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].

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：6990） 自願公告 核心產品TROP2 ADC蘆康沙妥珠單抗(sac-TMT) 獲 國 家 藥 品 監 督 管 理 局 批 准 第 四 項 適 應 症 上 市， 用於治療2L+ HR+/HER2-乳腺癌 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司（「本公司」）董 事（「董 事」）董 事 會（「董 事 會」）欣 然 宣 佈，近 日，本 公 司 靶 向 人 滋 養 細 胞 表 面 抗 原2(TROP2)的抗體 偶聯藥物(ADC)蘆 康 沙 妥 珠 單 抗（sac-TMT，亦稱SKB264/MK-2870）（佳 泰 萊®） 的一項新增適應症上市申請 已獲中國國家藥品監督管理局(NMPA)批 准， 用於治療既往接受過內分泌治療且在晚期疾病階段接受過至少一線化療 的不可切除或轉移性的激素受體陽性(HR+)且人類表皮生長因子受體2陰 性（HER2-）（免 疫 組 織 化 ...

转自：成都日报锦观 记者注意到，成都市银发经济重点产业链链主企业评定名单包括泰康之家蜀园（成都）健康服务有限公 司、成都九如城养老服务有限公司、四川千里倍益康医疗科技股份有限公司、都江堰五粮液合美健康投 资有限责任公司、四川科伦博泰生物医药股份有限公司、四川海思科制药有限公司、四川久远银海股份 有限公司、四川新绿色药业科技发展有限公司、成都第一制药有限公司9家企业。此外，银发经济重点 产业链链属企业共有412家，涵盖了健康养老、康养旅游、智慧养老、抗衰老产业、机器人等领域。 推动银发经济高质量发展，既是增进老年人福祉的现实需求，又是带动产业转型的时代机遇。《成都市 做优做强银发经济重点产业链三年行动计划》提出，到2027年，银发经济发展布局基本形成，优势特色 更加凸显，产业规模达1100亿元以上，争创一家国家级高水平银发经济产业园，打造15家以上具有全国 影响力的银发经济知名企业和一批品牌产品。 成都日报锦观新闻记者 刘泰山 9家企业入选成都市银发经济重点产业链链主 记者昨日从成都市发展改革委获悉，成都市银发经济重点产业链链主、链属企业评定结果正对外公示。 ...

Core Viewpoint - The company, Kelun Pharmaceutical, has received breakthrough therapy designation from the National Medical Products Administration (NMPA) in China for its antibody-drug conjugate (ADC) SKB264/MK-2870, in combination with Merck's PD-1 monoclonal antibody, for the treatment of specific types of non-small cell lung cancer (NSCLC) [1]. Group 1 - Kelun Pharmaceutical's subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., is involved in the development of the ADC targeting TROP2 [1]. - The combination therapy is aimed at patients with locally advanced or metastatic NSCLC who are negative for EGFR gene mutations and ALK [1]. - The therapy is specifically for patients with a tumor proportion score (TPS) of ≥1% for PD-L1 [1].

2025年12月，科伦博泰与 Crescent Biopharma, Inc. ("Crescent")就 SKB105/CR-003 与 SKB118 (程序性细 胞死亡蛋白-1(PD-1) x 血管内皮生长因子 (VEGF)双特异性抗体，亦称CR-001)达成战略合作，其中科伦 博泰授予Crescent 在美国、欧洲及所有其他大中华地区(包括中国内地、香港、澳门及台湾)以外市场研 究、开发、生产和商业化SKB105/CR-003的独家权利，Crescent则授予科伦博泰在大中华地区研究、开 发、生产和商业化SKB118/CR-001的独家权利。科伦博泰计划于近期向中国国家药品监督管理局药品审 评中心递交 SKB118/CR-001 的 IND 申请。 智通财经APP讯，科伦药业(002422.SZ)发布公告，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")自主研发的靶向整合素β6(ITGB6)抗体偶联药物(ADC)SKB105(亦 称 CR-003)的新药临床试验(IND)申请已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)批准， 用于治疗晚期实体瘤。 ...

Group 1 - The core point of the announcement is that Sichuan Kelun Pharmaceutical Co., Ltd. plans to implement a share incentive plan for its subsidiary, Kelun Biotech, to attract and retain core talent and align interests among shareholders, the company, and key personnel [1][10]. Group 2 - The incentive plan will grant restricted share units, with a maximum of 3,500,000 H-shares to be issued, representing approximately 1.5% of the total shares of Kelun Biotech on the date of approval [2]. - The plan aims to establish a long-term incentive mechanism to support the strategic and operational goals of Kelun Biotech [3]. - The plan will be effective for ten years from the adoption date, with no new share awards to be granted after the expiration [3]. Group 3 - Eligible participants include directors and employees of Kelun Biotech and its subsidiaries, with selection based on performance, tenure, and contributions [4]. - The purchase price for the shares is set at RMB 1.00 per share, with a vesting period of four years, and performance targets must be met for the shares to vest [6]. - The management of the incentive plan will be overseen by the board of directors or authorized representatives of Kelun Biotech [7]. Group 4 - The incentive plan has been approved by the board of directors of Kelun Biotech but requires shareholder approval and listing approval from the Hong Kong Stock Exchange [9]. - The implementation of the plan is expected to enhance the core competitiveness and sustainable development of Kelun Biotech without adversely affecting the financial status or operational results of the parent company [10].

