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。 HS387片是一款由公司自主研发的选择性KIF18A抑制剂，拟用于高级别浆液性卵巢癌、非小细胞肺癌 等晚期实体瘤治疗。该药品已经获得国家药品监督管理局颁发的《药物临床试验批准通知书》，详见公 司于2025年7月2日披露的《关于获得药物临床试验批准通知书的公告》（公告编号：临2025-37号）。 2025年11月，公司完成向美国FDA递交HS387片的临床试验申请，并于近日获得FDA批准。截至目前， 国内外有多款KIF18A抑制剂进入临床研发阶段，目前尚无药物上市。 近日，浙江海正药业股份有限公司（以下简称"公司"）收到美国食品药品监督管理局（以下简称"美国 FDA"）的通知，由公司申报的HS387片药品临床试验申请已获得美国FDA批准，可以在美国开展临床 试验。现就相关情况公告如下： 一、药品基本情况 药品名称：HS387片 IND编号：IND 178632 申请事项：新药临床试验申请 申请人：浙江海正药业股份有限公司 二、该药品研发及相关情况 董事会 二○二五年十二月二十三日 ...

证券代码：600267 证券简称：海正药业 公告编号：临2025-81号 浙江海正药业股份有限公司 关于公司HS387片获得美国FDA新药临床试验批准通知的公告 2025年11月，公司完成向美国FDA递交HS387片的临床试验申请，并于近日获得FDA批准。截至目前， 国内外有多款KIF18A抑制剂进入临床研发阶段，目前尚无药物上市。 三、风险提示 一、药品基本情况 药品名称：HS387片 IND编号：IND 178632 申请事项：新药临床试验申请 申请人：浙江海正药业股份有限公司 二、该药品研发及相关情况 HS387片是一款由公司自主研发的选择性KIF18A抑制剂，拟用于高级别浆液性卵巢癌、非小细胞肺癌 等晚期实体瘤治疗。该药品已经获得国家药品监督管理局颁发的《药物临床试验批准通知书》，详见公 司于2025年7月2日披露的《关于获得药物临床试验批准通知书的公告》（公告编号：临2025-37号）。 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。 近日，浙江海正药业股份有限公司（以下简称"公司"）收到美国食品药品监督管理局（以下 ...

Group 1 - Rongchang Biotech plans to repurchase shares worth between 20 million and 40 million yuan, with a maximum price of 95 yuan per share, aiming to buy back approximately 21,050 to 42,110 shares, representing about 0.04% to 0.07% of total share capital [1] - Nanya New Materials intends to raise no more than 900 million yuan through a private placement for AI computing power-based high-frequency high-speed copper-clad laminate R&D and working capital [2] - Xiechuang Data has signed a strategic cooperation agreement with Ping An Financial Leasing, aiming for a cooperation scale of 2 billion yuan over three years [3] Group 2 - Chuangshi Technology's controlling shareholder is under investigation and has been placed under detention, having resigned from all positions in the company [4] - Deep Kangjia A has reported overdue shareholder loans to Yikang Technology and Chuzhou Kangxin, totaling approximately 233 million yuan and 395 million yuan respectively, due to repayment issues [5] - Ningbo Yuanyang announced the resignation of two directors due to work adjustments [6] Group 3 - China Merchants Energy has delivered the world's first methanol dual-fuel VLCC oil tanker, with 15 oil tanker orders in hand [7] - Tianyu Co., Ltd. has received a drug registration certificate for hydrochloride trazodone tablets, which are used for treating depression [8] - Haizheng Pharmaceutical has received FDA approval for clinical trials of HS387 tablets for treating advanced solid tumors [9] Group 4 - Warner Pharmaceuticals has obtained a drug registration certificate for isoproterenol hydrochloride injection, used for treating shock and complete atrioventricular block [10] - Hekang New Energy's subsidiary received a government subsidy of 1.5 million yuan, which accounts for 14.57% of the company's latest audited net profit [11] - Duku Culture is planning a change in company control, with stock suspension expected for no more than two trading days [12] Group 5 - Haisco has received acceptance for an IND application for HSK46575 tablets for prostate cancer treatment [13] - *ST Xinyan is executing a capital reserve transfer to increase share capital, resulting in a stock suspension [14] - Nanjing Public Utilities is transferring a 45% stake in a subsidiary for 23.6443 million yuan [15] Group 6 - Action Education plans to repurchase shares worth between 20 million and 25 million yuan, with a maximum price of 45 yuan per share [16] - Bai'ao Tai has received government subsidies totaling 29 million yuan [18] - Weisi Medical intends to sell assets worth 119 million yuan, expecting a profit impact of approximately 10 million yuan [19] Group 7 - Tongyu Communications plans to increase capital by 10 million yuan to introduce investment from Wuchuang Institute [20] - Dongtu Technology's subsidiary is introducing strategic investor Guofeng Investment Fund with a capital increase of 11 million yuan [21] - China General Nuclear Power Technology's shareholder is facing a judicial auction of 2.91% of the company's shares [22] Group 8 - Nanshan Aluminum plans to repurchase shares worth between 300 million and 600 million yuan, with a maximum price of 7.52 yuan per share [23] - Yipin Hong's controlling shareholder has committed to transferring 9.07% equity in Arthrosi without compensation [24] - Sanli Pharmaceutical has signed a technology transfer contract worth 200 million yuan with Hainan University [25] Group 9 - Xin Nuo Wei plans to jointly invest 450 million yuan with Zhongqi Pharmaceutical to establish a joint venture focusing on innovative metabolic drugs [26] - Li Qun Co. has been approved to issue 1 billion yuan in medium-term notes to optimize debt structure and supplement working capital [27] - Dongfang Ocean's subsidiary has received a medical device registration certificate for a procalcitonin test kit [28] Group 10 - Tibet Mining's chairman has resigned due to work adjustments [29] - Wantai Biological's subsidiary has been shortlisted for a national immunization program vaccine procurement project, with a bid price of 27.5 yuan [30] - Xingfu Blue Sea has appointed Zhang Chen as the new deputy general manager [31] Group 11 - Changyuan Donggu has elected Li Yixuan as the vice chairman of the board [32] - Ningbo Huaxiang's subsidiary has signed a strategic cooperation agreement with Dahuang Robotics for collaboration in humanoid robot development [33] - Yongda Co. has been pre-selected for a procurement project worth approximately 350 million yuan [34] Group 12 - Fuan Pharmaceutical's subsidiary has received a drug registration certificate for hydrochloride trazodone tablets [35] - Nanjing Food reported a 71.03% year-on-year decrease in net profit for November due to rising raw material costs [36] - Changqing Technology's special polymer monomer project has commenced production [37]

