China Biopharmaceutical has acquired the world's first blockbuster drug with the potential to achieve a functional cure for hepatitis B in the fastest possible time. On May 11, China Biopharmaceutical (01177.HK) officially announced that its core subsidiary, Chia Tai Tianqing Pharmaceutical Group, has entered into an exclusive strategic collaboration with multinational pharmaceutical company GlaxoSmithKline (LSE/NYSE: GSK) to accelerate the latter's first-in-class innovative drug for chronic hepatitis B , Bepirovirsen (code name: GSK836), in China. This promising drug, which is highly anticipated by the industry, has received "breakthrough therapy" designation in China and has been included in the priority review and approval process. Its launch will bring a revolutionary breakthrough to the treatment of hepatitis B in China.

Under the terms of the agreement, Chia Tai Tianqing Pharmaceutical Group will be responsible for the import, distribution, hospital access, and promotional and non-promotional activities of bepirovirsen in mainland China. All sales revenue generated from this product will be recognized as Chia Tai Tianqing's operating revenue. GSK will continue to act as the Marketing Authorization Holder (MAH), responsible for regulatory registration, quality control, pharmacovigilance, and global medical strategy. Meanwhile, the two parties will also have the opportunity to further explore cooperation on R&D pipeline assets that Sinopharm is seeking collaboration opportunities in markets outside of China.

This collaboration not only further enriches Sinopharm's innovative product pipeline and is expected to significantly boost its future revenue, but also fully demonstrates the recognition of its commercialization capabilities, broad market access, and robust compliance system by multinational pharmaceutical companies, helping it maximize value in its core strength markets. This collaboration also further establishes and solidifies Sinopharm's core position as the preferred partner for MNCs in China.

At the 6th Asian Healthcare Summit, GSK Chairman Jonathan Symonds stated that this collaboration represents a complementary strength of two industry giants, ultimately bringing disruptive changes and tangible clinical benefits to hepatitis B patients. China has a massive hepatitis B market, affecting approximately 75 million people. Five to ten years ago, GSK would undoubtedly have chosen to pursue this project independently, building its own sales team for commercialization. However, today, China's pharmaceutical industry is increasingly mature, with leading domestic companies like Sinopharm possessing solid professional capabilities and established commercialization advantages. We firmly believe that through in-depth collaboration with Sinopharm, a leader in China's liver disease field, this innovative therapy can benefit Chinese patients more quickly and widely.

Xie Qirun, Chairman of the Board of Directors of China Biopharmaceutical, also expressed his delight at the transaction at the aforementioned forum, stating, "Pharmaceutical innovation and R&D are like a marathon, characterized by high risk and high investment. Future cutting-edge innovations in the healthcare field cannot be accomplished by a single country or company. China Biopharmaceutical is committed to building an open, interconnected, and collaborative industrial ecosystem, striving to become the preferred partner for global multinational pharmaceutical companies such as GSK, as well as leading domestic pharmaceutical companies and research institutions. Leveraging China's efficient and cost-effective innovation and R&D infrastructure, coupled with the deep empowerment of artificial intelligence technology, we will continuously accelerate the entire process of pharmaceutical innovation and empower the high-quality development of the industry."

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The 70 billion yuan hepatitis B market welcomes a blockbuster new drug for functional cure.

As a major global public health challenge, chronic hepatitis B affects over 250 million people worldwide, with China being a "hepatitis B superpower," indicating urgent clinical needs and a vast market potential. Research reports suggest that the market size for hepatitis B antiviral drugs in my country is projected to exceed 70 billion yuan by 2030, demonstrating strong growth potential.

For a long time, hepatitis B treatment has been trapped in the dilemma of "lifelong medication". The current standard treatment regimen is mainly based on nucleoside (acid) analogs (NA). Although they can inhibit viral replication, they are difficult to completely eliminate the virus. Only 1% to 4% of patients can achieve viral clearance within a period of time, and there may be related complications.

Addressing this clinical challenge, developing innovative therapies that can fundamentally break the shackles of lifelong medication and achieve functional cure has become a core focus of global pharmaceutical companies' research and development. "Functional cure" (also known as "clinical cure") refers to a patient's hepatitis B surface antigen remaining negative and hepatitis B virus DNA undetectable for six months or more after discontinuing medication. Bepirovirsen fills this gap: as a novel antisense oligonucleotide (ASO) antiviral therapy for hepatitis B, it utilizes a triple mechanism of "inhibiting viral replication + reducing antigens + activating immunity" to not only effectively reduce hepatitis B virus (HBV) DNA but also significantly reduce hepatitis B surface antigen (HBsAg) levels—a key indicator for achieving functional cure. Simultaneously, it activates the immune response, enhancing the body's antiviral capacity. Clinical data further confirms its potential: in January of this year, both of Bepirovirsen 's pivotal Phase III clinical trials met their primary endpoints, demonstrating statistically and clinically significant functional cure rates. If successfully approved, it will become the world's first antiviral therapy to directly achieve functional cure for hepatitis B with only a limited 6-month treatment course.

