Beijing Pugi Pharmaceutical Technology Co., Ltd. has submitted a listing application to the main board of the Hong Kong Stock Exchange, with CITIC Securities and Minyin Capital acting as joint sponsors. The company was previously listed on the New Third Board and terminated its listing in June 2025; based on its last trading day's share price, its market capitalization was approximately 2.4 billion yuan.
According to the prospectus, Pugi Pharma focuses on the immunology and inflammation field, positioning itself as a leader in locally delivered targeted therapies. Founded in 2016, the company centers its technology platform on innovative design and localized drug delivery, specializing in chronic inflammatory diseases such as atopic dermatitis and allergic rhinitis. As the company has not yet received approval for any product, it has not generated revenue from product sales. For the full year 2024 and the first nine months of 2025, other net income was 11.22 million yuan and 1.158 million yuan, respectively. Net losses for the same periods reached approximately 178 million yuan and 125 million yuan. As of September 2025, Pugi Pharma held only 155 million yuan in cash and cash equivalents, highlighting the urgency for the company to seek listing as a means of financing.
As a clinical-stage pharmaceutical company without commercialized products, Pugi Pharma urgently requires a listing to replenish capital. The Hong Kong Stock Exchange's Chapter 18A listing rules, designed specifically for pre-revenue biotech companies, offer a more flexible pathway, which may be one reason for the company's shift from the New Third Board to the Hong Kong market.
**Core Product in Late-Stage Clinical Development**
The future development and valuation support for Pugi Pharma, a yet-to-be-profitable innovative drug company, depend almost entirely on the clinical progress of its core product and the potential of its subsequent pipeline. The prospectus indicates that the company has developed various formulations, including gels, creams, ointments, nasal sprays, and eye drops, based on its core platform for innovative topical drug formulations. Its focus is on chronic inflammatory diseases, with a pipeline comprising five innovative drug candidates covering ten indications, as well as five generic drug candidates for various chronic inflammatory conditions.
The company's core product, PG-011 (Pumexitinib), is a JAK1/JAK2 inhibitor designed for topical use. It currently has two formulations in late-stage clinical development: a gel for atopic dermatitis and a nasal spray for allergic rhinitis. Specifically, Pumexitinib gel is the world's first JAK inhibitor gel for treating atopic dermatitis. The company has completed Phase III clinical trials for adult and adolescent (ages 12 to 17) atopic dermatitis and is preparing to submit a New Drug Application. It is also expanding the gel's indication to treat atopic dermatitis in children aged 2 to 11.
Pumexitinib nasal spray is 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 adult SAR. The company is also extending its indication to treat SAR in adolescents (ages 12 to 17) and perennial allergic rhinitis (PAR) in adults.
The competitive edge of Pumexitinib partly lies in its formulation advantages. As topical, locally delivered formulations, the gel and nasal spray allow direct application to the affected area, ensuring efficacy while significantly reducing systemic exposure and avoiding the systemic adverse effects associated with traditional oral formulations. Compared to approved同类药物, Pumexitinib gel's lower systemic absorption and gentle, skin-friendly properties may allow its use in pediatric populations, who have thinner, more sensitive skin and require higher safety standards.
**Can Pugi Pharma Capitalize on the JAK Inhibitor Market Opportunity?**
Autoimmune diseases have become the third-largest category of chronic illnesses globally, with the market expanding steadily. According to Frost & Sullivan data, the global market for autoimmune disease drugs grew from $116.9 billion in 2019 to $143.1 billion in 2024, representing a compound annual growth rate (CAGR) of 4.1%. The market is projected to reach $179.5 billion by 2028 and $217 billion by 2033, with corresponding CAGRs of 5.8% and 3.9%.
Driven by rising prevalence, significant unmet clinical needs, and increased R&D investment from both domestic and international pharmaceutical companies, the Chinese market is growing even more rapidly. Data shows that China's autoimmune disease drug market expanded rapidly from 16.2 billion yuan in 2019 to 32.8 billion yuan in 2024, with a high CAGR of 15.1%. From 2024 to 2028, the CAGR is expected to jump to 27.6%, remaining at a high level of 20.3% from 2028 to 2033, with the market size potentially exceeding 200 billion yuan by 2033.
Pugi Pharma operates in the high-growth immunology and inflammation sector, strategically positioning itself as a leader in locally delivered targeted therapies. Its R&D pipeline primarily targets pathways such as the JAK-STAT signaling pathway. However, the sector's high热度 also means intense competition. In China, the JAK inhibitor market has become highly saturated. To date, three oral JAK1 inhibitors have received NMPA approval for treating moderate-to-severe atopic dermatitis, including products from international giants like AbbVie and Pfizer. Furthermore, 19 JAK inhibitor candidates for atopic dermatitis are in clinical stages in China, with two in the NDA stage and seven in Phase III clinical trials.
In this crowded competitive landscape, Pugi Pharma, as a latecomer, faces significant challenges. It is under pressure to catch up within a limited time window and must establish sufficient differentiated advantages in efficacy, safety, or patient compliance.
Regarding the formulation advantages of Pumexitinib, the topical JAK inhibitor field is not Pugi's exclusive domain. Emma替尼软膏 submitted an application for market approval in February 2025, and the NDA for Itofacitinib ointment (MH004) was accepted in May of the same year. In contrast, Pumexitinib gel has only recently completed Phase III trials, lagging behind competitors in the approval timeline—a gap that could directly translate into a smaller market share.
Atopic dermatitis is a chronic inflammatory skin condition requiring long-term medication management, with patients often being price-sensitive due to extended treatment periods. Currently, oral JAK inhibitors like Upadacitinib and Abrocitinib have achieved volume-based access through inclusion in China's National Reimbursement Drug List (NRDL) following price negotiations. For Pumexitinib to achieve significant sales volume in the future, NRDL inclusion appears almost essential. This means that even if successfully launched, the product would likely face substantial price reduction pressure during NRDL negotiations, potentially weakening its profit margin per unit.
The outlook for the company's subsequent pipeline is also mixed. The indications targeted by the pipeline, such as glaucoma, pruritus, and membranous nephropathy, address large patient populations with clear clinical needs in established therapeutic areas. However, most of these pipeline assets are in early-stage development. For instance, PG-040 eye drops for glaucoma are undergoing clinical studies in both China and the U.S. but remain in the preclinical stage. Most other candidates are in Phase I or II trials. This suggests that for the next 3 to 5 years, Pugi Pharma will likely remain highly dependent on its core product, Pumexitinib, to support its valuation and cash flow, with the follow-on pipeline unlikely to contribute meaningfully to performance in the short term.
On the commercialization front, the company recently signed an exclusive agreement with a wholly-owned subsidiary of Jichuan Pharmaceutical Group. The agreement grants the subsidiary exclusive rights to commercialize Pumexitinib (PG-011) nasal spray in mainland China, Hong Kong, Macau, and Taiwan. The partner will pay up to a maximum of 100 million yuan (including tax) for these exclusive commercialization rights.
In summary, while the autoimmune disease market offers substantial growth potential, Pugi Pharma's current valuation rests primarily on a single product, Pumexitinib. The company faces challenges including a delayed development timeline and intense competition from surrounding rival products. In the short term, the approval progress of its core product and the outcome of potential NRDL negotiations will be critical variables for realizing value. Long-term prospects hinge on the successful clinical translation of its subsequent pipeline. To convince the market, Pugi Pharma will need to present a more compelling growth narrative.
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