After its initial IPO attempt fell through and its approval certificate lapsed, Xi'an Xintong Pharmaceutical Research Co., Ltd. is making a renewed push toward the STAR Market at the end of 2025, having recently completed its first round of inquiry responses as the listing process moves steadily forward. This time around, the company holds a new card—its first commercialized product, Pradefovir Mesylate tablets, now accounts for all of its revenue—yet the profitability puzzle remains unsolved, and its sales side leans heavily on a single exclusive agent, exposing structural weaknesses in its business model.
Meanwhile, the fundraising target has been trimmed from 1.279 billion yuan to 900 million yuan, a reduction of nearly 30%, which also serves as a snapshot of the cooling sentiment in innovative drug development. Overall, while Xintong Pharma has taken its first step toward commercialization, it faces a web of intertwined challenges: a thin product pipeline, an elusive turning point to profitability, and highly concentrated sales channels. Under the scrutiny of regulatory inquiries, can this innovative drugmaker clear the hurdle?
A Bumpy Road to Listing, Fundraising Slashed by Nearly 30%
Founded in 2000, Xintong Pharma has navigated three business phases: from 2000 to 2010, it focused on developing chemical generics and traditional Chinese medicines, building a CMC research platform through extensive preclinical studies, pilot-scale research, clinical trials, and regulatory filings; starting in 2011, it began undertaking commissioned innovative drug research, and in August 2015, through the full acquisition of Kaihua Company, it introduced the HepDirect technology to deepen its research in that area; since 2017, it has concentrated on drug development for major liver diseases such as hepatitis B, metabolic dysfunction-associated steatohepatitis, and liver cancer, aiming to create innovative drugs with independent intellectual property rights that are safe, effective, and clinically value-driven, with the goal of filling unmet clinical needs in liver disease treatment.
On the capital front, Xintong Pharma is no newcomer. On December 6, 2021, its first STAR Market IPO application was accepted; after completing two rounds of inquiry responses, its initial listing review was postponed on December 12, 2022, when the STAR Market listing committee requested further clarification on how the company's innovativeness is specifically demonstrated and whether it meets the requirements for science and technology attributes and STAR Market positioning. On January 12, 2023, a second review finally passed. In April of that same year, the company obtained its registration approval, but until the approval period expired, it never launched the issuance, leaving the first IPO attempt to fizzle out.
Two years later, Xintong Pharma resumed its filing for guidance, submitting another prospectus at the end of 2025, again targeting the STAR Market. The difference is that the previous filing sought 1.279 billion yuan, while this time it has been lowered to 900 million yuan, a drop of nearly 30%. A comparison of the two prospectus versions reveals that the funded projects still revolve around new drug R&D projects, an innovative drug industrialization production base construction project, and supplementary working capital; aside from the unchanged 200 million yuan for working capital, new drug R&D has been cut from 899 million yuan to 500 million yuan, while the production base project's fundraising has been raised from 180 million yuan to 200 million yuan. The slimming down of the fundraising scale not only reflects the company's concession to market conditions but also signals its cautious assessment of core R&D progress.
Single Product Carries the Load, Facing Formidable Market Rivals
Unlike the previous filing when there was no main product, Xintong Pharma has now achieved the launch of a commercialized product. According to reports, its Pradefovir Mesylate tablets were approved for market in October 2024 and are currently its only commercialized offering. Before this approval, the company's revenue came from third-party drug R&D technical development, technology transfer, technical services, and sales of CE-fosphenytoin sodium injection. After the approval, its main business revenue stems from sales of the core product and agency royalty income.
