Sinocelltech, the "U-removed" drugmaker, seeks A+H listing with market-leading flagship product and RMB 2.9 billion in R&D

Over the past decade, China's innovative biopharmaceuticals industry has completed a round of explosive yet disorderly growth. The sector has faced homogenization and hyper-competition, routine price reductions under the national medical insurance system, and a retreat in capital investment and financing. The industry has officially bid farewell to the era of "burning money for progress" and shifted towards commercial implementation, differentiated innovation breakthroughs, and sustainable profitability in a high-quality elimination race. In this round of industry reshuffle, a group of long-established self-research pharmaceutical enterprises with independent core technologies and full industrial chain capabilities has begun to carve out a differentiated growth curve. Sinocelltech is one of the most representative members.

On May 22, Sinocelltech, a domestic enterprise that has been deeply engaged in the independent research and development of biopharmaceuticals for over 20 years, officially submitted its prospectus for an initial public offering on the Hong Kong Stock Exchange, taking a crucial step towards establishing dual capital platforms in both A-shares and H-shares. From becoming a benchmark for unprofitable innovative drug companies after listing on the STAR Market in 2020, to now planning its listing on the Hong Kong Stock Exchange, Sinocelltech is not only expanding its financing channels but also leveraging dual listings as a fulcrum to drive the implementation of its globalization strategy. The company is bringing its 24 years of research and development accumulation, commercial breakthroughs, and industry competition onto the market stage for full scrutiny.

Looking back at the development trajectory, every capital move by Sinocelltech has been timed at critical nodes of enterprise transformation and industrial upgrading. In June 2020, Sinocelltech went public on the STAR Market of the Shanghai Stock Exchange as an unprofitable biotech company, becoming a core target for independent biopharmaceutical research and development in the A-share market, leveraging the local capital market to complete the first round of accumulation in research and development and production capacity.

In the nearly six years since its listing on the STAR Market, Sinocelltech has transformed from a pure research and development enterprise into a commercial pharmaceutical company, moving from continuous losses to achieving profitability in 2024 and officially removing the "U" label in April 2025. The STAR Market has provided a stable local financing environment, a compliance governance framework, and industrial capital endorsement, becoming the foundation for technology implementation and product scaling.

If the STAR Market is Sinocelltech's domestic foundation, then this Hong Kong initial public offering is its global launchpad. With the STAR Market as the base and the Hong Kong stock market as the international window, Sinocelltech is building an A+H dual capital platform. Leveraging the international rules of the Hong Kong stock market, coverage by global institutional investors, and the advantages of cross-border financing, the company aims to broaden its financing channels and enhance its international brand influence. It is clear that Sinocelltech is fully accelerating overseas clinical trials, overseas listings, and global business collaborations.

The strategic value of the A+H layout is clear: in China, it relies on the STAR Market to cultivate the local market, implement medical insurance and centralized procurement policies, and expand commercial scale; overseas, it leverages the Hong Kong stock market to connect with global capital, advance international multicenter clinical trials, and explore product out-licensing deals and overseas commercialization, forming a dual circulation pattern of domestic commercial self-sustaining and overseas globalization expansion.

For this pharmaceutical company that insists on full-chain self-research, the dual listing is no longer a simple capital accumulation, but a coordinated upgrade of the four major systems: research and development, production, commercialization, and globalization.

In 2002, the biopharmaceutical market in China was almost entirely dominated by imported drugs. High-end therapeutic antibodies and recombinant protein drugs were completely reliant on imports, while local companies mostly remained in the lower-end segments of generic drug production and simple contract manufacturing processes. No one dared to make heavy asset investments or commit to the long cycles required for independent innovation in core technologies. It was against this backdrop that Sinocelltech officially came into being, breaking away from the industry norm at the time where domestic pharmaceutical companies "sought speed and stability." Instead, it chose the hardest and slowest path — building a fully autonomous, end-to-end biopharmaceutical technology platform.

Unlike most startups that focus on single-point deployment and rapid pipeline output, Sinocelltech has spent more than two decades meticulously refining its capabilities. The company has gradually built a complete system covering drug discovery, preclinical development, process scale-up, and GMP large-scale production, while establishing three core technology platforms: therapeutic antibodies, recombinant proteins, and vaccines. This has laid a solid technical foundation for the subsequent parallel innovation of multiple pipelines.

