InventisBio (Shanghai) Co., Ltd. (SHA: 688382) announced that the registrational Phase III clinical study of nomelcitinib (D‑2570), its self‑developed novel oral selective TYK2 JH2 inhibitor, has met its primary endpoint and key secondary endpoints in the treatment of moderate‑to‑severe plaque psoriasis, positioning the company for a potential new drug application with China’s National Medical Products Administration (NMPA).
Trial Milestone
| Item | Detail |
|---|---|
| Sponsor | InventisBio (SHA: 688382) |
| Investigational Product | Nomelcitinib (D‑2570) – novel oral selective TYK2 JH2 inhibitor |
| Study Type | Registrational Phase III – multicenter, randomized, double‑blind, placebo‑controlled |
| Indication | Moderate‑to‑severe plaque psoriasis |
| Primary Endpoint | PASI 90 at Week 16 – met |
| Key Secondary Endpoint | PGA 0/1 at Week 16 – met |
| Announcement Date | 2 Nov 2026 |
| Filing Timeline | Not disclosed |
Drug Profile & Mechanism of Action
- Molecule: Nomelcitinib (D‑2570), a self‑developed oral selective inhibitor targeting the TYK2 JH2 (pseudokinase) domain.
- Target Biology: Tyrosine kinase 2 (TYK2) mediates signaling of key psoriasis‑driving cytokines, including IL‑23, IL‑12, and type I interferons; allosteric JH2‑domain inhibition selectively dampens this inflammatory axis while sparing broader JAK family functions – a mechanism class associated with a differentiated safety profile versus pan‑JAK inhibitors.
- Formulation Advantage: An oral therapy offering a systemic, pill‑based alternative to injectable biologics in moderate‑to‑severe disease.
- Class Positioning: Joins a small group of validated selective TYK2 JH2 inhibitors, with nomelcitinib as a China‑originated asset in the class.
Clinical Evidence – Phase III Trial
| Endpoint | Result (Nomelcitinib, both dose groups) | Comparator (Placebo) | Relative Benefit |
|---|---|---|---|
| PASI 90 @ Week 16 (Primary) | >70% of patients | Significantly lower | Statistically significant superiority |
| PGA 0/1 @ Week 16 (Key Secondary) | >80% of patients | Significantly lower | Statistically significant superiority |
| Other Secondary Endpoints | Consistently outperformed placebo | – | Clinical and statistical significance achieved |
| Onset of Action | Separation from placebo at Week 4 (PASI 90 and PGA 0/1), with efficacy improving over time | – | Rapid onset |
| Safety | Favorable safety and tolerability profile; no new safety signals | – | Consistent with prior Phase II trials and other selective TYK2 JH2 inhibitors |
The trial enrolled a total of 391 patients with moderate‑to‑severe plaque psoriasis, randomized 1:1:1 to two nomelcitinib treatment groups or placebo across multiple centers, providing the pivotal evidence base for registration.
Market Impact & Outlook
- Registrational Momentum: Meeting the primary and key secondary endpoints clears the major hurdle for an NDA submission to the NMPA, with filing timing not yet disclosed.
- Best‑in‑Class Potential: A PASI 90 response above 70% and PGA 0/1 above 80% at Week 16 in both dose groups places nomelcitinib among the more efficacious oral agents reported in plaque psoriasis.
- Oral Alternative to Biologics: Strong efficacy with a favorable safety profile and rapid onset from Week 4 could shift treatment sequencing toward oral therapy earlier in the moderate‑to‑severe patient journey.
- Class Validation: Consistency with previous Phase II results and the broader selective TYK2 JH2 inhibitor class de‑risks the asset ahead of regulatory review.
- Pipeline Value: As a self‑developed molecule, nomelcitinib strengthens InventisBio’s position in immunology and creates potential for label expansion into additional TYK2‑driven inflammatory indications.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory submissions, review timelines, and commercial expectations for nomelcitinib (D‑2570). Actual results may differ materially due to risks including NMPA review outcomes, long‑term safety data, competitive dynamics in the psoriasis market, and commercialization execution. Trial results are as reported in the company’s 2 Nov 2026 announcement; detailed subgroup and endpoint data will be presented at upcoming scientific venues.-Fineline Info & Tech
