Celltrion Makes Progress in COVID-19 Treatment Development
The authors are analysts of Shinhan Investment Corp. They can be reached at shawn1225@shinhan.com and jhwon@shinhan.com, respectively. – Ed.
1) Rituximab biosimilar M/S: Truxima 21.9% vs. Ruxience 17.8%
According to the US biosimilar prescription data for October, Celltrion’s Rituximab biosimilar Truxima expanded its presence by 1.5%p MoM to 21.9%, easing concerns over slowdown in market share growth. Worries remain over continued market share gains (over 3%p MoM) by competing product Ruxience, which represented 17.8% of October prescriptions. However, we believe that the process of switching to Ruxience at medical clinics has now ended. Such switching is typical after the launch of a new biosimilar as reimbursement is calculated based on wholesale acquisition cost (WAC) rather than ASP for the first six months. Truxima’s inclusion on United Health Group’s preferred drug list in October also added a boost to its market share, which should grow at a faster pace going forward.
① Remicade (Infliximab) biosimilar market share (100mg):
Inflectra (Celltrion) 11.2% (-0.1%p MoM)
Renflexis (Samsung Bioepis) 6.2% (+0.1%p MoM)
② Rituxan (Rituximab) biosimilar market share (10mg):
Truxima (Celltrion) 21.9% (+1.5%p MoM)
Ruxience (Pfizer) 17.8% (+3.7%p MoM)
③ Herceptin (Trastuzumab) biosimilar market share (10mg):
Kanjinti (Amgen) 38.9% (+4.9%p MoM)
Ogivri (Mylan) 7.9% (+1.0%p MoM)
④ Avastin (Bevacizumab) biosimilar market share (10mg):
Mvasi (Amgen) 50.5% (+4.9%p MoM)
Zirabev (Pfizer) 8.4%(+1.7%p MoM)
2) Celltrion completes COVID-19 treatment administration in global phase II clinical trials
On November 25, Celltrion announced that it has completed the administration of CT-P59 (regdanvimab), a COVID-19 antibody treatment candidate, to 327 patients enrolled in global phase II clinical trials. After obtaining approval for phase II/III clinical trials from the Korean Ministry of Food and Drug Safety (MFDS) in September, the company started phase II clinical trials in multiple countries, including Korea, the US, Spain, and Romania. The trials enrolled patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration). The candidate’s efficacy, safety, and proper dose level should be confirmed upon the release of interim results. Celltrion is forecast to apply for conditional approval from the MFDS based on interim phase II data and conduct phase III clinical trials in about ten countries.
The news sent shares in Celltrion up 9.45%, Celltrion Healthcare 8.32%, and Celltrion Pharm 25.27% on the same day. Once conditional approval is received, Celltrion should be able to start selling the treatment in the domestic and global markets as early as the beginning of 2021. The company plans to produce enough of the COVID-19 drug to treat about 1.5mn-2mn patients per year, which some worry will cause an inventory shortage for existing products. But we believe such concerns were dispelled after Celltrion’s preemptive supply of major biosimilar products (Remsima SC, etc.) to Celltrion Healthcare for inventory build-up was confirmed through its 3Q20 earnings release.