East China Pharmaceutical Co., Ltd. Announcement on the Approval of the Registration Application for the Exclusive Distribution Product, Recombinant Type A Botulinum Toxin for Injection, for Market Launch

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Stock Code: 000963 Stock Abbreviation: Huadong Medicine Announcement No.: 2026-012

Huadong Medicine Co., Ltd.

Announcement on the Approval of the Registration Application for the Exclusive Distribution Product Recombinant Botulinum Toxin Type A for Injection

The company and all members of the board of directors guarantee that the content of the information disclosure is true, accurate, and complete, without false records, misleading statements, or major omissions.

On March 25, 2026, Huadong Medicine Co., Ltd. (hereinafter referred to as “the Company”) received approval from the National Medical Products Administration (NMPA) for the exclusive distribution product Recombinant Botulinum Toxin Type A for Injection (Research and Development Code: YY001, Brand Name: Rejuva). It is intended for the temporary improvement of moderate to severe glabellar lines in adults aged 65 and below caused by the activity of the corrugator and/or procerus muscles. The relevant details are announced as follows:

I. Basic Information about the Drug

Product Name: Recombinant Botulinum Toxin Type A for Injection

English/Latin Name: Recombinant Botulinum Toxin Type A for Injection

Brand Name: Rejuva

Specification: 100 units/vial

Application Matter: Drug Registration (Domestic Production)

Acceptance Number: CXSS2400144

Drug Approval Number: National Drug Approval No. S20260019

Marketing Authorization Holder: Chongqing Yuyan Pharmaceutical Co., Ltd.

Manufacturer: Chongqing Yuyan Pharmaceutical Co., Ltd.

Review Conclusion: According to the “Drug Administration Law of the People’s Republic of China” and relevant regulations, after examination, this product meets the relevant requirements for drug registration, is approved for registration, and a drug registration certificate is issued.

II. Research and Registration Status of the Drug

YY001 is a recombinant botulinum toxin type A for injection independently developed by Chongqing Yuyan Pharmaceutical Co., Ltd., which holds global intellectual property rights. The company has exclusive commercialization rights and related preferential assignment rights and negotiation rights for this product in the medical aesthetics indications field in mainland China, Hong Kong SAR, and Macau SAR (see the relevant announcement disclosed by the company on the Giant Tide Information Network, Announcement No.: 2023-081).

YY001 is the world’s first recombinant botulinum toxin type A product. YY001 avoids the biosafety risks associated with traditional technology routes that use botulinum bacteria to produce botulinum toxin while maintaining protein activity. The production process, with a completely innovative design, results in recombinant botulinum toxin with high purity, high specific activity, and low immunogenicity.

The approval for YY001’s market launch is based on the completion of a multicenter, randomized, double-blind, placebo-controlled, and positive drug parallel-controlled phase III clinical trial in China that assessed the efficacy and safety of recombinant botulinum toxin type A for the treatment of moderate to severe glabellar lines. Clinical research results show that its efficacy, safety, and immunogenicity have reached the established clinical trial endpoints, and it performs exceptionally compared to the control drug.

In the treatment of moderate to severe glabellar lines, YY001 demonstrates robust efficacy and good safety characteristics, significantly outperforming solvent treatments, and within the predefined statistical testing framework, the composite response rate at week 4 is superior to onabotulinumtoxinA. The study results support YY001 as a promising new option in the treatment regimen for botulinum toxin type A. Further long-term multicenter studies are needed to comprehensively clarify its efficacy durability, immunogenicity, and application value in diverse populations (Reference: Therapeutic Efficacy and Safety of Recombinant Botulinum Toxin Type A for Moderate to Severe Glabellar Lines: A Randomized, Controlled, Double-blind, Phase III Trial in Chinese Adults. Aesthetic Surgery Journal, Published: February 14, 2026.).

III. Impact on Listed Company and Risk Warning

According to survey data from ISAPS (The International Society of Plastic Surgery), the volume of botulinum toxin treatments has remained the top non-surgical aesthetic procedure globally for the past five years, increasing from 6.214 million cases in 2020 to 7.888 million cases in 2024, a growth of approximately 26.9% over five years. China’s botulinum toxin market is vast and characterized by rapid growth. According to Frost & Sullivan data, from 2017 to 2021, the market size of botulinum toxin products in China grew from RMB 1.9 billion to RMB 4.6 billion, with a compound annual growth rate of 25.6%. The market size is expected to reach RMB 39 billion by 2030.

Rejuva is the world’s first recombinant botulinum toxin type A product, avoiding the biosafety risks associated with traditional technology routes that use botulinum bacteria to produce botulinum toxin and characterized by high purity, high specific activity, and low immunogenicity. The formal approval of Rejuva further enriches the company’s high-end aesthetic injection product and technology matrix, achieving full coverage of high-end regenerative, hyaluronic acid, and botulinum toxin injection categories, which helps provide a complete solution from facial contour shaping to dynamic wrinkle management for a broader audience. Rejuva will form effective synergy with products such as the Yiyan Shi series and MaiLi series based on the existing injection market of the company, significantly enhancing the joint treatment capabilities of medical institutions in the high-end market and increasing the depth and stickiness of institutional collaborations.

Based on its strong foundation in the domestic high-end medical aesthetic market, the company will collaborate with public institutions in the pharmaceutical industry for aesthetic promotion resources and strengthen the synergistic effectiveness of the pharmaceutical commercial system to fully promote the market work of Rejuva, thereby fully unleashing its technological generational leadership and market scarcity value as the world’s first recombinant botulinum toxin type A. The company has established a medical aesthetics division within its pharmaceutical industry, specifically responsible for the development of its aesthetic products in public hospitals, consolidating cooperation with high-end private aesthetic institutions while simultaneously deepening the company’s aesthetic business into the public hospital market. Additionally, the company’s pharmaceutical commercial team will work closely with the medical aesthetics team and the pharmaceutical industry team to handle the commercial distribution of Rejuva across various provinces in the country.

The approval of Rejuva for market launch has a positive impact on the company’s medical aesthetics business and will not have a significant impact on the company’s current financial status and operational results. Future product sales may be influenced by various factors such as industry policy changes, market demand, and competitive conditions, leading to some uncertainty regarding the final impact on the company’s profits. Investors are advised to make cautious decisions and pay attention to investment risks.

This announcement is hereby made.

Board of Directors of Huadong Medicine Co., Ltd.

March 28, 2026

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