2026 Foro de Zhongguancun Anual｜Huahui Anjian "Década de perfeccionamiento"

（来源：北京商报）

During the annual 2026 Zhongguancun Forum, Huahui Anjian (Beijing) Biotechnology Co., Ltd. (hereinafter referred to as “Huahui Anjian”) made an appearance at the exhibition area with our country’s first hepatitis D treatment drug, Lebevitamu single-antibody injection (brand name: HuaYouNuo). The drug is the world’s first approved antibody-class therapy in the field of viral hepatitis.

At an exclusive interview with Beijing Business Daily reporter, Huahui Anjian’s Chief Executive Officer Chen Bin said that on March 16, Jia Dong, chief physician and director of the Hepatology Center at Beijing Youyi Hospital affiliated with Capital Medical University, issued the world’s first prescription for Lebevitamu single-antibody injection. This new drug has already moved into clinical use.

Huahui Anjian is located in the Zhongguancun Life Sciences Park. In recent years, the Zhongguancun Life Sciences Park has achieved comprehensive breakthroughs in the biopharmaceutical field. From cross-border new indications approvals, to clinical access for potential new drugs, to device listings and multiple qualification certifications, a number of enterprises, leveraging core technological innovation, have continuously expanded the application boundaries of biopharmaceuticals, providing more options for clinical treatment.

Whole-process independent innovation

What is special about Lebevitamu single-antibody is mainly that it is a domestically developed original drug with full-process independent innovation “from the target mechanism to drug creation.” Its main mechanism is to specifically bind to the PreS1 region on the surface of the hepatitis B/hepatitis D virus, blocking the binding between hepatitis B/hepatitis D virus and its receptor NTCP, thereby preventing viral infection or reinfection of liver cells.

“Lebevitamu single-antibody is a ‘from start to finish’ new drug that is completely original to China, from discovering the viral infection mechanism and action target to drug R&D. It is different from generic drugs with a clear path to replication and follow-on innovation drugs. In the history of pharmaceutical development in China, it is also rare.” Chen Bin told Beijing Business Daily reporter.

According to data from the World Health Organization (WHO), about 12 million people worldwide are infected with the hepatitis D virus (HDV), affecting nearly 5% of people with chronic HBV infection. Previously, except Europe, China and the United States had not approved any drugs for treating chronic HDV infection. In China, there are over 75 million patients with chronic hepatitis B; previously, there were no treatment drugs targeting hepatitis D domestically. Clinical understanding was insufficient, and the HDV testing rate and diagnosis rate were low. Patients were trapped in a dilemma of “having the disease but no medicine,” making clinical demand extremely urgent.

Lebevitamu single-antibody received conditional approval from the National Medical Products Administration (NMPA) on January 20 for the treatment of adult patients with chronic HDV infection with or without decompensated-stage liver cirrhosis. In addition, the product had previously been granted “breakthrough therapy” designation by the Center for Drug Evaluation (CDE) in China and the Food and Drug Administration (FDA) in the United States.

In clinical diagnosis and treatment, based on antiviral therapy for chronic hepatitis B, doctors can use Lebevitamu single-antibody in combination, effectively reducing HDV viral load and improving liver function, thereby better controlling patients’ conditions and improving prognosis.

Origin at Beisheng Institute

Huahui Anjian’s story began, first of all, with the Beijing Institute of Life Sciences (hereinafter referred to as “Beisheng Institute”) located in the Zhongguancun Life Sciences Park.

In Beijing and even nationwide research circles, the Beisheng Institute is a “holy land” that researchers long for. In 2007, Li Wenhui, focusing on virology research, joined the Beisheng Institute and began to devote himself to research on the hepatitis B virus receptor. In 2012, Li Wenhui discovered the hepatitis B virus receptor in the world for the first time. Then in 2015, with support from the Beijing Municipal Science and Technology Commission, Li Wenhui, together with his wife Sui Jianhua and colleagues including Huang Song, founded Huahui Anjian, focusing on drugs in the field of liver diseases.

