Announcement on Promethazine Hydrochloride Injection Passing Generic Drug Consistency Evaluation
Securities code: 601607 Securities abbreviation: Shanghai Pharmaceuticals No.: Lin 2026-064
Shanghai Pharmaceutical Group Co., Ltd.
Announcement on Promethazine Hydrochloride Injection Passing the Consistency Evaluation of Generic Drugs
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 Hefeng Pharmaceutical Co., Ltd. (hereinafter referred to as "Shanghai Hefeng"), a subsidiary of Shanghai Pharmaceuticals Group Co., Ltd. (hereinafter referred to as the "Company"), received the "Drug Supplementary Application Approval Notice" (notice number: 2026B05365) issued by the State Food and Drug Administration (hereinafter referred to as the "NMPA") for Promethazine Hydrochloride Injection (hereinafter referred to as the "drug"). The drug passed the generic drug consistency evaluation.
1. Basic information about the drug
Drug name: Promethazine Hydrochloride Injection
Dosage form: injection
Specifications: 1ml: 25mg
Registration Category: Chemicals
Approval number: National Drug Approval No. H31021490
Applicant: Shanghai Hefeng Pharmaceutical Co., Ltd.
Approval conclusion: This product has passed the quality and efficacy consistency evaluation of generic drugs
2. Information related to the drug
The indications of Promethazine Hydrochloride Injection are: (1) Allergies of skin and mucous membranes: suitable for long-term, seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, urticaria, angioedema, allergic reactions to blood or plasma products, and skin scratches. (2) Motion sickness: Prevent and treat motion sickness, seasickness and airsickness. (3) Used for auxiliary treatment before and after anesthesia and surgery, including sedation, hypnosis, analgesia, and antiemetics. (4) Used to prevent and treat radiation sickness or drug-induced nausea and vomiting.
In August 2025, Shanghai Pharma Hefeng submitted a supplementary application to the State Food and Drug Administration for the quality and efficacy consistency evaluation of generic versions of this drug and was accepted. As of the date of this announcement, the company has invested approximately RMB 5.48 million in research and development expenses for the consistency evaluation of this drug.
As of the date of this announcement, the manufacturers of promethazine hydrochloride injection in China include Shanghai Hefeng Pharmaceutical Co., Ltd., Suicheng Pharmaceutical Co., Ltd., and Guangdong Nanguo Pharmaceutical Co., Ltd.
The IQVIA database shows that the purchase amount of promethazine hydrochloride injection by hospitals in mainland China in 2025 was RMB 32.83 million.
3. Impact on listed companies and risk warnings
According to relevant national policies, drug varieties that pass consistency evaluation will receive greater support in areas such as medical insurance payment and medical institution procurement. Therefore, Shanghai Pharma Hefeng’s Promethazine Hydrochloride Injection has passed the consistency evaluation of generic drugs, which will help expand the market share of the drug, enhance market competitiveness, and accumulate valuable experience for the company’s subsequent products to carry out generic drug consistency evaluation.
Due to the influence of national policies, market environment and other uncertain factors, the sales of this drug may not meet expectations, which is highly uncertain. Investors are advised to make prudent decisions and pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Shanghai Pharmaceutical Group Co., Ltd.
August 25, 2026