Shanghai Pharmaceuticals Group Co., Ltd. Announcement on Ticagrelor Tablets Obtaining U.S. FDA Approval Number
Securities code: 601607 Securities abbreviation: Shanghai Pharmaceuticals Announcement number: Lin 2025-103
Shanghai Pharmaceutical Group Co., Ltd.
Announcement on Ticagrelor Tablets Obtaining U.S. FDA Approval Number
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, Changzhou Pharmaceutical Factory Co., Ltd. (hereinafter referred to as "Changzhou Pharmaceutical Factory"), a subsidiary of Shanghai Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Shanghai Pharmaceutical" or the "Company"), received notification from the U.S. Food and Drug Administration (hereinafter referred to as the "U.S. FDA") that its abbreviated new drug application ("ANDA", i.e. U.S. generic drug application) for Ticagrelor Tablets (read the text for basic information, hereinafter referred to as the "drug") has received final approval for marketing ("Final") Approval"), the relevant information is now announced as follows:
1. Basic information about the drug
Drug name: Ticagrelor tablets
Dosage form: tablet
Specifications: 60 mg, 90 mg
Application matters: ANDA
Applicant: Changzhou Pharmaceutical Factory Co., Ltd.
ANDA number: ANDA216187
2. Information related to the drug
Ticagrelor tablets are used in patients with acute coronary syndrome, including those receiving drug therapy and percutaneous coronary intervention, to reduce the incidence of thrombotic cardiovascular events. The original research was developed by AstraZeneca and launched in the United States in 2011. In May 2021, Changzhou Pharmaceutical Factory submitted an ANDA application to the US FDA for this drug, and recently received final approval for marketing. As of the date of this announcement, the company has invested approximately RMB 9.6713 million in research and development expenses for this drug.
3. Competition in the drug market
As of the date of this announcement, generic versions of this drug have been launched in the United States, and listed companies include Apotex Inc., Alembic Pharmaceuticals Ltd, Alkem Laboratories Ltd, Dr. Reddy’s Laboratories Inc, Mylan Pharmaceuticals Inc., Watson Laboratories, Inc., etc.
According to the IMS database, the sales of original research and generic drugs of this drug in the United States in 2024 will be approximately US$1.284 billion.
4. Impact on listed companies and risk warnings
This time Changzhou Pharmaceutical Factory Co., Ltd.’s ANDA for Ticagrelor Tablets was approved by the US FDA, which is of positive significance for the company to further expand overseas markets and accumulate valuable experience.
The preparation export business is affected by uncertain factors such as changes in overseas market laws and policies and market environment, exchange rate fluctuations, and market competition. The sales of this drug may not meet expectations, which is highly uncertain. Investors are advised to invest rationally, make prudent decisions, and pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Shanghai Pharmaceutical Group Co., Ltd.
November 7, 2025