IPO News | Pugi Pharmaceutical Files for Hong Kong Listing, Core Product Pumicitinib Gel Completes Phase III Clinical Trial

Stock News
01/22

Beijing Pugi Pharmaceutical Technology Co., Ltd. (Pugi Pharmaceutical) has submitted a listing application to the Main Board of the Hong Kong Stock Exchange, with CITIC Securities and CMBC Capital acting as joint sponsors.

The prospectus reveals that Pugi Pharmaceutical is a biotechnology company focused on the immunology and inflammation field, aiming to become a leader in locally delivered targeted therapies. Since its establishment in 2016, the company has leveraged its core competencies in innovative original design and precise local delivery to deeply cultivate the chronic inflammatory disease treatment arena, striving to provide innovative solutions that offer efficacy, safety, and long-term patient satisfaction. Based on a deep understanding of immune inflammation-related signaling pathways, the company has identified that the core pathological processes of many chronic diseases are highly correlated with the synergistic effects of extracellular immune signal transduction and transcriptional regulation, and immune cell activation regulatory pathways. This insight has led to an innovative product pipeline with first-in-class potential, utilizing originally designed molecules to target multiple indications with significant unmet medical needs.

Leveraging this deep understanding of signaling pathways and an integrated innovative drug R&D system, Pugi Pharmaceutical has developed its late-stage core product PG-011 (Pumicitinib), which has two formulations: Pumicitinib Gel for atopic dermatitis and Pumicitinib Nasal Spray for allergic rhinitis. The company also boasts a diversified candidate product portfolio, including PG-033 tablets for pruritus, PG-018 tablets for autoimmune kidney disease, and PG-040 eye drops for glaucoma. The company is actively exploring expanding the indications for Pumicitinib to include perennial allergic rhinitis, prurigo nodularis, and non-segmental vitiligo.

Pumicitinib Gel: As the world's first JAK inhibitor gel for treating atopic dermatitis, the company has completed Phase III clinical trials for the adult and adolescent (ages 12-17) atopic dermatitis indication, pending submission of a New Drug Application. The company is currently expanding the indication of Pumicitinib Gel to treat atopic dermatitis in children aged 2 to 11.

Pumicitinib Nasal Spray: As the world's first clinical-stage JAK inhibitor nasal spray for treating seasonal allergic rhinitis (SAR), it is currently in Phase III clinical trials for the adult SAR indication. The company is also expanding its indications to treat SAR in adolescents (12-17 years old) and perennial allergic rhinitis (PAR) in adults.

PG-033 Tablets: A potential first-in-class transient receptor potential vanilloid subtype 3 (TRPV3) inhibitor that inhibits calcium ion release channels and blocks the itch signaling pathway, currently in Phase I clinical studies. Beyond treating pruritus associated with neurodermatitis, the company is expanding PG-033's indications to relieve refractory pruritus and hyperkeratosis associated with Olmsted syndrome, a genetic disease triggered by over-activation of the TRPV3 gene, for which there are currently no approved treatments, representing a pressing unmet medical need.

PG-018 Tablets: A potential first-in-class JAK1-ROCK dual-target inhibitor for treating autoimmune kidney disease, simultaneously targeting JAK1 and Rho-associated coiled-coil containing protein kinase (ROCK), currently in Phase I clinical studies. PG-018 is designed to inhibit abnormally activated immune function by acting on JAK1 and to lower blood pressure by acting on ROCK. By targeting two pathogenesis mechanisms simultaneously, PG-018 is expected to bring synergistic clinical benefits for treating autoimmune kidney diseases such as membranous nephropathy and IgA nephropathy.

PG-040 Eye Drops: A potential first-in-class ROCK-JAK dual-target eye drop, representing a new treatment option for glaucoma. It aims to reduce intraocular pressure (IOP) by inhibiting ROCK while achieving an anti-inflammatory effect by inhibiting JAK. Compared to traditional glaucoma therapies that primarily focus on lowering IOP, this drug is expected to provide synergistic clinical benefits and achieve superior optic nerve protection.

Regarding financial data, for the years 2024 and 2024, and for the nine months ended September 30, 2025, Pugi Pharmaceutical recorded other net income of RMB 11.22 million, RMB 819,000, and RMB 1.158 million, respectively.