Thanks to its outstanding clinical value, Bepirovirsen has garnered recognition from authoritative institutions in multiple countries. In addition to China's Breakthrough Therapy designation, it has also received Fast Track, Priority Review, and Breakthrough Therapy designations from the US FDA, as well as SENKU (Pioneer) designation in Japan. GSK predicts its peak global annual sales could exceed £2 billion (approximately RMB 19.5 billion), potentially becoming a blockbuster drug. Analysts point out that even if only 15%-20% of hepatitis B patients achieve functional cure with this drug, it will profoundly change the global landscape of hepatitis B treatment.

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Leading Liver Disease Company Upgrades Again: Sinopharm Builds Strongest Pipeline, Ushering in a New Growth Curve

Chia Tai Tianqing Pharmaceutical Group, hailed as the "King of Liver Diseases" in the industry, has been deeply involved in the field of liver disease for decades. It has played a crucial role in the popularization of hepatitis B diagnosis and treatment in China with its series of star products, including Tianqing Ganmei and Runzhong. The company has also continuously invested in full-cycle product development, establishing a broad commercial network covering over 5,000 medical institutions at all levels, firmly maintaining its leading position in the domestic liver disease treatment field. In this collaboration with GSK, Chia Tai Tianqing will leverage its channel advantages and clinical resources in the liver disease field to be responsible for the import, distribution, hospital access, and promotion of Bepirovirsen in mainland China, further improving the accessibility of this new drug to domestic patients. All sales revenue generated from this product will be recognized as Chia Tai Tianqing's operating revenue. GSK will continue to act as the Marketing Authorization Holder (MAH), responsible for core matters such as regulatory registration, quality control, pharmacovigilance, and medical strategy.

It is noteworthy that the introduction of Bepirovirsen is not simply a "pipeline addition," but rather a significant strategic move in China's biopharmaceutical industry's 2.0 era of liver disease treatment. Currently, in the areas of liver disease that Sinopharm focuses on, including metabolic-associated steatohepatitis (MASH), curative therapies for hepatitis B, cirrhosis, and acute liver injury, it has established a large self-developed pipeline: the pan-PPAR agonist lanyllano (a potential FIC for oral MASH in China, already included in the CDE's breakthrough therapy program) is undergoing Phase III clinical trials globally; the core protein allosteric modulator TQA3605 tablets and the TLR7 agonist TQ-A3334 tablets for chronic hepatitis B have both met their primary endpoints in Phase II clinical trials, completing key validations at the antiviral replication and immune regulation ends; Kylo-0603 (a THR-β agonist) is in Phase I clinical trials.

According to the agreement, the two parties will also have the opportunity to further explore cooperation opportunities for Sinopharm's R&D pipeline assets in markets outside of China. This means that this cooperation will not only support the establishment of a long-term partnership between the two parties, but also build a bridge for further expansion of cooperation on innovative assets in the future.

This "bringing in + going out" two-way cooperation model is the core logic behind China Biopharmaceutical's strengthened internationalization strategy—meeting domestic clinical needs by introducing top-tier global innovative drugs, while leveraging the global resources of MNC partners to help expand its self-developed pipeline into overseas markets, thereby continuously upgrading its international capabilities. Currently, China Biopharmaceutical has established deep strategic partnerships with leading global multinational pharmaceutical companies such as Boehringer Ingelheim, Sanofi, and Merck, fully demonstrating its comprehensive strength in commercialization, clinical registration, and compliance, laying a solid foundation for further collaboration with more global partners to achieve a comprehensive leap in its core international competitiveness.

Currently, China attaches great importance to the prevention and control of viral hepatitis. The "Action Plan for the Prevention and Control of Viral Hepatitis in China (2025-2030)" clearly proposes to actively develop innovative treatments for functional cure of hepatitis B. Industry experts point out that although functional cure of hepatitis B remains a complex medical challenge, with clearer mechanisms of action and more mature combination strategies, the dawn of a cure is already appearing. This strategic cooperation between Sino Biopharmaceutical and GSK not only represents the complementary advantages of a multinational pharmaceutical company and a leading domestic player, but also marks China's official entry into the crucial stage of "functional cure" in hepatitis B treatment, bringing new hope to millions of patients.

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