Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-9839 and HRS-4642, indicating progress in its oncology drug development pipeline [1] Group 1: Clinical Trials - The company and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., will conduct clinical trials for SHR-9839 in advanced colorectal cancer patients, focusing on safety, tolerability, and efficacy [1] - The clinical study for SHR-9839 is an open-label, multicenter Phase I/II trial [1] Group 2: Drug Details - SHR-9839 is a humanized antibody drug developed by the company, aimed at treating advanced solid tumors by blocking two key signaling pathways related to tumor development [1] - The subcutaneous formulation of SHR-9839 has one competitor drug approved globally targeting the same pathway [1] - The total R&D investment for SHR-9839 to date is approximately 93.9 million yuan (unaudited) [1] Group 3: HRS-4642 Injection - HRS-4642 injection specifically binds to KRASG12D and inhibits the phosphorylation of MEK and ERK proteins, demonstrating anti-tumor effects [1] - Currently, there are no similar drugs approved for HRS-4642 in both domestic and international markets [1] - The total R&D investment for HRS-4642 to date is approximately 254.2 million yuan (unaudited) [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-9839 and HRS-4642, indicating progress in its oncology drug development pipeline [1] Group 1: SHR-9839 - SHR-9839 is a humanized antibody drug developed by the company, intended for the treatment of advanced solid tumors by blocking two key signaling pathways related to tumor development [1] - The subcutaneous formulation of SHR-9839 has been developed, and there is currently one approved drug targeting the same pathway globally [1] Group 2: HRS-4642 - HRS-4642 is a KRAS G12D inhibitor developed by the company, formulated as a liposome injection [1] - HRS-4642 specifically binds to KRAS G12D and inhibits the phosphorylation of MEK and ERK proteins, demonstrating anti-tumor effects [1] - There are currently no similar drugs approved for HRS-4642 in both domestic and international markets [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-9839 and HRS-4642, indicating progress in its oncology drug development pipeline [1] Group 1: Drug Development - SHR-9839 is a humanized antibody drug developed by the company, intended for the treatment of advanced solid tumors by blocking two key signaling pathways related to tumor development [1] - The subcutaneous formulation of SHR-9839 has one competitor with the same target already approved globally [1] - HRS-4642 is a KRAS G12D inhibitor developed by the company, formulated as a liposome injection, which specifically binds to KRAS G12D and inhibits the phosphorylation of MEK and ERK proteins [1] - Currently, there are no similar drugs approved for HRS-4642 in both domestic and international markets [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-9839 and HRS-4642, indicating progress in its oncology drug development pipeline [1] Group 1: SHR-9839 - SHR-9839 is a humanized antibody drug developed by the company, intended for the treatment of advanced solid tumors by blocking two key signaling pathways related to tumor development [1] - The subcutaneous formulation of SHR-9839 has one competitor with the same target already approved globally [1] - The total R&D investment for the SHR-9839 project has reached approximately 93.9 million yuan (unaudited) [1] Group 2: HRS-4642 - HRS-4642 is a KRASG12D inhibitor developed by the company, formulated as a liposome injection [1] - HRS-4642 specifically binds to KRASG12D and inhibits the phosphorylation of MEK and ERK proteins, demonstrating anti-tumor effects [1] - Currently, there are no similar drugs approved for HRS-4642 in both domestic and international markets [1] - The total R&D investment for the HRS-4642 project has reached approximately 254.2 million yuan (unaudited) [1]

