Kexing Biopharm renews Hong Kong Stock Exchange filing, pursuing A+H dual listing

On May 6, Kexing Biopharm once again submitted its prospectus to the Hong Kong Stock Exchange, planning to list on the Main Board, with the sole sponsor being China Securities International. From becoming one of China's first batch of biopharmaceutical industrialization enterprises in 1989, to its listing on the Sci-Tech Innovation Board in 2020, and now aiming for an A+H dual listing, Kexing's development over more than three decades not only represents its own growth history but also fully reflects the transformation of China's biopharmaceutical industry from generic-innovation combination to original innovation, and from local deep cultivation to global expansion.

Holding flagship recombinant protein products such as SINOGEN and Yipuding, and occupying leading positions in the short-acting interferon and erythropoietin niches; building the 3KX full-chain technology platform to enter high-demand fields such as oncology, autoimmune diseases, and ophthalmic disorders; with overseas business covering more than 70 countries and regions including the European Union, Brazil, the Philippines, and Indonesia, and overseas revenue reaching RMB 366 million. Kexing's prospectus clearly presents a complete pathway for traditional biopharmaceutical enterprises to break through growth bottlenecks and advance innovative transformation.

Kexing Biopharm's origins predate the wave of innovative drugs in China by more than two decades. Over the course of its development, three key strategic decisions have shaped its current industry position and development direction.

The period from 1989 to 2019 marked the foundational stage of Kexing Biopharm. As one of the first industrialization bases of the national "863" Program, Kexing was among the earliest Chinese companies to enter the research, development, and production of recombinant protein drugs. At that time, China's domestic biopharmaceutical industry was still in its infancy, with multinational pharmaceutical companies dominating the mainstream market and local enterprises having to seek breakthroughs in niche areas.

Kexing's first key decision was to focus on the recombinant protein field and deeply cultivate specific high-demand niches. Leveraging two major technology systems — prokaryotic and eukaryotic cell expression — the company successively launched four core commercialized products: SINOGEN (Recombinant Human Interferon α1b for Injection), Yipuding (Recombinant Human Erythropoietin Injection), Baitexi (Recombinant Human Granulocyte Colony-Stimulating Factor), and Changlekang (Clostridium Butyricum Live Bacteria Combination). These products cover four major therapeutic areas: antiviral, hematology, oncology supportive care, and digestive microecology. This initial product portfolio established a stable cash flow foundation.

From 2019 to 2025, Kexing entered a strategic transformation period. After listing on the Shanghai Stock Exchange's Sci-Tech Innovation Board in December 2020, the company stepped out of the comfort zone of its mature products and launched the dual-engine strategy of "innovation plus internationalization" — its second key decision. Prior to this, Kexing's growth was heavily reliant on its four legacy products, facing multiple pressures including centralized procurement price reductions, slow product iteration, and insufficient innovation capability. The capital support from the Sci-Tech Innovation Board enabled the company to complete both technological and commercial layouts.

On the technology front, Kexing established the 3KX innovative technology platform, encompassing three core technologies: KX-FUSION for long-acting fusion, KX-BODY for bispecific/trispecific antibodies, and K'Exosome for exosome-based targeted delivery. This platform covers the entire process from molecular design and process scale-up to antibody discovery and targeted delivery, providing a solid underlying foundation for innovative drug development. On the commercial front, the company simultaneously advanced dual strategies of product in-licensing and overseas expansion. It introduced two major biosimilars, Apexelsin (Albumin-Bound Paclitaxel) and Leiting (Infliximab), rapidly filling product gaps in the oncology and autoimmune disease fields, while also accelerating the push of its mature products into overseas markets to create a second growth curve.

From 2025 to 2026, Kexing made its third key decision, successively filing prospectuses with the Hong Kong Stock Exchange to pursue an H-share listing, thereby establishing an A+H capital structure to facilitate global resource connectivity. For Kexing, innovative drug development requires continuous substantial investment, necessitating support from global capital. Its core innovation pipeline is aimed at dual filing in China and the United States and global launch, for which a Hong Kong listing platform can provide international regulatory recognition and capital endorsement. With overseas business now accounting for nearly 24% of total revenue, an international capital platform is needed to match its global commercialization footprint. Through these three strategic decisions, Kexing Biopharm has gradually transformed from a generic-innovation combination manufacturer into an innovative, globalized biopharmaceutical enterprise.

