Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the fourth indication of its core product, TROP2 ADC, sac-TMT, for the treatment of 2L+ HR+/HER2- breast cancer [2][6]. Drug Basic Information - The approval is based on positive results from the OptiTROP-Breast02 Phase III clinical study, which was presented at the 2025 European Society for Medical Oncology (ESMO) Congress [2][3]. - The new indication is for adult patients with unresectable or metastatic HR+/HER2- breast cancer who have previously received endocrine therapy and at least one line of chemotherapy [2][3]. Clinical Study Results - The OptiTROP-Breast02 study evaluated the efficacy and safety of sac-TMT compared to investigator's choice of chemotherapy in patients with HR+/HER2- breast cancer [3]. - Among enrolled patients, 95.7% had visceral metastases, and 75.9% had liver metastases [3]. - The study showed a significant improvement in progression-free survival (PFS) for the sac-TMT group compared to the chemotherapy group (8.3 months vs. 4.1 months; hazard ratio (HR): 0.35; 95% confidence interval (CI): 0.26-0.48; p<0.0001) [3]. - The overall survival (OS) benefit trend and objective response rate (ORR) were also significantly higher in the sac-TMT group (41.5% vs. 24.1%) [3]. Product Overview - Sac-TMT is a novel TROP2 ADC developed by Kelun Botai, targeting various advanced solid tumors, including non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), and gynecological tumors [5]. - The drug utilizes a new linker and has a drug-antibody ratio (DAR) of 7.4, delivering a topoisomerase I inhibitor as an effective payload [5]. - Sac-TMT has received six breakthrough therapy designations (BTD) from the NMPA [6]. Ongoing Research - Currently, sac-TMT is involved in nine registration clinical studies in China, with Merck conducting 16 ongoing global Phase III clinical studies for various cancer types [7].

Group 1 - ZTE Corporation plans to invest 200 million RMB to subscribe to the Guangdong-Hong Kong-Macao Greater Bay Area Venture Capital Guidance Fund, focusing on areas supported by national policies such as new generation information technology and biotechnology [1] - Huayi Jewelry's subsidiary has reported overdue loans totaling 200 million RMB due to tight liquidity, with a cumulative overdue principal of 254 million RMB [2] - Guangzhou Baiyunshan Pharmaceutical's subsidiary has received approval for the consistency evaluation of Alfacalcidol soft capsules, which are used to treat calcium metabolism disorders [3] Group 2 - Kunming Pharmaceutical Group reported a 21.72% decline in revenue to 6.577 billion RMB and a 46% drop in net profit to 350 million RMB for 2025 [4] - Jiantou Energy's application for a specific stock issuance has been approved by the Shenzhen Stock Exchange [5] - Jinchuan Titanium Industry's subsidiary has temporarily suspended its sulfuric acid production due to reduced demand [6] Group 3 - Kelun Pharmaceutical's subsidiary has received approval for a new indication for its antibody-drug conjugate, which is used to treat advanced hormone receptor-positive breast cancer [7] - Fawer Co., Ltd. has completed the relocation of its Chongqing Yuantai Shock Absorber Company and commenced production [8] - Jiuzhoutong's subsidiary has received acceptance for the listing application of Betahistine Hydrochloride tablets [9] Group 4 - Zhongguancun plans to build a traditional Chinese medicine and raw material drug production base in Jiamusi City, Heilongjiang Province [11] - China Wuyi announced that part of its land in Kenya has been requisitioned by the government, with compensation of approximately 6.25 million RMB [12] - Times Electric reported a 15.46% increase in revenue to 28.761 billion RMB and a 10.88% increase in net profit to 4.105 billion RMB for 2025 [13] Group 5 - Top Cloud Agriculture's shareholder has received regulatory measures from the Zhejiang Securities Regulatory Bureau for failing to timely disclose shareholding changes [14] - Xinwanda's subsidiary has reached a settlement in a lawsuit involving over 2.314 billion RMB, with an estimated impact of 500 to 800 million RMB on net profit for 2025 [15] - Dongrui Co., Ltd. reported a 25.19% increase in pig sales revenue in January, totaling 214 million RMB [16] Group 6 - Tianjin Tianshi reported a 3.08% decline in revenue to 8.236 billion RMB, while net profit increased by 15.68% to 1.105 billion RMB for 2025 [17] - Wantong Expressway plans to invest approximately 5.42 billion RMB in the renovation and expansion of the Lianhuo Expressway [18] - Qiaoyin Co., Ltd. has pre-qualified for a sanitation integration service project worth approximately 73.8 million RMB [20] Group 7 - Jindi Co., Ltd. plans to acquire 100% equity of Yuni Precision for 116 million RMB, focusing on precision stamping products [21] - Heng Rui Medicine's HRS-4642 injection has been included in the list of breakthrough therapeutic varieties [22] - Tongde Chemical has had some assets frozen due to a financing lease dispute [23] Group 8 - Zhongli Co., Ltd. is establishing an industrial fund with a total commitment of approximately 408.76 million RMB, focusing on new materials and artificial intelligence [24] - Tianbang Food reported a 9.93% increase in pig sales revenue in January, totaling 674 million RMB [25] - New Hope reported a 10.03% decrease in pig sales revenue in January, totaling 1.628 billion RMB [26] Group 9 - Tainkang's subsidiary has received a drug registration certificate for Minoxidil topical solution [27] - Lihua Co., Ltd. reported a 9.8% increase in chicken sales revenue in January, totaling 1.289 billion RMB [28] - Guojitong General reported a 45.71% increase in net profit to 58.52 million RMB for 2025 [29] Group 10 - Zhixin Co., Ltd. plans to invest up to 1.1 billion RMB in an automotive stamping and welding parts project [30] - Chuangyuan Technology's subsidiary has pre-qualified for a National Grid project worth approximately 94.77 million RMB [31] - Lisheng Pharmaceutical's adenine phosphate raw material has passed the listing application [32] Group 11 - Tongguang Cable's subsidiary has pre-qualified for a National Grid project worth approximately 108 million RMB [33] - Zhenghong Technology reported a 7.74% increase in pig sales revenue in January, totaling 14.35 million RMB [34] - Pengding Holdings reported a 0.07% decrease in consolidated revenue in January, totaling 2.701 billion RMB [35] Group 12 - Hongri Pharmaceutical has received approval for clinical trials of its injectable drug for acute pancreatitis [36][37] - Xinhua Medical has decided to terminate the acquisition of a 36.19% stake in Wuhan Zhongzhi Biotechnology [38] - Tianyu Bio reported an 11.23% decrease in pig sales revenue in January, totaling 54.29 million RMB [39]

