Sun Pharmaceutical Industries Limited has announced a significant breakthrough in its drug development pipeline for psoriatic arthritis. The company's Phase 3 clinical trials for Tildrakizumab 100 mg, marketed as ILUMYA®, have successfully met their primary endpoint in the treatment of active psoriatic arthritis.

Trial Results

The INSPIRE-1 and INSPIRE-2 studies, both global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials, evaluated the efficacy and safety of Tildrakizumab 100 mg in adult patients with active psoriatic arthritis. Key findings include:

• Both studies achieved their primary endpoint, with a statistically significant improvement in ACR20 response rates at Week 24 compared to placebo (p < 0.05).
• The safety profile was consistent with the known safety profile of ILUMYA, with no new safety signals identified.
• Over 800 adult patients participated in the trials, conducted across clinical sites in the US, Europe, and Asia.

Study Design

The trials had distinct patient populations:

• INSPIRE-1: Enrolled patients with prior exposure to an anti-TNF agent
• INSPIRE-2: Enrolled anti-TNF naïve patients

Patients received either Tildrakizumab 100 mg or placebo, with the active drug administered at Week 0 and then every 12 weeks. This differs from the dosing schedule used in chronic plaque psoriasis trials, which included doses at Week 0, Week 4, and then every 12 weeks.

Implications for Psoriatic Arthritis Treatment

Dr. Marek Honczarenko, Senior Vice President and Head of Global Specialty Development at Sun Pharma, expressed enthusiasm about the results: "These top-line results reinforce the therapeutic potential of ILUMYA as a treatment option for patients with active psoriatic arthritis."

Psoriatic arthritis, a chronic immune-related disease affecting approximately 1 in 3 people living with psoriasis, causes swelling, pain, and stiffness in joints and entheses. The positive results from these trials suggest that ILUMYA could potentially offer a new treatment option for the estimated 2.4 million Americans living with this condition.

Regulatory Outlook

While ILUMYA is currently approved for the treatment of moderate-to-severe plaque psoriasis in adults, its use in psoriatic arthritis is not yet approved. Sun Pharma plans to use these results to support potential regulatory submissions for ILUMYA in the treatment of active psoriatic arthritis in the US.

The company plans to present detailed findings from the INSPIRE studies at upcoming medical conferences and publish them in a peer-reviewed medical journal.

As Sun Pharma continues to expand its specialty portfolio, which currently accounts for about 20% of company sales, the success of these trials marks a significant step forward in addressing the unmet needs of patients with psoriatic arthritis.

Disclaimer: ILUMYA® (tildrakizumab-asmn) is currently only approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Its use in psoriatic arthritis is investigational and not approved by regulatory authorities.

Sun Pharmaceutical Industries Limited , one of India's leading pharmaceutical companies, has announced a significant expansion into the Chinese market with the establishment of a new subsidiary. The move marks a strategic step for the company as it seeks to strengthen its global presence and tap into one of the world's largest pharmaceutical markets.

New Subsidiary Details

According to a regulatory filing, Sun Pharma has incorporated a new subsidiary named Sun Pharma (Hainan) Company Limited in China. The subsidiary was officially registered on July 16, 2025, as per the company's intimation to the stock exchanges under SEBI regulations.

Strategic Objectives

The primary objective of this new subsidiary is to facilitate the localization of Sun Pharma's products in China. As stated in the regulatory filing, the newly set-up company will focus on:

• Localizing products for the Chinese market
• Collaborating with prospective partners in China for production
• Conducting sales locally within the Chinese market

This move aligns with Sun Pharma's global expansion strategy and its aim to establish a stronger foothold in key international markets.

Ownership and Structure

Sun Pharmaceutical Industries Limited will maintain full control over the new subsidiary, owning 100% equity either directly or through its existing subsidiaries. This structure ensures that Sun Pharma retains complete oversight of its operations in China.

Market Implications

The establishment of a dedicated subsidiary in China represents a significant opportunity for Sun Pharma:

1. Market Access: It provides direct access to the vast Chinese pharmaceutical market, potentially boosting the company's global revenue streams.
2. Local Production: By localizing production through partnerships, Sun Pharma can potentially reduce costs and adapt more quickly to local market demands.
3. Regulatory Compliance: A local presence may help navigate China's complex regulatory environment more effectively.

Industry Context

This expansion comes at a time when many global pharmaceutical companies are looking to increase their presence in China. The country's growing healthcare sector, large population, and increasing focus on healthcare reform make it an attractive market for pharmaceutical investments.

Sun Pharma's move into China demonstrates the company's commitment to global growth and its ability to identify and act on strategic opportunities in key markets. As the company establishes its operations in China, industry observers will be keen to see how this expansion impacts Sun Pharma's overall performance and market position in the coming years.

The company has not disclosed financial details or specific product plans for the new subsidiary at this time. Investors and industry analysts will likely watch closely for further updates on Sun Pharma's Chinese operations and their impact on the company's global strategy.