Quanguo Fund conducts research on Shenlian Biotechnology, and Shizhiyuan is conducting a phase II clinical trial of chronic spontaneous urticaria in China

August 15, 2025  Source: drugdu 71

According to the disclosed institutional research information, Quanguo Fund conducted research on listed company Shenlian Biotechnology from August 6, 2025 to August 8, 2025.

Attached research content:

1、 An introduction was given on the recent business situation of the company, the research and development progress of new products such as multi valent vaccines, the company's layout and positioning in the field of human biological products, and the future coordinated development strategy of animal protection and human drug use.

2、 Main communication Q&A

Quan Guo Fund Q1. Please introduce the basic situation of Yangzhou Shizhiyuan Biotechnology Co., Ltd.

Answer: Yangzhou Shizhiyuan Biotechnology Co., Ltd. is a high-tech biopharmaceutical enterprise established in October 2020. At the beginning of its establishment, it was an important biopharmaceutical development base set up by the United Biomedical, Inc. (UBI) group in mainland China, focusing on innovative drug development, clinical approval, project management, and promoting clinical trial progress and sample testing. It will achieve the complete commercialization of biologics. Founded in 1985, UBI of the United States has a profound technological accumulation in the field of immunotherapy and vaccine research and development of chronic and infectious diseases. Its product pipeline covers the treatment and prevention of Alzheimer's disease, AIDS, autoimmune diseases, allergies and other diseases.

Yangzhou Shizhiyuan was formed through the restructuring and strategic adjustment of related companies such as Liansheng Pharmaceutical (Yangzhou), Shanghai Manitide (formerly Lianyao (Shanghai)), and is responsible for promoting the clinical and commercialization of three innovative drugs with multiple indications in Chinese Mainland, including monoclonal antibody drugs for AIDS treatment (UB-421), anti allergy anti IgE monoclonal antibody drugs (UB-221), and anti herpes simplex virus monoclonal antibody drugs (UB-621). In February 2025, Shenlian Biotechnology increased its capital by 60 million yuan and acquired 20.48% of the shares of Shizhiyuan through its wholly-owned subsidiary Shanghai Benteng. The investment funds will be used to promote clinical trials of three innovative drugs and multiple indications.

Quanguo Fund Q2, please introduce the mechanism of action and research and development progress of monoclonal antibody drugs (UB-421) for AIDS treatment.

A: AIDS treatment monoclonal antibody drug (UB-421) is an innovative anti HIV monoclonal antibody drug. With its unique platform design, it has a variety of potential therapeutic effects. Its unique mechanism of action is that the drug effectively blocks the entry of HIV virus into host cells through competitive inhibition by binding to the CD4 receptor domain 1 on the surface of targeted T cells. Because UB-421 does not directly target the virus gene, compared with the existing AIDS drugs on the market, UB-421 has a lower probability of causing drug-resistant mutations in the virus, and has an immunomodulatory effect.

UB-421 has been approved for Phase II/III clinical trials in China by Lianyao (Shanghai). UB-421 will mainly focus on research in the fields of multidrug resistance and functional cure. This project has had deep cooperation with NIH in the United States overseas and has made significant progress. In January 2025, the research results of UB-421 were published in the journal Nature Medicine. In June 2024, the research results related to UB-421 were published in The Lancet. In addition, a related study was published in the New England Journal of Medicine (NEJM) in April 2019.

Recently, World Source plans to collaborate with well-known domestic universities in the field of functional healing, exploring the possibility of combination therapy in order to realize the potential for comprehensive healing. Shizhiyuan will apply for Phase II clinical approval in this field and conduct relevant research in a timely manner.

In addition, UB-421 can provide optimized treatment options for patients with hypoviremia. Through research, we hope to provide more effective treatment plans for these patients and improve their quality of life.

Q3 of Quanguo Fund: Please introduce the mechanism of action and research and development progress of anti allergy anti IgE monoclonal antibody drug (UB-221).

Answer: The second pipeline anti allergy anti IgE monoclonal antibody drug (UB-221) is a monoclonal antibody drug that targets immunoglobulin E (IgE). Its mechanism of action is as follows: on the one hand, UB-221 can bind to IgE, neutralize free IgE molecules in the blood, block their binding to surface receptors of mast cells and eosinophils, and inhibit the release of inflammatory mediators such as histamine. On the other hand, it can bind to CD23 receptors on the surface of B cells, reducing IgE synthesis. UB-221 is mainly used for the treatment of allergic diseases, with chronic spontaneous urticaria as the first indication. The main reason is that chronic urticaria has been shown to be highly correlated with IgE in previous research, with clear scientific verification and relatively short clinical trial cycles. The measurement items are standardized and easy to operate. Currently, Shizhiyuan is conducting a Phase II clinical trial in China for chronic spontaneous urticaria. UB-221, with its superior pharmacological mechanism, is expected to demonstrate strong competitiveness in the market once successfully launched. At the same time, the treatment field of UB-221 also includes asthma, food allergies, etc., and Shizhiyuan will gradually carry out clinical trials for relevant indications based on the subsequent market demand.

Quanguo Fund Q4, please introduce the mechanism of action and research and development progress of the monoclonal antibody drug against herpes simplex virus (UB-621).

