Announcement of Hainan Huluwa Pharmaceutical Group Co., Ltd. on obtaining the drug registration certificate for levalbuterol hydrochloride aerosol inhalation solution
Securities code: 605199 Securities abbreviation: ST Calabash Announcement number: 2026-004
Hainan Huluwa Pharmaceutical Group Co., Ltd.
About obtaining levalbuterol hydrochloride aerosol inhalation solution
Announcement of Drug Registration Certificate
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 assume legal responsibility for the authenticity, accuracy and completeness of its contents.
Hainan Huluwa Pharmaceutical Group Co., Ltd. (hereinafter referred to as the "Company") recently received the "Drug Registration Certificate" approved and issued by the State Food and Drug Administration (hereinafter referred to as the "NMPA") for levalbuterol hydrochloride atomized inhalation solution. The relevant situation is now announced as follows:
1. Basic information on drugs
Drug name: Levalbuterol hydrochloride aerosol inhalation solution
Dosage form: inhalation preparation
Registration classification: Chemicals Class 3
Specifications: 3ml: 0.63mg (based on C₁₃H₂₁NO₃)
Marketing authorization holder: Hainan Huluwa Pharmaceutical Group Co., Ltd.
Acceptance number: CYHS2302228
Drug approval number: National Drug Approval Number H20256401
Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this product meets the relevant requirements for drug registration, the registration is approved, and a drug registration certificate is issued.
2. Drug research and development and related
Levalbuterol hydrochloride nebulized inhalation solution is indicated for the treatment or prevention of bronchospasm caused by reversible airway obstructive diseases in adults and children over 6 years of age.
Levalbuterol hydrochloride aerosol inhalation solution was first developed by AKORN in the United States. It was approved for marketing in the United States in 1999 under the trade name XOPENEX®. Specifications: 0.31mg/3mL, 0.63mg/3mL. Products with specifications of 1.25mg/3mL and 1.25mg/0.5ml were approved for marketing in January 2002 and July 2003 respectively. The original preparation is not marketed in the country.
The drug was reviewed and approved in accordance with the technical requirements consistent with the quality and efficacy of the reference preparation. After approval, it will be deemed to have passed the consistency evaluation of generic drug quality and efficacy.
According to data query on the website of the State Food and Drug Administration, as of the disclosure date of this announcement, in addition to the Company, 22 domestic companies have obtained drug approval numbers for levalbuterol hydrochloride atomized inhalation solution.
Up to now, the company has invested a total of RMB 5.7097 million in research and development expenses for this product (unaudited).
3. Investment risks
The company attaches great importance to drug research and development and strictly controls the quality and safety of drug research and development, manufacturing and sales. The above-mentioned drugs have obtained the "Drug Registration Certificate", which will further enrich the company's product line and play a positive role in the company's development. Due to the characteristics of the pharmaceutical industry, the early research and development of drugs and products from development to production have long cycles and many links. Moreover, the production and sales of drugs after obtaining certificates are also easily affected by changes in national policies and market environment, and there is uncertainty in the sales performance of drugs. Investors are kindly requested to pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Hainan Huluwa Pharmaceutical Group Co., Ltd.
January 6, 2026