Core Viewpoint - The new regulations for traditional Chinese medicine (TCM) registration, referred to as the "death clause," will require that key safety information be clarified by July 1, 2026, or the products will face delisting. However, many industry insiders view this as an opportunity for the industry to eliminate "zombie approvals" that are no longer commercially viable [1][2][4]. Group 1: Regulatory Changes - The "New Regulations for TCM Registration" will take effect on July 1, 2026, mandating that any TCM product with unclear safety information will not be re-registered [2][3]. - Most of the TCM products likely to be eliminated are considered "zombie approvals," which are low-value, highly homogeneous products with minimal or zero market sales [2][4]. - The cost for updating safety information for TCM products ranges from thousands to tens of thousands of yuan, with an additional application fee of 9,600 yuan per approval [3][6]. Group 2: Industry Response - Industry experts believe that the impact of the new regulations on the overall sales volume of TCM will be minimal, as many products are already in excess supply [4][6]. - Companies are expected to take advantage of the three-year buffer period to either update their products or voluntarily abandon non-core approvals [10][11]. - The time frame for compliance is seen as generous, allowing companies ample opportunity to meet the new requirements without significant financial strain [8][10]. Group 3: Market Dynamics - The upcoming adjustments to the national essential drug list and the TCM centralized procurement process are viewed as more pressing concerns for the industry than the new registration regulations [10][11]. - The centralized procurement process, set to take place in November 2025, will involve 90 products and a market scale of over 45 billion yuan, raising concerns about future pricing and competition [11][12]. - The adjustment of the essential drug list is anticipated to be a critical window for TCM companies, with significant implications for core product viability and profitability [12].

恒瑞医药获得药物临床试验批准通知书公告要点核心要点 一、获批情况 子公司山东盛迪医药收到HRS-7535片《药物临床试验批准通知书》 获批开展Ⅲ期临床试验，适应症为慢性肾脏病治疗 二、药物特点 三、研发投入 截至目前累计研发投入约3.69亿元（未经审计） 四、风险提示 新型口服小分子GLP-1R激动剂，全球尚无同类口服药物上市 作用机制：促进胰岛素分泌、降低胰高血糖素、抑制胃排空、增强饱腹感 临床前数据显示可显著改善动物慢性肾脏病症状 仍需完成临床试验及国家药监局审评审批后方可上市 研发周期长、环节多，存在不确定性 风险提示及免责条款 市场有风险，投资需谨慎。本文不构成个人投资建议，也未考虑到个别用户特殊的投资目标、财务状况 或需要。用户应考虑本文中的任何意见、观点或结论是否符合其特定状况。据此投资，责任自负。 恒瑞医药获得药物临床试验批准通知书公告要点核心要点 二、药物特点 新型口服小分子GLP-1R激动剂，全球尚无同类口服药物上市 作用机制：促进胰岛素分泌、降低胰高血糖素、抑制胃排空、增强饱腹感 临床前数据显示可显著改善动物慢性肾脏病症状 三、研发投入 截至目前累计研发投入约3.69亿元（未经审计） 一、 ...

Earnings Forecasts - Shengyi Electronics expects a net profit of 1.431 billion to 1.513 billion yuan in 2025, an increase of 331.03% to 355.88% year-on-year [1] - Tigermed anticipates a net profit of 830 million to 1.23 billion yuan in 2025, representing a growth of 105% to 204% year-on-year [2] - Shunbo Alloy forecasts a net profit of 210 million to 270 million yuan in 2025, with an increase of 222.96% to 315.23% year-on-year [3] - Jinkong Electric expects a net profit of 155 million to 195 million yuan in 2025, reflecting a growth of 383.21% to 507.9% year-on-year [9] - Baiao Saitu anticipates a net profit of 162 million to 182 million yuan in 2025, with a year-on-year increase of 384.26% to 443.88% [18] - Panjiang Co. expects a net profit of 318 million to 380 million yuan in 2025, representing a growth of 205.30% to 264.83% year-on-year [38] Loss Forecasts - Liaoning Energy predicts a net loss of 273 million to 410 million yuan in 2025, compared to a profit of 202 million yuan in the previous year [5] - Anbotong anticipates a net loss of 114 million to 165 million yuan in 2025, with a revenue decrease of 19.65% to 27.25% [7] - Wantai Bio forecasts a net loss of 330 million to 410 million yuan in 2025, compared to a profit of 106 million yuan in the previous year [12] - Xingyun Co. expects a net loss of 155 million to 230 million yuan in 2025, compared to a loss of 82.44 million yuan in the previous year [20] - Huaxing Co. anticipates a net loss of 800 million to 1.2 billion yuan in 2025, with a reduction in loss compared to 1.67 billion yuan in the previous year [46] New Product Approvals - Hengrui Medicine received acceptance for a new indication application for its innovative drug, combining Carrelizumab and Apatinib for treating unresectable liver cancer [4] - Tianen Kang's subsidiary received a drug registration acceptance notice for Lidocaine and Prilocaine aerosol [31] - Lisheng Pharmaceutical announced that its Aminophylline tablets passed the consistency evaluation for generic drugs [40] Share Buyback Plans - Hengyuan Coal Power plans to repurchase shares with a total amount not less than 200 million yuan and not exceeding 250 million yuan [13] Contract Wins - China Communication Signal Co. won contracts totaling approximately 5.26 billion yuan for 21 important projects in the railway and urban rail transit markets [37]

