KRAS抑制剂

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聚焦抗癌药管线 加科思-B出售非核心项目
Zhi Tong Cai Jing· 2025-10-16 01:49
在临床数据不断验证、核心管线逐步进入后期开发的过程中,加科思有望凭借"高管增持+管线价值释 放"的双轮驱动,逐渐获得市场重估。 10月16日,加科思药业(01167)宣布其全资子公司北京加科思新药研发有限公司("北京加科思")与山西海 松管理咨询合伙企业(有限合伙)("海松资本")及一名产业合作方签署增资及股权转让协议。根据协议, 海松资本将以人民币2亿元收购北京加科思旗下北京加科瑞康医药(002589)科技有限公司("加科瑞 康")80%的股权。交易完成后,北京加科思、海松资本及产业合作方将分别持有加科瑞康10%、80%及 10%的股权。 加科瑞康是加科思公司早期心血管研发项目的项目公司,此次交易体现了加科思聚焦肿瘤创新药管线的 长期战略方向,有助于优化资源配置、提升组织效率,并通过风险共担模式保留项目未来价值。 除了KRAS G12C与pan-KRAS,加科思正在推进二代产品EGFR-KRAS G12D tADC。该项目通过EGFR 抗体实现精准递送,同时将KRAS G12D抑制剂作为高效载荷,或成为结直肠癌领域的大单品,公司预 计将在2026年下半年提交IND申请。日后,加科思有望通过不同的弹头与不同的 ...
和誉-B(02256.HK):口服PD-L1与多药联用布局 目标患者群体囊括近半NSCLC患者
Ge Long Hui· 2025-10-10 20:31
机构:天风证券 研究员:杨松/曹文清 事件 公司的PD-L1 小分子抑制剂ABSK043 联合KRAS G12C 抑制剂戈来雷塞片开展联合用药治疗KRAS G12C 突变的NSCLC 的临床研究申请获CDE 批准。此前,公司已经与艾力斯就联合用药达成了合作协 议。 ABSK043 初步临床数据疗效和安全性平衡,联合疗法瞄准近半NSCLC 市场ABSK043 具有FIC 潜力, 全球暂无PD-(L)1 小分子药物上市。ABSK043 是一款口服PD-L1 抑制剂,可与PD-L1 受体特异性结 合并诱导其从细胞表面内吞,有效地抑制PD-1/PD-L1 的相互作用,解除PD-L1 介导的T 细胞活化抑制 作用。ABSK043 在多个临床前模型中展现出与已获批PD-L1 抗体相当的抗肿瘤功效。PD-(L)1 口服 抑制剂研发的一大障碍就是出现周围神经病变的风险更高(如Incyte 的INCB086550),而ABSK043 在 临床试验中展现出良好的安全性和显著的抗肿瘤活性。在共入组77 例患者的实体瘤I 期临床中,87.0% 的患者出现TEAE,其中29.9%为≥3 级,无周围神经病变。 除NSCLC 以外,ABS ...
和誉-B(02256):口服PD-L1与多药联用布局,目标患者群体囊括近半NSCLC患者
Tianfeng Securities· 2025-10-09 03:28
Investment Rating - The report maintains a "Buy" rating for the company [5] Core Insights - The company’s PD-L1 small molecule inhibitor ABSK043 has received approval for clinical research to treat KRAS G12C mutated NSCLC in combination with the KRAS G12C inhibitor, adagrasib [1] - ABSK043 shows potential as a first-in-class (FIC) oral PD-L1 inhibitor, with no other oral PD-(L)1 drugs currently available globally [2] - The initial clinical data indicates a balance of efficacy and safety, with 87% of patients experiencing treatment-emergent adverse events (TEAEs) and no peripheral neuropathy observed [2] - ABSK043 is designed specifically for combination therapy, offering advantages such as a short half-life, reduced immunogenicity, and oral administration flexibility [3] - The market potential for ABSK043 is significant, targeting approximately 45%-60% of NSCLC cases, with ongoing clinical trials in various treatment settings [3] Financial Projections - The company is projected to achieve revenues of 630 million, 685 million, and 637 million yuan for the years 2025, 2026, and 2027 respectively [5] - Expected net profits for the same period are 45 million, 70 million, and 102 million yuan [5] - The target price for the stock is set at 22.88 HKD, with the current price at 19.62 HKD [5] Pipeline Developments - The company has several key assets nearing milestones, including: 1. KRAS-G12D inhibitor ABSK141, expected to receive IND approval in the second half of 2025 [4] 2. Pan-KRAS inhibitor ABSK211, anticipated to enter clinical stages in 2026 [4] 3. CSF-1R inhibitor ABSK021, with an NDA submission planned for the second half of 2025 [4] 4. A bispecific antibody-drug conjugate (BsADC) targeting two pan-cancer targets, expected to achieve preclinical candidate status in early 2026 [4]
被3000亿资金哄抢的创新药企,上市首日暴涨110%
3 6 Ke· 2025-09-23 04:35
Core Viewpoint - The successful IPO of Jinfang Pharmaceutical on the Hong Kong Stock Exchange marks a significant milestone in the innovative drug sector, with a first-day increase of nearly 110% and a market capitalization approaching 15 billion [1][2]. Group 1: Company Overview - Jinfang Pharmaceutical, founded in 2017 by returning scientist Lü Qiang, focuses on the research and development of oncology and autoimmune drugs [1][2]. - The company has completed seven rounds of financing totaling 1.421 billion, with a post-investment valuation of 3.124 billion after the C+ round [1]. - The company has a strong foundation of cornerstone investors, including RTW Fund and OrbiMed, with over half being professional pharmaceutical investment institutions [1][2]. Group 2: Product Pipeline and Market Position - Jinfang's core product, Fluzelezib, is set to be launched in August 2024, making it the first KRAS G12C inhibitor approved in China and the third globally [2][3]. - The KRAS target is still in its early stages, with the overall market not yet fully developed, but Jinfang is positioned to be among the first to market with its product [2][3]. - The company has established multiple business development (BD) collaborations, contributing significantly to its revenue stream [7][8]. Group 3: Financial Performance and Revenue Sources - Jinfang's revenue for 2023, 2024, and the first four months of 2025 were reported at 73.73 million, 105 million, and 82.15 million respectively, with corresponding losses of 508 million, 678 million, and 6.6 million [8]. - The company has relied on BD transactions for income, which has become a core revenue source, although this dependence poses potential risks [8][9]. - The termination of the overseas rights for Fluzelezib with Innovent Biologics raised concerns about the future market prospects of this core product [9].