Answer: The third pipeline of monoclonal antibody drugs against herpes simplex virus (UB-621) is used to treat human herpes simplex virus (HSV) infection. UB-621 can indirectly interfere with the binding of herpes virus to epidermal cells by binding to the gD protein of herpes virus, thereby inhibiting its ability to spread and infect tissues. UB-621 can simultaneously inhibit the common herpes simplex virus HSV-1 and HSV-2. This selection focuses precisely on recurrent genital herpes, which often requires long-term dependence on existing small molecule drugs for treatment. However, even with daily medication, the condition is still difficult to effectively control. This patient group accounts for a significant proportion and is expected to demonstrate strong market bargaining power and vast market space.

UB-621 will undergo Phase II clinical research overseas by our partners, and based on the results of overseas trials, we will actively promote its Phase III clinical research in China. After the product is launched, it is expected to bring new treatment hope to patients with recurrent genital herpes.

Will Quanguo Fund Q5 consider increasing capital and acquiring Shizhiyuan in the future?

Answer: On February 6, 2025, the company disclosed the "Announcement on Foreign Investment and Related Transactions of Wholly owned Subsidiaries", which clarifies that if Shizhiyuan subsequently increases its registered capital, issues shares, or is acquired, Shenlian Biotechnology will have the right to enjoy the right of first refusal or the right of first refusal under the same price terms and conditions according to its equity ratio. The company currently holds 20.48% equity in Shizhiyuan. At present, the company is more focused on efficiently promoting clinical trials of its core products through resource collaboration, utilizing the management experience, research and development capabilities, and production capabilities of Shenlian Biotechnology to assist Shizhiyuan in accelerating clinical applications, clinical trials, sample production, commercialization processes, and process management. The company will make a comprehensive evaluation based on clinical trials, market environment, and other factors before deciding whether to further increase capital or acquire.

Q6, Quanguo Fund. May I ask if your company has completed the repurchase and will consider implementing equity incentives in the future?

Answer: The company always attaches great importance to the synergy between team motivation and long-term development. The management is full of confidence in the future development of the company. The company has repurchased 3417373 shares between December 5, 2024 and May 23, 2025, which can be used for employee equity incentive plans. In the future, the company will timely launch equity incentive plans based on factors such as business development stage and team structure, further activating team vitality and promoting sustained performance growth.

What other layouts does Quanguo Fund Q7 have in the fields of human use biological products and innovative drugs besides World Source?

Answer: In addition to strategic investment in Shizhiyuan, based on the guidance of encouraging corporate mergers and acquisitions advocated by national policies such as the "National Nine Articles", the company can carry out mergers and acquisitions to layout in the field of human biological products and innovative drugs, or establish merger and acquisition funds to invest in and acquire innovative drug pipelines, especially focusing on the company's core technology platforms, including monoclonal antibodies, genetic engineering, nucleic acid (mRNA), and synthetic peptide platform technologies, to find biopharmaceutical targets with synergistic effects.

When are the expected launch dates for the two foot-and-mouth disease triple prevention and four prevention products developed by Quanguo Fund Q8 and the Lanzhou Veterinary Research Institute of the Chinese Academy of Agricultural Sciences?

Answer: In order to meet the urgent demand for multi valent vaccines in the market and respond to the prevalence of new variants of foot-and-mouth disease, the company recently signed a technical cooperation and development agreement with Lanzhou Veterinary Research Institute of Chinese Academy of Agricultural Sciences to jointly develop triple vaccines for porcine foot-and-mouth disease type O (new strain)/A, swine fever, and pseudorabies, as well as triple vaccines for bovine foot-and-mouth disease type O/A, viral diarrhea/mucosal disease, and infectious rhinotracheitis. Preliminary safety and efficacy tests have been conducted on two products in the early stage. After the product is launched, it can accurately meet the core needs of large-scale breeding groups for efficient vaccines, thereby achieving a high unit price and potentially occupying a certain market share. At present, the company has relevant GMP production lines. After the product is launched, it can improve the company's capacity utilization rate, further demonstrate the scale effect, and the revenue, interest rate scale, and profit level are expected to further increase.

Q9 of Quanguo Fund: The company has previously focused on the field of animal protection vaccines. This investment in World Source has entered the human biopharmaceutical track. How does the management position this investment: financial investment, strategic synergy, or a shift in the company's future business focus? What is the future development strategy and how to position the proportion of human and animal businesses?

Answer: Guided by the strategic vision of "building a world-class high-tech biotechnology company", Shenlian Biotechnology always pays attention to the broad prospects of the entire biopharmaceutical industry and considers expanding the human drug market at appropriate times. The company has a research and development technology platform with core competitiveness, including synthetic peptides, nucleic acids (mRNA), virus like particles, subunit vaccines, and new inactivated vaccines. These technology platforms have wide applicability in the fields of veterinary and human medicine, laying a solid foundation for the company to achieve technological collaboration and business expansion. In the past three years, the company's R&D investment has accounted for over 20% of its operating revenue. These investments are not only for current business development, but also for technological reserves for potential market opportunities in the future.

In addition to equity investment cooperation, the company also has a deep accumulation in production process technology and production capacity. Based on Shenlian Biotechnology's capabilities in long peptide chain (over 60 peptides) synthesis technology, cell expression, large-scale production, and quality control, it can provide production support or services for monoclonal antibodies and peptides for Shizhiyuan in the future, thereby achieving two-way empowerment.

In summary, this investment in Shizhiyuan is an important step for the company's strategic synergy and future shift in business focus. The company will continue to focus on innovative opportunities in the field of biological products, drive business development with technology, and create long-term value for investors.

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