Core Viewpoint - The approval of a new indication for the antibody-drug conjugate sac-TMT (also known as SKB264/MK-2870) by the National Medical Products Administration (NMPA) in China represents a significant advancement for the company in the treatment of specific breast cancer patients [1] Group 1: Company Developments - The company’s subsidiary, Sichuan Kelun-Botai Biopharmaceutical Co., Ltd., has received approval for sac-TMT to treat adult patients with hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer who have previously undergone endocrine therapy and at least one line of chemotherapy in advanced disease stages [1] - This new indication marks the fourth approved indication for sac-TMT in China, indicating the drug's expanding therapeutic potential [1]

Core Viewpoint - Kelun Pharmaceutical's subsidiary, Kelun Biotech, received approval from the National Medical Products Administration for a new indication of Lukanasa (Lukangshatu) for treating specific adult breast cancer patients, marking the fourth approved indication for this drug in China [1] Group 1: Drug Approval and Clinical Research - The approval is based on the results of the OptiTROP-Breast02 Phase 3 clinical study, which showed a significant improvement in progression-free survival for the drug group compared to the chemotherapy group [1] - There is a trend of benefit in overall survival and a notable increase in objective response rate [1] - Phase 3 clinical studies for Lukanasa in combination with or without Pembrolizumab for related breast cancer have been initiated globally and in China [1] Group 2: Previous Indications and Recognitions - Two previous indications for Lukanasa have been included in the medical insurance coverage [1] - The drug has also received six breakthrough therapy designations [1]

证券代码：002422 证券简称：科伦药业 公告编号：2026-008 四川科伦药业股份有限公司 关于子公司核心产品 TROP2 ADC 芦康沙妥珠单抗(sac-TMT) 获国家药品监督管理局批准 第四项适应症（用于治疗 2L+ HR+/HER2-乳腺癌）上市的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误 导性陈述或重大遗漏。 四川科伦药业股份有限公司（以下简称"公司"）近日获悉，公司控股子公 司四川科伦博泰生物医药股份有限公司（以下简称"科伦博泰"）靶向人滋养细 胞表面抗原 2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗(sac-TMT，亦称 SKB264/MK-2870)(佳泰莱®)的一项新增适应症上市申请已获中国国家药品监督 管理局(NMPA)批准，用于治疗既往接受过内分泌治疗且在晚期疾病阶段接受过 至少一线化疗的不可切除或转移性的激素受体阳性(HR+)且人类表皮生长因子 受体 2 阴性(HER2-)(免疫组织化学(IHC) 0、IHC 1+或 IHC 2+/原位杂交(ISH)-)乳 腺癌(BC)成人患者。该适应症是芦康沙妥珠单抗(sac-TMT)在中国上市的 ...

