and late-stage gastric cancer, among other indications. It is one of the fastest CLDN18.2ADCs in the world. CM369 and CM355 have reached a commercial collaboration with innocare. CM310 and CM326's indications for asthma and COPD have been licensed to Shiyao. The self-immune product CM512&CD536 was licensed to Belenos Biosciences in July 2024.

Continuously expanding the pipeline and external licensing, the research and development capabilities are gradually recognized by external parties, with strong backup support.

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