The Oral TYK2 Race Heats Up: InventisBio Unveils Phase III Data

SHANGHAI, China – November 02, 2026 – The landscape of autoimmune treatment is undergoing a seismic shift. For years, the gold standard for treating moderate-to-severe plaque psoriasis has been biologic injections—highly effective but burdened by patient reluctance, cold-chain logistics, and high costs. Oral alternatives existed, but they historically forced a compromise between safety and efficacy. Today, that compromise appears to be vanishing.

InventisBio Co., Ltd., a clinical-stage biopharmaceutical company, announced topline results from its registrational Phase III clinical trial of nomelcitinib (D-2570), an oral, JH2-selective TYK2 inhibitor. The data not only met primary and secondary endpoints but did so with numbers that demand the attention of the global pharmaceutical industry. At week 16, over 70% of patients treated with nomelcitinib achieved at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90), and over 80% achieved a Physician Global Assessment (PGA) score of 0 or 1, indicating clear or almost clear skin. Both endpoints demonstrated statistical significance (p<0.0001) over placebo.

As companies leverage novel manufacturing and strategic partnerships to navigate a world in flux, these results validate nomelcitinib as a potent, oral selective TYK2 inhibitor. More importantly, they position InventisBio to compete directly with existing oral psoriasis standards, signaling a new era in the industrialization of autoimmune therapies.

A New Challenger to Sotyktu: Inside the Oral TYK2 Race

The oral TYK2 inhibitor class is currently one of the most fiercely contested battlegrounds in immunology. The pathway targets IL-23, IL-12, and Type 1 interferon signaling—critical drivers of psoriasis—without triggering the broad immunosuppression associated with older, less selective Janus kinase (JAK) inhibitors.

Bristol Myers Squibb opened this frontier in September 2022 with the FDA approval of deucravacitinib (Sotyktu), the first-in-class oral, selective, allosteric TYK2 inhibitor. However, a close look at the clinical benchmarks reveals why InventisBio’s new data is turning heads. In Sotyktu’s pivotal POETYK PSO-1 and PSO-2 Phase III trials, PASI 90 rates at week 16 were 36% and 27%, respectively.

By reporting PASI 90 rates exceeding 70% at the same 16-week mark, nomelcitinib is demonstrating efficacy that rivals injectable biologics. This performance also outpaces other next-generation TYK2 inhibitors in advanced development. For context, Takeda’s zasocitinib achieved PASI 90 rates of 61.3% and 51.9% at week 16 in its Phase III trials, while Alumis’ envudeucitinib reported rates of 59.9% and 53.1%.

"We are very excited about the topline results of this registrational phase III study. This study confirmed the magnitude of improvement in PASI 90 and PGA 0/1 seen in our earlier Phase II study, while all other secondary efficacy endpoints maintained significant improvement over the placebo group," said Ling Zhang, CMO of InventisBio. "Importantly, the safety profile is matching that of our Phase II study with no new safety signals."

The safety aspect is critical. Nomelcitinib exhibits nearly 1,000-fold selectivity over JAK1 in preclinical evaluations. By selectively binding to the JH2 pseudokinase domain of TYK2, the drug is designed to avoid the major adverse cardiovascular events (MACE) and thromboembolism (VTE) that have plagued the broader JAK inhibitor class. InventisBio is not shying away from direct comparisons; an active-controlled Phase III trial pitting nomelcitinib head-to-head against deucravacitinib is already underway, setting the stage for a dramatic showdown in the dermatology market.

China's Domestic Innovation Closes the Efficacy Gap

From a strategic business perspective, nomelcitinib's success is a testament to the maturation of China’s biotechnology sector. Historically, Chinese biopharma companies were viewed as "fast followers," primarily focused on developing me-too drugs for oncology. InventisBio’s trajectory illustrates a profound shift toward first-in-class or best-in-class immunology candidates capable of competing on the global stage.

Regulatory reforms by China’s National Medical Products Administration (NMPA) have catalyzed this transition, aligning domestic clinical trial standards with international expectations and accelerating the approval of innovative therapies. InventisBio, leveraging comprehensive platforms—from computer-aided drug design to high-throughput screening and translational medicine—has independently developed a molecule that addresses a massive unmet global medical need.

"What we are seeing is the closing of the innovation gap," noted a healthcare policy analyst tracking APAC biotech innovation. "A decade ago, a Chinese biotech firm producing a small molecule that outperforms a multinational's flagship autoimmune drug in late-stage trials would have been an anomaly. Today, it is a clear indicator of the region's robust R&D capabilities and strategic focus on global commercialization."

InventisBio holds global rights to nomelcitinib. While the company is well-positioned for a New Drug Application (NDA) with the NMPA in China, it is simultaneously executing a Phase II psoriasis study in the United States. This dual-track approach highlights a sophisticated commercialization strategy aimed at securing lucrative international partnerships.

Oral Alternatives to Injections: The Patient Impact

Beyond the corporate maneuvering and competitive benchmarking lies the profound impact this innovation will have on patient care. Moderate-to-severe plaque psoriasis is a chronic, systemic inflammatory disease that exacts a heavy toll on physical health and psychological well-being.

For patients, the difference between an oral pill and a biologic injection is not merely a matter of convenience; it fundamentally alters treatment adherence and quality of life. The Phase III trial, which evaluated 391 patients randomized across two nomelcitinib treatment arms and a placebo arm, demonstrated a rapid onset of action. By week 4, statistically significant efficacy divergence from placebo was already observed for both PASI 90 and PGA 0/1.

"Achieving a 90 percent clearance of skin lesions by week 16 with a daily pill is a transformative milestone," explained a clinical dermatologist familiar with the TYK2 landscape. "Patients are often hesitant to initiate biologic therapies due to needle phobia or the logistical burdens of specialty pharmacies and refrigeration. If we can offer biologic-level clearance in a highly selective, well-tolerated oral format, we will likely see a paradigm shift where oral therapies become the definitive frontline intervention rather than a stepping stone."

The consistent safety profile across trials further de-risks the asset for patients and prescribers alike. With no serious adverse events reported and the majority of adverse events classified as mild to moderate, nomelcitinib is building a compelling case for chronic, long-term use.

Expanding the Autoimmune Horizon

The implications of InventisBio’s breakthrough extend far beyond psoriasis. TYK2 signaling is implicated in a wide array of immune-mediated inflammatory diseases. Capitalizing on the molecule's favorable safety and efficacy profile, the company is aggressively expanding its clinical development pipeline.

Multiple Phase II studies are currently underway in China evaluating nomelcitinib for ulcerative colitis (UC), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE), and vitiligo. Each of these indications represents a multi-billion-dollar market plagued by suboptimal standard-of-care options. If the selectivity and potency demonstrated in the psoriasis trials translate to these complex systemic diseases, nomelcitinib could become a foundational therapy across the immunology spectrum.

The ongoing head-to-head trial against deucravacitinib will be the ultimate proving ground. As the data matures and regulatory submissions approach, the biopharma industry will be watching closely. The successful industrialization of such highly selective, potent oral therapies underscores a broader technological revolution in drug design—one that promises to rewrite the rules of autoimmune disease management and redefine the competitive hierarchy of the global pharmaceutical market.