Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Pharmaceuticals Holding Co., Ltd., received notification from the U.S. FDA that its abbreviated new drug application for Eslicarbazepine Acetate Tablets has been approved for marketing [1] Group 1: Drug Approval and Market Potential - The drug is indicated for the treatment of partial seizures in patients aged 4 years and older, and it was originally launched in the U.S. in 2013 [1] - The application was submitted in January 2018 and received temporary approval in June 2020 [1] - The company has invested approximately 15.9371 million yuan in research and development for this drug [1] - The projected sales for both the original and generic versions of the drug in the U.S. for 2024 are approximately 382 million USD [1] Group 2: Export Business Uncertainty - There is uncertainty regarding the company's formulation export business [1]

Group 1: Approval of New Drugs - Shanghai Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application (ANDA) for Ticagrelor tablets, which are indicated for patients with acute coronary syndrome [1][2] - The drug is available in dosages of 60mg and 90mg, and the original drug was developed by AstraZeneca and launched in the U.S. in 2011 [1][6] - The company has invested approximately RMB 9.67 million in the research and development of this drug [1] Group 2: Market Competition - As of the announcement date, there are already generic versions of Ticagrelor available in the U.S. from companies such as Apotex Inc., Alembic Pharmaceuticals Ltd, and Mylan Pharmaceuticals Inc. [2] - According to IMS data, the combined sales of the original and generic versions of the drug in the U.S. are projected to be approximately $1.284 billion in 2024 [3] Group 3: Impact on Company - The approval of Ticagrelor tablets is expected to positively impact Shanghai Pharmaceuticals' efforts to expand into overseas markets and accumulate valuable experience [4] - The company has also received approval for the production of Tofacitinib citrate extended-release tablets, which are used to treat rheumatoid arthritis and other conditions [7][8] - The company has invested approximately RMB 19.42 million in the research and development of Tofacitinib citrate extended-release tablets [8] Group 4: Regulatory Changes - The company plans to cancel its supervisory board and amend its articles of association to enhance corporate governance, with the audit committee of the board taking over the supervisory functions [13][23] - This decision is in line with regulatory requirements and aims to improve the company's governance structure [13][24]

Core Viewpoint - Shanghai Pharmaceuticals has decided to abolish its supervisory board and amend its articles of association to enhance corporate governance, transferring the supervisory functions to the audit committee of the board of directors [1]. Group 1: Corporate Governance Changes - The decision to cancel the supervisory board was made during the 26th meeting of the 8th board of directors on November 6, 2025 [1]. - The amendments to the articles of association include the removal of references to the supervisory board and supervisors, and the renaming of the "president's office meeting" to "administrative office meeting" [2]. - The company aims to align its governance structure with relevant laws and regulations, including the Company Law and Securities Law of the People's Republic of China [1].

Core Points - Shanghai Pharmaceuticals announced the approval of its drug, citric acid tofacitinib sustained-release tablets, by the National Medical Products Administration [2] Company Summary - The drug received the Drug Registration Certificate (Certificate No: 2025S03257) and is now approved for production [2]

Group 1 - The core point of the article is that Changzhou Pharmaceutical Factory has received final approval from the FDA for its abbreviated new drug application (ANDA) for Ticagrelor tablets, which is significant for expanding the company's overseas market presence [1][2] - The drug Ticagrelor is used for patients with acute coronary syndrome to reduce the incidence of thrombotic cardiovascular events and was originally developed by AstraZeneca, launched in the U.S. in 2011 [1] - The company has invested approximately RMB 9.6713 million in research and development for this drug as of the announcement date [1]

Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Changzhou Pharmaceutical Factory, received final approval from the U.S. Food and Drug Administration (FDA) for the abbreviated new drug application of Ticagrelor tablets, allowing it to be marketed in the U.S. [1] Summary by Relevant Sections - **Product Approval** - The FDA has granted final approval for the Ticagrelor tablets, which are indicated for patients with acute coronary syndrome [1] - The original drug was launched in the U.S. in 2011 [1] - **Target Patient Population** - Ticagrelor tablets are used to reduce the incidence of thrombotic cardiovascular events in patients, including those receiving medical therapy and those undergoing percutaneous coronary intervention [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of Tocilizumab Sustained-Release Tablets, which are indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [1] Company Summary - The approved drug, Tocilizumab Sustained-Release Tablets, was originally developed by Pfizer and was launched in the United States in 2016 [1] Industry Summary - The approval of Tocilizumab Sustained-Release Tablets marks a significant development in the pharmaceutical industry, particularly in the treatment options available for autoimmune diseases [1]

Core Viewpoint - Shanghai Pharmaceuticals (02607) has received approval from the National Medical Products Administration for the production of its tofacitinib citrate sustained-release tablets, which is expected to enhance market share and competitiveness in the pharmaceutical sector [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Chinese and Western Medicine Co., Ltd., has been granted a drug registration certificate for tofacitinib citrate sustained-release tablets [1] - The approval is anticipated to provide significant support in areas such as medical insurance payments and procurement by medical institutions for newly registered generic drugs [1] - The successful approval of this drug will help the company expand its market presence and accumulate valuable experience for future generic drug applications [1]

Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Ticagrelor tablets, which is significant for expanding the company's overseas market presence and gaining valuable experience [1]. Summary by Relevant Sections - **Product Approval** - The U.S. FDA has granted final approval for Changzhou Pharmaceutical Factory's ANDA for Ticagrelor tablets, which are used to reduce the incidence of thrombotic cardiovascular events in patients with acute coronary syndrome [1]. - **Background Information** - Ticagrelor was originally developed by AstraZeneca and was launched in the U.S. in 2011. The ANDA application was submitted by Changzhou Pharmaceutical Factory in May 2021 [1]. - **Financial Investment** - The company has invested approximately RMB 9.6713 million in the research and development of this drug as of the date of the announcement [1]. - **Market Implications** - The approval of Ticagrelor tablets is expected to positively impact the company's efforts to expand into international markets and enhance its operational experience [1].

公司-董-025-2025-V1 上海医药集团股份有限公司 董事离职管理制度 第一章 总则 第一条 为进一步完善上海医药集团股份有限公司（以下简称"公司"）法 人治理结构，规范公司董事的行为，督促上述人员忠实勤勉地履行职责，维护 公司和全体股东的最大利益，根据《中华人民共和国公司法》（以下简称 "《公司法》"）、《中华人民共和国证券法》（以下简称"《证券法》"）、 《上海医药集团股份有限公司公司章程》（以下简称"《公司章程》"）及其他 有关规定，特制定本制度。 第二条 本制度适用范围为经选举产生的董事会成员（包括独立董事）因 任期届满、辞职、被解除职务或其他原因离职的情形。 第三条 公司董事离职管理应遵循以下原则： （一）合法合规原则：严格遵守国家法律法规、监管规定及《公司章程》的 要求； （二）公开透明原则：及时、准确、完整地披露董事离职相关信息； 第四条 董事可以在任期届满以前辞任。董事辞任应当向公司提交书面辞职 报告，公司收到辞职报告之日辞任生效。 如存在下列情形，在改选出的董事就任前，原董事仍应当依照法律、行政 法规、部门规章和《公司章程》的规定，履行董事职务，但存在相关法规另有 规定的除外： （一） ...