Investment Rating - The report indicates a significant acceleration in BD (Business Development) overseas for Chinese innovative drugs, suggesting a positive investment outlook for the industry [3]. Core Insights - The number of BD projects, upfront payments, and total amounts for Chinese pharmaceutical companies significantly increased in 2025, with 165 projects, over $7.03 billion in upfront payments (up 226.8% year-on-year), and a total amount of $136.68 billion (up 192.2% year-on-year) [2][7]. - The report highlights a focus on dual antibodies (双抗), antibody-drug conjugates (ADC), GLP-1 receptor agonists (GLP1RA), and small nucleic acids as key areas for BD overseas [2][3]. Summary by Sections BD Project Growth - In 2025, the quarterly breakdown of BD projects shows 41, 43, 30, and 51 projects in Q1, Q2, Q3, and Q4 respectively, with significant year-on-year increases [2][7]. - Upfront payments for each quarter were $0.9 billion, $2.0 billion, $1.86 billion, and $2.27 billion, reflecting substantial growth rates [2][7]. Outbound BD Models - The predominant model for BD remains license in/out, while the NewCo/Co-CoJV model is gaining attention, with limited successful cases of independent commercialization [2][12][13]. - In 2025, MNCs (Multinational Corporations) accounted for $4.71 billion in upfront payments, representing 67% of total BD upfront payments [12]. Key Drug Categories - Dual antibodies saw a remarkable increase, with $3.5 billion in upfront payments (up 414.7%) and a total amount of $21.85 billion (up 361.5%) in 2025 [2][18]. - ADCs emerged as a significant focus, with $1.63 billion in upfront payments (up 676.2%) and a total amount of $21.13 billion (up 390.6%) [2][26]. - GLP-1RA projects achieved $470 million in upfront payments, marking a 109.8% increase, with a total amount of $9.6 billion [2]. NewCo Model - The NewCo model has facilitated overseas BD, with a total of $350 million in upfront payments and $13.74 billion in potential total amounts from 2023 to 2025 [17]. - In 2025, NewCo projects secured $110 million in upfront payments and $4.76 billion in potential total amounts [17]. Clinical Development Stages - Approximately 62% of molecules were in early clinical stages (pre-clinical to before Phase II) at the time of BD, indicating a trend towards early-stage licensing [8][9].

Core Viewpoint - Heng Rui Medicine (01276) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HRS-2141 tablets (I) and (II), which will commence shortly [1] Group 1 - HRS-2141 tablets (I) and (II) are fixed-dose combination formulations designed to synergistically lower blood glucose through complementary pharmacological mechanisms [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] - As of the date of the announcement, the cumulative research and development investment for this drug project is approximately 5.4 million yuan (unaudited) [1]

Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of HRS-2141 tablets (I) and (II), which will commence shortly [1] Group 1: Product Development - HRS-2141 tablets (I) and (II) are fixed-dose combination formulations designed to synergistically lower blood sugar through complementary pharmacological mechanisms [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] Group 2: Financial Investment - As of the date of the announcement, the cumulative research and development investment for this drug project amounts to approximately 5.4 million yuan (unaudited) [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-9839 and HRS-4642, indicating progress in its oncology drug development pipeline [2] Group 1: Clinical Trial Approvals - The company and its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. have been granted a clinical trial approval notice for SHR-9839 and HRS-4642 [2] - SHR-9839 will undergo an open-label, multi-center Phase I/II clinical study to evaluate its safety, tolerability, and efficacy in patients with advanced colorectal cancer [2] Group 2: Drug Development Details - SHR-9839 is a humanized antibody drug developed by the company, aimed at treating advanced solid tumors by blocking two key signaling pathways related to tumor development [2] - The subcutaneous formulation of SHR-9839 has one competitor with the same target already approved globally [2] - The total R&D investment for SHR-9839 has reached approximately 93.9 million yuan (unaudited) [2] Group 3: HRS-4642 Injection - HRS-4642 injection specifically binds to KRASG12D and inhibits the phosphorylation of MEK and ERK proteins, demonstrating anti-tumor effects [2] - Currently, there are no similar drugs approved for HRS-4642 in both domestic and international markets [2] - The total R&D investment for HRS-4642 has reached approximately 254.2 million yuan (unaudited) [2]

Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for clinical trials of HRS-2141 tablets for type 2 diabetes [1] Group 1: Company Announcement - Jiangsu Heng Rui Medicine Co., Ltd.'s subsidiary, Shandong Shengdi Medicine Co., Ltd., has been granted a clinical trial approval notice for HRS-2141 tablets (I) and (II) [1] - The approval allows the company to conduct clinical trials for the drug targeting type 2 diabetes [1] - The acceptance numbers for the clinical trial applications are CXHL2501153 and CXHL2501154 [1] Group 2: Regulatory Details - The approval conclusion states that HRS-2141 tablets (I) and (II) meet the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1] - The clinical trials are set to commence following the approval, which was granted based on a review conducted on October 21, 2025 [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20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 ...