According to the prospectus, Kexing Biopharm's revenue from 2023 to 2025 reached RMB 1.259 billion, RMB 1.407 billion, and RMB 1.534 billion respectively, maintaining a steady growth trajectory. This revenue was entirely generated from four proprietary products and two in-licensed products, which together contributed 99.2% of the company's pharmaceutical revenue in 2025, forming a structure of "stable cash flow from mature products and rapid growth from in-licensed products," thereby supporting the company's innovative transformation and global expansion.

The proprietary products represent Kexing's core competitiveness. All four recombinant protein drugs address essential clinical needs, are included in the National Reimbursement Drug List (NRDL), and distribute through a channel network covering medical institutions at all levels across China, continuously generating cash flow to fund research and development investments.

Yipuding, a core product in the hematology field, achieved revenue of RMB 645 million in 2025, with exports covering more than 30 countries. SINOGEN, focused on antiviral and oncology indications, generated RMB 274 million in revenue in 2025, ranking first in the short-acting interferon α1b market with a 50.2% market share. Baitexi, used in oncology supportive care, generated RMB 146 million in revenue in 2025, with exports covering 20 countries and regions. Changlekang, focused on digestive microecology, generated RMB 147 million in revenue in 2025, leveraging its dual-channel advantages of hospital and non-hospital sales to become a benchmark product in the microecological formulation field.

The in-licensed products have become Kexing's core growth engine in recent years. Leiting (Infliximab), primarily indicated for autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease, received approval in 2021 and rapidly gained market adoption, achieving revenue of RMB 124 million in 2025. Apexelsin (Albumin-Bound Paclitaxel), a core chemotherapy drug indicated for breast cancer, pancreatic cancer, and non-small cell lung cancer, received EU approval in 2024 and achieved revenue of RMB 167 million in 2025, accounting for 52.8% of China's domestic exports of similar products, ranking first among Chinese domestic exports. The data best reflects its growth potential: the revenue contribution from in-licensed products increased from only 3.7% in 2023 to 19.2% in 2025, becoming the core driver of Kexing's growth.

Kexing's global footprint represents a differentiating barrier that sets it apart from most domestic peers. Unlike most local pharmaceutical companies that emphasize domestic operations while neglecting overseas markets, Kexing achieved overseas sales as early as 2000, making it one of the earliest Chinese biopharmaceutical companies to go global. As of the end of 2025, the company's products had entered more than 70 countries and regions, including the European Union, Brazil, the Philippines, and Indonesia, with overseas pharmaceutical revenue reaching RMB 366 million, accounting for 23.9% of total revenue. This overseas market expansion has effectively mitigated the pressure from centralized procurement price reductions in China, serving as a core advantage of Kexing's differentiated competitiveness while also laying the foundation for the execution of its globalization strategy.

If the mature commercialized products represent Kexing Biopharm's current foundation, then its innovative pipeline serves as the core support for unlocking future growth space. According to the prospectus, Kexing has built a tiered research and development pipeline spanning preclinical, Phase I, and Phase II/III stages, comprising a total of 15 product candidates. These candidates focus on four high-demand therapeutic areas — oncology, autoimmune diseases, ophthalmic disorders, and antiviral therapies — and are all based on its proprietary 3KX technology platform, with global intellectual property rights.

