香港联交所最新资料显示，11月20日，Taikang Insurance Group,Inc.增持复宏汉霖(02696)51.85万股，每 股作价67.0678港元，总金额约为3477.47万港元。增持后最新持股数目为860.65万股，最新持股比例 5.26%。 ...

智通财经APP获悉，香港联交所最新资料显示，11月20日，Taikang Insurance Group, Inc.增持复宏汉霖 (02696)51.85万股，每股作价67.0678港元，总金额约为3477.47万港元。增持后最新持股数目为860.65万 股，最新持股比例5.26%。 ...

Core Viewpoint - The company, Junshi Biosciences, has announced the completion of the first patient dosing in a Phase 1 clinical trial for its self-developed biosimilar HLX13, targeting unresectable hepatocellular carcinoma (HCC) patients in China [1] Group 1: Clinical Trial Details - The study is an international, multicenter, randomized, double-blind, parallel-controlled Phase 1 clinical trial [1] - The trial aims to evaluate the pharmacokinetic (PK) characteristics, safety, efficacy, and immunogenicity similarities between HLX13 and its reference drug YERVOY® when combined with OPDIVO® in previously untreated advanced HCC patients [1] - Eligible participants will be randomly assigned in a 1:1 ratio to receive either HLX13 or YERVOY® combined with OPDIVO® for the first four cycles, followed by OPDIVO® monotherapy for maintenance treatment every four weeks [1] Group 2: Study Endpoints - The primary endpoint includes the area under the concentration-time curve (AUC0-21d) from pre-dosing to 21 days post-first dosing and the steady-state AUC during the dosing interval after the fourth administration [1] - Secondary endpoints encompass other PK parameters, efficacy assessments, safety, and immunogenicity evaluations [1]

Core Viewpoint - The company, Junshi Biosciences, has announced the completion of the first patient dosing in a Phase 1 clinical trial for its self-developed biosimilar HLX13, targeting unresectable hepatocellular carcinoma (HCC) patients in China [1] Group 1: Clinical Trial Details - The study is an international, multicenter, randomized, double-blind, parallel-controlled Phase 1 clinical trial [1] - The trial aims to evaluate the pharmacokinetic (PK) characteristics, safety, efficacy, and immunogenicity similarities between HLX13 and its reference drug YERVOY® when combined with OPDIVO® in previously untreated advanced HCC patients [1] - Eligible participants will be randomly assigned in a 1:1 ratio to receive either HLX13 or YERVOY® combined with OPDIVO® for the first four cycles, followed by OPDIVO® monotherapy for maintenance treatment every four weeks [1] Group 2: Study Endpoints - The primary endpoint includes the area under the concentration-time curve (AUC0-21d) from pre-dosing to 21 days post-first dosing and the steady-state AUC during the dosing interval after the fourth administration [1] - Secondary endpoints encompass other PK parameters, efficacy assessments, safety, and immunogenicity evaluations [1]

Core Insights - Company announced the completion of the first patient dosing in a Phase 1 clinical trial for HLX13, a biosimilar of ipilimumab, for the treatment of unresectable hepatocellular carcinoma (HCC) in China [1] - The trial is a multicenter, randomized, double-blind, parallel-controlled study aimed at evaluating the pharmacokinetics, safety, efficacy, and immunogenicity of HLX13 compared to the original drug YERVOY® in previously untreated advanced HCC patients [1][2] - HLX13 is also being developed for multiple indications including melanoma, renal cell carcinoma, colorectal cancer, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [2] - The global sales of ipilimumab are projected to be approximately $2.873 billion in 2024 [3] Group 1 - HLX13 is a biosimilar of ipilimumab, designed to enhance immune response by blocking CTLA-4, thereby targeting tumors [2] - The Phase 1 trial involves a 1:1 random allocation of participants to receive either HLX13 or YERVOY® combined with OPDIVO® treatment [1] - The primary endpoint of the trial is the area under the concentration-time curve (AUC) from dosing to 21 days post-administration [1] Group 2 - The clinical trial application for HLX13 in HCC was approved by the National Medical Products Administration in June 2023 [2] - The company has entered into a licensing agreement with Sandoz AG for the commercialization of HLX13 in the U.S. and select European regions, Japan, Australia, and Canada [2] - The sales figure for ipilimumab indicates a significant market potential for HLX13 as a biosimilar in the oncology sector [3]

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而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 本公司董事會（「董事會」）欣然宣佈，近日，本公司自主研發的伊匹木單抗生 物類似藥HLX13（重組抗CTLA-4全人單克隆抗體注射液）（「HLX13」）一綫治 療不可切除的肝細胞癌(HCC)患者的國際多中心1期臨床研究於中國境內完成 首例患者給藥。 伊匹木單抗生物類似藥HLX13（重組抗CTLA-4全人單克隆抗體注射液） 一綫治療不可切除的肝細胞癌(HCC)患者的國際多中心1期臨床研究 於中國境內完成首例患者給藥 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 根據IQVIA MIDASTM的資料（IQVIA是全球醫藥健康產業專業信息和戰略諮 詢服務提供商） ...