HRS-7535 片是一种新型口服小分子胰高血糖素样肽-1 受体(GLP-1R)激动剂，可以通过激活人的 GLP- 1R，促进胰腺的胰岛素分泌和降低胰高血糖素分泌并抑制胃排空，还可以通过影响中枢增强饱腹感和 抑制食欲，直接减少能量的摄入。临床前数据显示 HRS-7535 可显著改善动物慢性肾脏病(CKD)症状。 全球范围内尚无口服小分子 GLP-1R 激动剂上市。截至目前，HRS-7535 片相关项目累计研发投入约 36,940 万元(未经审计)。 智通财经APP讯，恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")子公 司山东盛迪医药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发关于 HRS-7535 片 的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

HRS-7535 片是一种新型口服小分子胰高血糖素样肽-1 受体(GLP-1R)激动剂，可以通过激活人的 GLP- 1R，促进胰腺的胰岛素分泌和降低胰高血糖素分泌并抑制胃排空，还可以通过影响中枢增强饱腹感和 抑制食欲，直接减少能量的摄入。临床前数据显示 HRS-7535 可显著改善动物慢性肾脏病(CKD)症状。 全球范围内尚无口服小分子 GLP-1R 激动剂上市。截至目前，HRS-7535 片相关项目累计研发投入约 36,940 万元(未经审计)。 智通财经APP讯，恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")子公 司山东盛迪医药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发关于 HRS-7535 片 的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

格隆汇1月29日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司子公司山东盛迪医药有 限公司收到国家药品监督管理局核准签发关于HRS-7535 片的《药物临床试验批准通知书》，将于近期 开展临床试验。现将相关情况公告如下： 药物名称：HRS-7535 片 剂 型：片剂 申请事项：临床试验 受 理 号：CXHL2501214、CXHL2501215、CXHL2501216 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025年 11 月 5 日受理的 HRS- 7535 片符合药品注册的有关要求，同意本品开展Ⅲ期临床试验。申请的适应症：本品拟用于治疗慢性 肾脏病。 ...

Core Viewpoint - Heng Rui Medicine (01276) has received a notice from the National Medical Products Administration regarding the acceptance of its application for the marketing license of the innovative drug injection of Camrelizumab combined with Apatinib for a new indication [1] Group 1: Clinical Trial Details - The application for the new indication is based on a randomized, controlled, open-label, multicenter Phase III clinical trial (SHR-1210-III-336 study) evaluating the efficacy and safety of Camrelizumab and Apatinib combined with TACE compared to TACE alone in patients with unresectable hepatocellular carcinoma [1] - The study was led by Academician Fan Jia and Professor Qin Shukui from Zhongshan Hospital, Fudan University, with participation from 34 centers nationwide, enrolling a total of 423 patients [1] Group 2: Study Outcomes - The primary efficacy endpoint was progression-free survival (PFS) assessed by a blinded independent radiological review committee (BIRC); secondary endpoints included overall survival (OS), investigator-assessed PFS, BIRC and investigator-assessed objective response rate (ORR), disease control rate (DCR), and duration of response (DoR) [1] - Interim analysis results indicated that the PFS assessed by BIRC showed a significant clinical improvement in the Camrelizumab combined with Apatinib and TACE group compared to the TACE alone treatment, with a trend observed for OS benefit [1] - This combination therapy is expected to become a new clinical treatment option for patients with unresectable hepatocellular carcinoma [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) has received a notice from the National Medical Products Administration regarding the acceptance of its new indication application for the innovative drug injection of Carrelizumab combined with Apatinib Mesylate tablets [1] Group 1 - The company and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., have successfully submitted a listing application for a new indication [1]

Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2026年1月29日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司山东盛迪医 药有 ...

Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2026年1月29日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-01 ...