Zhejiang Huahai Pharmaceutical Co., Ltd.’s indicative announcement on the acceptance of its subsidiary’s drug marketing authorization application
Stock abbreviation: Huahai Pharmaceutical Stock code: 600521 Announcement number: Lin 2026-070 Bond abbreviation: Huahai convertible bonds Bond code: 110076
Zhejiang Huahai Pharmaceutical Co., Ltd.
Indicative Announcement on the Acceptance of the Subsidiary’s Drug Marketing Authorization Application
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and bear individual and joint liability for the authenticity, accuracy and completeness of its contents.
Recently, Shanghai Huaotai Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaotai"), a subsidiary of Zhejiang Huahai Pharmaceutical Co., Ltd. (hereinafter referred to as "Huahai Pharmaceutical" or the "Company"), received an "Acceptance Notice" for the registration and marketing authorization application for domestically produced drugs for HB0017 injection issued by the State Food and Drug Administration (hereinafter referred to as "NMPA"). The relevant information is now announced as follows:
1. Basic information about drugs
Drug name: HB0017 injection
Dosage form: injection
Specifications: 150 mg (1ml)/tube
Declared Indication: For the treatment of adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy.
Registration Category: Biological Products for Therapeutic Use Class 1
Acceptance number: CXSS2600100
Application matters: Registration and marketing authorization for domestically produced drugs
Applicant: Shanghai Huaotai Biopharmaceutical Co., Ltd.
Conclusion: According to the provisions of Article 32 of the "Administrative Licensing Law of the People's Republic of China", after review, it is decided to accept the application.
2. Other related information about drugs
In November 2025, the company's multi-center, double-blind, randomized, placebo parallel-controlled pivotal clinical trial of HB0017 injection for the treatment of psoriasis achieved the primary efficacy endpoint and all key secondary efficacy endpoints. For specific details, please refer to the "Zhejiang Huahai Pharmaceutical Co., Ltd. Announcement on the Progress of Subsidiary Drug Clinical Trials" published by the company on November 20, 2025 in China Securities Journal, Shanghai Securities News, Securities Times, Securities Daily and the Shanghai Stock Exchange website (www.sse.com.cn) (Announcement No.: Lin 2025-119).
Recently, the company received the "Notice of Acceptance" for the domestically produced drug registration and marketing license application for HB0017 injection issued by the State Food and Drug Administration.
Psoriasis is a chronic, relapsing, immune-mediated inflammatory skin disease that affects the skin and other organ systems throughout the body. The prevalence of psoriasis in my country is about 0.5%, and it can occur in all age groups. About 80% to 90% of psoriasis cases are plaque psoriasis. Psoriasis patients not only have an increased chance of suffering from multiple complications, but are often combined with other systemic diseases, such as cardiovascular disease, metabolic disease, liver and kidney disease, autoimmune diseases, etc., such as psoriatic arthritis, heart failure, obesity, hypertension, diabetes, and metabolic syndrome. At the same time, patients also suffer from tremendous mental pain. Mental illnesses such as depression, anxiety, and suicidal tendencies caused by the dual pressure of physical and mental pain are more common among psoriasis patients. Therefore, psoriasis is a disease that seriously affects the physical and mental health of patients, and is a disease that needs to be solved urgently worldwide.
HB0017 injection is a monoclonal antibody targeting interleukin-17A (IL-17A) independently developed by Huaotai. It is intended to be used to treat moderate to severe plaque psoriasis (domestic registration and marketing application has been accepted), ankylosing spondylitis (promoting Phase III clinical trials) and other autoimmune diseases.
Up to now, the company's R&D investment in the HB0017 injection project totals approximately RMB 454.03 million.
3. Risk warning
According to the requirements of laws and regulations related to drug registration, drugs must be reviewed and approved by the drug regulatory agency before they can be produced and marketed. At the same time, there is also uncertainty about whether and when the drug can finally obtain marketing approval. The competitive situation of future products may also change with the market environment. The company will pay close attention to the actual progress of subsequent registration applications and fulfill its information disclosure obligations in a timely manner.
Investors are kindly requested to invest rationally and pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Zhejiang Huahai Pharmaceutical Co., Ltd.
June 25, 2026