2021 became a critical turning point for Sinocelltech. For the previous nineteen years, Sinocelltech had been in a prolonged phase of "investment-only, no revenue" during its research and development dormancy. With the successful approval and market launch of its self-developed recombinant human coagulation factor VIII "Anjiayin," Sinocelltech officially ended its pure research and development model, completing its transformation into an integrated pharmaceutical enterprise encompassing "research and development plus production plus commercialization." This marked the full closure of the biopharmaceutical industry loop, from laboratory to clinical endpoint.

After four years of in-depth commercialization efforts, Sinocelltech has completely broken free from the constraints of being a pure research and development company, establishing an initial product portfolio of considerable scale. Currently, Sinocelltech holds five key commercial products, three COVID-19 vaccines granted emergency use authorization, and has 13 drug candidates at various stages of clinical research. All pipeline assets are independently developed with global intellectual property rights, and over 40 research and development projects have been selected for national and municipal key research and development programs. More crucially, all commercial products of Sinocelltech have been successfully included in the National Reimbursement Drug List, completing the core market access layout within China's healthcare system.

Among a host of commercialized products, the breakthrough of Anjiayin stands as a classic example of locally-produced rare disease drugs breaking the import monopoly in China. For a long time, the treatment of hemophilia A in China has relied on imported recombinant factor VIII, which is expensive and suffers from unstable supply. Targeting this pain point, Sinocelltech independently developed Anjiayin, a third-generation albumin-free recombinant factor VIII product. With stable production capacity, excellent safety, and efficacy, it quickly captured the market. Supported by the world's largest annual production capacity of 10 billion IU of recombinant factor VIII, Anjiayin topped the Chinese recombinant factor VIII market starting in 2023, achieving a market share of 35.5% in 2024, becoming a benchmark for the domestic substitution of hemophilia drugs in China.

No longer relying on a single product to support performance is the core signal of Sinocelltech's commercial advancement. Following Anjiayin, four antibody drugs — Anyouping, Anpingxi, Anjiarun, and Anbeizhu — have successively entered the market, targeting the golden tracks of oncology and autoimmune diseases, forming a diversified portfolio of "rare disease foundation plus oncology and autoimmune growth." On the production capacity side, the company's GMP integrated production system ensures full autonomy and control over the entire process from bulk drug substance to final formulation, reserving ample space for subsequent pipeline rollouts.

In recent years, China's innovative drug sector has fallen into serious homogenization, with a large number of companies clustering around mature targets, leading to a new normal where products face intense competition immediately upon approval. Sinocelltech has actively avoided pitfalls, breaking away from red ocean competition, and consistently focused on "genuine unmet clinical needs." It concentrates on five high-potential areas: oncology, autoimmune diseases, rare diseases, ophthalmology, and vaccines, building a clearly stratified product pipeline: stabilizing the foundation in the short term with mature products, delivering growth in the mid-term through clinically innovative varieties, and constructing barriers in the long term with globally first-in-class targets, forming a sustainable iterative system.

In the oncology sector, Sinocelltech has established a parallel research and development system with multiple technological platforms, including monoclonal antibodies, bispecific antibodies, trispecific antibodies, and T cell engagers. The core pipeline, SCTB14 (PD-1/VEGF bispecific antibody), with its best-in-class potential, has entered the first tier of global innovative therapies for non-small cell lung cancer; SCTB41 is the world's only PD-1/VEGF/TGFβRII trispecific antibody to enter first-line non-small cell lung cancer clinical trials, with the potential to break through the bottleneck of solid tumor immunotherapy.

In the field of hematological oncology, Sinocelltech takes the first-mover advantage. SCTC21C is the world's only CD38 monoclonal antibody in clinical trials for first-line light chain amyloidosis and also China's first self-developed CD38 monoclonal antibody to enter clinical trials for first-line multiple myeloma; SCTB35 (CD20/CD3 T cell engager) advances to phase III clinical trials with subcutaneous administration and low cytokine release syndrome risk, showing strong competitive potential in the lymphoma field.

Autoimmune diseases are major chronic conditions in China, with a large patient population requiring long-term continuous medication. However, existing drugs commonly have issues such as frequent dosing and heavy long-term medication burden. Targeting this clinical pain point, Sinocelltech has developed a long-acting differentiated pipeline product, SCT650C, an ultra-long-acting IL-17A monoclonal antibody that requires dosing only once every six months. Compared to similar drugs on the market that require monthly dosing, it significantly enhances patient convenience and long-term treatment adherence, and has entered phase III clinical trials for psoriasis.