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"）与Crescent Biopharma, Inc.及其全资子公司Crescent Biopharma Operating Company, LLC (以下合称"Crescent"或"Crescent Biopharma")已建立战略合作伙伴关系，共同开 发和商业化肿瘤治疗手段（包括新型联用疗法）。 一、合作基本情况 登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：002422 证券简称：科伦药业 公告编号：2025-083 四川科伦药业股份有限公司 关于子公司与Crescent Biopharma合作业务进展的公告 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。 CR-001(亦称SKB118) CR-001是一款四价双抗，目前正开发用于治疗实体瘤。其结合了肿瘤学中两种互补且经过验证的作用 机制一一PD-1和VEGF阻断，其中对PD-1检查点的抑制可恢复T细胞识别和摧毁肿瘤细胞的能力，而 VEGF阻断可减少对肿瘤细胞的血液供 ...

公告显示，此次合作涉及科伦博泰一款靶向整合素β6(ITGB6)并以拓扑异构酶抑制剂为载荷的抗体偶联 药物(ADC) SKB105，以及Crescent一款程序性细胞死亡-1(PD-1)×血管内皮生长因子(VEGF)双特异性抗 体CR-001。这两款候选药物均正在开发用于治疗实体瘤，预计于2026年第一季度开展1/2期单药治疗临 床试验。 基于此次合作，科伦博泰将向Crescent收取8000万美元的首付款，并有资格收取高达12.5亿美元的里程 碑付款，以及基于SKB105净销售额的中个位数至低双位数百分比的分级特许权使用费。Crescent将向科 伦博泰收取2000万美元的首付款，并有资格收取高达3000万美元的里程碑付款，以及基于CR-001净销 售额的低至中个位数百分比的分级特许权使用费。 北京商报讯（记者 丁宁）12月4日晚间，科伦药业（002422）发布公告称，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"）与Crescent Biopharma, Inc.及其全资 子公司Crescent Biopharma Operating Company, LLC(以下合称 ...

Core Viewpoint - The strategic partnership between Sichuan Kelun Biotech Co., Ltd. and Crescent Biopharma aims to develop and commercialize innovative cancer therapies, including new combination treatments [1][2]. Group 1: Partnership Details - The collaboration involves Kelun Biotech's SKB105, an antibody-drug conjugate targeting integrin β6, and Crescent's dual-specific antibody CR-001, which targets PD-1 and VEGF, both intended for solid tumor treatment [2]. - The partnership grants Crescent exclusive rights to research, develop, manufacture, and commercialize SKB105 outside of Greater China, while Kelun Biotech receives exclusive rights for CR-001 within Greater China [2]. Group 2: Financial Aspects - Kelun Biotech will receive an upfront payment of $80 million from Crescent, with potential milestone payments up to $1.25 billion and tiered royalties based on SKB105's net sales [3]. - Crescent will pay Kelun Biotech an upfront fee of $20 million, with milestone payments up to $30 million and tiered royalties based on CR-001's net sales [3]. Group 3: Strategic Implications - This collaboration enhances Kelun Biotech's differentiated oncology pipeline and accelerates the global development of SKB105, increasing its commercial potential and expanding the company's global partnership network [3]. - The partnership leverages both companies' resources to explore new monotherapy and combination therapy strategies in cancer treatment, maximizing the therapeutic potential of both candidates in China and globally [3].

Core Viewpoint - The company has established a strategic partnership with Crescent Biopharma to jointly develop and commercialize cancer treatment methods, which includes significant financial arrangements and potential future earnings from sales royalties [1] Financial Arrangements - Sichuan Kelun Botai Biopharmaceutical Co., Ltd. will receive an upfront payment of $80 million from Crescent Biopharma [1] - The company is eligible for up to $1.25 billion in milestone payments based on the partnership's success [1] - Additionally, Kelun Botai will receive tiered royalties ranging from mid-single to low-double digits percentage based on the net sales of SKB105 [1] Additional Financial Terms - Crescent Biopharma will pay an upfront fee of $20 million to Kelun Botai and is eligible for up to $30 million in milestone payments [1] - Crescent will also pay tiered royalties based on the net sales of CR-001, starting from low to mid-single digits percentage [1] Control Change Provisions - If there is a change in control at Crescent or if they enter into sublicensing agreements with third parties, Kelun Botai may receive additional payments [1]