重大事项： 百奥赛图-B(02315)业务合作伙伴IDEAYA取得美国食品药品监督管理局对IDE034的IND批准 劲方医药-B(02595)：GFH375治疗转移性胰腺癌注册性临床试验在首家研究中心启动 为全球首个口服 KRAS G12D抑制剂单药对照化疗III期研究 喜相逢集团(02473)附属与哈啰租车签订业务合作协议 拟于指定城市以"联名店"模式开展汽车租赁业务 合作 国际商业结算(00147)与香港南极光订立计算机芯片销售协议 以把握IC芯片市场的增长机遇 石药集团(01093)：GLP-1/GIP受体双偏向性激动多肽注射液在美国获临床试验批准 MIRXES-B(02629)拟与晶泰科技共建AI赋能的、创新的"诊疗一体化"研究及产业化平台 创胜集团-B(06628)：创胜医药于ESMO Asia公布osemitamab三联疗法一线治疗胃或胃食管结合部腺癌的 I/II期(Transtar102)更新疗效数据 力量发展(01277)拟3.84亿元收购太原实地100%股权及合共8633万元收购东直门物业 信达生物(01801)完成与武田制药的全球战略合作及根据一般授权发行691.38万股 亚盛医药-B(0 ...

劲方首席医学官汪裕博士表示："这是全球首个口服RAS抑制剂治疗胰腺癌的注册性临床研究，这一重 要里程碑体现了劲方临床团队的临床研发和执行能力、以及公司深耕于RAS疗法矩阵的一体化新药开发 实力。GFH375在去年进入临床试验，今年就已获得优秀的单药I/II期研究数据，并在近期进入多项单 药、联合疗法试验，我们期待该产品在这项注册性研究(GFH375X1301)中取得积极结果、早日造福患 者。我们也期待以GFH375为代表的劲方RAS靶向药物在未来实现更多突破，并与公司的恶病质双抗疗 法形成靶向胰腺癌的协同性治疗矩阵。" 智通财经APP讯，劲方医药-B(02595)发布公告，口服KRAS G12D (ON/OFF)抑制剂GFH375治疗经治 KRAS G12D突变型转移性胰腺癌患者的注册性III期试验(GFH375X1301)已在北京大学肿瘤医院启动。 目前GFH375开发进度位于全球口服KRAS G12D抑制剂第一梯队，多项GFH375(于中国境外称VS-7375) 单药和联合疗法正在中国(由劲方主导)及海外(由劲方合作伙伴Verastem Oncology主导)进行临床探索， 包括 GFH375联合化疗(白 ...

这项多中心、开放标签、随机对照的III期试验(GFH375X1301)将在约40家中心开展，计划入组约320例 既往接受至少一种标准系统性治疗的转移性胰腺癌患者。沙利文资料显示2037年全球胰腺癌新发病例将 超过77万人，胰腺癌恶性程度高、预后极差，5年生存率不足10%；目前胰腺癌治疗仍以化疗药物为 主，二线至三线客观缓解率(ORR)仅为10-20%，三线及以上治疗尚无标准治疗方案。科研文献显示近 40%胰腺癌患者存在KRAS G12D突变，而全球尚无相关靶向药获批上市；KRAS G12D突变是晚期 PDAC应答率及总生存期不佳的独立预后标志物，且KRAS G12D突变在调节性T细胞转化过程中发挥关 键作用，可促进形成免疫抑制性肿瘤微环境、并导致患者对免疫检查点抑制剂应答不佳。 格隆汇12月5日丨劲方医药-B(02595.HK)宣布，口服KRAS G12D (ON/OFF)抑制剂GFH375治疗经治 KRAS G12D突变型转移性胰腺癌患者的注册性III期试验(GFH375X1301)已在北京大学肿瘤医院启动。 目前GFH375开发进度位于全球口服KRAS G12D抑制剂第一梯队，多项GFH375(于中国境外 ...

Core Insights - The phase of capital frenzy driven by innovative drugs in China is coming to an end, but the long-term value of the Chinese innovative drug industry is becoming clearer, ushering in a more expansive era [1] - The essence of global innovation competition revolves around unmet clinical needs, particularly in high-mortality and low-survival-rate disease areas, where Chinese pharmaceutical companies are developing innovative therapies that are leading in the market [1][2] Group 1: Industry Trends - The narrative of Chinese innovative drugs remains focused on technological breakthroughs and research efficiency, positioning them as disruptors in the global arena [2] - Chinese biotech companies are demonstrating global competitiveness in hot areas, such as KRAS G12D, with significant developments showcased at recent conferences [2][3] - The demand for innovative treatments is driven by patients' survival needs, making them the ultimate price setters in the pharmaceutical innovation landscape [2] Group 2: GFH375 Developments - GFH375 has shown a 40.7% objective response rate (ORR) in patients with pancreatic ductal adenocarcinoma (PDAC), significantly higher than current standard chemotherapy treatments [2][3] - The patient population for GFH375 includes a high proportion of late-stage patients, indicating its potential effectiveness in difficult-to-treat cases [4] - Preliminary data from ongoing trials suggest that GFH375 may become a leading treatment option in the KRAS G12D space, with promising results in both Chinese and U.S. studies [7][8] Group 3: Market Potential - The global incidence of pancreatic cancer is projected to rise, with an estimated 542,000 new cases in 2024, highlighting the urgent need for effective treatments [10] - The market dynamics favor companies that can address large patient populations with unmet clinical needs, positioning GFH375 as a potential standard of care in its field [10][11] - The competitive landscape includes other innovative therapies, but GFH375's safety profile and efficacy suggest it may outperform existing options [13][14] Group 4: Broader Implications - The RAS mutation covers approximately 30% of cancer patients, indicating a significant market opportunity for therapies targeting this pathway [20] - Companies like Jinfang Pharmaceutical are not only focusing on single molecules but are also developing comprehensive treatment matrices, enhancing their competitive edge [20] - The industry is expected to shift towards a more rational phase, focusing on companies with solid fundamentals, which may lead to a more sustainable growth trajectory [21]

