交银国际发布研报称，首次覆盖劲方医药-B(02595)，给予买入评级，目标价51港元。作为一家扎根中 国内地、拥有全球视野的创新药企，劲方医药组建了一支平均拥有逾20年行业经验、执行力较强的核心 管理团队，建立了一条包括6款临床阶段候选药物的药物管线。 管理团队持续高效推进研发和对外合作 公司组建了一支平均拥有逾20年行业经验、执行力较强的核心管理团队，在GFH925的开发上创下自项 目启动到上市用时六年的纪录。同时，公司积极寻求多元化全球发展机会，策略性地选择合作伙伴，实 现优势互补并相互加强以创造价值，全球合作伙伴包括信达生物、默克、Verastem等MNC或知名生物科 技企业。 交银国际主要观点如下： 首予买入评级 该行预计公司2025-27年收入分别达到1.09/0.85/1.18亿元人民币，主要来自GFH925中国内地销售带来的 相关合作收入和GFH375的海外合作收入。基于DCF估值模型，该行得到公司目标价51港元，对应2.3倍 收入达峰时的市销率及87%的潜在升幅。未来12个月重点关注GFH925纳入医保后的销售放量节奏以及 RAS管线更多PoC/I期数据读出(包括GFH375海外)。 差异化创 ...

公司在RAS靶向药物开发上的竞争优势，在GFH925和GFH375上得到了较好体现：1）GFH925在2L+ KRASG12C突变非小细胞肺癌（NSCLC）患者中的单药疗效数据出色，非头对头对比显示优于海外同 靶点竞品、与国产竞品可比或更优（图表21），西妥昔联合疗法差异化布局一线NSCLC，初步数据优 于adagrasib + K药和sotorasib +化疗组合；2）GFH375是全球首批进入III期临床的KRASG12D靶向药物 之一，三线胰腺癌（3LPDAC）初步数据与RMC-6236、RMC-9805等主要竞品相比有优势，海外初步数 据（包括联合疗法）值得期待；3）GDF15/IL-16双抗GFS202A相比进展较快的单靶药物存在机制升 级，临床前阶段耐受性和活性优势已初步显现。 管理团队持续高效推进研发和对外合作 公司组建了一支平均拥有逾20年行业经验、执行力较强的核心管理团队，在GFH925的开发上创下自项 目启动到上市用时六年的纪录。同时，公司积极寻求多元化全球发展机会，策略性地选择合作伙伴，实 现优势互补并相互加强以创造价值，全球合作伙伴包括信达生物、默克、Verastem等MNC或知名生物 ...

Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of a Phase III clinical trial for Nilotinib as a first-line treatment for Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharmaceutical-B (02595) initiated a registration clinical trial for GFH375, the world's first oral KRAS G12D inhibitor in a controlled chemotherapy Phase III study [1] - Xixiangfeng Group (02473) signed a business cooperation agreement with Hello Car Rental to develop car rental services in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for a GLP-1/GIP receptor dual agonist injection [1] - MIRXES-B (02629) plans to collaborate with Crystal Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automobile (01728) intends to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) plans to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) successfully included seven innovative products (including new indications) in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biotech-B (09887) presented clinical data for LBL-034 at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Acid Vovizili Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) successfully included five new products in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) had its core products included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported a contract sales amount of approximately 47.7 billion yuan for the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported an equity power generation of 697.23 GWh in November, a year-on-year increase of 7.77% [2]

Core Viewpoint - The announcement highlights the initiation of a pivotal Phase III trial (GFH375X1301) for the oral KRAS G12D inhibitor GFH375, targeting previously treated patients with metastatic pancreatic cancer, marking a significant advancement in the treatment landscape for this aggressive disease [1][2]. Group 1: Clinical Development - GFH375 is currently in the leading tier of global oral KRAS G12D inhibitors, with multiple clinical explorations ongoing both in China and internationally [1]. - The Phase III trial will be conducted at approximately 40 centers, aiming to enroll around 320 patients who have previously received at least one standard systemic treatment for metastatic pancreatic cancer [2]. - GFH375 has received FDA Fast Track designation for the treatment of locally advanced and metastatic KRAS G12D mutant pancreatic ductal adenocarcinoma (PDAC) [1]. Group 2: Market Context - Pancreatic cancer is characterized by high malignancy and poor prognosis, with a 5-year survival rate of less than 10%, and the global incidence of new cases is projected to exceed 770,000 by 2037 [2]. - Current treatment options primarily involve chemotherapy, with objective response rates (ORR) for second-line to third-line treatments only ranging from 10% to 20%, and no standard treatment available for third-line and beyond [2]. - Nearly 40% of pancreatic cancer patients exhibit KRAS G12D mutations, which are independent prognostic markers associated with poor response rates and overall survival [2]. Group 3: Company Insights - The Chief Medical Officer of the company emphasized that this is the first global oral RAS inhibitor clinical study for pancreatic cancer, showcasing the company's capabilities in clinical research and integrated drug development [3]. - The company anticipates positive outcomes from the GFH375X1301 trial, which could benefit patients and lead to further breakthroughs in RAS-targeted therapies [3]. - GFH375 is expected to synergize with the company's dual antibody therapy for a comprehensive treatment approach to pancreatic cancer [3].

Core Viewpoint - The company has initiated a pivotal Phase III trial (GFH375X1301) for its oral KRAS G12D inhibitor GFH375, targeting previously treated patients with KRAS G12D mutant metastatic pancreatic cancer, marking a significant advancement in the treatment landscape for this aggressive cancer type [1][2]. Group 1: Clinical Development - The Phase III trial will be conducted at approximately 40 centers, aiming to enroll around 320 patients who have previously received at least one standard systemic treatment for metastatic pancreatic cancer [2]. - GFH375 is currently in the leading tier of global oral KRAS G12D inhibitors, with multiple clinical explorations ongoing both in China and internationally [1][2]. - The drug has received FDA Fast Track designation for the treatment of locally advanced and metastatic KRAS G12D mutant pancreatic ductal adenocarcinoma (PDAC) [1]. Group 2: Market Context - Pancreatic cancer is characterized by high malignancy and poor prognosis, with a 5-year survival rate of less than 10%, and the global incidence of new cases is projected to exceed 770,000 by 2037 [2]. - Approximately 40% of pancreatic cancer patients harbor the KRAS G12D mutation, which is an independent prognostic marker associated with poor response rates and overall survival in advanced PDAC [2]. Group 3: Company Insights - The Chief Medical Officer of the company highlighted that this is the first global oral RAS inhibitor clinical study for pancreatic cancer, showcasing the company's capabilities in clinical research and integrated drug development [3]. - The company anticipates positive outcomes from the GFH375X1301 study, which could benefit patients and lead to further breakthroughs in RAS-targeted therapies [3].

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]