Building on three decades of accumulated expertise in recombinant protein technology, Kexing has established the 3KX platform, which encompasses three core technologies. The KX-FUSION long-acting protein fusion technology effectively addresses the clinical pain points of short-acting proteins, namely short half-life and frequent dosing, and is primarily used for the long-acting improvement of products such as erythropoietin and G-CSF. The KX-BODY bispecific/trispecific antibody technology can target oncology, autoimmune diseases, and other fields, effectively overcoming the efficacy limitations of single-target antibodies. The K'Exosome exosome-based targeted delivery technology enables precise drug delivery and reduces side effects, with primary applications in areas such as acute kidney injury. These three technology platforms cover the entire chain from drug discovery and process development to production scale-up, endowing Kexing with end-to-end capabilities from fundamental innovation to commercial manufacturing.

All 15 of Kexing's pipeline candidates are aimed at unmet clinical needs, avoiding homogeneous competition and focusing on niche blue-ocean areas, with multiple products possessing first-in-class and best-in-class potential.

In the oncology field, the company focuses on products for cancer cachexia and solid tumor bispecific/trispecific antibodies. Among these, GB18 (GDF15 monoclonal antibody) targets the severe wasting and muscle atrophy symptoms of cancer cachexia in patients with advanced cancer; currently, only a few companies such as Pfizer in China have entered the clinical stage. GB-K02 (PEG-G-CSF), a long-acting granulocyte colony-stimulating factor, has completed Phase III clinical trials and is preparing to submit a new drug application, targeting imported long-acting products, with significant potential for future volume growth. GB23, GB25, and GB27, three bispecific/trispecific antibodies targeting solid tumors and colorectal cancer, are global first-in-class candidates and are currently in the preclinical stage.

The autoimmune disease field represents another core direction of Kexing's innovation strategy, focusing on major diseases such as atopic dermatitis, inflammatory bowel disease, and systemic lupus erythematosus. Among these, GB12 (IL-4R/IL-31 bispecific antibody) is a dual-target nanobody targeting atopic dermatitis, capable of simultaneously blocking itching and inflammation. It is currently advancing toward dual filing in China and the United States and is in the preclinical stage. GB19 (BDCA2 monoclonal antibody) targets systemic lupus erythematosus; between February and March 2026, it simultaneously received clinical trial approvals from both the National Medical Products Administration and the U.S. Food and Drug Administration, with global development progressing steadily. GB20 and GB24, respectively a TL1A monoclonal antibody and a TL1A-LIGHT bispecific antibody, target inflammatory bowel disease, aligning with internationally prominent targets, and are currently in the preclinical stage.

Ophthalmic disorders represent one of the areas with the greatest unmet medical needs globally, with the core pain point being frequent injections and poor patient compliance. Kexing's GB10 (VEGF/ANG-2 bispecific antibody) specifically addresses this pain point. This product targets neovascular age-related macular degeneration (nAMD) and adopts a high-concentration formulation, which extends the retention time in the vitreous cavity, with an expected dosing frequency of once every four months — far superior to the once-monthly dosing frequency of existing products. It is currently in Phase I clinical development and possesses global best-in-class potential.

In the antiviral and pediatric field, GB05 (interferon α1b inhalation solution) targets pediatric lower respiratory tract infection caused by respiratory syncytial virus. As a Class 2.1 improved new drug, it utilizes nebulized administration, eliminating the pain of injections for children. It has received Breakthrough Therapy Designation from the National Medical Products Administration and is in Phase III clinical development, with the potential to become the first dedicated antiviral drug for respiratory syncytial virus in China.

Since 2026, Kexing Pharmaceuticals has entered a period of concentrated clinical milestones for its innovation pipeline. GB-K02 has completed Phase III clinical trials and is about to submit a New Drug Application (NDA). GB19 has received clinical trial approvals in both China and the United States. GB10 and GB18 are steadily advancing through Phase I clinical trials with positive data. GB05, supported by breakthrough therapy designation, is progressing smoothly through Phase III clinical trials. For Kexing Pharmaceuticals, the years 2026 to 2027 are set to become the inaugural commercialization period for its innovation pipeline, with multiple products expected to be launched successively. This will help the company reduce its reliance on legacy drugs and unlock tens of billions of RMB in growth potential.