被3000亿资金哄抢的创新药企,上市首日暴涨110%
36氪· 2025-09-20 02:49
Core Viewpoint - The article discusses the successful IPO of Jinfang Pharmaceutical, which is the first domestic KRAS G12C inhibitor approved in China, highlighting its strong market performance and potential in the innovative drug sector [4][5][7]. Group 1: Company Overview - Jinfang Pharmaceutical was listed on the Hong Kong Stock Exchange on September 19, with a first-day increase of nearly 110%, reaching a market capitalization close to 15 billion [4]. - The company completed seven rounds of financing before its IPO, totaling 1.421 billion, with a post-investment valuation of 3.124 billion after the C+ round [5]. - Founded in 2017 by returning scientist Lü Qiang, Jinfang focuses on cancer drug development and has a strong background in the innovative drug ecosystem [5]. Group 2: Product Development - The core product, Fluorazirase, is the first KRAS G12C inhibitor approved in China and the third globally, with a market that is still in its early stages [7][10]. - The KRAS gene mutation is significant in cancer development, with approximately 14% of the 18 million new cancer cases annually carrying KRAS mutations [7]. - Jinfang's product pipeline includes another KRAS G12D inhibitor, GFH375, which is expected to enter Phase III clinical trials [11]. Group 3: Market Dynamics - The KRAS target is still considered to be in the early stages of market development, with existing approved products primarily for second-line treatment [8][10]. - Current sales figures for competing products like Sotorasib and Adagrasib are relatively low, indicating that the market has not yet fully opened [10]. - Jinfang's revenue from licensing agreements has become a significant income source, with various collaborations contributing to its financial stability [14][16]. Group 4: Financial Performance - Jinfang's revenues for 2023, 2024, and the first four months of 2025 are reported as 73.73 million, 105 million, and 82.15 million respectively, with corresponding losses primarily due to R&D investments [17]. - The company anticipates a reduction in net losses by 2025, attributed to income from intellectual property licensing [17]. - However, reliance on BD transactions for revenue poses risks, as market conditions and product valuations can change [18].
劲方医药-B招股中,怎么看?
