Chia Tai Tianqing partners with GSK, targeting the billion-dollar hepatitis B market and the commercialization strategy.

Ask AI · How will Bepirovirsen change the hepatitis B treatment pathway?

21st Century Business Herald Reporter Ji Yuanyuan

The Chinese hepatitis B treatment drug market is迎来 a key variable.

On May 11, China BioPharma (1177.HK) announced that its core subsidiary, Zhengda Tianqing, reached an exclusive strategic partnership with GlaxoSmithKline (GSK) regarding the antisense oligonucleotide (ASO) drug Bepirovirsen.

According to the cooperation agreement, Zhengda Tianqing will be responsible for importing, distributing, hospital access, and all promotional activities of the product in mainland China, and will confirm all sales revenue; GSK will continue as the Marketing Authorization Holder (MAH), overseeing registration, quality, pharmacovigilance, and global medical strategy.

Bepirovirsen is currently one of the fastest progressing candidates worldwide for functional cure of hepatitis B in clinical trials. In April 2026, the drug received priority review status from the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). If approved smoothly, it will become the first drug capable of achieving a functional cure of chronic hepatitis B with a limited course (about 6 months), breaking the long-term or even lifelong medication dependency for patients.

Some pharmaceutical industry analysts told the 21st Century Business Herald that Zhengda Tianqing, as a leading enterprise in the domestic liver disease market with a commercial network covering over 5,000 medical institutions, directly determines the efficiency of transforming this heavyweight product from regulatory approval to end-user patients.

From “Replacing Oral Drugs” to “Reshaping the Treatment Pathway”

Bepirovirsen is an ASO drug with triple mechanisms (degrading viral RNA, inhibiting DNA replication, reducing HBsAg). In the Phase III B-Well 1 and B-Well 2 studies, the drug combined with standard therapy showed statistically and clinically significant rates of functional cure, supporting its application for approval.

The so-called “functional cure” means that within 24 weeks after treatment, HBsAg and HBV DNA are undetectable in serum, indicating patients can be free from drug dependence, with a significantly reduced long-term risk of liver cancer.

The aforementioned analyst pointed out that for GSK, Bepirovirsen is an important supplement to its HIV/hepatitis business line. However, in the Chinese market, GSK has faced multiple challenges in recent years, including volume-based procurement and compliance adjustments, with high marginal costs and long cycles for building its own commercialization team. Choosing Zhengda Tianqing as an exclusive partner essentially matches the “most scarce product” with the “most grounded channels.”

“From an industry perspective, the commercial value of Bepirovirsen lies not only in its own sales revenue but also in driving a paradigm shift in hepatitis B treatment,” the analyst said. The shift from “long-term viral suppression” to “limited course cure” will redefine doctors’ prescribing habits, patients’ willingness to pay, and even the priority of negotiations in the medical insurance catalog.

For existing oral antiviral drugs, once functional cure therapies mature and are included in medical insurance, some patients will proactively choose limited course regimens, potentially shrinking the long-term user base of oral medications and affecting the cash flow of related generic companies. During the transition period, a more likely scenario is combination therapy: Bepirovirsen combined with oral drugs to improve functional cure rates.

The agreement shows that GSK retains the MAH status, responsible for registration, quality, safety monitoring, and global medical strategy. This means that the product’s intellectual property rights, global supply system, and safety management are still led by GSK, consistent with multinational pharmaceutical companies’ control over core products.

Meanwhile, Zhengda Tianqing does not bear direct legal responsibility for drug approval, reducing compliance risks related to product quality.

Zhengda Tianqing will handle import, distribution, access, promotion, and non-promotional activities, and confirm all sales revenue. Under this arrangement, Zhengda Tianqing essentially acts as the “channel general contractor.”

The two parties agreed on an initial cooperation period of 5.5 years, during which Zhengda Tianqing will purchase products from GSK and can recognize the sales revenue as its own income. This financial model is similar to a “buyout agency,” but differs from ordinary agency: Zhengda Tianqing not only earns sales commissions but also bears marketing and channel investment costs, while enjoying the profit margin after deducting procurement costs. This places higher demands on Zhengda Tianqing’s financial strength and commercialization capabilities, but if product volume increases smoothly, it will significantly boost its revenue and profit.