Since developing the prototype molecule in 2015, Huahui Anjian subsequently launched process development and preclinical toxicology work. In September 2018, Lebevitamu single-antibody obtained a clinical approval letter from the National Medical Products Administration, and clinical trials were carried out in many top-tier hospitals across the country, including Peking Union Medical College Hospital, Beijing Youyi Hospital affiliated with Capital Medical University, the First Hospital of Jilin University, etc., progressively validating the safety and efficacy of the drug. In April 2023 and November 2024, the drug was respectively approved by the regulators in China and the United States to grant “breakthrough therapy” qualifications.

“Ten years磨一剑.” In the 11th year after Huahui Anjian was established, Lebevitamu single-antibody received approval for market launch and moved into clinical use.

The market launch of Lebevitamu single-antibody not only brings new options to Chinese patients, but also offers hope to patients worldwide. Huahui Anjian stated that Lebevitamu single-antibody will provide more effective and accessible treatment options for patients with chronic HDV infection in China and in more countries participating in the Belt and Road Initiative.

Policy support helps drive commercialization

In an interview with Beijing Business Daily reporter, Chen Bin said that Huahui Anjian’s development is inseparable from strong support from relevant ministries and commissions of the state, Beijing Municipality, and Changping District.

It is understood that during the process of drug R&D and clinical development, Huahui Anjian received support in areas such as the Ministry of Science and Technology’s “13th Five-Year Plan” major new drug creation special project, as well as scientific research project specials at both Beijing Municipality and district levels, and support including talent introduction and settlement.

Regarding funding, in 2023, Zhongguancun Development Group’s Zhongguancun Capital continued to lay out the innovative drug sector, investing in Huahui Anjian’s A++ round financing, providing timely funding support to advance the company’s clinical R&D pipelines. Chen Bin said that during special periods such as the company’s start-up stage, Changping District’s and Beijing Municipality’s state-owned capital funds “sent help in times of need,” injecting R&D funds in a timely manner, helping the company ease funding pressure.

In addition, during the application and submission process for Lebevitamu single-antibody R&D, the Beijing municipal drug regulatory departments proactively included it in the city-level whole-process service system and the list of project-based management at the bureau level, implementing full-process dynamic tracking, proactive guidance, and precise services. They effectively accelerated key steps such as the issuance of the《Drug Manufacturing License》and GMP compliance inspections, helping this innovative drug achieve commercialization with “added momentum.”

When asked how he views the series of policies Beijing has introduced in recent years to encourage the development of innovative drugs, Chen Bin said that enterprises’ sense of gain is very tangible, and it further strengthens the company’s confidence in deepening its focus on innovation in Beijing.

“The drug review and approval process has been significantly sped up, giving precious time for R&D. With the introduction of multiple policies at the city and district levels, the range of projects enterprises can apply for is broader, which helps ease companies’ funding pressure throughout the entire drug R&D process. Policies such as talent settlement and housing security effectively help companies retain core talent. On the clinical application side, the National Health Commission and major medical institutions strongly support innovative drugs. Lebevitamu single-antibody injection obtained approval only two months later, and it was successfully prescribed for the first global prescription at Beijing Youyi Hospital, realizing rapid listing and landing after approval, truly enabling innovative achievements to benefit patients at the earliest time,” Chen Bin said.

Deng Yong, Director of the Center for Health Law and Governance Research and Innovation Transformation at Beijing University of Chinese Medicine, mentioned that a closed-loop ecological system for innovative drug industrial parks in Beijing has already taken shape. Industrial parks such as the Zhongguancun Life Sciences Park and Daxing Pharmaceutical Valley have formed a “lab—pilot—clinical—industrialization” 1-kilometer transformation circle, greatly shortening the time for results to land.

In the future, the Zhongguancun Life Sciences Park where Huahui Anjian is located will continue to focus on frontier fields, strengthen synergy across the industrial chain, and help more innovative products reach clinical use and benefit patients worldwide.

Beijing Business Daily reporter Ding Ning