The transformation of a biopharmaceutical company is essentially a restructuring of its financial profile. Kexing Pharmaceuticals' financial data over the past three years clearly illustrate a development logic characterized by "mature products providing a safety net, increased investment in innovation, and sustained profitability improvement." This also confirms the company's stable attributes as a mature innovative drugmaker, distinctly setting it apart from loss-making biotech firms.

Revenue and Profit: Kexing Pharmaceuticals has demonstrated a positive trend of steady growth and a return to profitability. From 2023 to 2025, the company's operating revenues were RMB 1.259 billion, RMB 1.407 billion, and RMB 1.534 billion, respectively, representing a three-year compound annual growth rate of 10.3%. Net profit turned from a loss of RMB 195 million in 2023 to a profit of RMB 27 million in 2024, further increasing to RMB 153 million in 2025, a year-on-year increase of 466%, indicating a fundamental improvement in its financial position. The key turning point occurred in 2024, when, driven by the continued sales growth of in-licensed products and the normalization of R&D investment, the company successfully achieved profitability. The significant increase in profit scale in 2025 further validated the feasibility of its commercialization model and the effectiveness of its innovative transformation.

R&D Investment: In 2023, as several innovation pipeline candidates entered clinical stages concurrently, Kexing Pharmaceuticals' R&D investment reached RMB 345 million, accounting for 27.4% of its operating revenue. From 2024 to 2025, R&D investment returned to a more sustainable pace, amounting to RMB 168 million and RMB 200 million, respectively, with an R&D expense ratio maintained at approximately 13%. These funds were precisely channeled into core innovative drug clinical development, iteration of the 3KX technology platform, process upgrades at manufacturing bases, and global patent layout, ensuring that R&D investment is efficiently converted into innovative outcomes.

Assets and Cash Flow: The company's solidity is further underscored by its asset and cash flow position. As of the end of 2025, Kexing Pharmaceuticals had net assets of RMB 1.753 billion, ample monetary funds, and positive operating cash flow for two consecutive years, capable of supporting R&D and commercialization spending for the next two to three years. These data fully demonstrate that Kexing Pharmaceuticals is a mature, innovative drugmaker with stable cash flow, a high-quality innovation pipeline, and global capabilities — which constitutes the core capital value underlying its Hong Kong IPO pursuit.

Kexing Pharmaceuticals' current pursuit of a Hong Kong IPO is not merely a secondary financing event, but rather a key component of its global strategic layout. The core objective is to leverage the A+H structure to gain access to global capital, clinical, and commercial resources. The net proceeds from this H-share offering will be primarily directed toward the R&D of core innovative pipeline candidates, the expansion of biosimilar offerings, the in-licensing of high-value products, and overseas market expansion, adhering to the philosophy of "using global capital to drive global innovation and sell to global markets," thereby supporting the dual filing (China and U.S.) and commercial realization of its pipeline.

The A+H structure is expected to bring multiple benefits to Kexing Pharmaceuticals. It will not only facilitate access to domestic and international financing channels and enhance its international brand influence, but also support the global advancement of its innovative pipeline, align with its commercial presence covering over 70 countries, and provide a replicable pathway for Chinese biopharmaceutical companies seeking to go global. At the same time, the company faces challenges including R&D risks inherent in innovative drugs, pricing pressures from centralized procurement, competition in overseas markets, and a concentrated product portfolio. In response, Kexing has formulated clear strategies to mitigate these risks by accelerating the clinical realization of its innovative pipeline, expanding into overseas markets, and strengthening its end-to-end industrial chain advantages.

After years of accumulation, Kexing Pharmaceuticals has established three core barriers: a full recombinant protein industrial chain, global commercial capabilities, and differentiated innovation. This makes the company a rare biopharmaceutical asset in the Hong Kong stock market that combines mature cash flow, a high-growth innovative pipeline, and global reach. This Hong Kong IPO represents not only a new capital markets starting point for Kexing Pharmaceuticals but also an important step for Chinese recombinant protein biologics to go global. Moving forward, as its core innovative pipeline matures, the company is well-positioned to play a significant role in the global biopharmaceutical market, offering a high-quality blueprint for industry transformation.