For the same periods, the company reported losses of approximately RMB 178 million, RMB 133 million, and RMB 125 million, respectively.

Autoimmune diseases, which have become the third major chronic disease after cardiovascular diseases and cancer, refer to a category of conditions where the body's immune system mistakenly identifies and attacks its own tissues or cells due to genetic, environmental, or other abnormalities, leading to tissue damage, dysfunction, or organ failure. The global autoimmune disease drug market grew from $116.9 billion in 2019 to $143.1 billion in 2024, representing a compound annual growth rate (CAGR) of 4.1%. It is projected to reach $179.5 billion by 2028 and $217 billion by 2033, with CAGRs of 5.8% from 2024 to 2028 and 3.9% from 2028 to 2033.

Driven by factors such as the rising prevalence of various autoimmune diseases, significant unmet clinical needs, and major R&D advancements, China's autoimmune disease drug market has experienced rapid growth in recent years. It expanded from RMB 16.2 billion in 2019 to RMB 32.8 billion in 2024, a CAGR of 15.1%. The market is projected to reach RMB 87 billion by 2028 and RMB 219.6 billion by 2033, with CAGRs of 27.6% from 2024 to 2028 and 20.3% from 2028 to 2033.

Globally, the incidence of allergic diseases is on the rise, particularly among children and adolescents, with major types including allergic rhinitis, allergic asthma, and urticaria. The global allergy drug market grew from $45.5 billion in 2019 to $68.8 billion in 2024, a CAGR of 8.6%. It is projected to reach $98.5 billion by 2028 and $131.1 billion by 2033, with CAGRs of 9.4% from 2024 to 2028 and 5.9% from 2028 to 2033.

With advancements in pharmaceutical technology, precision medicine and personalized treatment have become trends, leading to the emergence of new drugs that offer more choices for patients with allergic diseases. China's allergy drug market has shown rapid growth recently, increasing from RMB 30.5 billion in 2019 to RMB 57.5 billion in 2024, a CAGR of 13.5%. It is projected to reach RMB 108.9 billion by 2028 and RMB 293.8 billion by 2033, with CAGRs of 17.3% from 2024 to 2028 and 22.0% from 2028 to 2033.

Atopic dermatitis (AD) is a chronic, recurrent, inflammatory skin disease clinically characterized by itching, polymorphic skin lesions, and a tendency to exudate. The number of AD patients in China increased to 72.9 million in 2024, with a CAGR of 2.1% from 2019 to 2024. This number is expected to reach 77.5 million by 2028 (CAGR of 1.5% from 2024) and 80.8 million by 2033 (CAGR of 0.8% from 2028). As more innovative topical and systemic therapies are approved for clinical use, AD patients will have access to more treatment options with good efficacy and fewer side effects. Combined with factors like future increases in per capita disposable income and healthcare spending, China's AD drug market is set for continued growth. Valued at RMB 11 billion in 2024, the market is projected to grow to RMB 29.7 billion by 2028 (CAGR of 28.1%) and further to RMB 50.2 billion by 2033 (CAGR of 11.1% from 2028).

The Board of Directors comprises nine members, including four executive directors, one non-executive director, and four independent non-executive directors.

Mr. Li, Chifeng Qingxi, and Chifeng Mingquan are the company's controlling shareholders, holding 29.16%, 10.41%, and 3.65% stakes, respectively. Dr. Han holds a 7.44% stake, Chongqing Xianfeng holds 7.28%, Yuhang Longpan holds 6.11%, Medicine Fund holds 5.44%, Kaiyuan Hongdao holds 5.20%, and Tibet Zhifan holds 4.55%.

The intermediary team includes Joint Sponsors: CITIC Securities (Hong Kong) Limited and CMBC Capital Limited. The company's legal advisors are Fangda Partners for Hong Kong law and Chinese law. The Joint Sponsors' legal advisors are Clifford Chance for Hong Kong law and JunHe LLP for Chinese law. The auditor and reporting accountant is KPMG, and the industry consultant is Frost & Sullivan (Beijing) Consulting Co., Ltd. Shanghai Branch.

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