创新研发与国际化为公司重点发力方向。前三季度研发费用率同比提升1.36个百分点。第三季度，公司 正式获得HS387片临床试验批准，该药物为选择性KIF18A抑制剂，拟用于高级别浆液性卵巢癌、非小 细胞癌等晚期实体瘤治疗，该领域目前尚无上市产品。 在国际化方面，欧盟官方数据库已于10月移除海正药业台州工厂的《GMP不符合声明》，标志着欧盟 全面解禁公司台州工厂。这一进展将进一步提升公司在全球医药产业链中的竞争力，并与美国、巴西等 国际市场形成深度战略协同。 公司还积极拓展对外合作。9月与艾欣达伟就SMDC领域达成合作，将HSE-001纳入研发管线，双方将 围绕AKR1C3酶活化SMDC技术平台开展深度合作。同时，公司拟与浙江圣兆药物科技股份有限公司共 同投资设立合资公司，专注于11个复杂注射剂产品的研发、生产及商业化，以快速构建在该领域的全球 商业化能力。 随着2025年进入收官阶段，海正药业表示将继续深化战略推进，加强国内外交流合作，积极探索创新领 域，推动多业务协同发展，进一步提升在制药行业的市场地位。 10月28日，海正药业（600267）发布2025年第三季度报告。报告显示，公司前三季度实现营业收入 7 ...

Core Insights - Haizheng Pharmaceutical reported a strong performance in Q3 2025, achieving a total revenue of 7.923 billion yuan and a net profit of 461 million yuan for the first three quarters, with Q3 alone generating 2.672 billion yuan in revenue and 162 million yuan in net profit, marking a year-on-year increase of 102.14% [1] - The company achieved its best-ever performance in terms of non-recurring net profit since its listing, with significant improvements in operational quality, including a gross margin increase of 3.81 percentage points and a decrease in expense ratio by 1.35 percentage points [1] Business Performance - In the pharmaceutical formulation sector, the core product, Saismei (generic name: Haibomai Tablets), has become the new standard for lipid-lowering treatment in acute coronary syndrome (ACS) patients, enhancing brand recognition [2] - The product "Meiman" has been included in the 2025 edition of the "Guidelines for the Diagnosis and Treatment of Pediatric Pneumonia Caused by Mycoplasma," solidifying its position in community infection treatment [2] - In the active pharmaceutical ingredient (API) sector, the approval of fumarate bedaquiline API marks a significant advancement in the development of key drugs for multidrug-resistant tuberculosis [2] Innovation and Internationalization - The synthetic biology subsidiary, Yunseng, successfully launched a flexible production line and established a strategic partnership with Jiangnan University to accelerate the industrialization of technological achievements [3] - The company’s Taizhou factory has had its GMP non-compliance status removed by the EU, enhancing its core competitiveness in the global pharmaceutical supply chain [3] R&D Investment - Haizheng Pharmaceutical has increased its R&D expenditure ratio by 1.36 percentage points in the first three quarters, with the innovative drug HS387 (a selective KIF18A inhibitor) receiving clinical trial approval for treating advanced solid tumors [4] - The company announced a joint investment with Zhejiang Shengzhao Pharmaceutical Technology Co., Ltd. to establish a joint venture focused on complex injectable products, aiming to enhance its capabilities in R&D, production, and commercialization in this field [4]

Core Viewpoint - After parting ways with Pfizer, Zhejiang Hai Zheng Pharmaceutical Co., Ltd. is facing significant challenges in its development, despite recent approval of its fumarate bedaquiline raw material, which brings a glimmer of hope for the company [1] Group 1: Company Background - Hai Zheng Pharmaceutical was founded in 1956 and listed on the A-share market in 2000, operating as a state-controlled comprehensive pharmaceutical group with a diverse portfolio including chemical drugs, biological drugs, and veterinary drugs [2] - The company’s core products include the self-developed first-class new drug Haibo Maibu tablets and other medications for liver bile accumulation treatment [2] Group 2: Partnership with Pfizer - The partnership with Pfizer began in September 2012, forming Hai Zheng Pfizer Pharmaceutical Co., Ltd. with a total investment of $295 million, where Hai Zheng held a 51% stake [2] - Initially, the collaboration was beneficial, with the antibiotic "Tezhixing" becoming a major revenue source, contributing significantly to the company's profits in 2013 and 2014 [2][3] Group 3: Challenges Post-Partnership - In 2015, production issues at Pfizer's overseas factories led to a significant drop in sales, and by 2017, Pfizer completely exited the partnership, leaving Hai Zheng to adjust its strategies without a key growth driver [3] - The company has since faced continuous revenue declines from 2022 to 2024, with a drop of 0.82%, 13.82%, and 5.65% year-on-year, and a further decline of 3.48% in Q1 2025 [4] Group 4: Impact of Market Dynamics - The company’s performance has been adversely affected by centralized procurement policies, leading to a significant reduction in market share and a decrease in revenue from its main products [5][6] - In 2023, the revenue from self-operated pharmaceutical business decreased by 10.41 billion yuan, indicating the impact of competitive pressures in the market [6] Group 5: Innovation and R&D - Hai Zheng's self-developed drug Haibo Maibu tablets has shown promising sales growth, reaching over 4 billion yuan in 2023, with potential peak sales estimated at 19.54 billion yuan if market penetration improves [7] - The company has recently received approval for clinical trials of HS387 tablets targeting advanced ovarian cancer and non-small cell lung cancer, but faces stiff competition in these therapeutic areas [8] - The approval of fumarate bedaquiline raw material is a positive development, but the timeline for mass production and revenue contribution remains uncertain [9] Group 6: R&D Investment Trends - R&D investment has fluctuated, with 4.42 billion yuan in 2022, decreasing to 3.94 billion yuan in 2023, but showing a slight increase to 4.16 billion yuan in 2024 [9][10] - The company is establishing advanced R&D platforms, but the effectiveness and impact of these initiatives on innovation remain unclear [10]

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]