Investment Rating - The report rates the pharmaceutical industry as "Positive" [1][33] Core Viewpoints - The source of innovation in the pharmaceutical industry is improving, and short-term fluctuations do not change long-term value. The ESMO 2025 conference highlighted 23 "Late-Breaking Abstracts" led by Chinese scholars, with 3 significant results presented at the highest academic level, indicating China's growing position in global pharmaceutical innovation [5][26] - Domestic innovative drugs are showing competitive clinical data, with several products demonstrating global competitiveness. For instance, the sac-TMT from Kelun Biotech is expected to be a strong competitor for EGFR mutation NSCLC after EGFR-TKI resistance [5][6] - Investment suggestions focus on shifting attention from "expectations" to "realization" of clinical data and commercialization. Key directions include companies with validated R&D and commercialization capabilities, those entering performance release periods, and those with excellent clinical data pipelines [5][27] Summary by Sections Section 1: Kelun Biotech - The sac-TMT is expected to be a strong competitor for EGFR mutation NSCLC after EGFR-TKI treatment failure, with significant clinical data presented at ESMO 2025 [6][8] Section 2: Kangfang Biotech - The HARMONi-6 study results met expectations, showing significant PFS benefits compared to the control group, with ongoing overseas clinical research updates anticipated [9][10] Section 3: Basestone Pharmaceuticals - The CS2009's efficacy and safety have been preliminarily validated, showing promise as a next-generation I-O therapy competitor [12][14] Section 4: Shouyao Holdings - The SY-5007 demonstrated significant efficacy advantages in RET fusion-positive NSCLC patients, with a low treatment-related discontinuation rate [16][18] Section 5: Jinfang Pharmaceuticals - The GFH375 showed promising efficacy in treating KRAS G12D mutation pancreatic cancer, with a notable objective response rate [19][21] Section 6: Aosaikang - The ASKB589 combined with chemotherapy and PD-1 inhibitors showed significant survival benefits in advanced gastric cancer patients [23][25]

Core Viewpoint - Jinfang Pharmaceutical-B (02595) experienced significant stock volatility, initially dropping over 8% before recovering to a gain of 6.71%, closing at 28.3 HKD with a trading volume of 44.5183 million HKD [1] Group 1: Clinical Development - Jinfang Pharmaceutical announced the initiation of an Ib/II phase study for its oral high-potency and high-selectivity small molecule KRAS G12D inhibitor GFH375, in combination therapy for treating KRAS G12D mutant advanced solid tumors, with the first patient enrolled at Peking University Cancer Hospital [1] - The study received clinical trial approval from the National Medical Products Administration in September 2023, involving combination therapies with cetuximab or chemotherapy, with GFH375 being part of the first-line treatment regimen for pancreatic ductal adenocarcinoma (PDAC) [1] Group 2: Research Presentation - Data on GFH375 as a monotherapy for KRAS G12D mutant PDAC patients was presented at the 2025 ESMO annual meeting, highlighting its efficacy and safety [1] - The oral presentation was conducted by Professor Zhou Aiping from the Chinese Academy of Medical Sciences Cancer Hospital, focusing on the study data from the 600 mg QD (RP2D) dose group of PDAC patients, demonstrating significant efficacy and manageable safety [1]

Core Viewpoint - The stock of Jinfang Pharmaceutical-B (02595) experienced significant volatility, initially dropping over 8% before recovering to a gain of 6.71%, trading at 28.3 HKD with a transaction volume of 44.52 million HKD. This fluctuation is linked to the announcement of a clinical trial for their KRAS G12D inhibitor GFH375, which has garnered attention due to its potential in treating advanced solid tumors [1]. Group 1 - Jinfang Pharmaceutical announced the initiation of an Ib/II phase clinical trial for GFH375, a small molecule KRAS G12D inhibitor, in combination therapies for KRAS G12D mutant advanced solid tumors [1]. - The trial received approval from the National Medical Products Administration in September 2023 and involves combination therapies with cetuximab or chemotherapy, with GFH375 being part of the first-line treatment for pancreatic ductal adenocarcinoma (PDAC) [1]. - Data from GFH375's monotherapy for KRAS G12D mutant PDAC patients was presented at the 2025 ESMO annual meeting, highlighting its efficacy and safety [1]. Group 2 - The oral presentation at the ESMO meeting was conducted by Professor Zhou Aiping from the Chinese Academy of Medical Sciences, focusing on the efficacy and safety of GFH375 in a specific dosage group of PDAC patients [1]. - The study emphasized the promising results of GFH375 treatment, showcasing its potential as a significant therapeutic option for patients with advanced KRAS G12D mutant PDAC [1].