The vaccine sector carries Sinocelltech's public health responsibility and long-term consumer healthcare strategy. Its core pipeline, SCT1000 (14-valent HPV vaccine), is one of the most comprehensive HPV candidate vaccines in China, covering 12 high-risk carcinogenic subtypes and 2 genital wart-related subtypes recognized by the World Health Organization. Its coverage exceeds that of existing imported and domestically produced vaccines, with the potential to fill the gap in high-end multivalent vaccines in the future. The ophthalmology sector focuses on chronic fundus diseases, featuring innovative products such as anti-IGF1R monoclonal antibodies and high-concentration anti-VEGF Fab formulations. Core pipelines have entered phase II clinical trials, opening up a new growth curve for performance.

Overall, Sinocelltech's pipeline layout is logically clear and hierarchically distinct. It neither follows trends blindly nor chases novelty without direction. Each pipeline precisely addresses clinical needs, balancing short-term commercial realization with the construction of long-term technical barriers.

The growth of innovative pharmaceutical companies is always a balancing act of "high research and development investment, periodic performance fluctuations, and long-term value realization." Sinocelltech's financial data from 2023 to 2025 fully mirrors the commercial ramp-up trajectory of leading self-developed pharmaceutical enterprises in China.

The revenue trend of Sinocelltech clearly reflects the pace of commercialization. In terms of revenue, the company achieved 1.887 billion RMB in 2023, increased by 33.1% to 2.512 billion RMB in 2024, and then dropped to 1.560 billion RMB in 2025 due to industry policy adjustments. However, this fluctuation is not an isolated case but a phased adjustment faced by the entire innovative drug industry. On the other hand, Sinocelltech is gradually reducing its reliance on a single product and optimizing its performance structure. The proportion of recombinant protein drugs decreased from 94.3% to 63.9%, while the share of antibody drugs rose to 36.1%. New products such as Anbeizhu and Anyouping are progressively gaining market traction.

At the profitability level, Sinocelltech has consistently maintained the high gross margin characteristic of innovative drugs, with comprehensive gross margins over three years at 94.9%, 95.6%, and 91.8%, respectively, experiencing only a slight decline in 2025 due to product price reductions. The company has not yet achieved sustained and stable profitability. In 2023, it incurred a loss of 397 million RMB, turned a profit of 112 million RMB in 2024, and faced a loss of 566 million RMB in 2025. The core reason is the high-intensity research and development investment, with research and development expenses over the three years amounting to 1.148 billion RMB, 911 million RMB, and 838 million RMB, respectively, totaling more than 2.9 billion RMB. The fluctuations in performance fully align with the growth pattern of innovative pharmaceutical enterprises: "invest first, realize returns later."

In terms of commercialization, Sinocelltech has established a sales system adapted to the local market in China, adopting a lightweight commercialization model of "internal team plus contract sales organization," covering 116 distributors across 31 provincial regions in China, with channel revenue accounting for over 90%. Customer concentration is relatively high, with the top five clients' revenue share exceeding 58% over the past three years; the supply chain remains robust, with procurement from the top five suppliers accounting for less than 23%, effectively mitigating the risk of supply disruptions.

For innovative pharmaceutical companies in the growth phase, the capital market is the core support to navigate through cycles. After more than two decades of independent research and development, and four years of commercialization exploration, Sinocelltech has reached a critical tipping point: its core pipeline is entering the harvest period, and the A+H dual platforms will become a key strategy to break through financial bottlenecks and accelerate value realization.

The funds raised from this Hong Kong initial public offering will be mainly allocated to advancing core clinical pipelines, expanding commercial networks, early-stage research and development and process upgrades, capacity building, and global layout. In the short term, it can alleviate cash flow pressure and accelerate the market launch of key phase III products such as SCTB14 and SCT650C, optimizing the product mix; in the long term, it will help Sinocelltech upgrade from "pipeline innovation" to "platform-based innovation," deepen its presence in vaccines, ophthalmology, and rare diseases, and explore global collaborations and product internationalization.

The STAR Market focuses on local commercialization, while the HKEX drives global expansion. The A+H dual platforms enable Sinocelltech to form a closed loop of "domestic self-sufficiency and overseas expansion." From an unprofitable company on the STAR Market to a dual-listed pharmaceutical enterprise, Sinocelltech's growth reflects China's biopharmaceutical journey from imitation to independent research and development, and from local to global.

Standing at the turning point of the industry cycle, this long-standing self-research pharmaceutical company, which adheres to long-termism, is leveraging the A+H capital structure as a fulcrum to strike a balance among innovation in research and development, commercialization realization, and global layout. Whether it can break the profitability curse and achieve global breakthroughs by relying on its independent platform and rare pipeline will remain a core suspense for both the capital market and the industry to watch.