Hansoh Pharma's TYK2 Inhibitor Succeeds in Phase III Trial Amid Fierce Competition from Imported, Domestic, and Biologic Therapies: Commercialization Challenges Loom for Its Second Growth Curve

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Hansoh Pharma (03692.HK) Achieves Primary Endpoint in Phase III Clinical Trial of Oral TYK2 Inhibitor, Marking a Significant Milestone in the Field of Autoimmune Diseases

On September 21, Hansoh Pharma announced that its self-developed selective allosteric inhibitor of tyrosine kinase 2 (TYK2), HS-10374, met the co-primary endpoints and multiple secondary endpoints in a pivotal Phase III clinical trial for the treatment of moderate-to-severe plaque psoriasis in adults. The considerable skin lesion clearance observed after 16 weeks of treatment, along with its differentiated oral safety profile, offers a potential new therapeutic option for patients with moderate-to-severe plaque psoriasis.

However, the psoriasis therapeutic arena for HS-10374 is marked by intensifying undercurrents of competition: multiple domestic companies are advancing their TYK2 inhibitors in parallel through clinical development, next-generation overseas products are poised for launch, and biologic agents bolstered by national reimbursement coverage firmly dominate the mainstream market.

For Hansoh Pharma, whose oncology portfolio contributes over 60% of its revenue and which urgently needs to break its reliance on single products, HS-10374 is expected to drive new growth in the autoimmune field. However, whether its efficacy data can translate into commercial returns remains highly uncertain, making the realization of this second growth curve still fraught with variables.

On September 22, a reporter from The Times Weekly contacted Hansoh Pharma’s investor relations department via phone and email regarding the submission timeline for the marketing approval of HS-10374 and its commercialization plans. As of press time, no response had been received.

Oral administration with low toxicity constitutes the core differentiator of HS-10374; commercialization remains the biggest challenge.

According to public data, psoriasis is a chronic, recurrent, inflammatory, systemic immune-mediated disease triggered by the combined effects of genetic and environmental factors. The most common manifestation is plaque psoriasis, accounting for approximately 80%–90% of all psoriasis cases. Psoriasis is difficult to treat; patients often suffer from the condition lifelong, experiencing impaired quality of life and work capacity, with severe cases potentially leading to disability. The prevalence in China is approximately 0.47%–0.5%.

The core indication for HS-10374, which successfully completed Phase III clinical trials by Hansoh Pharma, is moderate-to-severe plaque psoriasis.

Hansoh Pharma announced that its self-developed selective allosteric inhibitor of tyrosine kinase 2 (TYK2), HS-10374, met the co-primary endpoints and multiple secondary endpoints in a pivotal Phase III clinical trial for the treatment of adults with moderate-to-severe plaque psoriasis. At Week 16, the proportion of patients in the HS-10374 group achieving PASI 75 (at least a 75% reduction from baseline in the Psoriasis Area and Severity Index) and sPGA 0/1 (a Static Physician’s Global Assessment score of 0 or 1, with at least a 2-point reduction from baseline) was significantly higher than that in the placebo group. More than half of the patients achieved PASI 90, and nearly one-third achieved PASI 100.

In other words, this means that more than half of the patients achieved near-clearance of skin lesions after 16 weeks of treatment, and nearly one-third of the patients achieved complete clearance.

Hansoh Pharma also stated that it will soon initiate communications with the Center for Drug Evaluation of the National Medical Products Administration to advance preparations for the new drug application of HS-10374 in China, with detailed data scheduled to be presented at upcoming academic conferences in the field of dermatology.

According to Hansoh Pharma, HS-10374 is an oral, highly selective allosteric TYK2 inhibitor. Its mechanism of action involves binding to the pseudokinase (JH2) domain of TYK2, rather than the ATP/JH1 catalytic site targeted by traditional JAK inhibitors, thereby inhibiting TYK2 kinase activity and downstream signaling pathways.

The aforementioned mechanism of action makes the safety profile of this drug one of its key highlights. Relevant academic papers indicate that selective inhibition of TYK2 can, in theory, reduce interference with physiological functions regulated by JAK1/2/3 while preserving anti-inflammatory efficacy, thereby avoiding the systemic toxicity risks associated with traditional JAK inhibitors.

Based on the clinical data for HS-10374, its Phase II trial report indicated that adverse events (AEs) in the category of “skin and subcutaneous tissue disorders” were more common in the placebo group. No acne-related AEs were reported, nor were any risks associated with the boxed warnings for JAK inhibitors, such as major adverse cardiovascular events (MACE), thrombosis, or malignancies. The Phase III clinical study similarly demonstrated a safety profile comparable to that of other TYK2 inhibitors, with no new safety signals observed.

Furthermore, oral administration is another differentiating feature of HS-10374.

Currently, biologics remain the mainstream treatment for moderate-to-severe psoriasis in China. Regarding the application potential of oral small-molecule targeted drugs such as HS-10374, the “Expert Consensus on the Clinical Application of Small-Molecule Targeted Therapies for Moderate-to-Severe Plaque Psoriasis,” published in 2026, indicates that small-molecule targeted therapies, leveraging their unique advantages—including low molecular weight, convenient oral administration, and high patient compliance—fill the therapeutic gap between topical treatments and biologics.

