泽璟制药公告称，2025年12月7日，公司自主研发的盐酸吉卡昔替尼片通过国家医保谈判，被纳入《国 家基本医疗保险、生育保险和工伤保险药品目录（2025年）》，将于2026年1月1日起执行，协议有效期 至2027年12月31日。该药品为1类新药，用于治疗骨髓纤维化等，已获多项指南推荐。其治疗重度斑秃 适应症申请已获受理，治疗活动性强直性脊柱炎达主要疗效终点。此次纳入医保利于销售，对长期经营 有积极影响，预计短期内不影响业绩。 ...

每经AI快讯，12月7日，智翔金泰(688443.SH)公告称，公司自主研发的赛立奇单抗注射液(金立希)成功 纳入《国家基本医疗保险、生育保险和工伤保险药品目录》，新版目录将于2026年1月1日起正式实施。 该药品为治疗用生物制品Ⅰ类，适用于中度至重度斑块状银屑病成人患者及常规治疗疗效欠佳的强直性 脊柱炎成人患者。纳入医保目录将有利于推动药品市场推广及未来销售，对公司长期经营业绩产生积极 影响。但医保支付标准、报销细则等以国家医保局公示信息为准，且销售受多种因素影响，存在不确定 性。 ...

据悉，芪防鼻通片是说明书明确治疗持续性变应性鼻炎（即过敏性鼻炎）的创新中药，填补临床用药空 白。该药于2025年1月获国家药品监督管理局批准上市，7月12日通过澳门特别行政区政府药物监督管理 局注册审批，成为首个在澳门获批注册的创新中药。 2025年《国家基本医疗保险、生育保险和工伤保险药品目录》（国家医保药品目录）今天在广州正式公 布。以岭药业自主研发的一类新药芪防鼻通片首次被纳入国家医保目录。 ...

从今日举行的2025创新药高质量发展大会现场获悉，恒瑞医药共10款产品首次被纳入新版国家医保药品 目录，覆盖肿瘤、代谢、心血管疾病、免疫系统疾病、眼科等多个领域，具体包括注射用瑞康曲妥珠单 抗、硫酸艾玛昔替尼片、夫那奇珠单抗注射液、注射用瑞卡西单抗、注射用磷罗拉匹坦帕洛诺司琼、瑞 格列汀二甲双胍片(I)/(II)、苹果酸法米替尼胶囊、醋酸阿比特龙片（II）、盐酸伊立替康脂质体注射液 （II）、全氟己基辛烷滴眼液。 ...

Core Viewpoint - The company reported a significant decline in sales and profits for the first half of 2025, with a focus on adapting to market challenges and enhancing product offerings to stabilize its business performance [1][2][3][4] Group 1: Financial Performance - The company achieved sales revenue of approximately HKD 21.47 billion, a year-on-year decrease of about 35.7% [1] - Profit attributable to equity holders was approximately HKD 283.5 million, down about 58.7% year-on-year [1] - Earnings per share were HKD 0.0962, with an interim dividend of HKD 0.05 per share [1] Group 2: Business Segments Infusion Business - Infusion sales volume decreased to approximately 715 million bottles (bags), a decline of 37% year-on-year, with sales revenue of HKD 1.199 billion, down 45% [1] - The company is focusing on product matrix development and digital transformation to enhance market positioning [1] Injectable Business - Ampoule water needle sales volume reached 17.818 million units, a year-on-year increase of 7%, but sales revenue fell by 57% to HKD 157 million [2] - Notable growth in specific products: Methylcobalamin injection sales increased by 61%, and Urapidil hydrochloride injection sales rose by 28% [2] Oral Formulations - Oral formulations achieved sales of HKD 296 million, a year-on-year increase of 16% [2] - New products contributed significantly, with sales of specific items like Rosuvastatin calcium tablets increasing by 32% [2] API Business - API sales amounted to HKD 361 million, a decline of 9.6% year-on-year, with caffeine sales down 15% [3] - The company is enhancing international collaborations and product registrations to mitigate market challenges [3] Export Business - The company reported a 42% increase in export volume for infusions, with significant growth in ampoule water needle and oral formulation exports [3] - The total export sales reached RMB 100.45 million, reflecting a 42% year-on-year increase [3] Packaging Materials - Sales of pharmaceutical packaging materials reached HKD 101 million, a year-on-year increase of 7.1% [4] - The company is focusing on enhancing its product offerings to meet market demands [4]

Investment Rating - The report maintains a "Buy" rating for the company, expecting a price increase of over 15% in the next 6-12 months [5][13]. Core Insights - The company reported a revenue of 950 million yuan for the first half of 2025, with a net loss of 145 million yuan [2]. - The commercialization year has begun, with sales starting to ramp up. The company has three products approved for sale: Jiatailai (TROP2 ADC), Ketailai (PD-L1 monoclonal antibody), and Datailai (Cetuximab) [3]. - The company has a strong clinical pipeline, with Jiatailai's core clinical layout entering a harvest period, and several key indications in various stages of clinical trials [4]. Financial Performance - The company is expected to achieve revenues of 2.325 billion yuan, 3.668 billion yuan, and 5.352 billion yuan for the years 2025, 2026, and 2027 respectively, showing significant growth compared to previous forecasts [5]. - The projected net profit for 2027 is 380 million yuan, indicating a turnaround from previous losses [5]. - The revenue growth rates are projected at 20.29%, 57.74%, and 45.91% for the years 2025, 2026, and 2027 respectively [10]. Clinical Development - The company has a robust pipeline with several products in various stages of clinical development, including A166 (HER2 ADC) in NDA stage and A400 (RET inhibitor) in registration clinical stage [4]. - The company is expanding its market reach, with products already covering 30 provinces and over 2000 hospitals [3]. Market Potential - The inclusion of Jiatailai, Ketailai, and Datailai in the basic medical insurance directory is expected to accelerate sales growth [3]. - The market potential for TROP2 ADC in breast and lung cancer is significant, with comprehensive coverage of patients anticipated upon completion of ongoing clinical trials [3].

Core Viewpoint - The implementation plan for the comprehensive reform of drug, medical device, and cosmetic regulation in Hainan Province aims to promote high-quality development of the pharmaceutical industry through various supportive measures for innovative drugs and medical devices [1] Group 1: Support for Innovative Drugs and Devices - The plan includes timely updates to the "Hainan Province Innovative Drug and Device Product Directory," allowing new drugs, first-generic drugs, and generics that pass quality and efficacy consistency evaluations, as well as certain classes of medical devices, to be included for procurement by medical institutions [1] - There is an emphasis on accelerating the use of innovative drugs and devices in hospitals by establishing a long-term mechanism for regular meetings of pharmacy, device management, and pharmacotherapy committees in public hospitals [1] - The initiative aims to facilitate the inclusion of innovative drugs and devices in the national medical insurance negotiations, providing guidance to companies to help eligible products enter the insurance directory [1] Group 2: Pricing and Market Access - A mechanism for the formation of initial pricing and full-cycle price management for innovative medical devices will be established, promoting rapid online trading through price negotiation between supply and demand parties for devices without listed prices [1]