Core Insights - The article discusses the recent clinical trial applications submitted by several pharmaceutical companies, focusing on the competitive landscape of PD-1 inhibitors in the oncology market [12][11]. Group 1: New Drug Applications - From June 13 to June 18, the National Medical Products Administration received applications for 9 new chemical and biological drugs from 6 listed companies [4]. - Companies such as Hengrui Medicine, Innovent Biologics, and CSPC Pharmaceutical Group submitted 2 clinical applications each, while companies like Ascletis Pharma, Junshi Biosciences, and Kintor Pharmaceutical submitted 1 application each [7]. Group 2: Focus on Oncology Drugs - All applications during this period were for anti-tumor drugs, indicating a strong focus on oncology within the pharmaceutical industry [8]. - The article highlights that the PD-1 inhibitors submitted by Shijiazhuang Yiling Pharmaceutical and Junshi Biosciences are still in clinical trials, with no products yet on the market [12]. Group 3: Competitive Landscape - Currently, there are 8 PD-1/PD-L1 products approved in China, leading to intense competition among companies [12]. - Shijiazhuang Yiling's PD-1 is in Phase I clinical trials for ovarian cancer and Phase II for advanced/metastatic cervical cancer, while Junshi's PD-1 is at the application stage for MSI-H solid tumors [12][13]. - The article suggests that both companies need to adopt differentiated development strategies to avoid excessive competition and achieve market success [12]. Group 4: Market Positioning - Junshi's PD-1, known as Surulitinib, is positioned to be the first anti-PD-1 monoclonal antibody for treating MSI-H solid tumors in China, despite its later market entry [12]. - In contrast, Shijiazhuang Yiling's prospects for its PD-1 product appear less optimistic, as there are no approved PD-1 products for cervical cancer in the domestic market [13]. Group 5: Historical Context - Shijiazhuang Yiling previously had a partnership with Junshi Biologics for a PD-1 product but terminated the agreement to avoid potential conflicts with another in-house PD-1 candidate [14]. - This decision has led to a delay in Shijiazhuang Yiling's PD-1 development, while Junshi's product has been on the market for over two years, generating significant revenue [14].

每经AI快讯，复宏汉霖(02696.HK)午后涨超6%，截至发稿，涨4.94%，报66.95港元，成交额6313.55万 港元。 （文章来源：每日经济新闻） ...

Core Viewpoint - The company Fuhong Hanlin (02696) has seen a significant stock price increase following the announcement that its innovative PD-1 inhibitor, H drug Surulitinib, has been officially included by the NMPA as a breakthrough therapy for gastric cancer treatment [1] Group 1: Company Developments - Fuhong Hanlin's H drug Surulitinib has been recognized as a breakthrough therapy by the NMPA for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer [1] - The phase 3 clinical study for the H drug targeting this indication has met its primary endpoint, potentially offering patients improved survival benefits and quality of life [1] Group 2: Market Context - As of the announcement date, there are currently no targeted PD-1 monoclonal antibody drugs approved globally for neoadjuvant/adjuvant treatment of gastric cancer [1] - According to the latest IQVIA MIDAS data, the global sales for targeted PD-1 monoclonal antibody drugs are projected to reach approximately $45.704 billion in 2024 [1]

Group 1 - The core point of the article is that Fuhong Hanlin's innovative PD-1 inhibitor, H drug Surulitinib, has been officially included by the NMPA as a breakthrough therapy for gastric cancer, which could significantly improve patient survival and quality of life [1] - Fuhong Hanlin's stock rose over 6% in the afternoon trading session, with a current price of 66.95 HKD and a trading volume of 63.1355 million HKD [1] - The phase III clinical study for the H drug has met its primary endpoint, indicating its potential to replace postoperative adjuvant chemotherapy in the perioperative treatment of gastric cancer [1] Group 2 - As of the announcement date, there are no approved targeted PD-1 monoclonal antibody drugs for neoadjuvant/adjuvant treatment of gastric cancer globally [1] - According to IQVIA MIDAS data, the global sales of targeted PD-1 monoclonal antibody drugs are projected to reach approximately 45.704 billion USD in 2024 [1]