Ge Long Hui· 2025-09-14 08:42
Group 1: Company Overview - Company name:劲方医药-B, established in 2017, focuses on innovative drug development for oncology, autoimmune, and inflammatory diseases [8][10] - The company has a product pipeline consisting of 8 candidate products, with 5 in clinical development, including core products GFH925 and GFH375 [10][12] - GFH925 is the first KRAS G12C inhibitor approved for commercialization in China, while GFH375 is a KRAS G12D inhibitor currently in clinical trials [12][16] Group 2: IPO Details - The IPO is scheduled from September 11 to September 16, with a listing date on September 19, at a price of HKD 20.39 per share [3][4] - The total fundraising amount is HKD 15.82 billion, with a total issuance of 77,600,000 shares, of which 10% is for public offering and 90% for international placement [3][4] - The company has a strong cornerstone investor base, with 9 investors committing USD 100 million, accounting for 49.27% of the total issuance [5] Group 3: Financial Performance - Revenue for 2023, 2024, and the first four months of 2025 is projected at RMB 73.74 million, RMB 104.70 million, and RMB 82.15 million respectively [18][22] - The company has been operating at a loss, with net profits of -RMB 508.32 million, -RMB 677.64 million, and -RMB 66.62 million for the respective periods [19][22] - As of April 30, 2025, the company has cash reserves of RMB 391 million [21] Group 4: Market and Competitive Landscape - The global KRAS G12C inhibitor market is expected to grow from USD 489 million in 2024 to USD 3.491 billion by 2033, with a compound annual growth rate of 24.4% [13][16] - The competitive landscape includes several approved KRAS G12C inhibitors, with GFH925 being the first in China and competing against products from major pharmaceutical companies [16] - The company aims to expand its product pipeline beyond RAS drugs, including candidates like GFS202A, a bispecific antibody targeting GDF15 and IL-6 [16][17]
加科思药业(01167)年内涨4倍后获一致行动人高位增持
智通财经网· 2025-07-21 01:52
Core Viewpoint - 加科思药业 has seen significant management confidence through recent share buybacks and purchases, indicating a belief in the undervaluation of the company and its pipeline potential [1][4] Group 1: Shareholder Actions - 加科思药业 announced that its concerted parties have recently increased their holdings by 854,400 shares at an average price of HKD 5.88 per share, totaling over HKD 5 million [1] - The company does not rule out the possibility of further share purchases in the future [1] - The management's high-level purchases reflect a strong belief in the company's value and pipeline confidence, especially after a 427% increase in stock price year-to-date [1] Group 2: Product Pipeline and Market Potential - The company's most notable product, the KRAS inhibitor JAB-23E73, has entered Phase I trials in China and the U.S., with a global sales peak potential of USD 12.1 billion, particularly in pancreatic and non-small cell lung cancers [2] - JAB-23E73 is a small molecule oral drug with promising pharmacokinetics and significant anti-tumor activity, showing a cost advantage over competitors [3] - 加科思's market capitalization is currently at HKD 5 billion, significantly lower than Revolution Medicine's USD 7 billion, indicating substantial upside potential [3] Group 3: Financial Outlook and Revenue Generation - The approval of the KRAS G12C inhibitor, 戈来雷塞, marks a critical milestone for 加科思, expected to generate stable cash flow through its commercialization [4] - 戈来雷塞 is priced at approximately HKD 38,000 per month, with a potential market size of HKD 6 billion based on patient demographics and market share estimates [4] - The strategic partnership with 艾力斯 for sales in China could yield approximately HKD 200 million annually from milestone and sales sharing, providing solid performance support for the company's current valuation [5] Group 4: Future Developments - The SHP2 inhibitor JAB-3312 is the first of its kind to enter Phase III trials, with potential implications for first-line treatment of non-small cell lung cancer, which could trigger additional milestones for 艾力斯 and become a new revenue source [6]
劲方医药冲刺港交所:国内首个KRAS G12C抑制剂已获批上市,IPO前估值31亿元
IPO早知道· 2024-12-30 02:52
聚焦肿瘤、自体免疫和炎症性疾病领域。 本文为IPO早知道原创 作者|罗宾 2021年,劲方医药与信达生物(1801.HK)就GFH925达成授权交易,授予信达生物于大中华区开 发及商业化GFH925权益,以及在中国以外的全球地区开发及商业化此款产品的中国境外选择权。 2024年1月,双方签订GFH925补充协议,终止上述协议中的中国境外选择权。 劲方正在推进GFH925的海外临床开发,包括在EMA监管区域内国家进行与cetuximab(一款靶向 EGFR的抗体药物)联用作为一线治疗晚期NSCLC的联合疗法的Ib/II期临床试验。公司认为此款联 合疗法有望在抑制EGFR-RAS通路方面实现协同效应。 劲方医药另一款核心产品GFH312为劲方医药自主研发的高效小分子抑制剂,能针对受体相互作用的 丝氨酸/苏氨酸蛋白激酶1(RIPK1)并抑制其激酶活性, GFH312已获得FDA关于在美国开展第II 期临床试验的IND批准 ,以评估GFH312对外周动脉疾病(PAD)伴间歇性跛行(IC)患者的安全 性和疗效。与全球其他临床阶段的RIPK1抑制剂相比,劲方医药聚焦 GFH312的差异化临床计划, 针对一些可能严重影响患 ...
加科思(01167) - 自愿公告 加科思完成泛KRAS抑制剂JAB-23E73 I/IIa期临牀...
2024-11-25 00:07
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之內容概不負責,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。 本公告由加科思藥業集團有限公司(「本公司」或「加科思」,連同其附屬公司,統 稱「本集團」)自願刊發,以告知本公司股東及潛在投資者有關本集團最新業務發 展的資料。 JACOBIO PHARMACEUTICALS GROUP CO., LTD. 加科思藥業集團有限公司 (於開曼群島註冊成立的有限公司) (股份代號:1167) 本公司董事(「董事」)會(「董事會」)欣然宣佈,本公司自主研發的泛KRAS抑制劑 JAB-23E73在中國完成I/IIa期臨床試驗首例患者給藥。 KRAS廣泛存在於多種腫瘤突變,約23%-25%的癌症患者帶有KRAS突變,全球 每年新增約270萬帶有KRAS相關突變的腫瘤患者有望從泛KRAS抑制劑中獲益。 自願公告 加科思完成泛KRAS抑制劑JAB-23E73 I/IIa期 臨牀試驗在中國的首例患者給藥 承董事會命 加科思藥業集團有限公司 董事長 王印祥 香港,2024年11月25日 ...