Group 1 - Chengdu has 7 companies listed in the "2025 Hurun China 500," with a threshold of 34 billion yuan, an increase of 7.5 billion yuan from the previous year, representing a growth of 28% [1] - The total value of the 500 companies increased by 21 trillion yuan, a growth of 38%, reaching 77 trillion yuan, with an average value growth of 41.5 billion yuan, totaling 1.53 trillion yuan [1] - Among the top three companies, TSMC's value increased by 3.5 trillion yuan to 10.5 trillion yuan, Tencent's value grew by 1.9 trillion yuan to 5.3 trillion yuan, and ByteDance's value rose by 1.8 trillion yuan to 3.4 trillion yuan [1] Group 2 - Chengdu's representative company, Xinyi Technology, saw its value increase by 218.5 billion yuan to 309 billion yuan, ranking 31st and rising 89 places [2] - In the innovative drug sector, Chengdu's representative company, Baili Tianheng, experienced a value increase of 79.5 billion yuan to 153 billion yuan, ranking 86th and rising 56 places [2] - The other five Chengdu companies listed are: Tongwei Co., Ltd. (ranked 120th, 116 billion yuan), Langjiu (ranked 205th, 72 billion yuan), Kelun Pharmaceutical (ranked 279th, 55 billion yuan), New Hope (ranked 354th, 45 billion yuan), and Guojin Securities (ranked 457th, 36 billion yuan) [2]

根据《中华人民共和国公司法》《中华人民共和国证券法》《深圳证券交易所上市公司自律监管指引第 9号一一回购股份》等有关规定，上市公司在回购期间应当在每个月的前3个交易日内披露截至上月末的 回购进展情况，现将目前公司回购股份的进展情况公告如下： 截至2026年1月31日，公司暂未通过股份回购专用证券账户以集中竞价方式回购公司A股股份。 登录新浪财经APP 搜索【信披】查看更多考评等级 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述或重大遗 漏。 四川科伦药业股份有限公司（以下简称"公司"）本次回购股份事项所涉议案《关于回购公司股份方案的 议案》已经2026年1月4日召开的第八届董事会第十一次会议审议通过。公司于2026年1月6日在公司指定 信息披露网站巨潮资讯网（www.cninfo.com.cn）、《证券时报》、《上海证券报》、《证券日报》和 《中国证券报》上披露了《第八届董事会第十一次会议决议公告》和《关于回购公司股份方案的公告暨 回购报告书》。 根据《关于回购公司股份方案的公告暨回购报告书》（以下统称"方案"），公司拟通过深圳证券交易所 以集中竞价交易方式回购公司股份。在 ...

格隆汇2月3日丨科伦药业(002422.SZ)公布，截至2026年1月31日，公司暂未通过股份回购专用证券账户 以集中竞价方式回购公司A股股份。 ...

证券代码：002422 证券简称：科伦药业 公告编号：2026-007 四川科伦药业股份有限公司 关于回购公司股份进展的公告 1 公司后续将根据市场情况实施本次回购方案，并根据相关规定及时履行信息 披露义务，敬请广大投资者注意投资风险。 特此公告。 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误 导性陈述或重大遗漏。 四川科伦药业股份有限公司（以下简称"公司"）本次回购股份事项所涉议 案《关于回购公司股份方案的议案》已经2026年1月4日召开的第八届董事会第十 一次会议审议通过。公司于2026年1月6日在公司指定信息披露网站巨潮资讯网 （www.cninfo.com.cn）、《证券时报》、《上海证券报》、《证券日报》和《中 国证券报》上披露了《第八届董事会第十一次会议决议公告》和《关于回购公司 股份方案的公告暨回购报告书》。 根据《关于回购公司股份方案的公告暨回购报告书》（以下统称"方案"）， 公司拟通过深圳证券交易所以集中竞价交易方式回购公司股份。在回购资金总额 不低于人民币5,000.00万元（含），且不超过人民币10,000.00万元（含），回购 价格不超过人民币35元/股（ ...

股票研究 /[Table_Date] 2026.02.01 持续推荐创新药械产业链 [Table_Industry] 医药 ——国泰海通医药 2026 年 2 月月报 | [姓名table_Authors] | 电话 | 邮箱 | 登记编号 | | --- | --- | --- | --- | | 余文心(分析师) | 021-38676666 | yuwenxin@gtht.com | S0880525040111 | | 郑琴(分析师) | 021-23219808 | zhengqin@gtht.com | S0880525040108 | | 谈嘉程(分析师) | 021-38038429 | tanjiacheng@gtht.com | S0880523070004 | 本报告导读： 持续推荐创新药械及产业链。 投资要点： | [Table_Invest] | | | --- | --- | | 评级： | 增持 | [Table_Report] 相关报告 医药《V940 五年随访数据披露，mRNA 肿瘤疫 苗长期价值验证》2026.01.30 医药《支持政策不断，持续推荐创新药械产业 链》202 ...