Lingke Pharma (Zhejiang) Co., Ltd. has officially submitted its IPO application to the Hong Kong Stock Exchange's main board, with CITIC Securities and CCB International acting as joint sponsors. According to the prospectus, Lingke Pharma, founded in 2017, focuses on the development of small-molecule inhibitors for autoimmune and inflammatory diseases. Its core pipeline revolves around the JAK-STAT signaling pathway, with its most notable products being the second-generation JAK1 inhibitor LNK01001 and the third-generation soft pan-JAK inhibitor LNK01004.
The company’s founding team hails from multinational pharmaceutical giants such as Pfizer and Merck. Since its inception, Lingke Pharma has completed multiple funding rounds, raising over RMB 1 billion in total, with a post-investment valuation of RMB 3.422 billion. It has attracted investments from prominent institutions like Lilly Asia Ventures, Legend Capital, and Grand Flight Investment. However, despite strong capital backing, Lingke Pharma faces significant challenges, including persistent cash flow deficits, slower development progress for its core products compared to competitors, and intensifying competition in the JAK inhibitor market.
**Accumulated Losses Exceed RMB 1.1 Billion; Core Product Development Lags Behind Competitors** Financially, the company has yet to commercialize any products, relying primarily on government subsidies and other income. In 2023, 2024, and the first three quarters of 2025, its other income—comprising bank interest and government grants—amounted to RMB 20.6 million, RMB 17 million, and RMB 54.8 million, respectively. Net losses for the same periods reached RMB 260 million, RMB 312 million, and RMB 145 million, bringing cumulative losses to RMB 1.1033 billion.
Cash flow remains strained, with net cash outflows from operating activities at RMB -227.6 million, RMB -240.9 million, and RMB -85.7 million during the reporting periods. Operations are entirely dependent on external financing. As of September 30, 2025, cash and cash equivalents stood at just RMB 147 million. With a monthly net cash burn of approximately RMB 9.5 million in the first nine months of 2025, existing funds can only sustain operations for about 15 months.
**Core Pipeline Faces Stiff Competition** Lingke Pharma’s key candidates include LNK01001 and LNK01004. LNK01001, the closest to commercialization, is undergoing multiple Phase III clinical trials, with New Drug Application (NDA) submissions expected for atopic dermatitis (2026 H1), rheumatoid arthritis (2026 H2), and ankylosing spondylitis (2027 H2).
However, the JAK inhibitor market is already crowded with established players and generics. LNK01001’s development timeline lags significantly behind competitors. While preclinical studies for LNK01001 began in 2019—when Pfizer’s first-generation JAK inhibitor tofacitinib was the only option in China—the subsequent years saw rapid market expansion for JAK inhibitors.
For instance, AbbVie’s second-generation JAK inhibitor upadacitinib, approved by the FDA in 2019 for rheumatoid arthritis, entered China in 2022 and now covers seven indications, including atopic dermatitis and ankylosing spondylitis. It was included in China’s National Reimbursement Drug List (NRDL) in 2022, with domestic sales reaching RMB 163 million in 2023. Meanwhile, Pfizer’s abrocitinib, another second-generation JAK1 inhibitor, was approved in China in April 2022 for moderate-to-severe atopic dermatitis. In contrast, LNK01001’s first NDA submission is slated for 2026—four years behind leading competitors.
**Market Competition Intensifies** LNK01001 faces competition from both branded drugs and generics. Upadacitinib and abrocitinib are already commercialized, with upadacitinib enjoying broad insurance coverage and clinical adoption. Additionally, the patent cliff for first-generation JAK inhibitors has arrived. Pfizer’s tofacitinib entered China’s volume-based procurement (VBP) program in 2020, with over 44 generic versions now available at low prices.
Moreover, upadacitinib’s core compound patent, originally set to expire in December 2030, was partially invalidated by China’s National Intellectual Property Administration in August 2023, paving the way for generics. Currently, 26 generic manufacturers have filed for approval.
Beyond existing competitors, multiple late-stage JAK inhibitors are in development, including Innovent Biologics’ itacitinib, China Medical System’s povorcitinib, and Jiangsu Carephar’s tigertinib, some of which entered Phase III trials earlier than LNK01001.
**Challenges in Pricing and Reimbursement** China’s autoimmune disease market, though large, is highly dependent on national insurance due to limited patient affordability. For example, 75% of China’s 7 million psoriasis patients seek initial treatment at primary care facilities, where expensive drugs are often unaffordable. Historical data shows that reimbursement status and pricing are critical for sales growth—upadacitinib, abrocitinib, and first-generation JAK inhibitors like baricitinib and tofacitinib all saw explosive growth post-NRDL inclusion or VBP participation.
Under China’s increasingly stringent cost-control policies, LNK01001—a latecomer with overlapping indications and no breakthrough efficacy—faces hurdles in pricing, reimbursement, and hospital access. To gain market share, it may need to adopt lower prices than predecessors, conflicting with the need to recoup R&D costs.
**Patent Risks Loom** Lingke Pharma’s patent portfolio remains incomplete. As of the latest practicable date, it holds 16 global patents in China (including Hong Kong, Macau, and Taiwan) and 37 overseas, with 106 pending approvals. Given the recent invalidation of upadacitinib’s core patent, the durability of JAK inhibitor patents is uncertain, posing potential risks to Lingke Pharma’s future business.
Amid rapid cash burn, delayed core product development, fierce competition, tightening reimbursement policies, and patent uncertainties, Lingke Pharma’s ability to successfully commercialize its "me-too" drug and achieve returns remains uncertain.
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