Beijing, China, July 19, 2023—Gan & Lee Pharmaceuticals (hereinafter referred to as Gan & Lee, stock code: 603087. SH), is pleased to announce that China’s National Medical Products Administration (NMPA) has cleared Gan & Lee’s Investigational New Drug (IND) application for GLR1023 Injection (hereafter referred as GLR1023). As a proposed biosimilar to Secukinumab (COSENTYX), GLR1023 is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Psoriasis is a chronic, immune-mediated, and recurrent skin disease that can last for decades and affect the physical and mental health of patients. Following the data released by the National Psoriasis Foundation (NPF), it is estimated that 125 million people worldwide have psoriasis. The global prevalence of psoriasis is 2 to 3 percent of the total population and can develop at any age in both males and females^1-2. According to data, the global sales of Secukinumab reached $4.788 billion in 2022³.

Current treatments for psoriasis include topical agents, photo-based therapies, traditional systemic drugs, and biologics. It has been suggested that cytokine-mediated signaling pathways of tumor necrosis factor-α(TNF-α), interleukin-17(IL-17), interleukin-12(IL-12), and interleukin-23(IL-23) play a significant role in the pathogenesis of psoriasis⁴. Therefore, a variety of biologics for the treatment of psoriasis have been developed targeting these cytokines, such as Adalimumab, Secukinumab, and so on.

In comparison with traditional systemic drugs, the biological agent is more effective and convenient in the treatment of moderate to severe plaque psoriasis. In addition, biological agents have fewer side effects and higher clearance rates, showing advantages in the treatment. At present, the biosimilar treating psoriasis in China mainly focuses on TNF-α blockers like adalimumab and infliximab. However, as a new target, IL-17A (member of the IL-17 cytokines family) has a better therapeutic effect and promising market prospects⁵.

Gan & Lee will accelerate the product development of GLR1023, striving to provide a more affordable treatment option with comparable safety, efficacy, and quality to reference products for patients with psoriasis.

References：

1. National Psoriasis Foundation (Psoriasis Statistics). Available at：https://www.psoriasis.org/psoriasis-statistics/

2.Li Huixian,Hu Li,Zheng Yan,et al. Epidemiological burden analysis of psoriasis in China based on the global burden of disease (GBD) big data[J]. Chinese Journal of Dermatology and Venereology, 2021. DOI:10.13735/j.cjdv.1001-7089.202003197.

3. Novartis 2022 Financial Report

4. Greb, J., Goldminz, A., Elder, J. et al. Psoriasis. Nat Rev Dis Primers 2, 16082 (2016).

5. Nash P, McInnes IB, Mease PJ,.etc Secukinumab Versus Adalimumab for Psoriatic Arthritis: Comparative Effectiveness up to 48 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2018 Jun;5(1):99-122. doi: 10.1007/s40744-018-0106-6. Epub 2018 Mar 31.

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have five recombinant insulin analogs commercialized in China including long-acting glargine injection (Basalin^®), fast-acting lispro injection (Prandilin^™), fast-acting aspart injection (Rapilin^®), mixed protamine zinc lispro injection (25R) (Prandilin^™25), aspart 30 injection (Rapilin^®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin^®30). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^®).

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.