/SH PHARMA - Shanghai Pharmaceutical Group Co., Ltd. Announcement on the Approval for Production of Omeprazole Sodium Bicarbonate Dry Suspension (I)
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SH PHARMA - Shanghai Pharmaceutical Group Co., Ltd. Announcement on the Approval for Production of Omeprazole Sodium Bicarbonate Dry Suspension (I)

HKEXnews
2026/08/03[Overseas Regulatory Announcement - Business Update]

SH PHARMA - Shanghai Pharmaceutical Group Co., Ltd. Announcement on the Approval for Production of Omeprazole Sodium Bicarbonate Dry Suspension (I)

Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement or its accuracy.

or completeness of this announcement, and expressly expressly disclaims any liability arising out of or in reliance upon the whole or any part of the contents of this announcement. assumes no responsibility for any losses caused by such content.

Shanghai Pharmaceutical Group Co., Ltd.

Shanghai Pharmaceuticals Holding Co., Ltd. *

(a joint stock limited company incorporated in the People's Republic of China)

(Stock code: 02607)

Overseas regulatory announcement

This announcement is made in accordance with Rule 13.10B of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited.

This is set forth on the website of Shanghai Stock Exchange (http://www.sse.com.cn) of Shanghai Pharmaceuticals Group Co., Ltd. (the "Company") Published "Shanghai Pharmaceutical Group Co., Ltd.'s approval for the production of Omeprazole Sodium Bicarbonate Dry Suspension (I)"

Announcement" is for reference only.

By order of the board of directors

Shanghai Pharmaceutical Group Co., Ltd. Yang Qiuhua Chairman

Shanghai, China, August 4, 2026 As at the date of this announcement, the executive directors of the Company are Mr. Yang Qiuhua, Mr. Shen Bo, Mr. Li Yongzhong and Mr. Dong Ming

Mr. Zhang; the non-executive director is Mr. Zhang Wenxue; the employee representative director is Mr. Zhao Yong; and the independent non-executive director The persons involved are Mr. Wang Zhong, Ms. Wan Jun, Mr. Xue Yunkui and Mr. Wang Qian.

*For identification only

Securities code: 601607 Securities abbreviation: Shanghai Pharmaceuticals No.: Lin 2026-061

Shanghai Pharmaceutical Group Co., Ltd.

Announcement on the approval for production of omeprazole sodium bicarbonate dry suspension ( ) I

The board of directors and all directors of the company guarantee that the contents of this announcement do not contain any false records or misleading statements.

or major omissions, and shall bear individual and joint liability for the authenticity, accuracy and completeness of its content.

Recently, Shanghai Pharmaceuticals Xinyi, a subsidiary of Shanghai Pharmaceuticals Group Co., Ltd. (hereinafter referred to as the "Company")

Pharmaceutical Co., Ltd. (hereinafter referred to as "Shanghai Xinyi") received a Omeprazole sodium bicarbonate dry suspension (I) (hereinafter referred to as the "drug") issued by the National Food and Drug Administration

The "Drug Registration Certificate" (certificate number: 2026S02750), the drug was approved for production.

  1. Basic information about the drug

Drug name: Omeprazole sodium bicarbonate dry suspension (I)

Dosage form: oral suspension

Specifications: Each bag contains omeprazole 20mg and sodium bicarbonate 1680mg

Registration classification: Chemicals Class 3

Drug approval number: National Drug Approval Number H20265385 Applicant: Shanghai Shanghai Xinyi Pharmaceutical Co., Ltd.

Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this product

Comply with the relevant requirements for drug registration, approve the registration, and issue a drug registration certificate.

  1. Information related to the drug

Omeprazole sodium bicarbonate dry suspension (I) (each bag contains omeprazole 20mg and sodium bicarbonate 1680mg)

Primarily indicated for the short-term treatment of active duodenal ulcers and gastroesophageal reflux disease, by Salix

Developed and produced by Pharmaceuticals Inc, the trade name is Zegerid, which was obtained by the United States in June 2004.

Food and Drug Administration approved marketing in the United States. In September 2024, Shanghai Pharmaceuticals Xinyi reported to the state on the drug The Food and Drug Administration submitted an application for registration and marketing, which was accepted. As of the date of this announcement, the company has invested in

R&D expenses are approximately RMB 5.9355 million.

As of the date of this announcement, the major manufacturers of this drug in China include Nanjing Haina Pharmaceutical Co., Ltd.,

Jining Huaneng Pharmaceutical Factory Co., Ltd., Shandong Qidu Pharmaceutical Co., Ltd., etc.

The IQVIA database shows that hospitals in mainland China purchased omeprazole sodium bicarbonate dry suspension in 2025 The amount is RMB 15.69 million.

  1. Impact on listed companies and risk warnings

According to relevant national policies, the varieties of generic drugs approved according to the new registration classification are subject to medical insurance payment and medical institutions.

Areas such as procurement will receive greater support. Therefore, Shangyao Xinyi’s Omeprazole Sodium Bicarbonate Dry Suspension

(I) Obtaining approval for production will help expand the market share of the drug, enhance market competitiveness, and at the same time provide

The company has accumulated valuable experience in applying for generic drugs for subsequent products. Due to the influence of national policies, market environment and other uncertain factors, the sales of this drug may not meet expectations.

Such situations are highly uncertain. Investors are advised to make prudent decisions and pay attention to investment risks.

Announcement is hereby made.

Shanghai Pharmaceutical Group Co., Ltd. board of directors

August 4, 2026