Core Insights - The company has initiated the clinical trial of GFH375, a KRAS G12D inhibitor, for treating advanced solid tumors, marking a significant step in its clinical development [1][2] - The trial, approved by the National Medical Products Administration, aims to evaluate the safety, efficacy, and pharmacokinetics of GFH375 in combination with chemotherapy and cetuximab [1] - GFH375 has shown promising results in preclinical studies and has received fast track designation from the FDA for treating advanced KRAS G12D mutant pancreatic ductal adenocarcinoma (PDAC) [2] Group 1 - GFH375's clinical trial (GFH375X1202) has commenced with the first patient enrolled at Peking University Cancer Hospital [1] - The trial will be conducted at approximately 15 centers, focusing on the safety and efficacy of GFH375 in combination with either cetuximab or chemotherapy [1] - The Phase II trial will specifically target first-line treatment for advanced PDAC and colorectal cancer (CRC) patients [1] Group 2 - Dr. Wang Yu, Chief Medical Officer, expressed optimism about advancing GFH375 into frontline PDAC treatment, highlighting its potential across multiple tumor types [2] - The single-agent study of GFH375 is set to begin in June 2024, with promising data already presented at major oncology conferences [2] - GFH375 is a highly selective oral small molecule that inhibits KRAS G12D, effectively disrupting downstream signaling pathways and tumor cell proliferation [2] Group 3 - The company has entered into a licensing and early collaboration agreement with Verastem for three RAS/MAPK-driven cancer products [3] - Verastem has chosen GFH375/VS-7375 as the lead project, granting them exclusive rights outside Greater China upon achieving specific clinical milestones [3] - The licensing agreement allows Verastem to develop and commercialize GFH375 outside of China, while the company retains rights within the country [3]

Core Insights - GFH375, a KRAS G12D inhibitor, has entered clinical trials for treating advanced solid tumors, marking a significant step in its development [1][2] - The study, GFH375X1202, received approval from the National Medical Products Administration in September and involves combination therapies with cetuximab or chemotherapy [1] - The primary objective of the trial is to assess the safety, tolerability, efficacy, and pharmacokinetics of GFH375 in patients with solid tumors [1] Group 1 - The first patient has been enrolled in the Ib/II phase study at Peking University Cancer Hospital [1] - The Ib phase will be conducted at approximately 15 centers, focusing on the safety and efficacy of GFH375 in combination with cetuximab or chemotherapy [1] - The II phase will specifically target first-line treatment for advanced pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC) patients [1] Group 2 - Dr. Wang Yu, Chief Medical Officer of the company, expressed optimism about advancing GFH375's clinical development from later lines to first-line treatment for PDAC [2] - Recent data on GFH375's monotherapy for PDAC and non-small cell lung cancer (NSCLC) were presented at ESMO and WCLC, indicating promising efficacy across multiple tumor types [2] - The company anticipates rapid progress in both domestic and international studies based on GFH375, aiming to benefit patients soon [2]

Core Insights - The company has initiated the clinical trial of GFH375 in combination therapies for treating KRAS G12D mutant advanced solid tumors, marking a significant step in its clinical development [1][2] Group 1: Clinical Trials and Research - GFH375 has received approval for clinical trials from the National Medical Products Administration, with the first patient enrolled at Peking University Cancer Hospital [1] - The trial (GFH375X1202) will evaluate the safety, tolerability, efficacy, and pharmacokinetics of GFH375 in combination with cetuximab or chemotherapy in approximately 15 centers [1] - The Ib phase will focus on assessing the combination of GFH375 with chemotherapy as a first-line treatment for pancreatic ductal adenocarcinoma (PDAC) [1] Group 2: Product Development and Efficacy - GFH375 is an oral, highly selective small molecule KRAS G12D inhibitor that disrupts the activation of downstream pathways, effectively inhibiting tumor cell proliferation [2] - Clinical data for GFH375 as a monotherapy for PDAC and non-small cell lung cancer (NSCLC) has shown promising efficacy, with recent presentations at ESMO and WCLC [2] - The drug has been granted FDA Fast Track designation for use in treating locally advanced and metastatic KRAS G12D mutant PDAC patients [2] Group 3: Strategic Partnerships - The company has entered into a licensing and early collaboration agreement with Verastem for three products related to RAS/MAPK-driven cancers [3] - Verastem has chosen GFH375/VS-7375 as the lead project, granting them exclusive rights for development and commercialization outside Greater China, while the company retains rights within China [3]