pumecitinib gel (PG-011 gel) / PrimeGenX Therapeutics, Simcere - LARVOL DELTA

SIMCERE PHARMA (02096.HK) announced that the Group entered into an exclusive promotion service agreement with PrimeGenX Therapeutics in relation to Pumecitinib Gel. (iis.aastocks.com) - "Pursuant to the Agreement, the Group will obtain the exclusive promotion rights for Pumecitinib Gel for all dermatology indications in Mainland China, Hong Kong, and Macau....This collaboration will further strengthen the Group’s product portfolio in the field of autoimmune diseases."

Licensing / partnership • Atopic Dermatitis • Immunology

The New Drug Application (NDA) of Pumecitinib Gel for the indication of atopic dermatitis (AD) in adults and adolescents has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. (iis.aastocks.com)

China filing • Atopic Dermatitis

PrimeGenX Therapeutics…made an initial public offering (IPO) filing to the Hong Kong Stock Exchange (flcube.com) - "The filing covers its core product, pumecitinib (G‑011), a locally delivered JAK inhibitor in gel and nasal spray formulations, along with a pipeline targeting atopic dermatitis, allergic rhinitis, and other autoimmune conditions."

Commercial • Allergic Rhinitis • Atopic Dermatitis

Efficacy and Safety of Pumecitinib Gel for Treating Mild-to-moderate Atopic Dermatitis: a Multicentre, Randomised, Double-blind, Parallel, Placebo-controlled Phase IIb Clinical Trial. (PubMed, Br J Dermatol) - "The 3% pumecitinib gel showed good efficacy and safety profiles treating mild-to-moderate AD in adults. The pumecitinib BID treatment regimen demonstrated greater efficacy than the QD regiment to treat AD. Pumecitinib gel was well tolerated and generated low systemic drug exposure when used topically. It can be a new choice of topical JAK inhibitors for treating AD."

Journal • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of the safety, tolerability, and pharmacokinetic profile of PG-011 Gel in healthy adolescent participants (ChiCTR) - P1 | N=30 | Completed | Sponsor: Shulan (Hangzhou) Hospital; Shulan (Hangzhou) Hospital | Not yet recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis (clinicaltrials.gov) - P3 | N=472 | Recruiting | Sponsor: Prime Gene Therapeutics Co., Ltd.

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology