Core Viewpoint - After parting ways with Pfizer, Zhejiang Haizheng Pharmaceutical Co., Ltd. is facing significant challenges in its development despite recent approval for its active pharmaceutical ingredient, fumarate bedaquiline [2] Group 1: Company Background - Haizheng Pharmaceutical, founded in 1956 and listed in 2000, is a state-controlled comprehensive pharmaceutical group with a diverse portfolio including chemical drugs, biological drugs, and veterinary drugs [3] - The company’s core products include the self-developed first-class new drug Haibomab, a cholesterol absorption inhibitor, and other medications for liver bile accumulation treatment [3] Group 2: Partnership with Pfizer - The partnership with Pfizer began in September 2012, creating Haizheng Pfizer Pharmaceutical Co., Ltd. with a total investment of $295 million, where Haizheng held a 51% stake [3][4] - Initially, the collaboration was beneficial, significantly boosting Haizheng's revenue through the exclusive production of off-patent antibiotics [4] - However, production issues at Pfizer's overseas factories led to a significant revenue drop, and by 2017, Pfizer completely exited the partnership [4] Group 3: Financial Performance - Haizheng Pharmaceutical has experienced a continuous decline in revenue from 2022 to 2024, with year-on-year decreases of 0.82%, 13.82%, and 5.65% respectively [5][6] - In Q1 2025, the company reported revenue of 2.632 billion yuan, a 3.48% decrease year-on-year, and a net profit of 194 million yuan, down 21.85% [5] Group 4: Market Challenges - The company’s performance has been adversely affected by centralized procurement policies, leading to a significant reduction in market share for key products [6] - In 2023, the revenue from self-operated pharmaceutical preparations decreased by 10.41 billion yuan, indicating a substantial impact from procurement policies [6] Group 5: Innovation and R&D - Haizheng's self-developed drug Haibomab has shown promising sales growth, reaching over 400 million yuan in 2023, with potential peak sales estimated at 1.954 billion yuan [7] - The company has recently received approval for HS387, targeting advanced ovarian cancer and non-small cell lung cancer, but faces intense competition in these markets [8] - R&D investment has fluctuated, with 2024's R&D expenditure at 416 million yuan, representing 4.25% of revenue, indicating a focus on innovation despite financial pressures [10] Group 6: Future Prospects - The approval of fumarate bedaquiline is a positive development, but the company faces challenges in scaling production and market entry [9] - The overall effectiveness of Haizheng's R&D platforms and the impact of past collaborations with Pfizer on current innovation efforts remain uncertain [10]

近日，浙江海正药业股份有限公司（以下简称"公司"或"海正药业"）收到国家药品监督管理局（以下简 称"国家药监局"）核准签发的丁二磺酸腺苷蛋氨酸肠溶片《药品补充申请批准通知书》，公司药品丁二 磺酸腺苷蛋氨酸肠溶片已通过仿制药质量和疗效一致性评价。现就相关情况公告如下： 一、药品的基本情况 药品名称：丁二磺酸腺苷蛋氨酸肠溶片 剂型：片剂 证券代码：600267 证券简称：海正药业 公告编号：临2025-26号 浙江海正药业股份有限公司 关于公司药品通过仿制药一致性评价的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 原药品批准文号：国药准字H20133197 申请内容：仿制药质量和疗效一致性评价 规格：0.5g(按C??H??N?O?S+计) 注册分类：化学药品 上市许可持有人：浙江海正药业股份有限公司 生产企业：浙江海正药业股份有限公司 受理号：CYHB2450105 通知书编号：2025B01724 审批结论：根据《中华人民共和国药品管理法》、《国务院关于改革药品医疗器械审评审批制度的意 见》(国发〔2015〕44号)和 ...

Core Viewpoint - The company has successfully passed the consistency evaluation of the quality and efficacy of its generic drug, Adenosine Methionine Disulfate Enteric-Coated Tablets, which is indicated for cholestasis due to liver cirrhosis [1] Group 1: Product Information - The drug is suitable for pre-cirrhosis and cholestasis caused by liver cirrhosis [1] - The original product was developed by Abbott Laboratories [1] Group 2: Market Potential - The global sales forecast for the drug in 2024 is approximately $170 million, with domestic sales expected to be around $38.4 million [1] - The company's projected sales for 2024 are about 145 million RMB [1]