Sun Pharma is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company. A vertically integrated business and a skilled team enable it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7-8% of annual revenues in R&D.
In May 2023, the New Drug Application (NDA) of Tildrakizumab Injection under the brand name of ILUMETRI has been approved by the National Medical Products Administration of China (NMPA). ILUMETRI is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMETRI has patents on composition and formulation in China.
The results of the extended study of its Phase III clinical trial in China demonstrated that the primary efficacy assessment indicator PASI 75 response rate continued to increase over treatment time. The PASI 75 response rate reached a high level after 28 weeks of treatment with ILUMETRI and maintained at 91.3% at week 52, and ILUMETRI showed good long-term safety and tolerance. ILUMETRI only needs to be administered 4 times a year during maintenance treatment period, which may bring higher patient compliance.
The incidence of psoriasis in China is about 0.47%, with the number of patients exceeding 7 million, of which more than 30% have developed into moderate-to-severe disease. ILUMETRI will provide moderate-to-severe plaque psoriasis patients with a safe and effective treatment option.
Cyclosporine Eye Drops 0.09% is a nanotechnology-enabled formulation in a clear solution. It uses a unique tiny structure called “micelle” as the vehicle to allow for greater tissue penetration and gentle side effect profiles in a high concentration. The product has been approved for marketing in the U.S., Australia and Canada.
In May 2021, the Group completed the enrollment of all 384 subjects for the phase III bridging trial in China, which only took around 4 months (including the Chinese Spring Festival).
The U.S. FDA approval was based on data from a multi-center, randomized, double-blind, vehicle-controlled phase III confirmatory study conducted on 744 patients with dry eye. After 12 weeks of treatment, as compared to vehicle, Cyclosporine Eye Drops 0.09% showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production) (p<0.01). Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after the initiating treatment.
The incidence of dry eye in China is 21%-30%, 40% of which are moderate-to-severe patients (about 118-168 million people). Although various symptom alleviating agents such as artificial tears are available in the market, there are few satisfactory options in practice. In addition, in terms of ophthalmic cyclosporine, related treatment options are still limited due to the historic challenge of making an optic formulation of this agent at a suitable concentration without increasing side effects. Cyclosporine Eye Drops 0.09% is expected to meet this clinical need and provide a safe and effective treatment option for patients with dry eye.
