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Treatment areas confirmed

Lundbeck has announced to first target TED and MS with APB-A1. The phase II study for TED should begin in 3Q24. Showing confidence in the CD40L pipeline, the firm sees superiority to IGF-1R inhibitors and FcRn drugs. We expect AprilBio to become a major player in the domestic autoimmune disease market, alongside HanAll Biopharma.

To begin with TED and MS

Highlights of a conference call with Lundbeck include: 1) pharmacokinetics (PK) results and proof of safety in the phase I study for APB-A1, a neutralizing anti-CD40L antibody-like drug candidate, the beginning of phase II for thyroid eye disease (TED) in 3Q24, and the addition of multiple sclerosis (MS) to its treatment area list; 2) anti-CD40L antibody’s blocking of B and T cell activation signals, implying that the two above indications are the right choices, as both B and T cells are directly involved in the diseases; 3) its superiority to IGF-1R inhibitors and anti-FcRn drugs in TED; and 4) no risk of embolism.

Estimated at US$21bn in 2023 and US$25bn in 2028, the MS market is sizeable. Leading the market is Roche’s Ocrevus, a humanized anti-CD20 monoclonal antibody. At EULAR 2023, Sanofi’s anti-CD40L antibody frexalimab showed efficacy in MS. We see increasing probability of success for the CD40L pipeline.

In the US, the TED treatment drug market is forecast at US$5.2bn in 2028, and APB-A1 is the first CD40L-targeting TED drug. The TED treatment market is currently led by IGF-1R inhibitors (Tepezza) and anti-FcRn drugs. Novartis’s CD40L inhibitor iscalimab delivered statistically meaningful results in terms of TSH-R-Ab reduction in phase II trials on Graves’ disease, and it may also prove effective as a treatment for TED. In the conference call, Lundbeck disclosed data showing the CD40L inhibitor’s superiority to IGF-1R inhibitors and anti-FcRn drugs against TED.

AprilBio following the footsteps of HanAll Biopharma

AprilBio’s cash holdings stand at W70bn (including W15bn in CBs). We expect the firm to become a main player in the domestic autoimmune diesease market along with HanAll Biopharma. There exists ample potential for the firm’s APB-A1 to be developed as an anti-cancer treatment and treatment for autoimmune diseases (Sjogren syndrome, lupus), for which Amgen and Sanofi are also conducting trials on CD40 inhibitors.