CMS-D001 / China Medical System, Dermavon - LARVOL DELTA

A single-center, randomized, open-label, two-period, two-sequence crossover clinical study to evaluate the effect of food on the pharmacokinetic characteristics of CMS-D001 tablets in healthy participants. (ChiCTR) - P=N/A | N=18 | Not yet recruiting | Sponsor: Beijing Friendship Hospital ,Capital Medical University; Hainan Dermavon Pharmaceutical Technology Co., Ltd.

New trial

China Medical System Holdings Limited has received approval from China’s National Medical Products Administration to conduct clinical trials of its innovative oral drug CMS-D001 for systemic lupus erythematosus (TipRanks)

New trial • Systemic Lupus Erythematosus

A Single-Center, Open-Label, Self-Controlled Clinical Study to Evaluate the Drug-Drug Interaction (DDI) of CMS-D001 with Itraconazole or Rifampicin in Healthy Participants (ChiCTR) - P1 | N=32 | Not yet recruiting | Sponsor: Beijing Friendship Hospital ,Capital Medical University; Hainan Dermavon Pharmaceutical Technology Co., Ltd.

New P1 trial

CMS…announced that its innovative drug CMS-D001 tablets have received approval from the National Medical Products Administration (NMPA) to commence clinical trials to evaluate the safety and efficacy of CMS-D001 for the treatment of ulcerative colitis and Crohn's disease (iis.aastocks.com)

New trial • Crohn's disease • Ulcerative Colitis

A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study evaluating the efficacy and safety of CMS-D001 in patients with moderate to severe atopic dermatitis (ChiCTR) - P2 | N=160 | Sponsor: China-Japan Friendship Hospital; Hainan Dermavon Pharmaceutical Technology Co., Ltd.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CMS-D001 Tablets in Adult Patients with Moderate to Severe Plaque Psoriasis. (ChiCTR) - P2/3 | N=540 | Sponsor: Shandong First Medical University Affiliated Dermatology Hospital; Dermavon Holdings Limited

New P2/3 trial • Dermatology • Immunology • Psoriasis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Dermavon Holdings Limited

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Clinical Study Evaluating the Efficacy and Safety of CMS-D001 Tablets in the Treatment of Adult Patients With Moderate to Severe Plaque-type Psoriasis (clinicaltrials.gov) - P2/3 | N=540 | Not yet recruiting | Sponsor: Dermavon Holdings Limited

New P2/3 trial • Dermatology • Immunology • Psoriasis

Study on the material balance of [14C] CMS-D001 in Chinese healthy adult male participants (ChiCTR) - P1 | N=8 | Not yet recruiting | Sponsor: Beijing Gaobo Hospital; Hainan Demai Pharmaceutical Technology Co., Ltd

New P1 trial

A multicenter, randomized, double-blind, placebo-controlled phase Ib clinical study assessing the efficacy and safety of CMS-D001 in patients with moderate to severe plaque psoriasis. (ChiCTR) - P1 | N=60 | Not yet recruiting | Sponsor: China-Japan Friendship Hospital; Hainan Dermavon Pharmaceutical Technology Co., Ltd.

New P1 trial • Dermatology • Immunology • Psoriasis

IND Approval: CMS’s Self-developed Innovative Drug Highly Selective TYK2 Inhibitor CMS-D001 is Approved for Drug Clinical Trials for Atopic Dermatitis Indication (CMS Press Release) - "China Medical System Holdings Limited (the 'Group' or 'CMS') is pleased to announce that innovative drug CMS-D001 tablets ('CMS-D001')...has been granted approval for drug clinical trials by National Medical Products Administration of the People’s Republic of China ('NMPA') on 11 July 2025. The NMPA grants the consent to conduct a clinical trial evaluating the safety and efficacy of CMS-D001 for the treatment of atopic dermatitis (AD)."

New trial • Atopic Dermatitis

A randomized, double-blind, placebo-controlled, single or multiple dose escalation and food effect (open) Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of CMS-D001 in healthy subjects (ChiCTR) - P1 | N=80 | Recruiting | Sponsor: Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital); Hainan Kangzhe Beauty Technology Co., Ltd.

New P1 trial • Dermatology • Immunology • Psoriasis