Additionally, both sides reserve the right for further overseas cooperation of China BioPharma’s pipeline.

If China BioPharma’s self-developed hepatitis B pipeline (such as the core protein allosteric regulator TQA3605, TLR-7 agonist TQ-A3334, etc.) obtains positive data in the future, GSK has priority to explore cooperation opportunities outside China. This provides a low-cost “ship-leaving” path for China BioPharma’s internationalization strategy.

In this round, Zhengda Tianqing does not need to pay large upfront payments but instead shares through procurement and sales, reducing initial financial pressure. Meanwhile, GSK retains ownership of the product and global supply pricing rights, ensuring product quality and supply chain stability.

Pricing, Medical Insurance, and Competitive Dynamics

The pricing and medical insurance access of Bepirovirsen after listing will be key variables determining its market share.

Market news indicates that the Chinese oral hepatitis B antiviral market is already highly mature and low-priced. After centralized procurement, the price of entecavir single tablets has dropped to about 0.2 yuan per tablet, with annual treatment costs only a few hundred yuan. Interferons (like Pegasys) cost about 30,000-50k yuan annually but have more side effects and require injections.

As an innovative ASO drug, Bepirovirsen’s price for a treatment course (24-48 weeks) is expected to be much higher than oral drugs, likely in the range of 100,000 to 300k yuan (referencing overseas pricing logic for similar innovative therapies). This price is a heavy burden for most patients, so in the short term, coverage will mainly be for high-paying, highly motivated patients seeking functional cure.

From the competitive landscape, Bepirovirsen is not the only candidate in development for functional cure. Globally, efforts include Vir Biotechnology and Gilead’s siRNA + immune modulator combination, Arbutus’s RNAi therapies, and other ASO molecules in collaboration with GSK. Domestically, companies like GenePharma, Hengrui Medicine, and Suzhou Rebo are also involved. However, Bepirovirsen is currently the only product that has submitted for listing and been included in priority review, enjoying at least 2-3 years of market exclusivity.

The analyst further pointed out that if Zhengda Tianqing’s own TQA3605 (Phase II) and TQ-A3334 (Phase II) are approved in the future, they could form a “Zhengda Tianqing combination therapy,” consolidating its leading position in liver disease and creating a synergistic product matrix.

Introducing Bepirovirsen extends Zhengda Tianqing’s product line from “viral suppression” to “cure,” filling a top-tier gap. Additionally, if the company’s self-developed pipelines like TQA3605 and TQ-A3334 can be combined with Bepirovirsen in sequential or joint therapies, it will build a “Zhengda Tianqing solution” that competitors find hard to replicate. “This ‘self-developed + imported’ dual-driven approach reduces risks associated with a single R&D pipeline and enhances bargaining power upstream and channel reuse downstream,” the analyst emphasized.

From a financial perspective, China BioPharma’s hepatitis business accounted for about 30% of total revenue in 2025, but growth has slowed due to centralized procurement. As a high-priced, high-margin innovative product, if Bepirovirsen can reach annual sales of over 1 billion yuan, it will significantly boost the company’s overall revenue and profit structure.

For GSK, transferring the Chinese rights of Bepirovirsen to Zhengda Tianqing as a commercialization agency avoids high fixed costs of market promotion in China and, through an option mechanism, locks in future overseas revenue sharing from the Chinese pipeline. This “asymmetric cooperation” model may serve as a reference for future collaborations between small-to-medium innovative drug companies and MNCs.

For investors, the short-term catalyst is the approval progress of Bepirovirsen (expected in late 2026 to early 2027), with medium-term focus on insurance negotiation prices and first-year prescription volumes, and long-term depends on data from combination therapies and overseas pipeline collaborations.

According to Frost & Sullivan, the global anti-HBV drug market is expected to grow at a compound annual growth rate (CAGR) of 16.5% from 2024 to 2029, and 11.6% from 2029 to 2034, reaching an estimated $77.8 billion worldwide by 2034.

In this billion-dollar segment of hepatitis B functional cure, whoever first establishes a “product + channel + combination plan” barrier may dominate pricing power in the next decade.