每经AI快讯，海正药业（SH 600267，收盘价：10.16元）12月22日晚间发布公告称，近日，浙江海正药 业股份有限公司（以下简称"公司"）收到美国食品药品监督管理局（以下简称"美国FDA"）的通知，由 公司申报的HS387片药品临床试验申请已获得美国FDA批准，可以在美国开展临床试验。 每经头条（nbdtoutiao）——新能源重卡爆单了，11月销量同比增长178%！两班倒都供不应求，客户直 接进厂催单，这情景十年难遇 2024年1至12月份，海正药业的营业收入构成为：医药生产占比58.46%，药品销售占比39.29%，其他行 业占比1.94%，其他业务占比0.23%，CMO/CDMO/CRO业务占比0.08%。 （记者 曾健辉） 截至发稿，海正药业市值为122亿元。 ...

智通财经APP讯，海正药业(600267.SH)发布公告，近日，公司收到美国食品药品监督管理局(简称"美国 FDA")的通知，由公司申报的HS387片药品临床试验申请已获得美国FDA批准，可以在美国开展临床试 验。HS387片是一款由公司自主研发的选择性KIF18A抑制剂，拟用于高级别浆液性卵巢癌、非小细胞 肺癌等晚期实体瘤治疗。 ...

海正药业公告称，公司申报的HS387片药品临床试验申请获美国FDA批准，可在美国开展临床试验。该 药是公司自主研发的选择性KIF18A抑制剂，拟用于治疗晚期实体瘤，此前已获国家药监局临床试验批 准。目前，国内外有多款KIF18A抑制剂进入临床研发阶段，尚无药物上市。不过，药物获批上市还需 开展一系列临床试验，短期内对公司经营业务影响不大，提醒投资者注意风险。 ...

Core Viewpoint - Haizheng Pharmaceutical reported significant growth in revenue and net profit for the third quarter of 2025, indicating strong operational performance and advancements in various business segments [1][2]. Financial Performance - The company achieved a total revenue of 7.923 billion yuan and a net profit attributable to shareholders of 461 million yuan in the first three quarters [1]. - In Q3 alone, revenue reached 2.672 billion yuan, with a net profit of 162 million yuan, marking a year-on-year increase of 102.14% [1]. - The non-recurring net profit for Q3 was 169 million yuan, up 96.13% year-on-year [1]. - The gross profit margin improved by 3.81 percentage points, while the expense ratio decreased by 1.35 percentage points [1]. - Net cash flow from operating activities increased by 12.99% year-on-year [1]. Business Segments - The pharmaceutical formulation sector made significant strides, with the launch of the combination therapy for ACS patients setting a new standard in lipid-lowering treatment [1]. - The product "Meiman" was included in the 2025 edition of the guidelines for treating pediatric pneumonia, becoming a recommended medication for resistant Mycoplasma pneumonia [1]. Raw Material and Innovation - The raw material drug for bedaquiline received approval from the National Medical Products Administration, marking a major advancement in the development of key drugs for multidrug-resistant tuberculosis [2]. - The company became the first in China and the fourth globally to receive European Pharmacopoeia suitability certification for tigecycline raw materials [2]. - In the pet medicine sector, the product "Haili Miao" celebrated its tenth anniversary with over 45 million units sold, achieving recognition as the top-selling cat internal medicine in China [2]. Research and Internationalization - R&D expenses increased by 1.36 percentage points year-on-year, with the company obtaining clinical trial approval for HS387, a selective KIF18A inhibitor for treating advanced solid tumors [2]. - The EU has removed the GMP non-compliance statement for the Taizhou factory, enhancing the company's competitiveness in the global pharmaceutical supply chain [2]. Strategic Collaborations - The company entered a collaboration with Aixin Dawei in the SMDC field, incorporating HSE-001 into its R&D pipeline [3]. - A joint venture with Zhejiang Shengzhao Pharmaceutical Technology Co., Ltd. is planned to focus on the development and commercialization of 11 complex injectable products [3]. Future Outlook - As 2025 approaches its end, the company aims to deepen strategic initiatives, enhance domestic and international collaborations, and explore innovative fields to strengthen its market position in the pharmaceutical industry [3].

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]