Meanwhile, Professor Tu Ping, Chief Physician of the Department of Dermatology at Peking University First Hospital, pointed out that small-molecule targeted drugs are particularly suitable for psoriasis patients who require systemic therapy but are not candidates for biologics, such as those who travel frequently and cannot receive regular injections or have concerns about injections. They can also be used in patients who have suboptimal response to biologics, experience adverse reactions, or exhibit immune drift.

However, the commercialization of oral drugs in this field has not been smooth. Currently, the only orally administered selective allosteric TYK2 inhibitor approved in China is deucravacitinib from Bristol-Myers Squibb (BMY.N). The drug was approved by the FDA for market launch in September 2022 and received approval in China in October 2023. Nevertheless, its global sales in 2025 amounted to only $291 million, far below the company’s initial peak sales expectation of $4 billion.

Similarly, for Hansoh Pharma, whether the efficacy data of HS-10374 can be translated into commercial returns is a core challenge to be addressed post-launch.

Revenue Structure Relies on a Single Product; Doubts Remain Over HS-10374 Driving the Second Growth Curve

Hansoh Pharma, established in 1995 and listed on the Hong Kong Stock Exchange in June 2019, is an innovation-driven pharmaceutical company. Its core business focuses on five major therapeutic areas: oncology, anti-infectives, central nervous system (CNS), metabolism, and autoimmune diseases.

The interim results for 2026, released on August 26, showed that the company’s total revenue in the first half of the year was approximately RMB 8.304 billion, a year-on-year increase of 11.7%; profit amounted to approximately RMB 4.258 billion, a year-on-year increase of 35.8%; revenue from innovative drugs reached approximately RMB 7.092 billion, accounting for 85.4% of total revenue, hitting a record high, with sales revenue from innovative drug products increasing by approximately 21.6% year on year.

However, it is worth noting that the high growth in innovative drug performance is underpinned by a revenue structure heavily reliant on single products.

The interim report shows that revenue from anti-tumor products amounted to approximately RMB 5.473 billion, accounting for about 65.9% of total revenue. The core single product, aumolertinib (Almonix), has been approved for five indications and was successively approved for marketing in the European Union and Macau in 2026. Cultivating new growth drivers beyond the oncology portfolio has become a pressing challenge currently facing Hansoh Pharma.

However, the psoriasis market in which HS-10374 operates is already highly competitive, both domestically and internationally.

First is the competition from domestically produced drugs in the same category. On July 27, InnoCare Pharma (688428.SH) announced that its independently developed TYK2 inhibitor, fadeucravacitinib (ICP-488), had met the primary endpoint in its Phase III registration study for the treatment of psoriasis, nearly two months ahead of HS-10374.

In addition, Yifang Biotech’s (688382.SH) D-2570 completed enrollment of all participants in its pivotal Phase III clinical trial in March 2026. Wenda Pharma’s WD-890 initiated its Phase III clinical trial in March 2026 and completed full enrollment by August. However, detailed efficacy data from the Phase III trials for both drugs have not yet been disclosed.

Next is the competitive pressure from overseas products. On September 14, the U.S. Food and Drug Administration (FDA) accepted the marketing application for Takeda Pharmaceutical Company Limited’s (TAK.N) next-generation TYK2 inhibitor, zasocitinib (TAK-279), and granted it priority review. In a head-to-head Phase III clinical trial, zasocitinib demonstrated superior efficacy compared to deucravacitinib.

On August 10, 2026, Alumis announced that in the Phase III ONWARD3 extension study of envudeucitinib, the PASI 90 response rate among patients receiving continuous treatment for 48 weeks reached 75%, and the PASI 100 response rate reached 54%, representing the highest long-term clearance rates reported to date among oral TYK2 inhibitors. Alumis plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2026.

Should the aforementioned drugs subsequently enter the Chinese market, they will directly compete with HS-10374 for market share.

Greater pressure stems from biologics. According to a research report by Ping An Securities, the share of biologics in psoriasis treatment is projected to rise from 43.4% in 2022 to 56.8% by 2030. Biologics targeting IL-17, IL-12/23, and IL-23 have all been included in the National Reimbursement Drug List.

In addition, Innovent Biologics’ (01801.HK) picanquimab, 3SBio’s (688336.SH) anmuqitumab, and UCB’s (UCB.BR) bimekizumab have passed the preliminary formal review for drugs outside the 2026 National Reimbursement Drug List. If subsequent negotiations are successful, they are expected to be officially included in the national medical insurance coverage starting January 1, 2027, further expanding the reimbursement landscape for biologics.

Amid fierce competition in the psoriasis field both domestically and internationally, and given the established advantages of biologics in market penetration and insurance coverage, there remains significant uncertainty as to whether Hansoh Pharma’s new drug can truly deliver on its promise as a second growth curve.

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