Tremfya (Guselkumab), the World’s First IL-23 Monoclonal Antibody, Enters Administrative Review Stage for Imminent China Launch

On December 13, 2019, the technical review of Johnson & Johnson’s blockbuster autoimmune drug Tremfya (guselkumab) was completed. The administrative approval process has now been initiated, and domestic approval in China is expected imminently. The anticipated approved indication is for moderate-to-severe plaque psoriasis. Please refer to acceptance number JXSS1900035.

NMPA

Tremfya (guselkumab) has been included in the first batch of urgently needed overseas new drugs for clinical use, as announced by the National Medical Products Administration (NMPA). On June 22, 2019, the NMPA accepted the marketing application for this drug, with acceptance number JXSS1900035. Merely six months later, the drug entered the administrative approval phase.

I. The First Globally Approved IL-23 Monoclonal Antibody: Tremfya (guselkumab)

Tremfya (guselkumab)

♦ Guselkumab targets the p19 subunit of IL-23, IgG1 lambda 2

♦ Guselkumab vs. Ustekinumab

Guselkumab differs from ustekinumab, another blockbuster autoimmune product from Johnson & Johnson, which is an IL-12/IL-23 monoclonal antibody;

1. The IL-12/IL-23 monoclonal antibody ustekinumab targets the shared p40 subunit of IL-12/IL-23, whereas guselkumab targets the p19 subunit of IL-23;

2. Early market entry and superior efficacy have driven rapid market growth; with sales reaching USD 5.156 billion in 2018 and USD 4.661 billion in the first nine months of 2019, full-year sales are projected to exceed USD 6.5 billion, establishing it as a blockbuster product;

3. Guselkumab surpasses ustekinumab, a development that the author believes was inevitable. Clinical trial data have confirmed that guselkumab is superior to adalimumab and secukinumab in patients with plaque psoriasis, demonstrating sustained clinical benefits. In 2018, guselkumab achieved annual sales of $544 million; in the first nine months of 2019 alone, sales reached $742 million, with full-year sales projected to exceed $1 billion for the first time, thereby establishing it as a blockbuster drug.

J&J

♦ Outstanding Clinical Data: Guselkumab Is a Force to Be Reckoned With in the Plaque Psoriasis Market

J&J

Plaque Psoriasis

ECLIPSE (NCT03090100)

VOYAGE 1 and 2 (NCT02207231 and NCT02207244)

VOYAGE 1 Clinical Data

http://dx.doi.org/10.1016/j.jaad.2016.11.041

J&J

♦ Guselkumab to expand into Crohn’s disease, ulcerative colitis, and other indications

J&J

II. Multiple Global Blockbuster Drugs Enter the Chinese Autoimmune Market

By late 2019 or early 2020, following the approval of Tremfya (guselkumab) in China, all globally blockbuster autoimmune disease therapeutics had become accessible in China. In 2020, the number of drugs in this field will reach 19, including both innovative medicines and biosimilars of etanercept and adalimumab.

Original Title: Market Launch | The World’s First IL-23 Monoclonal Antibody, Tremfya (guselkumab), Is Set to Enter the Chinese Market