The prospectus shows that Pradefovir Mesylate tablets generated revenue of 2.8403 million yuan in 2024 and 31.8436 million yuan in 2025, while Xintong Pharma's total operating revenue for those years stood at 3.0187 million yuan and 32.0147 million yuan, respectively. It is clear that the company's commercialization is heavily dependent on the market performance of this single product. However, the structural risk brought by this high product concentration cannot be overlooked. The hepatitis B drug market is vast but intensely competitive; current treatment primarily relies on antiviral drugs, mainly nucleos(t)ide analogs and interferon-alpha. While antiviral drugs can effectively suppress hepatitis B virus replication, they cannot cure chronic hepatitis B, and the vast majority of patients require long-term or even lifelong medication, with nucleos(t)ide analogs holding about 80% of the market share and dominating the space.
As of February 28, 2026, five first-line nucleos(t)ide analogs have been approved for sale in China. Xintong Pharma acknowledges that among the first-line recommended hepatitis B treatments, ETV, TDF, and TAF have already been included in centralized procurement, and all of these products have seen significant price reductions from winning bids. If the company fails to implement effective countermeasures, the sales and promotion of Pradefovir Mesylate and the future launch of Hepnofovir Fumarate could fall short of expectations, which would adversely impact its operating performance and development prospects. Despite holding a commercialized product, Xintong Pharma has yet to achieve profitability. From 2023 to 2025, its net losses attributable to shareholders were -62.2925 million yuan, -79.3555 million yuan, and -54.6352 million yuan, respectively. As of the end of 2025, the company's cumulative undistributed losses at the consolidated level stood at 388 million yuan.
Exclusive Agent Ties to Kaiji Xincheng, Minimum Sales Targets Under Scrutiny
As an innovative drug R&D enterprise, Xintong Pharma currently allocates its primary resources to clinical and preclinical research activities. On the sales strategy front, it has adopted an exclusive agency model, entrusting Anhui Kaiji Xincheng Biomedical Technology Co., Ltd. as the sole agent for the sales and marketing of Pradefovir Mesylate tablets. Kaiji Xincheng was established in April 2023 by Yu Kangxin, the former president of Chia Tai Tianqing. In 2024 and 2025, revenue derived from Kaiji Xincheng and its subsidiaries accounted for 94.09% and 98.88% of total operating revenue, respectively. Xintong Pharma acknowledges in its prospectus that as sales of Pradefovir Mesylate tablets grow, the revenue share from Kaiji Xincheng and its subsidiaries will further increase. Before building its own sales team, the company faces risks of high customer concentration and dependence on a single exclusive agent.
The agreement between the two parties includes annually escalating sales performance targets, along with minimum sales volume and deposit clauses. According to the agreement, the sales performance targets for 2025 and 2026 through 2029 are 150,000 boxes, 1 million boxes, 2 million boxes, 3 million boxes, and 4.5 million boxes, respectively, with qualifying sales targets of 120,000 boxes, 800,000 boxes, 1.6 million boxes, 2.4 million boxes, and 3.6 million boxes. If the agent fails to meet the minimum targets, it must pay a deposit to Xintong Pharma; if the cumulative qualifying target is not achieved by 2029, the deposit will not be refunded. In the first round of inquiries, the basis for the minimum sales targets and the reasonableness of the market size projections became a focal point. Xintong Pharma has argued its case from perspectives such as the size of the patient population, market competition dynamics, the ramp-up pace of similar competing products, PDF's competitive advantages, and Kaiji Xincheng's sales channel coverage. The company also noted that the growth logic of the minimum sales targets agreed with Kaiji Xincheng aligns with the trend of medical insurance-driven volume expansion in the innovative drug industry.
Since the partnership began, PDF product sales have grown rapidly, and in 2025, Kaiji Xincheng completed its minimum sales target with a completion rate of 163.91%. Xintong Pharma believes that the agreed minimum sales targets are based on sales performance commitments made after Kaiji Xincheng's assessment of the competitive landscape, with practical safeguards in place for meeting the minimums, and that choosing the minimum sales figures for market size projections is reasonable from a prudence standpoint. However, whether these guaranteed targets can actually be delivered remains a question that only time will answer.